chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.15
Sex: F
Vaccine: DTAPIPVHIB, HEP, HIBV, RV5
Symptoms: Inappropriate schedule of drug administration, Unevaluable event
Clinical narrative: No adverse effect -gave extra dose of Hib vaccine in addition to PENTACEL.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Child initially had a sore arm after vaccination. Mom states child woke early in morning with a fever (warm to touch). Mother had given MOTRIN to reduce fever and for comfort. Mom states on 4-27-10 that arm (left) was red and swollen. On 4-28-10, mom states that childs left arm was "worse" with redness from shoulder down to elbow. Mom will monitor and call doctor if necessary (increased redness).
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Activities of daily living impaired, Condition aggravated, Injected limb mobility decreased, Myalgia
Clinical narrative: Mild symptoms few minutes after shot, worsened over the next 24 hours. First felt like it was in bone, then in muscle, then both. Couldn't move the upper arm in most directions without pain. Had had much milder symptoms few weeks earlier, after seasonal flu shot. This is the same thing as before, but awful. Have recovered partially, 4 months later. Am still improving.
Age: 3.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling. Concern of cellulitis. Pt to ER - given IV antibiotic - Rt thigh swelling/redness
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Abasia, Bladder catheterisation, Hypoaesthesia, Laboratory test, Lumbar puncture
Clinical narrative: Report received from a Merck sales representative concerning her sister-in-law's mother on 21-APR-2010. The female, in her 60's, received an unspecified flu vaccine (manufacturer unspecified) on 12-JAN-2010. There was no concomitant therapy or pertinent medical history. On 15-JAN-2010, the female developed numbness of her right foot which progressed to an inability to walk. The patient sought medical attention. She was hospitalized and has a urinary catheter due to inability to pass her urine. Lumbar puncture and other unspecified studies were performed (not further specified, results unknown). The patient had not recovered. The events were reported as disabling. This case was reported as serious due to patient hospitalisation. Additional information has been requested. This case was originally report to Merck & Co, Inc (case# 1004USA03475).
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Urinary retention
Clinical narrative: Report received from a Merck sales representative concerning her sister-in-law's mother on 21-APR-2010. The female, in her 60's, received an unspecified flu vaccine (manufacturer unspecified) on 12-JAN-2010. There was no concomitant therapy or pertinent medical history. On 15-JAN-2010, the female developed numbness of her right foot which progressed to an inability to walk. The patient sought medical attention. She was hospitalized and has a urinary catheter due to inability to pass her urine. Lumbar puncture and other unspecified studies were performed (not further specified, results unknown). The patient had not recovered. The events were reported as disabling. This case was reported as serious due to patient hospitalisation. Additional information has been requested. This case was originally report to Merck & Co, Inc (case# 1004USA03475).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Inappropriate schedule of drug administration, Unevaluable event
Clinical narrative: Child is doing fine, no adverse reaction. Child got immunizations on. DTaP - 4-10-10. IPV - 4-10-10. DTaP - 4-16-10. IPV - 4-16-10.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Approximately 7:00 PM, elevation of temperature occurred and child experienced febrile seizure.  Child transported by EMS to ER.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Blood electrolytes, Blood magnesium, Computerised tomogram, Dizziness, Electroencephalogram
Clinical narrative: Patient received Hepatitis A (1st dose) and HPV (1st dose). C/O arm pain - sat down. Felt dizzy. Passed out then noted to have rhythmic tonic clonic movement of upper arms followed by enuresis. Lasted approximately 1 minute.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Enuresis, Loss of consciousness, Pain in extremity, Tonic clonic movements
Clinical narrative: Patient received Hepatitis A (1st dose) and HPV (1st dose). C/O arm pain - sat down. Felt dizzy. Passed out then noted to have rhythmic tonic clonic movement of upper arms followed by enuresis. Lasted approximately 1 minute.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Convulsion, Electroencephalogram, Laboratory test
Clinical narrative: Patient received Hepatitis A (1st dose) and HPV (1st dose). C/O arm pain - sat down. Felt dizzy. Passed out then noted to have rhythmic tonic clonic movement of upper arms followed by enuresis. Lasted approximately 1 minute.
