chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: F
Vaccine: HIBV
Symptoms: Body temperature increased, Contusion, Injection site bruising, Injection site mass, Lumbar puncture
Clinical narrative: Information has been received from a consumer concerning her 28 month old daughter with a history of being born 6 weeks premature and having ear infections who on 17-JUL-2007 was vaccinated with a third dose of PedvaxHIB (lot reported as "0067U"). The patient did not have a reaction to her two previous doses of PedvaxHIB. There was no concomitant medication. On 26-JUL-2007, the patient experienced a fever of 105-106 degrees and there was a lump the size of a pinball at the injection site which later turned into a bruise. She also developed a rash on the bottom of her feet. The patient was hospitalized for 6 days. Many tests, including a spinal tap were performed, but the physicians never figured out what was wrong. The patient got sick much more often than she used to and frequently had a high fever. The patient's mother also reported that the patient was treated with ceftriaxone Na (ROCEPHIN) which did not help clear up her daughter's symptoms (exact symptoms not specified). At the time of this report, the patient was recovering. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: HIBV
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a consumer concerning her 28 month old daughter with a history of being born 6 weeks premature and having ear infections who on 17-JUL-2007 was vaccinated with a third dose of PedvaxHIB (lot reported as "0067U"). The patient did not have a reaction to her two previous doses of PedvaxHIB. There was no concomitant medication. On 26-JUL-2007, the patient experienced a fever of 105-106 degrees and there was a lump the size of a pinball at the injection site which later turned into a bruise. She also developed a rash on the bottom of her feet. The patient was hospitalized for 6 days. Many tests, including a spinal tap were performed, but the physicians never figured out what was wrong. The patient got sick much more often than she used to and frequently had a high fever. The patient's mother also reported that the patient was treated with ceftriaxone Na (ROCEPHIN) which did not help clear up her daughter's symptoms (exact symptoms not specified). At the time of this report, the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: Information has been received from a physician concerning a female who began the vaccination series at "2 months of age" (date not reported) with Rotateq. It was reported that one month after receiving the third dose of the vaccine (date not reported) she developed intussusception and was hospitalized. Diagnostics were not reported. The intussusception was treated with a barium enema. At the time of this report, it was reported that the patient had recovered. Intussusception was considered to be life threatening and an other important medical event by the reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin increased, Drug exposure during pregnancy, Pregnancy test positive, Ultrasound scan abnormal
Clinical narrative: Information has been received through the pregnancy registry through a nurse concerning a 19 year old female with a history of social smoking, penicillin allergy, and with two previous pregnancies (two elective abortions) who on 01-AUG-2007 was vaccinated intramuscularly with her first dose of Gardasil (Lot # 0469U). There was no concomitant medication. The patient had a blood pregnancy test (date unspecified) which was positive (LMP=13-AUG-2007). The patient sought unspecified medical attention in the office. No symptoms were reported. On 23-OCT-2007 and 30-OCT-2007, the patient had an ultrasound due to elevated beta levels. The ultrasounds showed an empty sac. The reporter indicated that there was a question as to whether there was missed antibodies vs. an ectopic pregnancy, but it was probably missed antibodies. On an unspecified date, the patient had a spontaneous abortion, no further details were provided. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Decreased appetite, Dry skin, Lip haemorrhage, Lip swelling, Mouth ulceration
Clinical narrative: Stevens-Johnson syndrome.  Oral ulcers began 2d after vaccines; fever & decreased appetite also.  Seen in office 4d after vacs; sloughing oral mucosa & urethra, admit to hosp. Patient was complaining of cough with brown sputum at time of immunization; no eval or Rx undertaken.  Swollen, macerated, scabbed and yellow crusted lips-bleeding.  Erythematous macules on arms.  Dry skin around eyes. 12/20/07-records received with report for DOS 11/5-11/21/07-DC DX: Steven-Johnson syndrome with severe mucositis. Admitted with 4 day HX of swelling of eyes and face and 3 days HX of progressively worsening mouth ulcers. For previous week had non-productive cough and on morning of admission productive with green sputum. PE: swelling and sloughing of lips, greenish dischrage from right eye.DRESS.
Age: 15.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash macular, Scab, Skin exfoliation
Clinical narrative: Stevens-Johnson syndrome.  Oral ulcers began 2d after vaccines; fever & decreased appetite also.  Seen in office 4d after vacs; sloughing oral mucosa & urethra, admit to hosp. Patient was complaining of cough with brown sputum at time of immunization; no eval or Rx undertaken.  Swollen, macerated, scabbed and yellow crusted lips-bleeding.  Erythematous macules on arms.  Dry skin around eyes. 12/20/07-records received with report for DOS 11/5-11/21/07-DC DX: Steven-Johnson syndrome with severe mucositis. Admitted with 4 day HX of swelling of eyes and face and 3 days HX of progressively worsening mouth ulcers. For previous week had non-productive cough and on morning of admission productive with green sputum. PE: swelling and sloughing of lips, greenish dischrage from right eye.DRESS.
