chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Apnoea, Asthenia, Cold sweat, Peripheral coldness, Syncope
Clinical narrative: Client fainted following administration of vaccines.  Client was cold and clammy upon examination, with a short period of apnea, and no palpable pulse.  A cold cloth was placed on forehead and client feet were elevated.  Several seconds later client responded to questions, stating she felt weak.  Client also stated she hadn't eaten anything at all that day.  She was given a can of gatorade after being placed in a sitting position.  Approximately 2:50 client was in stable condition and able to walk to car.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Convulsion, Crying, Dyskinesia, Musculoskeletal stiffness, Opisthotonus
Clinical narrative: Patient was given the MMR on Monday.  Tuesday night he had seizure like symptoms including, stiffness of the body, arched back, jerking of the arms and legs, unresponsiveness and stuttered crying.  This episode lasted about 30 mins.  He was seen by Dr. at who said that he didn't need any further extensive testing or treatment because he is so young and the episode didn't seem to interfere with his breathing or do anything dangerous to him.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient was given the MMR on Monday.  Tuesday night he had seizure like symptoms including, stiffness of the body, arched back, jerking of the arms and legs, unresponsiveness and stuttered crying.  This episode lasted about 30 mins.  He was seen by Dr. at who said that he didn't need any further extensive testing or treatment because he is so young and the episode didn't seem to interfere with his breathing or do anything dangerous to him.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Band neutrophil count increased, Blood chloride normal, Blood glucose increased, Blood sodium decreased, Laboratory test
Clinical narrative: Patient developed severe large hives over entire body. Also she developed fever of 102. She was treated with Benadryl 50mg for 2 days without resolution of her symptoms. Prednisone 80mg was started on the night of the 2nd day in the ER. Hydroxazine 25mg was given instead of the Benadryl on the 3rd day. The symptoms resolved and treatment was stopped on day 7.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Lymphocyte count decreased, Neutrophil count increased, Platelet count increased, Pyrexia, Red blood cell count normal
Clinical narrative: Patient developed severe large hives over entire body. Also she developed fever of 102. She was treated with Benadryl 50mg for 2 days without resolution of her symptoms. Prednisone 80mg was started on the night of the 2nd day in the ER. Hydroxazine 25mg was given instead of the Benadryl on the 3rd day. The symptoms resolved and treatment was stopped on day 7.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Urticaria, White blood cell count increased
Clinical narrative: Patient developed severe large hives over entire body. Also she developed fever of 102. She was treated with Benadryl 50mg for 2 days without resolution of her symptoms. Prednisone 80mg was started on the night of the 2nd day in the ER. Hydroxazine 25mg was given instead of the Benadryl on the 3rd day. The symptoms resolved and treatment was stopped on day 7.
Age: 1.3
Sex: M
Vaccine: DTAP, PNC
Symptoms: Convulsion, Gaze palsy, Musculoskeletal stiffness, Pyrexia
Clinical narrative: 35 minute status seizure. Started with left sided stiffness. EMT diverted to left. Sl. fractory to Ativan x2. Regressive to Fospheaptoin. Tactile fever present during symptoms. No concomitant illness. Onset of seizure 6 hours after vaccination.  10/02/2007 TC to vax provider for vax info.  DTaP- Wyeth-Lot #: CZ606AA. 4th dose.  Prevnar-B47442D. 4th dose.  Database updated with same. 10/09/2007 MR recieved for DOS 9/28-29/2007 for DX: Atypical Seizure. Child presented to ER in status epilepticus.  Child had tactile fever at home then became stiff and started jerking.  Eyes deviated to the left with blank stare. Reportedly stopped breathing without cyanosis.  Lasted 35-40 minutes.  Ativan given x 2 with seizure ongoing. Phenytoin given with resulting hypotension resolved with fluid bolus. Assessment: focal febrile seizure.
Age: 45.0
Sex: M
Vaccine: HEP, HEPA, IPV, MNQ, TDAP, TYP
Symptoms: Blood pressure increased, Discomfort, Immunisation reaction, Nausea, Pain in extremity
Clinical narrative: Patient came in for booster shot, stated he had to go to ER day after vaccine for extreme discomfort, tingling, low fever, rash on head, T B/P, sore left arm and nausea.
Age: 45.0
Sex: M
Vaccine: HEP, HEPA, IPV, MNQ, TDAP, TYP
Symptoms: Paraesthesia, Pyrexia, Rash
Clinical narrative: Patient came in for booster shot, stated he had to go to ER day after vaccine for extreme discomfort, tingling, low fever, rash on head, T B/P, sore left arm and nausea.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash generalised, Urticaria
Clinical narrative: Generalized rash - urticaria within 2 hours - spread to entire body treated with Prednisone and antihistamines.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Generalized rash - urticaria within 2 hours - spread to entire body treated with Prednisone and antihistamines.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelids pruritus, Pruritus, Urticaria
Clinical narrative: Patient called on 9/28/07 at 2:45 to let us know that she had hives on both arms and c/o eye lids being very itchy this was at approximately 3:00 pm on day of injection patient took 50mg of Benadryl with relief noted. Also took another 25mg at bedtime due to itching arms and eyelids. Patient ? MSG allergy. Told patient to come in and be seen - noted healing hives on both arms.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, body ache, arm sore 5-7 days took Motrin for ache. Cough at night x = 1 week.
