chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: M
Vaccine: HIBV, PNC13, DTAPHEPBIP, RV5
Symptoms: Meningitis, Meningitis pneumococcal, Nuclear magnetic resonance imaging brain, Otitis media, Pallor
Clinical narrative: Initial case received on 14 February 2011 from a healthcare professional via another manufacturer (reference number US-WYE-H17670610). A 3-month old male infant received an intramuscular first right leg injection of ACTHIB (lot number UH125AB) and an intramuscular first left leg injection of PREVNAR 13 (lot number E57642) on 04 August 2010. On 17 August 2010 he received an intramuscular first right leg injection of PEDIARIX (lot number AC21B249AA) and a first oral dose of ROTATEQ (lot number 0500Z). On 17 September 2010 the patient developed symptoms of an upper respiratory infection with fever. The following day his symptoms worsened, and included fussiness, pallor, and bulging fontanel; he was also diagnosed with otitis media. On 19 September 2010 the patient experienced a seizure, and was diagnosed with "strep pneumo meningitis". He was hospitalized for 14 days. Relevant testing included a CT of the head, lumbar puncture, biochemistry work-up, MRI of the brain, EEG, and BSAER; results of this testing were not provided. Medical history at the time of vaccination included hematochezia and a possible allergy to cow's milk. The patient was 8 pounds 7 ounces at birth, and was delivered via C-section at 40 weeks gestation due to fetal distress and failure to progress. At the time of the event, the patient weighed 7.4 kg. Per the reporter, the vaccines were administered by a health care professional and medication was stored appropriately and not altered in any way. Patient's developmental milestones and physical growth were reported as normal. At the time of the report, the patient was recovering from the events with mild hearing loss. The other manufacturer also reported the event "drug ineffective" for the vaccine PREVNAR 13. Follow-up information has been requested by the manufacturer, and no further information was expected. Per the manufacturer's case comment, "Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13".
Age: 0.3
Sex: M
Vaccine: HIBV, PNC13, DTAPHEPBIP, RV5
Symptoms: Pyrexia, Upper respiratory tract infection
Clinical narrative: Initial case received on 14 February 2011 from a healthcare professional via another manufacturer (reference number US-WYE-H17670610). A 3-month old male infant received an intramuscular first right leg injection of ACTHIB (lot number UH125AB) and an intramuscular first left leg injection of PREVNAR 13 (lot number E57642) on 04 August 2010. On 17 August 2010 he received an intramuscular first right leg injection of PEDIARIX (lot number AC21B249AA) and a first oral dose of ROTATEQ (lot number 0500Z). On 17 September 2010 the patient developed symptoms of an upper respiratory infection with fever. The following day his symptoms worsened, and included fussiness, pallor, and bulging fontanel; he was also diagnosed with otitis media. On 19 September 2010 the patient experienced a seizure, and was diagnosed with "strep pneumo meningitis". He was hospitalized for 14 days. Relevant testing included a CT of the head, lumbar puncture, biochemistry work-up, MRI of the brain, EEG, and BSAER; results of this testing were not provided. Medical history at the time of vaccination included hematochezia and a possible allergy to cow's milk. The patient was 8 pounds 7 ounces at birth, and was delivered via C-section at 40 weeks gestation due to fetal distress and failure to progress. At the time of the event, the patient weighed 7.4 kg. Per the reporter, the vaccines were administered by a health care professional and medication was stored appropriately and not altered in any way. Patient's developmental milestones and physical growth were reported as normal. At the time of the report, the patient was recovering from the events with mild hearing loss. The other manufacturer also reported the event "drug ineffective" for the vaccine PREVNAR 13. Follow-up information has been requested by the manufacturer, and no further information was expected. Per the manufacturer's case comment, "Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13".