Age: 15.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Skin maceration, Stevens-Johnson syndrome
Clinical narrative: Stevens-Johnson syndrome.  Oral ulcers began 2d after vaccines; fever & decreased appetite also.  Seen in office 4d after vacs; sloughing oral mucosa & urethra, admit to hosp. Patient was complaining of cough with brown sputum at time of immunization; no eval or Rx undertaken.  Swollen, macerated, scabbed and yellow crusted lips-bleeding.  Erythematous macules on arms.  Dry skin around eyes. 12/20/07-records received with report for DOS 11/5-11/21/07-DC DX: Steven-Johnson syndrome with severe mucositis. Admitted with 4 day HX of swelling of eyes and face and 3 days HX of progressively worsening mouth ulcers. For previous week had non-productive cough and on morning of admission productive with green sputum. PE: swelling and sloughing of lips, greenish dischrage from right eye.DRESS.
Age: 10.0
Sex: F
Vaccine: HPVX
Symptoms: Biopsy skin, Blood test normal, Eczema, Pityriasis rosea, Rash
Clinical narrative: Daughter received HPV on 09/11/2007.  2 weeks after receiving the vaccine she started breaking out in a rash on her chest. It rapidly spread to her back, up her neck, her face and covered her entire trunk within a few days.  It continued to spread into her groin area, her arms, and her legs down to her ankles.  This all took place starting 09/27/2007.  I had to to her PCP, whom she received the shot and to a dermatologist, who first diagnosed her with Pitariosis Rosea.  The dermatologist did a biopsy and came back with "eczema".  The rash continued to break out until there was barely any skin NOT covered with this rash.  My daughter started swelling.  I immediately demanded full blood work up.  All of the counts came back as normal. I scheduled an appointment with an allergist, thinking that maybe she was allergic to something.  All tests were negative.  The only way we got her cleared up was with Prednisone.  After she did her round with Prednisone, she broke out again, but not as extreme.  My daughter had this rash for 2 months.  She is now scared from the biopsy and during all of this she has "white spots" where the pigment in her skin is gone.  She is possibly scared for life.
Age: 10.0
Sex: F
Vaccine: HPVX
Symptoms: Skin depigmentation, Swelling
Clinical narrative: Daughter received HPV on 09/11/2007.  2 weeks after receiving the vaccine she started breaking out in a rash on her chest. It rapidly spread to her back, up her neck, her face and covered her entire trunk within a few days.  It continued to spread into her groin area, her arms, and her legs down to her ankles.  This all took place starting 09/27/2007.  I had to to her PCP, whom she received the shot and to a dermatologist, who first diagnosed her with Pitariosis Rosea.  The dermatologist did a biopsy and came back with "eczema".  The rash continued to break out until there was barely any skin NOT covered with this rash.  My daughter started swelling.  I immediately demanded full blood work up.  All of the counts came back as normal. I scheduled an appointment with an allergist, thinking that maybe she was allergic to something.  All tests were negative.  The only way we got her cleared up was with Prednisone.  After she did her round with Prednisone, she broke out again, but not as extreme.  My daughter had this rash for 2 months.  She is now scared from the biopsy and during all of this she has "white spots" where the pigment in her skin is gone.  She is possibly scared for life.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Body temperature increased, Erythema, Fatigue, Feeling cold, Oedema peripheral
Clinical narrative: Left arm was very red and swollen from the shoulder to the elbow.  The red was a cherry color.  Warm to the touch.  Client felt cold and had a slight temp.  She was very tired and sleepy.  Slept through the day and all that night.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Skin warm, Somnolence
Clinical narrative: Left arm was very red and swollen from the shoulder to the elbow.  The red was a cherry color.  Warm to the touch.  Client felt cold and had a slight temp.  She was very tired and sleepy.  Slept through the day and all that night.
Age: 0.3
Sex: F
Vaccine: HIBV, PNC
Symptoms: Crying, Differential white blood cell count, Full blood count normal, Irritability, Platelet count increased
Clinical narrative: My daughter received the HIB vaccine on October 26, 2007. That evening she developed a fever, and we gave her Tylenol. On October 27, 2007, I contacted her physician because her fever was above 100.5 and she was only 2 months old. The fever continued to persist, typically in the 103 degree range. On October 28, 2007, Dr. examined her in the office and ordered blood work and collected a urine sample. The urine test came back ok, and so did the blood work, however, her platelet count was high. On Monday, October 29, 2007, her fever persisted and the physician called us to the office so she could again examine the baby. The fever was around 103 degrees (rectal) and she admitted the baby to the hospital. Patient received 2 antibiotics intraveneously and the fever proceeded to decline. Patient was discharged from the hospital at 5 pm on October 30th, and when we got home from the hospital she developed a rash over her belly, trunk and head. She was uncomfortable that nite until approx. 1 am, when she went to sleep. Until this instance, she never cried like this and she has always (every single nite) slept through the nite and NEVER cries. She continued to remain warm, around 99.90 rectal temp for the next 3 weeks. We even went to an infectious disease specialist at hospital because the hospital, nor the doctors could find the root of an infection, although the doctor's were certain she had an infection of some sort.  12/28/07 Reviewed hospital medical records which reveal patient experienced fever, bloody stool x 1, cough, coarse breath sounds, reduced oral intake & marked purulent nasal congestion.  Seen in pcp office & admitted to hospital 10/29-10/30/2007.   FINAL DX: fever, otitis media, bronchitis & sinusitis. 2/11/08 Reviewed vax record & database updated w/same.
