chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: FLU3, MMR
Symptoms: Tonic convulsion
Clinical narrative: Approximately 9 hours after receiving MMR (fist) and influenza vaccines patient experienced a generalized tonic seizure lasting less than 2 minutes. No treatment was necessary. No past medical or family history of seizures noted.  1/23/07 T/C to reporter to request missing info.  Parents called EMS for patient & called PCP but no treatement done & did not transport to ER.  Seen by PCP following day.  1/25/07 Received medical records from PCP which reveal patient had decreased growth velocity in all parameters, slightly worse in weight w/o evidence of chronic disease.  Patient eats well but is fussy & has had several URIs & otitis media infections.  On day of initial flu vax 11/9/06, patient noted to have bilat OM & was treated w/antibiotics & referred to ENT.  Seen again on 12/19 with thrush from antibiotics & mild cough.  Next visit was on 1/11 & received flu vax & MMR after well check up.  Seen s/p seizure on 1/12 & found to be well with no further seizure activity.  No family hx of seizures.  No treatment done & no further w/u recommended unless seizure recurs.
Age: 23.0
Sex: M
Vaccine: ANTH, FLU3, SMALL, TYP
Symptoms: Injection site cellulitis, Injection site erythema, Pyrexia, Rash vesicular, Vaccinia
Clinical narrative: 2 weeks after receiving smallpox vaccine developed erythema at site and vesicular rash on back and chest, fever. Received Bactrim at ER for presumed cellulitis at vaccine site. Diagnosed cellulitis, generalized vaccina
Age: 13.0
Sex: F
Vaccine: FLU3, MNQ, TDAP, VARCEL
Symptoms: Erythema, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Approximately 10 minutes after administering the Fluzone vaccine child began complaining that her arms and back was itching. I noticed red whelps on her back and chest. Physician was notified immediately and the patient was given Allervert (antihistamine) for allergic reaction. Fluzone was received 30 minutes after other vaccines.
Age: 8.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Localized swelling next day. Induration 45x25mm. 90x50 erythema. Follow up redness only.
Age: 65.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Blood creatine phosphokinase, Injection site pain
Clinical narrative: States that the arm vaccine was administered in has been sore for 1 month (since vaccine was given).
Age: 65.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Blood creatine phosphokinase, Pain in extremity
Clinical narrative: States that the arm vaccine was administered in has been sore for 1 month (since vaccine was given).
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Pyrexia, Urticaria
Clinical narrative: Fever, severe aches in joints, welts on arm. Patient had doctor visit. Treatment was time. MD stated this was a typical reaction.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Acne, Pruritus, Skin lesion
Clinical narrative: Patient reported eruption of one hive like lesion (wheal) morning after vaccination, followed by other "pimple like" area over her body. No pruritis except for the first lesion. Disappeared over several hours. No shortness of breath, swelling or other symptoms. Patient reported to Public Health on 1/16/07.
Age: 61.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles received AM 3 width
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Rash erythematous, Swelling
Clinical narrative: Severe swelling, arm was erythematous and hot. Patient went to local Emergency Room. Was given Ibuprofen and codeine.
Age: 38.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Pyrexia, Rash macular
Clinical narrative: Pain in left arm started four hours after injection could not life or move arm without pain. 24 hours after injection had elevated temp of 100.5 and red blotches below the injection site (but not at the injection site). 72 hours after injection temperature returned to normal and pain was slowly diminishing. 96 hours after injection pain is gone, red blotches are fading. 10 days after injection, red blotches are gone.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Crying, Disorientation, Musculoskeletal stiffness, Restlessness
Clinical narrative: Patient was asleep by 7:30pm on 1/10/07. Around 8:15 he started crying and screaming in his bed and was restless. Mom went in to get him and picked him up. His body would tense up and go stiff and flat as a board for about 5-10 seconds and then release. About 30 seconds to a minute later he would repeat this stiffening again. During the first episode this lasted for about 15 minutes. The whole time he was going through this mom was holding him in her arms while they say on the couch. He would repeatedly call out " I want mommy" as if he didn't even recognize that mom was right there and he was in moms arms. He was not cognizant of what was going on around him at all. As soon as it was over he went right to sleep as if nothing happened. This same thing went on at 9:30 and 11pm. It may have happened a fourth time, mom can't remember but the last time was at 11:15pm. Each time that it went on the reaction time was shorter. By the final time it lasted only about 3-5minutes. Every time he would wake up from his sleep crying and thrashing around very disoriented. He continued to go through the contraction and stiffening episodes and calling out I want mommy yet not recognizing that he was in mom's arms. He would not respond to anything that you said to him or asked him. If I asked him where he hurt or to point to where he hurt, he did not respond at all.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Screaming, Tension, Unresponsive to stimuli
