chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.49
Sex: M
Vaccine: HEPA
Symptoms: Rash, Similar reaction on previous exposure to drug, Urticaria
Clinical narrative: Rash on torso mainly on front with a few on back. Mom describes as "welts in groups". Mom gave BENADRYL. No itching with rash. Mom states pt had same reaction the last time he received immun at H. Dept (10/6/10). She reported this last time to pts previous phys who recommended BENADRYL. This is the 1st time immuns. were given at this office. Pt est at this visit.
Sex: F
Vaccine: HPV4
Symptoms: Cerebrovascular accident
Clinical narrative: Information has been received from a physician via telephone call about a conversation he heard concerning a teenage female patient who on an unspecified date was vaccinated with a dose of GARDASIL (Lot # not reported).  On an unspecified date the patient had a stroke.  At the time of the report, the patient's outcome was unknown.  Upon internal review strokes were considered to be an other important medical event.  It was unknown if the patient sought medical attention.  This is one of several reports received from the same source.  Additional information is not expected.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Rash papular
Clinical narrative: erythematous papules on hands and elbows, erythematous patch on back of neck
Age: 57.0
Sex: F
Vaccine: TTOX
Symptoms: Chills, Erythema, Pyrexia, Swelling, Urticaria
Clinical narrative: Hives, fever, swelling, chills, redness.
Age: 10.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Fluctuance, Injection site induration, Local reaction
Clinical narrative: Pt had delayed local reaction around injection. Total size=3 3/4 cm with slightly fluctuance, with 1 1/4 cm with induration. No tenderness. Pt = obese 1" needle. Occurred 6 days post vaccine ? 10 days post vaccine.
Age: 10.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Erythema, Induration, Purpura, Skin warm, Swelling
Clinical narrative: Pt had delayed local reaction around injection. Total size=3 3/4 cm with slightly fluctuance, with 1 1/4 cm with induration. No tenderness. Pt = obese 1" needle. Occurred 6 days post vaccine ? 10 days post vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Dyskinesia, Screaming, Somnolence, Vertigo, Vomiting
Clinical narrative: Received 4 yr vaccines. Emesis after dinner. Went to sleep, woke screaming, said room was shaking & wanting to be held. Rhythmic jerking of both legs, respiratory rate 45/min. Sleepy. No pain. Total of 5 episodes between 3:30 & 5:30. History of febrile seizures. Pt knows when seizure coming on unsure if fever.
Age: 0.51
Sex: M
Vaccine: FLU3, HIBV
Symptoms: Injection site erythema, Injection site rash, Oedema peripheral, Pallor, Radioallergosorbent test positive
Clinical narrative: Well-baby exam 11/22/2010 with mom reporting red bumps on child's arms, legs, and buttock. Child given sweet potatoes and used new diapers 3 days prior to bumps onset (11/19/2010). Providers documented a few "blanchable lesions on lower extremities and buttocks with papular rash in axilla and inguinal areas" otherwise a normal exam-diagnosed with Intertrigo and vaccinated with influenza vaccine and HIB #3 to right leg (approximately 9-9:30 am). Approximately 1.5 hours later mom noted some redness and bumps (like mosquito bites) to upper right thigh (at vaccine sites) and to posterior upper thighs R>L. Over then next several hours, this single macular red rash spread to both legs and feet with subjective swelling to bilateral anterior feet (per mom). Mom did not remember any rash to soles of feet. There was no fever, irritability, vomiting, dysphagia, respiratory distress, swelling, or rash to torso, hands, back or face. Child was treated that evening at nearby ER about 1900 hours for "hives" with oral BENADRYL and prednisone (approximately 10 hour post vaccination). Rash resolved after given BENADRYL (11/22/2010). Follow up evaluation 11/24/2010 noted a few "blanchable lesions on lower extremities and buttock" otherwise normal exam. Mom advised no exposure to new detergents, cloths, cleansing washes/soaps, or powders. She was using new diaper and no change in diet (liquids) other than adding pureed foods (sweet potato 11/19/2010). Mom advised this rash reflared 11/25/2010 (day 3) as small red pimp-like macules that progressed to hives (nickel-quater sized red raised areas) again on legs, buttock and a few on his forearms. Mom restarted the steroids and BENADRYL (per phone consult with HCP) stopping the steroids after 24 hours. She continued the BENADRYL x 5 days with resolution of symptoms. This rash re-flared 12/5/2010 and 12/13/2010 each lasting 1-5 days with BENADRYL use. Mom advised the rash began on the child's upper thighs with 2 episodes having raised lesion to bilateral forearms and once with 1 bump to face. Mom advised child appears to be in no distress, not fussy, no fever, or other systemic symptoms. Mom had been trying new food group such as carrots and squash (week of 12/13/2010) when she noticed reflare of the above rash; however, she does not remember the exact timing of the rash in relation to feeding her child. Mom also advised child had been off BENADRYL for a few days. Child was given other food groups such as banana (11/30/2010) and green beans (week of 12/13/2010) without reaction. Rash fully resolved w/o reflare as of 12/18/2010. Follow up vaccinations resulted no no rash or any adverse event.