Age: 0.3
Sex: F
Vaccine: HIBV, PNC
Symptoms: Pyrexia, Rash, Urine analysis normal
Clinical narrative: My daughter received the HIB vaccine on October 26, 2007. That evening she developed a fever, and we gave her Tylenol. On October 27, 2007, I contacted her physician because her fever was above 100.5 and she was only 2 months old. The fever continued to persist, typically in the 103 degree range. On October 28, 2007, Dr. examined her in the office and ordered blood work and collected a urine sample. The urine test came back ok, and so did the blood work, however, her platelet count was high. On Monday, October 29, 2007, her fever persisted and the physician called us to the office so she could again examine the baby. The fever was around 103 degrees (rectal) and she admitted the baby to the hospital. Patient received 2 antibiotics intraveneously and the fever proceeded to decline. Patient was discharged from the hospital at 5 pm on October 30th, and when we got home from the hospital she developed a rash over her belly, trunk and head. She was uncomfortable that nite until approx. 1 am, when she went to sleep. Until this instance, she never cried like this and she has always (every single nite) slept through the nite and NEVER cries. She continued to remain warm, around 99.90 rectal temp for the next 3 weeks. We even went to an infectious disease specialist at hospital because the hospital, nor the doctors could find the root of an infection, although the doctor's were certain she had an infection of some sort.  12/28/07 Reviewed hospital medical records which reveal patient experienced fever, bloody stool x 1, cough, coarse breath sounds, reduced oral intake & marked purulent nasal congestion.  Seen in pcp office & admitted to hospital 10/29-10/30/2007.   FINAL DX: fever, otitis media, bronchitis & sinusitis. 2/11/08 Reviewed vax record & database updated w/same.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pruritus, Injection site rash
Clinical narrative: pt called 12/13/07 to report feeling a hard bump at injection site and also had some small bumps and itching.  the site has cleared up but the bumps moved up his arm to his bicep area.  pt given triamcinolone acetanide cream and advised to call if any further problems come up.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Nausea, Rash
Clinical narrative: MMR received on 12/10/2007, on 12-15-07 pt experienced a raised red rash beginning on her forehead->neck ->chest, mild nausea.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Faecal incontinence, Muscular weakness, Urinary incontinence
Clinical narrative: Developed severe back pain, lower extremity weakness, and loss of bowel and bladder control 16 days after receiving flu vaccine.  1/4/08 Reviewed hospital D/C summary which reveals patient experienced  lower back pain &  LE weakness x 2 mo which became acute on 11/3/07 w/sudden onset of weakness in bilat LEs w/progression, multiple falls, urinary incontinence.  Seen in ER but sent home when spine & MRI were WNL.  Continued to deteriorate & admitted 11/6-11/21/2007.  Neurology & neurosurgery consults done.  Transferred to inpatient rehab upon d/c. FINAL DX: myelitis w/lower extremity weakness & bowel/bladder dysfunction, etiology unclear, thought to be most likely postvaccination.
Age: 1.83
Sex: M
Vaccine: DTAP, FLU3, HEPA, PNC
Symptoms: Wrong drug administered
Clinical narrative: An adult dose of Hep A was accidently given as the second dose in the series.  No treatment after CDC was consulted.
Age: 41.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site swelling, Skin infection
Clinical narrative: The patient reported to the HR office that she was seeking works mans compensation for adverse reaction symptoms that included swelling of the site of injection and redness. The HR manager refered her to the facility medical director for further evaluation and treatment.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Chest discomfort, Dysphonia, Injection site discolouration, Rhinorrhoea
Clinical narrative: Left arm where injection was given is a very large purple area, since 12-18-07. I have hoarsenes (12-20-07), wheezing (12-18-07), chest tightness (12-20-07). Running noise(12-19-07). I have ashma.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: Left arm where injection was given is a very large purple area, since 12-18-07. I have hoarsenes (12-20-07), wheezing (12-18-07), chest tightness (12-20-07). Running noise(12-19-07). I have ashma.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, VARCEL
Symptoms: Convulsion, Electroencephalogram, Familial risk factor, Flushing, Gaze palsy
Clinical narrative: History was obtained from the child's father, who did not witness the event.  Zeth received DTaP, Hep A, influenza, and varicella vaccines on 12/12/07 at a routine well child exam.  On 12/13/07, while at school, he reportedly had a seizure-like episode involving unresponsiveness, flushing, and eyes rolling back which lasted approximately 2 minutes.  The child appeared normal immediately after the event.  The child has a strong family history of seizure disorders (father and paternal uncles with poorly controlled seizures).  The child was brought to the ER several hours later where he appeared well.  Laboratory evaluation at that time was normal.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: History was obtained from the child's father, who did not witness the event.  Zeth received DTaP, Hep A, influenza, and varicella vaccines on 12/12/07 at a routine well child exam.  On 12/13/07, while at school, he reportedly had a seizure-like episode involving unresponsiveness, flushing, and eyes rolling back which lasted approximately 2 minutes.  The child appeared normal immediately after the event.  The child has a strong family history of seizure disorders (father and paternal uncles with poorly controlled seizures).  The child was brought to the ER several hours later where he appeared well.  Laboratory evaluation at that time was normal.
