chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.62
Sex: M
Vaccine: MMR
Symptoms: Blood culture negative, Blood test normal, Chest X-ray normal, Culture urine negative, Cyanosis
Clinical narrative: Three days after vaccine was given fevers began and lasted 9 days. Temperatures reached as high as 103.9 degrees and possibly higher. TYLENOL/MOTRIN. Day 7 came rash. Head to toe rash by day 8. Started in groin and abdomen. Day 6 swollen eyes, red eyes, swollen lymphs in neck, and runny nose. Red eyes lasted about 3 days, lymphs lasted about 10 days or more. On day 10 found baby early morning shaking and quaking in bed with blue lips. Went to ER. Baby was barely responsive. Possible febrile seizure. Temp was 103.2. Hadn't had any MOTRIN. In the E.R. after possible seizure/rigors episode. Blood culture was done. CBC was done. Chest X-ray taken. We were sent home saying all clear, negative cultures. Just keep fevers down. Did TYLENOL MOTRIN around the clock for 24 hours. On Day 11 at approximately 5:00 PM the baby's fever spiked and was climbing quickly. I hadn't done MOTRIN for 15 hours as I was giving his body a chance to see if it was over this mess. The quick temp. spike scared me. Temp was 99.2. A minute later it was 99.7. I gave a dose of MOTRIN and 10 minutes later temp was 100.7. We decided to go to hospital this time. Meanwhile we had followed up with our pediatrician and he did other blood tests and a urine culture. All were clear. No problems. Dr. feared a possible viral pneumonia based on is and radiologist's opinion before-mentioned chest x-ray. Hospital redid CBC and we saw infectious disease doctor. He requested test for Enterovirus. Bloodwork showed great. Clear result. He never even needed fluids as he ate and drank tremendously well all along this week and a half long battle. We were admitted but sent home same day. Enterovirus was negative. He was last fevered on Day 11. Doctors at hospital concurred lungs sounded great - no shot of viral pneumonia. His body's reaction to the MMR vaccine was absolutely textbook with all the literature we had received.
Age: 1.62
Sex: M
Vaccine: MMR
Symptoms: Enterovirus test negative, Eye swelling, Full blood count normal, Lymphadenopathy, Ocular hyperaemia
Clinical narrative: Three days after vaccine was given fevers began and lasted 9 days. Temperatures reached as high as 103.9 degrees and possibly higher. TYLENOL/MOTRIN. Day 7 came rash. Head to toe rash by day 8. Started in groin and abdomen. Day 6 swollen eyes, red eyes, swollen lymphs in neck, and runny nose. Red eyes lasted about 3 days, lymphs lasted about 10 days or more. On day 10 found baby early morning shaking and quaking in bed with blue lips. Went to ER. Baby was barely responsive. Possible febrile seizure. Temp was 103.2. Hadn't had any MOTRIN. In the E.R. after possible seizure/rigors episode. Blood culture was done. CBC was done. Chest X-ray taken. We were sent home saying all clear, negative cultures. Just keep fevers down. Did TYLENOL MOTRIN around the clock for 24 hours. On Day 11 at approximately 5:00 PM the baby's fever spiked and was climbing quickly. I hadn't done MOTRIN for 15 hours as I was giving his body a chance to see if it was over this mess. The quick temp. spike scared me. Temp was 99.2. A minute later it was 99.7. I gave a dose of MOTRIN and 10 minutes later temp was 100.7. We decided to go to hospital this time. Meanwhile we had followed up with our pediatrician and he did other blood tests and a urine culture. All were clear. No problems. Dr. feared a possible viral pneumonia based on is and radiologist's opinion before-mentioned chest x-ray. Hospital redid CBC and we saw infectious disease doctor. He requested test for Enterovirus. Bloodwork showed great. Clear result. He never even needed fluids as he ate and drank tremendously well all along this week and a half long battle. We were admitted but sent home same day. Enterovirus was negative. He was last fevered on Day 11. Doctors at hospital concurred lungs sounded great - no shot of viral pneumonia. His body's reaction to the MMR vaccine was absolutely textbook with all the literature we had received.