Clinical narrative: Patient was asleep by 7:30pm on 1/10/07. Around 8:15 he started crying and screaming in his bed and was restless. Mom went in to get him and picked him up. His body would tense up and go stiff and flat as a board for about 5-10 seconds and then release. About 30 seconds to a minute later he would repeat this stiffening again. During the first episode this lasted for about 15 minutes. The whole time he was going through this mom was holding him in her arms while they say on the couch. He would repeatedly call out " I want mommy" as if he didn't even recognize that mom was right there and he was in moms arms. He was not cognizant of what was going on around him at all. As soon as it was over he went right to sleep as if nothing happened. This same thing went on at 9:30 and 11pm. It may have happened a fourth time, mom can't remember but the last time was at 11:15pm. Each time that it went on the reaction time was shorter. By the final time it lasted only about 3-5minutes. Every time he would wake up from his sleep crying and thrashing around very disoriented. He continued to go through the contraction and stiffening episodes and calling out I want mommy yet not recognizing that he was in mom's arms. He would not respond to anything that you said to him or asked him. If I asked him where he hurt or to point to where he hurt, he did not respond at all.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Headache, Pharyngolaryngeal pain, Streptococcal serology negative, Vomiting
Clinical narrative: Vomiting several times, headache, sore throat occurred 3 days after immunizations.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site oedema
Clinical narrative: Immediate swelling after administration of Fluzone in left deltoid. Pt offered ice pack but Pt refused. Pt said they take a blood thinner. So did not want Ibuprofen. Pt observes for approx 10 min, swelling was less but still present. Pt decided to go to family Dr. Pt said Dr told them they were ok, no further treatment necessary by Dr.
Age: 9.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Large reddened area on right thigh about 4x4 inches on 1/9/07 submitted photograph taken by mother of patient. Pt not seen by MD not brought to office.
Age: 0.9
Sex: F
Vaccine: FLU3
Symptoms: Dyskinesia, Muscle twitching, Pyrexia, Rash, Tic
Clinical narrative: Rash on legs, fever, twitching to left. No fever with tick spells. Jerks 3-4 x hour happened with focusing on something. Referred to neurologist. Observation was only treatment done. Patient is better with ticks present.  1/26/07 Received neuro consult report which reveals patient seen on 12/7 for EEG & 12/8 for complete neuro eval.  Neuro exam was WNL. A video tape of the patients jerking movements was reviewed.  She rapidly twisted her head to the left & then returned back to neutral position.  No LOC, no facial expression change or any other associated movements.  No loss of eye contatct or focus & is developmentally on target. FINAL DX: Motor tic disorder; noted to be highly unusual for child of this age & probably better described as movement disorder.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray normal, Chest pain, Dyspnoea, Electrocardiogram normal
Clinical narrative: 36 hrs after vaccine pt had severe chest pain and SOB. Went to ER, Neg EKG and neg CXR. Symptoms resolved on their own.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site oedema, Oedema
Clinical narrative: Pt's mother called MD office stating that about 36 hrs after 2nd injection, the patient experienced swelling in her right arm that radiated down her arm into finger tips with middle of her back on right side. Her father is MD gave her 10 mg Prednisone with 800 mg Motrin. This was repeated by Dr next day. Manufacturer rep notified.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Pt presented with left thigh warm, swollen, and indurated. No other distress noted shots given 48 hours ago.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Eye swelling, Feeling hot, Ocular hyperaemia, Pruritus, Urticaria
Clinical narrative: Pt given all immunization in Vastus lateralis, on drive home, mother called stated, pt had hives, red, swollen eyes, feet hot and itching no respiratory problems.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dizziness, Pyrexia, Tremor
Clinical narrative: High fever, shaky, shills, rigors, dizzy.
Age: 1.1
Sex: F
Vaccine: HIBV, MMRV
Symptoms: Rash
Clinical narrative: Skin rash
Age: 16.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Skin lesion
Clinical narrative: Broke out with lesions the next day after Varicella immunization. No fever. No other symptoms. Benadryl, Calamine lotion, oatmeal bath.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic
Clinical narrative: Pruritic rash covering majority of body neck down.
