chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix, Chest pain, Dyspnoea, Urticaria
Clinical narrative: Initial and follow-up information has been received from a medical assistant concerning a 23 year old female with prior papilloma viral infection and no known drug allergies who on 27-APR-2010 was vaccinated IM with the first dose of GARDASIL (lot number 665768/1377Y). No other vaccines were administered at the time of the GARDASIL vaccination. At that time, the patient also received Monsel's solution topically to cervical area to stop bleeding, where a biopsy was performed. On 01-MAY-2010 the patient complained of trouble breathing, chest pain and outbreak of hives. The patient was sent to an emergency room (ER, name unknown), where the patient received a cortisone injection. This cortisone treatment was the intervention used to prevent serious criteria. The trouble breathing and chest pains resolved. On 11-MAY-2010, when the office spoke with the patient by phone, the patient was still resolving from the hives. Trouble breathing, chest pain and an outbreak of hives were considered to be other important medical event and disabling by the reporter. The health care professional contacted during telephone follow-up could not supply the following information: hospital name. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a Nurse practitioner for the pregnancy registry for VARIVAX (Merck) concerning a 35 year old female patient with a history of malaria at age 9 and no drug allergy who on 25-AUG-2009 was vaccinated with VARIVAX (Merck) and MMR II. Other concomitant therapy included FLONASE and pre natal vitamins (unspecified). On 25-AUG-2009 the patient was vaccinated with VARIVAX (Merck) and MMR II and was pregnant. The patient took a urine home pregnancy test and it was positive. The patient was vaccinated at another facility, so nurse practitioner stated she does not have all the details at the time. The patient went to the office on 03-SEP-2009. The patient sought unspecified medical attention. Follow up information received from an administrative manager indicated that the patient had not been seen at this office since her visit on 03-SEP-2009. The patient transferred to another clinic. The manager attempted to locate some patient information, since both offices were part of the same health system, and she saw information in the computer dated 13-APR-2010, she indicated that the patient was 16 weeks and 1/7 days pregnant. This gestational age was not compatible with the LMP given (31-JUL-2009). The manager indicated that she didn't see other information that would explain the discrepancy at the moment. The patient was scheduled for her next prenatal visit on 12-MAY-2010. Follow up information was received from an OB nurse at the OB clinic. According to the nurse who had access to the patient's chart and was able to clarify the pregnancy dates (the nurse indicated that the patient's original pregnancy was reported with a LMP of 31-JUL-2009). The nurse reported that the patient and her husband had an unplanned pregnancy and she was worried about having gotten VARIVAX (Merck). The patient and her husband met with the nurse practitioner to discuss their concerns, their options were discussed, and they chose to terminate the pregnancy. She had the termination in "the fall, sometime in September 2009", the patient recovered without problems according to the nurse practitioner. The patient then called to ask how long after the vaccine they needed to wait to conceive. She came to the office for a new OB visit on 17-FEB-2010. That was her fourth pregnancy; she had two living children. She had an early transvaginal ultrasound for dating on 16-MAR-2010, due to irregular menses with an LMP of 29-DEC-2009, and the ultrasound confirmed and estimated delivery date of 27-SEP-2010. In this pregnancy both she and her husband were having hemoglobin electrophoresis labs drawn, though the nurse was not sure what the patient's ethnicity was, or why she was having that done. Upon internal review they chose to terminate the pregnancy- elective termination- was determined to be an other important medical event. No further information is available.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site swelling, Injection site warmth, Oedema peripheral, Pain
Clinical narrative: Pt received ADACEL on 5/11/10 PM.  On 5/12/10, pt developed fever, aches, fatigue, warmth and swelling at injection site.  5/13, pt developed swelling of fingers on right hand, right arm heaviness.  As of 5/14, pt is improving, has fatigue, achiness, decreased swelling at injection site.  Treating with rest, analgesic, ice.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Sensation of heaviness
Clinical narrative: Pt received ADACEL on 5/11/10 PM.  On 5/12/10, pt developed fever, aches, fatigue, warmth and swelling at injection site.  5/13, pt developed swelling of fingers on right hand, right arm heaviness.  As of 5/14, pt is improving, has fatigue, achiness, decreased swelling at injection site.  Treating with rest, analgesic, ice.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased, Glucose urine present, Otitis media, Polydipsia, Polyuria
