chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Parotid gland enlargement, Red blood cell sedimentation rate, Swelling face
Clinical narrative: Woke around 6am and was fussy. Took a bottle, was given Motrin, and then slept some more. Woke around 8am and was noted to have right-sided facial swelling. Seen in the office same morning with marked right parotid swelling. Titers pending.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Injection site erythema, Irritability
Clinical narrative: Extreme fatigue, redness around injection area, uncharacteristically irritable.
Age: 0.01
Sex: M
Vaccine: DTP, MMR, VARCEL
Symptoms: Diet refusal, Irritability, Pyrexia, Rash
Clinical narrative: Mild fever (100), day 5. Fever (103), days 7-?. Rash day 9-?. Irritable, not eating.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Abdominal pain upper, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: First symptoms were stomach pain at 9:00pm on June 18th, then on the morning of June 19th 4:00am he presented with more stomach pain and a fever of 102 degrees.  Advil was given at that time.  At 12:00pm that same day fever developed again and Advil was given again at that time.  June 20th, fever is gone, but now a 2.5 inch red swollen area has developed on his right leg where the shot was given.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Computerised tomogram, Constipation, Dysphemia, Headache
Clinical narrative: Blurred vision, fainting, paralysis on left side, numbness, tingling, lethargic, stuttering, headache, constipation, abdominal pain.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hemiplegia, Hypoaesthesia, Laboratory test, Lethargy, Nuclear magnetic resonance imaging
Clinical narrative: Blurred vision, fainting, paralysis on left side, numbness, tingling, lethargic, stuttering, headache, constipation, abdominal pain.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Syncope, Vision blurred
Clinical narrative: Blurred vision, fainting, paralysis on left side, numbness, tingling, lethargic, stuttering, headache, constipation, abdominal pain.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Muscular weakness, Myelitis transverse, Paraesthesia
Clinical narrative: Pt received flu vaccine on 11/4/09 or 11/5/09 at husband's employer.  Pt suffered transverse myelitis.  Pt states 2 days after she experienced muscle weakness and numbness in bilateral hands and feet which progresses from lower extremities up through abdomen and sternum.  Pt also c/o of numbness and tingling in hands.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, RV1, PNC13
Symptoms: Coagulation test, Full blood count, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 2-month-old female patient who experienced purpura down right leg and fever 101 degrees Fahrenheit. At 2 months of age, the patient received the first dose on 08-Jun-2010. On 08-Jun-2010, approximately 3 to 4 hours post-vaccination, the patient experienced a fever of 101 degrees Fahrenheit and purpura down right leg which was the leg of the injection. Treatment was not reported. On an unspecified date in Jun-2010, the patient recovered from the events. The reported declined to be contacted for further information. No additional information was available at the time of this report.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, RV1, PNC13
Symptoms: Metabolic function test, Petechiae, Purpura, Pyrexia
Clinical narrative: This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 2-month-old female patient who experienced purpura down right leg and fever 101 degrees Fahrenheit. At 2 months of age, the patient received the first dose on 08-Jun-2010. On 08-Jun-2010, approximately 3 to 4 hours post-vaccination, the patient experienced a fever of 101 degrees Fahrenheit and purpura down right leg which was the leg of the injection. Treatment was not reported. On an unspecified date in Jun-2010, the patient recovered from the events. The reported declined to be contacted for further information. No additional information was available at the time of this report.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, RV1, PNC13
Symptoms: Injection site rash, Petechiae, Purpura, Pyrexia
Clinical narrative: This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 2-month-old female patient who experienced purpura down right leg and fever 101 degrees Fahrenheit. At 2 months of age, the patient received the first dose on 08-Jun-2010. On 08-Jun-2010, approximately 3 to 4 hours post-vaccination, the patient experienced a fever of 101 degrees Fahrenheit and purpura down right leg which was the leg of the injection. Treatment was not reported. On an unspecified date in Jun-2010, the patient recovered from the events. The reported declined to be contacted for further information. No additional information was available at the time of this report.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, RV1, PNC13
Symptoms: Body temperature increased, Injection site reaction, Purpura, Pyrexia
Clinical narrative: This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 2-month-old female patient who experienced purpura down right leg and fever 101 degrees Fahrenheit. At 2 months of age, the patient received the first dose on 08-Jun-2010. On 08-Jun-2010, approximately 3 to 4 hours post-vaccination, the patient experienced a fever of 101 degrees Fahrenheit and purpura down right leg which was the leg of the injection. Treatment was not reported. On an unspecified date in Jun-2010, the patient recovered from the events. The reported declined to be contacted for further information. No additional information was available at the time of this report.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Injection site erythema, Injection site rash
Clinical narrative: Pt has a silver sized red area around the injection site area. The red rash a grown larger 9 inch, first noticed on 6/19/10. 6/18/10 No noticeable site incubation observed. Onset approx. on 6/19/10. Noticeable angioedema.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Muscular weakness
Clinical narrative: Patient received vaccinations 6-9-10.  Slow progression of bilateral leg weakness.  Requiring urgent care visit 6/20/10 -> transferred to ER.
