chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.28
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Convulsion, Cyanosis, Dyskinesia, Dyspnoea, Fall
Clinical narrative: Pt was seen for Viral upper respiratory infection, pharyngitis, right otitis media, and local redness to injection sites on 12/20/2010.  On 12/21/11, patient experienced an apparent witnessed "seizure," mom reports that she "fell backwards," had rigidity and alternating movements, seem to stop breathing, and her legs and arms looked "purple." She had a low-grade fever, but was not really markedly febrile, and hadn't seemed sick although she did have a significant local reaction where she received her injections in the thigh.
Age: 1.28
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Injection site erythema, Injection site reaction, Local reaction, Muscle rigidity, Otitis media
Clinical narrative: Pt was seen for Viral upper respiratory infection, pharyngitis, right otitis media, and local redness to injection sites on 12/20/2010.  On 12/21/11, patient experienced an apparent witnessed "seizure," mom reports that she "fell backwards," had rigidity and alternating movements, seem to stop breathing, and her legs and arms looked "purple." She had a low-grade fever, but was not really markedly febrile, and hadn't seemed sick although she did have a significant local reaction where she received her injections in the thigh.
Age: 1.28
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Pharyngitis, Pyrexia, Viral upper respiratory tract infection
Clinical narrative: Pt was seen for Viral upper respiratory infection, pharyngitis, right otitis media, and local redness to injection sites on 12/20/2010.  On 12/21/11, patient experienced an apparent witnessed "seizure," mom reports that she "fell backwards," had rigidity and alternating movements, seem to stop breathing, and her legs and arms looked "purple." She had a low-grade fever, but was not really markedly febrile, and hadn't seemed sick although she did have a significant local reaction where she received her injections in the thigh.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Faeces discoloured, Fatigue, Irritability, Mucous stools
Clinical narrative: Patient started having VERY frequent, VERY runny VERY green mucousy stools.  This diarrhea and generally tired & grouchy baby continued for over two weeks.  Exclusively breast fed baby had always had mustard opaque stools before the vaccine.  Stools eventually returned to mustard & opaque (not slimy) after about 18 days.
Age: 1.04
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Arthritis, Pain, Skin hyperpigmentation, Urticaria
Clinical narrative: Twelve month old child work up with hives covering most of body along with inflammed joints on the knees, ankles, and wrists (Hot to touch).  Has continued off and on since that time.   Child had none of this prior to twelve month vaccinations. Child appears to be in pain due to this.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Oedema peripheral, Pain in extremity
Clinical narrative: Red, swelling, sore arm that last several months. Patient talked to her doctor; was taking CLARITIN for allergic reaction. Arm in not swelling or red now but still sore.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt. rec'd flu vaccine (2011-2012) x 2. Rec'd 1st vaccine 10/13/11 & 2nd vaccine 11/30/11. Pt did not remember getting 1st vaccine & req'd another. No known injury.
Age: 65.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Influenza like illness, Myalgia
Clinical narrative: Rec'd YF vaccine at 11 AM on 12/15 by RN. Pt stated that she went out for dinner that nite & felt fine. In AM awoke feeling sl. dizzy & muscle aches like flu. Pt. stated she was taking cough med. for bad cough & ABX - but could not name them. Enc. her to call physician.
Age: 11.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pyrexia, Swelling, Tenderness
Clinical narrative: Possible early cellulitis at injection site, fever 102-103, redness, tenderness, swelling.
Age: 1.23
Sex: F
Vaccine: DTAPIPVHIB, FLU3
Symptoms: Convulsion, Electroencephalogram, Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain, Tremor
Clinical narrative: Seizure requiring IV insert by paramedics after 8 minutes of rhythmic shaking of bilateral upper extremities and stiffening with unresponsiveness.
Age: 1.23
Sex: F
Vaccine: DTAPIPVHIB, FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: Seizure requiring IV insert by paramedics after 8 minutes of rhythmic shaking of bilateral upper extremities and stiffening with unresponsiveness.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia, VIIth nerve paralysis
Clinical narrative: After receiving vaccine, approximately 15 minutes, the patient experienced loss of movement in left leg and drooping of the right side of face. We called 911 and the emergency team took her to hospital in ambulance.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Pregnancy test positive
Clinical narrative: Miscarriage - MMR & varicella given 7/27/11 & 8/29/11. Positive pregnancy 9-13-11 (5-6 wks pregnant).
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Body temperature increased
Clinical narrative: Father and mother reported temp. of 106.0 on 12-27; pt. was then seen for OV for possible ear infection on 12-27 and given antibitiotics.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Pain in upper arm, with numbness down arm to fingers, unable to sleep in affected arm without feeling pain and numbness.  Can't lift arm up, across body or behind back.
Age: 14.0
Sex: M
Vaccine: HPV2
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Pt. recv'd flu vaccine on 12/24/11 at approx 3 pm on 12/25/11 pt. awoke to extreme chills. Chills lasted 6-8 hours. Pt also experienced a low grade fever, & knee pain.
