chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Laboratory test, Mechanical ventilation, Pneumococcal infection
Clinical narrative: Information has been received from a physician concerning an approximately 50 year old male, who "about four months ago," was vaccinated with a dose of Pneumovax 23. "Two months post vaccination" in approximately August 2007, the patient had been diagnosed with "invasive pneumococcal disease." The patient was admitted to the hospital and put on a ventilator. Bloodwork was performed (no results provided). At the time of the report, the patient was recovering. No product quality complaint was involved. The "invasive pneumococcal disease" was considered to be life threatening and an other important medical event by the reporting physician. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Abdominal X-ray, Barium enema, Intussusception
Clinical narrative: Information has been received from a physician concerning an 8 month old male with reflux and history of "MSPI type" diet with no other medical history or drug allergies who on 22-MAR-2007, 24-MAY-2007 and 25-JUL-2007 was vaccinated PO with his first, second and third doses (lot# 656381/0875U) of Rotateq. Concomitant vaccinations administered on 25-JUL-2007 included a dose of DTaP, a dose of poliovirus vaccine inactivated (unspecified) and a dose of (Prevnar). Other concomitant drug therapy included nizatidine (AXID) drops for reflux. On 04-OCT-2007 the patient experienced intussusception and was hospitalized. Medical attention was sought through the physician. Labs and abdominal x-rays were performed. A barium enema was also performed to reduce the intussusception. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.  10/26/07 Patient demographics provided by CDC.  10/30/07 Reviewed vax records which confirms RO dose & lot as reported & provides other vax info.  VAERS database updated w/same.  11/2/07 Received hospital medical records which reveal patient experienced bilious vomiting x 2 days & 1 episode of bloody stool.  Seen by pcp, sent to ER when vomiting persisted.  Admitted 10/4-10/5/2007. Noted to have exanthem, lethargy, reduced oral intake & urine output.  Progressed well s/p enema reduction & d/c to home. FINAL DX: Intussusception, enema reduced.  Records faxed to CDC.
Sex: M
Vaccine: FLUX
Symptoms: Urticaria, Urticaria chronic
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial information received on 16 October 2007 from a health care professional. An elderly, (age not specified), male patient had received an injection of influenza vaccine, manufacturer unknown, lot number unknown, and route and site of administration not provided; on an unspecified date in 2006. On hour post-vaccination, the patient developed generalized hives and since then has had chronic urticaria. The event required a doctor visit. Treatment included multiple unspecified antihistamines. Pre-existing medical history included a possible allergy to FluMist. It was unknown whether the patient was taking FluMist at the time of vaccination. Illness at the time of vaccination was unknown. At the time of this report, the patient had not recovered.
Age: 0.8
Sex: F
Vaccine: MNQ
Symptoms: Chest X-ray normal, Crying, Culture urine negative, Hypotonia, Hypoxia
Clinical narrative: Initial report received on 17 October 2007 from an investigator participating in the above-mentioned trial under the reference number MTA48. A nine-month-old female subject experienced respiratory distress 7.5 hours after receiving an intramuscular right thigh injection of Menactra (lot number U2359AA). On 05 October 2007 the subject was seen by her pediatrician, at which time her mother noted that she had been experiencing vomiting "on an off for two weeks", since the subject had advanced to stage three foods. In addition, the subject had one episode of vomiting in the pediatrician's office prior to vaccine administration. The pediatrician also noted intercostal retractions on exam, which her mother stated were "normal" for her. The doctor completed the exam and determined the subject to be a "healthy infant". Study vaccine was administered at 14:50, with no observed reaction. At 17:30, her mother noted that the subject "felt warm," and she gave the subject 0.4 mL of Tylenol orally. The subject then took a nap. At 22:30, she awoke crying; she then vomited, and subsequently became "limp" and "white as a ghost". Emergency medical services were called to the subject's home, and upon arrival it was noted that her oxygen saturation was 88 - 90% on room air. She was given oxygen at 10 liters, and transported to the emergency room. At 23:00, upon arrival at the emergency room, her rectal temperature was 101.7 degrees Fahrenheit, and oxygen saturation on room air was 96 - 100%. At 00.33 on 06 October 2007, the subject was given 120 mg acetaminophen rectally. Exam revealed a pulse of 170, respiratory rate of 36, and weight 8.5 kg. She was alert, with tears and a normal amount of wet diapers, had no diarrhea, and was eating well. Tympanic membranes were pearly bilaterally, and nasal crusting was noted. Lungs were clear to auscultation, skin clear with no rash. The subject was noted to be teething. Chest x-ray, urinalysis, and urine culture were all normal. At 02:15 the subject was given oral ibuprofen 20 mg/mL, and she was discharged at 02:53. The parents were instructed to follow-up with the pediatrician in two days; per the investigator, no other contact had been made despite several attempts. The investigator considered the respiratory distress to be an important medical event, "yielding a trip to the emergency room". The event was considered to be resolved on 06 October 2007, and the subject was not discontinued from the study. According to the investigator, the event was related to the study vaccine. Documents held by sender: ER record
Age: 0.8
Sex: F
Vaccine: MNQ
Symptoms: Intercostal retraction, Oxygen saturation decreased, Pallor, Pyrexia, Skin discolouration
Clinical narrative: Initial report received on 17 October 2007 from an investigator participating in the above-mentioned trial under the reference number MTA48. A nine-month-old female subject experienced respiratory distress 7.5 hours after receiving an intramuscular right thigh injection of Menactra (lot number U2359AA). On 05 October 2007 the subject was seen by her pediatrician, at which time her mother noted that she had been experiencing vomiting "on an off for two weeks", since the subject had advanced to stage three foods. In addition, the subject had one episode of vomiting in the pediatrician's office prior to vaccine administration. The pediatrician also noted intercostal retractions on exam, which her mother stated were "normal" for her. The doctor completed the exam and determined the subject to be a "healthy infant". Study vaccine was administered at 14:50, with no observed reaction. At 17:30, her mother noted that the subject "felt warm," and she gave the subject 0.4 mL of Tylenol orally. The subject then took a nap. At 22:30, she awoke crying; she then vomited, and subsequently became "limp" and "white as a ghost". Emergency medical services were called