chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: MMRV, PNC
Symptoms: Blood culture negative, CSF culture negative, Culture, Petechiae, Pyrexia
Clinical narrative: Petechial Rash and Fever.  Given Ceftriaxone for possible meningococemia. 8/27/07-records received for DOS 7/15-7/17/07-DC DX: Petechial rash possible secondary to MMR vaccination reaction.  presents with 5 day history of rash, fever, bilateral otitis media, diarrhea, lethargic on day of admission and temperature of 103.5. Patient had been chewing on hands more often.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site induration, Pruritus, Skin warm
Clinical narrative: TDAP GIVEN 7/11/07.LEFT DELTOID WITH 6 CM ROUND RED WARM ITCHY AREA. NO HX FEVER. HAD 2CM OF HARDNESS NOTED ABOUT THE INJECTION SITE. AREA HAS SOFTENED FROM FIRST SEVERAL DAYS. DR OBSERVED ARE AND ASKED SHE RETURN IN 1 WEEK IF NOT FURTHER RESOLVED.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Dissociation, Injection site pain, Muscle spasms, Palpitations
Clinical narrative: Pt states that the day of and 2 days following her 3rd HBV vaccine, she experienced muscle spasms and pain at site of admin- L delt. She also had episodes of heart palpitations and a feeling of "spaciness" which self-resolved by the 3rd day post-vaccine.
Age: 4.0
Sex: F
Vaccine: HBHEPB, IPV, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: None; pt was accidently given comvax instead of DTAP.No adverse events reported.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: within 24 hours the patient experienced mild/moderate nausea, mild dizziness and severe headache.  He was treated with ibuprofen 600mg tid.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria, Pyrexia
Clinical narrative: Pt received Pneumococcal vaccine (Pneumovax 23 Merck) Lot 0486U on 7/15, Sunday while she was an inpatient at this institution. Pt was dismissed on 7/16. On Tues 7/17, she called the pharmacy to report hives, " little red bumps", which had appeared that morning at the injection site and that she had had a 100.2 fever overnight. Suggested she take Benadryl if the hives were uncomfortable and to report to her primary care physician
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: s/s L arm was red & swollen, hot to touch.  Advised to apply cool moist towel to area
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Cold compress therapy, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: s/s L arm was red & swollen, hot to touch.  Advised to apply cool moist towel to area
Sex: M
Vaccine: TYP, UNK
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: Vaccinee states he experienced severe itching at the site of the Typhoid IM injection on the evening of the date of vaccination.  After scratching it he states he noticed a small pimple-like appearance to the injection site.  Upon visual inspection today 7/17/07 there is no abnormality noted to the skin at the injection site and vaccinee states itching is resolved.  He also states the IPPD site itched.  Upon inspection there is mild redness to the site but no induration and the itching has resolved.  He states that he has received many IPPD's through his civilian employer and never experiencing this itching on any prior occasion.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC
Symptoms: Injection site erythema, Injection site induration, Oedema peripheral, Pyrexia, Rash
Clinical narrative: she started with a rash about 3 days after the injections, she had a fever as high as 102, redness at the site and a hard lump at the injection site as well and her leg was swollen, symptoms started to subside about 3 weeks later
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Received vaccination on 07/02/2007. Symptoms started on 07/10/2007, went to emergency room on 07/12/2007 and mis-diagnosed with "rib pain", given prescriptions for vicodin and flexeril. On 07/17/2007 was diagnosed with Shingles and given a prescription for Valacyclovir for a 7 day course of therapy.
Age: 46.0
Sex: M
Vaccine: TDAP, TYP, TDAP, TYP
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Pain, Rash
Clinical narrative: Patient reported that approximately 2 days after receiving Typhoid/Typhim-Vi and Tdap/Adacel that he experienced headache, body aches, and a rash on his chest, back, and abdomen, stomach cramps, and an episode of diarrhea, all of which entirely resolved within four days of receiving the injections.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Cold compress therapy, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: 72 yo Male admitted for elective TUR incision of bladder neck contracture.  Procedure accomplished w/o difficulty on 4/13.  Postop course was complicated only by a temp spike to 101.3 following pneumovax injection, which as associated with swollen, painful erythematuous left arm.  That seemed to improve with time and cool packing and patient was discharged to outpatient follow-up on 4/16.  Pneumovax lot number not documented in nursing mar.  07/18/2007 MR received for DOS 4/13-16/2007 for TUR of a bladder neck contracture during which pt received Pneumovax on 4/14/07. Pt spiked a temp up to 101.3 and developed a swollen, painful erythematous L arm which improved over time.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: 72 yo Male admitted for elective TUR incision of bladder neck contracture.  Procedure accomplished w/o difficulty on 4/13.  Postop course was complicated only by a temp spike to 101.3 following pneumovax injection, which as associated with swollen, painful erythematuous left arm.  That seemed to improve with time and cool packing and patient was discharged to outpatient follow-up on 4/16.  Pneumovax lot number not documented in nursing mar.  07/18/2007 MR received for DOS 4/13-16/2007 for TUR of a bladder neck contracture during which pt received Pneumovax on 4/14/07. Pt spiked a temp up to 101.3 and developed a swollen, painful erythematous L arm which improved over time.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: red, hot, swollen bump at site of injection, starting to show a day or two after injection, reported to us 4 days after injection.