Age: 0.22
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: Information has been received from a registered nurse concerning an about 17 weeks old male patient who on 08-MAR-2010 was vaccinated oral with the first 2 ml dose of ROTATEQ (lot# 664685/1180Y). On 20-APR-2010, the patient was vaccinated oral with the second 2 ml dose of ROTATEQ (lot # 664685/1180Y). Concomitant therapy included PENTACEL and PREVNAR which were administered on 08-MAR-2010 and 20-APR-2010, and hepatitis B virus vaccine (unspecified) (manufactured by GlaxoSmithKline) which was administered on 08-MAR-2010. Subsequently the patient developed intussusception. On 21-APR-2010 the patient went to the hospital and stayed overnight. The patient was given a barium reduction while at the hospital. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 1.63
Sex: F
Vaccine: HEP, MMR
Symptoms: Injection site erythema, Injection site warmth, Rash
Clinical narrative: This pt was administered MMR #1 and HEP B #4.  Pt's grandmother was instructed to wait 15 min and at that time injection sites would be checked by myself.  When checking injection sites pt's grandmother noted a rash on pt's face and chest.  Pt was given 12.5 mg liquid BENADRYL per Dr. and was sent home.  Also noted at injection site of MMR red/warm, silver dollar sized.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Abortion induced, Drug exposure during pregnancy, Nausea, Pregnancy test urine positive, Ultrasound scan
Clinical narrative: Information has been received from a medical assistant concerning a 17 year old female patient with no other relevant medical histories or allergies who on 01-MAR-2010 was vaccinated intramuscularly with a 0.5ml dose of VAQTA (666629/1670Y). There was no concomitant medication. On an unspecified date, the patient complained of some nausea. Unspecified medical attention was sought. Ultrasound and urine test were performed. At the time of this report, the patient was "6 weeks pregnant", and her outcome was not reported. Follow-up information has been received concerning a female patient who had  no previous pregnancy. On 01-APR-2010 the ultrasound showed that the patient had a 6 weeks and 2 days old fetus. It was also reported that the patient terminated this pregnancy one week later. At the time of the report, the patient's status was unknown. Upon internal review, the patient's termination of pregnancy was considered an other medical event. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Congenital anomaly, Drug exposure during pregnancy, Duane's syndrome
Clinical narrative: Information has been received from a consumer, for the Pregnancy Registry for VARIVAX (Merck), concerning a male baby. On 19-JUN-2009 the baby's 39 year old with penicillin allergy, hyperthyroid and 3 previous pregnancies, 1 full-term delivery with no birth defects in any previous pregnancy and miscarriage in previous pregnancy mother was vaccinated with the first 0.5ml dose of VARIVAX (Merck) (lot# 662460/1535X). Concomitant therapy included levothyroxine Na. The baby's mother stated that she was 6 weeks pregnant after getting the first dose of VARIVAX (Merck) following the baby's mother's request for lacked immunity. It was reported that the baby's mother tested negative for varicella antibodies before vaccination with VARIVAX (Merck) during previous pregnancy. No adverse effects involved. Unspecified medical attention was sought. Home pregnancy test was performed. The baby's mother's LMP was 25-MAY-2009, and her EDD is 01-MAR-2010. The baby's mother reported that her son was born on 23-FEB-2010, full-term, "healthy and well, but he was born with DUANE Syndrome which was a neurological disorder that affects the eyes." The baby's mother added "that is the only problem he has." DUANE Syndrome was considered to be a congenital anomaly. The mother's experience has been captured in NWAES # 0907USA02020. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Pruritus, Rash generalised
Clinical narrative: Allergic Rxn -  started on same day to have rash all over body, itch, red some hives. Also, with redness directly at the site of vaccination in left leg.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Allergic Rxn -  started on same day to have rash all over body, itch, red some hives. Also, with redness directly at the site of vaccination in left leg.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix abnormal, Carcinoma in situ, Papilloma viral infection, Vulval cancer
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female patient who on unknown dates was vaccinated with the three doses GARDASIL (route and lot numbers not provided). It was reported that the patient received GARDASIL series at another physician's office. The patient did not know where she received the vaccinations. On 19-APR-2010 the patient experienced "vulvar carcinoma in situ" after getting all three doses of GARDASIL. The patient's vulvar carcinoma was confirmed upon biopsy. The patient was diagnosed positive for HPV "high risk genotype cervical". The patient was scheduled for a Pap test. The patient was referred to a Cancer Center. The patient's outcome was unknown at the time of reporting. The patient sought unspecified medical attention. Upon internal review, vulvar carcinoma in situ was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blood creatine phosphokinase abnormal, Blood test, Full blood count abnormal, Myalgia, Viral infection
Clinical narrative: Information has been received from a physician concerning a female patient with a history of obesity who on an unknown date, was vaccinated with a dose of GARDASIL (series, route and lot number unspecified). It was reported that the patient received other vaccines but which ones were unspecified. A week after the vaccination, "sometime in October or November 2009", the patient experienced muscle pain in their arms and legs so the patient went to the emergency room. At the emergency room, the patient had to be put in a wheel chair because of the muscle pain. A serum creatine kinase (CPK) test was performed an the levels were over 1000. A blood work test was performed and the results were not provided. A complete blood cell count (CBC) work up was performed and the results were that probably the patient had a viral infection (unspecified). The physician reported that the patient stopped the series of GARDASIL and had recovered (date not reported). The patient was initially seen by another physician. Viral infection was considered to be disabling by the physician. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Wheelchair user