Sex: M
Vaccine: TDAP
Symptoms: Cough, Pyrexia
Clinical narrative: Mild fever, dry cough forceful went to PCP doctor he prescription Albuterol inhaler, Zithromax for 5 days.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Hypersensitivity, Petechiae
Clinical narrative: Patient woke up with a purple petechial rash on his left lower arm approximately 24 hours after receiving Menactra vaccine in his left upper arm - seen by dermatologist who thought it hypersensitivity reaction.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site papule, Pain in extremity
Clinical narrative: Pain at arm, persists 2 months later persisted papule at injection site.
Age: 11.0
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: 9/20/07 right arm dorsum of humerus from first below shoulder to above elbow with axillary nodes 10cm x 10.5cm erythema, indurated and warm to touch. 9/26/07 Right arm decrease 14 x 12.5 erythema. 9/21/07 Called today increase redness to be seen 9/22/07 - Did not come in phone call ---much better - very little redness.
Age: 0.5
Sex: M
Vaccine: IPV, PNC
Symptoms: Crying
Clinical narrative: 1) Excessive crying - 6 hours 2) Hives all over body
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Incorrect dose administered, Overdose
Clinical narrative: Patient received Varivax 9/29/03, ProQuad 9/22/2004, and another Varivax 9/28/07. (I spoke with CDC on 9/28/07. May have increase local reaction, otherwise Ok).
Age: 29.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Injection site cellulitis, Lymphadenopathy
Clinical narrative: Cellulitis left upper arm anterior to smallpox vaccination site 1.5cm wide x 10cm long. Rx with PO antibiotics for 10 days  (Keflex). (+) enlarged left axillary lymph nodes - tender.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Erythema, Pyrexia, Skin warm
Clinical narrative: Looks like an insect bite, hand to touch and red. Low grade fever.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Fatigue, Hot flush, Malaise, Thinking abnormal
Clinical narrative: Patient states night of 9/25/07 starting feeling ill pain in joints, feeling of pressure in legs, exhaustion, hot flashed, moist skin and hard to think f/u with 9/26/07.
Sex: F
Vaccine: FLU3
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer and described the occurrence of unspecified event in an adult female subject who was vaccinated with influenza virus vaccine (Flu vaccine, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. On 31 October 2006 the subject received unspecified dose of Flu vaccine at 0.5 ml with an expiration date of 30 June 2007. In the first week of November 2006, at an unspecified time after vaccination with Flu vaccine, the subject developed "problems" (not specified). At the time of reporting the event was unresolved. No additional information is expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Anxiety, Hypertension, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Local reaction: erythema, heat, slight swelling for about 3 1/2 inch radius on Left upper arm where vaccine was administered on 9/27.  Onset of symptoms 24 hours post vaccination.  This was pneumovaccine # 1.   No shortness of breath or fever.  Allegra 180 mg po daily for 5 days and topical benadryl  2 times a day for 5 days.  Will follow up in office in 2 days.  If any breathing difficulties call 911.  Husband present and understands.  Patient has high chronic anxiety and white coat syndrome with poor retention of information.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Memory impairment
Clinical narrative: Local reaction: erythema, heat, slight swelling for about 3 1/2 inch radius on Left upper arm where vaccine was administered on 9/27.  Onset of symptoms 24 hours post vaccination.  This was pneumovaccine # 1.   No shortness of breath or fever.  Allegra 180 mg po daily for 5 days and topical benadryl  2 times a day for 5 days.  Will follow up in office in 2 days.  If any breathing difficulties call 911.  Husband present and understands.  Patient has high chronic anxiety and white coat syndrome with poor retention of information.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: 24 hours after injection in my left arm, my right arm began to itch with entire arm covered with little bumps. this itchie condition & bumps lasted 24 hours. the itchieness abated but the bumps are still barley visible under the skin
Age: 24.0
Sex: U
Vaccine: HPV4
Symptoms: Headache, Vomiting
Clinical narrative: headache, vomiting
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Following injection on 9/10/07 had severe continuous headaches(occipital) and nausea for 2.5 weeks, also during that period I experienced a spontaneous scleral hemorrhage along with increased BP.  Fever started with frequent vomiting and generalized muscular aches on 9/26.  On 9/28 rash then developed mainly with torso involvement and now has spread over body - non- pruritic raised red non-vesicular? headache and elevated BP has subsided with the onset of rash.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised, Scleral haemorrhage, Vomiting
Clinical narrative: Following injection on 9/10/07 had severe continuous headaches(occipital) and nausea for 2.5 weeks, also during that period I experienced a spontaneous scleral hemorrhage along with increased BP.  Fever started with frequent vomiting and generalized muscular aches on 9/26.  On 9/28 rash then developed mainly with torso involvement and now has spread over body - non- pruritic raised red non-vesicular? headache and elevated BP has subsided with the onset of rash.
Age: 33.0
Sex: M
Vaccine: ANTH, FLU3, HEPAB, ANTH, FLUX, HEPAB
Symptoms: Blood bilirubin increased, Blood gases abnormal, Blood immunoglobulin G, Blood immunoglobulin M, Chest X-ray normal
Clinical narrative: Description: Developed weakness in lower extremities and SOB, and pain in hips and back after AVA, Flu, Hep A-B. Sxs began 4 ds after vaccination and remains hospitalized. Symptom: Cough, dry Symptom: Dyspnea Symptom: Joint Pain, multiple joints Symptoms: Fever 17 Sep 07 Although sxs resolved in 7/07, they have again flared.