Age: 24.0
Sex: F
Vaccine: DT, UNK
Symptoms: Injection site cellulitis, Injection site lymphadenopathy
Clinical narrative: cellulitis at site w lymphadenopathy
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, RV5, UNK
Symptoms: Blood test, Chapped lips, Chest X-ray normal, Immunoglobulins, Kawasaki's disease
Clinical narrative: Fever/ throat infection began on 1/25/07.  Fever lasted for more than 5 days.  Rash developed on 1/27, lips were cracked and ulcers appeared inside and on mouth.  Blood tests ran on 1/29/07.  Sed rate above normal (30 on 1/29; increased to 81 by hospital admission).  Diagnosed with Kawasaki Disease and admitted to hospital on 1/30/07.  IVIG was given that night, baby released on 1/31/07.  07/30/2007 MR received for hospital DOS 1/30-31/2007.  Child initially presented to PCP 1/25/07 with fever and pharyngitis.  Conjunctivae were noted to be slightly red at that time. Cheilosis, mouth ulcers, rash and persistant fever were noted several days later and child was refered to ER with possible DX of Kawasaki's Disease. PMH: none.  Admitting DX:  Atypical Kawasaki. Addendum: Cardiology consult and echocardiogram mentioned in H&P, however TC to MR dept says there is no record of either.  TC to PCP office and request sent for any cardiology consults. 07/31/2007 cardiac consult received for OV and echocardiogram on 4/9/07 in F/U for Kawasaki disease.  Post treatment child had normal R & L coronary arteries. PE WNL.  EKG normal for age. Echo with normal intracardiac relationship, normal L & R coronary arteries, normal biventricular systolic function
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, RV5, UNK
Symptoms: Mouth ulceration, Pharyngitis, Pyrexia, Rash, Red blood cell sedimentation rate increased
Clinical narrative: Fever/ throat infection began on 1/25/07.  Fever lasted for more than 5 days.  Rash developed on 1/27, lips were cracked and ulcers appeared inside and on mouth.  Blood tests ran on 1/29/07.  Sed rate above normal (30 on 1/29; increased to 81 by hospital admission).  Diagnosed with Kawasaki Disease and admitted to hospital on 1/30/07.  IVIG was given that night, baby released on 1/31/07.  07/30/2007 MR received for hospital DOS 1/30-31/2007.  Child initially presented to PCP 1/25/07 with fever and pharyngitis.  Conjunctivae were noted to be slightly red at that time. Cheilosis, mouth ulcers, rash and persistant fever were noted several days later and child was refered to ER with possible DX of Kawasaki's Disease. PMH: none.  Admitting DX:  Atypical Kawasaki. Addendum: Cardiology consult and echocardiogram mentioned in H&P, however TC to MR dept says there is no record of either.  TC to PCP office and request sent for any cardiology consults. 07/31/2007 cardiac consult received for OV and echocardiogram on 4/9/07 in F/U for Kawasaki disease.  Post treatment child had normal R & L coronary arteries. PE WNL.  EKG normal for age. Echo with normal intracardiac relationship, normal L & R coronary arteries, normal biventricular systolic function
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, VARCEL
Symptoms: Pain, Pyrexia, Surgery, Swelling
Clinical narrative: 1st shot 3 days later swelling, fever, in right   arm & breast  next week later surgery     2 month later had nurse to put in     opposite arm swelling reaction from        neck down on left side lots of pain    no one told us of these side affects.  8/13/2007 MR received for ER visit 7/17/2007 for c/o swelling and tenderness in L deltoid.  PE (+) minimal induration at injection site and tenderness to palpation of the L back. DX: Local reaction to vaccination.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, VARCEL
Symptoms: Discomfort, Injection site swelling, Injection site warmth, Pain
Clinical narrative: 1st shot 3 days later swelling, fever, in right   arm & breast  next week later surgery     2 month later had nurse to put in     opposite arm swelling reaction from        neck down on left side lots of pain    no one told us of these side affects.  8/13/2007 MR received for ER visit 7/17/2007 for c/o swelling and tenderness in L deltoid.  PE (+) minimal induration at injection site and tenderness to palpation of the L back. DX: Local reaction to vaccination.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and low grade fever started 8 days after 1 year shots.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema multiforme, Full blood count, Haematocrit, Haemoglobin, Herpes simplex serology
Clinical narrative: Erythema Multiforme 12 days post Gardasil vaccine. Eruptions started on 10 day post vaccine
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Mononucleosis heterophile test, Red blood cell sedimentation rate