Clinical narrative: Information has been received from a physician concerning a female patient with a history of obesity who on an unknown date, was vaccinated with a dose of GARDASIL (series, route and lot number unspecified). It was reported that the patient received other vaccines but which ones were unspecified. A week after the vaccination, "sometime in October or November 2009", the patient experienced muscle pain in their arms and legs so the patient went to the emergency room. At the emergency room, the patient had to be put in a wheel chair because of the muscle pain. A serum creatine kinase (CPK) test was performed an the levels were over 1000. A blood work test was performed and the results were not provided. A complete blood cell count (CBC) work up was performed and the results were that probably the patient had a viral infection (unspecified). The physician reported that the patient stopped the series of GARDASIL and had recovered (date not reported). The patient was initially seen by another physician. Viral infection was considered to be disabling by the physician. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Death, Malaise
Clinical narrative: Initial report was received 22 April 2010 from a press article. A 22-year-old male college student had received a meningococcal vaccination before entering college (manufacturer, lot number, route, site and date of administration not reported), and an unspecified amount of time later on 13 April 2010, the patient reported feeling ill. He was taken to the emergency room by his friends at approximately 5:30pm and within hours (also reported as before 11:30pm), he died from meningococcal disease/bacterial meningitis. According to the report, test results (not specified) were pending. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Face oedema, Feeling abnormal, Pruritus, Rash
Clinical narrative: Rash, facial edema & itching. Said just felt 'bad', through the evening of the injection.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Injection site pain
Clinical narrative: Shingles vaccination began as a round circle, red in color, and enlarged as the weekend passed.  Injection site sore. May 3rd, 2010 area has begun to shrink in size, but still feels bruised.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV
Symptoms: Erythema, Milia, Pruritus
Clinical narrative: Red spot on leg, itches, white head; Treated with Antibiotic.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV
Symptoms: Cellulitis
Clinical narrative: Red spot on leg, itches, white head; Treated with Antibiotic.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV
Symptoms: Erythema, Milia, Pruritus
Clinical narrative: This case was reported by a pharmacist and described the occurrence of cellulitis in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject experienced cellulitis. The pharmacist had no other information at the time of the report. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the cellulitis was unspecified.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV
Symptoms: Cellulitis
Clinical narrative: This case was reported by a pharmacist and described the occurrence of cellulitis in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject experienced cellulitis. The pharmacist had no other information at the time of the report. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the cellulitis was unspecified.
Age: 17.0
Sex: F
Vaccine: RAB
Symptoms: Chest discomfort, Dysphonia, Pharyngeal oedema
Clinical narrative: Patient reported throat swollen, slightly hoarse, chest tight.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Nausea, pain in arm, later pain increased and whole body ached.  Lasted for 36 hours.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) upper arm swelling after DTP/AP/polio/Varicella with diffuse erythema of (L) upper arm and shoulder. Very warm to touch. Denied pain-when seen at ED 4/24/10.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Immediate post-injection reaction, Injection site haematoma, Swelling
Clinical narrative: Injection site bruised immediately after injection. Redness and swelling developed within 24 hours and extended in diameter over 72 hours. At office visit today was 4-5 cm diameter of redness. No evidence of cellulitis or abscess.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Skin lesion
Clinical narrative: Left upper arm with 8.5cm circular, raised tender red, swollen lesion at site of vaccine injection 40 hrs after injections. Very pruritic. No fever or chills, no enlarged axillary nodes.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 1.39
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Eczema, Rash erythematous, Rash generalised, Urticaria
Clinical narrative: 3"-5" hives over entire body that lead into small raised red bumps over entire body that lead to diagnosed eczema on arms, trunk and legs.
Age: 30.0
Sex: M
Vaccine: YF, YF
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS TO RIGHT DELTOID S/P INJECTION SITE.
Age: 30.0
Sex: M
Vaccine: YF, YF
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: REDNESS TO RIGHT DELTOID S/P INJECTION SITE.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: REDNESS W/SWELLING. ADVISED AUNT TO ICE AREA.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood culture, C-reactive protein normal, Cellulitis, Full blood count normal, Injection site erythema
Clinical narrative: MOM STATES VARICELLA INJECTION SITE IS RED, SWOLLEN AND WARM TO TOUCH. EXAMINED IN OFFICE,DX: POST VACCINATION CELLULITIS. TX: AUGMENTIN, ICE; CBC, BLOOD CULTURES, CRP.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: MOM STATES VARICELLA INJECTION SITE IS RED, SWOLLEN AND WARM TO TOUCH. EXAMINED IN OFFICE,DX: POST VACCINATION CELLULITIS. TX: AUGMENTIN, ICE; CBC, BLOOD CULTURES, CRP.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pain, Skin reaction, Swelling
Clinical narrative: 48 hours after receiving inj, pt noticed redness, swelling, induration pain with progression of symptoms.  Localized reaction with possible cellulitis.  Treated with Doxycycline, Claritin, Ibuprofen.