Age: 1.62
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised, Rhinorrhoea, Slow response to stimuli, Tremor
Clinical narrative: Three days after vaccine was given fevers began and lasted 9 days. Temperatures reached as high as 103.9 degrees and possibly higher. TYLENOL/MOTRIN. Day 7 came rash. Head to toe rash by day 8. Started in groin and abdomen. Day 6 swollen eyes, red eyes, swollen lymphs in neck, and runny nose. Red eyes lasted about 3 days, lymphs lasted about 10 days or more. On day 10 found baby early morning shaking and quaking in bed with blue lips. Went to ER. Baby was barely responsive. Possible febrile seizure. Temp was 103.2. Hadn't had any MOTRIN. In the E.R. after possible seizure/rigors episode. Blood culture was done. CBC was done. Chest X-ray taken. We were sent home saying all clear, negative cultures. Just keep fevers down. Did TYLENOL MOTRIN around the clock for 24 hours. On Day 11 at approximately 5:00 PM the baby's fever spiked and was climbing quickly. I hadn't done MOTRIN for 15 hours as I was giving his body a chance to see if it was over this mess. The quick temp. spike scared me. Temp was 99.2. A minute later it was 99.7. I gave a dose of MOTRIN and 10 minutes later temp was 100.7. We decided to go to hospital this time. Meanwhile we had followed up with our pediatrician and he did other blood tests and a urine culture. All were clear. No problems. Dr. feared a possible viral pneumonia based on is and radiologist's opinion before-mentioned chest x-ray. Hospital redid CBC and we saw infectious disease doctor. He requested test for Enterovirus. Bloodwork showed great. Clear result. He never even needed fluids as he ate and drank tremendously well all along this week and a half long battle. We were admitted but sent home same day. Enterovirus was negative. He was last fevered on Day 11. Doctors at hospital concurred lungs sounded great - no shot of viral pneumonia. His body's reaction to the MMR vaccine was absolutely textbook with all the literature we had received.
Age: 0.3
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Pain, Pyrexia
Clinical narrative: Vomiting, diarrhea, fever, chills, aches, exhaustion.
Age: 0.3
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Vomiting, diarrhea, fever, chills, aches, exhaustion.
Age: 24.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Patient reporting having redness at/around site that evening of immunization given.  Redness increased in area over next day.  On third day after immunization patient reported to local ER.  The ER marked the area of redness on her skin and started her on bactrim per PA note.  On fourth day patient reported to Family Practice clinic to be seen by PA.  Patient reported fevers, pain at/around site and the redness.  PA marked current size of redness area, had her continue her course of bactrim, will have patient return tomorrow to see him for f/u per PA note.
Age: 24.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Patient reporting having redness at/around site that evening of immunization given.  Redness increased in area over next day.  On third day after immunization patient reported to local ER.  The ER marked the area of redness on her skin and started her on bactrim per PA note.  On fourth day patient reported to Family Practice clinic to be seen by PA.  Patient reported fevers, pain at/around site and the redness.  PA marked current size of redness area, had her continue her course of bactrim, will have patient return tomorrow to see him for f/u per PA note.
Age: 1.57
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Blister, Rash generalised, Rash maculo-papular, Rash pruritic, Rhinorrhoea
Clinical narrative: Rash over entire body - some maculopapular, some vesicles, some scabbed, even in mouth, rash itches, denies fever, runny nose.
Age: 1.57
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Scab
Clinical narrative: Rash over entire body - some maculopapular, some vesicles, some scabbed, even in mouth, rash itches, denies fever, runny nose.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Faecal volume increased, Pruritus, Rash, Varicella post vaccine
Clinical narrative: 7-19-11 - approximately 2 weeks ago mom noticed bumps appear on trunk, arms, neck, legs, head; pt occasionally scratched at them; no fever; increased amt of stools since switching to milk; 16 pox were counted over the surface of the body.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: Starting 2 days after immunization SQ in (R) arm began experiencing tingling & burning in (L) arm radiating around elbow at times radiating to shoulder or down to hands (identified on 7/19/11 to clinician).
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Rash, fever on & off, fussiness x 4 days.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Pruritus, Rash generalised
Clinical narrative: Generalized rash, itching. Rx: Prednisone 20 mg x 5 days, Hydroxyzine 25 mg prn.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Axillary mass, Lymphadenitis, Secretion discharge
Clinical narrative: 6/15 - shot given; 6-16 started questioning if something in armpit; 6/17 - small, pimple-sized bump appears; 6/19 - marble sized lump appears; by 6/26 lump is enormous, measures 4cm by 6/28. Taken to office 6/20 and 6/28 & 6/30 to Hospital Dermatology - diagnosed with lymphadenitis, given 500mg cephalexin 3xday / 7 days - lump begins draining 6/29.
Age: 28.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, fever, diarrhea, vomiting.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Blood calcium normal, Blood magnesium normal, Blood phosphorus normal, Blood potassium normal, Injection site pain
Clinical narrative: Pain at injection site followed days later by tingling back of hand and 3rd finger with intermittent tetany.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Tetany
Clinical narrative: Pain at injection site followed days later by tingling back of hand and 3rd finger with intermittent tetany.