Clinical narrative: Erythema Multiforme 12 days post Gardasil vaccine. Eruptions started on 10 day post vaccine
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness
Clinical narrative: Pre faint in parking lot
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Eye swelling, Wheezing
Clinical narrative: Patient states the morning after Tdap administer she awoke with right eye swollen - took a Benadryl with no change went to MD - by now, both eyes swollen and she was wheezing - took "breathing treatment" with no change to where she received "a shot' - stayed overnight, better now. Was told "probable reaction to preservatives".  08/03/2007 MR received for ER visit DOS 7/10/07 for c/o worsening eyelid swelling, wheezing and cough. PE (+) for Swollen eye lids, red forehead, nasal bridge swollen. Assessment: Allergic reaction to Td. Anaphylaxis NOS. Elevated BP without DX of HTN.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: urticaria developed 7/16. pt seen in clinic 7/17 and Tx with Benadryl
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Eczema, Rash papular, Rash vesicular
Clinical narrative: Hx of Eczema 30 Lesions on trunk and proximal extremities most papular erythematous, but few vesicular lesions
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Pyrexia, Rash, Rubella
Clinical narrative: 8 days post vaccine developed fever x 1 day then exanthem c/w Rubella
Age: 63.0
Sex: M
Vaccine: TYP
Symptoms: Chills, Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Po Typhoid: 7/10-pill #1- no problems 7/12-pill #2- no problems 7/14-pill #3 -extreme exhaustion, fever, chills, N/V  felt better 7/15 7/16: pill#4: fever, chills, N/V, fatigue: not as severe as 7/14 Today 7/17: feeling better
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Pyrexia, Swelling
Clinical narrative: Pt with swollen, red and feverish arm to the outer 1/3 of subcutaneous tissue on (R) upper arm. Pt received Varicella (SQ) (R) arm 7-6- noticed elevation in swelling and erythema over past 3 days. Pt seen in office on 7/9 to r/o cellulitis.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Contusion, Disorientation, Fall, Loss of consciousness, Syncope
Clinical narrative: Patient passed out/fainted, fell to floor from examination table. Bruised, disoriented.
Age: 52.0
Sex: M
Vaccine: YF, YF
Symptoms: Arthralgia, Back pain, Condition aggravated, Hypoaesthesia, Insomnia
Clinical narrative: Initial report received from a nurse in the USA on 19 January 2007. A male patient (age not reported, with a history of back problems) complained of bilateral hip and leg pain with weakness, 2 days after he received YE-VAX (lot number, route and site of administration not reported) on 16 January 2007. It was reported that he had 1 or 2 previous doses of YF-VAX. There was no fever or injection site signs and symptoms were reported. At the time of the report, the patient had not recovered. Follow-up information received on 09 February 2007. The submitted VAERS from (E-14470) was provided. The patient was a 52 year old male who received YF-VAX (lot number UE896AA) subcutaneously in the left arm. He had 1 previous dose of YF-VAX. He complained of hip pain on 17 January 2007. On 19 January 2007, he stated he had not slept for 2 nights because of back and hip pain. He stated this was different then when he had sciatica before-limping, leg going numb. On 12 January 2007, an MRI showed a back problem. It was reported the patient recovered.
Age: 52.0
Sex: M
Vaccine: YF, YF
Symptoms: Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial report received from a nurse in the USA on 19 January 2007. A male patient (age not reported, with a history of back problems) complained of bilateral hip and leg pain with weakness, 2 days after he received YE-VAX (lot number, route and site of administration not reported) on 16 January 2007. It was reported that he had 1 or 2 previous doses of YF-VAX. There was no fever or injection site signs and symptoms were reported. At the time of the report, the patient had not recovered. Follow-up information received on 09 February 2007. The submitted VAERS from (E-14470) was provided. The patient was a 52 year old male who received YF-VAX (lot number UE896AA) subcutaneously in the left arm. He had 1 previous dose of YF-VAX. He complained of hip pain on 17 January 2007. On 19 January 2007, he stated he had not slept for 2 nights because of back and hip pain. He stated this was different then when he had sciatica before-limping, leg going numb. On 12 January 2007, an MRI showed a back problem. It was reported the patient recovered.
