chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Eosinophil percentage, Haematocrit normal, Haemoglobin normal, Impaired work ability, Laboratory test
Clinical narrative: Myopericarditis diagnosed  on 2/13
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume normal
Clinical narrative: Myopericarditis diagnosed  on 2/13
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Mean platelet volume decreased, Monocyte count increased, Monocyte percentage increased, Myalgia, Myocarditis
Clinical narrative: Myopericarditis diagnosed  on 2/13
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Neutrophil count normal, Neutrophil percentage, Nucleated red cells, Pericardial disease, Platelet count normal
Clinical narrative: Myopericarditis diagnosed  on 2/13
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Red blood cell count decreased, Red blood cell sedimentation rate increased, Red cell distribution width normal, Troponin I, White blood cell count normal
Clinical narrative: Myopericarditis diagnosed  on 2/13
Age: 19.0
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was mistakenly administered Haemophilus b Conjugate Vaccine; no adverse events were reported by the patient.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: diffuse papular rash itching at sites. started on extremities and is spreading
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site pruritus, Rash papular
Clinical narrative: diffuse papular rash itching at sites. started on extremities and is spreading
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Severe pain to (L) upper arm surrounding site of vaccine admin. swollen and very tender on exam.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: 1st dose MENACTRA given 02-16-11 (L) deltoid, pt not anxious, did not "jerk" (tolerated well). She noticed her arm next afternoon to be sore, swollen, warm to touch, pink->red. Brought into office. I marked area of swelling (5x7cm) no fever. No vomit or diarrhea. No chest pain or wheezing. Inst on TYLENOL or MOTRIN for discomfort/warm or cold compresses & to return if worsens. Returned 02-18-11 to Dr with affected area double in size. 2-18-11 cont to have minimal pain at site/is pink->red/swollen approx 10x14 cm now. No streaking, no bruise, no further systemic symptoms. To cont to watch. 2/21/11 - I called to check on pt -> arm "better" per parents over weekend. Inst. to call if further questions/concerns.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity, Skin warm
Clinical narrative: 1st dose MENACTRA given 02-16-11 (L) deltoid, pt not anxious, did not "jerk" (tolerated well). She noticed her arm next afternoon to be sore, swollen, warm to touch, pink->red. Brought into office. I marked area of swelling (5x7cm) no fever. No vomit or diarrhea. No chest pain or wheezing. Inst on TYLENOL or MOTRIN for discomfort/warm or cold compresses & to return if worsens. Returned 02-18-11 to Dr with affected area double in size. 2-18-11 cont to have minimal pain at site/is pink->red/swollen approx 10x14 cm now. No streaking, no bruise, no further systemic symptoms. To cont to watch. 2/21/11 - I called to check on pt -> arm "better" per parents over weekend. Inst. to call if further questions/concerns.
Age: 0.16
Sex: M
Vaccine: 6VAX-F, HEP, PNC13, RV5
Symptoms: Crying
Clinical narrative: Unconsolable high pitch cry with onset about 2 hours after receipt of vaccine.  Lasted for 6-7 hours even after administering acetamenophen.  No fever or selling of extremities noted.
Age: 0.1
Sex: M
Vaccine: PER
Symptoms: Attention deficit/hyperactivity disorder, Cardiac monitoring, Convulsion, Death, Dyspnoea
Clinical narrative: Initial report was received on 11 February 2011 from a consumer, who is also the patient's parent. A six week-old male infant with no reported past medical history, received a Pertussis vaccine (manufacturer, lot number, route, site and date of administration were not provided) and was reported to be grumpy later that same night. The next morning he became uncontrollably upset. The reporter stated that the infant completely quit making noise, was struggling to breathe, and then wasn't breathing. He vomited what was described as bright red jelly. The mother felt that the infant was having an allergic reaction. The patient began to convulse and CPR was started by a family member. Paramedics were called to the home and the patient was reported to be DOA (dead on arrival). The patient was then resuscitated with the use of electric defibrillator. The patient was transported to the hospital and spent one week in isolation connected to heart monitors and life support (unspecified). No further treatments were reported. The patient is now 17 years-old and according to the reporter he has lasting complications from the event including ADHD, ODD, and learning disabilities. At the time of this report, the patient was described as a young man who enjoys the life of a typical teenager. Documents held by sender: none.
Age: 0.1
Sex: M
Vaccine: PER
Symptoms: Haematemesis, Hypersensitivity, Irritability, Learning disability, Life support
Clinical narrative: Initial report was received on 11 February 2011 from a consumer, who is also the patient's parent. A six week-old male infant with no reported past medical history, received a Pertussis vaccine (manufacturer, lot number, route, site and date of administration were not provided) and was reported to be grumpy later that same night. The next morning he became uncontrollably upset. The reporter stated that the infant completely quit making noise, was struggling to breathe, and then wasn't breathing. He vomited what was described as bright red jelly. The mother felt that the infant was having an allergic reaction. The patient began to convulse and CPR was started by a family member. Paramedics were called to the home and the patient was reported to be DOA (dead on arrival). The patient was then resuscitated with the use of electric defibrillator. The patient was transported to the hospital and spent one week in isolation connected to heart monitors and life support (unspecified). No further treatments were reported. The patient is now 17 years-old and according to the reporter he has lasting complications from the event including ADHD, ODD, and learning disabilities. At the time of this report, the patient was described as a young man who enjoys the life of a typical teenager. Documents held by sender: none.