Age: 48.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Amnesia, Muscular weakness, Myalgia
Clinical narrative: Diffuse myalgia and muscle weakness, worst in bilat hips and lower extremities beginning 1 wk post-vaccination; pt. subsequently also complained of short term memory loss which persists.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection area developed 7X7 cm circle of redness, warmth and swelling as well as discomfort.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: C-reactive protein increased, Cellulitis, Full blood count normal, Injection site erythema, Injection site swelling
Clinical narrative: Mom complains of left arm injection site red, hot and swollen since day of injection. Dx: Cellulitis Tx: Augmentin, ice ibuprofen. Labs: CBC, blood cultures, ESR, c-reactive protein
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site warmth, Red blood cell sedimentation rate normal
Clinical narrative: Mom complains of left arm injection site red, hot and swollen since day of injection. Dx: Cellulitis Tx: Augmentin, ice ibuprofen. Labs: CBC, blood cultures, ESR, c-reactive protein
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Fall, Headache
Clinical narrative: Woke up at 3:00 AM 4/24 - Headaches, sick to stomach, shaking entire body - dizzy, had to hold on. 5:30 lay down and fell to floor within 1 hr shaken stop but weak beaten strange.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Woke up at 3:00 AM 4/24 - Headaches, sick to stomach, shaking entire body - dizzy, had to hold on. 5:30 lay down and fell to floor within 1 hr shaken stop but weak beaten strange.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Local reaction, Pruritus
Clinical narrative: Local faintly pink Rxn with induration and itching - likely secondary latex in DTaP stopper. (Location - Deltoid- IM) Exam DOS 4/21/10. No Rxn around VARIVAX injection.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Back pain, Pyrexia, Urticaria
Clinical narrative: Day after receiving KINRIX, MMR II, VARIVAX, developed fever, back pain, hives.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood culture, C-reactive protein, Cellulitis, Full blood count normal, Injection site erythema
Clinical narrative: Mom complains that injection site is red and swollen size: 3cm x 2.5 cm Dx: Post vaccination cellulitis. Tx: Augmentin Labs: CBC, Blood cultures, CRP
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Laboratory test
Clinical narrative: Mom complains that injection site is red and swollen size: 3cm x 2.5 cm Dx: Post vaccination cellulitis. Tx: Augmentin Labs: CBC, Blood cultures, CRP
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Rash generalised
Clinical narrative: Rash over most of body, began 8 days after receiving vaccine.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom called and stated that pt's injection site is red and swollen about the size of an egg. Instructed to give children's Benadryl and apply ice. If symtoms not resolved or worsen, come in.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Drug exposure during pregnancy, Transmission of an infectious agent via a medicinal product
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included migraine. On 24 September 2009 at 13:59 the subject received unspecified dose of FLULAVAL (0.5 ml, route unknown), and experienced vaccine exposure during pregnancy. No details regarding the pregnancy were available at the time of reporting. Follow-up was received from the reporter on 20 October 2009: The subject's estimated due date was on 03 January 2010. The pregnancy was ongoing with no complications at the time of this report. Follow-up informant was received on 30 April 2010 via healthcare professional. The reporter indicated the adverse event was a result of suspected transmission of an infectious agent via a medicinal product however the pregnancy was by normal conception. On an unspecified date in April 2010, at unspecified gestation age, the subject gave birth to a male live infant who was considered full term. The infant was delivered by normal vaginal delivery, weight 7 pounds 4 ounces; length and Apgar score were not provided. The healthcare professional considered vaccine exposure during pregnancy to be clinically significant. Follow-up information also indicated the vaccination date was 22 September 2009 as opposed to previously reported 24 September 2009.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Received ZOSTAVAX vacc by hospital on Fri 4/30/10, by that nite he had shingles not at vacc site - Placed on VALTREX.
Age: 49.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Lacrimation increased, Seasonal allergy, Throat irritation
Clinical narrative: Runny eyes, dry, scratchy throat. (No swelling no difficulty breathing).
Age: 22.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Breath sounds abnormal, Chest discomfort, Erythema, Loss of consciousness, Nausea
Clinical narrative: Individual experienced swelling with redness and chest tightness within minutes of administration.  Reportedly felt nauseous and like passing out but did not vomit.  Reduced breath sounds were observed.  IM epinephrine 0.3mg, IV diphenhydramine 25mg, and IV famotidine 20mg administered.  Symptoms improved within 15 minutes.