Age: 13.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: 20 hr. after Tdap injection, (L) arm with 4" diameter area of redness, swelling, extreme tenderness, hot to touch but no systemic fever. Mother taking her to pediatrician - physician ordered SEPTRA Bid x 10 days. On 7/25/2011 was doing better, per mother.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Diplopia, Headache, Nausea, Ophthalmological examination normal
Clinical narrative: HPV immunization given 7/19/2011 and on 7/20; pt had double vision, nausea and headache.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Nodule, Swelling
Clinical narrative: REDNESS, SWELLING, RAISED KNOT ON LEG.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile to 40.1 in ED following febrile seizures at home.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Full blood count normal, Rash generalised, Vomiting, Wheezing
Clinical narrative: 1.5 hours after shots child was vomiting and developed rash all over the body with wheezing.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Inappropriate schedule of drug administration, Lobar pneumonia
Clinical narrative: Pt given PREVNAR 13 as part of catch up vaccine. Pt is delayed due to parental deferral. Given vaccine 7/13 and seen 7/19 dx with RLL pneumonia (clinical).
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Feeling cold, Somnolence, Syncope
Clinical narrative: Fainted, recovered in 15 seconds. Felt cold & sleepy - observed & recovered, no residual effect.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema
Clinical narrative: MENACTRA place in Rt arm on 7/20/11. On 7/22/11 pt return to clinic PPD reading & c/o redness of right arm with circumferential with minimal raised.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Convulsion, Drooling, Flushing, Loss of consciousness
Clinical narrative: Issued four vaccinations at 1630. At 1634, patient passed out and when lowered to lay down, patient began convulsing for approx. 30 seconds. Patient became flushed and began drooling. Elevated legs and called MD.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling at site of injection (R) thigh, getting better.
Age: 1.01
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 5 x 2 cm erythematous edematous over at varicella injection site 10 days after injection. Treated with BACTRIM x 10 days.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Hypoaesthesia, Pain
Clinical narrative: Around 2 hours after the vaccination, her Right arm felt numb down to the fingertips. It lasted roughly 3 hours and then went away and did not return.Patient then felt weak and achy as if she had mono for a couple of days and then was back to baseline by 7/24/2011.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Activities of daily living impaired, Crying, Fatigue, Headache
Clinical narrative: Pt, who had a mild sore throat on day of visit, said she felt "tired" a few mins after the shot. I told her she would likely go to school anyway. A few minutes later she was crying with a bad headache. She was allowed to stay home from school & HA resolved < 1 hr later. She took HPV #2 with no side effects.
Age: 35.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Angioedema, Arthralgia, Chest pain, Urticaria
Clinical narrative: Patient developed hives, angioedema, and arthralgias as well as chest pain beginning 7-9-11 leading to hospitalization on 7-10-11. Treated with antihistamines and prednisone. Discharged 7-15-11. Recovered. last seen 7/22/11.
Age: 35.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Pulmonary oedema, Rash generalised, Tachycardia
Clinical narrative: Patient developed hives, angioedema, and arthralgias as well as chest pain beginning 7-9-11 leading to hospitalization on 7-10-11. Treated with antihistamines and prednisone. Discharged 7-15-11. Recovered. last seen 7/22/11.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dyskinesia
Clinical narrative: Pt was lying down after getting imms. Dad reported some jerking movements of arms & legs, then he picked her up and carried her to the door to alert us. Pt quiet but awake.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Orthostatic hypotension, Syncope
Clinical narrative: 24 hours later - fainting, postural hypotension. Treatment: patient advised to take fluids and keep hydrated.
Age: 42.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Abdominal discomfort, Diarrhoea, Dyspnoea, Nausea
Clinical narrative: Shortness of breath, nausea, upset stomach, diarrhea.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Erythema, Lethargy, Pharyngeal oedema, Productive cough, Salivary hypersecretion
Clinical narrative: Within 10-15 minutes he acutely started bubbling saliva out of his mouth as if he had acute throat swelling. Face very red. Lethargic and mucousy cough. Pulse ox 91%. Watched him in my office for 3 hours. Pulse ox improved to 99% and ate bottle well here.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Axillary pain, Chest pain, Local swelling, Muscle swelling, Oedema peripheral
Clinical narrative: Pt got shot in afternoon at 7/19. Deltoid swelling & swelling & pain under arm spreading to chest. No redness but swelling. Resolved on its own with MOTRIN.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: MENACTRA place on rt arm on 7/20/11. On 7/22/11 Rt arm has redness circumferential with minimal raised.
Age: 74.0
Sex: F
Vaccine: MMR
Symptoms: Herpes zoster
Clinical narrative: On 7/8/2011,  pt noticed skin patches on right shoulder, under arm. Right sided back area. On 7/15/11, seen physician and diagnosed shingles.
Age: 43.0
Sex: M
Vaccine: HEP, HEPA, TYP
Symptoms: Arthralgia, Dyspnoea
Clinical narrative: Shortness of breath, joint pain throughout body.
Age: 12.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site rash, Rash
Clinical narrative: Rash appeared on both arms, vaccinated Left arm on deltoid muscle. Rash progressed to neck. No anaphylactic reaction. No known allergies.