Clinical narrative: Initial report was received 05 May 2010 from another manufacturer (GlaxoSmithKline), who received the report from an investigator participating in their clinical trial. Verbatim from the report: "This male subject was enrolled in the study. On 23 October 2009 and 24 November 2009, he received a 1st and 2nd doses of FLULAVAL or Sanofi Pasteur's FLUZONE. This subject received FLUZONE. The subject's medical history included otitis media and upper respiratory tract infection. Concomitant medications included Cortisporin otic suspension and Amoxicillin. On 18 January 2010, 55 days after the second dose of Blinded vaccine, this four-year-old subject presented with insulin dependent diabetes mellitus. The subject was hospitalized and the event was clinically significant. The subject was treated with intermediate/long-acting insulin and insulin aspart. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the insulin dependent diabetes may have been caused by investigational product and that the event was possibly due to his past history. Relevant Risk Factors: Family history of adult onset Diabetes. Investigator Comments: Mom noted symptoms of polyuria and polydipsia for a few days. Clinic visit on 18 January 2010. Urinalysis was completed at this time with high glucose and ketones. At that time arrangements were made for a direct admission to hospital for treatment. While in hospital was given Lantus and Novolog Insulin for elevated blood sugars. Was discharged from hospital on 20 Jan 2010 on these medications. This condition is chronic and ongoing at this time. Per PI: There is a temporal relationship between the time difference between study vaccine and the diagnosis of diabetes. I doubt relationship as being causal however I cannot rule out the study vaccine from being related to developing diabetes. We will obtain further details from hospitalization and discussion with endocrinologist." No further information was provided. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Type 1 diabetes mellitus, Urine ketone body present
Clinical narrative: Initial report was received 05 May 2010 from another manufacturer (GlaxoSmithKline), who received the report from an investigator participating in their clinical trial. Verbatim from the report: "This male subject was enrolled in the study. On 23 October 2009 and 24 November 2009, he received a 1st and 2nd doses of FLULAVAL or Sanofi Pasteur's FLUZONE. This subject received FLUZONE. The subject's medical history included otitis media and upper respiratory tract infection. Concomitant medications included Cortisporin otic suspension and Amoxicillin. On 18 January 2010, 55 days after the second dose of Blinded vaccine, this four-year-old subject presented with insulin dependent diabetes mellitus. The subject was hospitalized and the event was clinically significant. The subject was treated with intermediate/long-acting insulin and insulin aspart. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the insulin dependent diabetes may have been caused by investigational product and that the event was possibly due to his past history. Relevant Risk Factors: Family history of adult onset Diabetes. Investigator Comments: Mom noted symptoms of polyuria and polydipsia for a few days. Clinic visit on 18 January 2010. Urinalysis was completed at this time with high glucose and ketones. At that time arrangements were made for a direct admission to hospital for treatment. While in hospital was given Lantus and Novolog Insulin for elevated blood sugars. Was discharged from hospital on 20 Jan 2010 on these medications. This condition is chronic and ongoing at this time. Per PI: There is a temporal relationship between the time difference between study vaccine and the diagnosis of diabetes. I doubt relationship as being causal however I cannot rule out the study vaccine from being related to developing diabetes. We will obtain further details from hospitalization and discussion with endocrinologist." No further information was provided. Documents held by sender: None.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Received injection on 5/4/10. Seen in office again 5/6/10 with c/o red, raised, warm area surround injection site. C/o s/s started on Wednesday 5/5/10. C/o pain, itching.
Sex: U
Vaccine: YF, YF
Symptoms: Hypoaesthesia, Hypoaesthesia facial, Paraesthesia, Pruritus, Rash erythematous
Clinical narrative: Initial report received from a health care professional on 05 May 2010. An unidentified patient, with medical history not reported, had received an injection of VF-VAX (Lot number not reported) on 23 March 2010 and developed hives widespread over the body. The hives, which were red, raised and itchy, appeared on the patient's shoulders, hips, and trunk. The patient was seen in the emergency room and had been placed on ZYRTEC with some improvement. Recently the patient reported numbness and tingling in the left hand and left side of face. The patient was being seen by an allergist. The outcome for the events was reported as not recovered. Documents held by sender none.
Sex: U
Vaccine: YF, YF
Symptoms: Urticaria
Clinical narrative: Initial report received from a health care professional on 05 May 2010. An unidentified patient, with medical history not reported, had received an injection of VF-VAX (Lot number not reported) on 23 March 2010 and developed hives widespread over the body. The hives, which were red, raised and itchy, appeared on the patient's shoulders, hips, and trunk. The patient was seen in the emergency room and had been placed on ZYRTEC with some improvement. Recently the patient reported numbness and tingling in the left hand and left side of face. The patient was being seen by an allergist. The outcome for the events was reported as not recovered. Documents held by sender none.