Age: 22.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Swelling
Clinical narrative: Individual experienced swelling with redness and chest tightness within minutes of administration.  Reportedly felt nauseous and like passing out but did not vomit.  Reduced breath sounds were observed.  IM epinephrine 0.3mg, IV diphenhydramine 25mg, and IV famotidine 20mg administered.  Symptoms improved within 15 minutes.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Nodule, Pyrexia
Clinical narrative: Awoke at 8 am with fever and knot in arm, ran fever and arm was red the size of baseball with huge knot, finally had to take to emergency room, had to be lanced and drained and packed and put on Bactrim and has to return to the doctor in 48 hours.
Age: 25.0
Sex: F
Vaccine: TTOX
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Myalgia, Pain
Clinical narrative: I received the tetanus shot in the right upper arm, immediately following, I had a muscular pain that restricted all movement and lifting ability.  It slowly became manageable, but even currently, three weeks later, it still limits my range of movement, becomes sore after a days' movement, and limits my ability to pick up normal items like a gallon of milk.  I have used ibuprofen, heat, showers, ice, and temporary limiting my use, nothing has helped more than temporarily.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Injected limb mobility decreased, Nausea, Vertigo, Vomiting
Clinical narrative: Vertigo, nausea, vomiting, diarrhea, complete uselessness of (no control over) but unfortunately not numbness of my right arm (Tdap). It just hung there.
Age: 28.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Injection site vesicles
Clinical narrative: Patient reported she had "blisters" develop to her right shoulder. She recieved H1N1 vaccine 01/09/2010 to right deltoid.
Age: 1.04
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Cough, Decreased appetite, Dehydration, Ear infection, Pyrexia
Clinical narrative: Fever of 101.8 which led to runny nose, cough, loss of appetite and hospitalization for severe dehydration and ear infection.
Age: 1.04
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Rhinorrhoea
Clinical narrative: Fever of 101.8 which led to runny nose, cough, loss of appetite and hospitalization for severe dehydration and ear infection.
Age: 25.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus generalised
Clinical narrative: Red, soreness, swelling at site of injection. Whole body itching.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, HPV4, MEN, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: PT WOKE UP WITH LA RED, SWOLLEN, AND PAINFUL. SITE MEASURED ABOUT 40MM IN LENGTH AND WAS HOT TO TOUCH.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Cyanosis, Hypotonia, Pallor, Somnolence, Staring
Clinical narrative: After getting home from office, patient was very sleepy and clingy, didn't want to be put down when they got home.  About 30 minutes after getting home grandmother was holding her and she and the mother noticed patient was staring and unresponsive.  Lips turned blue, she was limp, very pale, but no jerking, no fever.  Paramedics called and she was transported via ambulance to hospital.  She was not responding normally, but was alert by the time she got to the hospital.  She was pale and not herself for the past 2 days.  Today she is acting normally, eating normally.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Unresponsive to stimuli
Clinical narrative: After getting home from office, patient was very sleepy and clingy, didn't want to be put down when they got home.  About 30 minutes after getting home grandmother was holding her and she and the mother noticed patient was staring and unresponsive.  Lips turned blue, she was limp, very pale, but no jerking, no fever.  Paramedics called and she was transported via ambulance to hospital.  She was not responding normally, but was alert by the time she got to the hospital.  She was pale and not herself for the past 2 days.  Today she is acting normally, eating normally.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother stated her son came out of his bed room from playing with his brother and said the his brother hurt him, the injection site was red and swollen.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Body temperature increased, Convulsion, Grand mal convulsion
Clinical narrative: Mom reported that patient woke up and started to have seizure like activity. EMS recorded a temp of 102.4 at the scene and patient was taken to Hospital, where she had 2 more episode of seizures on the day of admission. Patient was given Ativan for seizure. Did well until day 3 when she experienced another clonic tonic seizure.
Age: 65.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Urticaria
Clinical narrative: Onset date is approximate.  Bad case of allergic urticaria.  Saw regular doctor on 1/25/10 and he prescribed methylprednisolone and ranitidine.  The hives came back and I saw a dermatologist 2/1/10 and then again about two weeks later.  The dermatologist prescribed prednisone, Xyzal and fluocinonide cream.  The hives eventually went away.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: No reaction on previous exposure to drug, Pain in extremity
Clinical narrative: Arm pain after immunization. Pt. received a Pneumovax vaccination approximately 24 hours ago.  He is not complaining of pain and swelling in the left arm.  He denies any fever or chills.  He denies any airway compromise or other complaints.  He has received pneumococcal vaccination in the past twice (as he reports) without any problems.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Hives at site of injection.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Blood test abnormal, Pyrexia
Clinical narrative: Very high fever ran for four days. Reached 104.1 with Tylenol in system for an hour.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Headache, onset 4/27/10, nausea, onset 5/1/10. Swelling at injection site, left upper arm, onset 5/1/10 worsening daily, approximately size of egg 5/3/10. Treatment: ibuprofen, elevation, cool pack to injection site, referred to MD. C/o feeling "feverish." Temp unknown.