Age: 13.0
Sex: M
Vaccine: HPV2
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 6.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Abasia, C-reactive protein increased, Decreased appetite, Dyspnoea, Fluid intake reduced
Clinical narrative: Nausea, no eating or drinking, pale, shortness of breath, high fever- 104, lymphangitis, swelling and redness approximately 7 inches wide, with red streaks from sight injection.  Could not walk.
Age: 6.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling, Leukocytosis, Lymphangitis
Clinical narrative: Nausea, no eating or drinking, pale, shortness of breath, high fever- 104, lymphangitis, swelling and redness approximately 7 inches wide, with red streaks from sight injection.  Could not walk.
Age: 6.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Nausea, Pallor, Pyrexia, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Nausea, no eating or drinking, pale, shortness of breath, high fever- 104, lymphangitis, swelling and redness approximately 7 inches wide, with red streaks from sight injection.  Could not walk.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Flu vaccine administered at 11:43 AM. Client waited 10 minutes for monitoring and left.  Returned at 2:10PM stating she had vomited around 1:30PM. Reported chills and feeling queasy. No other signs/symptoms of reaction. Denies dizziness, HA, itching. 2:20PM BP 150/92. 2:25PM BP 2:25PM 130/90, P 80.  Advised patient to seek medical evaluation. BP 2:35PM 152/98, P 84. 3:20PM denied any symptoms.  Patient states will see doctor.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: Rash at injection site starting 12-19-11 and lasting about 1 week. Starting 12-27-11 a shingles-type rash on buttocks.
Age: 65.0
Sex: M
Vaccine: DTP, PPV
Symptoms: Back pain, Muscle spasms
Clinical narrative: Per pt report, back pain/spasm resolved with massage.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Pt said have some rashes under the chin, right side of nose and forehead. Also, the rashes are itch and red. Pt called MD, per Pt MD made a recommend take BENADRYL.
Age: 1.02
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Body temperature increased
Clinical narrative: Elevated temp at home. Pt taken to ER T-102.3.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Pallor, Syncope
Clinical narrative: Patient experienced syncopal episode approx. 5 minutes past immunization. Patient was allowed to rest for about 30 minutes, color returned, pt left w/mother.
Age: 42.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: From PCP note: He has had some chills and fever. He has a rash over leg and into groin. He had a PNEUMOVAX on the right side, and it is fine.
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Anaphylactic reaction, Condition aggravated, Cough, Urticaria
Clinical narrative: Following administration of MMR 2 & Varicella # 2, Pt developed hives and a persistent cough in the car. Mom took him to Medical Center where he was diagnosed with anaphylaxis and stabilized with an EPI injection, BENADRYL and ORAPRED.
Age: 1.35
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: (L) leg redness, erythema, mildly warm to touch, slightly indurated, no central fluctuance or firmness. Pt not reacting to palpation of erythema.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Computerised tomogram, Convulsion, Electrocardiogram
Clinical narrative: Seizure.
Age: 0.28
Sex: M
Vaccine: HIBV, PPV
Symptoms: Diarrhoea, Frequent bowel movements
Clinical narrative: Diarrhea and frequent bowel movements.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cough, Dysphonia, Ear infection, Irritability, Pneumonia
Clinical narrative: Runny nose, fever, ear infection, irritabilty, hoarse cough. Diagnosed with pneumonia 12/24/2011.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rhinorrhoea, X-ray
Clinical narrative: Runny nose, fever, ear infection, irritabilty, hoarse cough. Diagnosed with pneumonia 12/24/2011.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash at the site where the vaccination was given.  The area is red, itchy, and slightly swollen with a raised bump.