Age: 1.03
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Rash macular, Urticaria
Clinical narrative: 15 minutes after MMR and VZV administered, orange size red splotches appeared at injection site. child had not ever eaten egg yolks. no other allergies noted.child was alert and playful, abdomen became whelped and splotches around neck appeared.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Aphthous stomatitis, Injection site erythema, Swollen tongue, Tongue disorder, Tongue dry
Clinical narrative: Showed the common signs of redness and swelling around the varicella vaccination site already the day afterwards, but around 72 hours later, my tongue became swollen enough that in talking I was chewing on my tongue.  Developed canker sores on the bottom of my tongue and it was dry and sticky no matter the volume of water consumed.  This lasted for about 48 hours.  MD did not advise follow-up other than reporting incedent as other symptoms did not arise.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination site swelling
Clinical narrative: Showed the common signs of redness and swelling around the varicella vaccination site already the day afterwards, but around 72 hours later, my tongue became swollen enough that in talking I was chewing on my tongue.  Developed canker sores on the bottom of my tongue and it was dry and sticky no matter the volume of water consumed.  This lasted for about 48 hours.  MD did not advise follow-up other than reporting incedent as other symptoms did not arise.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: PATIENT PRESENTED TO OFFICE ON 07/22/11 WITH A 3CM X 3CM AREA OF MILD REDNESS AND TENDERNEDSS NOTED ON THE LEFT UPPER ARM AT VACCINATION SITE.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Tingling sensation in left hand-all day every day. She is still experiencing it.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: One hive on each thigh below injection sight. Benadryl 12.5mg PO ordered and ice packs applied to sites.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Swollen tongue
Clinical narrative: Noted onset of swelling underneath tongue at frenulum.  No rash, sob, chest tightness, swelling, wheezing, LAD or other symptoms.
Age: 1.02
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Blood test normal, Ear, nose and throat examination normal, Injection site urticaria, Irritability
Clinical narrative: High fever - 103F Small Hives on face, legs, arms High pitch screaming, irritability Behavior changes, clinginess
Age: 1.02
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Screaming, Streptococcus test negative, Urticaria
Clinical narrative: High fever - 103F Small Hives on face, legs, arms High pitch screaming, irritability Behavior changes, clinginess
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: ZOSTER VACCINE WAS GIVEN TO A 1 YEAR OLD, NO ADVERSE REACIONS.
Age: 3.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Left thigh increased redness the night of the immunization (7-12-11) at 10 pm. Was given OTC TYLENOL, c/o thigh pain & warmth, acting fine. No temp, NVD. Reaction was 170 x 140 cm (L) thigh 7-14-11.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Cold sweat, Hyperhidrosis
Clinical narrative: Perspiring, cool, clammy to touch and O2 sat from 45% -> 100% 15 mins after vaccines administered. O2 per mask at 1.7 L until EMS arrived. O2 started by RN. Client transported to hospital ER.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: At site of injection, patient experienced swelling, soreness, redness, and warmth. Acetaminophen 650 MG Other, cephalexin 500 - Rx, but never too MG QID.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Swollen lymph nodes with body aches next day after receiving vaccine. Seen in  office today 7/25/11 with symptoms x's 3 days.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Developed chest wall rash c/w acute shingles outbreak.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Parent reports red & swollen (L) arm.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) arm red & swollen.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Parent called & reported child had red & swollen left leg.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Irritability, Pruritus, Swelling, Urticaria
Clinical narrative: Swelling - OU. Urticaria (over body) acute itching and irritability. EPI Jr 0.15 mg - BENADRYL 12.5 mg. Occurred within 30 to 40 minutes after shots.
Age: 1.06
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Rash generalised, Rash morbilliform
Clinical narrative: Rash started on 7/23/11 - on the back, gradually spread to all over the body. Palms & soles spared. Hx MMR, Varicella administered on 7/14/11. No other symptoms. Rash appeared erythematous morbilliform, papular about 2-3 mm to 7-8 mm in size. Child well appearing.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: TC from parent to report child has red & swollen (R) arm.
Age: 0.38
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Rash all over body after one day of shots.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Erythema, Eschar, Face oedema, Induration
Clinical narrative: 1 x 1 cm area of erythema and 4 small vesicles over the right lateral brow. Small eschar noted 2 cm area of induration extends beyond vesicles laterally. There is mild edema near the (R) upper lid but no periorbital cellulitis. Pt. has appt 26 Jul 11.
