chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Anorexia, Arthralgia, Arthralgia, Blister, Blood cholesterol increased
Clinical narrative: Heat blisters, arthritis on my low back, ache bones, joints and muscles sleeping disorders, appetite loss, right arm pain, mobility and hot to touch problems,high blood pressure, dizzy upon standing and falling down, high cholesterol, fever and others. 1/4/10 Still with high blood pressure, joint pain, sleep disturbance, muscle pain and depression.  03/26/2007 VAERS report submitted with vax. record and several pages of medical records attached, including a report of 4/29/2003 for a fall which resulted in injury to right shoulder and left knee.  DX:  Impingement Syndrome.  F/U 5/4/2003 for same shoulder injury DX: Strained muscle Right Shoulder. TC to Pt/reporter to verify AE onset date.  Pt. stated it was on/about May 1, 2004.  Updated in VAERS.  04/09/2007 MR received for multiple OVs beginning 5/27/2004 through 3/6/2007. Initial c/o R shoulder pain 2' past trauma. Multiple OVs with problem list including the following DXs: Hypercholesteremia, Joint Pain, HTN, Depressive Disorder Alcohol Abuse, Rotator Cuff tear, Neck Pain, DDD-cervical, Spinal Stenosis, LBP, Hip arthralgia.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Bone pain, Depression, Dizziness postural, Fall, Hypertension
Clinical narrative: Heat blisters, arthritis on my low back, ache bones, joints and muscles sleeping disorders, appetite loss, right arm pain, mobility and hot to touch problems,high blood pressure, dizzy upon standing and falling down, high cholesterol, fever and others. 1/4/10 Still with high blood pressure, joint pain, sleep disturbance, muscle pain and depression.  03/26/2007 VAERS report submitted with vax. record and several pages of medical records attached, including a report of 4/29/2003 for a fall which resulted in injury to right shoulder and left knee.  DX:  Impingement Syndrome.  F/U 5/4/2003 for same shoulder injury DX: Strained muscle Right Shoulder. TC to Pt/reporter to verify AE onset date.  Pt. stated it was on/about May 1, 2004.  Updated in VAERS.  04/09/2007 MR received for multiple OVs beginning 5/27/2004 through 3/6/2007. Initial c/o R shoulder pain 2' past trauma. Multiple OVs with problem list including the following DXs: Hypercholesteremia, Joint Pain, HTN, Depressive Disorder Alcohol Abuse, Rotator Cuff tear, Neck Pain, DDD-cervical, Spinal Stenosis, LBP, Hip arthralgia.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Mobility decreased, Muscle strain, Myalgia, Myalgia, Pain in extremity
Clinical narrative: Heat blisters, arthritis on my low back, ache bones, joints and muscles sleeping disorders, appetite loss, right arm pain, mobility and hot to touch problems,high blood pressure, dizzy upon standing and falling down, high cholesterol, fever and others. 1/4/10 Still with high blood pressure, joint pain, sleep disturbance, muscle pain and depression.  03/26/2007 VAERS report submitted with vax. record and several pages of medical records attached, including a report of 4/29/2003 for a fall which resulted in injury to right shoulder and left knee.  DX:  Impingement Syndrome.  F/U 5/4/2003 for same shoulder injury DX: Strained muscle Right Shoulder. TC to Pt/reporter to verify AE onset date.  Pt. stated it was on/about May 1, 2004.  Updated in VAERS.  04/09/2007 MR received for multiple OVs beginning 5/27/2004 through 3/6/2007. Initial c/o R shoulder pain 2' past trauma. Multiple OVs with problem list including the following DXs: Hypercholesteremia, Joint Pain, HTN, Depressive Disorder Alcohol Abuse, Rotator Cuff tear, Neck Pain, DDD-cervical, Spinal Stenosis, LBP, Hip arthralgia.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia, Rotator cuff syndrome, Skin warm, Sleep disorder
Clinical narrative: Heat blisters, arthritis on my low back, ache bones, joints and muscles sleeping disorders, appetite loss, right arm pain, mobility and hot to touch problems,high blood pressure, dizzy upon standing and falling down, high cholesterol, fever and others. 1/4/10 Still with high blood pressure, joint pain, sleep disturbance, muscle pain and depression.  03/26/2007 VAERS report submitted with vax. record and several pages of medical records attached, including a report of 4/29/2003 for a fall which resulted in injury to right shoulder and left knee.  DX:  Impingement Syndrome.  F/U 5/4/2003 for same shoulder injury DX: Strained muscle Right Shoulder. TC to Pt/reporter to verify AE onset date.  Pt. stated it was on/about May 1, 2004.  Updated in VAERS.  04/09/2007 MR received for multiple OVs beginning 5/27/2004 through 3/6/2007. Initial c/o R shoulder pain 2' past trauma. Multiple OVs with problem list including the following DXs: Hypercholesteremia, Joint Pain, HTN, Depressive Disorder Alcohol Abuse, Rotator Cuff tear, Neck Pain, DDD-cervical, Spinal Stenosis, LBP, Hip arthralgia.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Balance disorder, Coordination abnormal, Demyelinating polyneuropathy, Electromyogram abnormal, Guillain-Barre syndrome
Clinical narrative: Patient admitted to neurology ward on 19 Mar 2007, after presenting with weakness and numbness in all limbs that began 09 Mar 2007. Pt complained of poor balance, difficulty ascending stairs, lifting his legs, removing shoes and buttoning uniform. Pt was admitted for Guillain-Barre, presumptively, ruled-in by EMG study and was treated with IVIG. Discharged to home 03/23/07.  5/10/07 Received medical records from hospital which reveal patient experienced tingling of fingers & toes for 3.5 weeks preceded by a viral illness w/cough, fever, myalgia & pt seen in ER on 2/19/07.  When viral illness resolved, developed severe right occipital HA.  10 days prior to admit patient noted weakness & pain of legs.  Difficult to initiate movement & had unsteady gait.  Admitted 3/19-3/20/07.  Exam revealed symetrical weakness of UE & LE, areflexia & distal sensory loss.  Patient refused LP.  Treated w/IVIG x 5 doses started in hospital & completed as outpatient.  FINAL DX: Guillain Barre syndrome.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Hypoaesthesia, Hypokinesia, Inflammation, Mobility decreased, Muscular weakness