Age: 3.0
Sex: M
Vaccine: FLU3, HIBV
Symptoms: Cellulitis, Erythema, Pain, Swelling, Tenderness
Clinical narrative: Cellulitis, swollen, redness, sourness, tender; ice area, BENADRYL po. prn.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid redness, hot, swollen.  Follow-up - Correct patient's last name; patient's last name updated.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site infection, Oedema peripheral, Pain in extremity, Staphylococcal infection
Clinical narrative: Patient's parent said patient had soreness, swelling, in Left arm. Said she took patient to the Urgent Care. Parent claims the physician said the client had a staph infection at the injection site.
Age: 37.0
Sex: M
Vaccine: DT, RAB
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Initial report received on 04 September 2009 from a consumer.  A 37-year-old patient, who has medical condition of "GERD" (gastroesophageal reflux disease) for which he takes PROTONIX, had received a first right deltoid injection of DECAVAC; a first left deltoid/thigh/buttocks dose of IMOGAM; and a first dose of IMOVAX on 02 September 2009.  The indications for post exposure vaccination was not provided.  The next day after receiving the vaccinations, the patient experienced body aches, sore throat and a fever.  It was not reported whether the patient required medical evaluation, or if he received any treatments.  At the time of this report, the patient had not recovered.  Documents held by sender:
Age: 38.0
Sex: F
Vaccine: DT
Symptoms: Influenza like illness, Injection site erythema, Pyrexia
Clinical narrative: Initial report was received 08 July 2009 from a health care professional. A 38-year-old female patient with an unknown medical history, had received an injection of DECAVAC, lot number U2590CA on 06 July 2009 and within 24 hours, she developed flu like symptoms, fever and injection site redness which measured 8 - 12 inches in diameter. The event required a doctor's visit. It was unknown if the patient had any concurrent illness at the time of vaccination and her recovery status was reported as unknown. The reporter for this case is the same as for case number 2009-03018. Documents held by sender: None
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Blood electrolytes, Blood magnesium, Computerised tomogram, Dizziness, Electroencephalogram
Clinical narrative: Initial and follow-up information has been received from a registered nurse and a physician concerning a 14 year old female with no pertinent medical history who on 21-APR-2010 was vaccinated IM with a first dose of GARDASIL (lot # 663559/1178Y) and a dose of VAQTA (lot # 667009/0095Z). There were no concomitant medications. It was reported that on 21-APR-2010, five minutes after the vaccination, the patient experienced seizure which lasted about 1 minute. The patient went to the emergency room where lab work was done (results not specified) but she was not admitted. On 26-APR-2010, the patient had an EEG done (results pending). As of this date, the patient had not been referred to neurology or any other specialty, awaiting results of EEG. The patient recovered from seizure, but neither physician nor nurse would say if the event was disabling or life-threatening until further testing was done. Upon internal review, the event of seizure was considered an Other Important Medical Event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Enuresis, Loss of consciousness, Pain in extremity, Tonic clonic movements
Clinical narrative: Initial and follow-up information has been received from a registered nurse and a physician concerning a 14 year old female with no pertinent medical history who on 21-APR-2010 was vaccinated IM with a first dose of GARDASIL (lot # 663559/1178Y) and a dose of VAQTA (lot # 667009/0095Z). There were no concomitant medications. It was reported that on 21-APR-2010, five minutes after the vaccination, the patient experienced seizure which lasted about 1 minute. The patient went to the emergency room where lab work was done (results not specified) but she was not admitted. On 26-APR-2010, the patient had an EEG done (results pending). As of this date, the patient had not been referred to neurology or any other specialty, awaiting results of EEG. The patient recovered from seizure, but neither physician nor nurse would say if the event was disabling or life-threatening until further testing was done. Upon internal review, the event of seizure was considered an Other Important Medical Event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Convulsion, Electroencephalogram, Laboratory test
Clinical narrative: Initial and follow-up information has been received from a registered nurse and a physician concerning a 14 year old female with no pertinent medical history who on 21-APR-2010 was vaccinated IM with a first dose of GARDASIL (lot # 663559/1178Y) and a dose of VAQTA (lot # 667009/0095Z). There were no concomitant medications. It was reported that on 21-APR-2010, five minutes after the vaccination, the patient experienced seizure which lasted about 1 minute. The patient went to the emergency room where lab work was done (results not specified) but she was not admitted. On 26-APR-2010, the patient had an EEG done (results pending). As of this date, the patient had not been referred to neurology or any other specialty, awaiting results of EEG. The patient recovered from seizure, but neither physician nor nurse would say if the event was disabling or life-threatening until further testing was done. Upon internal review, the event of seizure was considered an Other Important Medical Event. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: YF, YF
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swelling of the injection site, right arm, with knot under the skin and redness at injection site about 5cm in diameter
Age: 30.0
Sex: M
Vaccine: YF, YF
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: swelling of the injection site, right arm, with knot under the skin and redness at injection site about 5cm in diameter
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Dizziness, Headache, Injection site erythema, Injection site pain
Clinical narrative: Redness and pain in injection area in morning. By afternoon:  Body aches, fever (102 degrees). Around midnight:  nausea, vomiting, diarrhea, dizziness, fainting. Next day:  severe headaches. Recovered within 3 days with some lingering redness and soreness in injection area.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Pain, Pyrexia, Syncope, Vomiting
Clinical narrative: Redness and pain in injection area in morning. By afternoon:  Body aches, fever (102 degrees). Around midnight:  nausea, vomiting, diarrhea, dizziness, fainting. Next day:  severe headaches. Recovered within 3 days with some lingering redness and soreness in injection area.