Age: 0.1
Sex: M
Vaccine: PER
Symptoms: Oppositional defiant disorder, Respiratory arrest, Resuscitation
Clinical narrative: Initial report was received on 11 February 2011 from a consumer, who is also the patient's parent. A six week-old male infant with no reported past medical history, received a Pertussis vaccine (manufacturer, lot number, route, site and date of administration were not provided) and was reported to be grumpy later that same night. The next morning he became uncontrollably upset. The reporter stated that the infant completely quit making noise, was struggling to breathe, and then wasn't breathing. He vomited what was described as bright red jelly. The mother felt that the infant was having an allergic reaction. The patient began to convulse and CPR was started by a family member. Paramedics were called to the home and the patient was reported to be DOA (dead on arrival). The patient was then resuscitated with the use of electric defibrillator. The patient was transported to the hospital and spent one week in isolation connected to heart monitors and life support (unspecified). No further treatments were reported. The patient is now 17 years-old and according to the reporter he has lasting complications from the event including ADHD, ODD, and learning disabilities. At the time of this report, the patient was described as a young man who enjoys the life of a typical teenager. Documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Myelitis transverse, Spinal cord injury, Vomiting
Clinical narrative: Information has been received from a mother concerning her 13 year old (reported as "16 year old") daughter with no medical history or drug reactions/allergies, who on 02-MAY-2008 was vaccinated with a 0.5 ml primary dose of VAQTA (lot # not reported) intramuscularly. Other suspect therapy included hepatitis B vaccine, recomb (MSD, lot # not reported) on the same day. There was no concomitant medication. On an unspecified date, the patient received a 0.5 ml booster dose of VAQTA (lot # not reported). The mother stated that her daughter began vomiting after the injection on 02-MAY-2008, developed transverse myelitis and had spinal cord damage t4-t12 around 09-MAY-2008. The mother also stated that her daughter required periodic hospitalization. The patient had blood work and a magnetic resonance imaging (MRI) (results not reported). The patient was given steroids for transverse myelitis. The patient's vomiting and transverse myelitis and spinal cord damage t4-t12 persisted. No further information is available.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Fatigue, Headache
Clinical narrative: Fatigue, headaches, body aches, multiple joint pains, debilitating to the point that student misses school days, music school, fencing, etc. Doctors visits including Rheumatology, Physical Medicine, PCP, Urgent Cares.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Fatigue, headaches, body aches, multiple joint pains, debilitating to the point that student misses school days, music school, fencing, etc. Doctors visits including Rheumatology, Physical Medicine, PCP, Urgent Cares.
Age: 1.31
Sex: F
Vaccine: DTAP, FLU3, MMR, VARCEL
Symptoms: Crying, Disorientation, Emotional distress, Irritability, Pyrexia
Clinical narrative: Fever and crankiness on Dec. 3rd - followed by 2 evenings of uncontrollable high pitched crying for about 7 hours each night. Very disoriented and unresponsive to consoling. In constant phone contact w regular physician.
Age: 1.31
Sex: F
Vaccine: DTAP, FLU3, MMR, VARCEL
Symptoms: Crying, Disorientation, Irritability, Pyrexia, Unresponsive to stimuli
Clinical narrative: Fever and crankiness on Dec. 3rd - followed by 2 evenings of uncontrollable high pitched crying for about 7 hours each night - very disoriented and unresponsive to consoling constant contact w physician.
Age: 0.55
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a physician concerning a 25 month old male patient with a history of wheezes who was vaccinated with three doses of ROTATEQ orally on 02-MAR-2009 (lot # 663217/1472X), 05-MAY-2009 (lot # 663711/0107Y) and 20-JUL-2009 (lot # 663682/0015Y) respectively. There was no concomitant medication. On 03-FEB-2011 the patient had symptoms diarrhea (not bloody stool) and some vomiting; stool was tested and found to be positive for rotavirus. The patient was hospitalized overnight. The patient was given fluid for the adverse event. The physician didn't think the patient was born pre-maturely. In February 2011, the patient had recovered. No further information is available.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Patient called 2/18/11 complaining of muscle soreness in shoulder where shot was given that seems to have gradually worsened. No swelling, no redness, no itching, no warmth to touch, but can't lift arm over head.