to the subject's home, and upon arrival it was noted that her oxygen saturation was 88 - 90% on room air. She was given oxygen at 10 liters, and transported to the emergency room. At 23:00, upon arrival at the emergency room, her rectal temperature was 101.7 degrees Fahrenheit, and oxygen saturation on room air was 96 - 100%. At 00.33 on 06 October 2007, the subject was given 120 mg acetaminophen rectally. Exam revealed a pulse of 170, respiratory rate of 36, and weight 8.5 kg. She was alert, with tears and a normal amount of wet diapers, had no diarrhea, and was eating well. Tympanic membranes were pearly bilaterally, and nasal crusting was noted. Lungs were clear to auscultation, skin clear with no rash. The subject was noted to be teething. Chest x-ray, urinalysis, and urine culture were all normal. At 02:15 the subject was given oral ibuprofen 20 mg/mL, and she was discharged at 02:53. The parents were instructed to follow-up with the pediatrician in two days; per the investigator, no other contact had been made despite several attempts. The investigator considered the respiratory distress to be an important medical event, "yielding a trip to the emergency room". The event was considered to be resolved on 06 October 2007, and the subject was not discontinued from the study. According to the investigator, the event was related to the study vaccine. Documents held by sender: ER record
Age: 0.8
Sex: F
Vaccine: MNQ
Symptoms: Skin warm, Urine analysis normal, Vomiting
Clinical narrative: Initial report received on 17 October 2007 from an investigator participating in the above-mentioned trial under the reference number MTA48. A nine-month-old female subject experienced respiratory distress 7.5 hours after receiving an intramuscular right thigh injection of Menactra (lot number U2359AA). On 05 October 2007 the subject was seen by her pediatrician, at which time her mother noted that she had been experiencing vomiting "on an off for two weeks", since the subject had advanced to stage three foods. In addition, the subject had one episode of vomiting in the pediatrician's office prior to vaccine administration. The pediatrician also noted intercostal retractions on exam, which her mother stated were "normal" for her. The doctor completed the exam and determined the subject to be a "healthy infant". Study vaccine was administered at 14:50, with no observed reaction. At 17:30, her mother noted that the subject "felt warm," and she gave the subject 0.4 mL of Tylenol orally. The subject then took a nap. At 22:30, she awoke crying; she then vomited, and subsequently became "limp" and "white as a ghost". Emergency medical services were called to the subject's home, and upon arrival it was noted that her oxygen saturation was 88 - 90% on room air. She was given oxygen at 10 liters, and transported to the emergency room. At 23:00, upon arrival at the emergency room, her rectal temperature was 101.7 degrees Fahrenheit, and oxygen saturation on room air was 96 - 100%. At 00.33 on 06 October 2007, the subject was given 120 mg acetaminophen rectally. Exam revealed a pulse of 170, respiratory rate of 36, and weight 8.5 kg. She was alert, with tears and a normal amount of wet diapers, had no diarrhea, and was eating well. Tympanic membranes were pearly bilaterally, and nasal crusting was noted. Lungs were clear to auscultation, skin clear with no rash. The subject was noted to be teething. Chest x-ray, urinalysis, and urine culture were all normal. At 02:15 the subject was given oral ibuprofen 20 mg/mL, and she was discharged at 02:53. The parents were instructed to follow-up with the pediatrician in two days; per the investigator, no other contact had been made despite several attempts. The investigator considered the respiratory distress to be an important medical event, "yielding a trip to the emergency room". The event was considered to be resolved on 06 October 2007, and the subject was not discontinued from the study. According to the investigator, the event was related to the study vaccine. Documents held by sender: ER record
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Body temperature decreased, Cold sweat, Crying, Hypotonic-hyporesponsive episode, Pallor
Clinical narrative: Initial literature report was published on 10 October 2007. The article was received on 15 October 2007. A 2 month-old female patient with a normal birth history, that was breast-fed and thriving, received her routine 2-month immunizations, including Prevnar, Rotateq, Daptacel (lot#not reported), ActHib, Recombivax HB, and inactivated polio vaccine (manufacturer unknown). She cried immediately after vaccination, quieted down in a few minutes, and then left the office. The mother reported that the baby fell asleep in the car and looked fine. When she got home, the mother put her into her bed, where she slept about 3 hours. She then cried, and when the mom picked her up, she was cool and clammy, with a pale skin color. Her temperature rectally was 96.5 F. The mom called the physician and took her to the nearest emergency room. By the time she was seen about an hour later, her color was good and the temperature was said to be normal. A sepsis evaluation was performed (except for lumbar puncture); all tests were normal. At the end of the examination, the baby was acting entirely normally, and she has been free of symptoms ever since the single episode. According to the reporter the illness in this 2 month-old female infant fitted the definition of a DTaP vaccine-related hypotonic hyporesponsive episode (HHE). The cause of HHE was not known. An extensive follow-up assessment in 1998 did not reveal permanent sequelae after HHE. The reporter believed that the patient should continue her regular immunization schedule without change after a single HHE event.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site mass, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: There was swelling in the area that the vaccine was given along with itching and a knot that is still present on the arm.  Fever was in the arm and muscles were aching and unusual tiredness.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: There was swelling in the area that the vaccine was given along with itching and a knot that is still present on the arm.  Fever was in the arm and muscles were aching and unusual tiredness.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Pain, Pruritus, Rash papular, Sick relative
Clinical narrative: Morning after shots, she noticed an itchy raised spot on her back.  Subsequently she developed 5 more lesions.  They were itchy, but then became painful.  They appear to be erythematous, papular with small excoriated centers. No pustules. Cough did seem worse, but she had other ill contacts in the family.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Skin lesion
Clinical narrative: Morning after shots, she noticed an itchy raised spot on her back.  Subsequently she developed 5 more lesions.  They were itchy, but then became painful.  They appear to be erythematous, papular with small excoriated centers. No pustules. Cough did seem worse, but she had other ill contacts in the family.
