chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Local reaction
Clinical narrative: 5" X 3" area erythema left upper arm lateral aspect at site of Pneumovax. Rx: Cipro, infirmary admit, Prednisone 20mg BID x 4 days. Diagnosis: local reaction secondary to Pneumovax, allergic reaction. Chart label allergic to Pneumovax. Resolved completely by 6/11/07 followup appointment.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling of left lateral upper thigh (11 x 11cm) and redness, warm to touch, slight induration centrally. Seen again 11/12/07 with increase in size to 11 x 16cm.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Blister, Erythema, Injection site swelling, Pyrexia, Skin lesion
Clinical narrative: Swelling of arm (r) from elbow to shoulder, fever (100.2), warm to touch, blister/ lesion in the center of the red swollen area.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Skin warm
Clinical narrative: Swelling of arm (r) from elbow to shoulder, fever (100.2), warm to touch, blister/ lesion in the center of the red swollen area.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Approx 24 hours after Varivax given patient had onset of redness and swelling at site of Varivax. We saw patient back in office 2 days after Varivax given a 8 x 9cm erythema with 5 x 6cm area of induration / more sig. erythema and advised to take Advil 900mg TID. Dx: Local reaction to Varivax.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site induration, Personality change, Pyrexia
Clinical narrative: Hard knot at injection site; whole personality changed day after shot; fever spiked and stayed up for several days (102.7 degrees) took 2 weeks + to return to normal.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Pallor, Skin warm, Swelling
Clinical narrative: Local reaction left posterior arm. Moderate swelling warmth, blanching erythema medical to vaccine site. Increase vascular markings.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Diarrhoea, Rash, Urticaria
Clinical narrative: Patient developed rash reported in early am hours of 7/7/07. Patient seem 7/7/07 diagnosed with hives vs erythema multiforme. Patient received diagnosis of hives after phone calls from patient's mother stating rash would resolved then return. Treated with Atarax 7/10/07. Rotateq given 7/2/07 diarrhea, also noted.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, hot to touch. Tylenol 5ml PO now. Bactrim 400 80mg tabs 2 tsp PO BID start 7/11/07 Benadryl.
Age: 9.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Inappropriate schedule of drug administration, Oedema peripheral, Pyrexia, Wrong drug administered
Clinical narrative: Right arm very swollen, low grade fever.
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram normal, Grimacing
Clinical narrative: Infant developed seizures (facial grimacing) and arm movements within a week of administration of DTaP.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Cellulitis left arm 4", Cleocin 300mg TID x 10 days.
Age: 1.8
Sex: M
Vaccine: DTAP
Symptoms: Decreased activity, Decreased appetite, Irritability, Pyrexia
Clinical narrative: Fever, irritability, fatigue, decreased activity and appetite for 4 - 8 days after receiving DTaP. Child has history of immunodeficiency (IgG and IgA). Was given DTaP on 6/22/07. Prior to that patient was given DT on 5/22/07 and 12/28/06, 3/28/06, 1/20/06, 11/24/05
Age: 75.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Pain
Clinical narrative: Excruciating pain on left side from buttock to toe.
Age: 75.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Bone pain, Erythema, Herpes zoster, Laboratory test, Skin lesion
Clinical narrative: Excruciating pain on left side from buttock to toe.
Age: 1.8
Sex: F
Vaccine: DTAP, HBHEPB, HEPA
Symptoms: Erythema
Clinical narrative: Vaccines given 7/5/07 at well child exam within 24 hours LUT with red circle, later worse. Seen in clinic 7/9/07 was beginning to improve, no sign of local infection seen. (Also just starting URI sx).
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Convulsion, Otitis media acute
Clinical narrative: Well child visit where child received imm. on 6-13-07. On 6-20-07 child had seizures and was transported to ER - CXR and urine (-) child sent home, 2 days later had seizure and upon to ER found acute otitis media. Treated will amoxicillin. At conclusion of antibiotic a 3rd seizure occurred. ER changed to a different antibiotic Augmentin. I have referred patient for neurology consult.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Coordination abnormal, Rash
Clinical narrative: Ataxia and rash day 7 after MMR and VZV administration. No treatment. Resolved after 2 days.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right arm swelled from shoulder to elbow area and redness extended from shoulder to distal area of humerus to just above elbow. Motrin was given, which helped reduce swelling somewhat. Benadryl treatment was suggested on 7/4/07 at the visit.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Developed hives on wrist within 5 minutes of Hep A #2 vaccines. Received Benadryl and hives progressed to face and other wrist. Received Prolone and observed for 1 hour with resolution of symptoms. No facial swelling, no wheeze, no shortness of breath.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity
Clinical narrative: Arm pain.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Abasia
Clinical narrative: Mom called at 440pm - stated son had imm 7/5/07 and now would not walk -, no swelling, no redness, no bruising
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Large local reaction 1.75 x 1.25 erythema and induration.