Age: 33.0
Sex: M
Vaccine: ANTH, FLU3, HEPAB, ANTH, FLUX, HEPAB
Symptoms: Chest discomfort, Chills, Cough, Dyspnoea, Dyspnoea
Clinical narrative: Description: Developed weakness in lower extremities and SOB, and pain in hips and back after AVA, Flu, Hep A-B. Sxs began 4 ds after vaccination and remains hospitalized. Symptom: Cough, dry Symptom: Dyspnea Symptom: Joint Pain, multiple joints Symptoms: Fever 17 Sep 07 Although sxs resolved in 7/07, they have again flared.
Age: 33.0
Sex: M
Vaccine: ANTH, FLU3, HEPAB, ANTH, FLUX, HEPAB
Symptoms: Electrocardiogram normal, Hot flush, Lymphocyte count decreased, Pain, Productive cough
Clinical narrative: Description: Developed weakness in lower extremities and SOB, and pain in hips and back after AVA, Flu, Hep A-B. Sxs began 4 ds after vaccination and remains hospitalized. Symptom: Cough, dry Symptom: Dyspnea Symptom: Joint Pain, multiple joints Symptoms: Fever 17 Sep 07 Although sxs resolved in 7/07, they have again flared.
Age: 33.0
Sex: M
Vaccine: ANTH, FLU3, HEPAB, ANTH, FLUX, HEPAB
Symptoms: Urine analysis normal, Wheezing, White blood cell count increased
Clinical narrative: Description: Developed weakness in lower extremities and SOB, and pain in hips and back after AVA, Flu, Hep A-B. Sxs began 4 ds after vaccination and remains hospitalized. Symptom: Cough, dry Symptom: Dyspnea Symptom: Joint Pain, multiple joints Symptoms: Fever 17 Sep 07 Although sxs resolved in 7/07, they have again flared.
Age: 33.0
Sex: M
Vaccine: ANTH, FLU3, HEPAB, ANTH, FLUX, HEPAB
Symptoms: Arthralgia, Back pain, Cough, Dyspnoea, Muscular weakness
Clinical narrative: Description: Developed weakness in lower extremities and SOB, and pain in hips and back after AVA, Flu, Hep A-B. Sxs began 4 ds after vaccination and remains hospitalized. Symptom: Cough, dry Symptom: Dyspnea Symptom: Joint Pain, multiple joints Symptoms: Fever 17 Sep 07 Although sxs resolved in 7/07, they have again flared.
Age: 33.0
Sex: M
Vaccine: ANTH, FLU3, HEPAB, ANTH, FLUX, HEPAB
Symptoms: Pyrexia, Spirometry abnormal
Clinical narrative: Description: Developed weakness in lower extremities and SOB, and pain in hips and back after AVA, Flu, Hep A-B. Sxs began 4 ds after vaccination and remains hospitalized. Symptom: Cough, dry Symptom: Dyspnea Symptom: Joint Pain, multiple joints Symptoms: Fever 17 Sep 07 Although sxs resolved in 7/07, they have again flared.
Age: 61.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site oedema, Malaise, Urticaria
Clinical narrative: Initial report received from a health care provider on 25 September 2007. A 61-year-old female patient had received an intramuscular left deltoid injection of Adacel, lot number C2730AA on 20 June 2007 and 24 hours later experienced "erythema and edema on her left upper arm and hives on her body". The reporter stated the patient was " not feeling well". The patient received corrective treatment with Prednisone and Augmentin. The duration for the event was not reported. The patient was not ill at the time of vaccination, was not receiving any concomitant medications and had no medical history. Prior date(s) for receipt of Tetanus booster doses and the patient's vaccination history were not provided. No additional information was received and the patient was listed as recovered at the time of the report. The reporter of this case is the same as for cases 2007-03235, 2007-03236 and 2007-02814 which concern large areas of redness, swelling and pain. These cases have also been submitted to VAERS by the initial reporter.