Age: 52.0
Sex: M
Vaccine: YF, YF
Symptoms: Arthralgia, Asthenia, Back pain, Insomnia, Pain in extremity
Clinical narrative: Initial report received from a nurse in the USA on 19 January 2007. A male patient (age not reported, with a history of back problems) complained of bilateral hip and leg pain with weakness, 2 days after he received YE-VAX (lot number, route and site of administration not reported) on 16 January 2007. It was reported that he had 1 or 2 previous doses of YF-VAX. There was no fever or injection site signs and symptoms were reported. At the time of the report, the patient had not recovered. Follow-up information received on 09 February 2007. The submitted VAERS from (E-14470) was provided. The patient was a 52 year old male who received YF-VAX (lot number UE896AA) subcutaneously in the left arm. He had 1 previous dose of YF-VAX. He complained of hip pain on 17 January 2007. On 19 January 2007, he stated he had not slept for 2 nights because of back and hip pain. He stated this was different then when he had sciatica before-limping, leg going numb. On 12 January 2007, an MRI showed a back problem. It was reported the patient recovered.
Age: 0.17
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Listless, Moaning, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of Rotateq. "About four months ago," in approximately February 2007, the patient developed diarrhea that lasted for eight days. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested. 3/25/2010 Information has been received from a health professiona concerning an 8 week sold male, with no medical history and no allergies, who on 11-DEC-2006, at 11:00 a.m., was vacinated with a first oral dose of ROTATEQ (Lot# 655863/1034F). Concomitant vaccine adminstered at the same time included a first imtramuscular dose in the left lwoer thigh of TRIPEDIA (Lot# C2552AA), a first intramuscular dose in the right lwoer thigh of COMVAX, a first subucutaneous dose on the right of IPOL (Lot# V1032-2) and a first intramuscular dose int eh left lwoer thigh of PREVENAR (Lot# B08683C). There was no illness at the time of vaccination. "About four months ago," in approximately February 2007, the patient developed diarrhea that lasted for eith days. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a helath profession indicated that 9 hours after the vaccines were administered on 11-DEC-2006 at 10:00 p.m. the paitient had an episode of becoming limp and started to moan. the episode lasted 1 minute and the patient was febrile with a temperatur of 100.6, It was reporte that the patient recovered. Additional information has been requested. The patient's vaccination history included a first dose of COMVAX.
Age: 0.17
Sex: M
Vaccine: DTAP, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea, Hypotonia, Moaning
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of Rotateq. "About four months ago," in approximately February 2007, the patient developed diarrhea that lasted for eight days. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested. 3/25/2010 Information has been received from a health professiona concerning an 8 week sold male, with no medical history and no allergies, who on 11-DEC-2006, at 11:00 a.m., was vacinated with a first oral dose of ROTATEQ (Lot# 655863/1034F). Concomitant vaccine adminstered at the same time included a first imtramuscular dose in the left lwoer thigh of TRIPEDIA (Lot# C2552AA), a first intramuscular dose in the right lwoer thigh of COMVAX, a first subucutaneous dose on the right of IPOL (Lot# V1032-2) and a first intramuscular dose int eh left lwoer thigh of PREVENAR (Lot# B08683C). There was no illness at the time of vaccination. "About four months ago," in approximately February 2007, the patient developed diarrhea that lasted for eith days. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a helath profession indicated that 9 hours after the vaccines were administered on 11-DEC-2006 at 10:00 p.m. the paitient had an episode of becoming limp and started to moan. the episode lasted 1 minute and the patient was febrile with a temperatur of 100.6, It was reporte that the patient recovered. Additional information has been requested. The patient's vaccination history included a first dose of COMVAX.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Blood pressure, Chills, Confusional state, Dizziness, Muscle contracture
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. The physician reported that patient had a serious allergic reaction after the first injection. Patient sought unspecified medical attention. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. In follow-up information from the doctor's office it was reported that within a minute or two, the patient's chin fell to chest while arm contracted at elbow up off lap. She did not respond to name or shaking of shoulders for approximatel one minute. Her blood pressure was 100/60 and pulse was 64. Then she became aroused, although very confused and unsure where she was. Patient called out for her mother and asked where she was and said she felt dizzy. She was then assisted off chair to floor. She became extremely pale, complained of lips tingling. Her blood pressure was 130/64 at 18:00. While resting she complained of "heavy head" feeling and paresthia in right arm, right and left hands and feet as well as complained of chills. At 18:05 emergency medical services was called and responded by 18:10. At 18:05 patient's B/P was 130/66, respiration rates was 18. She was given oxygent per emergency medical service. Patient was transported to the ER. Client was discharged from ER within a couple hours. Her parents were contacted at 2:00 and stated client was "fine now". She returned to school on 23-Mar-2007. Additionla information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Oxygen supplementation, Pallor, Paraesthesia, Paraesthesia oral, Posture abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. The physician reported that patient had a serious allergic reaction after the first injection. Patient sought unspecified medical attention. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. In follow-up information from the doctor's office it was reported that within a minute or two, the patient's chin fell to chest while arm contracted at elbow up off lap. She did not respond to name or shaking of shoulders for approximatel one minute. Her blood pressure was 100/60 and pulse was 64. Then she became aroused, although very confused and unsure where she was. Patient called out for her mother and asked where she was and said she felt dizzy. She was then assisted off chair to floor. She became extremely pale, complained of lips tingling. Her blood pressure was 130/64 at 18:00. While resting she complained of "heavy head" feeling and paresthia in right arm, right and left hands and feet as well as complained of chills. At 18:05 emergency medical services was called and responded by 18:10. At 18:05 patient's B/P was 130/66, respiration rates was 18. She was given oxygent per emergency medical service. Patient was transported to the ER. Client was discharged from ER within a couple hours. Her parents were contacted at 2:00 and stated client was "fine now". She returned to school on 23-Mar-2007. Additionla information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Sensation of heaviness, Unresponsive to stimuli