Age: 39.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Pyrexia, Swelling
Clinical narrative: Redness, induration, swelling Right upper are.  Laterally 3"X2" adenopathy; mild; fever.  treated with Motrin; rest & reassurance
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Headache, Nausea
Clinical narrative: Elevated temp (101), naseua, chills, headache for over 24 hours.
Sex: U
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: The site where the vaccine was taken started swelling
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: ON 11/20/07 MMR GIVEN IN LEFT THIGH AND INFULENZA AND HEP. A GIVEN IN RIGHT THIGH.  MOTHER STATED BABY DEVELOPED FEVER-101 AND A COMPLETE BODY RASH ON 12/02/07.  WENT TO SEE HER PEDIATRIC MD, AND SHE STATED THAT THE BODY RASH WAS POSSIBLY FROM THE MMR.  MOTHER CAME IN TODAY FOR THE 2ND FLU INJECTION AND INFORMED ME OF THE ABOVE.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Erythema, Induration, Myalgia, Oedema peripheral
Clinical narrative: Left upper arm got red, hot, edematous and firm with moderate pain 15 hours after administration and sx persist till today. Urticaria behind knees with myalgias and arthralgiax.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Skin warm, Urticaria
Clinical narrative: Left upper arm got red, hot, edematous and firm with moderate pain 15 hours after administration and sx persist till today. Urticaria behind knees with myalgias and arthralgiax.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eye swelling, Fatigue, Flushing, Paraesthesia
Clinical narrative: 12/19/07 Face was red.  Felt fatigued. That night scapl started tingling. Today 12/20/07 red bumpy rash starting midline on forehead at hair line, extending to above ear on right side. Rash and swelling also under right eye.  Feeling of pin and needles in area of rash..
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: 12/19/07 Face was red.  Felt fatigued. That night scapl started tingling. Today 12/20/07 red bumpy rash starting midline on forehead at hair line, extending to above ear on right side. Rash and swelling also under right eye.  Feeling of pin and needles in area of rash..
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Injection site mass
Clinical narrative: My daughter received her vaccination on Dec 4.  Tonight, Dec 20, 2007, I noticed a bump the size of a quarter on her leg where the shot was administered.  There is no redness and it does not seem to bother her when I touch it.  It just feels like a lump in her leg.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Body temperature increased, C-reactive protein increased, Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: Patient had a viral infection earlier that week.  Received her HPV Vaccine on Friday 11/30/07 at 4:25 p.m. Pt was feeling fine ,until 8:30p.m.. Complained of hip pain. By 9:30, pt was in horrible bilateral hip pain over the greater trochanters. Given motrin 400mg by mother and a warm bath,  no relief. Called pediatrian,  no noted side effects.  Wnt to the emergency department.  Temperature 102,  WBC 17 sed rate 5 & C-reactive protein 1.5. Pt.  also developed bilteral knee pain.  Pt was given torodolwhich brought the pain down from 10/10 to 5/10. Pt the was given a percocet for the pain bring the pain down to a 2/10.  Sent home.  Called back for + blood culture on Sunday .  Back to the emergency department for I.V. antibiotics.  WBC 9,C- reactive protein was 41.5. Pt. was admitted to the hospital.  Diagnosis: acute tendonitis of the hips & knees. 2/7/08-records received for DOS 12/2-12/5/07-DC DX: Polyarticular arthritis. Presented with bilateral knee and hip pain times 3 days after symptoms of viral syndrome. Six days prior to admission developed sore throat, headache, vomiting and abdominal pain that lasted 3 days. On 11/30/07 febrile to 102,  Post infectious arthritis.  Developed red man syndrome to vancomycin.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Tendonitis, White blood cell count increased, X-ray of pelvis and hip
Clinical narrative: Patient had a viral infection earlier that week.  Received her HPV Vaccine on Friday 11/30/07 at 4:25 p.m. Pt was feeling fine ,until 8:30p.m.. Complained of hip pain. By 9:30, pt was in horrible bilateral hip pain over the greater trochanters. Given motrin 400mg by mother and a warm bath,  no relief. Called pediatrian,  no noted side effects.  Wnt to the emergency department.  Temperature 102,  WBC 17 sed rate 5 & C-reactive protein 1.5. Pt.  also developed bilteral knee pain.  Pt was given torodolwhich brought the pain down from 10/10 to 5/10. Pt the was given a percocet for the pain bring the pain down to a 2/10.  Sent home.  Called back for + blood culture on Sunday .  Back to the emergency department for I.V. antibiotics.  WBC 9,C- reactive protein was 41.5. Pt. was admitted to the hospital.  Diagnosis: acute tendonitis of the hips & knees. 2/7/08-records received for DOS 12/2-12/5/07-DC DX: Polyarticular arthritis. Presented with bilateral knee and hip pain times 3 days after symptoms of viral syndrome. Six days prior to admission developed sore throat, headache, vomiting and abdominal pain that lasted 3 days. On 11/30/07 febrile to 102,  Post infectious arthritis.  Developed red man syndrome to vancomycin.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Crying, Injection site induration, Petechiae, Vasculitis
Clinical narrative: Pt developed unconsolable crying 2 hours prior to immunization to peds office. Also developed a rash that started on lower extremities and spread to face and scalp - vasculitis type, rash/petechiae, induration (>4cm) at injection site. 12/21/07-records received for DOS 12/14-12/17/07- DC DX: Irritability, resolved. Rash, resolved. Rule out bacterial etiology to this illness. Five days after vaccination suddenly started crying and was inconsolable for fifty minutes. Generalized redness of whole body that resolved prior to admission. PE petechiael rash on legs and face.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Drug exposure during pregnancy, Erythema, Feeling hot, Oedema peripheral