Age: 4.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Red rash consisting of small red bumps.  Started on face and spread over entire body.  It has now been three days and it is starting to improve, especially on the face.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure increased, Dizziness, Heart rate increased
Clinical narrative: Approximately 10-15 minutes after injection felt a rush-flush in head, dizziness and heart started racing. Sent to ER, with dizziness, weakness, heart racing and blood pressure elevated, and shivering. IV placed and Potassium supplement, EKG.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Blood glucose normal, Blood potassium decreased, Blood pressure increased, Chills
Clinical narrative: Approximately 10-15 minutes after injection felt a rush-flush in head, dizziness and heart started racing. Sent to ER, with dizziness, weakness, heart racing and blood pressure elevated, and shivering. IV placed and Potassium supplement, EKG.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Electrocardiogram, Flushing, Palpitations
Clinical narrative: Approximately 10-15 minutes after injection felt a rush-flush in head, dizziness and heart started racing. Sent to ER, with dizziness, weakness, heart racing and blood pressure elevated, and shivering. IV placed and Potassium supplement, EKG.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: 1) Pt. stated on 11/28/11, her arm started to hurt from shot received on 11/2/11; no redness or tenderness at site. Pt stated that cousin had same rxn on her arm also from flu shot, a week later. Pt went to doctor on 12/6/11 for arm pain.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Pain, Somnolence
Clinical narrative: - Stomache AE (diarrhea, nausea), - body aches, - drowsiness > x 2 days.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Arthritis infective, Blood test, Injection site warmth, Pain in extremity, X-ray normal
Clinical narrative: Pt had injection on 11-13-11 and pain started 11-14-11. Injection site felt a little hot but no real swelling. Pain radiating into hand. Took Ibuprofen for several days then went to doctor. Dr gave antibiotics and to rule out infection. Did not help. Dr took x-rays (came out normal). Pt told to make appt with hand surgeon. Was told he had infection in joint and got steroid shot. Also starting physical therapy for a few weeks.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP
Symptoms: Crying, Local swelling
Clinical narrative: Moderate local swelling, crying for longer than 1 hour. Advised TYLENOL q 4 hours and local heat. Follow-up PRN.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Sore left arm persisting after INFLUENZA vaccine administrating to left deltoid 11/11/11.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) deltoid red raised area. - cold pack/observe.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Dysgeusia, Eye irritation, Eye pruritus
Clinical narrative: Had fever and chills the 1st night; felt like throat closed a little but no breathing trouble (she already uses oxygen); eyes itching; eyes burning & closed; nausea for 2 weeks; back pain at 1st; flu-like symptoms; food still doesn't taste right.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Nausea, Pyrexia, Throat tightness
Clinical narrative: Had fever and chills the 1st night; felt like throat closed a little but no breathing trouble (she already uses oxygen); eyes itching; eyes burning & closed; nausea for 2 weeks; back pain at 1st; flu-like symptoms; food still doesn't taste right.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient came back on 12/23/11 complaining of soreness of arm (cannot lift arm), had to take ALEVE everyday for soreness.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Patient was given vaccine that was expired by 8 days. Manufacturer notified and advised vaccine was adequate and does not need to be readministered. Patient had no ill effects.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Myalgia, Oropharyngeal pain
Clinical narrative: Sneezing, sore throat, difficulty breathing, floating/dizzy feeling for 36+ hours. Muscle pain in legs, arms and back that is ongoing. (Antihistamine to open throat and Acetaminophen for pain.)
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing
Clinical narrative: Sneezing, sore throat, difficulty breathing, floating/dizzy feeling for 36+ hours. Muscle pain in legs, arms and back that is ongoing. (Antihistamine to open throat and Acetaminophen for pain.)
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Oedema peripheral, Pain, Swelling
Clinical narrative: No fever patient complained of swelling, redness and pain. Vacc. adm. 12/27/11 around 4:30. No sign of adv. symptoms then. Patient called 12/28/11 about 11:30 AM. I advised her to apply cold compresses and take ADVIL. Ask her to wait 24 hours if sympt. continue go to her DRs office. 12-29-11 I called patient to see how was she doing, she told us her arm was getting better, but still swollen. I advised her to go to see her DR., she responded by telling us that she wanted to wait another day. Then I offer to call her DR. but she absolutely did not want for me to call. I insisted if her arm turned for the worst she had to go see a DR. With that she thank us for my concern and use said good bye.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Extreme pain in arm.  Unable to move arm due to pain.  Pain present without moving arm.  Ice pack, Vicodin.  The next day only hurt if moved.  Pain on scale of 1-10 was a 9.
Age: 26.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Body temperature increased, Erythema, Infection, Oedema peripheral
Clinical narrative: Infection following vaccination. Arm developed increased redness, swelling and temperature. Treated with Bactrim.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR
Symptoms: Wrong drug administered
Clinical narrative: Zostavax given instead of varicella.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Injection site rash, Rash
Clinical narrative: Patient had a rash that appeared up & down entire left arm 1 -2 hrs after vaccine was given. She also said she had extreme chills that night as well.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site joint pain, Injection site pain
Clinical narrative: C/o severe pain at injection site going into shoulder. Sudden onset secondary after injection. Still painful 1 1/2 wks later. Treated with heat.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Croup infectious, Dyspnoea, Gaze palsy
Clinical narrative: 12/22/11 2 yr old in for check up administered INFLUENZA vaccine 0.25 IM RT - 5 hours later father heard noise & went to infants crib child "gasping for air" eyes rolled upward. EMS to ED - Dx croup.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Skin discolouration, Vomiting
Clinical narrative: Shortly after receiving Rotavirus orally, after a few drops child vomited, cried & became startled - attempted again in upright position in my arm when mother noticed left leg appeared purple lasting approx 1 minute.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Nausea, Neurological examination normal, Paraesthesia, Tremor
Clinical narrative: Had anthrax vaccine #1 on 10/21/2011. Within 10 min after injection had mild headache 3-4/10, whole body tingling and shaky hands. Next morning headache intensified to 8/10. Headache persisted at thigh level with temporary relief only with MOTRIN 800mg until November 12 when headache resolved. Beginning on Nov 17, has had recurring h/a lasting up to I week/episode with intensity about 6/10 to about 4/10 with MOTRIN. Has not gone more that five consecutive days without a headache recurrence since but over time the intensity seems to be decreasing with typical 4/10 decreasing to 2/10 with MOTRIN. H/A is frontal, bilateral and steady dull ache. Occ nausea no V with more severe h/a episodes. No hearing, visual, or motor changes, no balance problems. No other symptoms identified. Neuro exam normal.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Cellulitis at injection site, red, hot tender.