Age: 40.0
Sex: F
Vaccine: YF
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Nausea, Somnolence
Clinical narrative: Had swelling, warmth, tenderness (L) upper arm 7/23/11. 7/25/11 feels drowsy, has some nausea, seen by Dr. Advised rest and continue to observe.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Pt. fainted in the lobby following Tdap/ADACEL vaccine et Mantoux TST. BP 114/20, pulse 60. After pt laid down for approximately 10 min. helped her into a wheelchair et out to her father's car.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Computerised tomogram abnormal, Diarrhoea haemorrhagic, Enema administration, Intensive care, Intussusception
Clinical narrative: 7/12/11 Immunizations et WCC. Infant dev. vomiting that pm. To ER et f/u at office. 6 month male vomiting, diarrhea (blood tinged), irritability (cyclic 10-15 minute every hour) 6 day prior to admission. 2 days prior to admission sx improved. Day of admission sx aggravated and patient was admitted to hospital. Barium enema was done for intussusception seen on CT scan. Repeat Xray and sono showed recurrent intussusception that spontaneously reduced during observation in PICU. Patient was feeling well with no irritability and discharged on HD #2.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Irritability, Laboratory test, Ultrasound scan abnormal, Vomiting, X-ray abnormal
Clinical narrative: 7/12/11 Immunizations et WCC. Infant dev. vomiting that pm. To ER et f/u at office. 6 month male vomiting, diarrhea (blood tinged), irritability (cyclic 10-15 minute every hour) 6 day prior to admission. 2 days prior to admission sx improved. Day of admission sx aggravated and patient was admitted to hospital. Barium enema was done for intussusception seen on CT scan. Repeat Xray and sono showed recurrent intussusception that spontaneously reduced during observation in PICU. Patient was feeling well with no irritability and discharged on HD #2.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Barium enema, Blood alkaline phosphatase normal, Computerised tomogram abnormal, Diarrhoea haemorrhagic, Intensive care
Clinical narrative: 7/12/11 Immunizations et WCC. Infant dev. vomiting that pm. To ER et f/u at office. 6 month male vomiting, diarrhea (blood tinged), irritability (cyclic 10-15 minute every hour) 6 day prior to admission. 2 days prior to admission sx improved. Day of admission sx aggravated and patient was admitted to hospital. Barium enema was done for intussusception seen on CT scan. Repeat Xray and sono showed recurrent intussusception that spontaneously reduced during observation in PICU. Patient was feeling well with no irritability and discharged on HD #2.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Intussusception, Irritability, Ultrasound abdomen abnormal, Vomiting, White blood cell count normal
Clinical narrative: 7/12/11 Immunizations et WCC. Infant dev. vomiting that pm. To ER et f/u at office. 6 month male vomiting, diarrhea (blood tinged), irritability (cyclic 10-15 minute every hour) 6 day prior to admission. 2 days prior to admission sx improved. Day of admission sx aggravated and patient was admitted to hospital. Barium enema was done for intussusception seen on CT scan. Repeat Xray and sono showed recurrent intussusception that spontaneously reduced during observation in PICU. Patient was feeling well with no irritability and discharged on HD #2.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: X-ray gastrointestinal tract abnormal
Clinical narrative: 7/12/11 Immunizations et WCC. Infant dev. vomiting that pm. To ER et f/u at office. 6 month male vomiting, diarrhea (blood tinged), irritability (cyclic 10-15 minute every hour) 6 day prior to admission. 2 days prior to admission sx improved. Day of admission sx aggravated and patient was admitted to hospital. Barium enema was done for intussusception seen on CT scan. Repeat Xray and sono showed recurrent intussusception that spontaneously reduced during observation in PICU. Patient was feeling well with no irritability and discharged on HD #2.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Chromaturia
Clinical narrative: Pt. states her urine appeared to be dark and reddish in color 2 days after vaccination. Pt is also starting on PRILOSEC and has an appointment today with MD.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope, Vomiting
Clinical narrative: Fainted, recovered in 30 seconds. Vomited x 1. Observed & recovered. No residual effects.