Age: 1.3
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Electroencephalogram abnormal, Fall, Gaze palsy, Irritability, Nuclear magnetic resonance imaging normal
Clinical narrative: Staring spells with in 2 wks after vaccinations also eye rolling, eyes gently close then tremors lasting up to 3 sec, 1 spell resulted in falling backward. EEG done consistent with generalized cortical irritability. MRI nl, F/U EEG x 4 hours back to normal.
Age: 1.3
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Staring, Tremor
Clinical narrative: Staring spells with in 2 wks after vaccinations also eye rolling, eyes gently close then tremors lasting up to 3 sec, 1 spell resulted in falling backward. EEG done consistent with generalized cortical irritability. MRI nl, F/U EEG x 4 hours back to normal.
Age: 43.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Very large red swollen and painful area left upper arm-very large local reaction.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: H1N1 influenza, Respiratory distress
Clinical narrative: Initial report received from a local newspaper via Novartis employee on 14 Jun 2010: This child patient was vaccinated with influenza virus vaccine (manufacturer unknown) on an unknown date. After vaccination, the patient presented with mild respiratory episode and got infected with H1N1 virus. A pediatrician commented that the patient was not hospitalized due to the events. The time interval between respiratory distress and vaccination was reported as less than 15 days. However, no therapy and event onset dates were specified. The child was healthy and at home at the time of this report. Two cases of same events were reported in the newspaper (see companion case PHHY2010AR39547).
Age: 1.5
Sex: F
Vaccine: FLU3
Symptoms: H1N1 influenza, Respiratory distress
Clinical narrative: Initial report received from a local newspaper via Novartis employee on 14 Jun 2010: This child patient was vaccinated with FLUVIRIN (manufacturer unknown) on an unknown date. After vaccination, the patient presented with mild respiratory episode and got infected with H1N1. A pediatrician commented that the patient was not hospitalized due to the events. The time interval between respiratory distress and vaccination was reported as less than 15 days. However, no therapy and event onset dates were specified. The child was healthy and at home at the time of this report. Two cases with same event were reported in this newspaper (see companion case PHHY2010AR39545 also).
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: At site of ZOSTAVAX injection LUE erythema and induration 4.5 x 5.5 cm.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pain in extremity
Clinical narrative: Pt receive Tdap 06-09-10. Noticed on 06-15-10 arm sore with red area. Red area 2.25cm x 2.25 cm slightly raised with knot under skin. No SOB, no other signs of anaphylaxis or serious reaction.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Facial bones fracture, Fall, Loss of consciousness
Clinical narrative: Information has been received from a physician, via an Agency (manufacturer # not reported), concerning a 16 year old female patient who was vaccinated with a dose of GARDASIL (date not reported). This report was part of a post-marketing surveillance program. Subsequently the patient passed out after administration and broke nose after falling. The event required a visit to the emergency room. Diagnostic tests carried out to diagnose the AE were blood work and blood pressure (results not reported). The patient recovered with sequelae. It was reported that therapy with GARDASIL was discontinued and that the events diminished after stopping therapy. The reporting investigator felt that passes out and broke nose were related to study therapy. Upon internal review it was considered that passes out and broke nose were other important medical events because the reporting investigator reported it as serious and no serious criteria were reported. No further information is available.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site pain, Injection site swelling, Joint range of motion decreased, Pain
Clinical narrative: Fever of 101+ degrees F, chills, aches, shaking, decreased range of motion of left arm; 6/20/10 left shoulder began to swell and is still swollen and sore to touch; fever broke 6/20/10.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Tremor
Clinical narrative: Fever of 101+ degrees F, chills, aches, shaking, decreased range of motion of left arm; 6/20/10 left shoulder began to swell and is still swollen and sore to touch; fever broke 6/20/10.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral, Vertigo, Viral infection
Clinical narrative: Rec'd ZOSTAVAX on 5/20/10. On 5/21/10 pt. had vertigo decrease hearing loss in Rt ear. His MD said a "virus probably killed the nerves in inner ear". Vertigo better now but hearing loss in Rt. ear continues.