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Bacterial infection, Injection site vesicles
Clinical narrative: Blister around the injection site. Dr verified that it is a bacterial infection and given an antibiotic, all within 3 days.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Erythema, Oedema peripheral
Clinical narrative: Pt received PENTACEL and PCV-13 on left leg, non stop crying, swelling and redness noted from knee to mid thigh.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: PEDIARIX given in Left thigh. Vaccine leaked around needle where connected to syringe. Unsure of how much of the vaccine that infant received.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Dermatitis, Dyspnoea
Clinical narrative: Symptoms:, 1. Dermatitis, shortness of breath.
Age: 25.0
Sex: F
Vaccine: FLU3, HPV4, TDAP, VARCEL
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: History of adverse event was given at subsequent clinic visit 12/27/11 - recalled it occurred within a week of the vaccination - pain, erythema, "cellulitis" diagnosed by client's sister who is a medical doctor. Client was given antibiotics and it resolved quickly.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: LEFT DELTOID AREA (WHERE INJECTION GIVEN) WAS SWOLLEN AND TENDER. NO REDNESS OR WARMTH. PT WAS GIVEN RX OF PREDNISONE PO AND INSTRUCTION TO USE WARM COMPRESS. BUT SHE DID NOT TAKE THE MED. JUST WARM COMPRESS. OVERNIGHT, SWELLING AND TENDERNESS SUBSIDED. BY 9AM IN NEXT MORNING, ALL SYMPTOMS AND SIGNS RESOLVED.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Areflexia, Asthenia, CSF protein increased, Culture negative, Culture stool negative
Clinical narrative: Pt vaccinated at work on 25OCT2011.  Experienced bloody diarrhea from 10DEC2011 to 12DEC2011.  Received abx, had urticarial rash, abx d/c'd and steroids started 14DEC.  Diplopia noted 15DEC, worsened on 16DEC, went to ER.  Admitted with rapid worsening to absent gag and cough reflex, paralysis of upper and lower extremiies, intubated.  Received botulinum antitoxin but weakness progressed, EMG on 17DEC inconclusive, repeat EMG on 21DEC classic for Guillain-Barre.  Pt plasmapharesed five times between 21DEC and 29DEC with moderate improvement.  Received trach and peg and discharged to long-term care facility on 29DEC.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea haemorrhagic, Diplegia, Diplopia, Electromyogram abnormal, Endotracheal intubation
Clinical narrative: Pt vaccinated at work on 25OCT2011.  Experienced bloody diarrhea from 10DEC2011 to 12DEC2011.  Received abx, had urticarial rash, abx d/c'd and steroids started 14DEC.  Diplopia noted 15DEC, worsened on 16DEC, went to ER.  Admitted with rapid worsening to absent gag and cough reflex, paralysis of upper and lower extremiies, intubated.  Received botulinum antitoxin but weakness progressed, EMG on 17DEC inconclusive, repeat EMG on 21DEC classic for Guillain-Barre.  Pt plasmapharesed five times between 21DEC and 29DEC with moderate improvement.  Received trach and peg and discharged to long-term care facility on 29DEC.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Gastrostomy tube insertion, Guillain-Barre syndrome, Helicobacter test negative, Laboratory test normal, Lumbar puncture
Clinical narrative: Pt vaccinated at work on 25OCT2011.  Experienced bloody diarrhea from 10DEC2011 to 12DEC2011.  Received abx, had urticarial rash, abx d/c'd and steroids started 14DEC.  Diplopia noted 15DEC, worsened on 16DEC, went to ER.  Admitted with rapid worsening to absent gag and cough reflex, paralysis of upper and lower extremiies, intubated.  Received botulinum antitoxin but weakness progressed, EMG on 17DEC inconclusive, repeat EMG on 21DEC classic for Guillain-Barre.  Pt plasmapharesed five times between 21DEC and 29DEC with moderate improvement.  Received trach and peg and discharged to long-term care facility on 29DEC.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Plasmapheresis, Tracheostomy, Urticaria
Clinical narrative: Pt vaccinated at work on 25OCT2011.  Experienced bloody diarrhea from 10DEC2011 to 12DEC2011.  Received abx, had urticarial rash, abx d/c'd and steroids started 14DEC.  Diplopia noted 15DEC, worsened on 16DEC, went to ER.  Admitted with rapid worsening to absent gag and cough reflex, paralysis of upper and lower extremiies, intubated.  Received botulinum antitoxin but weakness progressed, EMG on 17DEC inconclusive, repeat EMG on 21DEC classic for Guillain-Barre.  Pt plasmapharesed five times between 21DEC and 29DEC with moderate improvement.  Received trach and peg and discharged to long-term care facility on 29DEC.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chills, Musculoskeletal pain, Pain, Pyrexia
Clinical narrative: (1) Fever 102.0, chills, body aches < 3 hrs after shot, pain into shoulder. (2) Within 2 days after developed a large whelp, then hives around upper arm, pain into back next to spine.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: (1) Fever 102.0, chills, body aches < 3 hrs after shot, pain into shoulder. (2) Within 2 days after developed a large whelp, then hives around upper arm, pain into back next to spine.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: 1st time patient received DtaP-IPV combo vaccine at approximately 4:30pm on 16Dec2011. Hives chest, back, arms, neck legs, 8:00 am 17Dec2011. PM of 17Dec2011 hives face, neck back legs.