Age: 7.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness, swelling and warmth at site.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Bone pain, Hypersensitivity, Hypertension, Musculoskeletal stiffness
Clinical narrative: Swollen body, rash, fever, joint, bone and muscle pain and stiffness. Hypertension. Up to day still getting treatment in some conditions.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Myalgia, Pyrexia, Rash, Swelling
Clinical narrative: Swollen body, rash, fever, joint, bone and muscle pain and stiffness. Hypertension. Up to day still getting treatment in some conditions.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Oedema
Clinical narrative: Called to say: swelling from elbow to wrist. Disappeared following days. (Animal Control officer) pre-exposure. Primary medical doctor prescribed Steroid. Recommend discontinue Rabies series.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Arm swelled down to elbow, redness went around arm and down to elbow, started next morning. Mother giving Benadryl, still has redness and some swelling on 1/2/07. On Prednisone per Emergency Room doctor.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Right arm red from shoulder to elbow.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying
Clinical narrative: Was given shots at 10am, gave 0.4ml Tylenol and 4 hours later started crying for 12 hours before settled down-would not settle down to even take a bottle.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Rash
Clinical narrative: Received Varivax #2 1/11/07 to left deltoid after cleansing with alcohol. Shortly after shot while still in office developed very small area of redness around injection site. Evaluated by doctors, given Zyrtec pill. 1/12-phone follow up rash better. 1/13-rash spread to 1-2 inches wide started on Augmentin. Developed streaking prior to starting Augmentin.
Age: 78.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Oedema, Pain, Pyrexia
Clinical narrative: High fever 102+ 3 days, swelling 6 days, redness 6 days, aching in entire arm.
Age: 86.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: Left arm swelling with low grade fever.
Age: 86.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Left arm swelling with low grade fever.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Lethargy, Pyrexia
Clinical narrative: Lethargy after immunization. Started aprox evening through night until early afternoon, aprox 18 hrs and low grade fever.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Hypersensitivity, Rash, Stridor, Wheezing
Clinical narrative: C/O allergic reaction wheezing, stridor, red rash noted upon arrival to ER. Pt was treated with IV Benadryl, Pepcid, and Decadron. Then treated with Epi SQ and Depo Medrol IM. Pt was given consent from here and she answered no on consent as to allergic to any medicine or food. Seen in ER 1-11-07.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site mass
Clinical narrative: 10mm firm moveable mass at site if IPV reported today, has been that way since immunized on 8/29/06 )L mid upper arm).
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: Red very itchy filled with liquid spots they stay permanently after the heal arms, legs, buttock.
Age: 1.1
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Irritability, Pruritus, Pyrexia, Urticaria
Clinical narrative: 09/11/06 mother reports, itchy hives over entire body, fever (unknown) irritability (length of time unknown), after varicella, MMR and again with DTaP. Mother also reports that the child reacted with the same symptoms after each one of her previous vaccine.
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Pt presented with rash covering torso and back starting 3 days prior.
Age: 1.52
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: Pt presented 01/10/07 with L arm red and slightly swollen. Per mom, L arm was red, swollen, hot to touch am of 1/9 child was awake night of 1/8 with fever. Swelling was receding. Amoxicillin was prescribed.
Age: 1.38
Sex: U
Vaccine: DTAP, MMR
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: About 24 hrs post vaccine high fever TID3. Fever broke 3 days later (1/14/07). Developed maculopapular rash trunk and head a bit on extremities.
Age: 1.26
Sex: F
Vaccine: DTAP, PPV, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Within 20 mins of vaccination, a hive formed at site of injection with red border 2 1/2 in x 2 1/2 in (lasted 24-30), no wheezing, body/face swelling, no resp distress.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin discolouration
Clinical narrative: Left arm, purplish, lump, complain of itching, redness and warmth. Painful to touch. No fever, no difficulty breathing, states started itching day after shot. 1/12/07 arm is completely better.
Age: 0.53
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Erythema, Injection site swelling, Swelling
Clinical narrative: Patient presented 1/9/07 with right arm red and swollen. Swelling was progressing outward from injection site. Patient received Dtap, IPOL and Hepatitis A ON 1/8/07. Amoxicillin prescribed.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Patient noted tenderness and edematous at site of injection without redness. Patient also noticed under left axilla without lump noted. Patient had breast exam 10/15/06 without tenderness noted at that time. Patient due for mammo 11/15/06.
Age: 41.0
Sex: F
Vaccine: FLUX, HEP, HEPA, TYP
Symptoms: Unevaluable event
Clinical narrative: No adverse symptoms noted thus far (immediately).