Age: 0.51
Sex: M
Vaccine: FLU3, HIBV
Symptoms: Rash erythematous, Rash macular, Skin lesion
Clinical narrative: Well-baby exam 11/22/2010 with mom reporting red bumps on child's arms, legs, and buttock. Child given sweet potatoes and used new diapers 3 days prior to bumps onset (11/19/2010). Providers documented a few "blanchable lesions on lower extremities and buttocks with papular rash in axilla and inguinal areas" otherwise a normal exam-diagnosed with Intertrigo and vaccinated with influenza vaccine and HIB #3 to right leg (approximately 9-9:30 am). Approximately 1.5 hours later mom noted some redness and bumps (like mosquito bites) to upper right thigh (at vaccine sites) and to posterior upper thighs R>L. Over then next several hours, this single macular red rash spread to both legs and feet with subjective swelling to bilateral anterior feet (per mom). Mom did not remember any rash to soles of feet. There was no fever, irritability, vomiting, dysphagia, respiratory distress, swelling, or rash to torso, hands, back or face. Child was treated that evening at nearby ER about 1900 hours for "hives" with oral BENADRYL and prednisone (approximately 10 hour post vaccination). Rash resolved after given BENADRYL (11/22/2010). Follow up evaluation 11/24/2010 noted a few "blanchable lesions on lower extremities and buttock" otherwise normal exam. Mom advised no exposure to new detergents, cloths, cleansing washes/soaps, or powders. She was using new diaper and no change in diet (liquids) other than adding pureed foods (sweet potato 11/19/2010). Mom advised this rash reflared 11/25/2010 (day 3) as small red pimp-like macules that progressed to hives (nickel-quater sized red raised areas) again on legs, buttock and a few on his forearms. Mom restarted the steroids and BENADRYL (per phone consult with HCP) stopping the steroids after 24 hours. She continued the BENADRYL x 5 days with resolution of symptoms. This rash re-flared 12/5/2010 and 12/13/2010 each lasting 1-5 days with BENADRYL use. Mom advised the rash began on the child's upper thighs with 2 episodes having raised lesion to bilateral forearms and once with 1 bump to face. Mom advised child appears to be in no distress, not fussy, no fever, or other systemic symptoms. Mom had been trying new food group such as carrots and squash (week of 12/13/2010) when she noticed reflare of the above rash; however, she does not remember the exact timing of the rash in relation to feeding her child. Mom also advised child had been off BENADRYL for a few days. Child was given other food groups such as banana (11/30/2010) and green beans (week of 12/13/2010) without reaction. Rash fully resolved w/o reflare as of 12/18/2010. Follow up vaccinations resulted no no rash or any adverse event.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Induration, Local swelling, Rash
Clinical narrative: Localized swelling about 10cm of induration.  No other rash.  Recommended to mom to use Tylenol for pain and Benadryl for itching.  If rash spreads to be reevaluated.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Fever of 100, headache, stomachache, body aches, dizziness
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cardiac imaging procedure, Dyspnoea, Echocardiogram, Electroencephalogram
Clinical narrative: 10/21/10: Numbness/tingling arms and eventually whole body.  Difficulty breathing- felt like I was forced to take a deep breath. 10/30/10: Husband called 911. I was numb/tingling in whole body. Weakness. Felt like I was becomng paralyzed. Difficulty breathing. Metabolic acidosis upon arrival to hospital. Was intubated for 1 day. Diaganosed with stress cardiomyopathy, toxic metabolic encephalopathy.Was hositalized or 1 month.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Endotracheal intubation, Hypoaesthesia, Lumbar puncture, Metabolic acidosis, Metabolic encephalopathy
Clinical narrative: 10/21/10: Numbness/tingling arms and eventually whole body.  Difficulty breathing- felt like I was forced to take a deep breath. 10/30/10: Husband called 911. I was numb/tingling in whole body. Weakness. Felt like I was becomng paralyzed. Difficulty breathing. Metabolic acidosis upon arrival to hospital. Was intubated for 1 day. Diaganosed with stress cardiomyopathy, toxic metabolic encephalopathy.Was hositalized or 1 month.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Paraesthesia, Stress cardiomyopathy, Toxic encephalopathy
Clinical narrative: 10/21/10: Numbness/tingling arms and eventually whole body.  Difficulty breathing- felt like I was forced to take a deep breath. 10/30/10: Husband called 911. I was numb/tingling in whole body. Weakness. Felt like I was becomng paralyzed. Difficulty breathing. Metabolic acidosis upon arrival to hospital. Was intubated for 1 day. Diaganosed with stress cardiomyopathy, toxic metabolic encephalopathy.Was hositalized or 1 month.
Age: 19.0
Sex: F
Vaccine: HEPAB, IPV, YF
Symptoms: CSF test abnormal, Death, Meningococcal infection, Neisseria test positive
Clinical narrative: No known adverse event at tim eof the vaccination. Pt died on 02/05/2011.