Age: 0.6
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: After taking off the band aid we noticed a red bump left to the injection site on the left thigh. Warm to touch and leg is sore. Redness is 3 x 11/2 cm.
Age: 1.2
Sex: M
Vaccine: HBHEPB
Symptoms: Injection site bruising, Injection site mass
Clinical narrative: On 6-25-07, patient returned to office for additional vaccines. Mother informed us of a knot with bruising at site. Doctor examined the area. Advised mom to watch it and put some ice on it, call in 2 - 3 days if not better.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Rash macular, Urticaria
Clinical narrative: Received shots. One hour later mom returned to office. Child with red, blotchy, hivey rash to both calves.
Age: 27.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: "Feeling itchy all over" and reports rash in arm pits and on legs. Sent her to hospital ER. She also reported her skin was red all over. IV med given and discharged with Prednisone and Benadryl x 3 days.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC
Symptoms: Heat therapy, Oedema peripheral, Pain in extremity
Clinical narrative: Right arm upper area swelling pain check by doctor no meds needed, hot compressions needed only.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Allergy test negative, Eye swelling, Pruritus, Rash generalised, Urticaria
Clinical narrative: Child received normal 15 months imm's at check up on 6/28/07 (DTaP/ HIB/ Prevnar) along with (MMR) catch up (refused before). 1 Hour after appointment itchy, eyes, swollen, ears very swollen. Rash all over. Diffuse hives head to toe. Benadryl given script, given for Orapred but never used, rash gone the next day. * Used just Benadryl.
Age: 43.0
Sex: F
Vaccine: HEP, TD, UNK
Symptoms: Dizziness, Pyrexia
Clinical narrative: Patient received Td in left deltoid and Hepatitis B #1 in right deltoid IM on 7/16/07 at 11:20am; no local reaction after 30 minutes went. Patient called 7/17/07 at 1330 - c/o dizziness and fever of 102.2 since 0530 that AM. Denied diarrhea, vomiting or rash. Temp at 1340 = 101.7. NP advised to come to clinic for observation.  Patient refused, advised patient to go to ER immediately if symptoms worsen. Patient - NP tried to call patient at 1900. Patient called back - feeling better, temp 99.0 and not dizzy. Follow-up on 7/18 no local reaction at site and no complaints per patient.
Age: 59.0
Sex: M
Vaccine: TDAP, UNK
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Patient was given Tdap and PPD for employee health on 7-16-07. Presented today with c/o systemic bodyaches, nausea, chills, per patient had fever, and fatigue. No erythema at injection site pain at Tdap injection site.
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Pain, Pruritus
Clinical narrative: Itchy and painful 6 cm x 4 cm
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Depressed level of consciousness, Hypotonia, Hypoventilation, Vomiting
Clinical narrative: Vomited. Became limp and could not wake up. Shallow breathing.
Age: 1.3
Sex: M
Vaccine: DTAP, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Developed fever 102.5 at 1 AM and had a seizure lasting under 1 min. Otherwise doing well.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Pruritus, Stomach discomfort, Urticaria
Clinical narrative: 7-12-07 - employee c/o itching immediately after injection. After 20 min. no worsening - actually improved. Employee went home. 7-19-07 / 4:00 Employee calls to say that on 7-12-07 2-3 hours after inj. c/o itching and hives - took her Allegra, went home from work - had stomach upset and diarrhea - resolved by morning 7-13-07.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis left deltoid.
Age: 1.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Pyrexia, Somnolence, Unresponsive to stimuli
Clinical narrative: Low grade fever, somnolence, unconsolable crying x 1-2 hours, not responding to parents
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 6-13-07 Patient received Td right deltoid. Patient was given antibiotic for cellulitis of toe/wound also. 6-22-07 Patient reported redness and swelling of right arm where Td was given; seen by doctor here - 11 cm induration and redness - resolved
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Confusional state, Pain, Rash pruritic
Clinical narrative: Rash, itching/Painful. 7/14-07. Pt confused night of 7-13-07
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site abscess
Clinical narrative: Sterile abscess at injection site
Age: 1.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Child had swollen left thigh and the area was red and warm. Child was seen by Doctor on 7/18/07 and was prescribed Keflex antibiotic and recommended warm soaks.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: DTaP and IPOL given right deltoid 7/2/07 AM. By 7/2/07 PM mother noted swelling of right arm from shoulder to elbow. Redness and warmth developed by Tuesday 7/3. Mother took child to Doctor on 7/5. Pt saw NP who gave client PO antibiotic per mom.