Age: 61.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Erythema, Malaise, Oedema, Pain, Urticaria
Clinical narrative: Initial report received from a health care provider on 25 September 2007. A 61-year-old female patient had received an intramuscular left deltoid injection of Adacel, lot number C2730AA on 20 June 2007 and 24 hours later experienced "erythema and edema on her left upper arm and hives on her body". The reporter stated the patient was " not feeling well". The patient received corrective treatment with Prednisone and Augmentin. The duration for the event was not reported. The patient was not ill at the time of vaccination, was not receiving any concomitant medications and had no medical history. Prior date(s) for receipt of Tetanus booster doses and the patient's vaccination history were not provided. No additional information was received and the patient was listed as recovered at the time of the report. The reporter of this case is the same as for cases 2007-03235, 2007-03236 and 2007-02814 which concern large areas of redness, swelling and pain. These cases have also been submitted to VAERS by the initial reporter.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Agitation, Body temperature increased, Diarrhoea, Diet refusal, Faeces discoloured
Clinical narrative: Information has been received from a medical assistant (MA) concerning a 9-week-old male who on 24-AUG-2007 was vaccinated with a dose of Rotateq (Lot #657459/0509U). Concomitant vaccinations administered on that same day included a dose of Pediarix (Lot #AC21B124BA), a dose of ActHib (Lot #UF2088A) and a dose of Prevnar (Lot #B47442K). The MA reported that on 30-AUG-2007, the patient was seen in the physician's office with fever, decreased appetite, fussiness, mucous in the diaper and loose stools. He had a distended and tender abdomen on examination and was sent to the Emergency Room (ER) to rule-out intussusception. The patient was admitted to the hospital for three days where ultrasound produced a diagnosis of self-reduced intussusception. No Barium enema was performed. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Mucous stools, Occult blood positive, Pyrexia
Clinical narrative: Information has been received from a medical assistant (MA) concerning a 9-week-old male who on 24-AUG-2007 was vaccinated with a dose of Rotateq (Lot #657459/0509U). Concomitant vaccinations administered on that same day included a dose of Pediarix (Lot #AC21B124BA), a dose of ActHib (Lot #UF2088A) and a dose of Prevnar (Lot #B47442K). The MA reported that on 30-AUG-2007, the patient was seen in the physician's office with fever, decreased appetite, fussiness, mucous in the diaper and loose stools. He had a distended and tender abdomen on examination and was sent to the Emergency Room (ER) to rule-out intussusception. The patient was admitted to the hospital for three days where ultrasound produced a diagnosis of self-reduced intussusception. No Barium enema was performed. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal distension, Abdominal tenderness, Decreased appetite, Diarrhoea, Irritability
Clinical narrative: Information has been received from a medical assistant (MA) concerning a 9-week-old male who on 24-AUG-2007 was vaccinated with a dose of Rotateq (Lot #657459/0509U). Concomitant vaccinations administered on that same day included a dose of Pediarix (Lot #AC21B124BA), a dose of ActHib (Lot #UF2088A) and a dose of Prevnar (Lot #B47442K). The MA reported that on 30-AUG-2007, the patient was seen in the physician's office with fever, decreased appetite, fussiness, mucous in the diaper and loose stools. He had a distended and tender abdomen on examination and was sent to the Emergency Room (ER) to rule-out intussusception. The patient was admitted to the hospital for three days where ultrasound produced a diagnosis of self-reduced intussusception. No Barium enema was performed. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Mucous stools, Pyrexia, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a medical assistant (MA) concerning a 9-week-old male who on 24-AUG-2007 was vaccinated with a dose of Rotateq (Lot #657459/0509U). Concomitant vaccinations administered on that same day included a dose of Pediarix (Lot #AC21B124BA), a dose of ActHib (Lot #UF2088A) and a dose of Prevnar (Lot #B47442K). The MA reported that on 30-AUG-2007, the patient was seen in the physician's office with fever, decreased appetite, fussiness, mucous in the diaper and loose stools. He had a distended and tender abdomen on examination and was sent to the Emergency Room (ER) to rule-out intussusception. The patient was admitted to the hospital for three days where ultrasound produced a diagnosis of self-reduced intussusception. No Barium enema was performed. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: Patient had an angry, red rash appear at one of the injection sites. 10 days after the immunizations, he was suffering from a high fever that ranged from 101.5 to 103.6 degrees. He was taken to the emergency room.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Clinical narrative: Pt died within 24 hrs of receiving vaccine.  1/4/08 Reviewed autopsy report which states COD as SIDS.  Findings at autopsy included severe congestion in lungs, petechial hemorrhages of thymus gland & probe patent foramen ovale.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU3, MMR, VARCEL, MMR, VARCEL
Symptoms: Death
Clinical narrative: Healthy 18 mo male with history of febrile seizure in 3/07 given MMR II, VZV, DTaP & Flu vaccine on 9/24/07. Child discovered by mother deceased in bed approx 9/25/07.  11/30/07 Reviewed autopsy report which states COD as undetermined & manner of death undetermined.  Anatomic diagnoses: pulmonary congestion & edema, sudden of unknown etiology.  Patient was found unresponsive face down on mattress in crib.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Facial palsy, Pharyngitis, Virus culture