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Arthritis, Injection site pain, Injection site reaction, Myalgia, Pain in extremity
Clinical narrative: Initial report received from a health care professional on 15 February 2011. A 43-year-old female patient received on 07 June 2010 a right deltoid injection (route unknown) of ADACEL, sanofi pasteur lot number unknown. The patient's medical history and concomitant medications were unknown. On 10 June 2010, three days after the vaccine, the patient had developed muscle aching in the right arm and soreness in the arms and legs. On 19 November 2010, the patient still had right upper arm soreness and was seen by an orthopedic surgeon who diagnosed her with adhesive capsulitis with acromid clavicular arthritis resulting from injection in the right deltoid. The outcome was reported as not recovered. Documents held by sender: None.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Periarthritis
Clinical narrative: Initial report received from a health care professional on 15 February 2011. A 43-year-old female patient received on 07 June 2010 a right deltoid injection (route unknown) of ADACEL, sanofi pasteur lot number unknown. The patient's medical history and concomitant medications were unknown. On 10 June 2010, three days after the vaccine, the patient had developed muscle aching in the right arm and soreness in the arms and legs. On 19 November 2010, the patient still had right upper arm soreness and was seen by an orthopedic surgeon who diagnosed her with adhesive capsulitis with acromid clavicular arthritis resulting from injection in the right deltoid. The outcome was reported as not recovered. Documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Loss of consciousness
Clinical narrative: Initial report was received 16 February 2011 from a health care professional. A 26-year-old female patient, who had a past history of lupus, anemia, hypertension and allergies to sulfa and penicillin, had received an intramuscular injection of ADACEL, lot number C3727AA (site not reported) on 14 February 2011 and one day later, she experienced intermittent faint tingling in her fingers and she blacked out for a second. The injection site was also noted to be red, swollen, tender and warm to touch. The events required a doctor's visit. The patient had no concurrent illness and she had not received any other vaccines within four weeks of ADACEL. Laboratory and diagnostic testing had not been performed. Concomitant medications consisted of Acyclovir, "COZAR", NEXIUM, PLAVIX, Vitamin D and B12. Outcome was not recovered. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Initial report was received 16 February 2011 from a health care professional. A 26-year-old female patient, who had a past history of lupus, anemia, hypertension and allergies to sulfa and penicillin, had received an intramuscular injection of ADACEL, lot number C3727AA (site not reported) on 14 February 2011 and one day later, she experienced intermittent faint tingling in her fingers and she blacked out for a second. The injection site was also noted to be red, swollen, tender and warm to touch. The events required a doctor's visit. The patient had no concurrent illness and she had not received any other vaccines within four weeks of ADACEL. Laboratory and diagnostic testing had not been performed. Concomitant medications consisted of Acyclovir, "COZAR", NEXIUM, PLAVIX, Vitamin D and B12. Outcome was not recovered. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: HPV4, MEN, TDAP, VARCEL
Symptoms: Fall
Clinical narrative: Client was walking out of entrance when she slumped to the floor. First encountered lying on floor, awake, no compliants. BP 118/64 P 72 R 16. Able to sit in chair, no visual signs of injury. Stated she felt okay. No dizziness, nausea or discomfort. Stayed 15 minutes. family with client.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Angiogram, Dizziness, Scan with contrast, Vertigo
Clinical narrative: PATIENT REFERS EXPERIENCING VERTIGO/DIZZINESS.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, RV1
Symptoms: Cardiac arrest, Cerebral haemorrhage, Crying, Diet refusal, Hypotonia
Clinical narrative: Onset duration 12 days. Fussy, crying, not wanting to eat. Then suddenly stopped breathing, nasal discharge, cold, went limp and was given CPR and rushed to the hospital for life saving intervention aid was hospitalized. Cardiac arrest, cerebral hemorrhage.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, RV1
Symptoms: Irritability, Nasopharyngitis, Respiratory arrest, Resuscitation, Rhinorrhoea
Clinical narrative: Onset duration 12 days. Fussy, crying, not wanting to eat. Then suddenly stopped breathing, nasal discharge, cold, went limp and was given CPR and rushed to the hospital for life saving intervention aid was hospitalized. Cardiac arrest, cerebral hemorrhage.
Age: 1.28
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Body temperature increased, Chest X-ray normal, Cyanosis, Full blood count normal, Laboratory test normal
Clinical narrative: Parents presented at Hosp. ER with pt. having 101 degrees F temperature & had a seizure earlier & turned "blue" TYLENOL, MOTRIN, IV ROCEPHIN given, CBC, Chemistry Panel, CXR all WNL; U/A -> increased WBC's, culture pending. Bld cultures pending.
Age: 1.28
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Urine analysis abnormal, White blood cell count increased
Clinical narrative: Parents presented at Hosp. ER with pt. having 101 degrees F temperature & had a seizure earlier & turned "blue" TYLENOL, MOTRIN, IV ROCEPHIN given, CBC, Chemistry Panel, CXR all WNL; U/A -> increased WBC's, culture pending. Bld cultures pending.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Body temperature increased
Clinical narrative: T 103, in evening of 2/10/11, date of immunizations, next day T 101, Pt did not appear ill to parents, on 2/12/11, afebrile.