Sex: U
Vaccine: YF, YF
Symptoms: Hypoaesthesia, Hypoaesthesia facial, Paraesthesia, Pruritus, Urticaria
Clinical narrative: Initial report received from a health care professional on 05 May 2010. An unidentified patient, with medical history not reported, had received an injection of VF-VAX (Lot number not reported) on 23 March 2010 and developed hives widespread over the body. The hives, which were red, raised and itchy, appeared on the patient's shoulders, hips, and trunk. The patient was seen in the emergency room and had been placed on ZYRTEC with some improvement. Recently the patient reported numbness and tingling in the left hand and left side of face. The patient was being seen by an allergist. The outcome for the events was reported as not recovered. Documents held by sender none.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Pt received ADACEL injection on 4/22/10. Pt developed pain, redness, swelling at injection site on 4/26/10. Pt also developed tingling down arm and hand with difficulty gripping objects.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Chest discomfort, Injection site pain, Wheezing
Clinical narrative: Initial case was received on 11 May 2010 from a healthcare professional. A 50 year old male patient received an injection (route and site not reported) of ADACEL (sanofi pasteur Inc., lot number U3049CA, sanofi pasteur Ltd. lot number C3258) on 25 March 2010. The patient had no illness at the time of the vaccination and no other vaccinations were given within the 4 weeks prior. His medical history included seasonal allergic rhinitis. He had no other pre-existing medical conditions and no concomitant medications. The patient called the doctor's office on 08 April 2010 to report experiencing wheezing on exertion which started on 31 March 2010. He also experienced tightness in chest and arm soreness at injection site on unspecified dates. The patient was seen in the office on 09 April 2010 and had an unspecified work-up done to rule out medical conditions. The results of the work-up and the outcome of the events were not reported. Documents held by sender: None.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Injection site swelling
Clinical narrative: Pt received immunizations on 4/21/2010. Returned to office on 4/28/10 with 10cc red area on ( L ) shoulder/deltoid with tenderness & swelling.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received ADACEL injection 4/19/10.  Pt seen again 4/21/10 for large red, swollen, warm area on right arm at injection site.
Age: 25.0
Sex: M
Vaccine: HEP, HEPA, TYP, YF
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular rash on face, chest and arms, palms, knees.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Headache, Hypoaesthesia
Clinical narrative: Acute onset of H/A, dizziness and numbness of hands one day after GARDASIL #2 and HEP A#1. Normal neuro exam and treated as migraine with Sumatriptan.
Age: 1.07
Sex: M
Vaccine: VARCEL
Symptoms: Electroencephalogram, Musculoskeletal stiffness
Clinical narrative: Few hrs after VARIVAX shot- mom noticed him stiffening in his high chair and turning of head to 1 side for brief sec. Occurred 2x again after 30-60 min from 1st episode. Patient was awake and stopped the stiffening when mom got him out of the high chair.
Age: 9.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Full blood count normal, Injection site erythema, Injection site swelling, Oropharyngeal pain, Pyrexia
Clinical narrative: Swelling and redness left upper arm. Fever on day after injection 101 degrees F sore throat. Redness of skin was at the site of chickenpox vaccine redness resolved without treatment.
Age: 9.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Streptococcus test
Clinical narrative: Swelling and redness left upper arm. Fever on day after injection 101 degrees F sore throat. Redness of skin was at the site of chickenpox vaccine redness resolved without treatment.
Sex: U
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Large tender swelling-site of DTAP.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Wound
Clinical narrative: Left deltoid with erythema and swelling about 4.5 cm in diameter with visible puncture from needle. Tender to touch.
Age: 1.01
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Urticaria
Clinical narrative: Hives to body 30 hours after vaccines given.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dizziness, Erythema, Pain, Pruritus
Clinical narrative: Pt had 1) fever x 3 days, 2) itchy, arm bright red & white bump x 2 wks, a couple days later had on both arms, both legs, & feet, & 3) stomach ache pain can't eat & felt like vomiting & dizzy.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash papular
Clinical narrative: Pt had 1) fever x 3 days, 2) itchy, arm bright red & white bump x 2 wks, a couple days later had on both arms, both legs, & feet, & 3) stomach ache pain can't eat & felt like vomiting & dizzy.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Body temperature increased, Rash
Clinical narrative: Temp 97.8, no allergies. Vaccines given 15 min post administration of vaccine a rash was noted on pts abd., chest and neck. Pt. given BENADRYL 12.5 mg/5mL is liquid. Pt given 3 mL for rash, no swelling, no breathing difficulties noted. Pt was sent home.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Pyrexia
Clinical narrative: Significant left arm swelling at site of PNEUMOVAX. Fever last night, also when swelling began (5-10-10). Vaccine administered early am. 14 cm circumferential redness. Tx-ASA 2 po QID and elevate/moist heat.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: HIBERIX given in error no reaction noted pt to return for age appropriate vaccine.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Muscular weakness, Weight bearing difficulty
Clinical narrative: 04/23/10 APX, 10:30 AM received shot Vacline APX 12:30PM inability to bear own weight. Severe muscle weakness. Taken to ER hospital APX 1:45PM muscle began to return to normal. By 3:00PM he seemed back to normal while in ER. Monitoring of vitals-no other treatment.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Asthenia, Eye disorder, Fatigue, Gait disturbance, Muscular weakness
Clinical narrative: 04/23/10 APX, 10:30 AM received shot Vacline APX 12:30PM inability to bear own weight. Severe muscle weakness. Taken to ER hospital APX 1:45PM muscle began to return to normal. By 3:00PM he seemed back to normal while in ER. Monitoring of vitals-no other treatment.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4, HPV4
Symptoms: Weight bearing difficulty
Clinical narrative: 04/23/10 APX, 10:30 AM received shot Vacline APX 12:30PM inability to bear own weight. Severe muscle weakness. Taken to ER hospital APX 1:45PM muscle began to return to normal. By 3:00PM he seemed back to normal while in ER. Monitoring of vitals-no other treatment.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site haematoma, Pain in extremity, Swelling
Clinical narrative: 3 days following TDAP vaccine developed swelling, erythema & soreness to 2/3 of upper arm mostly distal to injection site. Bruising at injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site nodule, Injection site warmth, Skin warm
Clinical narrative: "3 x5 inch area of coalesced redness (right) anterior thigh that is warm to touch. No exudates. No hematoma formation." per ARNP, 05/13/10 11:33 am. 5/12/10 Mom phoned health center, reported "red knots" on right leg where vaccines given.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash maculo-papular, Rash morbilliform
Clinical narrative: Measley macrol papular rash noted on trunk and neck.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Possible immunization error.  Pt may have been given VARIVAX vaccine in error instead of HEP A d/t mislabeling of syringe.