Age: 44.0
Sex: F
Vaccine: HEPA, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: "Right arm where I got my shots became red, swollen, sore to touch yesterday. Still the same today, but darker red." Saw M.D. at Health Clinic who said there was 1 large red welt and 3 small ones and recommended ice pack to site, Benadryl, and cortisone cream.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pruritus
Clinical narrative: Left leg redness with erythema and pruritus measuring about 10cm.
Age: 32.0
Sex: F
Vaccine: HEP, PPV, TDAP
Symptoms: Erythema, Injection site warmth, Pyrexia, Rash macular
Clinical narrative: Fever, redness to arm, site hot, red blotches on inner aspect of arm.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Headache, Influenza virus test negative, Injection site swelling, Pain
Clinical narrative: Received TDAP 2/22/11 in am, a few hours later developed body aches, T 101, headache. Experienced redness/swelling at site of admin. Fever as high as 103 evening of 2/24/11. Started on abx 2/24 to cover for possible cellulitis.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Received TDAP 2/22/11 in am, a few hours later developed body aches, T 101, headache. Experienced redness/swelling at site of admin. Fever as high as 103 evening of 2/24/11. Started on abx 2/24 to cover for possible cellulitis.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Pain
Clinical narrative: 2 hrs after injection, felt itching, soreness. Later felt hard lump at injection site with surrounding redness, swelling. No fevers, myalgias. Was improving by 24 hrs after injection.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: 2 hrs after injection, felt itching, soreness. Later felt hard lump at injection site with surrounding redness, swelling. No fevers, myalgias. Was improving by 24 hrs after injection.
Age: 0.57
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh became red & swollen after receiving vaccines on 02/23/11. 02/25/11 left leg increase in size & was warm to touch.
Age: 29.0
Sex: F
Vaccine: UNK, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Started 9-10h after injection. Redness, swelling, pain, itching at site of injection. Continued to grow 41 h after injection (without treatment). At 41 h. initiated BENADRYL, ibuprofen & ice, topical hydrocortisone.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm to touch area size of quarter on 2/17/11, by evening on 2/18/11 was nearly size of thigh. Pt returned to clinic for evaluation.
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: Dysphonia, Oropharyngeal pain, Pharyngeal erythema, Pharyngeal oedema
Clinical narrative: Received Hepatitis B vaccination on 2/21/2011 at 11 AM. At 1900 on 2/21/2011 noticed sore throat - raw feeling coming on - hoarseness, back of throat reddened/swollen. Went home gargled with salt water; took NYQUIL and slept propped up. Soreness and hoarseness persists. Concerned over symptoms - unsure related.
Age: 21.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Arthralgia, Blister, Pain in extremity, Pruritus, Rash papular
Clinical narrative: Itchy hands, one day later erythematous papular rash with pain to hands and elbow region. A few vesicles day of examination. No fever. No N/V/D. No past hx of skin problems.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, PNC13
Symptoms: Local reaction
Clinical narrative: Local effects of vaccines. Recommendations: warm compress and clean area well TID, if no improvement or worsening symptoms develop call the office.
Age: 1.01
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Diarrhoea, Fatigue, Irritability, Pain, Vomiting
Clinical narrative: My daughter started vomiting around 12 pm on the 25th and started having very watery poop as well.  I took her to the er at 7:30 where the started an iv.  She is very fussy, tired, achy and has vomiting and runny poop.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Lethargy, Vomiting
Clinical narrative: Daughter was fine and then out of nowhere started vomiting. She didn't eat anything differently or wasn't ill with a stomach bug. The vomiting lasted about 3 hours. She was very lethargic. After 3 hours the vomiting stopped and she was running around the house like normal. No treatment was done.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Blood test, Chest X-ray, Computerised tomogram head, Dizziness
Clinical narrative: Extreme dizziness, Increase in blood pressure,
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Electrocardiogram
Clinical narrative: Extreme dizziness, Increase in blood pressure,
Age: 1.32
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Abasia, Injection site swelling
Clinical narrative: extreme swelling at injection site, unable to walk for several hours
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Insomnia, Pain in extremity, Rash
Clinical narrative: Patient experienced pain in left arm right away and had a hard time sleeping that evening because of the pain. Pt took 400mg ibuprofen for pain. Rash (mostly below injection site) appeared 2/25/11 afternoon. Pt. reports less pain 2/26/11 but rash still present. She will try BENADRYL.
Age: 68.0
Sex: F
Vaccine: PPV, TD
Symptoms: Chills, Inflammation, Injection site inflammation
Clinical narrative: 18 hours of chills, then 7 days of inflamed arm, after receiving pneumococcal polysaccharide vaccine, spreading to over 6 inches in circumference at sight of injection.  Arm reddened, hot and itchy increasing and peaking on 4th day and then gradually subsiding, finally normalizing by 7 or 8th day.