Age: 46.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: This case is part of a cluster of 5 patients who experienced similar adverse events following vaccination with ADACEL. The original report (mother case) had been received on 17 May 2011 from a health care professional and contained the following information: A group of 5 unidentified patients received on unknown dates an intramuscular injection (sites not reported) of ADACEL, sanofi pasteur Ltd. lot number C3823 corresponding to sanofi pasteur Inc. lot number U3874CA. The patients developed 5-7 days after vaccination, red, raised welt about the size of a half dollar at the injection site which was warm and tender to touch, painful and itchy. The patients also had rashes, hives and swelling. The vaccinations were given over the last two weeks. The patients required a doctor's visit. The outcomes were reported as unknown. Follow-up information was received on 26 May 2011 from the healthcare professional. Additional information was also received on 01 June 2011. Identifying information was provided for 4 of the 5 previously noted patients. This case pertains to 1 of the 4 identified patients. The patient was a 46-year-old female who received the ADACEL injection in the left deltoid. Medical history included shoulder and back pain. At the time of vaccination, the patient had a cat bite. The reporter also noted that the ADACEL prefilled syringe had a clear appearance with white particulant matter. Follow-up information was received from the health care professional on 14 July 2011. Based upon receipt of new information, it was determined that the event meets seriousness criteria. The patient received ADACEL on 09 May 2011; no other vaccines had been administered within 4 weeks of vaccination. The patient reported that she experienced a "twisted arm/left shoulder" 1 hours after the catbite on 09 May 2011. On 11 May 2011, she was treated with BENADRYL, AMOXIL 500mg three times daily, ADVIL as needed, and PERCOCET 5/325 as needed for pain. On 16 May 2011 she was seen in the emergency room with complaints of severe neck pain. She was diagnosed with a "pinched nerve", and treated with prednisone and FLEXERIL. On 17 May 2011 she underwent an MRI of the c-spine, which showed small disc herniation of the C5-C7, with degenerative changes in C6-C7. No cord compromise was observed. An EMG and nerve conduction study performed 19 May 2011 were normal. The patient was seen by a neurologist on 25 May 2011, and was prescribed gabapentin. An MRI of the brachial plexus on 03 June 2011 was normal. The patient had a repeat EMG on 23 June 2011 which was abnormal, and she was diagnosed with brachial neuralgia at that time. Treatment included physical therapy, shoulder mobilization, and exercise; per the reporter, the patient "is good". Outcome was still unknown. The events for the other 3 patients are captured in cases 2011-02872 (mother case), 2011-03100 and 2011-03101. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Nausea, Neck pain, Pain in extremity
Clinical narrative: This case is part of a cluster of 5 patients who experienced similar adverse events following vaccination with ADACEL. The original report (mother case) had been received on 17 May 2011 from a health care professional and contained the following information: A group of 5 unidentified patients received on unknown dates an intramuscular injection (sites not reported) of ADACEL, sanofi pasteur Ltd. lot number C3823 corresponding to sanofi pasteur Inc. lot number U3874CA. The patients developed 5-7 days after vaccination, red, raised welt about the size of a half dollar at the injection site which was warm and tender to touch, painful and itchy. The patients also had rashes, hives and swelling. The vaccinations were given over the last two weeks. The patients required a doctor's visit. The outcomes were reported as unknown. Follow-up information was received on 26 May 2011 from the healthcare professional. Additional information was also received on 01 June 2011. Identifying information was provided for 4 of the 5 previously noted patients. This case pertains to 1 of the 4 identified patients. The patient was a 46-year-old female who received the ADACEL injection in the left deltoid. Medical history included shoulder and back pain. At the time of vaccination, the patient had a cat bite. The reporter also noted that the ADACEL prefilled syringe had a clear appearance with white particulant matter. Follow-up information was received from the health care professional on 14 July 2011. Based upon receipt of new information, it was determined that the event meets seriousness criteria. The patient received ADACEL on 09 May 2011; no other vaccines had been administered within 4 weeks of vaccination. The patient reported that she experienced a "twisted arm/left shoulder" 1 hours after the catbite on 09 May 2011. On 11 May 2011, she was treated with BENADRYL, AMOXIL 500mg three times daily, ADVIL as needed, and PERCOCET 5/325 as needed for pain. On 16 May 2011 she was seen in the emergency room with complaints of severe neck pain. She was diagnosed with a "pinched nerve", and treated with prednisone and FLEXERIL. On 17 May 2011 she underwent an MRI of the c-spine, which showed small disc herniation of the C5-C7, with degenerative changes in C6-C7. No cord compromise was observed. An EMG and nerve conduction study performed 19 May 2011 were normal. The patient was seen by a neurologist on 25 May 2011, and was prescribed gabapentin. An MRI of the brachial plexus on 03 June 2011 was normal. The patient had a repeat EMG on 23 June 2011 which was abnormal, and she was diagnosed with brachial neuralgia at that time. Treatment included physical therapy, shoulder mobilization, and exercise; per the reporter, the patient "is good". Outcome was still unknown. The events for the other 3 patients are captured in cases 2011-02872 (mother case), 2011-03100 and 2011-03101. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Pyrexia