Clinical narrative: Patient admitted to neurology ward on 19 Mar 2007, after presenting with weakness and numbness in all limbs that began 09 Mar 2007. Pt complained of poor balance, difficulty ascending stairs, lifting his legs, removing shoes and buttoning uniform. Pt was admitted for Guillain-Barre, presumptively, ruled-in by EMG study and was treated with IVIG. Discharged to home 03/23/07.  5/10/07 Received medical records from hospital which reveal patient experienced tingling of fingers & toes for 3.5 weeks preceded by a viral illness w/cough, fever, myalgia & pt seen in ER on 2/19/07.  When viral illness resolved, developed severe right occipital HA.  10 days prior to admit patient noted weakness & pain of legs.  Difficult to initiate movement & had unsteady gait.  Admitted 3/19-3/20/07.  Exam revealed symetrical weakness of UE & LE, areflexia & distal sensory loss.  Patient refused LP.  Treated w/IVIG x 5 doses started in hospital & completed as outpatient.  FINAL DX: Guillain Barre syndrome.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Nerve conduction studies abnormal
Clinical narrative: Patient admitted to neurology ward on 19 Mar 2007, after presenting with weakness and numbness in all limbs that began 09 Mar 2007. Pt complained of poor balance, difficulty ascending stairs, lifting his legs, removing shoes and buttoning uniform. Pt was admitted for Guillain-Barre, presumptively, ruled-in by EMG study and was treated with IVIG. Discharged to home 03/23/07.  5/10/07 Received medical records from hospital which reveal patient experienced tingling of fingers & toes for 3.5 weeks preceded by a viral illness w/cough, fever, myalgia & pt seen in ER on 2/19/07.  When viral illness resolved, developed severe right occipital HA.  10 days prior to admit patient noted weakness & pain of legs.  Difficult to initiate movement & had unsteady gait.  Admitted 3/19-3/20/07.  Exam revealed symetrical weakness of UE & LE, areflexia & distal sensory loss.  Patient refused LP.  Treated w/IVIG x 5 doses started in hospital & completed as outpatient.  FINAL DX: Guillain Barre syndrome.
Age: 0.16
Sex: M
Vaccine: HIBV, IPV, PNC, RV5, TD
Symptoms: Inappropriate schedule of drug administration, No adverse effect, Wrong drug administered
Clinical narrative: child had no adverse symptoms or symptoms. Child was given wrong immunizations Td instead of DTap for 2 months immunization.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: We are reporting that the patient became pregnant after receiving 1st dose of Gardasil. Her last menstrual period was 1/17/07. She reported pregnancy to us on 3/1/07. Her EDC is 10/24/07.  She received Gardasil on 1/16/07.  Follow-up - Adverse event onset 01/16/2007 at 15:30 PM.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Nausea, Syncope
Clinical narrative: Fainting, sweating, nausea
Age: 27.0
Sex: F
Vaccine: HPVX
Symptoms: Dyspnoea, Tachycardia
Clinical narrative: Patient experienced rapid heart rate and shortness of breath. Patient went to ER.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Cyanosis, Joint swelling, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: fever, rash, swollen joints (ankles, elbows, shoulders), can't walk, sore throat, toes blue. Probable Serum sickness
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Serum sickness
Clinical narrative: fever, rash, swollen joints (ankles, elbows, shoulders), can't walk, sore throat, toes blue. Probable Serum sickness
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL, TTOX
Symptoms: Folliculitis, Rash macular, Rash pustular
Clinical narrative: Patient developed a rash that consisted of macules, with some papules and pustules covering his body. There was no ocular involvement. Patient presented to medical center ER on Sunday, March 18, 2007 at 8 am. Patient was referred to dermatology where he was diagnosed with folliculitis and treated with doxycycline.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pyrexia, Tenderness
Clinical narrative: 3 Hours after administration began swelling and tender to touch - 6 hours after administration. Started fever. 24 hours after red and still tender.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Folliculitis, Rash maculo-papular, Rash pruritic
Clinical narrative: Patient received smallpox vaccine on 02/26/07; onset of sx on 03/04/07. Patient presented with bilateral axillary maculopapular rash - confluent at center of bilateral axialle, approximately 12cm across, roughly, annular, tender bilateral axillary lymph nodes, pruritic, thought to be c/w viral or bacterial folliculitis, per dermatology. Tx: Keflex 500mg TID x 20 days, Atarax 25-50 mg QID PRN.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV
Symptoms: Body temperature increased, Cough, Diarrhoea, Malaise, Rash papular
Clinical narrative: Varicella -like rash developed 7 days after vaccine. 8 papul-vesicular lesion, malaise, T99.8, cough, loose stool.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV
Symptoms: Rash vesicular
Clinical narrative: Varicella -like rash developed 7 days after vaccine. 8 papul-vesicular lesion, malaise, T99.8, cough, loose stool.