Age: 33.0
Sex: F
Vaccine: ANTH, MEN
Symptoms: Cold sweat, Headache, Nausea, Pain
Clinical narrative: Severe headache, body aches, nausea, cold sweats. Vital signs stable, afebrile.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: achy-ness, soreness to touch, chills, shakiness grew intensity into the evening, fever broke mid-morning after sleep and ibuprofen
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Rash covering hands, arms, legs, neck and face
Age: 23.0
Sex: M
Vaccine: ANTH, FLU(H1N1)
Symptoms: Alopecia, Blood bilirubin increased, Blood test, Computerised tomogram, Dizziness
Clinical narrative: vertigo chronic lightheaded surreal feelings of environment hair thinning elevated liver enzymes/bilirubin  Three weeks after vaccinations was when I first noticed any changes in my health. I have had experiences with the above issues for over thirteen months. There has been no diagnosis, prognosis, or definitive answers as to what has caused these symptoms, and issues. I was given Anthrax, H1N1, and a tuberculin skin test all in the same setting. Up to ninety nine percent of my visits to any care provider have been military. I am currently at a facility attempting to resolve this matter, and to alleviate my concerns.
Age: 23.0
Sex: M
Vaccine: ANTH, FLU(H1N1)
Symptoms: Feeling abnormal, Hepatic enzyme increased, Nuclear magnetic resonance imaging, Vertigo
Clinical narrative: vertigo chronic lightheaded surreal feelings of environment hair thinning elevated liver enzymes/bilirubin  Three weeks after vaccinations was when I first noticed any changes in my health. I have had experiences with the above issues for over thirteen months. There has been no diagnosis, prognosis, or definitive answers as to what has caused these symptoms, and issues. I was given Anthrax, H1N1, and a tuberculin skin test all in the same setting. Up to ninety nine percent of my visits to any care provider have been military. I am currently at a facility attempting to resolve this matter, and to alleviate my concerns.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Influenza like illness, Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: Pain at injection site; arm continued to be sore all week and became red and swollen, according to the patient.  Now one week later she is c/o flu-like symptoms with fever but not actually measured.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: Pain at injection site; arm continued to be sore all week and became red and swollen, according to the patient.  Now one week later she is c/o flu-like symptoms with fever but not actually measured.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site; arm continued to be sore all week and became red and swollen, according to the patient.  Now one week later she is c/o flu-like symptoms with fever but not actually measured.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Myalgia, Pyrexia, Rash
Clinical narrative: fever, arm rash, aching muscles, movement in arm of vaccine severly impacted was unable to move it for two weeks
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Autoimmune thrombocytopenia, Blood test abnormal
Clinical narrative: Immune Thrombocytopenic Purpura following Influenza vaccination. I was in the hospital for 13 days.
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of influenza type a in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline).  On an unspecified date in November 2010 the subject received a dose of FLUARIX (unknown).  At an unspecified time after vaccination with FLUARIX, the subject experienced influenza type a and vaccination failure.  The sales representative stated a subject was vaccinated with FLUARIX in November 2010, came into the office and tested positive for influenza (tested for type A).  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the influenza type a and vaccination failure was unspecified.  This is one of three cases the sales representative reported that tested positive for influenza (two subjects tested for type A and one subject tested for type B).  Please see cases A0914708A and A0914709A.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, PNC13
Symptoms: Injection site erythema, Injection site haematoma, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: PREVNAR 13 injected in right thigh.  Redness that continued to darken.  Swelling half inch above skin that hardened the following 24 hrs.  The red welt and hard swelling spanned over four inches away from actual injection site.  Fever of 100.2  Intense pain on that leg.  This is compared to a different vaccine on the other leg that left only a tiny little dot @ injection site.  Large bruising and lump still across thigh, two days later.  Still watching leg/mood/etc.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, PNC13
Symptoms: Injection site swelling, Injection site urticaria, Pyrexia
Clinical narrative: PREVNAR 13 injected in right thigh.  Redness that continued to darken.  Swelling half inch above skin that hardened the following 24 hrs.  The red welt and hard swelling spanned over four inches away from actual injection site.  Fever of 100.2  Intense pain on that leg.  This is compared to a different vaccine on the other leg that left only a tiny little dot @ injection site.  Large bruising and lump still across thigh, two days later.  Still watching leg/mood/etc.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site induration, Injection site pain, Local reaction, Pyrexia
Clinical narrative: Localized reaction to left upper arm - induration, tender, no drainage, low grade fever - about 99 degrees-100 degrees, no numbness, tingling to arm currently on Cephalexin, BENADRYL.
Age: 0.71
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HIBV, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site pain, Injection site rash, Pruritus, Skin warm
Clinical narrative: Redness, warmth, itching, pt. c/o bumps around site, tender to touch. Pt. noticed these on day after inject. 2/24/11 (Thursday).