Age: 0.37
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Eye irritation, Irritability, Nasal discomfort, Pyrexia, Rash
Clinical narrative: Seen 6/15 in office with 2wks of nasal sx and 3 days eye sx. Started on abx. on 6/17 developed fever 102, rash and fussiness. Fever resolved after 24hr. rash spreading, still fussy.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: Fifty cent sized raised red welt. Felt hot. Did not itch or hurt.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted within a few minutes of receiving vaccinations.  Patient regained consciousness within about a minute of fainting.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Red, warm, raised rash about 2" in diameter.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Blood chloride, Blood chloride increased, Blood glucose increased, Cardiac enzymes
Clinical narrative: Sudden onset of chest pain with tightness (elephant sitting on chest) shortness of breath, weakness, diaphoresis. Patient stated she had panic attacks. Cardiac enzymes, EKG, & Chest X-ray was performed in the ED. ASA was given PO. Patient refused admission for observation or to complete lab studies of second myoglobin.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Chest X-ray, Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: Sudden onset of chest pain with tightness (elephant sitting on chest) shortness of breath, weakness, diaphoresis. Patient stated she had panic attacks. Cardiac enzymes, EKG, & Chest X-ray was performed in the ED. ASA was given PO. Patient refused admission for observation or to complete lab studies of second myoglobin.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Full blood count, Haemoglobin decreased, Hyperhidrosis, Metabolic function test, Myoglobin blood
Clinical narrative: Sudden onset of chest pain with tightness (elephant sitting on chest) shortness of breath, weakness, diaphoresis. Patient stated she had panic attacks. Cardiac enzymes, EKG, & Chest X-ray was performed in the ED. ASA was given PO. Patient refused admission for observation or to complete lab studies of second myoglobin.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Panic attack
Clinical narrative: Sudden onset of chest pain with tightness (elephant sitting on chest) shortness of breath, weakness, diaphoresis. Patient stated she had panic attacks. Cardiac enzymes, EKG, & Chest X-ray was performed in the ED. ASA was given PO. Patient refused admission for observation or to complete lab studies of second myoglobin.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Convulsion
Clinical narrative: Pt has a history of seizures. Last seizure was in January 2010. She is on LAMICTAL, TRILEPTAL. About 16 hours after getting vaccines (KINRIX, MMR, VARIVAX). She had a 3 minute seizure. No fever. She is fine now.
Age: 1.49
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site reaction
Clinical narrative: A 1 1/2" x 1/4 in indent is located on the pt's (L) thigh. Parent noticed it for the first time 6-14/10. Saw PCP today. He believes it may be due to H1N1 vaccine dose #2. Thinks the vaccine deteriorated the muscle tissue. Pt. has no decrease in movement or pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Erythema, Injection site erythema
Clinical narrative: Vaccination given 5/24; redness started 5/25; evaluated 5/26 and treated for cellulitis. (tx: KEFLEX and BENADRYL).
Age: 7.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Local reaction
Clinical narrative: Vaccination given 5/18/10 - evaluated 5/20 and treated for local reaction (BENADRYL).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Vaccinations given 4/26. Redness and swelling the same day.   Evaluated 4/27, circle drawn around area and treated with BENADRYL.  Returned 4/28 with increasing redness and swelling and treated for cellulitis (tx: KEFLEX & BENADRYL).
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Local reaction
Clinical narrative: Vaccination given 5/3; evaluated 5/6 and treated for local reaction with BENADRYL.
Age: 4.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 8 x 10 cm. area of redness and swelling left upper arm which had onset one day after he received BOOSTRIX and VARIVAX in that site. Assessment: Typical local reaction.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling
Clinical narrative: Left thigh (injection site) with redness and swelling from thigh to knee. No warmth non tender to touch. Walks with mild limp. Motrin for pain.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Similar reaction on previous exposure to drug
Clinical narrative: At first administration of vaccines gave PEDIARIX, ROTA, PREVNAR, and HIB, infant cried with out console for greater than 3 hours. This time we gave PENTACEL separately from vaccines got same reaction.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cyanosis, Lethargy, Skin discolouration, Vaccination complication
Clinical narrative: Patient 90 mins. after vaccinations became gray, lethargic, and cyanotic. No seizures. Was seen in E.R. at Medical Center soon after reaction; labs recommended by family left E.R. Seen in my office next day - Looked great.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Patient received ZOSTAVAX vaccine in (L) SQ arm on 6.9.10 at approx 6:30pm. Injection site rash, itch, redness and swelling manifested on Friday AM 06.11.10. Patient says it has not worsened but warm to touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Tenderness
Clinical narrative: Pt was given MMR and VZV on left arm two days ago (6/11/10). Mom noticed erythema on left arm today which has worsened since. Erythema 19 cm in length from shoulder to above elbow and circumferential all the way around. Normal ROM shoulder, elbow. Mild tenderness on palpation.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Laceration, Syncope
Clinical narrative: Syncope approx 15 min after injection of GARDASIL. Laceration to chin possible neck injury secondary to fall.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Large localized reaction at the injection site approximately 15-20cm diameter occurring within 24 hr - successfully resolved treated with oral antihistamines.