Age: 12.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Oedema peripheral, Tenderness
Clinical narrative: Right upper arm, lateral aspect, swelling roundish, tender skin & subcutaneous tissue same reaction to left arm.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, VARCEL
Symptoms: Bone pain, Crying, Discomfort, Oedema peripheral, Pain
Clinical narrative: Pt received vaccines 2/7/11 at 8:30 am. Around 8-8:30 p.m. she started hurting - "deep bone ache". Around 9:30pm started crying and c/o body aching from head to toe. Parents took to E.R. at 9:49 pm. Pt. was discharged home in "improved, stable" condition at 11:10 pm. Pt. did not run a temperature. Was given TYL #3 for discomfort. Had swelling in left arm. "Back to normal" in 3 days according to mother.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia
Clinical narrative: Pt returned after 1 1/2 hrs from injection stating difficulty swallowing. No other visible sx. Advised to take BENADRYL and go to ER. Patient took BENADRYL did not go to ER, seemed recovered next day.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Decreased appetite, Diarrhoea, Dysgeusia
Clinical narrative: Facial swelling, low grade fever, tightness in chest, nasal congestion, coughing, fatigue, achy, nausea/loss of appetite, diarrhea, metallic taste in mouth.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Nasal congestion, Nausea, Pain, Pyrexia
Clinical narrative: Facial swelling, low grade fever, tightness in chest, nasal congestion, coughing, fatigue, achy, nausea/loss of appetite, diarrhea, metallic taste in mouth.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Facial swelling, low grade fever, tightness in chest, nasal congestion, coughing, fatigue, achy, nausea/loss of appetite, diarrhea, metallic taste in mouth.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased immune responsiveness, Fatigue, Headache, Influenza, Influenza like illness
Clinical narrative: The evening of the flu shot and the following day, I experienced malaise and flu-like symptoms of fatigue and headache. Left arm was sore. Fatigue and mild non-continuous headaches have continued to present. 1-18-11 I came down with a urinary tract inflection, followed by symptoms of lowered immune response in form of skin infections and outbreak of oral herpes, fingernails breaking (not usual for me) and extreme need of extra sleep. Also for two weeks after the shot, when showering (light water flow), the injection site would itch when water hit it. Came down with flu on 2-16-11. Something is wrong!
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Malaise, Onychoclasis, Oral herpes, Pain in extremity
Clinical narrative: The evening of the flu shot and the following day, I experienced malaise and flu-like symptoms of fatigue and headache. Left arm was sore. Fatigue and mild non-continuous headaches have continued to present. 1-18-11 I came down with a urinary tract inflection, followed by symptoms of lowered immune response in form of skin infections and outbreak of oral herpes, fingernails breaking (not usual for me) and extreme need of extra sleep. Also for two weeks after the shot, when showering (light water flow), the injection site would itch when water hit it. Came down with flu on 2-16-11. Something is wrong!
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Skin infection, Somnolence, Urinary tract infection
Clinical narrative: The evening of the flu shot and the following day, I experienced malaise and flu-like symptoms of fatigue and headache. Left arm was sore. Fatigue and mild non-continuous headaches have continued to present. 1-18-11 I came down with a urinary tract inflection, followed by symptoms of lowered immune response in form of skin infections and outbreak of oral herpes, fingernails breaking (not usual for me) and extreme need of extra sleep. Also for two weeks after the shot, when showering (light water flow), the injection site would itch when water hit it. Came down with flu on 2-16-11. Something is wrong!
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Injection site induration, Injection site inflammation, Injection site warmth, Local swelling
Clinical narrative: ADACEL (TDAP) administered 2/9/2011. Patient c/o (L) arm (local) redness, pain and swelling on 2/12/11, with triage nurse. Used TYLENOL, heat for 3-4 days. Seen 2/14/11 for office visit. Area where injection given felt hard, warm to touch, area of inflammation 8.5 cm. Much improvement with Ibuprofen and ice also to area.
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain
Clinical narrative: ADACEL (TDAP) administered 2/9/2011. Patient c/o (L) arm (local) redness, pain and swelling on 2/12/11, with triage nurse. Used TYLENOL, heat for 3-4 days. Seen 2/14/11 for office visit. Area where injection given felt hard, warm to touch, area of inflammation 8.5 cm. Much improvement with Ibuprofen and ice also to area.
Age: 1.05
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Scratch, Urticaria
Clinical narrative: Patient received MMR, VARIVAX, HAV, Flu shot on 2/15/11. In the evening the next day, he started to scratch his head. Today, he woke up with urticaria.
Age: 1.01
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Blood test, Computerised tomogram head, Lethargy, Somnolence
Clinical narrative: Mom referred that patient was lethargic, difficult to wake up. Event happened 3 days post vaccine.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Rash
Clinical narrative: Rash & difficulty breathing, treated by PMD with Epinephrine & BENADRYL.