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. The physician reported that patient had a serious allergic reaction after the first injection. Patient sought unspecified medical attention. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. In follow-up information from the doctor's office it was reported that within a minute or two, the patient's chin fell to chest while arm contracted at elbow up off lap. She did not respond to name or shaking of shoulders for approximatel one minute. Her blood pressure was 100/60 and pulse was 64. Then she became aroused, although very confused and unsure where she was. Patient called out for her mother and asked where she was and said she felt dizzy. She was then assisted off chair to floor. She became extremely pale, complained of lips tingling. Her blood pressure was 130/64 at 18:00. While resting she complained of "heavy head" feeling and paresthia in right arm, right and left hands and feet as well as complained of chills. At 18:05 emergency medical services was called and responded by 18:10. At 18:05 patient's B/P was 130/66, respiration rates was 18. She was given oxygent per emergency medical service. Patient was transported to the ER. Client was discharged from ER within a couple hours. Her parents were contacted at 2:00 and stated client was "fine now". She returned to school on 23-Mar-2007. Additionla information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Chills, Confusional state, Dizziness, Extremity contracture, Head discomfort
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. The physician reported that patient had a serious allergic reaction after the first injection. Patient sought unspecified medical attention. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. In follow-up information from the doctor's office it was reported that within a minute or two, the patient's chin fell to chest while arm contracted at elbow up off lap. She did not respond to name or shaking of shoulders for approximatel one minute. Her blood pressure was 100/60 and pulse was 64. Then she became aroused, although very confused and unsure where she was. Patient called out for her mother and asked where she was and said she felt dizzy. She was then assisted off chair to floor. She became extremely pale, complained of lips tingling. Her blood pressure was 130/64 at 18:00. While resting she complained of "heavy head" feeling and paresthia in right arm, right and left hands and feet as well as complained of chills. At 18:05 emergency medical services was called and responded by 18:10. At 18:05 patient's B/P was 130/66, respiration rates was 18. She was given oxygent per emergency medical service. Patient was transported to the ER. Client was discharged from ER within a couple hours. Her parents were contacted at 2:00 and stated client was "fine now". She returned to school on 23-Mar-2007. Additionla information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Hypersensitivity, Pallor, Paraesthesia, Paraesthesia oral, Posture abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. The physician reported that patient had a serious allergic reaction after the first injection. Patient sought unspecified medical attention. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. In follow-up information from the doctor's office it was reported that within a minute or two, the patient's chin fell to chest while arm contracted at elbow up off lap. She did not respond to name or shaking of shoulders for approximatel one minute. Her blood pressure was 100/60 and pulse was 64. Then she became aroused, although very confused and unsure where she was. Patient called out for her mother and asked where she was and said she felt dizzy. She was then assisted off chair to floor. She became extremely pale, complained of lips tingling. Her blood pressure was 130/64 at 18:00. While resting she complained of "heavy head" feeling and paresthia in right arm, right and left hands and feet as well as complained of chills. At 18:05 emergency medical services was called and responded by 18:10. At 18:05 patient's B/P was 130/66, respiration rates was 18. She was given oxygent per emergency medical service. Patient was transported to the ER. Client was discharged from ER within a couple hours. Her parents were contacted at 2:00 and stated client was "fine now". She returned to school on 23-Mar-2007. Additionla information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil. The physician reported that patient had a serious allergic reaction after the first injection. Patient sought unspecified medical attention. The outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. In follow-up information from the doctor's office it was reported that within a minute or two, the patient's chin fell to chest while arm contracted at elbow up off lap. She did not respond to name or shaking of shoulders for approximatel one minute. Her blood pressure was 100/60 and pulse was 64. Then she became aroused, although very confused and unsure where she was. Patient called out for her mother and asked where she was and said she felt dizzy. She was then assisted off chair to floor. She became extremely pale, complained of lips tingling. Her blood pressure was 130/64 at 18:00. While resting she complained of "heavy head" feeling and paresthia in right arm, right and left hands and feet as well as complained of chills. At 18:05 emergency medical services was called and responded by 18:10. At 18:05 patient's B/P was 130/66, respiration rates was 18. She was given oxygent per emergency medical service. Patient was transported to the ER. Client was discharged from ER within a couple hours. Her parents were contacted at 2:00 and stated client was "fine now". She returned to school on 23-Mar-2007. Additionla information is not expected.