Age: 22.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Abdominal pain upper, Allergy to vaccine, Dyspnoea, Feeling hot, Rash
Clinical narrative: Pt. had allergic reaction to Tetanus, developed rash felt warm c/o SOB & stomach ache. Gave pt. BENADRYL 50 mg IM ( R ) delt. per orders PA. Pt. responded well & was released from Clinic.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Red bumps all over, fever.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: Pt received 2nd ANTHRAX on 28 Apr 10 in right deltoid.  On Sunday, pt states rash began on left rib and as of Tuesday 4 May 10, rash is beginning to spread to back and towards left torso.  Pt has not been seen by provided yet & no medications have been used or taken.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Measles antibody negative, Pyrexia
Clinical narrative: Localized reaction at injection site, erythema, fever 5/10/10 seen in office 5/11/10.  C/o pain at injection site.  No further vaccination per Dr.
Age: 30.0
Sex: F
Vaccine: DTAPIPV, HEP
Symptoms: Incorrect dose administered, Unevaluable event
Clinical narrative: On Tuesday 5/11/10 patient was given DTAP-IPV which is a pediatric dose of TETANUS and POLIO.  I called patient immediately after realizing this was given.  Patient had no questions at the time and did not complain of any problems.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Body temperature increased, Paranasal sinus hypersecretion, Rash generalised, Rash macular, Skin warm
Clinical narrative: Pt received HIB, MMR, VZV, PCV7 4-29-10.  5-11-10 had OV with c/o rash of > 12 hours duration.  Felt warm, temp none taken.  Return OV 5-12-10, temp 100.7 R, rash diffuse red macular lesions with some clumping, lesions blanch.  Rash does not itch.  Has mild nasal drainage.
Age: 36.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Cough, Dyspnoea, Headache, Injection site pain, Pain
Clinical narrative: Patient went to ER on 5/12/10 c/o increased fever, coughing, shaking, pain over most of body, headache, SOB, soreness at site.  MD examined and discharged pt.
Age: 36.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Pyrexia, Tremor
Clinical narrative: Patient went to ER on 5/12/10 c/o increased fever, coughing, shaking, pain over most of body, headache, SOB, soreness at site.  MD examined and discharged pt.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Antinuclear antibody, Arthralgia, Blood uric acid, C-reactive protein increased, Diarrhoea
Clinical narrative: On 4/12/10, pt. felt nausea, achiness, diarrhea, vomited.  On 4/17/10, began having joint and muscle pain.  Main event: severe joint and muscle pain, CRP and ESR elevated.  Currently on steroids for pain relief.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Full blood count, Metabolic function test, Myalgia, Nausea, Pain
Clinical narrative: On 4/12/10, pt. felt nausea, achiness, diarrhea, vomited.  On 4/17/10, began having joint and muscle pain.  Main event: severe joint and muscle pain, CRP and ESR elevated.  Currently on steroids for pain relief.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Parvovirus B19 test, Red blood cell sedimentation rate increased, Rheumatoid factor, Streptococcus test, Urine analysis
Clinical narrative: On 4/12/10, pt. felt nausea, achiness, diarrhea, vomited.  On 4/17/10, began having joint and muscle pain.  Main event: severe joint and muscle pain, CRP and ESR elevated.  Currently on steroids for pain relief.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: On 4/12/10, pt. felt nausea, achiness, diarrhea, vomited.  On 4/17/10, began having joint and muscle pain.  Main event: severe joint and muscle pain, CRP and ESR elevated.  Currently on steroids for pain relief.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Arthropod bite, Rash vesicular
Clinical narrative: Vesicular circular patches overlying resolving mosquito bites.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Cough, Dizziness, Pruritus, Pyrexia, Rash
Clinical narrative: Developed itching, fever, dizziness and cough 1 hr. after injection. No local site redness. Subsequently developed rash which is slowly resolving. Reported 5-6-10 to nurse. Given BENADRYL and Hydrocort. cream.