Age: 0.45
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Rash papular
Clinical narrative: 5-10 minutes after vaccine administration, pt developed scattered erythematous papular rash across face & scalp. Rash resolved/faded over course of subsequent 15 minutes.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 5 x 7cm area of swelling, mild erythema, induration on posterior right upper arm, mildly tender, developed 24 hours after MMR & VZV vaccines were given. No fever.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Rash, Urticaria
Clinical narrative: The day after vaccine the patient reported to school nurse with rash. School nurse phoned mother of child that she had hives over most of her body, and swollen hands. Currently taking BENADRYL to control symptoms.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Tues - 2/15 c/o weakness, dizziness and fatigue with 2 1/2 hrs. Ran fever of 100 degrees and below. On Weds 2/16 same complaints with addition of shortness of breath and right sided chest pain. Arm sore but not swollen she states. Thurs 2/17 - Better - back to normal.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Tues - 2/15 c/o weakness, dizziness and fatigue with 2 1/2 hrs. Ran fever of 100 degrees and below. On Weds 2/16 same complaints with addition of shortness of breath and right sided chest pain. Arm sore but not swollen she states. Thurs 2/17 - Better - back to normal.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Very fussy, leg swollen red and warm to touch. TYLENOL & BENADRYL given. Ice pack applied.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Thigh swelling & redness R >> L pt seen also 2/16/11 by Dr. given cephalexin 250 mg 3x/d x 10d cool compress & BENADRYL 1 tsp 2x/d x 3 days then PRN.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Differential white blood cell count normal, Fatigue, Full blood count normal, Lymphadenopathy
Clinical narrative: 1/28 pt received her vaccine in her left arm Fri. afternoon Sat. and Sun. she felt tired. Sun. she developed some swollen lymph nodes in her (L) axilla that grew to between 3-4 cm in diameter - these have slowly resolved. They were very painful. She also developed swollen lymph nodes in (R) axilla.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling notices 2/10 am.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site papule, Injection site rash, Rash papular
Clinical narrative: Rash, pinpoint papular starting on thighs at injection sites spreading in 3 days to most of trunk & extremities.
Age: 56.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Abdominal discomfort, Depressed mood, Influenza like illness
Clinical narrative: 12/14/10 Client took 1st dose of oral Typhoid - waited 1 hr. to eat - said his stomach "felt upset - like the flu" & he became "depressed". He felt the vaccine "messed with my mind". The depression only occurred the day of the 1st dose. He didn't take any other dose but continued to have "upset stomach" for a wk. Client (after 1 wk) took Ranitidine x 3 days & symptoms ceased.
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3 x 3 1/2 inch raised erythematous area around TDAP injection site.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: Right shoulder swelling after PCV #13.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Redness, warmth at injection site. *Physician treated with NSAID & antihistamine.
Age: 0.56
Sex: F
Vaccine: PNC13
Symptoms: Crying, Pain, Pyrexia
Clinical narrative: Tel-com. with mother, pt had her PCV-13 on 2-9-11 at around 14:00. At 22:00 pt started with a high temp 103 degrees. Parent gave TYLENOL. The temp. came down with med but would return. On 2-10-11 parent said that pt would cry with movement adv. to go to ER.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Pain in extremity, Pyrexia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm pain x 3 days fever 104 degrees F ear, swelling and redness around vaccination site, warm to touch.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pyrexia, Swelling, Tenderness
Clinical narrative: Fever, raised localized area of erythema & tenderness.
Age: 61.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Diarrhoea, Headache, Hypoaesthesia, Injection site erythema
Clinical narrative: Redness of injection site; swelling; head and joint aches; diarrhea; muscle ache in upper arm of where injection occurred; slight numbness of fingers on injection arm.
Age: 61.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site reaction, Myalgia, Swelling
Clinical narrative: Redness of injection site; swelling; head and joint aches; diarrhea; muscle ache in upper arm of where injection occurred; slight numbness of fingers on injection arm.
Age: 25.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dyskinesia, Unresponsive to stimuli
Clinical narrative: A few minutes following vaccine administration, client became unresponsive with jerking movements which lasted for 15 to 20 seconds. Client became responsive immediately afterward. Juice given and client was observed for 15 minutes. Recovered fully. No injury. No fall.
Age: 0.37
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash erythematous, Rash generalised, Swelling face
Clinical narrative: 2/9/11 4:30pm facial swelling & fine, red, raised rash over rest of body. Seen in ER & given BENADRYL. Body rash gone before leaving ER and facial swelling gone by AM of 2/10/11.
Age: 34.0
Sex: M
Vaccine: DTAP, FLUX, FLUX(H1N1)
Symptoms: Aphthous stomatitis, Blood culture, Blood test
Clinical narrative: Major aphthous ulcers.  Still persist today (2/23/2011).