Age: 66.0
Sex: F
Vaccine: DT, HPV4, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Zostavax vaccine given SC was mistakenly diluted by nurse with Gardisil vaccine instead of sterile diluent.Given 7/18/2007 at about 2 pm. Patient notified. Has had no problems resulting from this.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: On 7/17/07 patient diagnosed with shingles and pain. Information has been received from a nurse concerning a 74 year old female with history of Hodgkin's disease and chemotherapy, six years ago, who on 04-JAN-2007 was vaccinated SC on the left arm with a first dose of ZOSTAVAX (Merck) (lot# 652947/1411F). Concomitant therapy included lovastatin (manufacturer unknown). FLOSNASE. ALLERGA. GLUCOPHAGE. On 17-JUL-2007 the patient developed shingles on the first flank area. At the time of the report the shingles was spreading. Medical attention was sought and treatment included DEMEROL for pain, DARVOCET and VALTREX. At the time of the report the patient had not recovered. No additional information was provided. There was no product quality complaint involved. Additional information from another nurse indicated that the patient was enrolled in the program: the program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the OKA/Merck vaccine VZV strain. The specimen was collected by the physician and was being sent for evaluation. Follow up information was received it was reported that the PCR sample was damaged during delivery and the HCP would not be resending another sample. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: On 7/17/07 patient diagnosed with shingles and pain. Information has been received from a nurse concerning a 74 year old female with history of Hodgkin's disease and chemotherapy, six years ago, who on 04-JAN-2007 was vaccinated SC on the left arm with a first dose of ZOSTAVAX (Merck) (lot# 652947/1411F). Concomitant therapy included lovastatin (manufacturer unknown). FLOSNASE. ALLERGA. GLUCOPHAGE. On 17-JUL-2007 the patient developed shingles on the first flank area. At the time of the report the shingles was spreading. Medical attention was sought and treatment included DEMEROL for pain, DARVOCET and VALTREX. At the time of the report the patient had not recovered. No additional information was provided. There was no product quality complaint involved. Additional information from another nurse indicated that the patient was enrolled in the program: the program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the OKA/Merck vaccine VZV strain. The specimen was collected by the physician and was being sent for evaluation. Follow up information was received it was reported that the PCR sample was damaged during delivery and the HCP would not be resending another sample. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DPP, FLUX, HEP, MMR, OPV, PPV, RVX, VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Irritability, Malaise
Clinical narrative: Legs swollen where injection administered, raised red lump about an inch long and half a centimeter high.  Madison was acting fussy and cranky, like she wasn't feeling well and in slight discomfort.  We gave her baby Tylenol a couple times.
Age: 0.22
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Bacteraemia, Convulsion, Full blood count, Pyrexia, Urine analysis
Clinical narrative: Fever and seizures. Patient was admitted to hospital on 7/17/07 to Dr. with the diagnosis of Bacteremia and Seizure. Initial treatment was: Rocephin 125 mg IVPB Q12 hrs, Tylenol 80 mg Q4hrs x3 then prn for fever. 8/8/07-records received for DOS 7/18-7/21/07 DC DX: UTI, Sepsis. Admitted with high fever and seizure Temp in ER 103.4 (R).
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray, Laboratory test, Pain, Pyrexia
Clinical narrative: high fever and severe sternum pain
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: DTaP was administer to Right arm on 07-17-07, and returned to clinic on 07-19-07, and right deltoid area was firm to touch and extra warm, reddish in color and complain of itching. vaccine used: Infarix.  Referred to a clinic or family care center to be seen today by a Physician.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthenia, Vomiting
Clinical narrative: patient presented with stomach pains, vomiting and weakness. 8/8/07-records received, DX: acute appendicitis. Seen in ER on 7/17/07-four day history abdominal pain, followed by vomiting two and three days ago. Pain on right side of abdomen. No stool at all in past 3 days.
Age: 13.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient was given a pedarix (Dtap) instead of TD
Age: 27.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Lip blister
Clinical narrative: Clt. received MMR and Tdap vaccine at 10:30am today. Called in to our clinic at 1:15 pm today, reporting "a couple of blisters on her lip". No other symptoms, no trouble breathing.  Reassured client, explained to observe for a more generalized rash, or trouble breathing, if she were to experience any of those, call (911) or go to closest emergency room immediately.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: Mom called the afternoon of 07/18/2007 to report fever and upper right arm swelling.  Immunizations received 07/17/2007 at walk-in immunization clinic from 4:00 - 6:30 PM.  Mom did not have a thermometer to check his temperature but stated he felt very warm.  Treatment with Tylenol, push fluids and cool cloth to right arm.  PHN called mom back 07/19/2007 in AM for follow-up. No longer had fever but upper right arm remains swollen and warm to touch.  Mom continuing Tylenol for discomfort.
Age: 62.0
Sex: M
Vaccine: TD
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 7/16/07 A.M. Received Td vaccine left deltoid 7/16/07 P.M. Noted pain in (L) arm, chills, aches; did not sleep well. 7/17/07: Noted red, raised area around shot site; aches chills at night continued; did not sleep well.  7/18/07: returned to health center; Temp= 101.3F.  Area around injection site 3" diam red, indurated, warm to touch.  Given Ibuprofen 600 mg. P.O.  7/18/07: returned to health center; Temp+ 98.8F.  Left upper arm swelling decreased, induration decreased.  No chills or aciness last night.  Slept well.  Denies any previous reaction to Td immunization.