Age: 11.0
Sex: U
Vaccine: MNQ, VARCEL
Symptoms: Erythema
Clinical narrative: Left arm redness. ABX given KEFLEX 500mg tid. TAC 0.1% ointment.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Blood test, CSF culture negative, Culture urine negative, Encephalitis, Flow cytometry
Clinical narrative: Pt received vaccines on 3-3-10, developed fever on 3-26-10. Presented with post viral cerebellitis on 3-28-10. Spent 2 days at PICU and 4 days on regular floor. Developed severe neutropenia & neurology diagnosed pt with post viral cerebellitis. OF rate CSF no WBC.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Intensive care, Neutropenia, Pyrexia
Clinical narrative: Pt received vaccines on 3-3-10, developed fever on 3-26-10. Presented with post viral cerebellitis on 3-28-10. Spent 2 days at PICU and 4 days on regular floor. Developed severe neutropenia & neurology diagnosed pt with post viral cerebellitis. OF rate CSF no WBC.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Eye swelling, Rash pruritic, Wheezing
Clinical narrative: Per mom patient broke out in five pruritic bumps with red skin in chest, back and legs, + swelling around eyes, + wheezing resolved with BENADRYL and albuterol.
Age: 36.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Anaemia, Anti-cyclic citrullinated peptide antibody positive, Autoimmune disorder, Blood iron decreased, C-reactive protein increased
Clinical narrative: Stiff neck following H1N1 vaccine, persisted for 3 mos. despite use of Rx muscle relaxant, heat pad, neck massager; then had knee surgery with unexpected complications I had no risk factors for blood clot, blood thinners, autoimmune reaction, now Rheumatoid Arthritis. Question if H1N1 vaccine contributed to this.
Age: 36.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Full blood count abnormal, Haematocrit decreased, Haemoglobin decreased, Iron binding capacity total normal, Knee operation
Clinical narrative: Stiff neck following H1N1 vaccine, persisted for 3 mos. despite use of Rx muscle relaxant, heat pad, neck massager; then had knee surgery with unexpected complications I had no risk factors for blood clot, blood thinners, autoimmune reaction, now Rheumatoid Arthritis. Question if H1N1 vaccine contributed to this.
Age: 36.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Mean cell haemoglobin decreased, Mean cell volume decreased, Musculoskeletal stiffness, Red blood cell sedimentation rate increased, Rheumatoid arthritis
Clinical narrative: Stiff neck following H1N1 vaccine, persisted for 3 mos. despite use of Rx muscle relaxant, heat pad, neck massager; then had knee surgery with unexpected complications I had no risk factors for blood clot, blood thinners, autoimmune reaction, now Rheumatoid Arthritis. Question if H1N1 vaccine contributed to this.
Age: 36.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Rheumatoid factor positive, Serum ferritin decreased
Clinical narrative: Stiff neck following H1N1 vaccine, persisted for 3 mos. despite use of Rx muscle relaxant, heat pad, neck massager; then had knee surgery with unexpected complications I had no risk factors for blood clot, blood thinners, autoimmune reaction, now Rheumatoid Arthritis. Question if H1N1 vaccine contributed to this.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Pain, itchiness, rash - inner ( L ) thigh & mid abdomen, no hives, no joint issues. Treatment ~ 1% hydrocortisone cream to affected area.
Age: 16.0
Sex: F
Vaccine: FLU3, FLUN(H1N1), HEPA, HPV4, TDAP
Symptoms: Blood test, Cerebrovascular accident, Lumbar puncture, Nuclear magnetic resonance imaging, Optic neuritis
Clinical narrative: Small stroke in left optic nerve - optic neuritis.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: "Allergic urticaria" after receiving vaccines according to Pediatrician. The child was admitted for observation (24 hrs) and sent home the next day. Was in ED at 10:15 p.m. and admitted at 11:30 p.m.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Abdominal pain, Hyperhidrosis, Oropharyngeal pain, Pallor
Clinical narrative: Patient received PREVNAR, PEDIARIX and PPD. About 10 minutes after receiving vaccines, patient complained of abdominal and throat pain. Patient was pale and sweaty too. No presence of hives. Lung sounds clear. Doctor examined patient. Patient was given BENADRYL upon request. 10 mL/25mg given by doctor.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm SQ injection, varicella redness welling, redness warm at site.
Age: 16.0
Sex: M
Vaccine: FLU(H1N1), HEPA, TYP, VARCEL, YF
Symptoms: Fatigue, Nausea
Clinical narrative: Parent of client receiving vaccines said client became nauseous on 5/13/10 (no vomiting) and extremely fatigued on 5/13/10 ("enough to miss school on 5/13/10"). Parent said s/s subsided by 5/14/10 morning ("he felt good enough to go to work").