Age: 3.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Gait disturbance, Injection site erythema, Injection site induration
Clinical narrative: Erythema and induration (R) anterior thigh. 5cm dia. Made him limp and hard to bear weight.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Myalgia
Clinical narrative: Chills, body aches, T 103 deg. No treatment needed, monitor symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling approximately 8 by 7 cm. on external surface of left upper arm.
Age: 64.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Headache, Injection site swelling, Myalgia, Oedema peripheral
Clinical narrative: Complains of arm swelling right arm at injection site, fever, chills, myalgia, headache.
Age: 64.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Complains of arm swelling right arm at injection site, fever, chills, myalgia, headache.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Syncope
Clinical narrative: GARDASIL & VARICELLA vaccine given.  Pt alert, appropriate.  Escorted to hall.  Pt had syncopal episode, attended & examined by PA. VSS.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Injection site abscess, Lymphangitis, Rash erythematous
Clinical narrative: Pt received ADACEL inj. to Rt upper arm and one day later hard softball size redness. This did decrease in size to quarter size but abscess developed at inj. site with small area medical with sl. lymphangitis. Needed drained and antibiotics.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash pruritic, Skin warm, Swelling
Clinical narrative: Patient received ZOSTAVAX on Tuesday May 25th at approximately 6pm and reports that she had developed an itchy rash that became hot, red and swollen. At this point, patient has presented to her physician and the pharmacy as it has been over two weeks and has gradually improved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Hypoaesthesia facial
Clinical narrative: (R) breast ache at site of previous biopsy that took place around 1 yr ago. Pain at site was affected by movement; also experienced transient numbness on (R) side of face. Both symptoms started day of to next day after vaccine. Improved today 6-21-10.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site erythema, Injection site reaction
Clinical narrative: (L) leg immediately turned purple and then red while it began to turn in, like muscle contraction.
Age: 1.32
Sex: M
Vaccine: HIBV, PNC
Symptoms: Rash macular, Swelling, Urticaria
Clinical narrative: Parent phoned - Approx 7:00pm blotchy skin noted around ears, throat; increase swelling approx 7:20pm. Taken to urgent care where BENADRYL was administered approx 20min hives and swelling disappeared.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site scab, Injection site warmth
Clinical narrative: Mom came in today with client. Mom states client got immunizations on 06/15/10. She said "my son complained that evening of itching on his left arm." She said when she looked at it she saw nothing except where the needle went into his arm. She then stated on 06/16/10 he complained of itching again on his left arm where he got his shot. She stated "when I looked at it I saw nothing except a dot where the shot went into his arm." She said that evening they went swimming & she happened to notice his arm as they were getting out of the pool. She stated "I saw pus running out where the shot had went into his arm." She said she cleaned it with warm water & a little bit of soap & put a bandaid on it. She said she cleaned it again later on last night & when she looked at the bandaid there was a little bit of pus on it. She said that she then decided to call & come up here today for us to look at it. Both the nurse and I looked at the injection site of the left arm. It was slightly warm to touch. Very small amount of redness noted around the injection site. No discharge was noted. There was a small scab over the injection site. Patient was moving his arm without difficulty. When I asked him if his arm hurt he said "it is a little sore." Told Mom to give him something she usually gives for a fever or soreness such as TYLENOL or MOTRIN to help with the soreness of his arm. Told her to call us back if symptoms worsen or to see private doctor. She verbalized understanding. Called this morning to follow-up on patient. Mom brought him into the health department on 06/18/10 for us to look at his left arm where he received an injection on 06/15/10. The progress note for 06/18/10 visit is in the encounter screen under the note section. When I spoke with mother this morning she stated "the arm is better. There is only a little bit of drainage, not much at all." She also said "I'm not giving him any TYLENOL and he is not complaining about his arm." I told her if he continues to have even a small amount of drainage to see her private provider & to let us know." She said she would and thanked me for calling.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Syncope, Vomiting
Clinical narrative: Sudden onset of dizziness, nausea, vomit & syncope sensation approx 20-30 min. after vaccination of HPV, MCV, DTP, VARIVAX.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Abdominal pain, Diarrhoea, Vomiting
Clinical narrative: Diarrhea, vomiting, abdominal pain
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Swelling & pain (L) upper arm & redness.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Bordetella test positive, Pertussis, Polymerase chain reaction
Clinical narrative: Patient contracted pertussis.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood test, Chest X-ray, Culture urine, Pyrexia, Rash macular
Clinical narrative: High fever after 24 hours (103.8). Blotchy skin on hands and feet. Shakes after fever.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Tremor
Clinical narrative: High fever after 24 hours (103.8). Blotchy skin on hands and feet. Shakes after fever.