Age: 13.0
Sex: M
Vaccine: FLUN3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Activities of daily living impaired, Blood glucose increased, Erythema, Feeling hot, Injection site erythema
Clinical narrative: Friday 02/11/11 c/o tenderness of arms bilat with erythema. Sat 02/12 (L) arm noted to have swelling of back of arm down to the elbow with bright red "hard" to touch area. This cont. throughout the weekend client felt like he had fever - caretaker reports "afebrile". Insulin depend. DM - BS elevated 200-400 throughout weekend. This AM 02/14 FBS - 245, no keytones. Client lethargic. (L) arm cont swollen, erythema 3h area "now more dk colored; like bruise" cont. to have area firm/hard to touch. No temp obtained. Stayed home from school. 02/14/11 resolving mom sent a picture a few hours after the initial call. Notes "looking better already".
Age: 13.0
Sex: M
Vaccine: FLUN3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site induration, Injection site swelling, Lethargy, Oedema peripheral, Skin discolouration
Clinical narrative: Friday 02/11/11 c/o tenderness of arms bilat with erythema. Sat 02/12 (L) arm noted to have swelling of back of arm down to the elbow with bright red "hard" to touch area. This cont. throughout the weekend client felt like he had fever - caretaker reports "afebrile". Insulin depend. DM - BS elevated 200-400 throughout weekend. This AM 02/14 FBS - 245, no keytones. Client lethargic. (L) arm cont swollen, erythema 3h area "now more dk colored; like bruise" cont. to have area firm/hard to touch. No temp obtained. Stayed home from school. 02/14/11 resolving mom sent a picture a few hours after the initial call. Notes "looking better already".
Age: 13.0
Sex: M
Vaccine: FLUN3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Tenderness
Clinical narrative: Friday 02/11/11 c/o tenderness of arms bilat with erythema. Sat 02/12 (L) arm noted to have swelling of back of arm down to the elbow with bright red "hard" to touch area. This cont. throughout the weekend client felt like he had fever - caretaker reports "afebrile". Insulin depend. DM - BS elevated 200-400 throughout weekend. This AM 02/14 FBS - 245, no keytones. Client lethargic. (L) arm cont swollen, erythema 3h area "now more dk colored; like bruise" cont. to have area firm/hard to touch. No temp obtained. Stayed home from school. 02/14/11 resolving mom sent a picture a few hours after the initial call. Notes "looking better already".
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Anti-SS-B antibody positive, Antinuclear antibody positive, Optic nerve disorder, Sjogren's syndrome
Clinical narrative: This spontaneous report (initial receipt: 08-FEB-2011) concerns a 13 year old female patient, who had a medical history of asthma, environment allergies and an anxiety disorder.  The patient did not have any illness at the time of vaccination.  On 27-OCT-2008 the patient received a Flu vaccine (brand name unspecified).  The patient also received intramuscular GARDASIL (batch number: 0279X) on the same day.  She received her third dose of GARDASIL (batch number: 0570X) on 26-MAY-2009.  On 09-MAR-2009, 134 days after flu vaccination, the patient was found to have elevated optic nerve (on examination).  Subsequently she had a positive ANA test twice and elevated anti-SSB antibody associated with Sjogren's syndrome, but no eye symptoms.  The patient outcome was not provided.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Oral papilloma
Clinical narrative: Information has been received from a registered nurse concerning her 12 year old daughter with no allergies and no medical history who in 2009 was vaccinated with a first dose of GARDASIL (Lot# not reported). There was no concomitant medication. The nurse stated that her daughter completed her third dose of GARDASIL in March 2010 and on 09-NOV-2010 her dentist detected oral papilloma on her tonsil during a routine check. At the time of the report the patient's outcome was unknown. The patient did not seek medical attention. Follow up information has been received from the physician concerning a 12 year old female student, with no pre-existing allergies or medical conditions, who on 15-SEP-2009, 19-NOV-2009, and 19-MAR-2010 was vaccinated intramuscularly with a first, second and third dose of GARDASIL (Lot # 662724/0313Y, 663454/0672Y, and 663573/0969Y respectively). Past vaccination history included a first dose of MENACTRA (Lot # U2926AA) IM, a first dose of ACTACEL (Lot # WF451BA) IM, and a first dose of FLUMIST (Lot # 500673P) nasal, all of them given on 15-SEP-2009. In October 2010, the patient was seen by a dentist and he noted to have "growth" of "papilloma" on tonsil. The patient was referred to the oral surgeon who she will see on 18-FEB-2011. The patient would be evaluated for probable removal/biopsy. At the time of this report, the patient still was being evaluated. The patient sought medical attention. Oral papilloma on her tonsil was considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure before pregnancy, Ectopic pregnancy, Muscle spasms, Ultrasound scan abnormal
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a  25 year old female patient who on 14-SEP-2010 was vaccinated with a first dose of GARDASIL (Lot # 666931/0337Z, dose and route not reported), and on 29-NOV-2010 was vaccinated with a second 0.5ml dose of GARDASIL (Lot # 666162/0565Z, route not reported). It was reported that the patient found out she was pregnant after receiving her second dose of GARDASIL. The patient's last menstrual period (LMP) was on 15-DEC-2010 and the estimated date of delivery (EDD) is on 21-SEP-2011. No adverse side effects were reported. Follow up information has been received from the registered nurse concerning a female patient with no concurrent medical conditions. It was reported that on 27-JAN-2011, an ultrasound was performed because of cramping, the result showed a right ectopic pregnancy. It was reported that on the same day, the patient experienced spontaneous abortion at 6 weeks from LMP. The products of conception were examined (results not reported). Upon internal review, ectopic pregnancy and spontaneous abortion were considered to be other important medical events. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria Pruritis.