Age: 62.0
Sex: M
Vaccine: TD
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: 7/16/07 A.M. Received Td vaccine left deltoid 7/16/07 P.M. Noted pain in (L) arm, chills, aches; did not sleep well. 7/17/07: Noted red, raised area around shot site; aches chills at night continued; did not sleep well.  7/18/07: returned to health center; Temp= 101.3F.  Area around injection site 3" diam red, indurated, warm to touch.  Given Ibuprofen 600 mg. P.O.  7/18/07: returned to health center; Temp+ 98.8F.  Left upper arm swelling decreased, induration decreased.  No chills or aciness last night.  Slept well.  Denies any previous reaction to Td immunization.
Age: 1.08
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Pt. presented with rash on back, face, and behind ears. Mom stated that new lesions keep appearing. Pt. positive for itching, negative for temp., negative for n/v/d.  Mom states rash began on 7/17/2007.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Rash pruritic
Clinical narrative: Rash with puritis started 7/18/2007. Initially mother thought they were bug bites. Mother describes as red raised bumps with white spots in middlesome as big as 1/4" across on arms, legs and back. Benadryl given and not real helpful, decreased itching somewhat. some have faded. Four other siblings had similar reactions. Two had Td, and 2 had DtaP.
Age: 10.0
Sex: U
Vaccine: TD
Symptoms: Erythema, Rash pruritic
Clinical narrative: Rash with puritis started 7/18/2007. Initially mother thought they were bug bites. Mother describes as red raised bumps with white spots in middlesome as big as 1/4" across on arms, legs and back. Benadryl given and not real helpful, decreased itching somewhat. some have faded. four other siblings had similar rash. One receved Td, one Received Tdap, two recevied DTaP
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Rash pruritic
Clinical narrative: Rash with puritis started 7/18/2007. Initially mother thought they were bug bites. Mother describes as red raised bumps with white spots in middlesome as big as 1/4" across on arms, legs and back. Benadryl given and not real helpful, decreased itching somewhat. some have faded. Had four other siblings with similar rash. one received Tdap, two recived TD, one received DTaP
Age: 9.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Rash pruritic
Clinical narrative: Rash with puritis started 7/18/2007. Initially mother thought they were bug bites. Mother describes as red raised bumps with white spots in middlesome as big as 1/4" across on arms, legs and back. Benadryl given and not real helpful, decreased itching somewhat. some have faded. Four other siblings with similar rash. One received Tdap, one Recived Td, and two received DTaP
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Rash pruritic
Clinical narrative: Rash with puritis started 7/19/2007. Initially mother thought they were bug bites. Mother describes as red raised bumps with white spots in middle some as big as 1/4" across on arms, legs and back. Benadryl given and not real helpful, decreased itching somewhat. Some have faded. Client also received Tetnus Diptheria at local hospital on 6/15/07 for an injury. Does not appear that he received gamma globulin at that time.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Client received vaccines on 7-18-07.  Mother returned with child 7-19-07 to report adverse reaction.  DTaP injection site (upper left arm) appears red and swollen from shoulder to elbow.  Child reports minimal discomfort and appears happy and playful.  Reassured mother and educated on pain management and cool compresses.  Sent home with bottle of children's tylenol and instructions for use.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Cellulitis, Erythema, Gait disturbance, Induration, Pain in extremity
Clinical narrative: 13 x 18 area of erythema and induration; mother noted 42 hours after immunization with Hep A #2 and DTaP #4. C/O leg pain and fever the night before and had some limp. Seen 48 hours after immunizations and dx with cellulitis and given cephalexin and ibuprofen and will f/u tomorrow.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Pyrexia
Clinical narrative: 13 x 18 area of erythema and induration; mother noted 42 hours after immunization with Hep A #2 and DTaP #4. C/O leg pain and fever the night before and had some limp. Seen 48 hours after immunizations and dx with cellulitis and given cephalexin and ibuprofen and will f/u tomorrow.
Age: 12.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Erythema, Nausea, Oedema, Skin warm
Clinical narrative: Erythema, Edema, Warmth. Patient experienced nausea. No fever and no temperature.
Age: 49.0
Sex: F
Vaccine: HEPAB
Symptoms: Asthenia, Musculoskeletal pain, Tendonitis
Clinical narrative: Vaccine administered 7/12/07  Pt presented at clinic 7/19/07 with c/o of pain R shoulder extending into neck, down R arm, weakness of grip.  Dx tendonitis, tx NSAIDS, sling, recheck 3 days
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Chills, Fatigue, Malaise, Pyrexia
Clinical narrative: Fever to 102 (oral), malaise, fatigue, chills
Age: 32.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Arthralgia, Inappropriate schedule of drug administration, Injection site pain, Myalgia
Clinical narrative: Muscle ache at site of injection and sore elbow joint of the injected arm. Symptoms started exactly 1 week after the DTaP vaccine and have lasted for approximately 4 weeks.