Age: 1.07
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC
Symptoms: Agitation, Blood culture negative, CSF glucose normal, CSF protein decreased, Endotracheal intubation
Clinical narrative: Pt developed generalized tonic clonic seizures at 2200 on 6/18/10. 911 was called and pt taked to Medical Center. He received multiple doses of IV Ativan (total 3 mg) was intubated for respiratory failure, still having seizures, recieved 15 mg/kg of phenobarbital, still seizing, recieved 15 mg Dilantin. Hospital transport team contancted, arrived on scene, administered another 5 mg/kg of phenobarbital. Pt was having generalized seizure for approximately 2 hours. Transferred to Pediatric Intensive Care unit intubated. Initial blood gas 6.9, pCo2 130, pt with Right main stem intubation, tube adjusted. Got CT of brain, ET tube came out, re-intubated and transported to another hospital. He was extubated on day 2 of hospitalization to room air. Neurology was consulted, pt had an EEG with generalized slowing after multiple drugs administered. MRI with small areas of periventricular white matter TR signal hyperintensity in bilateral occipital/frontal lobes, otherwise normal. Pt transferred to general hospital floor on day 2 of hospitalization, still very agitated with poor tone.
Age: 1.07
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC
Symptoms: Grand mal convulsion, Intensive care, Nuclear magnetic resonance imaging brain abnormal, Red blood cells CSF positive, Respiratory failure
Clinical narrative: Pt developed generalized tonic clonic seizures at 2200 on 6/18/10. 911 was called and pt taked to Medical Center. He received multiple doses of IV Ativan (total 3 mg) was intubated for respiratory failure, still having seizures, recieved 15 mg/kg of phenobarbital, still seizing, recieved 15 mg Dilantin. Hospital transport team contancted, arrived on scene, administered another 5 mg/kg of phenobarbital. Pt was having generalized seizure for approximately 2 hours. Transferred to Pediatric Intensive Care unit intubated. Initial blood gas 6.9, pCo2 130, pt with Right main stem intubation, tube adjusted. Got CT of brain, ET tube came out, re-intubated and transported to another hospital. He was extubated on day 2 of hospitalization to room air. Neurology was consulted, pt had an EEG with generalized slowing after multiple drugs administered. MRI with small areas of periventricular white matter TR signal hyperintensity in bilateral occipital/frontal lobes, otherwise normal. Pt transferred to general hospital floor on day 2 of hospitalization, still very agitated with poor tone.
Age: 1.26
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Upon waking in the AM, patient had a red rash on the outside of his thigh near the vaccination site.  The rash was made up of round red spots that were brighter red at the edges.  After he had been awake for a while (and skin cooled off?) the rash faded away so I could barely see it anymore.  Daycare called me in the afternoon after his nap when they were changing his diaper, the rash was back, redder than it had been in the AM, and did not fade away.  Also at the Dr office at 4:45pm that day, we found a few more spots of the rash on the opposite leg.  Dr told me not to be concerned, that it looked like hives to him, and that I would probably see the rash come and go and move over his body in the course of the next 3-4 days.  Dr would not confirm if he thought it was a reaction to the vaccines given on 6/8. Dr advised me to give Benadryl if patient seemed uncomfortable/itchy.  Over the next two days, I saw the rash move over his body from legs to arms and torso in smaller red spots - almost like pinprick red spots.  The rash would fade and return. Patient did not seem uncomfortable at all.
Age: 39.0
Sex: M
Vaccine: DPP, HEPA
Symptoms: Induration, Muscular weakness, Pain in extremity
Clinical narrative: Hard lump in the underarm area of the arm that received the shot. Size approximately of a dime. Lasted four days so far with strong soreness, weakness in arm and arm "falling asleep" during night.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash erythematous, Varicella
Clinical narrative: Developed moderate to large (half dollar sized) red, fluid-filled lesions in (Rt) axillary area and down (Rt) side of anterior chest.  Has 20-50 lesions.  Child seen by Dr. MD on 6/21/10.  Dr. believed these lesions to be VARICELLA & prescribed BACITRACIN ointment to lesions.
Age: 48.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Lymphadenopathy, Yellow skin
Clinical narrative: 4 days after Hep A and Hep B vaccine developed yellowing of skin in (B) arms. (+) submandubular glands swollen.