Age: 49.0
Sex: M
Vaccine: FLUN3
Symptoms: Muscle spasms
Clinical narrative: Back spasm.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Pain in extremity, Pruritus
Clinical narrative: Phone call from school secretary on 2/17/11 patient c/o (L) arm being sore. On back of (L) arm has red, hard lump about size of a quarter, itchy.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Mass, Oedema peripheral, Pain in extremity
Clinical narrative: Phone call from school secretary, on 2/17/11. Patient c/o (L) sore arm, has a red, little raised, hard lump about size of a quarter, itchy, back of (L) arm.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pruritus
Clinical narrative: Phone call from school secretary, on 2/17/11. Patient c/o (L) sore arm, has a red, little raised, hard lump about size of a quarter, itchy, back of (L) arm.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Influenza virus test negative, Pyrexia, Rash generalised, Streptococcus test negative
Clinical narrative: Fever of 102, rash across body, legs and arms. Doctor prognosis - Tylenol and Motrin. Still ongoing day 2.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Epstein-Barr virus test negative, Full blood count, Granulocyte percentage, Lymphocyte percentage increased, Mononucleosis heterophile test negative
Clinical narrative: Fever of 102, rash across body, legs and arms. Doctor prognosis - Tylenol and Motrin. Still ongoing day 2.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Perianal streptococcal infection, Pharyngitis streptococcal, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Fever of 102, rash across body, legs and arms. Doctor prognosis - Tylenol and Motrin. Still ongoing day 2.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: White blood cell count normal
Clinical narrative: Fever of 102, rash across body, legs and arms. Doctor prognosis - Tylenol and Motrin. Still ongoing day 2.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Chest X-ray abnormal, Chest pain, Cough, Decreased appetite, Influenza virus test negative
Clinical narrative: Pt received HPV, TDAP, & MCV4 vaccines on 2/15/11 approximately 930am. By 3pm had cough, which worsened considerably & kept him up at night. Approximately 9pm had nausea & decreased appetite. On 2/16 approximately 630am had sore throat & chest pain. Fever at 7am. In clinic responded to albuterol nebulizer treatment. Rapid flu & rapid strep tests negative. CXR showed perihilar markings. Pt went to ED on 2/18 due to worsening symptoms - given azithromycin & prednisone.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Nausea, Oropharyngeal pain, Pyrexia, Sleep disorder, Streptococcus test
Clinical narrative: Pt received HPV, TDAP, & MCV4 vaccines on 2/15/11 approximately 930am. By 3pm had cough, which worsened considerably & kept him up at night. Approximately 9pm had nausea & decreased appetite. On 2/16 approximately 630am had sore throat & chest pain. Fever at 7am. In clinic responded to albuterol nebulizer treatment. Rapid flu & rapid strep tests negative. CXR showed perihilar markings. Pt went to ED on 2/18 due to worsening symptoms - given azithromycin & prednisone.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Streptococcus test negative
Clinical narrative: Pt received HPV, TDAP, & MCV4 vaccines on 2/15/11 approximately 930am. By 3pm had cough, which worsened considerably & kept him up at night. Approximately 9pm had nausea & decreased appetite. On 2/16 approximately 630am had sore throat & chest pain. Fever at 7am. In clinic responded to albuterol nebulizer treatment. Rapid flu & rapid strep tests negative. CXR showed perihilar markings. Pt went to ED on 2/18 due to worsening symptoms - given azithromycin & prednisone.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Flatulence, Fluid retention, Pharyngeal oedema, Swelling face
Clinical narrative: Approx. 3 hrs after shot pt. had throat swelling, eyes & face swelling, fluid retention in face, hands and gas type pain.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Swelling
Clinical narrative: (+) red, swollen induration 6 x 5 cm.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Local swelling, Lymphadenopathy, Neck pain
Clinical narrative: 2/16/11 - Pt states she noticed redness & swelling in Lt arm at injection site on 2/14/11 also noted neck was swollen 2/16/11 painful to touch. Lymph node swollen in neck as well. No SOB - diff swallowing or fever - 4mm soft movable cystic area consistent w/possible node given Cephalexin 500mg BID #20.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches, chills and fever.  Fever continued to rise up to 104 at 02:00 am on 2/23/11.
Age: 9.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: Itchy red and warm 10*9 area at site of injection on left upper arm.  Started Keflex orally since seems to be worsening from yesterday.