Clinical narrative: Information has been received from a physician concerning a 62-year-old male with no known allergies, who has diabetes, "blood pressure" and a history of prostate cancer, who on 14-SEP-2007 was vaccinated with a dose of Zostavax. No other vaccines were given at that time. On 15-SEP-2007, the patient developed left sided pharyngitis and ear pain. On an unspecified date, the patient was seen in the office and was diagnosed with ulcerative pharyngitis and Bell Palsy. On an unspecified date viral cultures were done. The patient was treated with valacyclovir hydrochloride (VALTREX). The outcome was reported as not recovered. No product quality complaint was involved. The reporter considered ulcerative pharyngitis and Bells Palsy to be disabling and an other important medical event. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Immune system disorder, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a female infant who was diagnosed with rotavirus after 2 doses of Rotateq (lot number was not available). Unspecified medical attention was sought. Subsequently the patient's immune system became severely compromised and the patient was hospitalized. Lab diagnostic studies included "serotyping the rotavirus strain." The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with the second dose of Rotateq. The patient developed bloody loose stools which have continued for six months. It was unknown whether medical attention was sought. The patient's recovery status was unknown. Upon internal review, bloody loose stools were determined to be an other important medical event. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: HIBV, MMRV, PNC
Symptoms: Body temperature increased, Chest X-ray, Convulsion, Pneumonia
Clinical narrative: Information has been received from a health professional concerning a 13 month old female, with no medical history and no allergies, who on 28-AUG-2007 was vaccinated with a first subcutaneous dose of ProQuad (Oka/Merck upgrade process) (Lot# 657782/0612U). Concomitant vaccines, administered on the same day, included a fourth intramuscular dose of Prevnar (Lot# B53981A) and a fourth intramuscular dose of ActHib (Lot# UF024AB). There was no illness at the time of vaccination and no adverse events following prior vaccinations. On 04-SEP-2007, at 6:00 a.m., the patient experienced a seizure, as stated by the patient's mother, and a high temp of 103.2, measured rectally. The patient was diagnosed with pneumonia of the lower right lung and was hospitalized for three days. Subsequently, the patient recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Clinical narrative: Information has been received from Merck Pregnancy Registry for the Gardasil vaccine from a health professional concerning a 17 year old female patient who on 31-MAY-2007 was vaccinated with a dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified) and antimicrobial (unspecified). The reporter reported that patient miscarried on 18-AUG-2007 after receiving the dose of Gardasil. The estimated date of conception was about 06-JUN-2007. On an unspecified day laboratory test serum beta-human chorionic gonadotropin test was done. Unspecified medical attention was sought. The outcome was unknown. Upon internal review, miscarried was considered an other important medical event. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy
Clinical narrative: Information has been received from a female who in October 2006, was vaccinated with the first dose of Gardasil (Lot # not reported). Concomitant therapy included Yasmin. In February 2007, the patient experienced facial paralysis. It was reported that the patient could not move the left side of her face, but she was able to talk. Subsequently, the patient recovered from facial paralysis about 4 weeks later. Patient did not receive the second dose of Gardasil. Patient sought unspecified medical attention. It was determined that facial paralysis was an other important medical event. Additional information has been requested.
Sex: F
Vaccine: SMALL
Symptoms: Skin lesion, Vaccinia, Virus culture positive
Clinical narrative: This case was considered medically important. Information regarding Dryvax was received from a literature source regarding a 54-year-old female patient who on unspecified dates received a dose and experienced progressive vaccinia. In December of 1970, the patient experienced progressive vaccinia. The virus was thought to have been isolated from a single skin crusted lesion, but the source may have been as many as four lesions. Patient was treated with vaccinia immune globulin. The outcome was not provided. The authors commented that it was not known if the patient was vaccinated or became infected following contact with a vaccinated individual. The immune status of the individual is not known, thus the underlying basis for the clinical findings is not clear. Furthermore, became virus was isolated from only one of a few lesions it is not known how the sequence of VACV-DUKE would compare to virus isolated from other lesions. Virus culture (results: VACV-DUKE vaccinia virus) was done in 1970. No additional information was available at the time of this report. See attached literature article.
Age: 21.0
Sex: M
Vaccine: MEN
Symptoms: Lumbar puncture, Malaise, Meningitis bacterial
Clinical narrative: Initial report received from a health care professional on 17 September 2007. A 21-year-old male university student was reported to have received a meningococcal vaccine from Sanofi-Pasteur (trade name not reported, batch number unknown; route/site of administration not reported) in 2004 (specific date unknown). On 03 September 2007, the patient became "ill" and was admitted to the hospital. A spinal tap was performed and the patient was diagnosed with bacterial meningitis, unknown strain. The patient was treated with intravenous antibiotics. He recovered and was discharged one week later. No additional information was provided at the time of this report.
Sex: M
Vaccine: YF
Symptoms: Basal cell carcinoma