Age: 38.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes simplex serology negative, Rash, Rash erythematous, Rash papular
Clinical narrative: Rec'd varicella vaccine 3/4/10. 4-5 days later developed rash on legs and arms (per chart notes-erythematous papules). Pruritic. Given BACTRIM-rash worsened. Seen by dermatology service who thought rash was likely either atypical varicella reaction vs hypersensitivity reaction to vaccine. Client states had rash 4 wks before varicella vaccination and rec'd steroids.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Developed redness, swelling, warmth at injection site requiring ER visit for antihistamine and antibiotic.
Age: 27.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Chills, Dysarthria, Fatigue, Myalgia, Pallor
Clinical narrative: L Delt IM DTAP sore muscle 4 days, paleness, tiredness shivering low grade fever, unable to talk clearly for 2 days.
Age: 27.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pyrexia
Clinical narrative: L Delt IM DTAP sore muscle 4 days, paleness, tiredness shivering low grade fever, unable to talk clearly for 2 days.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Received PCV 13 and Hep A on 6-15-10; Mom reported on 6-17-10 he was non weight bearing, had pain complaints on palpation of thigh, was drowsy, no swelling.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Adenovirus test, Biopsy skin abnormal, Cytomegalovirus test negative, Differential white blood cell count normal, Eosinophil count decreased
Clinical narrative: Dermatology Provider, Dr., calls (24MAY10) to consult re possible vaccine related etiology of pruritic, papulo-vesicular rash of 3 days evolution on 20 y/o AD SM's upper arms & back of neck- predominantly on sun exposed areas- but has several isolated lesions on abdomen and legs bilaterally. No rash on trunk or back. Patient's tan lines from t-shirt mark the distribution on the upper body. (See digital photos attached in VAECS). The rash began, per Clinic Note (24MAY10, 11:26 EDT), as a "small patch located on the lateral aspect of SM's right upper arm...it was extremely pruritic and he scratched it excessively- about a day later, he noticed that it had spread. The SM was on detail pulling weeds and trimming grass last week." Other than the pruritic rash, the SM is asymptomatic. No recent colds or illnesses. NKDA.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Haematocrit normal, Haemoglobin normal, Herpes simplex serology negative, Lymphocyte percentage decreased, Mean cell haemoglobin concentration
Clinical narrative: Dermatology Provider, Dr., calls (24MAY10) to consult re possible vaccine related etiology of pruritic, papulo-vesicular rash of 3 days evolution on 20 y/o AD SM's upper arms & back of neck- predominantly on sun exposed areas- but has several isolated lesions on abdomen and legs bilaterally. No rash on trunk or back. Patient's tan lines from t-shirt mark the distribution on the upper body. (See digital photos attached in VAECS). The rash began, per Clinic Note (24MAY10, 11:26 EDT), as a "small patch located on the lateral aspect of SM's right upper arm...it was extremely pruritic and he scratched it excessively- about a day later, he noticed that it had spread. The SM was on detail pulling weeds and trimming grass last week." Other than the pruritic rash, the SM is asymptomatic. No recent colds or illnesses. NKDA.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte count increased, Neutrophil count normal
Clinical narrative: Dermatology Provider, Dr., calls (24MAY10) to consult re possible vaccine related etiology of pruritic, papulo-vesicular rash of 3 days evolution on 20 y/o AD SM's upper arms & back of neck- predominantly on sun exposed areas- but has several isolated lesions on abdomen and legs bilaterally. No rash on trunk or back. Patient's tan lines from t-shirt mark the distribution on the upper body. (See digital photos attached in VAECS). The rash began, per Clinic Note (24MAY10, 11:26 EDT), as a "small patch located on the lateral aspect of SM's right upper arm...it was extremely pruritic and he scratched it excessively- about a day later, he noticed that it had spread. The SM was on detail pulling weeds and trimming grass last week." Other than the pruritic rash, the SM is asymptomatic. No recent colds or illnesses. NKDA.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash papular, Rash pruritic, Red blood cell count normal, Skin lesion, Varicella
Clinical narrative: Dermatology Provider, Dr., calls (24MAY10) to consult re possible vaccine related etiology of pruritic, papulo-vesicular rash of 3 days evolution on 20 y/o AD SM's upper arms & back of neck- predominantly on sun exposed areas- but has several isolated lesions on abdomen and legs bilaterally. No rash on trunk or back. Patient's tan lines from t-shirt mark the distribution on the upper body. (See digital photos attached in VAECS). The rash began, per Clinic Note (24MAY10, 11:26 EDT), as a "small patch located on the lateral aspect of SM's right upper arm...it was extremely pruritic and he scratched it excessively- about a day later, he noticed that it had spread. The SM was on detail pulling weeds and trimming grass last week." Other than the pruritic rash, the SM is asymptomatic. No recent colds or illnesses. NKDA.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Varicella virus test negative, Viral test negative