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Hyperaesthesia, Neuralgia, Rash
Clinical narrative: noted a rash at the base of his spine and had nerve pain radiating from his spine to his crotch.  The skin area is very sensitive to touch and clothing. Immediately started taking his famvir
Age: 0.51
Sex: F
Vaccine: DTAP, FLUX, MMRV, RVX
Symptoms: Irritability, Pyrexia
Clinical narrative: HIGH FEVER of 103.6 rectally, very fussy, unaware of all surroundings.
Age: 1.26
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Hives around injection site of varicella vaccine.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Rash, Rash macular
Clinical narrative: 5 minutes after KINRIX & MMRV given, moc came out of room and stated "patient has a rash starting". When asked by R.N. where, moc lifted shirt. Small fine red rash on area of underpants waist, upper thighs, and 3-4 10 cent size red raised blotches on back. Sl. small area fine rash on arms. Dr. saw this. Pt. advised to wait 10 min & leave after staff d/c them.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Rotavirus infection, Stool analysis
Clinical narrative: Dx with Rotavirus on 2/18/2011.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Eye irritation, Lip disorder, Muscle twitching, Neck pain, VIIth nerve paralysis
Clinical narrative: 2-15-11 complained to mother of pain in neck and eye irritation. 2-16-11 noticed lazy lip. 2/17/11 twitching & crooked smile. Diagnosed on 2/18/11 with Bell's Palsy in the ER.
Age: 0.64
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rotavirus infection
Clinical narrative: Pt. was diagnosed with Rotavirus 2/16/11.
Age: 39.0
Sex: F
Vaccine: ANTH, HEP, TYP
Symptoms: Chills, Headache, Pain, Pyrexia, Swelling
Clinical narrative: Headaches, chills, fever, body aches, swelling around area, treated with MOTRIN until able to get to a doctor.
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 the second 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 A0914702A and A0914709A.
Age: 0.07
Sex: M
Vaccine: FLU3
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: mother stated that her son got a high fever and cold like symptoms after receiving the influenza vaccine on 9/20/10.She does not want him to get fluenza vaccine anymore.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Erythema, Pain in extremity, Rash, Rash papular, Rash pruritic
Clinical narrative: Itchy rash on hands and elbows.  Painful hands.  Rash consists of multiple erythematous edematous papules coalesing into plaques over the elbows.  No fever, joint pain, abdominal pain, nausea, emesis
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Skin plaque
Clinical narrative: Itchy rash on hands and elbows.  Painful hands.  Rash consists of multiple erythematous edematous papules coalesing into plaques over the elbows.  No fever, joint pain, abdominal pain, nausea, emesis
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Localised oedema, Pain in extremity, Rash papular, Rash pruritic, Skin plaque
Clinical narrative: Itchy rash on hands and elbows.  Painful hands.  Rash consists of multiple erythematous edematous papules coalesing into plaques over the elbows.  No fever, joint pain, abdominal pain, nausea, emesis
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Headache, Injection site pain, Insomnia, Irritability
Clinical narrative: This is nothing as serious as hospitalization or worse, but my son has never reacted to a single immunization in 4 years, and he has had a very very tough time with the Prevnar 13 vaccine. He complained for more than 24 hours about pain/soreness at the site of the shot. He did not sleep through the night as he almost always does. He had a low-grade fever for 24 hours (100.5.) He complained of a headache and he did not eat well. When I called the pediatrician, they said they have received a lot of feedback from parents about increased soreness at the site of the shot with this new vaccine. In talking to friends, I have also learned that other children had a hard time recovering from this vaccine. I don't know if these side effects are worth reporting or not, but since my son has never reacted this way to a vaccine, and has been so miserable for more than 24 hours, I felt I needed to report it for your recordkeeping.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is nothing as serious as hospitalization or worse, but my son has never reacted to a single immunization in 4 years, and he has had a very very tough time with the Prevnar 13 vaccine. He complained for more than 24 hours about pain/soreness at the site of the shot. He did not sleep through the night as he almost always does. He had a low-grade fever for 24 hours (100.5.) He complained of a headache and he did not eat well. When I called the pediatrician, they said they have received a lot of feedback from parents about increased soreness at the site of the shot with this new vaccine. In talking to friends, I have also learned that other children had a hard time recovering from this vaccine. I don't know if these side effects are worth reporting or not, but since my son has never reacted this way to a vaccine, and has been so miserable for more than 24 hours, I felt I needed to report it for your recordkeeping.