Clinical narrative: Initial report received from a physician on 25 June 2007. A male patient in his 70s (exact age, date of birth not provided) developed a non-healing lesion at the injection site after he received YF-VAX (lot number, route, site and date of administration not reported) at another facility. It was reported the patient had not recovered. Follow-up information received on 21 September 2007 from a health care professional. Per the reporter, "The patient did not have a reaction. The lesion was actually a basal cell cancer near the vaccine site." The event in this case was amended in order to reflect this new information. Additional information was not provided.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin exfoliation
Clinical narrative: Initial report received from a heath care provider on 24 September 2007. A 27-year-old female had received a left deltoid intramuscular injection of Adacel (Lot number reported as C2822AA) and a right deltoid intramuscular injection of Hepatitis B vaccine (manufacturer and lot number not reported) on 12 September 2007. The following day, the patient experienced left deltoid injection site swelling and redness. The swelling and redness then extended down to the forearm. The left deltoid area became a deeper red and the skin was peeling. The patient complained of pain in the whole arm. The event required a visit to the doctor's office. Treatment included a five day course of prednisone and placing the patient's arm in a sling. Outcome was reported as "not recovered". No additional information was provided at the time of this report.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Autism, Ear infection, Gait disturbance, Hyperacusis, Photophobia
Clinical narrative: Patient seemed to be a healthy baby until late October of 1999. He developed a series of ear infections and by November he regressed. His ability to speak words stopped and he displayed autistic behaviors such as repetitious play, toe walking, lack of comprehension, sensitivity to noise and light, etc. 10/15/07-records received-office visit notes from 7/15/98-10/27/04-well baby visits with occasional otitis media, URI, viral illness. 5/5/99-scratch left eye. 9/19/02-seen for poor speech, delayed, also very active at school , does not sit still. ADHD. Fractured clavicle 6/16/03-Parents felt child developed normally until about 16-18 months of age seemed to lose some of his vocabulary words. Seen in speech therapy, very short attention span and bursts of energy. Sing song voice, echolalia. Performance test responses slow. Tests showed scores in the mentally retarded range on standardized measure of intelligence and appears to meet diagnostic criteria for ADHD and Autistic Disorder
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Regressive behaviour, Speech disorder developmental
Clinical narrative: Patient seemed to be a healthy baby until late October of 1999. He developed a series of ear infections and by November he regressed. His ability to speak words stopped and he displayed autistic behaviors such as repetitious play, toe walking, lack of comprehension, sensitivity to noise and light, etc. 10/15/07-records received-office visit notes from 7/15/98-10/27/04-well baby visits with occasional otitis media, URI, viral illness. 5/5/99-scratch left eye. 9/19/02-seen for poor speech, delayed, also very active at school , does not sit still. ADHD. Fractured clavicle 6/16/03-Parents felt child developed normally until about 16-18 months of age seemed to lose some of his vocabulary words. Seen in speech therapy, very short attention span and bursts of energy. Sing song voice, echolalia. Performance test responses slow. Tests showed scores in the mentally retarded range on standardized measure of intelligence and appears to meet diagnostic criteria for ADHD and Autistic Disorder
Age: 38.0
Sex: M
Vaccine: ANTH, FLU3, HEP, HEPA
Symptoms: Amnesia, Back pain, Blood cholesterol increased, Hypersensitivity, Hypertension
Clinical narrative: Allerg react - blood pressure high - blood - high cholesterol - memory difficulty - memory loss - pain back - rash - infection with rash - sleep problems 10/8/07-records received-Referred to psychiartry for nightmares. Treated in clinic for DX of essential hypertension. Obesity. Tobacco use. Hyperlipidemia. PTSD.  Alcohol dependence.
Age: 38.0
Sex: M
Vaccine: ANTH, FLU3, HEP, HEPA
Symptoms: Infection, Memory impairment, Rash, Sleep disorder
Clinical narrative: Allerg react - blood pressure high - blood - high cholesterol - memory difficulty - memory loss - pain back - rash - infection with rash - sleep problems 10/8/07-records received-Referred to psychiartry for nightmares. Treated in clinic for DX of essential hypertension. Obesity. Tobacco use. Hyperlipidemia. PTSD.  Alcohol dependence.
Age: 0.89
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Constipation, Intestinal obstruction, Small intestinal obstruction
Clinical narrative: Was given 3rd Rotavirus vaccination 5/7/07. Developed abd pain, vomiting, constipation. Needed surgery for small bowel obstruction done in hospital.  10/02/2007 MR received for 2 hospital admissions DOS 6/20-7/02/2007 and 7/06/2007 for DX: Small bowel obstruction and Partial Small Bowel Obstruction.  Child presented on 6/20/2007 with 6 day hx of emesis, vomiting all meals ~ 5 minutes after eating.  One episode of bilious emesis. No diarrhea or fever.  Pt had Exploratory lap, lysis of adhesions, and placement of a central venous line on 6/27/07/.  Discharge on 7/2/07. Pt returned to hospital on 7/6/07 with c/o emesis x 3 days after had been tolerating feeds s/p ex lap.  Txd with NPO, IVF and and NG tube. Records also received from PCP for hospital DOS 7/13-18/2007 and 7/30-8/6/2007 for DX:  Hx of volvulus and small bowel obstruction, hx of small bowel obstruction with post-op ileus and narrowing at the anastomosis and GERD. Small bowel obstruction s/p resection. Infant presented this admission (7/13/07) with persistant projectile vomiting, decreased UO and weight loss.  PE (+) for dehydration.  Discharged home with segmental bowel resection scheduled. Infant presented 7/30/07 after an episode of bright red rectal bleeding on 7/28/07 after constipation. Pt was admitted for another small bowel resection on 7/31/07. Pt remained NPO until 8/4/07 when po fluids were initiated without problems.  D/c after 36 hours of normal feeds.