Age: 33.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Oedema peripheral
Clinical narrative: Left arm swollen after receiving Tdap and MMR injection.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Came into emergency room department c/o fever, irritability.
Age: 26.0
Sex: M
Vaccine: ANTH, FLU3, SMALL, TYP, UNK
Symptoms: Cellulitis, Injection site erythema, Malaise, Pyrexia
Clinical narrative: Patient vaccinated on 2/26/07 for smallpox, onset of sx. on 03/07/07. Patient presented with malaise, low grade temp. and expanding area of erythema around inoculation site on left deltoid (approximately 20cm x 7cm), thought to be c/w cellulitis. Tx: Keflex 500mg PO TID x 10 days.
Age: 1.67
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Swelling and blister formation around the site of both Hep A and Influenza injections (R) THIGH.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug hypersensitivity, Erythema, Erythema, Pruritus, Swelling
Clinical narrative: Patient called 3/15/07. Patient states the morning after she received her 2nd dose of Gardasil, when she woke up her face and neck was red and cheeks were puffy and also itchy. Patient did state she was in the sun x 45 minutes after she left our office- was using a new sunblock x 4days. Patient states swelling and redness was gone by the next day. No treatment. Information has been received from a registered nurse concerning a 19 year old female with no illness at the time of vaccination, allergy to ibuprofen, and seasonal allergies who on an unspecified date was vaccinated with a first dose of GARDASIL. On 12-MAR-2007, the patient was vaccinated with a second dose of GARDASIL (lot # 6555619/1427F). 0.5 ml IM in the right deltoid at 10:30 AM. Concomitant therapy included unspecified therapies. On 13-MAR-2007, in the early morning, the patient experienced redness of her neck and cheeks, face was little puffym, and itchy almost like sunburn after receiving the second dose of GARDASIL. Medical attention was sought. At the time of reporting, the outcome was unknown. No further information was available at the time of reporting. Additional information was received from the registered nurse. The patient had called on 15-MAR-2007 to report that the morning after she received the second dose of vaccine, when she woke up, her face and neck were red and her cheeks were pufy and also itchy. The patient was in the sun for 45 minutes after she left the office. She was using a new sunblock for four days. The patient reported the swellinf and redness were gone by the next day, No treatment. At the time of reporting, the patient had recovered. No additional information is expected.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Swelling face, Vaccine positive rechallenge
Clinical narrative: Patient called 3/15/07. Patient states the morning after she received her 2nd dose of Gardasil, when she woke up her face and neck was red and cheeks were puffy and also itchy. Patient did state she was in the sun x 45 minutes after she left our office- was using a new sunblock x 4days. Patient states swelling and redness was gone by the next day. No treatment. Information has been received from a registered nurse concerning a 19 year old female with no illness at the time of vaccination, allergy to ibuprofen, and seasonal allergies who on an unspecified date was vaccinated with a first dose of GARDASIL. On 12-MAR-2007, the patient was vaccinated with a second dose of GARDASIL (lot # 6555619/1427F). 0.5 ml IM in the right deltoid at 10:30 AM. Concomitant therapy included unspecified therapies. On 13-MAR-2007, in the early morning, the patient experienced redness of her neck and cheeks, face was little puffym, and itchy almost like sunburn after receiving the second dose of GARDASIL. Medical attention was sought. At the time of reporting, the outcome was unknown. No further information was available at the time of reporting. Additional information was received from the registered nurse. The patient had called on 15-MAR-2007 to report that the morning after she received the second dose of vaccine, when she woke up, her face and neck were red and her cheeks were pufy and also itchy. The patient was in the sun for 45 minutes after she left the office. She was using a new sunblock for four days. The patient reported the swellinf and redness were gone by the next day, No treatment. At the time of reporting, the patient had recovered. No additional information is expected.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: Patient called 3/15/07. Patient states the morning after she received her 2nd dose of Gardasil, when she woke up her face and neck was red and cheeks were puffy and also itchy. Patient did state she was in the sun x 45 minutes after she left our office- was using a new sunblock x 4days. Patient states swelling and redness was gone by the next day. No treatment. Information has been received from a registered nurse concerning a 19 year old female with no illness at the time of vaccination, allergy to ibuprofen, and seasonal allergies who on an unspecified date was vaccinated with a first dose of GARDASIL. On 12-MAR-2007, the patient was vaccinated with a second dose of GARDASIL (lot # 6555619/1427F). 