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Culture, Diarrhoea, Faeces discoloured, Occult blood negative, Pyrexia
Clinical narrative: FEVER, REDDISH COLOR STOOL, DIARRHEA, WITHIN 8 HOURS OF VACCINE.TREATED WITH TYLENOL, FLUIDS.GUAIC NEGATIVE
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: White blood cell count
Clinical narrative: FEVER, REDDISH COLOR STOOL, DIARRHEA, WITHIN 8 HOURS OF VACCINE.TREATED WITH TYLENOL, FLUIDS.GUAIC NEGATIVE
Age: 46.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site pain, Muscular weakness, Myalgia
Clinical narrative: Initial report received from a patient in the USA on 01 March 2007. A female patient (age, date of birth not reported) experienced muscle ache in the arm in which she received an injection of Tetanus Toxoid Absorbed vaccine (lot number U1583AB) in July 2006. She continues to experience the muscle ache. No further information was provided. Follow-up information received on 06 March 2007 from the patient. Tetanus Toxoid Absorbed, lot number U1683AB, was administered intramuscularly in the right arm. Per the reporter, she experienced site soreness with severe muscle aches for four days post-immunization, in July 2006, that was aggravated by flexing her arm. She continues to have muscle aches in the upper and lower right arm. The patient did not receive pain medications for the event. At the time of this report, the patient had not recovered. Follow-up information received on 23 April 2007 from the physician. The event did not require a special visit to the physician's office but was handled in the context of a patient's follow-up for a motor vehicle accident. There was no diagnostic testing needed and no treatment was rendered. Her muscle ache was constant for 2 weeks and then was intermittent. The symptoms were confined to the vaccinated arm only. Continuing symptoms include some ongoing weakness with particular movements
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a health care professional in the USA on 26 March 2007. A 40 year old, female patient (with no known allergies and a history of anxiety) developed localized swelling, redness, warmth, and pain at the site, within 24 hours after she received Tetanus Toxoid Absorbed vaccine (lot number U1715BA) intramuscularly in the right deltoid on 21 March 2007. She also complained of a dull headache at the base of the neck. The patient had a previous dose of Tetanus Toxoid Absorbed vaccine in 1997. She denied any illness at the time of vaccination and was taking Bactrim and Macrodentin. At the time of the report, the symptoms continued to persist and the patient had not recovered. Follow-up information received on 21 May 2007 from a health care professional. It was reported that patient had complete resolution of the adverse events on 11 May 2007. Per the reporter, the case was reviewed and no other additional information is available at this time. No further information is expected.
Age: 47.0
Sex: M
Vaccine: TTOX
Symptoms: Headache, Incorrect route of drug administration, Injection site erythema, Injection site reaction, Injection site urticaria
Clinical narrative: Initial report received on 29/Aug/2006 from a health care professional. A 67-year-old male patient with no current illnesses had received a 0.1 milliliter intra-dermal dose of TET TOX ABS USP, lot number U1289AA< in the left forearm on 18/Mar/2006. The patient was inadvertently administered the TET TOX ADS instead of a PPD test. Two days later, when the patient returned to have the test read he had developed an eight to ten millimeter area of redness, with a dull red spot on the left forearm. The patient reported that he had also experienced a raised red welt, headache and vomiting. This was not previously reported to the facility. The patient was medically evaluated, and a chest x-ray was negative. The patient subsequently received a Mantoux test on 25/Aug/2006 that was negative. The patient recovered from these adverse events. Follow-up information received via telephone on 01 November 2006. Per the reporter, the TET TOX ABS USP vaccine administered on 18 March 2006, was administered subcutaneously. Follow up information received from the reporter on 20 November 2006: The reporter confirmed that the TET TOX ABS USP vaccine (corrected) was given subcutaneously on 18 March 2006. Follow up information received on 07 December 2006. The date of the chest x-ray was 21 March 2006 and it was negative. A corrective version was created with the same latest received date of 07 December 2006 for the sole purpose of amending the coding for the event of medication error to wrong route of administration.
Age: 47.0
Sex: M
Vaccine: TTOX
Symptoms: Rash erythematous, Vomiting
Clinical narrative: Initial report received on 29/Aug/2006 from a health care professional. A 67-year-old male patient with no current illnesses had received a 0.1 milliliter intra-dermal dose of TET TOX ABS USP, lot number U1289AA< in the left forearm on 18/Mar/2006. The patient was inadvertently administered the TET TOX ADS instead of a PPD test. Two days later, when the patient returned to have the test read he had developed an eight to ten millimeter area of redness, with a dull red spot on the left forearm. The patient reported that he had also experienced a raised red welt, headache and vomiting. This was not previously reported to the facility. The patient was medically evaluated, and a chest x-ray was negative. The patient subsequently received a Mantoux test on 25/Aug/2006 that was negative. The patient recovered from these adverse events. Follow-up information received via telephone on 01 November 2006. Per the reporter, the TET TOX ABS USP vaccine administered on 18 March 2006, was administered subcutaneously. Follow up information received from the reporter on 20 November 2006: The reporter confirmed that the TET TOX ABS USP vaccine (corrected) was given subcutaneously on 18 March 2006. Follow up information received on 07 December 2006. The date of the chest x-ray was 21 March 2006 and it was negative. A corrective version was created with the same latest received date of 07 December 2006 for the sole purpose of amending the coding for the event of medication error to wrong route of administration.