Age: 0.89
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Surgery, Vomiting, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Was given 3rd Rotavirus vaccination 5/7/07. Developed abd pain, vomiting, constipation. Needed surgery for small bowel obstruction done in hospital.  10/02/2007 MR received for 2 hospital admissions DOS 6/20-7/02/2007 and 7/06/2007 for DX: Small bowel obstruction and Partial Small Bowel Obstruction.  Child presented on 6/20/2007 with 6 day hx of emesis, vomiting all meals ~ 5 minutes after eating.  One episode of bilious emesis. No diarrhea or fever.  Pt had Exploratory lap, lysis of adhesions, and placement of a central venous line on 6/27/07/.  Discharge on 7/2/07. Pt returned to hospital on 7/6/07 with c/o emesis x 3 days after had been tolerating feeds s/p ex lap.  Txd with NPO, IVF and and NG tube. Records also received from PCP for hospital DOS 7/13-18/2007 and 7/30-8/6/2007 for DX:  Hx of volvulus and small bowel obstruction, hx of small bowel obstruction with post-op ileus and narrowing at the anastomosis and GERD. Small bowel obstruction s/p resection. Infant presented this admission (7/13/07) with persistant projectile vomiting, decreased UO and weight loss.  PE (+) for dehydration.  Discharged home with segmental bowel resection scheduled. Infant presented 7/30/07 after an episode of bright red rectal bleeding on 7/28/07 after constipation. Pt was admitted for another small bowel resection on 7/31/07. Pt remained NPO until 8/4/07 when po fluids were initiated without problems.  D/c after 36 hours of normal feeds.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: CSF glucose normal, CSF protein normal, Confusional state, Disturbance in attention, Erythema
Clinical narrative: Description: feeling general malaise over the weekend and into the following week, pain, redness at inoculation site. Decreased mental clarity noted by fellow service members. Flu-like symptoms < 96 hours Start: 09/22/2007 Confused Start: 09/27/2007 Comment: decrease in mental clarity Erythema Start: 09/25/2007 Swelling Start: 09/25/2007 Pain Start: 09/25/2007 Comment: at inoculation site. 6/26/08-records received for DOS 9/27-9/28/08-DC DX: Vaccine Reaction non specific. Presented with fever and confusion, mental acuity slower, malaise, decreased appetite and fatigue over past 1-2 days. Fever and chills.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Lumbar puncture normal, Malaise
Clinical narrative: Description: feeling general malaise over the weekend and into the following week, pain, redness at inoculation site. Decreased mental clarity noted by fellow service members. Flu-like symptoms < 96 hours Start: 09/22/2007 Confused Start: 09/27/2007 Comment: decrease in mental clarity Erythema Start: 09/25/2007 Swelling Start: 09/25/2007 Pain Start: 09/25/2007 Comment: at inoculation site. 6/26/08-records received for DOS 9/27-9/28/08-DC DX: Vaccine Reaction non specific. Presented with fever and confusion, mental acuity slower, malaise, decreased appetite and fatigue over past 1-2 days. Fever and chills.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Scan brain, Swelling
Clinical narrative: Description: feeling general malaise over the weekend and into the following week, pain, redness at inoculation site. Decreased mental clarity noted by fellow service members. Flu-like symptoms < 96 hours Start: 09/22/2007 Confused Start: 09/27/2007 Comment: decrease in mental clarity Erythema Start: 09/25/2007 Swelling Start: 09/25/2007 Pain Start: 09/25/2007 Comment: at inoculation site. 6/26/08-records received for DOS 9/27-9/28/08-DC DX: Vaccine Reaction non specific. Presented with fever and confusion, mental acuity slower, malaise, decreased appetite and fatigue over past 1-2 days. Fever and chills.
Age: 53.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Mass, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Patient c/o fever, body aches and lt arm was swollen with knot, red and warm to the touch.
Age: 53.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Skin warm
Clinical narrative: Patient c/o fever, body aches and lt arm was swollen with knot, red and warm to the touch.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Vaccine positive rechallenge
Clinical narrative: At approximately 12 hours after vaccinations 2 and 3 of human papilloma virus,Gardasil, patient exhibited severe abdominal pain for a period of time lasting 2-3 hours.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site mass, Injection site pruritus
Clinical narrative: Pt. reports today that she felt some discomfort at injection site for "some time" after receiving the vaccine.  Since then she has intermittently ( 6-8 times in 8 months) felt itching/discomfort at the site.  Yesterday she experienced the itching and noticed that there is a small lump (dime size) under the skin at the site.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Erythema, Nodule, Oedema peripheral, Skin warm
Clinical narrative: 2 inch x 2 inch hard nodule & swelling left deltoid area. 2" x 1" area of redness over nodule with yellowish bruising above the redness.  Area warm to touch.  Symptoms noticed the next morning after receiving injection, 9/29/07.  Area observed today 10/01/07.  No increase in symptoms since 9/29/07.  Ibuprofen 400 mg. given.  Told to ice area at least twice a day until swelling down.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, IPV, PPV
Symptoms: Infection in an immunocompromised host, Inflammation, Movement disorder, Myositis
Clinical narrative: Note:  patient immunocompromised s/p heart transplant.  Developed inflammation/?myositis in both legs; refused to move them.  Admitted, given iv antibiotics x48 hours, then oral abx.  Recovered uneventfully.  10/15/2007 MR received from PCP. Vax record included and lot numbers updated in VAERS database. Pt in for WCC and vax on 9/17/2007.  Seen again 9/19/07 for fever, decreased po intake, diarrhea, and "won't move body since 9/17/07". (+) bladder incontinence because of refusal to get up.  PE (+) for refusal to move and generalized tenderness of the lower extremities.  Admited to hospital for presumed myositis.    01/14/2008 MR received for DOS 9/19-22/2007 with D/C DX:  Myositis.  Child presented for direct admit for c/o fever, pain and refusal to walk.    PE (+) for tenderness from the L hip to knee.  Red streaking noted on 9/20/07.  Txd with abx with good result.  Pt became hyperkalemic during admit with EKG changes which resolved with IVF changes and kayexolate.  D/C on po abx.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Developed redness and welts at injection site immediately after shot given.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Discomfort, Injection site erythema, Injection site swelling