0.5 ml IM in the right deltoid at 10:30 AM. Concomitant therapy included unspecified therapies. On 13-MAR-2007, in the early morning, the patient experienced redness of her neck and cheeks, face was little puffym, and itchy almost like sunburn after receiving the second dose of GARDASIL. Medical attention was sought. At the time of reporting, the outcome was unknown. No further information was available at the time of reporting. Additional information was received from the registered nurse. The patient had called on 15-MAR-2007 to report that the morning after she received the second dose of vaccine, when she woke up, her face and neck were red and her cheeks were pufy and also itchy. The patient was in the sun for 45 minutes after she left the office. She was using a new sunblock for four days. The patient reported the swellinf and redness were gone by the next day, No treatment. At the time of reporting, the patient had recovered. No additional information is expected.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Injection site swelling
Clinical narrative: Chills, arthralgias, swelling at injection site, fever to 100.4 (F) w/chills, loose stools and nausea and headache. Took 2 doses of Ibuprofen + 1 dose of Tylenol for above symptoms. Sx began approximately 24 hours after injection - patient missed day of work (3/16/07) and symptoms treated 24 hours.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: Chills, arthralgias, swelling at injection site, fever to 100.4 (F) w/chills, loose stools and nausea and headache. Took 2 doses of Ibuprofen + 1 dose of Tylenol for above symptoms. Sx began approximately 24 hours after injection - patient missed day of work (3/16/07) and symptoms treated 24 hours.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature decreased, Chills, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: Sweats, chills, myalgia, lethargy, injection site erythematous/tender
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Lethargy, Myalgia
Clinical narrative: Sweats, chills, myalgia, lethargy, injection site erythematous/tender
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC, RV5
Symptoms: Occult blood positive, Unevaluable event
Clinical narrative: NONE Explained
Age: 48.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Blood test normal, Electrocardiogram normal, Hypoaesthesia, Mobility decreased
Clinical narrative: Right hand soreness and numbness, afebrile, pain with movement limits use of hand, no weakness. Right knee aching, worse with waking. BP 139/93, pulse 97
Age: 48.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity
Clinical narrative: Right hand soreness and numbness, afebrile, pain with movement limits use of hand, no weakness. Right knee aching, worse with waking. BP 139/93, pulse 97
Age: 48.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Arthralgia, Blood electrolytes normal, Electrocardiogram normal, Full blood count normal
Clinical narrative: Right hand soreness and numbness, afebrile, pain with movement limits use of hand, no weakness. Right knee aching, worse with waking. BP 139/93, pulse 97
Age: 48.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Inappropriate schedule of drug administration, Medication error, Mobility decreased, Pain
Clinical narrative: Right hand soreness and numbness, afebrile, pain with movement limits use of hand, no weakness. Right knee aching, worse with waking. BP 139/93, pulse 97
Age: 48.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Urine analysis normal
Clinical narrative: Right hand soreness and numbness, afebrile, pain with movement limits use of hand, no weakness. Right knee aching, worse with waking. BP 139/93, pulse 97
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia, Vomiting, X-ray with contrast upper gastrointestinal tract
Clinical narrative: About 1 hour after administration of vaccine, patient began vomiting; she had blood in her stool the next morning and no bowel movements for the next 36 hours. Radiographs revealed a dilated loop of bowel consistent with intussusception vs. mid gut volvulus. Subsequent u/s, CT and upper GI exams normal consistent with spontaneous reduction of obstruction. 3/30/07 Received medical records from hospital which reveal patient experienced fever following vax on 3/13/07 & following day had a streak of blood in stool.  Seen by PCP who sent for x-rays.  Sent home from x-ray & to return if no stool in 3 hrs.  Returned to ER w/o BM.  Taking oral fluids well & normal behavior. FINAL DX: Constipation.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Pruritus
Clinical narrative: Both arm and elbow itchy.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Erythema, Injection site pruritus, Malaise, Oedema peripheral
Clinical narrative: Swelling, redness, hot to touch, swelling under arm (lymph gland), temp 99-100. General malaise. Pain in arm, itchy at sight.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Skin warm, Swelling
Clinical narrative: Swelling, redness, hot to touch, swelling under arm (lymph gland), temp 99-100. General malaise. Pain in arm, itchy at sight.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Patient with erythema 4x4 area left deltoid area, swollen and warm to touch.