Age: 44.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Fall, Palpitations
Clinical narrative: Client reports vaccine was administered on 2/22/11 at 17:00. Reports began feeling chest palpitations and experiencing dizziness at 1800. Ct reports she fell down at this time. Did not seek medical attention. Arrived at clinic on 2/23/11 at 1000. No further dizziness/palpitations reported. Encouraged to go to emergency room for further medical evaluation at this time.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Balance disorder, Chest X-ray, Computerised tomogram, Cough, Malaise
Clinical narrative: Within 2 weeks got a horrible sore throat and coughing. I had been sick since Oct-Nov (Thanksgiving). I feel like the room is spinning - then I feel out of balance I have been fighting sore throat and cough since then. There maybe some scarring of the lungs/chest.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Vertigo
Clinical narrative: Within 2 weeks got a horrible sore throat and coughing. I had been sick since Oct-Nov (Thanksgiving). I feel like the room is spinning - then I feel out of balance I have been fighting sore throat and cough since then. There maybe some scarring of the lungs/chest.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Dizziness, Pyrexia
Clinical narrative: Chills/fever, weakness (severe), lightheadedness.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration
Clinical narrative: Redness, erythema, induration two days after administration. Treated in ED. Given prescription for KEFLEX and doxycycline. Warm soak 2-3 times per day.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain, Pyrexia, Skin burning sensation, Swelling
Clinical narrative: Pneumo vac & flu vaccine given on 9/21/10 pt's appt was 3 pm. Later that evening pt experienced moderately severe pain. Swelling & burning. On 9/22 pt had fever & nausea DEPO MEDROL 80mg injected. PHENERGAN 25mg.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Vaccine given 2/8/11. Pt experienced redness, swelling & pain (moderate to severe) Ibuprofen 800mg TID PRN cool compresses.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Periarthritis, Rotator cuff syndrome
Clinical narrative: Patient states that the flu shot reulted in her shoulder being frozen and her rotator cuff being torn, although this is impossible the 5/8 inch needle could not have reached her rotator cuff, proper technique was observed, and even if the cuff had been penetrated by a needle it would not have resulted in an injury
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, PNC13, VARCEL
Symptoms: Band neutrophil count decreased, Full blood count, Local swelling, Lymphocyte count normal, Monocyte count increased
Clinical narrative: Three day history of fever, runny nose and swelling to bilateral jaw/neck. Mono screen and CBC completed.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rhinorrhoea, Swelling
Clinical narrative: Three day history of fever, runny nose and swelling to bilateral jaw/neck. Mono screen and CBC completed.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: both arms injection sites with erythema/hot/tender. no induration or fluctuance
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling to arm from shoulder to wrist.  No warmth. Redness to Left Deltoid. Benadryl and cool packs prescribed.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Chills, Cough, Dizziness, Headache
Clinical narrative: Developed a fever about 5 hrs after BOOSTRIX which climbed to 104 & slowly came down over the next 5 days. Also c/o ringing of ears & muffled hearing, chills, back pain, nausea, dizziness, headache, swollen, painful injection site, & cough.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoacusis, Injection site pain, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Developed a fever about 5 hrs after BOOSTRIX which climbed to 104 & slowly came down over the next 5 days. Also c/o ringing of ears & muffled hearing, chills, back pain, nausea, dizziness, headache, swollen, painful injection site, & cough.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Tinnitus
Clinical narrative: Developed a fever about 5 hrs after BOOSTRIX which climbed to 104 & slowly came down over the next 5 days. Also c/o ringing of ears & muffled hearing, chills, back pain, nausea, dizziness, headache, swollen, painful injection site, & cough.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Chest discomfort, Peripheral coldness, Sneezing
Clinical narrative: Within 5 min after receiving vaccines, child started sneezing continuously x 20 - c/o "funny feeling" in chest - extremities cool. Flushing. Upper lip slightly cyanotic. Called 911. BP 110/68 P 120 R-20. Epinephrine (1:1000) - 0.3 ml in RA; BENADRYL (50 mg/cc) - 30mg (0.6 ml) given in LA. Four minutes later: BP 124/78, P 160 R-16. EMS arrived & evaluated child. Parents chose to see own pediatrician instead of going to ED. EMS had family sign a release form. Dr called by RN & notified of above reaction and emergency meds given. BP 120/54 P 160.
Age: 23.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: Localized induration 3"x2", warm to touch, erythematous, patient reports itching.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Dizziness, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: 2-11-11 - dizziness, muscles on entire rt. side sore, cough. Right arm from shoulder to elbow swollen & red. Muscles from shoulder to hip painful & pain down rt. leg - couldn't bend over or lay on Rt. side due to extreme pain. Rash, swollen gland in throat.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain in extremity, Rash
Clinical narrative: 2-11-11 - dizziness, muscles on entire rt. side sore, cough. Right arm from shoulder to elbow swollen & red. Muscles from shoulder to hip painful & pain down rt. leg - couldn't bend over or lay on Rt. side due to extreme pain. Rash, swollen gland in throat.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hypotonia, Immediate post-injection reaction, Muscle rigidity, Somnolence
Clinical narrative: HPV vaccine was adm. 1st, immediately after vaccine was adm. pt. held (R) side of her head & went limb. Her body then became rigid while in the chair. I held her head & instructed her to take deep breaths, she followed command. Rigidness lasted approx. 20 - 30 sec. she then came to. When asked what she felt she replied she did not recall anything. Monitored pt. for extra 30 min. after vaccine c/o sleepiness only on exit.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Pruritus generalised, Rash
Clinical narrative: Pt awoke 02-18-11 with rash & itching all over body.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient states her arm has been sore & slightly dysfunctional since the administration of this vaccine.
Age: 24.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dyspnoea, Throat tightness, Wheezing
Clinical narrative: TDAP administered at client's workplace during health dept. onsite clinic. Client reported ED visit on 2-12-11 d/t complaints of shortness of breath, wheezing, & sensation of "throat closing". Drove self to ED where she received oral Prednisone treatment. Also given Prednisone 20 mg tablets #4 to self administer 1 tab po BID x 2 d. States symptoms resolved 2-14-11. No further medical care/eval necessary.