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in a 38-year-old pregnant female subject who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis.  On 20 November 2007, the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm).  On 22 November 2007, 2 days after vaccination with Flulaval, the subject experienced extensive swelling of vaccinated limb, tenderness, erythema, rash and warm to touch.  The swelling occurred in the left elbow, slightly above the elbow area and into the lower forearm.  The subject went to the emergency department and was admitted to the hospital.  The subject was diagnosed with cellulites.  At the time, the events occurred the subject was 6 weeks pregnant and had not seen a gynecologist for a delivery date.  The subject was treated with amoxicillin trihydrate + potassium clavulanate (Augmentin (oral)) 875 mg twice daily.  At the time of reporting the outcome of the events were unspecified.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Skin warm, Tenderness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of extensive swelling of vaccinated limb in a 38-year-old pregnant female subject who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline) for prophylaxis.  On 20 November 2007, the subject received unspecified dose of Flulaval (.5 ml, unknown, left arm).  On 22 November 2007, 2 days after vaccination with Flulaval, the subject experienced extensive swelling of vaccinated limb, tenderness, erythema, rash and warm to touch.  The swelling occurred in the left elbow, slightly above the elbow area and into the lower forearm.  The subject went to the emergency department and was admitted to the hospital.  The subject was diagnosed with cellulites.  At the time, the events occurred the subject was 6 weeks pregnant and had not seen a gynecologist for a delivery date.  The subject was treated with amoxicillin trihydrate + potassium clavulanate (Augmentin (oral)) 875 mg twice daily.  At the time of reporting the outcome of the events were unspecified.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) thigh swollen - red and warm to touch. Area measured 19cm x 10 1/2 cm (at ER). ER visit 12/12/07. Vaccinated 12/10/2007 - Seen 12/17/07 in ECC.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Erythema at injection site. Pain at injection site (mild 1/10 scale).
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Immediately after receiving Rotateq PO, infant vomited up formula (Mom said was fed about 1/2 to 45 minutes prior to immun.)
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Pain, Pyrexia, Viral infection
Clinical narrative: The same day of shot I started feel achey. I started running fever from 99-100 every day since. Her nurse said I had a virus and I am still sick. My daughter and grandson has gotten what I have I am still sick
Age: 11.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness/swelling of left upper arm at injection site.
Age: 0.1
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Infant was given adult dose 0.5 ml influenza vaccine in (L) thigh. No adverse effects noted.
Age: 0.2
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Swelling in upper left leg.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin warm, Swelling
Clinical narrative: Redness to site, swelling inferior and superior to site, warmth.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Tremor
Clinical narrative: 12/5/07 PM: Pt rcvd vaccine and said during night he was shaking and chills and took Tylenol, felt better next AM, but felt weak.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Large, non-tender, itchy area to skin at left deltoid injections site.
Age: 6.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: Redness with some swelling noted at injection site of the Varivax. 5.1 cm x 6.2 cm redness, 4.2 cm x 4.2 cm knot, warm to touch. Doesn't itch or bother her. Mom to call if knot and redness persist. Right upper thigh.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria, Injection site warmth, Musculoskeletal pain
Clinical narrative: Soreness at site RSQ, no symptoms noted, then noted in mirror "hives" at injection site, warm to touch and itchy, and redness which went away week of 11/16/07. Approx 11/14 symptoms of Rt shoulder pain with ROM and touch began. Has treated with moist heat, anti-inflammatories, Tylenol, changed bras and different bed pillows - no relief. Has some noted swelling of Rt axilla. No redness, tenderness or swelling at injection site.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral
Clinical narrative: Soreness at site RSQ, no symptoms noted, then noted in mirror "hives" at injection site, warm to touch and itchy, and redness which went away week of 11/16/07. Approx 11/14 symptoms of Rt shoulder pain with ROM and touch began. Has treated with moist heat, anti-inflammatories, Tylenol, changed bras and different bed pillows - no relief. Has some noted swelling of Rt axilla. No redness, tenderness or swelling at injection site.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: 2 days after getting Zostavax, he had the same lip irritation that he can get like a fever blister (cold sore) breaks out. This lasted one week. Never a a fever blister.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cough, Headache, Pain, Pyrexia
Clinical narrative: Fever, body aches, headache, cough
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Facial palsy
Clinical narrative: L sided Bell's palsy, 5 days of oral steroids.  2/19/08 Reviewed vax records & provider medical records which reveal patient in good health on 10/22/07.  Next vs 11/29 after ER vs 11/15 for left Bell's palsy.  Tx w/steroids & doing much better.  Reported no illness prior to onset of palsy.  T/C w/neuro who felt palsy probably due to varivax.   FINAL DX: Left side Bell's palsy.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The evening of day of administration the patient c/o pain but nothing seen by mom.  In the AM, the arm looked red and swollen.  The redness and swelling progressed down to forearm.