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Pain, Pruritus, Swelling
Clinical narrative: Recieved DtaP, Ipol, and MMR on 10/16/07.  On 10/17/07 developed redness, swelling, pain ,and itchiness.  Senn in our office on 10/18/07.  Diagnosised with L arm cellulitis secondary to immunization reaction.
Age: 10.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Skin lesion
Clinical narrative: Several lesions on arm and abdomen, under arm, no treatment
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: Patient received the influenza vaccine 10/23/07 in the afternoon. Had no problems until she woke up the next morning with erythematous rash to her axillae, trunk, abdomen, ears and right foot. Her right foot was swollen to the extent that her shoe had to be removed. She had no breathing difficulties and her vitals were BP 124/86 P 71 respiratory rate 18. Her only c/o was itching. She was sent toDr.'s office for evaluation and treatment. She was given a steroid injction, zyrtec and a medrol dose pack. She called in this morning (10/25/2007)to report that all of her symptoms were resolved except her Right foot which remains swollen and painful. She was instructed to start the medrol dose pack (Dr. told her to begin that today if her symptoms were not resolved.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Haematoma
Clinical narrative: Client received flu shot and then went home and using the arm he received the shot in, washed 3 large trucks. By the next morning he had a large hematoma covering his upper arm.
Age: 26.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Erythema, Gastrointestinal disorder, Myalgia, Pyrexia
Clinical narrative: Pt reported significant fevers >102.5, myalgias/arthralgias, tender erythema left upper arm. Significant gastrointestinal symptoms.
Age: 26.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Pt reported significant fevers >102.5, myalgias/arthralgias, tender erythema left upper arm. Significant gastrointestinal symptoms.
Age: 26.0
Sex: F
Vaccine: TTOX
Symptoms: Ear discomfort, Headache, Nausea, Vomiting
Clinical narrative: Received vaccine on 10/22/07, next day complained of severe headache, ears felt blocked, nausea and vomiting.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Approximately one hour following vaccine administration patient developed  lightheadedness, clamy, sweating reaction, mild nausea no vomiting. symptoms completely resolved < 4 hours
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Pyrexia, Stomach discomfort, Vomiting
Clinical narrative: Patient started getting extreme upset stomach, vomiting, diarrhea, fever and fatigue. Lasted 4 days. 11/27/07 Reviewed hospital medical records which reveal patient experienced a syncopal episode.  After having diffuse abdominal cramps & straining to have BM, got weak, dizzy & passed out.  Then had nausea, vomiting x 3 & diarrhea.  Admitted to ER on 10/12 & kept overnight for observation, d/c to home 10/13/2007. Cardiac consult done. FINAL DX: vasovagal syncope.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site irritation, Injection site pain, Musculoskeletal pain
Clinical narrative: 18 JUN 2007 Recieved Anthrax shot left arm burning pain x 1 week 4/10, 02 July 2007 Anthrax right arm burning pain x 1 week 3/10, Still having nagging soreness remaining after 5 months in bilateral shoulder joints. Never had any problem before no trauma or sports injuries to shoulders. Symptoms are non specific however constant; low burning throbbing irritation in the joint. Full range of motion, no weakness, no radiation of symptoms
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Dyspnoea, Gaze palsy, Hyperhidrosis, Oxygen saturation decreased
Clinical narrative: injection given approx 2:25pm-at 3:15, pt went into resp distress, O2 sat 71, swelling to face and throat, SOB, eyes rolled back, pale, diaphoretic with blue lips 10/25/07-records received for DOS-10/20/07-DC DX: Anaphylaxis. Quadraplegia. UTI. Presented to ER with C/O shortness of breath. Developed immediate anaphylatic reaction after receipt of flu shot. Became cyanotic and hypotensive. Observed in ICU overnight.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pallor, Pharyngeal oedema, Respiratory distress, Swelling face
Clinical narrative: injection given approx 2:25pm-at 3:15, pt went into resp distress, O2 sat 71, swelling to face and throat, SOB, eyes rolled back, pale, diaphoretic with blue lips 10/25/07-records received for DOS-10/20/07-DC DX: Anaphylaxis. Quadraplegia. UTI. Presented to ER with C/O shortness of breath. Developed immediate anaphylatic reaction after receipt of flu shot. Became cyanotic and hypotensive. Observed in ICU overnight.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site oedema
Clinical narrative: eight hours after injection developed erythema and edema (5cm circular area) around injection site; also complained of headache for first 10 hours