Clinical narrative: This case is part of a cluster of 5 patients who experienced similar adverse events following vaccination with ADACEL. The original report (mother case) had been received on 17 May 2011 from a health care professional and contained the following information: A group of 5 unidentified patients received on unknown dates an intramuscular injection (sites not reported) of ADACEL, sanofi pasteur Ltd. lot number C3823 corresponding to sanofi pasteur Inc. lot number U3874CA. The patients developed 5-7 days after vaccination, red, raised welt about the size of a half dollar at the injection site which was warm and tender to touch, painful and itchy. The patients also had rashes, hives and swelling. The vaccinations were given over the last two weeks. The patients required a doctor's visit. The outcomes were reported as unknown. Follow-up information was received on 26 May 2011 from the healthcare professional. Additional information was also received on 01 June 2011. Identifying information was provided for 4 of the 5 previously noted patients. This case pertains to 1 of the 4 identified patients. The patient was a 46-year-old female who received the ADACEL injection in the left deltoid. Medical history included shoulder and back pain. At the time of vaccination, the patient had a cat bite. The reporter also noted that the ADACEL prefilled syringe had a clear appearance with white particulant matter. Follow-up information was received from the health care professional on 14 July 2011. Based upon receipt of new information, it was determined that the event meets seriousness criteria. The patient received ADACEL on 09 May 2011; no other vaccines had been administered within 4 weeks of vaccination. The patient reported that she experienced a "twisted arm/left shoulder" 1 hours after the catbite on 09 May 2011. On 11 May 2011, she was treated with BENADRYL, AMOXIL 500mg three times daily, ADVIL as needed, and PERCOCET 5/325 as needed for pain. On 16 May 2011 she was seen in the emergency room with complaints of severe neck pain. She was diagnosed with a "pinched nerve", and treated with prednisone and FLEXERIL. On 17 May 2011 she underwent an MRI of the c-spine, which showed small disc herniation of the C5-C7, with degenerative changes in C6-C7. No cord compromise was observed. An EMG and nerve conduction study performed 19 May 2011 were normal. The patient was seen by a neurologist on 25 May 2011, and was prescribed gabapentin. An MRI of the brachial plexus on 03 June 2011 was normal. The patient had a repeat EMG on 23 June 2011 which was abnormal, and she was diagnosed with brachial neuralgia at that time. Treatment included physical therapy, shoulder mobilization, and exercise; per the reporter, the patient "is good". Outcome was still unknown. The events for the other 3 patients are captured in cases 2011-02872 (mother case), 2011-03100 and 2011-03101. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Electromyogram abnormal, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: This case is part of a cluster of 5 patients who experienced similar adverse events following vaccination with ADACEL. The original report (mother case) had been received on 17 May 2011 from a health care professional and contained the following information: A group of 5 unidentified patients received on unknown dates an intramuscular injection (sites not reported) of ADACEL, sanofi pasteur Ltd. lot number C3823 corresponding to sanofi pasteur Inc. lot number U3874CA. The patients developed 5-7 days after vaccination, red, raised welt about the size of a half dollar at the injection site which was warm and tender to touch, painful and itchy. The patients also had rashes, hives and swelling. The vaccinations were given over the last two weeks. The patients required a doctor's visit. The outcomes were reported as unknown. Follow-up information was received on 26 May 2011 from the healthcare professional. Additional information was also received on 01 June 2011. Identifying information was provided for 4 of the 5 previously noted patients. This case pertains to 1 of the 4 identified patients. The patient was a 46-year-old female who received the ADACEL injection in the left deltoid. Medical history included shoulder and back pain. At the time of vaccination, the patient had a cat bite. The reporter also noted that the ADACEL prefilled syringe had a clear appearance with white particulant matter. Follow-up information was received from the health care professional on 14 July 2011. Based upon receipt of new information, it was determined that the event meets seriousness criteria. The patient received ADACEL on 09 May 2011; no other vaccines had been administered within 4 weeks of vaccination. The patient reported that she experienced a "twisted arm/left shoulder" 1 hours after the catbite on 09 May 2011. On 11 May 2011, she was treated with BENADRYL, AMOXIL 500mg three times daily, ADVIL as needed, and PERCOCET 5/325 as needed for pain. On 16 May 2011 she was seen in the emergency room with complaints of severe neck pain. She was diagnosed with a "pinched nerve", and treated with prednisone and FLEXERIL. On 17 May 2011 she underwent an MRI of the c-spine, which showed small disc herniation of the C5-C7, with degenerative changes in C6-C7. No cord compromise was observed. An EMG and nerve conduction study performed 19 May 2011 were normal. The patient was seen by a neurologist on 25 May 2011, and was prescribed gabapentin. An MRI of the brachial plexus on 03 June 2011 was normal. The patient had a repeat EMG on 23 June 2011 which was abnormal, and she was diagnosed with brachial neuralgia at that time. Treatment included physical therapy, shoulder mobilization, and exercise; per the reporter, the patient "is good". Outcome was still unknown. The events for the other 3 patients are captured in cases 2011-02872 (mother case), 2011-03100 and 2011-03101. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Injection site urticaria, Injection site warmth, Intervertebral disc degeneration, Intervertebral disc protrusion, Joint sprain