Age: 16.0
Sex: M
Vaccine: FLU3, HEPA, HPV4
Symptoms: Computerised tomogram, Nuclear magnetic resonance imaging, Unevaluable event
Clinical narrative: None stated.
Age: 46.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Lymphadenopathy, Nodule, Oedema peripheral
Clinical narrative: Patient received both Tdap and influenza (inactive) vaccine in same arm on 10/30/2006. Reports that arm was swollen and had palpable knot for 1 month after receiving vaccine, and lymph nodes underneath arm were swollen for 6 months following vaccination. Patient has since received her annual influenza vaccines without complication.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Pain in extremity
Clinical narrative: Child awoke at night with arm pain, no visible abnormalities at that time.  24 hours after shot, erythema and calor developed in a 5" diameter area around shot site in Left Deltoid (as of this writing at 11:45 AM 12/29/11).
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Oropharyngeal pain, Sensation of heaviness
Clinical narrative: Husband came into Health Department on 12/29/2011 at 11:00 AM to report his wife experienced SOB, throat pain and "Heaviness" in tongue 5 hours after receiving the fluzone vaccine. symptoms resolved in 15 minutes and she remained asymptomatic for the rest of the day and feels "normal" this morning. She did not take any medication or seek medical attention during or after epidsode. I advised him to report episode to his wife's family physican and told him that I will report this event to VAERS. At 1:00 PM Husband telephoned Health Department to report that his wife experienced the same symptoms again approximately 1 hour ago. He states that the symptoms again lasted about 15 minutes and were self limiting and she is presently asymptomatic. I advised him to take his wife for immediate medical evaluation.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site haematoma, Injection site induration, Injection site swelling
Clinical narrative: PT GIVEN FLU VACCINE 11/23/11.  PT CALLED 11/25/11 TO REPORT A 2" HARD SWOLLEN BRUISE IN THE AREA WHERE THE VACCINE WAS GIVEN (RT DELTOID).  PT DENIES ANY RASH ITCHING, DENY ANY OTHER SYMPTOMS.  PT STATES HE IS ON ASPIRIN THERAPY.  BRUISE AT INFLUENZA SITE, REDNESS AND SWELLING AT PNEUMOVAX SITE.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Injection site pain, Swelling
Clinical narrative: Tenderness when she went to bed and inability to lay on the side of injection. Later noticed swelling and inflammation.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Expired drug administered, Faecal incontinence, Loss of control of legs, Nuclear magnetic resonance imaging, Urinary incontinence
Clinical narrative: LOSS OF MOTOR CONTROL IN LOWER EXTREMETIES STARTING APPROX 11/11/11. DEVELOPED BOWEL AND BLADDER INCONTINENCE.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Fainting for aprox. 30 sec. Treatment: lay teen down for 15 minutes and gave Apple juice.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Injection site pain, Local reaction
Clinical narrative: Local reaction (L) deltoid 5 x 6 cm not tender, slightly raised.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Nonspecific reaction
Clinical narrative: Had Tdap 12/23 RD. No signs or sx until 12/28 (R) upper arm and sh pn with ? swelling. MD treated with doxycycline as precaution. Possible cellulitis.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Fainted after vaccinations.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Anterior itching, redness, & bumps on both wrists 36-48 hours after receiving vaccine.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Condition aggravated, Eczema
Clinical narrative: 2 days post vaccination parents noted an increase in eczematous patches behind knees inner thigh abdomen across hip. 3 days post vaccine noted cheeks & eyelids affected which have never been affected with eczema in past. Mom describes eczema as "intense". Eczema has been manageable for the past 6 months. No other symptoms are present.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Areflexia, Carnitine, Hypotonia, Metabolic function test, Mobility decreased
Clinical narrative: After vaccine wouldn't latch on, 12/21 worse, decreased tone & movement on 12/23/11, lost reflexes (gag, Moro, DTR) & improved to date 50-60% to baseline.