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Urticaria
Clinical narrative: Hives and swelling of the airway-Given Benadryl and set to Primary Care Provider who gave her oral steroids.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain, Lip swelling, Nausea, Tachycardia, Vomiting
Clinical narrative: 15 minutes after receiving varivax, patient c/o abd pain, nausea.  His mother noted that  his lips were starting to swell.  He was brought back into an exam room where he started vomitting.  He had a secure airway, no wheezing, no other hives, only swelling of his lips.  RR 12, HR 116, pulse ox 97-99% on room air.  Before he started vomitting we tried to administer p.o. Benedryl.  After his emesis we administered IM EpiPen Jr.  He stopped throwing up, got drowsy, but breathing remained unlabored, no wheezing, tachycardia resolved within 5-10 minutes and he did not require oxygen or albuterol.  He was observed for 45 minutes and maintained normal RR, HR 60's, oxyegen saturation 99-100% on room air, decreased lip swelling.  He was discharged home with instructions to give p.o. benadryl Q6 hours and to call or return if his symptoms returned or worsened.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Aphthous stomatitis, Local reaction, Pharyngitis, Streptococcal identification test negative, Vomiting
Clinical narrative: "Half-dollar" sized local reaction at injection starting 24 hours post injection, lasting 3 days.  Seen in office on 10/25/2007 (6 days later for 3 days of pharyngitis (strep negative),and a 3 mm apthous ulcer above uvula on physical exam, as well as some increase anterior nodes.  No fevers.  Had some self-limited vomiting 10/19 - 10/20.  No prior history of oral ulcers.  Child is not toxic appearing.  No cutaneous vesicles.  Local reaction has resolved.
Age: 1.08
Sex: F
Vaccine: FLUX, HBHEPB, MMR
Symptoms: Abnormal behaviour, Hypersomnia, Listless, Pain, Pruritus
Clinical narrative: 7 days after vaccination a severe rash developed. Began at hairline and moved down over face and whole torso. Next day continued over arms, legs, hands, feet. Torso so completely covered in rash, there is little non-rash area - looks just like pictures of measles rash seen in books and online. Marin is listless, clingy, sleeping a lot, acts achy, slightly itchy on palms and neck. Ibuprofen given to make more comfortable. Went to doctor office on first day rash developed and told not to worry, that it would be better in a couple days and could be caused by MMR shot or another virus she happened to pick up.
Age: 1.08
Sex: F
Vaccine: FLUX, HBHEPB, MMR
Symptoms: Rash, Rash generalised, Rash morbilliform
Clinical narrative: 7 days after vaccination a severe rash developed. Began at hairline and moved down over face and whole torso. Next day continued over arms, legs, hands, feet. Torso so completely covered in rash, there is little non-rash area - looks just like pictures of measles rash seen in books and online. Marin is listless, clingy, sleeping a lot, acts achy, slightly itchy on palms and neck. Ibuprofen given to make more comfortable. Went to doctor office on first day rash developed and told not to worry, that it would be better in a couple days and could be caused by MMR shot or another virus she happened to pick up.
Age: 54.0
Sex: M
Vaccine: ANTH
Symptoms: Furuncle, Pruritus, Skin infection
Clinical narrative: Skin infection begins as a raised itchy bump that resembles an insect bite but within 1-2 days develops into a boil or pimple like sore
Age: 61.0
Sex: F
Vaccine: DTAP
Symptoms: Injected limb mobility decreased, Pain in extremity, X-ray abnormal
Clinical narrative: i received .5cc t dap on 10/09/07-very high up on left arm. pain began that evening. became progressively worse-unable to move arm without severe pain. called the clinic10/15/07, advised to continue working out the arm-stated pain may continue more than 2days-may be hyper reaction. expressed my concern that injection may have been placed too high(trainee placed injection-name?) pain continued to worsen. called clinic again 10/19/07-connected to message machine, which was not taking messages. pain prgressed to excruciating over the weekend. called clinic again 10/22/07-left message with appt.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, HIBV, IPV
Symptoms: Pyrexia
Clinical narrative: Gave Comvax which has Hib and ActHib. Should have given Comvax and DTAP. Called Mother day after immunization were given and she states child is "fine" only symptom is a low grade fever.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Hypoaesthesia, Oedema peripheral, Paraesthesia
Clinical narrative: 0900 Prickly sensation to back, hand swelling.  Patient given Benadryl cream and 2 tablets of Motrin with signs and symptoms subsiding. 1254 began again with hand swelling, prickly back and numbness at joint of right knee down to foot.  Patient went to ER, given Benadryl and Decadron (16mg).  Discharged to home, to continue Benadryl.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Pyrexia, Swelling