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Ultrasound foetal, Ultrasound scan abnormal, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a Nurse Practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female with no pertinent medical history or drug/allergies reactions, who was vaccinated with the first and second dose of GARDASIL (dose, route and lot # unspecified) on 18-AUG-2010 and 20-JAN-2011 respectively.  There was no concomitant medication.  The nurse reported that the patient discovered to be pregnant the same day (on 20-JAN-2011) GARDASIL was received, through urine pregnancy testing.  It was reported the last menstrual period (LMP) was on 29-DEC-2010 and the estimated delivery (EDD) date on 05-OCT-2011.  The nurse also mentioned patient was tested because she was being followed for an IUD, and the IUD was found to have been expelled.  No adverse effects were reported by the patient.  In follow up information the nurse practitioner reported that the 20 year old female patient had two previous pregnancies with two live births in the last two years of which neither had any birth defects in 20-JAN-2011 (also reported as 20-JAN-2010) received intramuscularly into the right deltoid the second dose of GARDASIL (Lot # 666118/1539Y).  On 25-JAN-2011 the patient underwent an ultrasound to clarify the estimated delivery date (EDD), result which 10 wld IUP, which was reported as 22-AUG-2011.  On 02-FEB-2011 the patient terminated her pregnancy at 4 weeks from LMP.  The EDD was reported as being 22-AUG-2011.  It was stated that the patient did not want a third baby in 3 years.  She got pregnant due to spontaneous expulsion of MIRENA.  It was unknown if the products of conception were examined.  It was unknown if the fetus was normal.  The nurse practitioner stated that the patient had an elective termination which was not at all related to GARDASIL.  Upon internal review, patient had terminated the pregnancy was determined to be an other important medical event.  The patient sought for unspecified medical attention.  Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Fungal test negative, Headache, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Chronic headache beginning the day after AVA #9. Multiple visits for evaluation and treatment. Controlled on meds.
Age: 1.75
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema
Clinical narrative: Day after shots developed erythema around area of immunization. Still present 3 days later.
Age: 3.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Febrile convulsion
Clinical narrative: Pt. reported to ER with febrile seizures 8 days after administration of MMRV (PROQUAD).
Age: 0.59
Sex: M
Vaccine: DTAP, IPV
Symptoms: Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: Pt. began having seizures 10 days following the administration of vaccines.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Mass
Clinical narrative: Patient received a flu shot and immediately experienced a small dome, about quarter size, raised lump about 5 mm. No bleeding, no systemic issues. Subsequent follow-up -day later- patient's left deltoid was present with a large erythema at the site of injection.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Haemoglobin normal, Petechiae, Platelet count decreased, White blood cell count normal
Clinical narrative: Pt. developed petechial rash on 2/17/11 which progressed over the course of 3 days. Platelet count found to be 21,000 (WBC + Hg nl).
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Blood culture negative, Chills, Full blood count normal, Headache, Pyrexia
Clinical narrative: High fever 104 degrees, chills, bad headache about 10 hrs after vaccine. No redness or swelling at vaccine site treated with ROCEPHIN, then oral antibiotics (? viral illness).
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 2/16/11 at 7pm c/o (R) deltoid pain (10/10), swollen (3+), itching, site warm & firm to touch, erythema, below injection site & limited ROM RUE. States 'felt like fever' 2/17/11 felt exhausted, fever-did not check temp. Called PMD Rx'd & took MOTRIN 600mg & BENADRYL 25mg- felt a little better x 2-3hrs & repeated same meds at night. 2/18/11- felt better, (R) deltoid with red spots below site at 4 pm seen by PMD & Rx Amoxicillin & anti inflammatory. Took 2 doses & states on 2/19/11 possible allergic reaction to antibiotic/anti inflam. Stopped meds. 2/20/11 c/o HA & RUE s/s resolved & ROM WNL to RUE.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 2/16/11 at 7pm c/o (R) deltoid pain (10/10), swollen (3+), itching, site warm & firm to touch, erythema, below injection site & limited ROM RUE. States 'felt like fever' 2/17/11 felt exhausted, fever-did not check temp. Called PMD Rx'd & took MOTRIN 600mg & BENADRYL 25mg- felt a little better x 2-3hrs & repeated same meds at night. 2/18/11- felt better, (R) deltoid with red spots below site at 4 pm seen by PMD & Rx Amoxicillin & anti inflammatory. Took 2 doses & states on 2/19/11 possible allergic reaction to antibiotic/anti inflam. Stopped meds. 2/20/11 c/o HA & RUE s/s resolved & ROM WNL to RUE.
Age: 1.15
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Abasia, Balance disorder, Dysstasia, Fall, Gait disturbance
Clinical narrative: Per MOC, evening of 6-30-10 child vomited, was losing her balance & falling down. Next day mom stated "she would swing herself over backward" & couldn't sit up, stand or walk. MOC called her MD who advised her to be seen at walk-in care. She took child to walk-in care & was told by health care provider to return if child was not able to walk after one week. Per MOC child was wobbly & needed assistance with walking after a week but eventually improved & recovered.
Age: 1.15
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Vomiting, Walking aid user
Clinical narrative: Per MOC, evening of 6-30-10 child vomited, was losing her balance & falling down. Next day mom stated "she would swing herself over backward" & couldn't sit up, stand or walk. MOC called her MD who advised her to be seen at walk-in care. She took child to walk-in care & was told by health care provider to return if child was not able to walk after one week. Per MOC child was wobbly & needed assistance with walking after a week but eventually improved & recovered.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swollen thigh hardened, red/hot to touch. Limping. MOTRIN given by mom with relief.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swollen thigh hardened, red & hot to touch. Limping. MOTRIN given by mom with relief.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Fever 2/17 - PM 101 - Rt leg extremely swollen with mild rash - inner thigh no edema or redness at knee.