Age: 1.04
Sex: F
Vaccine: HIBV, MMRV, PNC
Symptoms: Erythema, Rash, Rash maculo-papular
Clinical narrative: Rash on day #10, trurncal, 2-3 mm pink-red maculopapular lesions. No vesicles, no crusting approximately 20-25 cm.
Age: 1.5
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMRV, PNC
Symptoms: Irritability, Oral soft tissue disorder
Clinical narrative: 01/21/2007 pm patient became irritable and began to manifest lesions in the mouth, lips and tongue.  No treatment was administered
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Agitation, Injection site erythema, Injection site oedema
Clinical narrative: Zaria receied 5 injections 12/18/2006 and had reactions associated with IPC. There was a dime sized selling on her (L) arm with redness as reported by mother. Child was fussy, mom took child to Primary Provider 12/24/2006. Zaria was started on Amoxcillin for 6 days after the shots. Broght child toHD 1/4/2007 with mom's FP visit to let nurse look at arm. Arm still swollen red-child did not cry when arm touched. Mother instructed by nurse not to receive shots in arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Eczema
Clinical narrative: Local eczema skin reaction
Age: 1.93
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site induration, Injection site oedema
Clinical narrative: Patient received 4 injections 1/2/2007 and had reaction associated with DTap and IPC. Staff wrote that themother called 1/8/2007 and stated patient had (L) Thigh swelling the size of a quarter 1/7/2007 (hard knot) but it was less 1/8/07. Staff instructed her to apply warm soaks to L thigh and report if not better on Friday 1/12/2007.   1/12/2007 Denied pain,redness or fever.
Age: 24.0
Sex: F
Vaccine: FLU3, JEV
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: PAIN AND SWELLING AT INJECTION SITE. AWAKENED FROM SLEEP FROM BITING TONGUE. LATER DEVELOPED CELLULITIS AT THE INJECTION SITE (RIGHT ARM)
Age: 6.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Dyspnoea, Eye swelling, Heart rate normal, Hypersensitivity, Oxygen saturation decreased
Clinical narrative: 1130 SHOTS ADMINISTERED. 1255 MOTHER CALLED QUESTIONING AN ALLERGIC REACTION, INSTRUCTED MOTHER TO RETURN TO CLINIC. 1305 MOTHER RETURNED WITH DAUGHTER: PUFFY EYES, SOB, TAKE TO ROOM, BENADRYL 12.5MG GIVEN PO, EPIPEN JR .15MG ADMINISTERED RT THIGH. ALBUTEROL NEBULIZER TREATMENT ADMINISTERED.PULSE OX PRIOR TO NEB 91 PERCENT, POST NEB TREATMENT 95 PERCENT. PULSE 1305 WAS 130, PULSE AT 1330 141, PULSE OX 95 PERCENT.  MR received revealing a 6 yr. old with reported nomal growth and development at her well child check, who had an anaphylactic reaction 1-1 1/2 hours after Proquad and MMRV vax.   Child developed swollen eyes (nearly shut), wheezing, increased work of breathing, and hives.  Returned to MD's office where she was treated with Benadryl, Albuterol, and Epinephrine.  Wheezing abated and breathing easier however eyes remained swollen. Home on benadryl and albuterol nebs PRN. Assessment:  Anaphylaxis due to vaccines.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: INJECTION SITE DEVELOPED A 2" RED RASH AREA (LEFT DELTOID). NO VESICLES/BREAKDOWN.  DENIES PAIN OR ITCH. NO SYSTEMIC SYMPTOMS.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Pt received Tdap vaccine left deltoid at appx 3pm on 1/17/2007.  By 10:00pm, left arm had become extremely painful.  On 1/19/2007 pt began having headache on left side of head, arm continued to be painful.  Pt experienced minimal relief with OTC Ibuprofen.  By 1/20/2007, redness at site began developing, headache, and arm pain continued.  Today 1/22/2007 redness persists;  covering area from shoulder to elbow.  Area is hot to touch.  No lymph node enlargement is noted.  Arm remains extremely painful with movement and is tender to touch.  HA persists but has improved.  Pt has been advised to see family MD tomorrow.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: Development of Herpes Zoster lesions in C7 dermatome started several days ago.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Teething
Clinical narrative: Received phone call from Ellisville Clinic regarding child presented with pain in teeth and jaw dx with Bells Palsy.
Age: 41.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Axillary mass, Injection site nodule, Skin warm
Clinical narrative: Noted elevated area in his axillary ares. He's afebrile. It was warm to touch.  The injection site felt "lumpy". Was sent to Kaiser for evaluation and was advised to monitor the sites for any S&S of infection.