Clinical narrative: Dermatology Provider, Dr., calls (24MAY10) to consult re possible vaccine related etiology of pruritic, papulo-vesicular rash of 3 days evolution on 20 y/o AD SM's upper arms & back of neck- predominantly on sun exposed areas- but has several isolated lesions on abdomen and legs bilaterally. No rash on trunk or back. Patient's tan lines from t-shirt mark the distribution on the upper body. (See digital photos attached in VAECS). The rash began, per Clinic Note (24MAY10, 11:26 EDT), as a "small patch located on the lateral aspect of SM's right upper arm...it was extremely pruritic and he scratched it excessively- about a day later, he noticed that it had spread. The SM was on detail pulling weeds and trimming grass last week." Other than the pruritic rash, the SM is asymptomatic. No recent colds or illnesses. NKDA.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Arthralgia, Decreased appetite, Dizziness, Ear pain
Clinical narrative: Stomach cramps, migraine headache, nausea, decreased appetite, aches and pains, dizziness, ear ache, and joint pains.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Migraine, Nausea, Pain
Clinical narrative: Stomach cramps, migraine headache, nausea, decreased appetite, aches and pains, dizziness, ear ache, and joint pains.
Age: 0.33
Sex: M
Vaccine: 6VAX-F, PNC
Symptoms: Diarrhoea
Clinical narrative: Diarrhea x10 days.
Age: 97.0
Sex: M
Vaccine: PNC
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with a COPD exacerbation. Vaccination took place 01.27.2009. According to the physician the relationship is None. We would be happy to fax you the Study SAE report.
Age: 96.0
Sex: M
Vaccine: PNC
Symptoms: Road traffic accident
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with because of a car accident. Vaccination took place 10.09.2008. According to the physician the relationship is None. We would be happy to fax you the Study SAE report.
Age: 45.0
Sex: F
Vaccine: DTAP
Symptoms: Convulsion, Dyskinesia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Severe body ache and inability to move arm due to severe pain, high fever over 102 degrees, experienced seizure type whole body jerking two times during evening of 6-18, continued pain throughout body and right arm even now 6-21-2010.
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Induration, Injection site erythema, Injection site pain, Injection site warmth, Musculoskeletal pain
Clinical narrative: 6/10/10: follow-up visits - red warm tender at injection site with pain.  6/18/10 - 1 1/2 inch diameter firm area, no redness, pain radiates thru shoulder and increases with movement.
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Pain
Clinical narrative: 6/10/10: follow-up visits - red warm tender at injection site with pain.  6/18/10 - 1 1/2 inch diameter firm area, no redness, pain radiates thru shoulder and increases with movement.
Age: 0.18
Sex: F
Vaccine: RV5
Symptoms: Crying, Diarrhoea, Irritability
Clinical narrative: Diarrhea and increased fussiness. No blood or mucus with stools. Also had intense crying for 2 days. No treatment needed.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Alanine aminotransferase increased, Anaemia haemolytic autoimmune, Antinuclear antibody negative, Aspartate aminotransferase increased, Basophil percentage
Clinical narrative: 59YO female who was admitted to hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable.  Her reticulocyte count was not elevated though she did not have any prodromal viral symptoms. However, she did receive the H1N1 vaccine just about four weeks before the development of the autoimmune hemolytic anemia.  Parvovirus IgM was low.  ANA was negative.  Pt started on steroids and remains on prednisone and dose was slowly tapered off.  She is tolerating therapy well.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood amylase decreased, Blood bilirubin increased, Blood bilirubin unconjugated increased
Clinical narrative: 59YO female who was admitted to hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable.  Her reticulocyte count was not elevated though she did not have any prodromal viral symptoms. However, she did receive the H1N1 vaccine just about four weeks before the development of the autoimmune hemolytic anemia.  Parvovirus IgM was low.  ANA was negative.  Pt started on steroids and remains on prednisone and dose was slowly tapered off.  She is tolerating therapy well.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Blood calcium normal, Blood chloride increased, Blood creatinine normal, Blood glucose normal, Blood lactate dehydrogenase increased
Clinical narrative: 59YO female who was admitted to hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable.  Her reticulocyte count was not elevated though she did not have any prodromal viral symptoms. However, she did receive the H1N1 vaccine just about four weeks before the development of the autoimmune hemolytic anemia.  Parvovirus IgM was low.  ANA was negative.  Pt started on steroids and remains on prednisone and dose was slowly tapered off.  She is tolerating therapy well.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide normal, Coombs test positive