Age: 1.35
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Arthropod bite, Cellulitis, Erythema, Pruritus
Clinical narrative: Onset on 5/9/10 of itching and red patch on (R) anterior thigh. Treated as insect bite w/ cellulitis. Uncertain if that or vaccine related.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: (L) arm swelling redness @ site and warm.
Age: 32.0
Sex: F
Vaccine: OPV
Symptoms: Culture stool positive, Death, Exposure to vaccinated person, Muscle spasms, Muscular weakness
Clinical narrative: Pt with combined immune deficiency was exposed to OPV through daughter's vaccination in 1996. In December 2008 developed (L) calf cramping which progressed to bilateral lower extremity weakness. (see attached sheet)
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Computerised tomogram, Convulsion, Full blood count normal, Head injury
Clinical narrative: 1135 AM.  Standing up and fainted after vaccine.  Hit head on floor.  Diagnosed with post impact seizure.  Seizure lasted 20 seconds maintained airway, elevated feet.  Pulse O2 was 99%.  BP stable.  Developed nausea/vomited within 2 hours.  Sent to ER. Admitted to hosp. with concussion.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Oxygen saturation normal, Syncope, Vomiting
Clinical narrative: 1135 AM.  Standing up and fainted after vaccine.  Hit head on floor.  Diagnosed with post impact seizure.  Seizure lasted 20 seconds maintained airway, elevated feet.  Pulse O2 was 99%.  BP stable.  Developed nausea/vomited within 2 hours.  Sent to ER. Admitted to hosp. with concussion.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Vaccination site began to swell to the size of an egg on 5/13/10. No Fever, No Rash. Site itchy. 5/18 - site has large red circle, swelling has subsided. Pt applied ice and took ibuprofen.
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient has mild swelling and erythema of L arm aroung injection site.  No treamtment rendered, to follow up with PMD in 2-3 days, or return to Emergency room for increaed pain or fever.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Body temperature normal, Dizziness, Flushing, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning an 11 year old male with a history of pertussis and no drug allergy who on 02-JUN-2009 was vaccinated with VARIVAX (Merck) (lot # 664018/0475Y) 0.5 mL, SQ. Concomitant therapy included ADACEL (unspecified) (+) tetanus toxoid and tuberculosis skin test. On 03-JUN-2009 the patient developed local injection site reaction. The patient had red, swollen, hot tender area that covered most of the upper arm. There was some "streaking" on the area. An antibiotic (not specified) was given to the patient. The patient had no lab diagnostics studies performed. The physician saw the patient. At the time of the report the patient was recovering. Follow-up information has been received from a physician concerning this 11 year old male student with amoxicillin and dairy allergies and a history of pertussis in the winter and peanut allergy (resolved) who on 02-JUN-2009 at approximately 04:40 PM was vaccinated  SQ with the second dose of VARIVAX (Merck) (lot # 664018/0475Y) in left the tricep. Concomitant vaccination on the same day at approximately 4:40 PM included the first IM dose of ADACEL (lot # C3058AA) in the left tricep. There was no illness at the time of vaccination. Subsequently, on 03-JUN-2009, the patient experienced flushed, nausea and edema and erythema of the left triceps. The patient also experienced worsening dizziness. Medical attention was sought, the patient was seen on 04-JUN-2009 and diagnosed with possible cellulitis. The patient did not have a fever. The patient was treated with KEFLEX for 7 days. At the time of the report, the patient recovered on an unknown day. No further information is available.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site reaction, Injection site swelling, Nausea
Clinical narrative: Information has been received from a physician concerning an 11 year old male with a history of pertussis and no drug allergy who on 02-JUN-2009 was vaccinated with VARIVAX (Merck) (lot # 664018/0475Y) 0.5 mL, SQ. Concomitant therapy included ADACEL (unspecified) (+) tetanus toxoid and tuberculosis skin test. On 03-JUN-2009 the patient developed local injection site reaction. The patient had red, swollen, hot tender area that covered most of the upper arm. There was some "streaking" on the area. An antibiotic (not specified) was given to the patient. The patient had no lab diagnostics studies performed. The physician saw the patient. At the time of the report the patient was recovering. Follow-up information has been received from a physician concerning this 11 year old male student with amoxicillin and dairy allergies and a history of pertussis in the winter and peanut allergy (resolved) who on 02-JUN-2009 at approximately 04:40 PM was vaccinated  SQ with the second dose of VARIVAX (Merck) (lot # 664018/0475Y) in left the tricep. Concomitant vaccination on the same day at approximately 4:40 PM included the first IM dose of ADACEL (lot # C3058AA) in the left tricep. There was no illness at the time of vaccination. Subsequently, on 03-JUN-2009, the patient experienced flushed, nausea and edema and erythema of the left triceps. The patient also experienced worsening dizziness. Medical attention was sought, the patient was seen on 04-JUN-2009 and diagnosed with possible cellulitis. The patient did not have a fever. The patient was treated with KEFLEX for 7 days. At the time of the report, the patient recovered on an unknown day. No further information is available.