Age: 0.1
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Abdominal pain, Barium double contrast, Gastrointestinal disorder, Haematochezia, Hemiparesis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 4 weeks male patient with no pertinent medical history, was vaccinated with a first dose of ROTATEQ (lot # 667989/0687Z), orally, on 30-JUL-2010. Other concomitant therapy administered on the same date included PENTACEL (Lot # C684AA), IM, given in the left leg; PREVNAR (Lot # E69009), IM, given in the right leg and HEPTATITIS (unspecified) (Lot #, manufacturer, route and site of administration unknown). It was reported that the patient experienced diaphoresis, pallor, staring spells and fussiness. The patient was admitted to hospital where he was eventually diagnosed with intussusception. This was successfully corrected with air enema, confirmed by ultrasound.  The following information was obtained through follow up and/or provided by the government on 12-AUG-2010 and 16-AUG-2010. Received vaccine, laboratories and hospital medical records for service dated 05-AUG-2010 - 10-AUG-2010. Final diagnosis: Ileocolic intussusception, enema reduced. Records reveal that the patient experienced pallor, diaphoresis with feeding, abdominal pain, emesis, and blood stools. The patient was originally admitted for possible seizures with right sided weakness and sick sibling. Neurology and surgery consults were done. Eventually, the patient was taken to radiology for an ultrasound on 07-AUG-2010. Enema successfully reduced. Overnight the patient had increased irritability and paleness. The patient returned to radiology where an ultrasound did not demonstrate intussusception but revealed bowel wall thickening in right lower quadrant. On 23-AUG-2010 and 24-AUG-2010 were received additional hospital medical records for service dates 05-AUG-2010 - 10-AUG-2010 and ER medical records from outlying ER for 05-AUG-2010 with diagnosis of mental status changes, possible seizure after he suddenly became unresponsive and pale at home and again in ER with staring episode. The patient was transferred to higher level of care. The following laboratory results were reported: home positive stools; intussusception on ultrasound performed on 07-AUG-2010, ultrasound were repeated. At the time of this report, the patient's outcome was unknown. This report was considered to be serious due to hospitalization and life threatening criteria. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. The VAERS ID # is  394758. No further information is available.
Age: 0.1
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Hyperhidrosis, Intussusception, Irritability, Large intestinal obstruction reduction, Mental status changes
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 4 weeks male patient with no pertinent medical history, was vaccinated with a first dose of ROTATEQ (lot # 667989/0687Z), orally, on 30-JUL-2010. Other concomitant therapy administered on the same date included PENTACEL (Lot # C684AA), IM, given in the left leg; PREVNAR (Lot # E69009), IM, given in the right leg and HEPTATITIS (unspecified) (Lot #, manufacturer, route and site of administration unknown). It was reported that the patient experienced diaphoresis, pallor, staring spells and fussiness. The patient was admitted to hospital where he was eventually diagnosed with intussusception. This was successfully corrected with air enema, confirmed by ultrasound.  The following information was obtained through follow up and/or provided by the government on 12-AUG-2010 and 16-AUG-2010. Received vaccine, laboratories and hospital medical records for service dated 05-AUG-2010 - 10-AUG-2010. Final diagnosis: Ileocolic intussusception, enema reduced. Records reveal that the patient experienced pallor, diaphoresis with feeding, abdominal pain, emesis, and blood stools. The patient was originally admitted for possible seizures with right sided weakness and sick sibling. Neurology and surgery consults were done. Eventually, the patient was taken to radiology for an ultrasound on 07-AUG-2010. Enema successfully reduced. Overnight the patient had increased irritability and paleness. The patient returned to radiology where an ultrasound did not demonstrate intussusception but revealed bowel wall thickening in right lower quadrant. On 23-AUG-2010 and 24-AUG-2010 were received additional hospital medical records for service dates 05-AUG-2010 - 10-AUG-2010 and ER medical records from outlying ER for 05-AUG-2010 with diagnosis of mental status changes, possible seizure after he suddenly became unresponsive and pale at home and again in ER with staring episode. The patient was transferred to higher level of care. The following laboratory results were reported: home positive stools; intussusception on ultrasound performed on 07-AUG-2010, ultrasound were repeated. At the time of this report, the patient's outcome was unknown. This report was considered to be serious due to hospitalization and life threatening criteria. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. The VAERS ID # is  394758. No further information is available.