Age: 28.0
Sex: F
Vaccine: DTP, TDAP
Symptoms: Asthenia, Grip strength decreased, Hypoaesthesia, Paraesthesia
Clinical narrative: Pt noticed decreased strength both hands, feet & right leg. Numbness & tingling in (R) leg. Improving but not resolved, weakness worse in am and unable to open jar. Pain after excessive use.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Herpes zoster, Pain in extremity, Rash
Clinical narrative: Had shot (shingles - ZOSTAVAX) on 12/21/11. On 12/25/11 began experiencing pain under right breast & inside of right arm. Got worse over next couple of days. Rash appeared 12/28/11. Went to urgent care - physician diagnosed it as shingles. Started antiviral.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Rash
Clinical narrative: Pt. describes feeling a lot of pain and swelling at site of injection. Next day, pt. felt worse to the point of going home early from work to see her physician. A rash spread from her arm to her face and neck. Her doctor recommended taking an antihistamine and an anti-inflammatory. Pt. was feeling better by 12/29/11.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Pain with movement in left arm from shoulder to just below elbow (Recommended patient discuss with her medical provider). No swelling or redness in area also.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Haematemesis, Haematochezia, Intussusception, Somnolence
Clinical narrative: Patient is a 5-month-old female admitted via the emergency room for hematemesis, hematochezia and increased sleep. Symptoms began a few days prior to admission, when they just noticed that she was sleeping a lot more than usual. She had been exposed to her maternal grandfather, who had been sick with some sort of illness, mom was not sure. Two days prior to admission, she started having a few diarrheal stools and, on the day of admission, apparently had some blood in her diaper. She was brought to the emergency room and they thought they might have seen some blood in her emesis and, based on age and hematemesis and hematochezia, the decision was made for observation and treatment in the hospital. Final dx: Intussusception.
Age: 0.28
Sex: F
Vaccine: HEP, RV5
Symptoms: Blood test, Decreased appetite, Diarrhoea, Frequent bowel movements, Vaccination complication
Clinical narrative: On 12/23, baby was given rotavirus vaccine. On 12/25/11, patient presented with decreased appetite and feeding. At 6:30 pm on 12/25 baby has first loose stool. At 2:30am on 12/26 baby had diarrhea, each episode occuring every 1 to 2 hours. Baby had one occasion of vomiting on 12/26, one occasion on 12/27, one occasion on 12/28 and two occasions on 12/29. Diarrhea has continued since 12/25. Patient was brought to physician who administered vaccine for office visits on 12/26 and 12/27 was was told that this was "just a little diarrhea" and not to be concerned. Baby was brought to a different physician on 12/29 who preformed an exam including blood draw to determine diarrhea's origin. It was this physician's conclusion that the diarrhea was brought by the vaccine. I, as the patient's mother, was advised by this physician not to have the second or third doses of the rotavirus vaccine to be given.
Age: 0.28
Sex: F
Vaccine: HEP, RV5
Symptoms: Vomiting
Clinical narrative: On 12/23, baby was given rotavirus vaccine. On 12/25/11, patient presented with decreased appetite and feeding. At 6:30 pm on 12/25 baby has first loose stool. At 2:30am on 12/26 baby had diarrhea, each episode occuring every 1 to 2 hours. Baby had one occasion of vomiting on 12/26, one occasion on 12/27, one occasion on 12/28 and two occasions on 12/29. Diarrhea has continued since 12/25. Patient was brought to physician who administered vaccine for office visits on 12/26 and 12/27 was was told that this was "just a little diarrhea" and not to be concerned. Baby was brought to a different physician on 12/29 who preformed an exam including blood draw to determine diarrhea's origin. It was this physician's conclusion that the diarrhea was brought by the vaccine. I, as the patient's mother, was advised by this physician not to have the second or third doses of the rotavirus vaccine to be given.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Myalgia
Clinical narrative: Chills, muscle aches, temperature of 101.2, onset Friday am, lasted until Sunday am.