Age: 51.0
Sex: F
Vaccine: DT
Symptoms: Chills, Pyrexia
Clinical narrative: Fever chills occurring evening after injection.
Age: 34.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site erythema, Injection site swelling, Pain, Skin lesion
Clinical narrative: Woke up with pain under left armpit and felt a lump. Smallpox vaccination site was red and swollen with other lesions present.
Age: 1.6
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The child received a DTaP vaccination on 04/30/2010. Injection site became erythematous, warm and painful to the touch by the next morning. On 05/02/2010, the erythematous area enlarged and the child was taken to a local ER for evaluation. He was diagnosed with acute cellulitis and given a prescription for Duricef. By the time the parents filled the prescription, the child had fallen asleep and when he awoke several hours later, the redness and warmth had begun to resolve (no antibiotic had been administered). The parents did administer the antibiotic and on the child's presentation to the Pediatric Clinic on 05/03/2010, the erythema, tenderness and warmth had completely resolved.
Age: 60.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Musculoskeletal pain
Clinical narrative: Pain in (R) shoulder beginning 3-4 wks post vaccination in same arm. Dx by orthopedist that "capsule is freezing up" from the immunization. Improving with exercise, local therapy but not back to baseline.
Age: 54.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Arthralgia, Laboratory test, Musculoskeletal pain
Clinical narrative: Shoulder pain at time of administration of vacc. Pain persisted & now involves both shoulders & now hips.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Haematoma, Immediate post-injection reaction, Injection site pain, Muscular weakness, Myalgia
Clinical narrative: Pt. states immediately after vaccination in left deltoid, she had penetrating, burning pain from the shoulder to the wrist.  She felt the arm to be limp and just hanging as if paralyzed.  She also complained of muscle soreness, and a hematoma which resolved within one week.  She still continues with weakness, burning, and shooting pains in the left deltoid muscle.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pain
Clinical narrative: Pt. states immediately after vaccination in left deltoid, she had penetrating, burning pain from the shoulder to the wrist.  She felt the arm to be limp and just hanging as if paralyzed.  She also complained of muscle soreness, and a hematoma which resolved within one week.  She still continues with weakness, burning, and shooting pains in the left deltoid muscle.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Decreased appetite, Lethargy, Nausea, Pyrexia, Restlessness
Clinical narrative: Vomiting, dry heaves, lethargic.  This continued all day on 5/1/2010.  He was seemingly better on 5/2/2010.  On 5/3/2010 he started vomiting again.  He also had dry heaves, no appetite/ nausea, slight fever, lethargic, and very restless.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Retching, Vomiting
Clinical narrative: Vomiting, dry heaves, lethargic.  This continued all day on 5/1/2010.  He was seemingly better on 5/2/2010.  On 5/3/2010 he started vomiting again.  He also had dry heaves, no appetite/ nausea, slight fever, lethargic, and very restless.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a female patient of unknown age who on an unspecified date was vaccinated with an unknown dose of GARDASIL. The patient's medical history, past drug history and concomitant medications were unknown. On an unknown date the patient experienced seizures. It was unknown if any laboratory testing was performed. As of 21-APR-2010, the patient was no longer receiving GARDASIL and it was unknown if the seizures continued. It was unspecified if the patient sought medical attention. Upon internal review, seizures was considered serious as an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Anxiety, Back pain, Blood test normal, Chest pain
Clinical narrative: Pleural effusion, stomach/pelvic pain - ER visit - no treatment. Nausea, headaches, weight loss, anxiety, pericarditis, light sensitivity, sore muscles, back pain, no recovery, swollen lymph nodes, acid reflux - no treatment. Chest pain, confusion, rashes, fatique, fevers, migrains, bruises, neck pain, and vomiting. 7/23/10 swelling, insomnia, blood clots, and intestinal problems and earaches.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Colonoscopy, Colonoscopy normal, Confusional state, Contusion, Ear pain