Age: 21.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Erythema, Pain in extremity, Rash, Rash papular, Rash pruritic
Clinical narrative: Itchy rash on hands and feet.  Painful hands.  Rash is multiple erythematous edematous papules on hands and elbows.  No fever, joint pains, abdominal pain, nausea, emesis, URI symptoms.
Age: 21.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Localised oedema, Pain in extremity, Rash papular, Rash pruritic
Clinical narrative: Itchy rash on hands and feet.  Painful hands.  Rash is multiple erythematous edematous papules on hands and elbows.  No fever, joint pains, abdominal pain, nausea, emesis, URI symptoms.
Age: 30.0
Sex: F
Vaccine: FLU3, MMR, TDAP, VARCEL
Symptoms: Induration
Clinical narrative: Client called Public Health and reported that his arm was "hard' several days after his immunizations on 02/02/2011. He reported that the hard area was the size of "a golf ball". The client denied any redness or tenderness at the site. Ct is symptom free now. Ct reported symptoms lasted 2 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, UNK, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: RECEIVED EXTRA DOSE OF PENTACEL ALONG WITH REGULAR 4YEAR SHOTS.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Pallor, Syncope
Clinical narrative: Child became pale then fainted after receiving flu shot; positioned on trendelenburg, V/S were taken, initial BP 100/60. RR 82; 11:15AM - 110/60; 11:25AM 100/60; then brought to the health office to call parents.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Gaze palsy, Muscle contracture, Musculoskeletal stiffness, Pallor, Tremor
Clinical narrative: Pt. was sitting in the waiting area, as she had been asked to do after getting her shot.  She C/O not being able to see well.  She turned pale, her eyes rolled back, she stiffened and her arms flexed, hands drew into fists, hands shook quickly 2-3 times.  She relaxed, and her eyes opened.  We laid her on a cot with her feet elevated.  When she started to get some color in her face and responded well, she was given a glass of fruit drink through a straw.  She left with her mother, when she felt better.  Her mother was called later in the day.  She reported that pt. was "doing fine".  She further said that when they got home, pt. said, "Wow, I don't even feel wierd or anything."
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Visual acuity reduced
Clinical narrative: Pt. was sitting in the waiting area, as she had been asked to do after getting her shot.  She C/O not being able to see well.  She turned pale, her eyes rolled back, she stiffened and her arms flexed, hands drew into fists, hands shook quickly 2-3 times.  She relaxed, and her eyes opened.  We laid her on a cot with her feet elevated.  When she started to get some color in her face and responded well, she was given a glass of fruit drink through a straw.  She left with her mother, when she felt better.  Her mother was called later in the day.  She reported that pt. was "doing fine".  She further said that when they got home, pt. said, "Wow, I don't even feel wierd or anything."
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, SMALL, TYP, ANTH, HEPAB, SMALL, TYP, ANTH, HEPAB, SMALL, TYP
Symptoms: Cellulitis, Injection site vesicles, Tattoo
Clinical narrative: Case is a soldier who was vaccinated at medical center with vaccinia and antrax vacccines.  Presented to Hospital Emergency Room on 2/21/2011 complaining of blisters around vaccination site.  Patient initally evaluated by Dr who reportedly called CDC and discussed the case with a representative CDC.  I talked to Dr, Infectious Disease attending at Hospital today.  Patient was and remains afebrile and nontoxic.  There is a large blister at the innoculation site with a few scattered vessicles ~2-3 inches from the innoculation site.  No other involvemnt.  Apparently, patient did get a tatoo placed above the innoculation site after he was vaccinate.  Dr. feels that patient has some cellulites and he is being treated with iv antibiotics but anticipates the patients discharge tomorrow on oral antibiotics.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, SMALL, TYP, ANTH, HEPAB, SMALL, TYP, ANTH, HEPAB, SMALL, TYP
Symptoms: Injection site pustule, Injection site rash, Rash pustular
Clinical narrative: Case is a soldier who was vaccinated at medical center with vaccinia and antrax vacccines.  Presented to Hospital Emergency Room on 2/21/2011 complaining of blisters around vaccination site.  Patient initally evaluated by Dr who reportedly called CDC and discussed the case with a representative CDC.  I talked to Dr, Infectious Disease attending at Hospital today.  Patient was and remains afebrile and nontoxic.  There is a large blister at the innoculation site with a few scattered vessicles ~2-3 inches from the innoculation site.  No other involvemnt.  Apparently, patient did get a tatoo placed above the innoculation site after he was vaccinate.  Dr. feels that patient has some cellulites and he is being treated with iv antibiotics but anticipates the patients discharge tomorrow on oral antibiotics.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, SMALL, TYP, ANTH, HEPAB, SMALL, TYP, ANTH, HEPAB, SMALL, TYP
Symptoms: Blister, Cellulitis, Injection site vesicles
Clinical narrative: Case is a soldier who was vaccinated at medical center with vaccinia and antrax vacccines.  Presented to Hospital Emergency Room on 2/21/2011 complaining of blisters around vaccination site.  Patient initally evaluated by Dr who reportedly called CDC and discussed the case with a representative CDC.  I talked to Dr, Infectious Disease attending at Hospital today.  Patient was and remains afebrile and nontoxic.  There is a large blister at the innoculation site with a few scattered vessicles ~2-3 inches from the innoculation site.  No other involvemnt.  Apparently, patient did get a tatoo placed above the innoculation site after he was vaccinate.  Dr. feels that patient has some cellulites and he is being treated with iv antibiotics but anticipates the patients discharge tomorrow on oral antibiotics.