Age: 38.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Increased upper airway secretion, Vomiting
Clinical narrative: Received rabies injection 03 20 07 waited 15 minutes in center for reaction-was ok. Went home felt dizzy and vomited slight amount of phlegm. Lay down and went to sleep for 1 hour upon awakening felt fine no nausea or dizziness present.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Local reaction at injection site.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered, Medication error
Clinical narrative: Patient was given expired Hep B vaccine on 11/29/06 at approx 3pm. Patient developed no problems. Advised to revaccinate.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Encephalopathy, Pyrexia, Quadriplegia
Clinical narrative: 100 F Fever and mild seizures. Within 3 weeks seizures became severe
Age: 0.5
Sex: M
Vaccine: HBHEPB, HEP, PNC
Symptoms: Body temperature increased, Injection site rash
Clinical narrative: Inj site on right leg has quarter sized, raised, bumpy pink area. Pt also has temp of 101 deg. This was patient's first post hospital vaccinations.
Age: 1.25
Sex: F
Vaccine: BCG, DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt received immunization on 3-13-07. Came back to clinic 3-15-07 to have PPD read. Mom reported redness and swelling at injection site right and left deltoid. Right deltoid area revealed approx 8 cm x 3 cm red slightly swollen area. Left deltoid area approx 3 cm x 1 cm. Non-tender.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: 1 day after receiving Varivax booster developed swelling and redness around site.  Seen at local urgent care and diagnosed with possible cellulitis. Treated with oral antibiotics and IM steroids.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Irritability, Rash erythematous, Urticaria
Clinical narrative: Mother phoned 3/16 reporting at 12:30 pm today noted red raised areas on arms, back, thighs. Had given Motrin x 1; during night slightly fussy, no fever. 3/19/07 phone call from mother, brought child to urgent care 3/17. 3/10 doctor diagnosed reactive hives from Hepatitis A injection.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Adverse reaction noted approx. 12 hours post injection. Redness, itching, hot to touch, edema noted at site of injection to left upper arm. Area today measures 4cm x 4 1/2 cm. Today serious red but not hot or swollen.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Hypersensitivity, Skin warm, Swelling
Clinical narrative: Pt was administered Varivax right arm on 3/13/07 and had an allergic reaction. Came back into our office on 3/16/07 patient had swelling and red all over, arm warm to touch. Benadryl given PO.
Age: 0.5
Sex: F
Vaccine: DTAP, PNC
Symptoms: Haematocrit normal, Haemoglobin normal, Lymphocyte count, Lymphocyte morphology abnormal, Nasal congestion
Clinical narrative: 48-72 hours of fever, reaching 105 deg max. Vomiting, lack cough, nasal congestion. Resolved within 72 hours of beginning. Visited ER. IV fluids given.
Age: 0.5
Sex: F
Vaccine: DTAP, PNC
Symptoms: Neutrophil count, Platelet count increased, Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: 48-72 hours of fever, reaching 105 deg max. Vomiting, lack cough, nasal congestion. Resolved within 72 hours of beginning. Visited ER. IV fluids given.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Eye swelling, Lip swelling, Pyrexia, Tenderness
Clinical narrative: No localized redness at site where shots were given. Eyelids swollen and lip swollen, no respiratory symptoms, note fever and bilateral leg tenderness around area of shots (3).
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Rash erythematous
Clinical narrative: He received DTaP, IPV, Varicella in left thigh and Hep A, MMR and Prevnar in right thigh on 3/13/07. Left thigh,entire outer thigh pale red with dark red inner area of erythema on day 2. Irregular edges-mildly reddened and mildy tender.
Sex: M
Vaccine: BCG, IPV, VARCEL
Symptoms: Unevaluable event, Varicella
Clinical narrative: None stated.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Fatigue, Migraine, Muscle spasms, Nausea
Clinical narrative: Migraine, nausea, bladder, loss of motion, cramps in arms and legs, fatigue.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Dysphagia, Eating disorder, Headache, Pain
Clinical narrative: Headache for 48 hrs within 30 minutes after injection, arm very painful, fever on and off for two weeks, body aches and pains, very low energy, infected throat which led to self check in due to inability to eat/ swallow.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Headache for 48 hrs within 30 minutes after injection, arm very painful, fever on and off for two weeks, body aches and pains, very low energy, infected throat which led to self check in due to inability to eat/ swallow.
Age: 22.0
Sex: F
Vaccine: ANTH, FLU3, HEPAB, TYP
Symptoms: Pharyngeal oedema
Clinical narrative: PT REPORTED SENSATION OF HER THROAT SWELLING CLOSED, SIMILAR TO WHEN SHE IS EXPOSED TO MUSHROOMS (ALLERGIC TO MUSHROOMS).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: She ran a fever of 101 F for 24 hours beginning beginning 4-6 hours after the administration of the second dose of the vaccine.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness, light headed, sudden headache.  I laid down with a cool cloth on my forehead.  I also took ibuprofin and went to sleep.