Age: 27.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Syncope, Vomiting
Clinical narrative: Uncontrollable vomiting, syncope and collapse few hours after receiving influenza and Tdap vaccination.  Pt went to ED for treatment.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Started with pain, itching, redness and swelling.  Low grade temp.  Treatment was just ice.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall
Clinical narrative: After injection pt. waited 20min. no symptoms.  Got up to make appt. standing, told mom she felt faint, went to the floor. No head injury helped to exam room cool cloth applied to neck, requested cool cup water, examined by provider. Releases home approx 11:45 am.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site pain, Nausea, Pain in extremity
Clinical narrative: 11/15 significant arm pain, chills, nausea, fatigue.  11/16 to 11/27 arm pain and fatigue gradually decreased.  11/28 to 12/29 arm tender to touch at injection site, very slight ache in upper arm, fatigue would come and go sometimes severe.  12/29 injection site painful to touch, upper arm aches, severe fatigue.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Cough, Throat irritation
Clinical narrative: Cough, tickly throat, asthmatic feeling. Still occurring.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dehydration, Vomiting
Clinical narrative: Recurrent vomiting of formula for the rest of the day with mild accompanying dehydration.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Joint range of motion decreased, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain in upper arm and shoulder and restricted range of motion.  Difficulty lifting arm or moving arm behind back.  Difficulty dressing and completing other physical tasks.  Treatment has included Motrin, ice, and physical therapy.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Periarthritis
Clinical narrative: Severe pain in upper arm and shoulder and restricted range of motion.  Difficulty lifting arm or moving arm behind back.  Difficulty dressing and completing other physical tasks.  Treatment has included Motrin, ice, and physical therapy.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: 12 month old 10 days after varicella immunization administration redness/swelling that increased after 4 days starting on antibiotics for possible secondary infection.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Culture negative, Endometriosis, Erythema, Injection site pain
Clinical narrative: Initial report received from a health care professional on 22 December 2011. The reporter in this case is the same as case number 2011-12527. A 31-year-old female patient received an intramuscular right deltoid injection of ADACEL, sanofi pasteur Ltd. lot number C4015AA, on 16 December 2011. On 16 December 2011, the patient experienced pain at the injection site and developed a red, swollen upper arm and fever. The patient was post C-section. The patient was hospitalized (reason not specified). She was diagnosed with cellulitis. Concerns were that the fever could have been related to an endometritis. The patient's cultures were negative. The patient received treatment with intravenous (IV) antibiotics and oral antibiotics for 10 days. The outcome was reported as not recovered. Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Initial report received from a health care professional on 22 December 2011. The reporter in this case is the same as case number 2011-12527. A 31-year-old female patient received an intramuscular right deltoid injection of ADACEL, sanofi pasteur Ltd. lot number C4015AA, on 16 December 2011. On 16 December 2011, the patient experienced pain at the injection site and developed a red, swollen upper arm and fever. The patient was post C-section. The patient was hospitalized (reason not specified). She was diagnosed with cellulitis. Concerns were that the fever could have been related to an endometritis. The patient's cultures were negative. The patient received treatment with intravenous (IV) antibiotics and oral antibiotics for 10 days. The outcome was reported as not recovered. Documents held by sender: None.
Age: 0.58
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Depressed level of consciousness, Laboratory test, Pyrexia, Tremor
Clinical narrative: Initial report was received on 22 December 2011 from a consumer who is also the patient's parent. A seven month-old male patient who had a possible ear infection at the time of vaccination had received at 2PM on 21 December 2011 a second dose intramuscular left thigh injection of FLUZONE, lot number UT4119BA and later the same date at 9:30PM, developed a fever, shaking, vomiting and decreased alertness. The parents called 911 and the patient was taken to the ER (emergency room). According to the parent, "tests done" and the patient was prescribed antibiotics and was sent home. The patient was reported to have been tugging on his ears two weeks prior to vaccination. The patient had received a flu vaccine "one month ago" and developed a fever. No further information was available at the time of the report. Outcome was not recovered. Documents held by sender: none.
Age: 0.58
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Initial report was received on 22 December 2011 from a consumer who is also the patient's parent. A seven month-old male patient who had a possible ear infection at the time of vaccination had received at 2PM on 21 December 2011 a second dose intramuscular left thigh injection of FLUZONE, lot number UT4119BA and later the same date at 9:30PM, developed a fever, shaking, vomiting and decreased alertness. The parents called 911 and the patient was taken to the ER (emergency room). According to the parent, "tests done" and the patient was prescribed antibiotics and was sent home. The patient was reported to have been tugging on his ears two weeks prior to vaccination. The patient had received a flu vaccine "one month ago" and developed a fever. No further information was available at the time of the report. Outcome was not recovered. Documents held by sender: none.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Initial report received from a health care professional on 22 December 2011. The reporter in this case is the same reporter as in case number 2011-12528. A 26-year-old female patient received an intramuscular left deltoid injection of ADACEL, sanofi pasteur Ltd. lot number C04008AA (invalid sanofi pasteur lot number), on 19 December 2011. On 20 December 2011, the patient developed pain, swelling, redness and rash at the injection site and upper arm. The patient was hospitalized (reason not specified). The patient was to be seen by a physician on 22 December 2011. The outcome was reported as not recovered. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain, Pruritus
Clinical narrative: Case number PHHY2011US87701 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS ref: 420155) website on 30 Sep 2011. This report refers to a 11-year-old male patient. He was vaccinated with MENVEO (batch number: unknown) at dose of 0.5 ml into left arm on 08 Dec 2010 and also vaccinated with TDAP vaccine (manufacturer and batch number unknown) at dose of 0.5 ml into left arm on 08 Dec 2010. In the evening of 08 Dec 20110, he had tactile fever. He awoke on 09 Dec 2010 with some swelling and erythema. On 10 Dec 2010, significant swelling and erythema (5 cm area) around site of immunizations were present. He complained of pain and itching. He was treated with BENADRYL and AUGMENTIN for possible infection and his physician was notified. He was recovered.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Pyrexia, Swelling
Clinical narrative: Case number PHHY2011US87701 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS ref: 420155) website on 30 Sep 2011. This report refers to a 11-year-old male patient. He was vaccinated with MENVEO (batch number: unknown) at dose of 0.5 ml into left arm on 08 Dec 2010 and also vaccinated with TDAP vaccine (manufacturer and batch number unknown) at dose of 0.5 ml into left arm on 08 Dec 2010. In the evening of 08 Dec 20110, he had tactile fever. He awoke on 09 Dec 2010 with some swelling and erythema. On 10 Dec 2010, significant swelling and erythema (5 cm area) around site of immunizations were present. He complained of pain and itching. He was treated with BENADRYL and AUGMENTIN for possible infection and his physician was notified. He was recovered.