Clinical narrative: PT STATES HER ARM IS VERY SORE AND HAS A 2 AND 1/2 IN RAISED AREA AFTER RECEIVEING BOTH A FLU SHOT AND PNEUMONIA SHOT.  SHE IS ALSO COMPLAINGING OF A 103 DEGREEE FEVER
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood culture, Erythema, Oedema peripheral, Platelet count, Skin warm
Clinical narrative: Left upper arm redness, warmth, swelling from below shoulder to elbow.  Perimeters marked by hospital ER.  Lab work done at hospital.  Report by patient WBC elevated.  Received injection about 2:40 p.m., 1st symptoms occurred at 4:40p.m.  Treated self for 24 hours then received medical care at ER.  Received IV antibiotic and prescription for Clindomycin po 300 QID.  Diagnosis from physician as reported by patient was cellulitis.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: White blood cell count increased
Clinical narrative: Left upper arm redness, warmth, swelling from below shoulder to elbow.  Perimeters marked by hospital ER.  Lab work done at hospital.  Report by patient WBC elevated.  Received injection about 2:40 p.m., 1st symptoms occurred at 4:40p.m.  Treated self for 24 hours then received medical care at ER.  Received IV antibiotic and prescription for Clindomycin po 300 QID.  Diagnosis from physician as reported by patient was cellulitis.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash Developed within 24-48 hours of vaccination and persisted for over 1 week. Patient seen in office 10/19/2007, and treated with Prednisone.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Dysphonia, Dyspnoea, Erythema, Hypersensitivity, Increased upper airway secretion
Clinical narrative: Mom reports 10 minutes after leaving clinic site, child was experiencing wheezing, hoarsenss, shortness of breath, phlem, and difficulty breathing.  He was very red in color.  No rash present.  Mom took him immediately to the local emergency room, which was within 30 minutes.  She reports patient received Benadryl and she thinks Zyrtec po X1 dose.  She states the doctor diagnosed the episode as an allergic reaction.  They remained in the ER for 3 hours.  She reports patient has not experienced any further problems.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Wheezing
Clinical narrative: Mom reports 10 minutes after leaving clinic site, child was experiencing wheezing, hoarsenss, shortness of breath, phlem, and difficulty breathing.  He was very red in color.  No rash present.  Mom took him immediately to the local emergency room, which was within 30 minutes.  She reports patient received Benadryl and she thinks Zyrtec po X1 dose.  She states the doctor diagnosed the episode as an allergic reaction.  They remained in the ER for 3 hours.  She reports patient has not experienced any further problems.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered
Clinical narrative: Administered 0.5ml of Non-VFC flu vaccine to child under four years of age.  Mother had reported that child had had previous flu vaccines but no record available.  Contacted child's mother by telephone and she denied that child had any reactions to vaccine whatsoever.
Age: 0.5
Sex: M
Vaccine: DTAP, DTIPV, HIBV, PPV, RVX
Symptoms: Breath sounds abnormal, Wheezing
Clinical narrative: AT SIX MONTHS, MY SON HAS GOT SHOTS THAT MADE HIM BREATH WEIRD. HE STARTED WHEEZING REALLY BAD TO A POINT THAT THE DOCTOR PRESCRIBED ASTHMA MEDICINE ALBUTEROL. THE ONLY WAY FOR HIM TO BREATH BETTER IS IF WE GIVE HIM THE ALBUTEROL.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Pt developed a urticarial rash with swelling of hands and feet.  No stridor noted.  consistant with serum sickness in earlt stages.  of note patient also received syagis with the other vaccines.
Age: 38.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: erythema and induration at site of injection
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given the second HPV vaccine dose 17 days after the first dose.  CDC called and there should be no adverse effect on patient.  The second dose that was given is considered an extra dose, and will need real second dose 2 months from "extra"second dose.  Parent notified.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pain,swelling,  and redness at injection site.  Also developed a fever low-grade 99.1.  Diagnosed with cellulitis and treated with keflex 500mg tid X7days.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: I was administered influenza vaccine by my colleague on 10/19/07 evening.  I proceeded to go to exercise class then.  On Saturday morning, I woke up with a headache and a neck ache.  I took aleve and the headache improved, but the neck ache persisted.  On 10/22/07, I woke up with a very stiff neck, much worse than Saturday.  No further exercise was done after the initial 10/19/07 class.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Patient received vaccination in right arm 10/24/07 at 12 noon.  Next morning upper right arm was swollen and painful to move; swelling was anterior and superior to vaccination site.  No complaints of difficulty breathing, chest pain, nausea, vomiting, fever, joint pain or pain upon touchen swollen extremity.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Hyperhidrosis, Nausea, Oxygen saturation decreased