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female with no adverse event for the first dose of VARIVAX (Merck) (date not reported) who on 09-JUN-2009 was vaccinated with the second dose of VARIVAX (Merck) (lot # was not provided), 0.5ml.  On 10-JUN-2009 the patient developed 1 and half inch rash at the injection site.  On 11-JUN-2009 the rash was 13 cm pink and red with deep center and physician confirmed that it was an allergic reaction.  The patient sought unspecified medical attention.  At the time of the report the patient had not recovered.  Follow up information has been received from a registered nurse concerning the patient with musical murmur and was well at time of vaccination who on 09-JUN-2009 was vaccinated with the second dose of VARIVAX (Merck) (lot # 663948/0360Y) in right thigh.  Concomitant therapy included the second dose of MMR II ( lot # 663877/0356Y) in left thigh.  On 09-JUN-2009 the patient experienced 3cm cellulitis.  On 10-JUN-2009 the cellulitis grew to 13cm.  The area was red, swollen and warm to touch.  The patient was prescribed BENADRYL as needed every 4-6 hours.  At the time of the report the patient was recovered.  No further information is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 5 year old female patient who in 2005 was vaccinated with the first dose of VARIVAX (Merck). On 09-JUN-2009 the patient was vaccinated with the second dose of VARIVAX (Merck) 0.5 ml subcutaneous. She developed an injection site reaction and a dozen papules scattered over her body. She was taken to an emergency room and given acyclovir and hydrocortisone cream. She presented in the office on 11-JUN-2009 with worsening at the injection site. The area affected was 8cm warm, red, tender with induration. She was afebrile. The patient had not recovered at the time of reporting. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: Information has been received from a physician concerning a 5 year old female patient who in 2005 was vaccinated with the first dose of VARIVAX (Merck). On 09-JUN-2009 the patient was vaccinated with the second dose of VARIVAX (Merck) 0.5 ml subcutaneous. She developed an injection site reaction and a dozen papules scattered over her body. She was taken to an emergency room and given acyclovir and hydrocortisone cream. She presented in the office on 11-JUN-2009 with worsening at the injection site. The area affected was 8cm warm, red, tender with induration. She was afebrile. The patient had not recovered at the time of reporting. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 34 month old male child with a history of mild asthma and no allergies who on 29-JUN-2002 was vaccinated with the first dose of VARIVAX (Merck). There was no concomitant medication. In April 2004, the patient experienced a mild case of shingles. The mother of the child mentioned in the email she may hold off on her child getting the second dose of VARIVAX (Merck). There were no laboratory studies performed. The patient sought medical attention by the pediatrician but unknown if by phone or office visit. The patient had recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Epistaxis, Erythema, Pruritus, Rash papular, Skin reaction
Clinical narrative: Information has been received from a nurse practitioner concerning a 60 year old female who on 10-JUN-2009 was vaccinated with a dose of VARIVAX (Merck). On 10-JUN-2009 the patient experienced a nosebleed and a skin reaction after vaccination with VARIVAX (Merck). The patient had itchy, erythematous, fluid filled papules: one near left armpit, one next to her left breast, and two on her left thigh near her groin. Nose appeared normal when examined. The patient sought medical attention in the office. At the time of report,  the patient had not recovered from the itchy, erythematous, fluid filled papules. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an 11 years old patient who was vaccinated with two doses of VARIVAX on an unspecified date. On 15-JUN-2009 the patient experienced a mild case of chickenpox breakthrough. The patient reported that the patient had no fever. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Information has been received from a physician concerning a 14 year old (previous reported as 11 year old) male with environmental allergy and food allergy who on 22-MAY-2008 was vaccinated with the second dose of VARIVAX in the left deltoid at 3:30 pm. At the time of vaccination, the patient had a well child check up. On 15-JUN-2009 the patient not itchy red spots on trunk with lesions and vesicles on torso and legs. It was diagnosed to be varicella-mild case. At the time of the report, the patient recovered. No further information is available.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Pain, Skin warm, Swelling, Tenderness
Clinical narrative: Information has been received from a nurse concerning a 9 year old male who on 11-JUN-2009 was vaccinated with the second dose of VARIVAX (Merck), 0.5ml/SC (Lot# 663948/0360Y). Concomitant medication was unspecified. On 12-JUN-2009 the patient experienced tenderness, swelling and pain in his left arm pit that was 9 and 1/2 by 9 and 1/2 cms. There was no palpable ancillary swelling and it appeared to be a tissue reaction. On 13-JUN-2009 the patient to the office and was prescribed AUGMENTIN. As of 16-JUN-2009, the outcome was unknown. Follow up information was received from the nurse concerning the 9 year old male: The patient was well at the time of the second vaccination on 11-JUN-2009. The patient had reaction two days after received vaccine (AE onset date reported as 11-JUN-2009 while previously reported as 12-JUN-2009). His arm was warm to touch. He was given BENADRYL (PRN) and AUGMENTIN 875 BID if worsen. the patient recovered on approximately 23-JUN-2009. No further information is available.