Age: 67.0
Sex: F
Vaccine: YF, YF
Symptoms: Muscular weakness, Pain, Paraesthesia, Pyrexia
Clinical narrative: A 67 year old, female patient, was "sore and achy" all over, feverish and had tingling in her extremities after she received YF-VAX (lot number UE913AA) subcutaneously in the left arm on 15 November 2006. She referred to her primary care physician on 29 March 2007 and was referred to a neurologist. She did not have any illness at the time of the vaccination. At the time of the report, she had not recovered. Follow-up information received on 19 April 2007. The patient did not provide the reporter with specific information regarding her health history. She did not receive any other vaccinations. On 20 November 2006, she called the reporter to inform that she felt "sore all over" and she felt "feverish". On 30 March 2007, she stated that she experienced tingling and numbness in her arms and legs for an unspecified period of time. Her attending physician was aware of the symptoms, and had referred her to see a neurologist and another physician who specializes in Rheumatoid Arthritis. She also stated that both her specialist and primary attending physician, report no significant findings. Her recovery status was unknown.
Age: 67.0
Sex: F
Vaccine: YF, YF
Symptoms: Pain, Paraesthesia, Pyrexia
Clinical narrative: A 67 year old, female patient, was "sore and achy" all over, feverish and had tingling in her extremities after she received YF-VAX (lot number UE913AA) subcutaneously in the left arm on 15 November 2006. She referred to her primary care physician on 29 March 2007 and was referred to a neurologist. She did not have any illness at the time of the vaccination. At the time of the report, she had not recovered. Follow-up information received on 19 April 2007. The patient did not provide the reporter with specific information regarding her health history. She did not receive any other vaccinations. On 20 November 2006, she called the reporter to inform that she felt "sore all over" and she felt "feverish". On 30 March 2007, she stated that she experienced tingling and numbness in her arms and legs for an unspecified period of time. Her attending physician was aware of the symptoms, and had referred her to see a neurologist and another physician who specializes in Rheumatoid Arthritis. She also stated that both her specialist and primary attending physician, report no significant findings. Her recovery status was unknown.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure decreased, Cold sweat, Dizziness, Pallor
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 06-APR-2007, at 16:00, was vaccinated IM with the first dose of Gardasil (lot#654272/0319U). There was no concomitant medication. On 06-APR-2007, at 16:05, the patient experienced dizziness, became pale and clammy, and her blood pressure decreased to 80/52 from 110/68. On 06-APR-2007, the patient recovered. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Asthenia, Dizziness, Lymphadenopathy, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a 23 year old female who on 09-APR-2007 was vaccinated with a first dose of Gardasil and one month early on 08-MAY-2007, she was vaccinated with a second dose of Gardasil. After being vaccinated the second time she developed Pharyngitis. Patient stated that she tolerated the first dose without any event and plans to receive the third dose. The patient did seek unspecified medical attention. At the time of the report, the patient had recovered shortly after receiving the second dose. No product quality complaint was involved. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Inappropriate schedule of drug administration, Pharyngitis
Clinical narrative: Information has been received from a 23 year old female who on 09-APR-2007 was vaccinated with a first dose of Gardasil and one month early on 08-MAY-2007, she was vaccinated with a second dose of Gardasil. After being vaccinated the second time she developed Pharyngitis. Patient stated that she tolerated the first dose without any event and plans to receive the third dose. The patient did seek unspecified medical attention. At the time of the report, the patient had recovered shortly after receiving the second dose. No product quality complaint was involved. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Asthenia, Dizziness, Inappropriate schedule of drug administration, Pharyngitis, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a 23 year old female who on 09-APR-2007 was vaccinated with a first dose of Gardasil and one month early on 08-MAY-2007, she was vaccinated with a second dose of Gardasil. After being vaccinated the second time she developed Pharyngitis. Patient stated that she tolerated the first dose without any event and plans to receive the third dose. The patient did seek unspecified medical attention. At the time of the report, the patient had recovered shortly after receiving the second dose. No product quality complaint was involved. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Fatigue, Influenza like illness, Musculoskeletal pain
Clinical narrative: This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow up information has been received from two registered nurses, concerning a 25 year old female patient, with migraines and no known allergies, who on 21-MAY-2007 was vaccinated IM with the first dose, 0.5ml, of Gardasil (Lot #657737/0522U). Concomitant therapy included unspecified therapy for migraines and multivitamins (manufacturer unspecified). 22-MAY-2007, the day following vaccination, the patient experienced fatigue, a low grade temperature, flu-like symptoms, dizziness and musculoskeletal aches; the patient called the office on approximately 23-MAY-2007 to report the symptoms, but an office visit was not reported. Subsequently, the patient recovered from the events on approximately 24-MAY-2007 ("within 48 hours"). Follow up information confirmed that the patient was vaccinated with the second dose of GARDASIL (date not reported), and had no symptoms. The patient sought unspecified medical attention. The nurse reported that 2 other patients experienced similar symptoms following vaccination with Gardasil (WAES 0706USA04348). No further information is expected.