Clinical narrative: 9:18 received her flu vaccine.  She had received the flu vaccine 1 other time approx 3 years ago and "got the flu from it" but had no other reaction 10:05 returned to treatment suite stating she didn't "feel right" and that is had started about 10 minutes after her vaccine.  She complained of lightheadedness, chest tightness and was diaphoretic.  VS 98.5, 96, 132/92 O2 sat 100% 10:10 Dr.  back to assess and ordered Tylenol 650mg & Benadryl 25 mg, they were administered. 10:15 Continues to c/o chest tightness (rated 10/10), dizziness and was pale, rechecked O2 sat and was 90%, loosing connection but possibly dropped to 75%.  02 applied at 2L. 10:22 O2 sat increased to 100%.  Dr. back to assess ordered PIV and continue to monitor which was started in left AC with NS free flowing.  Pt continues to c/o chest tightness/pressure (now 7/10). 10:30 Stated feels "little better" but chest pressure continues at 7/10.  O2 sat 100%.  Dr. ordered wait 30 minutes and if she is back to normal she may return to work. 10:40 02 removed, sats 100% 10:45  c/o dizziness.  BP 128/80 Pulse 80 per Dr. probably rx to Benadryl. 11:00  states chest tightness continues at 7/10 and not improving also now has nausea, O2 sat 100%  BP 122/85 P 77 Resp 16 11:15 10mg ordered by Dr. and administered.  Per Dr. patient to go home when no longer short of breath, to take Claritin or Benadryl for next 2-3 days and see primary MD for any further complications. 11:25 Chest pressure decreasing 11:30 Family called.  Father came to pick her up and informed of situation.  She returned to work the next day with no further complications.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Oxygen supplementation, Pallor
Clinical narrative: 9:18 received her flu vaccine.  She had received the flu vaccine 1 other time approx 3 years ago and "got the flu from it" but had no other reaction 10:05 returned to treatment suite stating she didn't "feel right" and that is had started about 10 minutes after her vaccine.  She complained of lightheadedness, chest tightness and was diaphoretic.  VS 98.5, 96, 132/92 O2 sat 100% 10:10 Dr.  back to assess and ordered Tylenol 650mg & Benadryl 25 mg, they were administered. 10:15 Continues to c/o chest tightness (rated 10/10), dizziness and was pale, rechecked O2 sat and was 90%, loosing connection but possibly dropped to 75%.  02 applied at 2L. 10:22 O2 sat increased to 100%.  Dr. back to assess ordered PIV and continue to monitor which was started in left AC with NS free flowing.  Pt continues to c/o chest tightness/pressure (now 7/10). 10:30 Stated feels "little better" but chest pressure continues at 7/10.  O2 sat 100%.  Dr. ordered wait 30 minutes and if she is back to normal she may return to work. 10:40 02 removed, sats 100% 10:45  c/o dizziness.  BP 128/80 Pulse 80 per Dr. probably rx to Benadryl. 11:00  states chest tightness continues at 7/10 and not improving also now has nausea, O2 sat 100%  BP 122/85 P 77 Resp 16 11:15 10mg ordered by Dr. and administered.  Per Dr. patient to go home when no longer short of breath, to take Claritin or Benadryl for next 2-3 days and see primary MD for any further complications. 11:25 Chest pressure decreasing 11:30 Family called.  Father came to pick her up and informed of situation.  She returned to work the next day with no further complications.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Flushing, Joint swelling, Oedema peripheral, Rash
Clinical narrative: Received vaccine 10/22/2007@2:30pm. At 5:30pm had rash on arms legs and tops of feet. None on torso. Pt took Benadryl at home. Morning of 10/23/2007 pt still had rash and red cheeks. Physician at her work place gave Zantac and Loratidine. Wed AM 10/24/2007 pt had joint pain in wrists, elbows, knees and ankles.  Hands and ankles were swollen. Pt saw private physician and was given injection of Kenalog. Thurs 10/25/2007 after tx at Dr. office pt sx almost completely resolved.
Age: 11.0
Sex: M
Vaccine: FLUN3, TDAP, VARCEL
Symptoms: Erythema, Induration, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: PT SEEN IN OFFICE ON 10/25/2007 FOR POSSIBLE VACCINE REACTION. PT RECEIVED TDAP AND VARIVAX ON TUESDAY, 10/23/07. ON 10/25/07 PT PRESENTED WITH LEFT ARM SWOLLEN, RED, AND SLIGHTLY ITCHY. PROVIDER NOTED THAT LEFT UPPER ARM WAS RED, INDURATED, AND WARM, AFFECTED AREA 3 X 4 CM, NONTENDER TO TOUCH. PT WAS ADVISED TO USE COOL COMPRESSES PRN AND HYDROCORTISONE CREAM PRN ITCHING. TO CALL BACK FOR INCREASED REDNESS, PAIN, OR SWELLING.