Age: 1.46
Sex: F
Vaccine: HEP, TDAP
Symptoms: Hyperventilation, Pyrexia, Vomiting
Clinical narrative: Breathing heavy, vomited one time. Fever 102-103 lasted close to 48 hours. MOTRIN every 6-8 hours kept fever down.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Received already 3 doses of PCV 7. Red, circle, warm to touch extending in whole front thigh area not the back. Not in pain. Sunday redness spread further but lighter. Gone today.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pt in with dad. Dad stated pt got shots on Thursday and dad notice a little redness and swelling. Pt dad stated progressly got worse pt right leg was bright red and swollen. Pt leg red spot, was the size 6x4 gauze. Pt stated tender to touch and could feel hardness under skin.
Age: 15.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Pt had rash & itching on both arms within 1 hr. of getting shots.
Age: 31.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Post vaccination autoinoculation
Clinical narrative: Autoinoculation angler of mouth occurring 24DEC10. No testing performed so probable autoinoculation of vaccine (smallpox vaccination).
Age: 24.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal pain, Arthralgia, Dizziness, Headache, Myalgia
Clinical narrative: headache, nausea, abdominal pain, muscle aches, dizziness, hives, pain in the joints, fever, skin feels like it is burning
Age: 24.0
Sex: M
Vaccine: RAB
Symptoms: Nausea, Pyrexia, Skin burning sensation, Urticaria
Clinical narrative: headache, nausea, abdominal pain, muscle aches, dizziness, hives, pain in the joints, fever, skin feels like it is burning
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Computerised tomogram, Guillain-Barre syndrome, Influenza like illness, Lumbar puncture abnormal
Clinical narrative: APPROXIMATELY ONE WEEK AFTER RECEIVING VACCINE BEGAN HAVING PAIN AND FLU-LIKE SYMPTOMS.  WAS DIAGNOSED WITH GUILLIAN BARRE SYNDROME WITH A LUMBAR PUNCTURE.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain
Clinical narrative: APPROXIMATELY ONE WEEK AFTER RECEIVING VACCINE BEGAN HAVING PAIN AND FLU-LIKE SYMPTOMS.  WAS DIAGNOSED WITH GUILLIAN BARRE SYNDROME WITH A LUMBAR PUNCTURE.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Oedema peripheral, Pain in extremity, Palpitations
Clinical narrative: Arm became reddened, painful and swollen about the size of a golf ball.  Temp 101.2F.  She experienced a feeling like her heart was racing, and her hR was 120 at the walk in center.
Age: 1.21
Sex: F
Vaccine: FLU3
Symptoms: Drooling, Gaze palsy, Pyrexia, Tonic convulsion
Clinical narrative: Less than 1 week after immunization mom reports fever with 3-5 min. episodes of drooling, eyes rolling & tonic seizure.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 10 x 8 cm area of erythema to (L) bicep & 1-2 cm area of  -> & warmth over injection site.
Age: 29.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Vaccines were administered Thursday morning. By Thursday evening I had 102 degree fever, which lasted through Sunday. Friday evening arm where Pneumococcal vaccine was administered, was red and swollen. Progressively worse until Sunday evening when it started to get better. Treated with BENADRYL.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Pt. developed rah on (L) thigh sl. redness, small bumps all over thigh
Age: 32.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Chills, Decreased appetite, Delirium, Dizziness
Clinical narrative: Initial report received from a consumer on 16 Feb 2011: The patient had no medical history and no allergy.  The patient did not smoke, drink and did not take illicit substance and practiced regularly body building.  The patient's vaccination status was up to date and had scheduled DTP vaccine before the end of 2011.  The patient was vaccinated with MENVEO (meningoccal groups A, C, W135 and Y conjugate vaccine, batch number: 360379-1) on 12 Feb 2011.  On 13 Feb 2011, the patient experienced hot flushes, nausea, vomiting, headache, coated tongue and loss of appetite.  At 3.00 pm the patient developed severe chills with chattering teeth, and the body temperature increased to 38.8 and then at 39 degree Celsius.  During fever, the patient also experienced delirium and hallucinations, the patient developed muscular pains on thighs, calves, loin and back and flu like symptoms that lead to walking difficulty.  At 9.00 pm, the patient went to emergency room.  The tension was normal, fever was 40 degree Celsius and urinary tests were normal.  Thoracic and abdominal percussions, knees/feet control were done (no details provided).  The patient was treated with paracetamol every six hours.  The outcome for muscular pain in thighs, calves, loin and back, flu like symptoms, walking difficulty, nausea, headache and dizziness was reported as condition improving whereas the outcome for increased body temperature, delirium and hallucinations was reported as recovered, the outcome for loss of appetite was reported as condition unchanged and the outcome for nausea was not reported.