Clinical narrative: Pleural effusion, stomach/pelvic pain - ER visit - no treatment. Nausea, headaches, weight loss, anxiety, pericarditis, light sensitivity, sore muscles, back pain, no recovery, swollen lymph nodes, acid reflux - no treatment. Chest pain, confusion, rashes, fatique, fevers, migrains, bruises, neck pain, and vomiting. 7/23/10 swelling, insomnia, blood clots, and intestinal problems and earaches.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Endoscopy, Endoscopy normal, Fatigue, Gastrointestinal disorder, Gastrooesophageal reflux disease
Clinical narrative: Pleural effusion, stomach/pelvic pain - ER visit - no treatment. Nausea, headaches, weight loss, anxiety, pericarditis, light sensitivity, sore muscles, back pain, no recovery, swollen lymph nodes, acid reflux - no treatment. Chest pain, confusion, rashes, fatique, fevers, migrains, bruises, neck pain, and vomiting. 7/23/10 swelling, insomnia, blood clots, and intestinal problems and earaches.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Insomnia, Intestinal functional disorder, Laparoscopy, Laparoscopy normal
Clinical narrative: Pleural effusion, stomach/pelvic pain - ER visit - no treatment. Nausea, headaches, weight loss, anxiety, pericarditis, light sensitivity, sore muscles, back pain, no recovery, swollen lymph nodes, acid reflux - no treatment. Chest pain, confusion, rashes, fatique, fevers, migrains, bruises, neck pain, and vomiting. 7/23/10 swelling, insomnia, blood clots, and intestinal problems and earaches.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Migraine, Myalgia, Nausea, Neck pain
Clinical narrative: Pleural effusion, stomach/pelvic pain - ER visit - no treatment. Nausea, headaches, weight loss, anxiety, pericarditis, light sensitivity, sore muscles, back pain, no recovery, swollen lymph nodes, acid reflux - no treatment. Chest pain, confusion, rashes, fatique, fevers, migrains, bruises, neck pain, and vomiting. 7/23/10 swelling, insomnia, blood clots, and intestinal problems and earaches.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pelvic pain, Pericarditis, Photophobia, Pleural effusion, Pyrexia
Clinical narrative: Pleural effusion, stomach/pelvic pain - ER visit - no treatment. Nausea, headaches, weight loss, anxiety, pericarditis, light sensitivity, sore muscles, back pain, no recovery, swollen lymph nodes, acid reflux - no treatment. Chest pain, confusion, rashes, fatique, fevers, migrains, bruises, neck pain, and vomiting. 7/23/10 swelling, insomnia, blood clots, and intestinal problems and earaches.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Swelling, Thrombosis, Vomiting, Weight decreased
Clinical narrative: Pleural effusion, stomach/pelvic pain - ER visit - no treatment. Nausea, headaches, weight loss, anxiety, pericarditis, light sensitivity, sore muscles, back pain, no recovery, swollen lymph nodes, acid reflux - no treatment. Chest pain, confusion, rashes, fatique, fevers, migrains, bruises, neck pain, and vomiting. 7/23/10 swelling, insomnia, blood clots, and intestinal problems and earaches.
Age: 58.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Musculoskeletal pain, Nuclear magnetic resonance imaging, Rotator cuff syndrome, X-ray
Clinical narrative: X-ray 12/18/09. Chronic rotator cuff tendinopathy (left) above the greater tuberosity of the left humerus near the insertion of the rotator cuff. Pain started off slowly and increased over time and spread to up per shoulder and back of shoulder.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Redness and mild edema and induration left arm in area of vaccination. No fever, no systemic symptoms.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Leg swelled up around injection site, warm to the touch, red splotchy rash was given DPT Tox, seemed to help.
Age: 1.52
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt given shot on 4-26-10. On 4-28-10, pt developed warm, red patch on (R) thigh.
Age: 13.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Balance disorder, Fatigue, Feeling abnormal, Laboratory test, Muscular weakness
Clinical narrative: Episodic intense fatigue, muscle weakness, mental fogginess and general loss of balance - lasts from 2-12 hrs - cries 2-4 x 1 week - in between totally nl.
Age: 12.0
Sex: M
Vaccine: IPV, MNQ, TDAP
Symptoms: Blood culture, Full blood count, Injection site erythema, Injection site swelling
Clinical narrative: 12-24 hours after 4th Tdap, pt developed redness, swelling of (L) upper arm at site of injection. Increased in size over next 24 hours to encompass 2/3 of length and 1/3 circumference of (L) upper arm.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Patient's wife reported on 4-29-10 that the day after he received injection that the site was red, swollen, itching and patient had "light" fever. He wasn't treated by a doctor.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 48 hrs after vaccine given, deltoid muscle became markedly swollen, red, firmness at site of vaccine, markedly tender.  Pt has returned to be seen twice for this concern at our office.  Site is improving as of 4/29/10.