Clinical narrative: 59YO female who was admitted to hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable.  Her reticulocyte count was not elevated though she did not have any prodromal viral symptoms. However, she did receive the H1N1 vaccine just about four weeks before the development of the autoimmune hemolytic anemia.  Parvovirus IgM was low.  ANA was negative.  Pt started on steroids and remains on prednisone and dose was slowly tapered off.  She is tolerating therapy well.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Eosinophil percentage, Haematocrit decreased, Haemoglobin decreased, Lymphocyte percentage, Mean cell haemoglobin concentration
Clinical narrative: 59YO female who was admitted to hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable.  Her reticulocyte count was not elevated though she did not have any prodromal viral symptoms. However, she did receive the H1N1 vaccine just about four weeks before the development of the autoimmune hemolytic anemia.  Parvovirus IgM was low.  ANA was negative.  Pt started on steroids and remains on prednisone and dose was slowly tapered off.  She is tolerating therapy well.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte percentage, Neutrophil percentage
Clinical narrative: 59YO female who was admitted to hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable.  Her reticulocyte count was not elevated though she did not have any prodromal viral symptoms. However, she did receive the H1N1 vaccine just about four weeks before the development of the autoimmune hemolytic anemia.  Parvovirus IgM was low.  ANA was negative.  Pt started on steroids and remains on prednisone and dose was slowly tapered off.  She is tolerating therapy well.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Parvovirus B19 test, Platelet count normal, Protein total decreased, Red blood cell count decreased, Red cell distribution width increased
Clinical narrative: 59YO female who was admitted to hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable.  Her reticulocyte count was not elevated though she did not have any prodromal viral symptoms. However, she did receive the H1N1 vaccine just about four weeks before the development of the autoimmune hemolytic anemia.  Parvovirus IgM was low.  ANA was negative.  Pt started on steroids and remains on prednisone and dose was slowly tapered off.  She is tolerating therapy well.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Reticulocyte count normal, White blood cell count normal
Clinical narrative: 59YO female who was admitted to hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable.  Her reticulocyte count was not elevated though she did not have any prodromal viral symptoms. However, she did receive the H1N1 vaccine just about four weeks before the development of the autoimmune hemolytic anemia.  Parvovirus IgM was low.  ANA was negative.  Pt started on steroids and remains on prednisone and dose was slowly tapered off.  She is tolerating therapy well.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Alanine aminotransferase increased, Anaemia haemolytic autoimmune, Antinuclear antibody negative, Aspartate aminotransferase increased, Basophil percentage decreased
Clinical narrative: 59YO female who was admitted to hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable.  Her reticulocyte count was not elevated though she did not have any prodromal viral symptoms. However, she did receive the H1N1 vaccine just about four weeks before the development of the autoimmune hemolytic anemia.  Parvovirus IgM was low.  ANA was negative.  Pt started on steroids and remains on prednisone and dose was slowly tapered off.  She is tolerating therapy well.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin increased, Blood bilirubin unconjugated increased, Blood calcium normal
Clinical narrative: 59YO female who was admitted to hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable.  Her reticulocyte count was not elevated though she did not have any prodromal viral symptoms. However, she did receive the H1N1 vaccine just about four weeks before the development of the autoimmune hemolytic anemia.  Parvovirus IgM was low.  ANA was negative.  Pt started on steroids and remains on prednisone and dose was slowly tapered off.  She is tolerating therapy well.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Blood chloride increased, Blood creatinine normal, Blood lactate dehydrogenase increased, Blood potassium normal, Blood sodium normal
Clinical narrative: 59YO female who was admitted to hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable.  Her reticulocyte count was not elevated though she did not have any prodromal viral symptoms. However, she did receive the H1N1 vaccine just about four weeks before the development of the autoimmune hemolytic anemia.  Parvovirus IgM was low.  ANA was negative.  Pt started on steroids and remains on prednisone and dose was slowly tapered off.  She is tolerating therapy well.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Blood urea increased, Carbon dioxide normal, Coombs test positive, Eosinophil percentage decreased, Haematocrit decreased
Clinical narrative: 59YO female who was admitted to hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable.  Her reticulocyte count was not elevated though she did not have any prodromal viral symptoms. However, she did receive the H1N1 vaccine just about four weeks before the development of the autoimmune hemolytic anemia.  Parvovirus IgM was low.  ANA was negative.  Pt started on steroids and remains on prednisone and dose was slowly tapered off.  She is tolerating therapy well.