Age: 49.0
Sex: F
Vaccine: TYP
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Patient reports taking dose #1 of live oral typhoid vaccine (Vivotif Berna)with her dinner at 5 pm on 2/1/2011. Sometime between 1 and 2 am on 2/2/2011 she experienced a seizure as reported by her husband.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test abnormal, Convulsion, Electroencephalogram abnormal, Epilepsy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Seizure, Syncope, Vomiting
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: Seizure, Syncope, Vomiting
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood sodium decreased, Convulsion, Dizziness, Electroencephalogram abnormal, Epilepsy
Clinical narrative: Seizure, Syncope, Vomiting
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging abnormal, Syncope, Tunnel vision, Vomiting
Clinical narrative: Seizure, Syncope, Vomiting
Age: 0.35
Sex: M
Vaccine: HIBV, RVX
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting and diarrhea
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram abnormal, Gastrointestinal pain, Intussusception
Clinical narrative: intestinal cramps and pain, leading to diagnosis of intussusception by CT Scan.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Pt. with left arm redness, pain and itching. AUGMENTIN 875 mg one twice a day for 10 days.
Age: 1.26
Sex: M
Vaccine: MMR, PNC13
Symptoms: Injection site rash, Rash erythematous, Rash generalised
Clinical narrative: Rash diffuse raised red patches to entire body of varying shapes & sizes.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Pt called to report an oblong lump at the injection site. Feels as though it's warm & has some redness. Treat with antihistamines & cool compresses recommended.
Age: 35.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis which developed at site of injections approximately 2 days after they were given. Patient did respond to antibiotic therapy.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Colitis, Haematochezia, Stool reducing substances increased, White blood cells stool positive
Clinical narrative: 2 mo vaccinations on 12/13/10 -> PEDIARIX/HIB/PREVNAR/ROTARIX started with bloody stools about 1 week later; intermittent bloody stools since.
Age: 11.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Hyperventilation, Injection site pruritus
Clinical narrative: Child c/o itching around injection site (RD) & started hyperventilating; positioned in Trendelenburg; initial BP 98/68, AP 60/min; fought w/us when we attempted to give Epinephrine; called 911; child awake, conscious - BP 100/60. Father came & took child home in good condition.
Age: 11.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Syncope
Clinical narrative: Child c/o itching around injection site (RD) & started hyperventilating; positioned in Trendelenburg; initial BP 98/68, AP 60/min; fought w/us when we attempted to give Epinephrine; called 911; child awake, conscious - BP 100/60. Father came & took child home in good condition.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site swelling
Clinical narrative: After PENTACEL injection, pt had swelling in a circular pattern. On left thigh the size of a quarter. Called mother 2-21-11. Pts swelling is gone no other reaction.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Incorrect route of drug administration, Injected limb mobility decreased, Tendonitis
Clinical narrative: pt report thta by the night she could not lift her arm 2-3 weeks later she saw her physcian who diagnosised her with clinical induced tendonitis. shot was given in the arm pt took a steriod pack. she stared PT 2-3 times per week
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Tendonitis
Clinical narrative: pt report thta by the night she could not lift her arm 2-3 weeks later she saw her physcian who diagnosised her with clinical induced tendonitis. shot was given in the arm pt took a steriod pack. she stared PT 2-3 times per week
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Pain, Tendonitis
Clinical narrative: Pt reports had trouble by that afterbnoon after the vaccine. pt couldn't lift her  Left arm. 2-3 weeks later she was diagnosis with tendernitisi by DR. She recieved a Cortisone shot, Still has pain and does not have full ROM.
Age: 1.59
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, PNC13, DTAP
Symptoms: Erythema, Injection site eczema, Injection site rash, Rash, Scratch
Clinical narrative: Rash noted which picked up from school the following day, taken to ER on 2/2/11. Seen by PCP on 2/4/11. Rash mainly resolved. Atopy continue.