Sex: U
Vaccine: TTOX
Symptoms: Pruritus, Rash erythematous, Wrong drug administered
Clinical narrative: Twelve patients had inadvertantly received a 0.1 ml., intradermal administration of Tet Tox ADS USP, lot number UL298AA, "instead of Tubersol", on an unspecified date. Per the reporter, post-administration"the patient's complained of itchiness and red raised swollen areas (the largest area described as 1.5 by 1.5 inches). Recovery status "varies" per the reporter. Additional information was not provided.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Autopsy, Death, Unresponsive to stimuli
Clinical narrative: Pt died unexpectedly and without any known illness. He was previously well and found in the crib unresponsive.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood test, Hypoaesthesia, Nerve conduction studies, Paraesthesia
Clinical narrative: diagnosed with Guillian Barre by neurologist after 1 doses of Gardasil no hospitalization required. 8/15/07-note from neurologist for DOS 6/26/07-Over past two weeks had numbness that started in her feet. States that this is especially prominent in her heels and now has migrated up to hip area. Denies pain denies traums. No weakness but does report a decrease in sensation.  PE: extremties she has 2+ dorsalis pedes and posterior tibial pulses. DTR's are symmetrical and 3+ at the achilles and patella. She has 5/5 muscle strength at hip, knee and ankle. Does report minimal decrease in sensation. Assessment: paraesthesias of lower extremities, etiology unknown. No evidence for the above medications to support paraesthesia. EMG and NCV to be performed.  9/26/07-neurology note received for DOS 7/12/07- Assessment: mild case of Guillain-Barre related to Gardisil vaccination.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Guillain-Barre syndrome, Pregnancy test negative
Clinical narrative: diagnosed with Guillian Barre by neurologist after 1 doses of Gardasil no hospitalization required. 8/15/07-note from neurologist for DOS 6/26/07-Over past two weeks had numbness that started in her feet. States that this is especially prominent in her heels and now has migrated up to hip area. Denies pain denies traums. No weakness but does report a decrease in sensation.  PE: extremties she has 2+ dorsalis pedes and posterior tibial pulses. DTR's are symmetrical and 3+ at the achilles and patella. She has 5/5 muscle strength at hip, knee and ankle. Does report minimal decrease in sensation. Assessment: paraesthesias of lower extremities, etiology unknown. No evidence for the above medications to support paraesthesia. EMG and NCV to be performed.  9/26/07-neurology note received for DOS 7/12/07- Assessment: mild case of Guillain-Barre related to Gardisil vaccination.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: diagnosed with Guillian Barre by neurologist after 1 doses of Gardasil no hospitalization required. 8/15/07-note from neurologist for DOS 6/26/07-Over past two weeks had numbness that started in her feet. States that this is especially prominent in her heels and now has migrated up to hip area. Denies pain denies traums. No weakness but does report a decrease in sensation.  PE: extremties she has 2+ dorsalis pedes and posterior tibial pulses. DTR's are symmetrical and 3+ at the achilles and patella. She has 5/5 muscle strength at hip, knee and ankle. Does report minimal decrease in sensation. Assessment: paraesthesias of lower extremities, etiology unknown. No evidence for the above medications to support paraesthesia. EMG and NCV to be performed.  9/26/07-neurology note received for DOS 7/12/07- Assessment: mild case of Guillain-Barre related to Gardisil vaccination.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Erythema, Swelling
Clinical narrative: 11x11 cm area of erythema and swelling with central large vesicles over 3x3 cm base
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Erythema, Induration
Clinical narrative: 11x11 cm area of erythema and swelling with central large vesicles over 3x3 cm base
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Information has been received from a medical assistant through the Merck pregnancy registry concerning an approximately 15 year old female patient with no pertinent medical history or drug reactions/allergies, who in November 2006, was vaccinated intramuscularly with the first dose of Gardasil (0.5 ml). There was no concomitant medication. It was reported that the patient did not receive her second vaccination due to pregnancy. The patient subsequently had a miscarriage. The date of miscarriage was not known. Upon internal review, the miscarriage was felt to be an other important medical event. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Convulsion, Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 year old female with a sulfonamide allergy and no pertinent medical history who on 15-DEC-2006 was vaccinated with a first dose of Gardasil (lot # 654389/0961F) 0.5mL IM in the arm. Concomitant therapy included birth control pills (unspecified). On 15-DEC-2006 the patient fainted immediately after the needle was withdrawn from her arm after receiving Gardasil. The patient experienced a brief loss of consciousness and possible mild seizure activity. Medical attention was sought. Her symptoms resolved in 5 minutes after smelling salts were administered. The patient was very pale and her blood pressure measurement was 60/40 mmHg post vaccination. Prior to vaccination the patient's blood pressure was 110/78mm Hg. The patient has not received her second dose of Gardasil. No further information was available. At the time of reporting the patient recovered from syncope, brief loss of consciousness, decreased blood pressure, possible mild seizure activity and looking pale. Upon internal review, mild seizure activity was determined to be an other important medical event. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 year old female with a sulfonamide allergy and no pertinent medical history who on 15-DEC-2006 was vaccinated with a first dose of Gardasil (lot # 654389/0961F) 0.5mL IM in the arm. Concomitant therapy included birth control pills (unspecified). On 15-DEC-2006 the patient fainted immediately after the needle was withdrawn from her arm after receiving Gardasil. The patient experienced a brief loss of consciousness and possible mild seizure activity. Medical attention was sought. Her symptoms resolved in 5 minutes after smelling salts were administered. The patient was very pale and her blood pressure measurement was 60/40 mmHg post vaccination. Prior to vaccination the patient's blood pressure was 110/78mm Hg. The patient has not received her second dose of Gardasil. No further information was available. At the time of reporting the patient recovered from syncope, brief loss of consciousness, decreased blood pressure, possible mild seizure activity and looking pale. Upon internal review, mild seizure activity was determined to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: DTAP, HEPA, HPV4
Symptoms: Fall, Head injury, Inappropriate schedule of drug administration, Skull X-ray, Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 10-JUL-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy on 10-JUL-2007 included DTaP, tetanus toxoid and Vaqta. On 10-JUL-2007 after the vaccination, the patient was seated for several minutes. When the patient got up to make an appointment, the patient fainted, hit the floor and had a knot on her head. The physician referred the patient to the hospital for the skull X-Rays, results were reported as negative.  At the time of the report the patient was recovering. The physician considered fainting, hitting the floor and had a knot on her head to be an other important medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of Gardasil (lot number unknown). The physician also mentioned that the patient fainted after receiving a first dose of Gardasil but did not have a seizure. On 11-JUL-2007 the patient was vaccinated with a second dose of Gardasil injection and fainted. The physician believes that the patient might have had a seizure as well. Medical attention was sought. The patient was watched for a while after the vaccination and was okay to leave. At the time of reporting the patient is was recovering with therapy (unspecified). No further adverse event information was available. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/19/2007, 9/27/2007. Follow-up information was recieved via telephone from a licensed pratical nurse. On 26-Apr-2007 the patient fainted/passed out about 2 minutes for 5 to 10 seconds after receiving the vaccination while checking out at front desk. There was no seizure activity. The patient hit her head on the concrete floor and had a knot on her head (2 x 2) hematoma after the fall. The patient was given an ice pack. She complained of headache. Her blood pressure was 330/90 after the fall and she was given juice. Later her Blood pressure was 118/78 and she was discharged 1 hour later. The patient had recovered from this event. On 11-Jul-2007 (also reported as 26-Jul-2007) the nurse had the patient sit and lean against he wall prior to her second vaccination. The nurse gave the vaccine and within 2 seconds the patietn had vainted and slid downt he wall. "There was no seizure activity" (preivously reported by physician as "might have had a seizure"). The patient was out for about 5 seconds, she was laid down for approximately 30 minutes while being awake and alert. She was given a cold towel and some water. The patient sat up within 5 minutes she passed out again, was laid back down and the nurse called the physician. The patient was alert and was asked if she knew she passed out. She had no recolleciton of passing out. The patient's father went to get the patient a soda. The patient laid down for approximately 15 minutes, then stood and sat for 15 minutes more. The patient then started to feel dizzy, had a headache and tremors, became nauseous and threw up. The patient sat for 5 minutes more and then felt fine and was discharged. After the patient had vomitted she felt fine and was ready to go. The patient had eaten and was not dehydrated. The doctor was informed that the patient does not drink soda only water and this may have been why she got sick. At 5:05 the patient's blood pressure measurement was 100/76, pulse 54 and at 5:15 pulse was 60. It was unknown if the patient had recoverd as the patient did not call to give her status and the doctor's office has not heard from the patient since the day of the vaccination. No further information  is available.