Age: 0.8
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, Pyrexia
Clinical narrative: Received flu vaccine in office and developed 104 fever in late evening. Went to Emergency Room and after exam was told fever due to flu vaccine.
Age: 1.3
Sex: F
Vaccine: HIBV, PNC
Symptoms: Abasia, Irritability, Pyrexia, Screaming
Clinical narrative: Fever 102.1 x24 hours, irritability, screaming, not walking.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site swelling, Irritability, Vomiting
Clinical narrative: Swelling at injection site-bilat, vomited x1, irritable.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blister, Lip blister, Sneezing
Clinical narrative: Back ache, blister on Lt side of upper outside of lip, sneezing, dried blood in nose. 3 pox like blisters on Rt side of face.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Full blood count, Oedema, Pain in extremity, Red blood cell sedimentation rate
Clinical narrative: Experienced erythema/edema/pain to tricep. Rec'd Tdp (Adacel) above affected area. Occurred w/n 24 of rec vaccine.
Age: 3.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received DTaP, MMR 12/18/07. This AM Mom noticed (L) arm swollen, red circle size of fist - swollen to elbow - feels hot to touch. No Tylenol/Motrin or cold compresses at this time.
Age: 25.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Noticed a 15cm x 9 cm erythema area on Left upperarm. Two hard lumps contained within the erythemous area. Positive for pruritis.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Syncopal episode aprox 5 min after receive HPV.
Age: 1.0
Sex: M
Vaccine: FLU3, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Redness, rash looking bumps on upper right thigh, warm to touch.
Age: 62.0
Sex: F
Vaccine: RAB
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Vaccinated on Thursday 6 Dec on Sunday (3 days later) had pain in left arm, severe enough that she had pain moving it and did not move to anymore than necessary. Took one Advil, without good effect. Monday 10 Dec-arms was better. Today 11 Dec arm nearly normal. No redness or swelling noted at anytime after vaccine administered. Plans to return in 2 weeks for 3rd dose.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Erythema heat, tenderness at injection site Left deltoid
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood lead, Dizziness, Migraine, Pallor
Clinical narrative: Information has been received from the government through the information act concerning a 16 year old female with no medical history, pre-existing illnesses or concomitant medication usage who on 28-AUG-2007 was vaccinated (route and site were not reported) with the 1st dose of the Gardasil (lot#658282/0929U). On 29-AUG-2007, during a blood test the patient went pale and had a seizure. First had them 2 or 3 a day or more than 3 times per week during period of 29-Aug-2007 to 11-Oct-2007. The patient went to the emergency room for testing on 11-Sep-2007. Started taking topiramate (TOPAMAX) on 18-OCT-2007. Doctor described them as migraine induced seizures. It is unknown if patient recovered. No further information is available. The VAERS ID number is 295876. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood lead, Convulsion, Electroencephalogram, Laboratory test, Migraine
Clinical narrative: Information has been received from the government through the information act concerning a 16 year old female with no medical history, pre-existing illnesses or concomitant medication usage who on 28-AUG-2007 was vaccinated (route and site were not reported) with the 1st dose of the Gardasil (lot#658282/0929U). On 29-AUG-2007, during a blood test the patient went pale and had a seizure. First had them 2 or 3 a day or more than 3 times per week during period of 29-Aug-2007 to 11-Oct-2007. The patient went to the emergency room for testing on 11-Sep-2007. Started taking topiramate (TOPAMAX) on 18-OCT-2007. Doctor described them as migraine induced seizures. It is unknown if patient recovered. No further information is available. The VAERS ID number is 295876. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging, Pallor
Clinical narrative: Information has been received from the government through the information act concerning a 16 year old female with no medical history, pre-existing illnesses or concomitant medication usage who on 28-AUG-2007 was vaccinated (route and site were not reported) with the 1st dose of the Gardasil (lot#658282/0929U). On 29-AUG-2007, during a blood test the patient went pale and had a seizure. First had them 2 or 3 a day or more than 3 times per week during period of 29-Aug-2007 to 11-Oct-2007. The patient went to the emergency room for testing on 11-Sep-2007. Started taking topiramate (TOPAMAX) on 18-OCT-2007. Doctor described them as migraine induced seizures. It is unknown if patient recovered. No further information is available. The VAERS ID number is 295876. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the government and was released.