Age: 1.59
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV, PNC13, DTAP
Symptoms: Atopy, Rash
Clinical narrative: Rash noted which picked up from school the following day, taken to ER on 2/2/11. Seen by PCP on 2/4/11. Rash mainly resolved. Atopy continue.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash on upper right arm (area surrounding where the immunization was given).  As of today, 2/23/11, rash is still itching and bothering the patient.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Renal pain
Clinical narrative: Pain in right kidney for 5-7 days
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Pt developed fever of 101 degrees F on day of vaccine and over 2 days fever increased to over 102 degrees F. On 2/16/11 pt developed redness to entire left arm. TYLENOL & MOTRIN given. Redness decreasing.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Clostridial infection, Clostridium test positive, Diarrhoea haemorrhagic, Full blood count, Rotavirus test negative
Clinical narrative: Information has been received from a physician's assistant concerning an 9 week old male infant with no drug reactions or allergies and a history of "premature (born at 34 weeks)" who on 17-JAN-2011 was vaccinated with a first dose of ROTATEQ orally (lot # 668967/1201Z). Concomitant therapy included: a dose of PENTACEL and a dose of PREVNAR. on 20-JAN-2011 the patient experienced bloody diarrhea. The child tested negative for rotavirus but positive for C. difficile toxin. Complete blood cell count (CBC), "OMP" were also performed, although, the results were not provided. The patient was treated with metronidazole. On 11-FEB-2011, the patient had recovered. The patient sought unspecified medical attention. Upon internal review, bloody diarrhea was determined to be an other important medical event. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Viral test negative
Clinical narrative: Information has been received from a physician's assistant concerning an 9 week old male infant with no drug reactions or allergies and a history of "premature (born at 34 weeks)" who on 17-JAN-2011 was vaccinated with a first dose of ROTATEQ orally (lot # 668967/1201Z). Concomitant therapy included: a dose of PENTACEL and a dose of PREVNAR. on 20-JAN-2011 the patient experienced bloody diarrhea. The child tested negative for rotavirus but positive for C. difficile toxin. Complete blood cell count (CBC), "OMP" were also performed, although, the results were not provided. The patient was treated with metronidazole. On 11-FEB-2011, the patient had recovered. The patient sought unspecified medical attention. Upon internal review, bloody diarrhea was determined to be an other important medical event. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: HIBV, PNC13, DTAPHEPBIP, RV5
Symptoms: Brain stem auditory evoked response, Computerised tomogram head, Convulsion, Deafness, Drug ineffective
Clinical narrative: Initial case received on 14 February 2011 from a healthcare professional via another manufacturer (reference number US-WYE-H17670610). A 3-month old male infant received an intramuscular first right leg injection of ACTHIB (lot number UH125AB) and an intramuscular first left leg injection of PREVNAR 13 (lot number E57642) on 04 August 2010. On 17 August 2010 he received an intramuscular first right leg injection of PEDIARIX (lot number AC21B249AA) and a first oral dose of ROTATEQ (lot number 0500Z). On 17 September 2010 the patient developed symptoms of an upper respiratory infection with fever. The following day his symptoms worsened, and included fussiness, pallor, and bulging fontanel; he was also diagnosed with otitis media. On 19 September 2010 the patient experienced a seizure, and was diagnosed with "strep pneumo meningitis". He was hospitalized for 14 days. Relevant testing included a CT of the head, lumbar puncture, biochemistry work-up, MRI of the brain, EEG, and BSAER; results of this testing were not provided. Medical history at the time of vaccination included hematochezia and a possible allergy to cow's milk. The patient was 8 pounds 7 ounces at birth, and was delivered via C-section at 40 weeks gestation due to fetal distress and failure to progress. At the time of the event, the patient weighed 7.4 kg. Per the reporter, the vaccines were administered by a health care professional and medication was stored appropriately and not altered in any way. Patient's developmental milestones and physical growth were reported as normal. At the time of the report, the patient was recovering from the events with mild hearing loss. The other manufacturer also reported the event "drug ineffective" for the vaccine PREVNAR 13. Follow-up information has been requested by the manufacturer, and no further information was expected. Per the manufacturer's case comment, "Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13".