Age: 32.0
Sex: M
Vaccine: MNQ
Symptoms: Gait disturbance, Hallucination, Headache, Hot flush, Influenza like illness
Clinical narrative: Initial report received from a consumer on 16 Feb 2011: The patient had no medical history and no allergy.  The patient did not smoke, drink and did not take illicit substance and practiced regularly body building.  The patient's vaccination status was up to date and had scheduled DTP vaccine before the end of 2011.  The patient was vaccinated with MENVEO (meningoccal groups A, C, W135 and Y conjugate vaccine, batch number: 360379-1) on 12 Feb 2011.  On 13 Feb 2011, the patient experienced hot flushes, nausea, vomiting, headache, coated tongue and loss of appetite.  At 3.00 pm the patient developed severe chills with chattering teeth, and the body temperature increased to 38.8 and then at 39 degree Celsius.  During fever, the patient also experienced delirium and hallucinations, the patient developed muscular pains on thighs, calves, loin and back and flu like symptoms that lead to walking difficulty.  At 9.00 pm, the patient went to emergency room.  The tension was normal, fever was 40 degree Celsius and urinary tests were normal.  Thoracic and abdominal percussions, knees/feet control were done (no details provided).  The patient was treated with paracetamol every six hours.  The outcome for muscular pain in thighs, calves, loin and back, flu like symptoms, walking difficulty, nausea, headache and dizziness was reported as condition improving whereas the outcome for increased body temperature, delirium and hallucinations was reported as recovered, the outcome for loss of appetite was reported as condition unchanged and the outcome for nausea was not reported.
Age: 32.0
Sex: M
Vaccine: MNQ
Symptoms: Myalgia, Nausea, Percussion test, Tongue coated, Urine analysis normal
Clinical narrative: Initial report received from a consumer on 16 Feb 2011: The patient had no medical history and no allergy.  The patient did not smoke, drink and did not take illicit substance and practiced regularly body building.  The patient's vaccination status was up to date and had scheduled DTP vaccine before the end of 2011.  The patient was vaccinated with MENVEO (meningoccal groups A, C, W135 and Y conjugate vaccine, batch number: 360379-1) on 12 Feb 2011.  On 13 Feb 2011, the patient experienced hot flushes, nausea, vomiting, headache, coated tongue and loss of appetite.  At 3.00 pm the patient developed severe chills with chattering teeth, and the body temperature increased to 38.8 and then at 39 degree Celsius.  During fever, the patient also experienced delirium and hallucinations, the patient developed muscular pains on thighs, calves, loin and back and flu like symptoms that lead to walking difficulty.  At 9.00 pm, the patient went to emergency room.  The tension was normal, fever was 40 degree Celsius and urinary tests were normal.  Thoracic and abdominal percussions, knees/feet control were done (no details provided).  The patient was treated with paracetamol every six hours.  The outcome for muscular pain in thighs, calves, loin and back, flu like symptoms, walking difficulty, nausea, headache and dizziness was reported as condition improving whereas the outcome for increased body temperature, delirium and hallucinations was reported as recovered, the outcome for loss of appetite was reported as condition unchanged and the outcome for nausea was not reported.
Age: 32.0
Sex: M
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Initial report received from a consumer on 16 Feb 2011: The patient had no medical history and no allergy.  The patient did not smoke, drink and did not take illicit substance and practiced regularly body building.  The patient's vaccination status was up to date and had scheduled DTP vaccine before the end of 2011.  The patient was vaccinated with MENVEO (meningoccal groups A, C, W135 and Y conjugate vaccine, batch number: 360379-1) on 12 Feb 2011.  On 13 Feb 2011, the patient experienced hot flushes, nausea, vomiting, headache, coated tongue and loss of appetite.  At 3.00 pm the patient developed severe chills with chattering teeth, and the body temperature increased to 38.8 and then at 39 degree Celsius.  During fever, the patient also experienced delirium and hallucinations, the patient developed muscular pains on thighs, calves, loin and back and flu like symptoms that lead to walking difficulty.  At 9.00 pm, the patient went to emergency room.  The tension was normal, fever was 40 degree Celsius and urinary tests were normal.  Thoracic and abdominal percussions, knees/feet control were done (no details provided).  The patient was treated with paracetamol every six hours.  The outcome for muscular pain in thighs, calves, loin and back, flu like symptoms, walking difficulty, nausea, headache and dizziness was reported as condition improving whereas the outcome for increased body temperature, delirium and hallucinations was reported as recovered, the outcome for loss of appetite was reported as condition unchanged and the outcome for nausea was not reported.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash macular
Clinical narrative: Mother of child notes pt had mild swelling on (R) thigh Saturday. On Sunday (R) thigh appeared a little red. She did not touch his thigh. No fever. Possible that child, scratch site of injection. Now skin appears blotchy no warm to touch no induration no treatment.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea, Sneezing, Urticaria
Clinical narrative: Severe runny nose and sneezing. Hives on top of left ribs and on top of right ribs.