Age: 1.04
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Convulsion, Electroencephalogram
Clinical narrative: One week later, patient ran a very high fever within a matter of a few minutes which caused a seizure to occur. During seizure patient was convulsing. Seizure and fever took place around midnight exactly one week after he received vaccinations of MMR, chickenpox, influenzae type b, dtp and pneumococcal conjugate. Within 10 minutes the seizure had stopped and the fever dropped to normal. The following morning, patient started to get another fever and then had another seizure around 9:30 am, at which point we took him to the ER. The administered some medicine to stop the seizure and ran some tests and then sent us to Hospital to be examined further, where we stayed for 3 days.  04/03/2007 MRs received from PCP for well child check on 01/10/2007.  Meeting developmental milestones.  PE: WNL.  Vax given. F/U for hospitalization for atypical febrile seizure, prolonged and recurrent. Assessment:  Complex Febrile Convulsions. Neurology Consult with assessment of Atypical Febrile Seizures. F/U with PCP 3/19/07-no further seizures reported.  MR received from hospitalization of 3 days for fever and seizure activity x 2.  With the first seizure, the child had a temp of 103.8 ax., and consisted of twitching involving the entire body.  This lasted ~20 minutes and resolved.  Post-ictal for ~20 minutes. 2nd similar seizure in the morning which lasted ~ 40 minutes. To ER via EMS in status epilepticus. Txd with Ativan, Cerebyx, phenytoin and antibiotics. Discharge DX: 1) Status epilepticus, resolved. 2) Seizure disorder. 3) Asthma. 4) Febrile illness.  R/o sepsis.
Age: 1.04
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Pyrexia, Urine analysis
Clinical narrative: One week later, patient ran a very high fever within a matter of a few minutes which caused a seizure to occur. During seizure patient was convulsing. Seizure and fever took place around midnight exactly one week after he received vaccinations of MMR, chickenpox, influenzae type b, dtp and pneumococcal conjugate. Within 10 minutes the seizure had stopped and the fever dropped to normal. The following morning, patient started to get another fever and then had another seizure around 9:30 am, at which point we took him to the ER. The administered some medicine to stop the seizure and ran some tests and then sent us to Hospital to be examined further, where we stayed for 3 days.  04/03/2007 MRs received from PCP for well child check on 01/10/2007.  Meeting developmental milestones.  PE: WNL.  Vax given. F/U for hospitalization for atypical febrile seizure, prolonged and recurrent. Assessment:  Complex Febrile Convulsions. Neurology Consult with assessment of Atypical Febrile Seizures. F/U with PCP 3/19/07-no further seizures reported.  MR received from hospitalization of 3 days for fever and seizure activity x 2.  With the first seizure, the child had a temp of 103.8 ax., and consisted of twitching involving the entire body.  This lasted ~20 minutes and resolved.  Post-ictal for ~20 minutes. 2nd similar seizure in the morning which lasted ~ 40 minutes. To ER via EMS in status epilepticus. Txd with Ativan, Cerebyx, phenytoin and antibiotics. Discharge DX: 1) Status epilepticus, resolved. 2) Seizure disorder. 3) Asthma. 4) Febrile illness.  R/o sepsis.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pyrexia
Clinical narrative: Developed a fever of 104.8 1 week after the MMR, Chickenpox, Hepatitis A vaccines. Treated him at home.  Fever went down.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia
Clinical narrative: January 2006, I had an adverse reaction due to the 2nd Anthrax shot.  I had conditions of numbness to my right upper torso, my right shoulder, my right arm, and my right hand.  I was taken to the Medical Center's emergency and monitored for 24 hours, this happened approximately 6 hours after receiving the shot.  I was then released and continued to be treated for the numbness.  Some time in February 2006 I was giving a nerve test and was cleared Fit For Duty, but the numbness on my right hand did not go away (Today's date is 24March2007).
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Body temperature increased, Diarrhoea, Vomiting
Clinical narrative: Vommiting and watery diarrhea. Temp 100.4 Supportive Care.
Age: 46.0
Sex: F
Vaccine: DTOX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: 32 hours after injection, aching pain in upper arm and difficulty to use the muscle of the upper arm
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Memory impairment
Clinical narrative: Forgetting things, sometimes strong headache
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: She received the immunization at school - broke out in hives the day after. Urticaria
Sex: M
Vaccine: HEP, HIBV
Symptoms: Crying, Urticaria
Clinical narrative: Information has been received from a consumer concerning her son, with no known medical history who on an unspecified date was vaccinated with a dose of Recombivax HB (manufacturer unknown). Concomitant vaccination including PedvaxHib (manufacturer unknown). Subsequently the patient experienced a large welt on his leg and cried when the area was touched. No laboratory tests were performed. No further information was available. It was reported that at 20 months of age, the patient experience adverse experiences following vaccination with MMR II (WAES # 0603USA02303).