Age: 0.3
Sex: M
Vaccine: HIBV, PNC13, DTAPHEPBIP, RV5
Symptoms: Electroencephalogram, Fontanelle bulging, Irritability, Laboratory test, Lumbar puncture
Clinical narrative: Initial case received on 14 February 2011 from a healthcare professional via another manufacturer (reference number US-WYE-H17670610). A 3-month old male infant received an intramuscular first right leg injection of ACTHIB (lot number UH125AB) and an intramuscular first left leg injection of PREVNAR 13 (lot number E57642) on 04 August 2010. On 17 August 2010 he received an intramuscular first right leg injection of PEDIARIX (lot number AC21B249AA) and a first oral dose of ROTATEQ (lot number 0500Z). On 17 September 2010 the patient developed symptoms of an upper respiratory infection with fever. The following day his symptoms worsened, and included fussiness, pallor, and bulging fontanel; he was also diagnosed with otitis media. On 19 September 2010 the patient experienced a seizure, and was diagnosed with "strep pneumo meningitis". He was hospitalized for 14 days. Relevant testing included a CT of the head, lumbar puncture, biochemistry work-up, MRI of the brain, EEG, and BSAER; results of this testing were not provided. Medical history at the time of vaccination included hematochezia and a possible allergy to cow's milk. The patient was 8 pounds 7 ounces at birth, and was delivered via C-section at 40 weeks gestation due to fetal distress and failure to progress. At the time of the event, the patient weighed 7.4 kg. Per the reporter, the vaccines were administered by a health care professional and medication was stored appropriately and not altered in any way. Patient's developmental milestones and physical growth were reported as normal. At the time of the report, the patient was recovering from the events with mild hearing loss. The other manufacturer also reported the event "drug ineffective" for the vaccine PREVNAR 13. Follow-up information has been requested by the manufacturer, and no further information was expected. Per the manufacturer's case comment, "Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13".
Age: 0.3
Sex: M
Vaccine: HIBV, PNC13, DTAPHEPBIP, RV5
Symptoms: Meningitis pneumococcal, Nuclear magnetic resonance imaging brain, Otitis media, Pallor, Pyrexia
Clinical narrative: Initial case received on 14 February 2011 from a healthcare professional via another manufacturer (reference number US-WYE-H17670610). A 3-month old male infant received an intramuscular first right leg injection of ACTHIB (lot number UH125AB) and an intramuscular first left leg injection of PREVNAR 13 (lot number E57642) on 04 August 2010. On 17 August 2010 he received an intramuscular first right leg injection of PEDIARIX (lot number AC21B249AA) and a first oral dose of ROTATEQ (lot number 0500Z). On 17 September 2010 the patient developed symptoms of an upper respiratory infection with fever. The following day his symptoms worsened, and included fussiness, pallor, and bulging fontanel; he was also diagnosed with otitis media. On 19 September 2010 the patient experienced a seizure, and was diagnosed with "strep pneumo meningitis". He was hospitalized for 14 days. Relevant testing included a CT of the head, lumbar puncture, biochemistry work-up, MRI of the brain, EEG, and BSAER; results of this testing were not provided. Medical history at the time of vaccination included hematochezia and a possible allergy to cow's milk. The patient was 8 pounds 7 ounces at birth, and was delivered via C-section at 40 weeks gestation due to fetal distress and failure to progress. At the time of the event, the patient weighed 7.4 kg. Per the reporter, the vaccines were administered by a health care professional and medication was stored appropriately and not altered in any way. Patient's developmental milestones and physical growth were reported as normal. At the time of the report, the patient was recovering from the events with mild hearing loss. The other manufacturer also reported the event "drug ineffective" for the vaccine PREVNAR 13. Follow-up information has been requested by the manufacturer, and no further information was expected. Per the manufacturer's case comment, "Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13".
Age: 0.3
Sex: M
Vaccine: HIBV, PNC13, DTAPHEPBIP, RV5
Symptoms: Upper respiratory tract infection
Clinical narrative: Initial case received on 14 February 2011 from a healthcare professional via another manufacturer (reference number US-WYE-H17670610). A 3-month old male infant received an intramuscular first right leg injection of ACTHIB (lot number UH125AB) and an intramuscular first left leg injection of PREVNAR 13 (lot number E57642) on 04 August 2010. On 17 August 2010 he received an intramuscular first right leg injection of PEDIARIX (lot number AC21B249AA) and a first oral dose of ROTATEQ (lot number 0500Z). On 17 September 2010 the patient developed symptoms of an upper respiratory infection with fever. The following day his symptoms worsened, and included fussiness, pallor, and bulging fontanel; he was also diagnosed with otitis media. On 19 September 2010 the patient experienced a seizure, and was diagnosed with "strep pneumo meningitis". He was hospitalized for 14 days. Relevant testing included a CT of the head, lumbar puncture, biochemistry work-up, MRI of the brain, EEG, and BSAER; results of this testing were not provided. Medical history at the time of vaccination included hematochezia and a possible allergy to cow's milk. The patient was 8 pounds 7 ounces at birth, and was delivered via C-section at 40 weeks gestation due to fetal distress and failure to progress. At the time of the event, the patient weighed 7.4 kg. Per the reporter, the vaccines were administered by a health care professional and medication was stored appropriately and not altered in any way. Patient's developmental milestones and physical growth were reported as normal. At the time of the report, the patient was recovering from the events with mild hearing loss. The other manufacturer also reported the event "drug ineffective" for the vaccine PREVNAR 13. Follow-up information has been requested by the manufacturer, and no further information was expected. Per the manufacturer's case comment, "Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13".