Age: 5.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Phone call from family at 2/18/11 at 4:25 pm reporting that child had started with fever (102 degrees) (highest) on Wed. 2/16/11. Also had rash and had vomited x 1. Instructed to take child to urgent care or ER. Spoke with family on 2/22/11. Child not taken to doctor & fully recovered.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Papule, Pruritus
Clinical narrative: A few days after receiving injection, patient starting feeling pain in the muscle which began to radiate to shoulder & elbow & eventually to wrist. She could not raise her arm above her head & went to her physician who started her on an antibiotic to treat the infection. The pain went away but has reoccurred multiple times & most recently she had a small bump that itched but was treated with topical antibiotics. Patient is still in pain today.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash, Skin burning sensation
Clinical narrative: Rash to bilateral chest and left shoulder/axillary with reported burning sensation to affected area 5 days post smallpox vaccine.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness
Clinical narrative: Child passed out for 1 to 2 minutes.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash erythematous
Clinical narrative: Very painful, red rash on right upper arm MD suspected shingles. Prescribed FAMVIR, NEURONTIN rash & pain still present.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash
Clinical narrative: For past day - mild rash on lower back. Pt. reports itching and painful with pressure. No blister seen at pharmacy.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope. Vitals. 96/62, 50, pulse ox 97. Revived with ammonia salts, O2 administered by nasal canula. Supportive therapy administered. Vitals 102/65, 74, 100% O2 sat. RR 16. Released to mother 40 min later. Sent for head CT.
Age: 51.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Chest X-ray normal, Cough, Laboratory test normal, Lower respiratory tract infection, Pain
Clinical narrative: 3 days post vaccination pt developed fever 101 degrees, chest cold, "hacking cough" & body aches. Cold & cough lasted over 1.5 months. Pt treated w/ TESSALON PEARLS, ROBITUSSIN w/ codeine. Chest x-ray negative. Lab work showed no significant findings. Dr. said it was "light or pre-pneumonia".
Age: 51.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Pneumonia, Pyrexia
Clinical narrative: 3 days post vaccination pt developed fever 101 degrees, chest cold, "hacking cough" & body aches. Cold & cough lasted over 1.5 months. Pt treated w/ TESSALON PEARLS, ROBITUSSIN w/ codeine. Chest x-ray negative. Lab work showed no significant findings. Dr. said it was "light or pre-pneumonia".
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Biopsy mucosa abnormal, Fungal test negative, Hepatitis B test negative, Hepatitis C test negative, Lymphocytic infiltration
Clinical narrative: Initial literature report received on 03 Jan 2011: The authors presented 3 cases of lichen planus (LP) occurring after influenza vaccination.  This patient was vaccinated with inactivated INFLUENZA (manufacturer and batch number: unknown) and 2 weeks after vaccination the patient developed lacy white plaques and erosions on both buccal mucosa and later spread.  She had neither dental alloys nor dental fillings.  She had not received any medical treatment for any diseases before the injection.  A test for oral fungal infection was negative.  HBV or HCV infection testing was negative.  A biopsy specimen obtained from the buccal mucosa showed basal cell liquefaction with band-like lymphocytic cell infiltration, consistent with oral LP.  During the follow-up period of 1 year, the eruption had gradually disappeared with topical dexamethasone.  The author commented that subclinical reactivations of varicella zoster virus (though the patient was asymptomatic, the serological evidence does not necessarily exclude the possibility of previous herpes zoster) subsequent to influenza vaccination may be involved in the occurrence of LP in a striking linear pattern.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Oral lichen planus, Oral mucosa erosion, Oropharyngeal plaque
Clinical narrative: Initial literature report received on 03 Jan 2011: The authors presented 3 cases of lichen planus (LP) occurring after influenza vaccination.  This patient was vaccinated with inactivated INFLUENZA (manufacturer and batch number: unknown) and 2 weeks after vaccination the patient developed lacy white plaques and erosions on both buccal mucosa and later spread.  She had neither dental alloys nor dental fillings.  She had not received any medical treatment for any diseases before the injection.  A test for oral fungal infection was negative.  HBV or HCV infection testing was negative.  A biopsy specimen obtained from the buccal mucosa showed basal cell liquefaction with band-like lymphocytic cell infiltration, consistent with oral LP.  During the follow-up period of 1 year, the eruption had gradually disappeared with topical dexamethasone.  The author commented that subclinical reactivations of varicella zoster virus (though the patient was asymptomatic, the serological evidence does not necessarily exclude the possibility of previous herpes zoster) subsequent to influenza vaccination may be involved in the occurrence of LP in a striking linear pattern.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Biopsy skin abnormal, Erythema, Hepatitis B virus test, Hepatitis C virus test, Lichen planus
Clinical narrative: Initial literature report received on 03 Jan 2011: The authors presented 3 cases of lichen planus (LP) occurring after INFLUENZA vaccination. This patient was vaccinated with INFLUENZA (manufacturer and batch number: unknown) and 2 weeks after vaccination the patient developed itchy, erythematous papules on the left leg. The lesions gradually increased in number and size, following the lines of Blaschko or a dermatomal distribution. No oral lesions were observed. Neither hepatitis B virus (HBV) nor HCV infection was detected. A skin biopsy showed a lichenoid tissue reaction consistent with LP. According to the histological and clinical findings, the patient was diagnosed with linear LP. The patient was treated with clobetasol propionate topically. After 6 months, the eruption was completely suppressed. The author commented that subclinical reactivations of varicella zoster virus (though the patient was asymptomatic, the serological evidence does not necessarily exclude the possibility of previous herpes zoster) subsequent to INFLUENZA vaccination may be involved in the occurrence of LP in a striking linear pattern.