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Expired drug administered, Fatigue, Headache, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old male with no known medical history or allergies who on 16-JUN-2006 at 13:45 was vaccinated IM in the deltoid with a first dose of Recombivax HB (lot # 647274/0426P). There was no concomitant medications or illness at the time of vaccination. It was reported that the vaccine expired "3 weeks earlier". He did not display any immediate symptoms. On 19-JUN-2006 the patient's father called the pediatrician to report that the patient had a headache and was experiencing nausea. Unspecified medical attention was sought. At the time of the report the patent had not recovered. There was no product complaint involved. Additional information indicated that the vaccine expired by "2 weeks". On 17-JUN-2006 at approximately 17:00 the patient experiencing fatigue, nausea and headache. The patient's recovery status was unknown. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Neuropathy peripheral, Rash, Rash macular, Vasculitis
Clinical narrative: Information has been received from manufacturer for hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) and was assigned manufacturer report number A0609599A. This report concerns a 27 year old male who in 2002 was vaccinated with hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). On an unspecified date in 2002, less than one year after vaccination, the patient developed "vasculitits or skin eruptions like red blotches" on the trunk and arms, and peripheral neuropathy. The patient was seen at the Physician's office and was treated with steriods and colchicine. As of 19 Jun 2006 the events were ongoing. Vasculitis was assessed as medically serious. This was originally reported by a physician. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with penicillin, sulfonamide, and cephalosporin allergies and no other dates was vaccinated with a first and second dose of Recombivax HB (yeast). After the first and second doses, on unspecified dates, the patient reported that she was sore, "as if someone had hit her in the arm. On 17-JUL-2006, the patient was vaccinated IM with a third dose of Recombivax HB (yeast) (lot # 652711/1213R). It was noted that the patient received two 0.5 mL pediatric doses. Concomitant therapy included Ortho-Cyclen. Within six hours of vaccination, the patient developed a dull ache. Within 12 to 16 hours, swelling developed around the injection site. Other symptoms included warmth, pain, and erythema on the left deltoid. Unspecified medical attention was sought. The patient's white blood cell count was 9400. Compresses were used to relieve the swelling. At the time of the report, the patient was recovering. The nurse requested a lot check. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. The patient's experiences after the third dose of vaccine were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pain in extremity, Skin warm, White blood cell count normal
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with penicillin, sulfonamide, and cephalosporin allergies and no other dates was vaccinated with a first and second dose of Recombivax HB (yeast). After the first and second doses, on unspecified dates, the patient reported that she was sore, "as if someone had hit her in the arm. On 17-JUL-2006, the patient was vaccinated IM with a third dose of Recombivax HB (yeast) (lot # 652711/1213R). It was noted that the patient received two 0.5 mL pediatric doses. Concomitant therapy included Ortho-Cyclen. Within six hours of vaccination, the patient developed a dull ache. Within 12 to 16 hours, swelling developed around the injection site. Other symptoms included warmth, pain, and erythema on the left deltoid. Unspecified medical attention was sought. The patient's white blood cell count was 9400. Compresses were used to relieve the swelling. At the time of the report, the patient was recovering. The nurse requested a lot check. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. The patient's experiences after the third dose of vaccine were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received concerning a 43 year old male with no known history or allergies who on 25-JUL-2006 at 10:05 was vaccinated IM in the right arm with a third dose of Recombivax HB (lot#653786/0185F). There was no illness at the time of vaccination. On 26-JUL-2006 the patient developed right arm numbness up into the neck with right arm redness and swelling and tenderness at the injection site. At the time of report the patient was going to see his doctor. No further information was available. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: HEPA, IPV, TYP, HEPA, IPV, TYP, HEPA, OPV, TYP
Symptoms: Drug hypersensitivity, Erythema, Rash pruritic
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a 51-year-old male subject who was vaccinated with Havrix, for prophylaxis. The subject has a history of Neomycin allergy (allergist tested and identified after the fact) and no history of adverse events following previous vaccination. Concurrent vaccination given on the same day as Havrix, 23 February 2003, included OPV and Typhoid (manufacturer not provided). On 23 February 2006 the subject received 2nd dose of Havrix at 1440 elisa units, intramuscularly in the left deltoid. The lot number and expiration date for Havrix were not reported. A few days after vaccination with Havrix, the subject developed a rash under bot arms, chest, back, around the waist, behind the left knee and on the right calf. At the time of reporting the event was unresolved. It was unknown if the rash was associated with the Havrix vaccination.
Age: 51.0
Sex: M
Vaccine: HEPA, IPV, TYP, HEPA, IPV, TYP, HEPA, OPV, TYP
Symptoms: Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a 51-year-old male subject who was vaccinated with Havrix, for prophylaxis. The subject has a history of Neomycin allergy (allergist tested and identified after the fact) and no history of adverse events following previous vaccination. Concurrent vaccination given on the same day as Havrix, 23 February 2003, included OPV and Typhoid (manufacturer not provided). On 23 February 2006 the subject received 2nd dose of Havrix at 1440 elisa units, intramuscularly in the left deltoid. The lot number and expiration date for Havrix were not reported. A few days after vaccination with Havrix, the subject developed a rash under bot arms, chest, back, around the waist, behind the left knee and on the right calf. At the time of reporting the event was unresolved. It was unknown if the rash was associated with the Havrix vaccination.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Stomach discomfort
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 3-year-old female subject who was vaccinated with Havrix, for prophylaxis. A physician or other health care professional has not verified this report. Subject was born 4 weeks premature. Past medical history of fever with Infanrix and Daptacel. On 18 September 2006 the subject received 1st dose of Havrix. It was reported that no other vaccinations were administered on 18 September 2006. On 19 September 2006, the subject experienced fever and upset stomach. The subject was seen in an emergency department and her fever was 104 degrees Fahrenheit. She was treated with alternating doses of ibuprofen and acetaminophen. At the time of initial reporting, 22 September 2006, the fever ad upset stomach persisted.