Sex: M
Vaccine: MMR, MNQ, VARCEL, MMR, PNC13, VARCEL, MMR, MNQ, PNC, VARCEL
Symptoms: Cough, Dyspnoea, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Case number PHHY2011US94943 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 424476) website on 27 Oct 2011. This report refers to a male patient, age group: infant (1.5 years). This patient had a previous history of vaccination with PREVNAR (batch number: not mentioned) with which he dyspnea, cough and fever and MENVEO (given at the age of 0.5 years). His comedication include SINGULAIR. He was vaccinated with the second dose of MENVEO (batch number: not mentioned), MMR (batch number: not mentioned), PREVNAR (batch number: unknown) and VARCEL (batch number: not mentioned) on 27 May 2011. On the same day, the patient experienced breathing problems, bad coughing and fever. He was taken to emergency room, because his breathing was getting worse. He was put on steroids and it was helping. The outcome was reported as condition unchanged at the time of reporting (02 Jun 2011). The events were suspected to PREVNAR (had prior history).
Sex: M
Vaccine: MMR, MNQ, VARCEL, MMR, PNC13, VARCEL, MMR, MNQ, PNC, VARCEL
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: Case number PHHY2011US94943 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 424476) website on 27 Oct 2011. This report refers to a male patient, age group: infant (1.5 years). This patient had a previous history of vaccination with PREVNAR (batch number: not mentioned) with which he dyspnea, cough and fever and MENVEO (given at the age of 0.5 years). His comedication include SINGULAIR. He was vaccinated with the second dose of MENVEO (batch number: not mentioned), MMR (batch number: not mentioned), PREVNAR (batch number: unknown) and VARCEL (batch number: not mentioned) on 27 May 2011. On the same day, the patient experienced breathing problems, bad coughing and fever. He was taken to emergency room, because his breathing was getting worse. He was put on steroids and it was helping. The outcome was reported as condition unchanged at the time of reporting (02 Jun 2011). The events were suspected to PREVNAR (had prior history).
Sex: M
Vaccine: MMR, MNQ, VARCEL, MMR, PNC13, VARCEL, MMR, MNQ, PNC, VARCEL
Symptoms: Cough, Dyspnoea, Pyrexia
Clinical narrative: Case number PHHY2011US94943 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 424476) website on 27 Oct 2011. This report refers to a male patient, age group: infant (1.5 years). This patient had a previous history of vaccination with PREVNAR (batch number: not mentioned) with which he dyspnea, cough and fever and MENVEO (given at the age of 0.5 years). His comedication include SINGULAIR. He was vaccinated with the second dose of MENVEO (batch number: not mentioned), MMR (batch number: not mentioned), PREVNAR (batch number: unknown) and VARCEL (batch number: not mentioned) on 27 May 2011. On the same day, the patient experienced breathing problems, bad coughing and fever. He was taken to emergency room, because his breathing was getting worse. He was put on steroids and it was helping. The outcome was reported as condition unchanged at the time of reporting (02 Jun 2011). The events were suspected to PREVNAR (had prior history).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHHY2011US86842 is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 426043) website on 30 Sep 2011: This report refers to an 11-year-old female patient. Her current condition included folliculitis. She was vaccinated with MENVEO (batch number: M10032) intramuscularly into the right arm and with TDAP (batch number: AC52B067EA, other manufacturer) intramuscularly into the left arm on 16 Jun 2011. On 18 Jun 2011 she experienced swelling and erythema at injection site of MENVEO but there was no fever. She further developed tenderness, purulent head and pruritus on the right arm. The outcome was reported as complete recovery of the patient on an undetermined date. Following internal non serious line listing review done on 22 Nov 2011 of the data received on 30 Sep 2011 it was noted that the listedness for event vaccination site pustule was incorrectly captured as listed. Therefore, it was correctly captured as unlisted.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Purulent discharge, Tenderness
Clinical narrative: Case number PHHY2011US86842 is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 426043) website on 30 Sep 2011: This report refers to an 11-year-old female patient. Her current condition included folliculitis. She was vaccinated with MENVEO (batch number: M10032) intramuscularly into the right arm and with TDAP (batch number: AC52B067EA, other manufacturer) intramuscularly into the left arm on 16 Jun 2011. On 18 Jun 2011 she experienced swelling and erythema at injection site of MENVEO but there was no fever. She further developed tenderness, purulent head and pruritus on the right arm. The outcome was reported as complete recovery of the patient on an undetermined date. Following internal non serious line listing review done on 22 Nov 2011 of the data received on 30 Sep 2011 it was noted that the listedness for event vaccination site pustule was incorrectly captured as listed. Therefore, it was correctly captured as unlisted.