Age: 55.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: CLIENT HAD FLU VACCINE 11/13/2007. CLIENT WAS ADMITTED TO HOSPITAL ON 11/25/2007, HAD SPINAL TAP (ALBUMIN 129), ON RESPIRATOR,RECEIVED IMMUNOGLOBULIN THERAPY AT MEDICAL CENTER,THEN ON 12/03/07, WAS TRANSFERRED TO HOSPITAL FOR SUPPORTIVE CARE. CLIENT HAS A TRACH, COMPLETE PARALYSIS, AND ABLE TO OPEN & MOVE EYES ON 12/10/07,DIALYSIS STARTED ON 12/15/07. PHYSICIAN WILL DECIDE ON USE OF PLASMAPHERESIS ON 12/28/07. CLIENT HAS NOT STARTED ON PHYSICAL THERAPY YET DUE TO COLLAPSE LUNG AND POOR O2 LEVELS.  SPOUSE RELATES THE NEUROLOGIST HAS SENT A REPORT TO CDC & MDA.  CLIENT RECEIVED THE INFLUENZA VACCINE AT DR. OFFICE.
Age: 55.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Albumin CSF increased, Collapse of lung, Dialysis, Life support, Lumbar puncture
Clinical narrative: CLIENT HAD FLU VACCINE 11/13/2007. CLIENT WAS ADMITTED TO HOSPITAL ON 11/25/2007, HAD SPINAL TAP (ALBUMIN 129), ON RESPIRATOR,RECEIVED IMMUNOGLOBULIN THERAPY AT MEDICAL CENTER,THEN ON 12/03/07, WAS TRANSFERRED TO HOSPITAL FOR SUPPORTIVE CARE. CLIENT HAS A TRACH, COMPLETE PARALYSIS, AND ABLE TO OPEN & MOVE EYES ON 12/10/07,DIALYSIS STARTED ON 12/15/07. PHYSICIAN WILL DECIDE ON USE OF PLASMAPHERESIS ON 12/28/07. CLIENT HAS NOT STARTED ON PHYSICAL THERAPY YET DUE TO COLLAPSE LUNG AND POOR O2 LEVELS.  SPOUSE RELATES THE NEUROLOGIST HAS SENT A REPORT TO CDC & MDA.  CLIENT RECEIVED THE INFLUENZA VACCINE AT DR. OFFICE.
Age: 55.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Oxygen saturation abnormal, Paralysis, Tracheostomy
Clinical narrative: CLIENT HAD FLU VACCINE 11/13/2007. CLIENT WAS ADMITTED TO HOSPITAL ON 11/25/2007, HAD SPINAL TAP (ALBUMIN 129), ON RESPIRATOR,RECEIVED IMMUNOGLOBULIN THERAPY AT MEDICAL CENTER,THEN ON 12/03/07, WAS TRANSFERRED TO HOSPITAL FOR SUPPORTIVE CARE. CLIENT HAS A TRACH, COMPLETE PARALYSIS, AND ABLE TO OPEN & MOVE EYES ON 12/10/07,DIALYSIS STARTED ON 12/15/07. PHYSICIAN WILL DECIDE ON USE OF PLASMAPHERESIS ON 12/28/07. CLIENT HAS NOT STARTED ON PHYSICAL THERAPY YET DUE TO COLLAPSE LUNG AND POOR O2 LEVELS.  SPOUSE RELATES THE NEUROLOGIST HAS SENT A REPORT TO CDC & MDA.  CLIENT RECEIVED THE INFLUENZA VACCINE AT DR. OFFICE.