Age: 35.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Varicella
Clinical narrative: Information has been received from a nurse concerning 2 & 5 year old sisters who in 2008 were vaccinated with VARIVAX (Merck) the same day. Five days later, their father in his mid 30s developed fever and rash and was diagnosed of having mild chickenpox. The outcome was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 66 year old male who on 11-JUN-2009 was vaccinated with VARIVAX (Merck) (lot #664018/0475Y) instead of ZOSTAVAX (Merck) (human error not a product quality complaint). No adverse effects had been reported. The outcome was unknown. The patient hadn't sought medical attention. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised, Varicella post vaccine, Varicella virus test negative
Clinical narrative: Information has been received from Associate Research Scientist and patient's mom via e-mail concerning an 8 year old female patient, who was vaccinated on 28-FEB-2003 with a first dose and on 4-JUN-2007 with a second dose of VARIVAX (routes and lot numbers not reported). The mother stated, on 11-JUN-2009 (also reported as 11-MAY-2009), the patient's rash was generalized, just under 40 spots, they were as far down as her upper thighs and as high as her shoulders. The patient had more on her belly but some scattered around her entire mid-section. The spots had been roughly doubling each day. About a quarter of them had a distinct whit dot of fluid at the center of the otherwise red spot. The patient was exposed 2-3 weeks before onset, approximately 21-MAY-2009, for "several hours" to the baby sitter with history of past chicken pox. The physician reported that the type of rash was vesicles and "paps", there were 50 lesions and generalized in distribution. The physician reported the rash as break through of varicella after two doses on 11-JUN-2009. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 11-JUN-2009. The sample was taken from vesicular lesion (specimen site not specified). The PCR results for the specimen from the vesicle lesion was negative. At the time of the report, the outcome of the patient was recovered (date unspecified). The patient sought medical attention. Further information is not expected.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella, Varicella virus test negative
Clinical narrative: Information has been received from a Registered Nurse concerning a 21 year old female patient who "over 10 years ago" was vaccinated with two doses of VARIVAX (Merck). It was reported that on an unspecified date the patient had a chickenpox outbreak. It was reported that the patient still had negative titers to varicella. It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse indicated that their practice has recently see 4 cases of cellulitis with VARIVAX (Merck). It's unknown if the patients had sought any medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a physician concerning a father who's one year old son on 01-JUN-2009, was vaccinated subcutaneously with 0.5 ml of VARIVAX (Merck). The one year old son did not develop a rash or adverse experiences, however, the father reported he "now" has shingles. The physician was not interested in the VZV analysis by PCR. It was reported that medical attention was sought for the 1 year old son via a phone call. The father's outcome was unknown. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella virus test negative
Clinical narrative: Information has been received from a nurse practitioner concerning a 34 year old female with no pertinent medical history and allergies to penicillin, sulfa, LEVAQUIN and ZITHROMAX who on 04-DEC-2006 was vaccinated SC with the first 0.5 ml dose of VARIVAX (Merck) (lot # 653435/0561F). On 04-JAN-2007 the patient was vaccinated SC with the second 0.5 ml dose of VARIVAX (Merck) (lot # 653435/0561F). There was no concomitant medication. In May 2009, the varicella titer test was done and the result was negative. On 23-MAY-2009 the patient developed rash. It was reported that the rash did not appear to be the varicella lesions. At the time of this report, the patient was recovering from the events. The patient was seen in the office and sought unspecified medical attention. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 2 year old male with a history of eczema who "one year ago" in approximately 2008 was vaccinated with a dose of VARIVAX (Merck) (lot # not reported).  Concomitant therapy included unspecified topical skin cream.  "Recently" in approximately June 2009, the patient came down with a case of shingles.  The patient had a titer test for varicella and result was unknown.  The patient sought unspecified medical attention.  At the time of report, the patient's outcome was unknown.  No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: no adverse event
Age: 1.01
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Cellulitis, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female who on 18-MAY-2009 was vaccinated with the first dose of VARIVAX (Merck) (lot # 0481X, which was valid for MMR). Concomitant therapy included a dose of PREVNAR given on the same day. On 18-MAY-2009, after receiving the vaccines, the patient developed three small hives on her left thigh. On 27-MAY-2009 the patient came into the office and was diagnosed with cellulitis on her left thigh. The patient was being treated with AUGMENTIN and BACTROBAN cream. At the time of this report, the outcome was unknown. The patients' parents were told to follow up with the office in 7 days. This is one of several reports received from the same source. Additional information has been requested.