Sex: M
Vaccine: PPV
Symptoms: Fall
Clinical narrative: Our FDA contact checked with a VAERS person who said VAERS wants all of the SAE reports from our clinical trial. If you want to change that after seeing this report, please let us know. Subject in pneumococcal vaccine trial fell from wheelchair and was hospitalized for a few days. I don't know his age but all of our subjects are middle age or older.  10/29/07 Per direction of FDA, will initiate f/u.  10/30/07 Spoke w/reporters office who states patient definitely received pneumovax but no lot number available.  No medical recods available either, only the SAE report form from site.  Message left for FDA to see whether SAE report form is required.  11/1/07 Letter faxed to reporter to request SAE report per FDA request.  11/06/07 SAE report reviewed which reveals patient experienced fall 18 days s/p vaccination when trying to transfer from wheelchair to transport van & hit his head.  Resulted in 5 staples to back of head & admitted to hospital for observation 10/12-10/15/2007.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Convulsion, Excoriation, Face injury, Fall
Clinical narrative: Fainted and fell from chair hitting face on floor causing abrasions. Showed seizure like activity. Was incontinent of urine. Pale color. Paramedics called. Oxygen and IV started. Transported to  Hospital.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Oxygen supplementation, Pallor, Syncope, Urinary incontinence
Clinical narrative: Fainted and fell from chair hitting face on floor causing abrasions. Showed seizure like activity. Was incontinent of urine. Pale color. Paramedics called. Oxygen and IV started. Transported to  Hospital.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema, swelling and pain at the injection site. Supportive care instructions given- no antibiotics required.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: 2-3 cm ertythmetous area with warmth, swelling and pain. Symptomatic care with pain reliever and cool compress.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain, Tenderness, Yellow skin
Clinical narrative: pt returned to the pharmacy within a week of receiving the influenza vaccination. she complained of heavy bruising, yellowing of the skin, and pain/tenderness near the injection site.  pt mentioned she is taking OTC pain killers to treat it.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, No reaction on previous exposure to drug, Rash macular, Urticaria
Clinical narrative: Client developed large red blotches/raised red welts on back, waist, arms, and neck the evening after flu vaccine was given.  Client also received a PPD Mantoux skin test (left forearm, Lot C2678AA), which was negative, 0 mm at 72 hours. She was taken to the emergency room at 8:30 pm that evening.  No fever, no change in usual blood pressure, no itching, no temperature elevation, no change in behavior of client.  In ER, client received an injection of diphendramine x 1,  and Zantac.  Prescribed oral prednisone qd x 7 days, Zantac bid x 7 days, and loratadine 10 mg qd x 7 days.  Client has finished with prednisone and loratadine today, and has last dose of Zantac this evening.  The client was noted to be "back to normal" the next morning.  Client has had flu shots in the past with no problems. Client has profound mental retardation due to PKU.  She has a public guardian.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Breast swelling, Erythema, Nausea, Oedema peripheral, Stomach discomfort
Clinical narrative: SEVERE SWELLING ENTIRE LEFT ARM & BREAST.  REDNESS IN SAME AREA. NAUSEA UPSET STOMACH LASTING 4 DAYS...ARM STILL TENDER TILL NOW.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Tenderness
Clinical narrative: SEVERE SWELLING ENTIRE LEFT ARM & BREAST.  REDNESS IN SAME AREA. NAUSEA UPSET STOMACH LASTING 4 DAYS...ARM STILL TENDER TILL NOW.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Iron deficiency, Syncope
Clinical narrative: Patient sitting on top bunk watching a movie. Back of earring came off so she "jumped down" from bed and went to mirror to put earring back in. As she stood in front of mirror, she "felt whoozy and blood was rushing to head, and had pukey feeling in throat." Said "I am going to faint." Roommate reported she then "crumpled" to the floor. Patient says she came to and saw her roommate running out the door to get help.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Headache, Influenza like illness, Restlessness
Clinical narrative: That same evening as the shot, I began having having flu-like symptoms between 8:15 and 8:30. First was slight headache, then chills/shakes, then 102 temperature - generally miserable. I went to bed about midnight but I was so restless I went into another room to sleep. Then about 3:00 AM, it all broke, and I felt normal - just fine. I have had a shot every year for at least 20 years, but have never had any other negative reaction except in 1990 when I had a similar rection and outcome. I always thought this may happen with a live virus shot, but not with the dead virus. Am I wrong?
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Sleep disorder, Tremor
Clinical narrative: That same evening as the shot, I began having having flu-like symptoms between 8:15 and 8:30. First was slight headache, then chills/shakes, then 102 temperature - generally miserable. I went to bed about midnight but I was so restless I went into another room to sleep. Then about 3:00 AM, it all broke, and I felt normal - just fine. I have had a shot every year for at least 20 years, but have never had any other negative reaction except in 1990 when I had a similar rection and outcome. I always thought this may happen with a live virus shot, but not with the dead virus. Am I wrong?
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Hypoaesthesia, Multiple sclerosis, Peroneal nerve palsy