Clinical narrative: States that 2 hours after receiving pneumococcal vaccine, his right arm became red & swollen at the injection site.  State that he took Tylenol & used a heating pad for relief.  States that redness & discomfort lasted about 48 hours, then all symptoms resolved.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria, Vomiting
Clinical narrative: Patient received Hep A vaccine #1 at 0843. At 1000 mother of patient noticed red hives on patient's left shoulder. At 1030 hives begin to cover the patients entire body. Mother of patient reports one episode of vomitting. Patient reports no signs of breathing difficulty or itching.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: REDNESS,SWELLING,TENDERNESS TO L DELTOID
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Rash papular
Clinical narrative: ONE CM SLIGHTLY RAISED FLESHY COLORED PAPULE, TO LEFT SHOULDER.  PATIENT C/O "ITCHY".  NON-ERYTHEMATOUS, WITHOUT PUS DRAINAGE.  PATIENT STATES PRIOR H/O SIMILAR EPISODES.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: Pin point rash developed first on wrist and then spread from neck down to the rest of the body.  The rash lasted one week.  Patient did NOT seek medical care but just took OTC Benedryl.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Injected limb mobility decreased, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: PT. C/O RIGHT ARM TENDERNESS, SUBQ NODULE, WARMTH TO SITE, ERYTHEMA, LIMITED R. ARM MOTION, NAUSEA.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Nausea
Clinical narrative: PT. C/O RIGHT ARM TENDERNESS, SUBQ NODULE, WARMTH TO SITE, ERYTHEMA, LIMITED R. ARM MOTION, NAUSEA.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Body temperature increased, Diarrhoea, Diet refusal, Irritability
Clinical narrative: Pt. Became irritable within 36 hrs. Had diarrhea, slightly elevated temp. of 100.0 and refused to nurse for a normal length of time for approx. 2.5 days after onset of irritability.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Blister, Erythema, Rash macular, Urticaria
Clinical narrative: Child received immunizations at 2:00 pm, Tuesday, September 25, 2007.  Parent states that evening child developed redness and a welt on Left thigh - applied cold washcloth.  Wednesday afternoon child then developed red, blotchy rash on both legs and blisters on her perineal area and both buttocks.  Went to ER - prednisone prescribed.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Half dollar sized erythematous area around injection site.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Ear infection, Hypersensitivity, Pyrexia, Urticaria
Clinical narrative: Approximately 7 days after vaccinations, my baby developed a fever. The fever was treated for two days at home, but seemed to reappear. On 9/22 he wakened with huge welts all over his body. Initally on the left arm then on the legs. I was alarmed by this and called the nurse advice line and was advised to take him to immediate care. I was told he had developed an ear infection and had an allergic reaction "to something". The welts/hives reappeared again that evening (9/22), the next morning (9/23), and the day after (9/24. Each time only lasting between 1 1/2 - 2 hours each course. The physician prescribed antibiotics and benadryl.
Age: 1.33
Sex: F
Vaccine: MEA
Symptoms: Rash morbilliform
Clinical narrative: had measles vaccine on 9/13/07 ad on 9/24/07 developed measles-like rash head to toe.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Conjunctivitis, Dermatitis, Herpes zoster
Clinical narrative: Herpes Zoster, dermatitis around left eye and conjuctivtis
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Asthenia, Cold sweat, Diarrhoea, Pyrexia
Clinical narrative: Extreme abdominal pain, vomitting, diarrhea, slight fever, cold sweats, weakness
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: Extreme abdominal pain, vomitting, diarrhea, slight fever, cold sweats, weakness
Age: 57.0
Sex: U
Vaccine: UNK
Symptoms: Erythema, Musculoskeletal stiffness, Nausea, Pain, Pyrexia
Clinical narrative: extreme pain; large area of redness on left arm increasing to area going around arm; arm area very hard; fever recorded at 101.6; nausea with some vomiting; aches; severe pain in back of head and along neck area; stiffness in shoulders and neck; used ice packs on arm; took tylenol; could only keep down Sprite, mashed potatoes, crackers; on Sun Sept. 30  went to ER where I received medication by mouth for swelling of arm and given 2 prescriptions for swelling, itching
Age: 57.0
Sex: U
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: extreme pain; large area of redness on left arm increasing to area going around arm; arm area very hard; fever recorded at 101.6; nausea with some vomiting; aches; severe pain in back of head and along neck area; stiffness in shoulders and neck; used ice packs on arm; took tylenol; could only keep down Sprite, mashed potatoes, crackers; on Sun Sept. 30  went to ER where I received medication by mouth for swelling of arm and given 2 prescriptions for swelling, itching
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Erythema, Swelling
Clinical narrative: Extreme upper extremity erythema and swelling starting within 12 hrs of vaccine admin and continuing with minimal improvement over 7 days.  No fever. No breathing difficulties. No pain.  Treated with ibuprofen 200mg tid.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dysphonia, Headache, Rash
Clinical narrative: SHINGLES VACCINE - Rash on back initially, now spreading to stomach, arms.  Headache, horseness, chills. Patient unable to work. Patient went to a dermatologist the day following the vaccination and was given Famciclovir (generic for Famvir), 500mg to be taken 3 times a day for 7 days. This has not helped at all.
Age: 0.45
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warmth at vaccine site from 07/18/2007 DTaP series 3.