Age: 0.5
Sex: M
Vaccine: RV5, RV5
Symptoms: Cyanosis
Clinical narrative: Information has been received from a consumer concerning her 6-month-old son who on 04-JUN-2007 was vaccinated PO with the third 2mL dose of Rotateq. It was noted that therapy with Rotateq started at 2-months of age. Subsequently, on 04-JUN-2007, the patient was "turning blue everytime he lays on his back". The outcome was recovered on 04-JUN-2007. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Eye pain, Headache, Nausea, Vomiting
Clinical narrative: Information has been received from a office worker concerning a 21 year old female with no pertinent medical history or drug reactions/allergies on 07-JUN-2007 who was vaccinated with a first dose of Gardasil (lot # 654702/0011U) IM at 9 AM in the left deltoid. There was no concomitant medication used. On 07-JUN-2007 the patient called at 4 PM complaining of nausea, vomiting, left frontal headache with left orbital pain. On 07-JUN-2007, the patient recovered from nausea, vomiting, left frontal headache and left orbital pain. No additional information was given. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning a 20 year old white female student who on 06-JUN-2007 at 04:30 PM was vaccinated IM with a third dose of Gardasil, lot #657868/0523U. Concomitant therapy included Tdap. On 08-JUN-2007 at 09:00 AM, patient developed generalized hives. She was treated with BENADRYL. Her mother reported that she had same reaction occurred one week after the first and second dose of Gardasil. On 08-JUN-2007 the patient recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Information has been received from a health professional concerning a 17 year old female who on 05-JUN-2007 was vaccinated IM into the right deltoid with a dose of GARDASIL (lot# 654885/1424F). Concomitant therapy included a SC dose given into the left arm of VARIVAX vaccine (lot4 656569/0114U), an IM dose into the left deltoid of MENACTRA (batch# U2115AA) and hormonal contraceptives (unspecified). On 07-JUN-2007 within 36 hours, the patient experienced a "10 x 8 centimeter of left arm redness, warmth and tender." No medical attention was sought. At the time of this report, the patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. The reporter felt that the events were not related to GARDASIL vaccine. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 17 year old female who on 05-JUN-2007 was vaccinated IM into the right deltoid with a dose of GARDASIL (lot# 654885/1424F). Concomitant therapy included a SC dose given into the left arm of VARIVAX vaccine (lot4 656569/0114U), an IM dose into the left deltoid of MENACTRA (batch# U2115AA) and hormonal contraceptives (unspecified). On 07-JUN-2007 within 36 hours, the patient experienced a "10 x 8 centimeter of left arm redness, warmth and tender." No medical attention was sought. At the time of this report, the patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/16/2007. The reporter felt that the events were not related to GARDASIL vaccine. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Full blood count, Infection, Laboratory test normal, Lymphadenopathy, Mononucleosis heterophile test negative
Clinical narrative: Information has been received from a physician concerning an 11 year old white female student who on 16-JAN-2007 at 6:15 p.m. was vaccinated IM in left arm with her first dose of Gardasil, lot #655619/1427F. Concomitant therapy included a first dose of hepatitis A virus vaccine (unspecified), lot #AHAVB143BA, also given IM in left arm on 16-JAN-2007 at 6:15 p.m. On 29-JAN-2007 the patient was seen in the office for sore throat and enlarged lymph nodes. "RST" and 24 hour throat culture were negative. She was put on amoxicillin. On 04-APR-2007 at 4:00 p.m. the patient was vaccinated IM in left arm with her second dose of Gardasil, lot #657617/0384U. On 08-MAY-2007 she was diagnosed with lymphadenitis and put on AUGMENTIN. On 22-MAY-2007 the patient was seen by ENT and put on CEFTIN. Her outcome was not reported. Additional information is not expected. Follow-up information has been reported from a deputy health officer, who indicated that on 29-JAN-2007 the patient was diagnosed with an infected lymph node on the left sideof her neck after receiving her first dose of GARDASIL along with a Hepatitis A vaccine on 16-JAN-2007. She was treated with AMOXICILLIN. On 04-APR-2007 the patient recieved her second dose and on 08-MAY-2007 was diagnosed with an infected lymph node on the left side of her neck. She was treated with AMOXICILLIN for 10 days with no improvement so she was referred to an ENT physician. On 22-MAY-2007 the ENT physician confirmed the diagnosis and treated her with a stronger antibiotic. It was reported that unspecified blood work was normsl. The patient recovered. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning an 11 year old white female student who on 16-JAN-2007 at 6:15 p.m. was vaccinated IM in left arm with her first dose of Gardasil, lot #655619/1427F. Concomitant therapy included a first dose of hepatitis A virus vaccine (unspecified), lot #AHAVB143BA, also given IM in left arm on 16-JAN-2007 at 6:15 p.m. On 29-JAN-2007 the patient was seen in the office for sore throat and enlarged lymph nodes. "RST" and 24 hour throat culture were negative. She was put on amoxicillin. On 04-APR-2007 at 4:00 p.m. the patient was vaccinated IM in left arm with her second dose of Gardasil, lot #657617/0384U. On 08-MAY-2007 she was diagnosed with lymphadenitis and put on AUGMENTIN. On 22-MAY-2007 the patient was seen by ENT and put on CEFTIN. Her outcome was not reported. Additional information is not expected. Follow-up information has been reported from a deputy health officer, who indicated that on 29-JAN-2007 the patient was diagnosed with an infected lymph node on the left sideof her neck after receiving her first dose of GARDASIL along with a Hepatitis A vaccine on 16-JAN-2007. She was treated with AMOXICILLIN. On 04-APR-2007 the patient recieved her second dose and on 08-MAY-2007 was diagnosed with an infected lymph node on the left side of her neck. She was treated with AMOXICILLIN for 10 days with no improvement so she was referred to an ENT physician. On 22-MAY-2007 the ENT physician confirmed the diagnosis and treated her with a stronger antibiotic. It was reported that unspecified blood work was normsl. The patient recovered. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Culture throat negative, Lymphadenitis, Lymphadenopathy, Lymphadenopathy, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a physician concerning an 11 year old white female student who on 16-JAN-2007 at 6:15 p.m. was vaccinated IM in left arm with her first dose of Gardasil, lot #655619/1427F. Concomitant therapy included a first dose of hepatitis A virus vaccine (unspecified), lot #AHAVB143BA, also given IM in left arm on 16-JAN-2007 at 6:15 p.m. On 29-JAN-2007 the patient was seen in the office for sore throat and enlarged lymph nodes. "RST" and 24 hour throat culture were negative. She was put on amoxicillin. On 04-APR-2007 at 4:00 p.m. the patient was vaccinated IM in left arm with her second dose of Gardasil, lot #657617/0384U. On 08-MAY-2007 she was diagnosed with lymphadenitis and put on AUGMENTIN. On 22-MAY-2007 the patient was seen by ENT and put on CEFTIN. Her outcome was not reported. Additional information is not expected. Follow-up information has been reported from a deputy health officer, who indicated that on 29-JAN-2007 the patient was diagnosed with an infected lymph node on the left sideof her neck after receiving her first dose of GARDASIL along with a Hepatitis A vaccine on 16-JAN-2007. She was treated with AMOXICILLIN. On 04-APR-2007 the patient recieved her second dose and on 08-MAY-2007 was diagnosed with an infected lymph node on the left side of her neck. She was treated with AMOXICILLIN for 10 days with no improvement so she was referred to an ENT physician. On 22-MAY-2007 the ENT physician confirmed the diagnosis and treated her with a stronger antibiotic. It was reported that unspecified blood work was normsl. The patient recovered. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Nausea, Syncope vasovagal, Vomiting
Clinical narrative: Information has been received from a nurse concerning a female (age unknown) with an history of vasovagal reactions after vaccinations and no allergies, who on 17-MAY-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot#0210U). There was no concomitant medication. The patient experienced a vagal reaction immediately after the injection. The patient sought unspecified medical attention. The patient had recovered on 17-MAY-2007. No product quality complaint was involved. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Information has been received from a health professional concerning a 16 year old female with a history of vasovagal reactions after vaccinations and no allergies, who on 17-MAY-2007 at 10:00am was vaccinated intramuscularly in the left deltoid with a 0.5mL first dose of GARDASIL (Lot#0210U). There was no concomitant medication. The patient experienced a vagal reaction immediately after the injection followed by nausea with vomiting 15 minutes post injection. No laboratory diagnostics were performed. The patient had recovered on 17-MAY-2007. No product quality complaint was involved. Additional information is not expected.