Age: 0.1
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Information has been received from a registered nurse concerning a 43 day old female with no known allergies and with premature birth (36 weeks) who on 29-NOV-2007 was vaccinated with a dose of PEDVAXHIB (657395/0819U) 0.5 mL intramuscularly and a dose of Rotateq (657518/1192U). Concomitant vaccinations, in approximately November 2007, included PEDIARIX and PREVNAR. On 30-NOV-2007 the patient died. The cause of death was not provided. There was no product quality complaint. Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, RV5
Symptoms: Death
Clinical narrative: Information has been received from a registered nurse concerning a 43 day old female with no known allergies and with premature birth (36 weeks) who on 29-NOV-2007 was vaccinated with a dose of PEDVAXHIB (657395/0819U) 0.5 mL intramuscularly and a dose of Rotateq (657518/1192U). Concomitant vaccinations, in approximately November 2007, included PEDIARIX and PREVNAR. On 30-NOV-2007 the patient died. The cause of death was not provided. There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Death
Clinical narrative: Initial and follow-up information has been received from a pharmacy technician concerning an infant female who on 26-NOV-2007 was vaccinated with a 0.5 ml IM dose of PEDVAX-HIB (lot# "638811/0498L"). Suspect vaccination administered on that same day included a 2.0 ml dose of Rotateq (lot# 657671/0902U). Concomitant vaccinations administered on that same day included a dose of PEDIARIX and a dose of PREVNAR. Subsequently the patient died. The cause and date of death were unknown. The patient sought unspecified medical attention. It was noted that the reporter stated that documentation of lot numbers was in a computer system and confirmed the lot numbers as reported above. She also stated that this case was originally reported from the hospital risk management staff to the pharmacy manager. There was no product quality complaint. The event was considered to be immediately life-threatening by the reporter. Additional follow-up information has been received from the pharmacist indicating that the patient received the vaccinations at a pediatric clinic and did not have a general phone number for the clinic. She stated that she believed that on the day the patient was vaccinated, it was the first date that this patient was seen at this clinic. An autopsy was or was being done and she reported a possible cause of death of (Sudden Infant Death Syndrome (SIDS) or "social issues with the family " however; she was unsure. She noted when reviewing this patient's medical record that a nurse practitioner had written a progress note. On 14-DEC-2007 a request for information regarding the lot numbers and the prescribing health care provider along with contact information for that person or persons was requested. The nurse practitioner also stated that the lot number recorded for HIB conj vaccine was (lot# 638811/0498L) (invalid for this product. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Body temperature increased, Computerised tomogram, Fasciitis, Lymphocyte count decreased, Neutrophil count increased
Clinical narrative: Information has been received from a registered nurse, concerning a 4 year old female child with a history of otitis media, who on 11-DEC-2007 was vaccinated IM in the left thigh, with a dose, 0.5 ml, of Pneumovax 23 (lot #657525/0554U). There was no concomitant medication. On 12-DEC-2007 at 9:00 a.m., the child developed a fever of greater than 102 F, with swelling and soreness at the injection site. The child visited the office that day, and was non-weight bearing, with a fever 104.1 F. The entire quadriceps was tender to the touch, with a small lesion noted at the site. There was no significant bruising or swelling. The child refused to sit up until noon, due to leg pain. Treatment included a prescription for hydrocodone (LORTAB). On 13-DEC-2007, the child continued to have pain and fever despite treatment with acetaminophen (TYLENOL) and ibuprofen (MOTRIN). On 14-DEC-2007, the child's temperature was normal 1 hour after treatment medications, but her leg was still non-weight bearing, painful and sensitive to the touch. The nurse indicated the event was an injection site reaction of fasciitis. Multiple lab tests were performed (results not available). At the time of this report, the child was in the process of admission to the hospital for treatment with IV antibiotics. The nurse considered the events to be serious as disabling/incapacitating. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Information has been received from a registered nurse, concerning a 4 year old female child with a history of otitis media, who on 11-DEC-2007 was vaccinated IM in the left thigh, with a dose, 0.5 ml, of Pneumovax 23 (lot #657525/0554U). There was no concomitant medication. On 12-DEC-2007 at 9:00 a.m., the child developed a fever of greater than 102 F, with swelling and soreness at the injection site. The child visited the office that day, and was non-weight bearing, with a fever 104.1 F. The entire quadriceps was tender to the touch, with a small lesion noted at the site. There was no significant bruising or swelling. The child refused to sit up until noon, due to leg pain. Treatment included a prescription for hydrocodone (LORTAB). On 13-DEC-2007, the child continued to have pain and fever despite treatment with acetaminophen (TYLENOL) and ibuprofen (MOTRIN). On 14-DEC-2007, the child's temperature was normal 1 hour after treatment medications, but her leg was still non-weight bearing, painful and sensitive to the touch. The nurse indicated the event was an injection site reaction of fasciitis. Multiple lab tests were performed (results not available). At the time of this report, the child was in the process of admission to the hospital for treatment with IV antibiotics. The nurse considered the events to be serious as disabling/incapacitating. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood creatine phosphokinase, Blood culture, Body temperature increased, C-reactive protein, Fasciitis
Clinical narrative: Information has been received from a registered nurse, concerning a 4 year old female child with a history of otitis media, who on 11-DEC-2007 was vaccinated IM in the left thigh, with a dose, 0.5 ml, of Pneumovax 23 (lot #657525/0554U). There was no concomitant medication. On 12-DEC-2007 at 9:00 a.m., the child developed a fever of greater than 102 F, with swelling and soreness at the injection site. The child visited the office that day, and was non-weight bearing, with a fever 104.1 F. The entire quadriceps was tender to the touch, with a small lesion noted at the site. There was no significant bruising or swelling. The child refused to sit up until noon, due to leg pain. Treatment included a prescription for hydrocodone (LORTAB). On 13-DEC-2007, the child continued to have pain and fever despite treatment with acetaminophen (TYLENOL) and ibuprofen (MOTRIN). On 14-DEC-2007, the child's temperature was normal 1 hour after treatment medications, but her leg was still non-weight bearing, painful and sensitive to the touch. The nurse indicated the event was an injection site reaction of fasciitis. Multiple lab tests were performed (results not available). At the time of this report, the child was in the process of admission to the hospital for treatment with IV antibiotics. The nurse considered the events to be serious as disabling/incapacitating. Additional information has been requested.