Age: 2.0
Sex: U
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Alopecia, Alopecia effluvium
Clinical narrative: This case was reported by a mother of a consumer and described the occurrence of hair loss in a 2-year-old subject of unspecified gender who was vaccinated with Havrix, for prophylaxis. A physician or other health care professional has not verified this report. The subject has no significant medical history or concurrent conditions. Concurrent vaccination included Varivax given on the same day as Havrix, 31 August 2006. On 31 August 2006 at 12:30 the subject received 1st dose of Havrix at 0.5 ml. About 1 month after vaccination with Havrix, the subject experienced hair loss and was later diagnosed with telogen effluvium. At the time of reporting the events were unresolved.
Age: 2.0
Sex: U
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Alopecia, Blood test, Full blood count, Liver function test, Thyroid function test
Clinical narrative: This case was reported by a mother of a consumer and described the occurrence of hair loss in a 2-year-old subject of unspecified gender who was vaccinated with Havrix, for prophylaxis. A physician or other health care professional has not verified this report. The subject has no significant medical history or concurrent conditions. Concurrent vaccination included Varivax given on the same day as Havrix, 31 August 2006. On 31 August 2006 at 12:30 the subject received 1st dose of Havrix at 0.5 ml. About 1 month after vaccination with Havrix, the subject experienced hair loss and was later diagnosed with telogen effluvium. At the time of reporting the events were unresolved.
Age: 2.0
Sex: U
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Urine analysis
Clinical narrative: This case was reported by a mother of a consumer and described the occurrence of hair loss in a 2-year-old subject of unspecified gender who was vaccinated with Havrix, for prophylaxis. A physician or other health care professional has not verified this report. The subject has no significant medical history or concurrent conditions. Concurrent vaccination included Varivax given on the same day as Havrix, 31 August 2006. On 31 August 2006 at 12:30 the subject received 1st dose of Havrix at 0.5 ml. About 1 month after vaccination with Havrix, the subject experienced hair loss and was later diagnosed with telogen effluvium. At the time of reporting the events were unresolved.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site atrophy, Muscle atrophy, Rash erythematous
Clinical narrative: Initial report received on 15 March 2007 from the patient. A 49-year-old female patient who had no concurrent illnesses, and medical history of allergies to Tylenol with Codeine and Keflex, and who was taking Tamoxifen, had received a fifth, left arm intramuscular injection of FLUZONE SV '2006-'2007 USP, lot number U2275AA, on 10 November 2006 at 06:30 a.m. Approximately 48 hours post-immunization, around 18:30 p.m. on 12 November 2006, the patient developed a raised red rash under the armpit (also reported as under affected arm) that lasted three days. Ninety-six hours post-immunization, the patient noticed an indentation of "armpit" (also reported as "3" x 1" indentation in arm") and one week later, she experienced deltoid muscle atrophy in that area. The patient provided pictures of her "left upper arm". The patient reported that she had experienced any other adverse events with prior flu vaccinations and had not received any other vaccinations within four weeks of the vaccination on 10 November 2006. The patient indicated that she had been evaluated by her primary care physician so she could obtain referrals to a physical therapist, rheumatologist, and dermatologist. At the time of this report, the patient was being evaluated by an orthopedist. Treatment received and diagnostic testing's performed were not reported. The patient has not recovered.
Age: 0.31
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from agency through another agency reported concerning a 17-week-old male with mild hydrocephalus on 18-JAN-2007, at 1330, was vaccinated PO with the first dose of Rotateq (Lot #654248/0577F). Concomitant vaccinations administered on that same day and time included the first IM dose on the left leg of PEDIARIX (Lot #AC21B084BA), the first IM dose in the left leg of HIBERIX (Lot #UF025AA) and the first IM dose in the right leg PREVNAR (Lot #B08691B). There was no illness or other concomitant drug therapy at the time of vaccination. On the morning of 25-JAN-2007, the patient was found dead in his crib. No symptoms were reported prior to the patient's death. The records of testing prior to releaser of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the Center for Biologics and Research and was released by the regulatory agency. No further information is available.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: Information has been received from the agency through another agency reported concerning a male who on 29-DEC-2006 was vaccinated with the first oral dose Rotateq (Lot #655317/0980F). Concomitant vaccine administered on that same day included intramuscular dose in the left leg of PEDIARIX (Lot #AC21B070AA), first intramuscular dose in the lower leg of PEDVAXHIB (Lot #654071/0658F) and first intramuscular dose in the right leg of PREVNAR (Lot #B08674F). On 23-FEB-2007 the patient developed intussusception which was successfully reduced by barium enema. The child did well following reduction with significant sequalae. Relevant diagnostic tests and laboratory data included X-rays and barium enema. Subsequently, the patient recovered from intussusception. The event was considered to be immediately life-threatening and required hospitalization. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the Center for Biologics and Research and was released by the regulatory agency. Additional information has been requested.