Clinical narrative: This case is part of a cluster of 5 patients who experienced similar adverse events following vaccination with ADACEL. The original report (mother case) had been received on 17 May 2011 from a health care professional and contained the following information: A group of 5 unidentified patients received on unknown dates an intramuscular injection (sites not reported) of ADACEL, sanofi pasteur Ltd. lot number C3823 corresponding to sanofi pasteur Inc. lot number U3874CA. The patients developed 5-7 days after vaccination, red, raised welt about the size of a half dollar at the injection site which was warm and tender to touch, painful and itchy. The patients also had rashes, hives and swelling. The vaccinations were given over the last two weeks. The patients required a doctor's visit. The outcomes were reported as unknown. Follow-up information was received on 26 May 2011 from the healthcare professional. Additional information was also received on 01 June 2011. Identifying information was provided for 4 of the 5 previously noted patients. This case pertains to 1 of the 4 identified patients. The patient was a 46-year-old female who received the ADACEL injection in the left deltoid. Medical history included shoulder and back pain. At the time of vaccination, the patient had a cat bite. The reporter also noted that the ADACEL prefilled syringe had a clear appearance with white particulant matter. Follow-up information was received from the health care professional on 14 July 2011. Based upon receipt of new information, it was determined that the event meets seriousness criteria. The patient received ADACEL on 09 May 2011; no other vaccines had been administered within 4 weeks of vaccination. The patient reported that she experienced a "twisted arm/left shoulder" 1 hours after the catbite on 09 May 2011. On 11 May 2011, she was treated with BENADRYL, AMOXIL 500mg three times daily, ADVIL as needed, and PERCOCET 5/325 as needed for pain. On 16 May 2011 she was seen in the emergency room with complaints of severe neck pain. She was diagnosed with a "pinched nerve", and treated with prednisone and FLEXERIL. On 17 May 2011 she underwent an MRI of the c-spine, which showed small disc herniation of the C5-C7, with degenerative changes in C6-C7. No cord compromise was observed. An EMG and nerve conduction study performed 19 May 2011 were normal. The patient was seen by a neurologist on 25 May 2011, and was prescribed gabapentin. An MRI of the brachial plexus on 03 June 2011 was normal. The patient had a repeat EMG on 23 June 2011 which was abnormal, and she was diagnosed with brachial neuralgia at that time. Treatment included physical therapy, shoulder mobilization, and exercise; per the reporter, the patient "is good". Outcome was still unknown. The events for the other 3 patients are captured in cases 2011-02872 (mother case), 2011-03100 and 2011-03101. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Neck pain, Nerve compression, Nerve conduction studies normal, Neuralgia, Nuclear magnetic resonance imaging normal
Clinical narrative: This case is part of a cluster of 5 patients who experienced similar adverse events following vaccination with ADACEL. The original report (mother case) had been received on 17 May 2011 from a health care professional and contained the following information: A group of 5 unidentified patients received on unknown dates an intramuscular injection (sites not reported) of ADACEL, sanofi pasteur Ltd. lot number C3823 corresponding to sanofi pasteur Inc. lot number U3874CA. The patients developed 5-7 days after vaccination, red, raised welt about the size of a half dollar at the injection site which was warm and tender to touch, painful and itchy. The patients also had rashes, hives and swelling. The vaccinations were given over the last two weeks. The patients required a doctor's visit. The outcomes were reported as unknown. Follow-up information was received on 26 May 2011 from the healthcare professional. Additional information was also received on 01 June 2011. Identifying information was provided for 4 of the 5 previously noted patients. This case pertains to 1 of the 4 identified patients. The patient was a 46-year-old female who received the ADACEL injection in the left deltoid. Medical history included shoulder and back pain. At the time of vaccination, the patient had a cat bite. The reporter also noted that the ADACEL prefilled syringe had a clear appearance with white particulant matter. Follow-up information was received from the health care professional on 14 July 2011. Based upon receipt of new information, it was determined that the event meets seriousness criteria. The patient received ADACEL on 09 May 2011; no other vaccines had been administered within 4 weeks of vaccination. The patient reported that she experienced a "twisted arm/left shoulder" 1 hours after the catbite on 09 May 2011. On 11 May 2011, she was treated with BENADRYL, AMOXIL 500mg three times daily, ADVIL as needed, and PERCOCET 5/325 as needed for pain. On 16 May 2011 she was seen in the emergency room with complaints of severe neck pain. She was diagnosed with a "pinched nerve", and treated with prednisone and FLEXERIL. On 17 May 2011 she underwent an MRI of the c-spine, which showed small disc herniation of the C5-C7, with degenerative changes in C6-C7. No cord compromise was observed. An EMG and nerve conduction study performed 19 May 2011 were normal. The patient was seen by a neurologist on 25 May 2011, and was prescribed gabapentin. An MRI of the brachial plexus on 03 June 2011 was normal. The patient had a repeat EMG on 23 June 2011 which was abnormal, and she was diagnosed with brachial neuralgia at that time. Treatment included physical therapy, shoulder mobilization, and exercise; per the reporter, the patient "is good". Outcome was still unknown. The events for the other 3 patients are captured in cases 2011-02872 (mother case), 2011-03100 and 2011-03101. Documents held by sender: None.