Clinical narrative: 2 hours after MMR vaccine numbness in lower extremities foot drop bilaterally 12/31/07-records received for DOS 10/24/07-After vaccination suffered an MS attack day after vaccination. Manifested itself with leg weakness and some numbnes. Not worked since then. Right foot drop and unable to dorseflex. Impression: Multiple sclerosis exacerbation. Per 60 follow up: R & L leg weakness & numbness.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Infant hospitalized for intussusception on 10/21/07-Rotateq given on 7/11/07 and 9/12/07.  10/26/07 Received vax record from reporter which provides RO dose #2 & lot #.  VAERS database updated w/same. Record faxed to CDC.  11/13/07 Linked w/296061. 12/4/07 Reviewed hospital medical records which reveal patient experienced vomiting & bloody stools.  Admitted 10/21-10/23/2007.  BE/air enema diagnosed IS but unable to completely reduce.  Did well post operatively & d/c to home. FINAL DX: Intussusception, surgically reduced & appendectomy.  Records faxed to CDC.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Infant hospitalized for intussusception on 10/21/07-Rotateq given on 7/11/07 and 9/12/07.  10/26/07 Received vax record from reporter which provides RO dose #2 & lot #.  VAERS database updated w/same. Record faxed to CDC.  11/13/07 Linked w/296061. 12/4/07 Reviewed hospital medical records which reveal patient experienced vomiting & bloody stools.  Admitted 10/21-10/23/2007.  BE/air enema diagnosed IS but unable to completely reduce.  Did well post operatively & d/c to home. FINAL DX: Intussusception, surgically reduced & appendectomy.  Records faxed to CDC.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Cyanosis, Electroencephalogram, Hypotonia, Pallor
Clinical narrative: 5 hours after receiving DTaP #1, IPV #1, Hib #1, Prevnar #1, Rotateq #1 pt had 20 minute episode of acute pallor, cyanosis, and was limp. Evaluated at ER, transferred to hospital. Observed overnight, tests normal. Patient reviewed fully to date.  0/30/07 Reviewed pcp records which consisted of vax records, ER records & hospital records.  Vax record confirms dose & lot #s as reported.  ER records indicate patient seen in ER on 10/22/2007 for ALTE.  Awakened from nap, turned pale w/cyanotic lips, eyes that were not alert, limp body, not reponsive to stimulation followed by slow improvement back to normal.  Transferred to higher level of care & kept in observation overnight.  No further episodes & was d/c to outpatient f/u.  Seen by pcp on 10/24 & f/u CXR, EKG & EEG to be done. FINAL DX: ALTE. 1/7/08 Reviewed additional hospital records received.  No new information.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Balance disorder, Coordination abnormal, Dizziness, Electrocardiogram, Headache
Clinical narrative: Gardasil vaccine #3 on 9-2007; On morning of 9-24-07 woke up dizzy, pale, unbalance, headache, change coordination-Referred to Neurologist-eval 9-26-07 Had Exam, MRI Brain, Labs, EKG-Follow up visit with PCP on 10-25-07. 10/26/07-records received for DOS 9/26/07-neurology consultation. Impression vertigo and near syncope. May represent a begign post infectious type phenomenon. Little odd in that they occur episodically rather than with movement. Three episodes of veritgo and near syncope have occurred in last 6 weeks. No positional type veritgo. Occasional headache after episodes. Some shortness of breath with episodes.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Nuclear magnetic resonance imaging brain, Pallor
Clinical narrative: Gardasil vaccine #3 on 9-2007; On morning of 9-24-07 woke up dizzy, pale, unbalance, headache, change coordination-Referred to Neurologist-eval 9-26-07 Had Exam, MRI Brain, Labs, EKG-Follow up visit with PCP on 10-25-07. 10/26/07-records received for DOS 9/26/07-neurology consultation. Impression vertigo and near syncope. May represent a begign post infectious type phenomenon. Little odd in that they occur episodically rather than with movement. Three episodes of veritgo and near syncope have occurred in last 6 weeks. No positional type veritgo. Occasional headache after episodes. Some shortness of breath with episodes.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pain in extremity, Skin warm
Clinical narrative: (L) deltoid warm to touch, painful. 2 3/4"x4" erythema and induration. Patient took Tylenol 325 mg po once that evening. After showing to LPN - advised to ice, continue monitoring and Tylenol PRN.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pharyngolaryngeal pain, Pruritus
Clinical narrative: Itching, sore throat, shot site swollen and warm to touch pain when moving arm. Given a sling and pain medication told to apply warm compress.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Hyperhidrosis, Pallor, Paraesthesia, Vomiting
Clinical narrative: Diaphoretic, pale, hands tingling, abdominal pain, vomited - BP 98/60 and 98/50, P 80 but weak. Gave Adrenal 1:1000 0.5 ml SQ - called ambulance and went to ER.
Age: 50.0
Sex: U
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Malaise, Stomach discomfort
Clinical narrative: Headache, upset stomach, diarrhea, general malaise within 5 days of shot.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: 10/19/07 Received HPV #3, itchy rash started several hours after HPV #3 at injection site. Spread all over body. Took Benadryl. Rash gone 3-4 hrs later.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: C-reactive protein increased, CSF test normal, Musculoskeletal stiffness, Pyrexia, Red blood cell count normal
Clinical narrative: The evening of immunizations started with leg warmth and fever to 101 F. Then developed eye crossing and stiffening of arms/legs/back. Admitted to hospital had lumbar puncture, labs, urine done all negative, antibiotics x 48 hours. Symptoms resolved after initial evening. 11/5/07-record received for DOS 10/12-10/18/07-DC DX: Fever episode most porbably due to immunizations. Three days prior to admission developed fever and swelling of left thing, rolling her eyes and question of apnea. Temp in ED 100.4.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Skin warm, Strabismus, Urine analysis normal, White blood cell count normal
Clinical narrative: The evening of immunizations started with leg warmth and fever to 101 F. Then developed eye crossing and stiffening of arms/legs/back. Admitted to hospital had lumbar puncture, labs, urine done all negative, antibiotics x 48 hours. Symptoms resolved after initial evening. 11/5/07-record received for DOS 10/12-10/18/07-DC DX: Fever episode most porbably due to immunizations. Three days prior to admission developed fever and swelling of left thing, rolling her eyes and question of apnea. Temp in ED 100.4.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at site with redness and heat; flu like symptoms.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: After 7 1/2 hours started dizziness-Less than 5 minutes.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Pt reports 24 hours after shot she had pain and weakness so severe in right arm that she went to Urgent Care. They gave her a sling, 800 mg Motrin, a "pain" shot. 48 hours after PPV 23, she went to a different Urgent Care with a temp of 102. Arm was now swollen and "hot". They changed her antibiotic to Cipro. 4 days after injection, 1 week later she has full use of arm, no sling use, slight swelling, redness and heat in right arm.