Sex: F
Vaccine: HPV4
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Information has been received from a physician's assistant concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, in January 2007, the patient developed "Stevens-Johnson syndrome". The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 16 year old female, who on 12-JUL-2007 was vaccinated with a 0.5mL first dose of Gardasil. Concomitant vaccinations included Menactra and DTaP (+) tetanus toxoid. On 12-JUL-2007 after receiving the vaccination, the patient "stood and passed out", experienced a small seizure, regained consciousness and experienced another seizure. The patient went to the emergency room and was admitted to the hospital. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Angioedema, Urticaria
Clinical narrative: Woke up with bilateral angioedema of eyes, hives over entire body. Received Benadryl at home and given a prescription for Atarax
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cyanosis, Pallor, Urticaria
Clinical narrative: Patient received Pediarix, Hib, Prevnar, and Rotavirus vaccines at approximately 1300 on 6/11/07.  Mother reports that patient developed hives at approximately 1600.  He became very pale with blue lips.  He was taken to the Emergency room and evaluated.  He was sent home without medical intervention after observation.
Age: 1.94
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV, IPV, PNC
Symptoms: Rash
Clinical narrative: Mom called HD 6/28/07 And reported "bumps all over her body" this am. Denies fever. States child is eating and taking fluids well.  Mother was advised to have the child evaluated by her physcian.  Mother phoned later and state the physcian told her it was a"possible reaction to Hepatitis A since that was the only new vaccine that she had received". She was instructed by MD to use Benadryl lotion on rash and "to keep and eye on her". She was to go back to MD if rash increased.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: egg-sized swelling at area of vaccine with cervical lymphadenopathy, body aches and fever.  Called nurse line and spoke with on-call physician.  Advised to take ibuprofen and fexofenadine and has improved.
Age: 18.0
Sex: F
Vaccine: HEPAB, HPV4, TDAP
Symptoms: Eye rolling, Moaning, Syncope, Tonic convulsion, Unresponsive to stimuli
Clinical narrative: After receiving 3 of 4 forecasted vaccines, client stated, "I'm going to faint".  She then fainted and had tonic like seizure activity during which time her eyes rolled back and she had periods of moaning. The seizure like activity lasted approximately 2 minutes during which time she was non-responsive to verbal commands.  She was breathing and had a pulse during the entire episode.  After she regained consciousness she was asked about previous seizure history and said she had two seizures in the past.  One was related to a hand injury and the other I am unclear about.  She was placed in a supine position during the incident and allowed to remain there for about 10 minutes after regaining consciuosness.  Client then stayed in a sitting position in 'clinic area' for approximately 20 minutes.  She declined transport to an emergency room.  She left the area with her boyfriend.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Dizziness, Fatigue, Flushing, Pyrexia
Clinical narrative: LIGHT HEADED, FLUSH,DIZZY,FEVER'TIRED,ABD.PAIN
Sex: F
Vaccine: HEPAB
Symptoms: Pyrexia, Viraemia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of viremia in a female subject aged between 30 and 39 years old who was vaccinated with Twinrix for needlestick prophylaxis. In June 2007 the subject received the first dose of Twinrix (1 ml, unknown). At an unspecified time after vaccination with Twinrix, the subject experienced viremia and fever of 103 degrees Fahrenheit. The events persisted for 48 hours. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved. The healthcare professional considered the events were probably related to vaccination with Twinrix.
Age: 13.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Blood glucose increased, Cellulitis, Condition aggravated, Hyperglycaemia
Clinical narrative: Chief complaint Hyperglycemia. Possible exacerbation R/T varicella reaction. Rocephin IV given while hosp. D/T cellulitis R arm.  07/31/2007 MR received for DOS 6/1-2/2007.  Child with 12 year hx of type 1 Diabetes on insulin pump presented with high blood sugars (>500) x 1 week.  Pump site had not been changed as needed q 2 days.  Right upper arm swelling where varivax given.    PE (+) for large goose egg sized bump on the posterior aspect of R upper arm with erythema and warmth.  Impression:  Uncontrolled DM1. Dehydration.  Possible skin infection
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Body temperature increased, Pruritus, Skin lesion
Clinical narrative: Increased number of firm, itchy lesions, low grade temp. Tx: Tylenol, Benadryl. ? Varicella
Age: 12.0
Sex: F
Vaccine: HEP, HEPA, MMRV, MNQ, TDAP
Symptoms: Blood pressure normal, Fall, Head injury, Heart rate normal, Loss of consciousness
Clinical narrative: Client was standing and talking to her mother and passed out falling backward and hitting her head on the floor - hit occipital area.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Local redness covering front of left thigh
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Chest pain, Influenza like illness
Clinical narrative: Flu like symptoms, back pain, chest pain x 1 day
Age: 1.0
Sex: M
Vaccine: MMRV, PNC, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient was in for immunizations today 7/20/07 and was accidentally given ProQuad (MMRV) and Varivax so got double dose of varicella.
Age: 55.0
Sex: M
Vaccine: FLUN3
Symptoms: Anosmia, Nasal congestion, Skin lesion, Wrong drug administered
Clinical narrative: immediate lesions at opening of each nostril, within one week severe head and chest congestion, within 6 weeks - near total loss of smell