Age: 0.1
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Pallor, Staring, Stool analysis abnormal, Ultrasound scan abnormal, Unresponsive to stimuli
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 4 weeks male patient with no pertinent medical history, was vaccinated with a first dose of ROTATEQ (lot # 667989/0687Z), orally, on 30-JUL-2010. Other concomitant therapy administered on the same date included PENTACEL (Lot # C684AA), IM, given in the left leg; PREVNAR (Lot # E69009), IM, given in the right leg and HEPTATITIS (unspecified) (Lot #, manufacturer, route and site of administration unknown). It was reported that the patient experienced diaphoresis, pallor, staring spells and fussiness. The patient was admitted to hospital where he was eventually diagnosed with intussusception. This was successfully corrected with air enema, confirmed by ultrasound.  The following information was obtained through follow up and/or provided by the government on 12-AUG-2010 and 16-AUG-2010. Received vaccine, laboratories and hospital medical records for service dated 05-AUG-2010 - 10-AUG-2010. Final diagnosis: Ileocolic intussusception, enema reduced. Records reveal that the patient experienced pallor, diaphoresis with feeding, abdominal pain, emesis, and blood stools. The patient was originally admitted for possible seizures with right sided weakness and sick sibling. Neurology and surgery consults were done. Eventually, the patient was taken to radiology for an ultrasound on 07-AUG-2010. Enema successfully reduced. Overnight the patient had increased irritability and paleness. The patient returned to radiology where an ultrasound did not demonstrate intussusception but revealed bowel wall thickening in right lower quadrant. On 23-AUG-2010 and 24-AUG-2010 were received additional hospital medical records for service dates 05-AUG-2010 - 10-AUG-2010 and ER medical records from outlying ER for 05-AUG-2010 with diagnosis of mental status changes, possible seizure after he suddenly became unresponsive and pale at home and again in ER with staring episode. The patient was transferred to higher level of care. The following laboratory results were reported: home positive stools; intussusception on ultrasound performed on 07-AUG-2010, ultrasound were repeated. At the time of this report, the patient's outcome was unknown. This report was considered to be serious due to hospitalization and life threatening criteria. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. The VAERS ID # is  394758. No further information is available.
Age: 0.1
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 4 weeks male patient with no pertinent medical history, was vaccinated with a first dose of ROTATEQ (lot # 667989/0687Z), orally, on 30-JUL-2010. Other concomitant therapy administered on the same date included PENTACEL (Lot # C684AA), IM, given in the left leg; PREVNAR (Lot # E69009), IM, given in the right leg and HEPTATITIS (unspecified) (Lot #, manufacturer, route and site of administration unknown). It was reported that the patient experienced diaphoresis, pallor, staring spells and fussiness. The patient was admitted to hospital where he was eventually diagnosed with intussusception. This was successfully corrected with air enema, confirmed by ultrasound.  The following information was obtained through follow up and/or provided by the government on 12-AUG-2010 and 16-AUG-2010. Received vaccine, laboratories and hospital medical records for service dated 05-AUG-2010 - 10-AUG-2010. Final diagnosis: Ileocolic intussusception, enema reduced. Records reveal that the patient experienced pallor, diaphoresis with feeding, abdominal pain, emesis, and blood stools. The patient was originally admitted for possible seizures with right sided weakness and sick sibling. Neurology and surgery consults were done. Eventually, the patient was taken to radiology for an ultrasound on 07-AUG-2010. Enema successfully reduced. Overnight the patient had increased irritability and paleness. The patient returned to radiology where an ultrasound did not demonstrate intussusception but revealed bowel wall thickening in right lower quadrant. On 23-AUG-2010 and 24-AUG-2010 were received additional hospital medical records for service dates 05-AUG-2010 - 10-AUG-2010 and ER medical records from outlying ER for 05-AUG-2010 with diagnosis of mental status changes, possible seizure after he suddenly became unresponsive and pale at home and again in ER with staring episode. The patient was transferred to higher level of care. The following laboratory results were reported: home positive stools; intussusception on ultrasound performed on 07-AUG-2010, ultrasound were repeated. At the time of this report, the patient's outcome was unknown. This report was considered to be serious due to hospitalization and life threatening criteria. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Research Center and was released. The VAERS ID # is  394758. No further information is available.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Barium enema, Intussusception, Surgery, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 8 weeks old female patient with no pertinent medical history or no known drug allergies, on 06-AUG-2010 was vaccinated with the first dose of ROTATEQ (lot number: 664880/1473Y) orally. There were no concomitant medications reported. On 10-AUG-2010 the patient started to vomit and was hospitalized. On 11-AUG-2010 the patient was diagnosed with intussusception. On 12-AUG-2010 the patient underwent  a surgery which was unable to reduce in radiology. The patient also received a barium enema. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. The originally reporting source was not provided. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 664880/1473Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 1.26
Sex: M
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction, Varicella virus test positive
Clinical narrative: herpes zoster - varaicella vaccine strain reactivation
Age: 1.26
Sex: M
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Herpes zoster, Rash vesicular, Skin lesion, Varicella virus test positive
Clinical narrative: herpes zoster - varaicella vaccine strain reactivation
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt complained of arm soreness, saw Dr about a month later and received a cortisone shot. had Physical Therapy for 2 week full ROM but still sore