Age: 41.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Erythema, Pain
Clinical narrative: Noted elevated area in his axillary ares. He's afebrile. It was warm to touch.  The injection site felt "lumpy". Was sent to Kaiser for evaluation and was advised to monitor the sites for any S&S of infection.
Age: 0.2
Sex: F
Vaccine: HIBV, RVX, HIBV, RV5
Symptoms: Dermatitis diaper, Diarrhoea
Clinical narrative: severe diarrhea and diaper rash 2 days following administration of the vaccine
Age: 0.2
Sex: F
Vaccine: HIBV, RVX, HIBV, RV5
Symptoms: Dermatitis diaper, Diarrhoea, Skin atrophy, Stool analysis
Clinical narrative: severe diarrhea and diaper rash 2 days following administration of the vaccine
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Nerve conduction studies
Clinical narrative: Weakness in upper arm that was used for vaccination.  Influenza Vaccine administered subcutaneously on 11-8-2006.  Symptoms began to occur around 12-25-2006.  Physical therapy, nerve conduction studies have been done by VA facility in Asheville NC.  5/18/07 Received medical records from VAMC which reveal patient experienced numbness of left arm w/tingling of fingers, unable to lift left arm & difficulty using left hand since 12/31/06.  Exam on 1/8/07 revealed significantly decreased ROM of left  arm.  numbness of left arm had resolved.  Dx w/left arm neuropathy.  Referred for EMG.  PMR consult on 1/12/07 revealed left shoulder girdle atrophy & limited ROM.  Left elbow flexion was limited.  There was generalized muscle weakness of the left arm.   DTRs absent at biceps & brachial radialis & there was decreased sensation.   Issued sling & referred for OT.  Neuro consult done 2/12/07 agreed w/dx.  Treated w/steroids & referred for MRI of left brachial plexus. FINAL DX: Left Brachial plexitis.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Received vaccine approximately noon on 1/12/07. Complained of significant arm soreness that night. Woke with 103 degrees fever 1/13 continued arm pain and extreme fatigue lasted until approximately 3pm 1/14. Treated with rest and Tylenol.
Age: 1.55
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: 1/17/07 - Child received DTaP/ Hib, Hep A, Influenza vaccines. 1/18/07 - Febrile seizure, Temperature 102.9 rectal
Age: 0.85
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever 105 48 hours after flu vaccine (booster).
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Fever, hot and tender and injection site, red at site of arm.
Age: 26.0
Sex: F
Vaccine: ANTH, HEP, TYP
Symptoms: Erythema, Pain in extremity, Rash, Swelling, Tenderness
Clinical narrative: 26 year old female developed bilateral thigh swelling, pain, and redness associated with a "rash" at the inner thighs about 4-5 hours after several vaccines. Rash 01/11/2007. Rash noted on the inner thighs starting a few hours after vaccines. Tumor 01/11/2007 - 01/12/2007 Patient reports swelling in both thighs and at the rash site. Erythema 01/11/2007 Redness reported at the rash site and still persisting. Tenderness 01/11/2007 The thighs and the rash areas were reported as "tender".
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Laboratory test abnormal, Pregnancy test positive, Ultrasound abdomen abnormal
Clinical narrative: This is in follow-up to report(s) previously submitted on 1/16/2007. Initial and follow-up information has been received from a physician through the Merck pregnancy registry concerning a 17 year old female with episodic reflux and dyspepsia and no known drug allergies and no previous pregnancies who on 16-Oct-2006 was vaccinated intramuscularly with the first dose of GARDASIL (0.5 ml) (lot # 653735/0688F). Concomitant therapy included PRILOSEC OTC and prenatal vitamins. From 20-Oct-2006 to 26-Oct-2006 the patient was placed on therapy with FLAGYL 500 mg twice daily for bacterial vaginitis. On 31-Oct-2006 the patient was found to have a positive pregnancy test. LMP was 11-Sep-2006. Unspecified medical attention was sought and the patient was placed on prenatal vitamins. On 19-Dec-2006, an ultrasound revealed gestational age 24.7 weeks which was not consistent with the estimated date of last menstrual period (LMP). On an unspecified date a Cystic Fibrosis carrier screen was performed, results were negative. On 22-MAR-2007 she delivered a normal, healthy male baby weighing 6 pounds 3 ounces and 18 1/2" long, with a head circumference of 33.5 cm, and APGAR scores of 9 at one and five minutes. The patient's labor and delivery was uncomplicated. No other symptoms were noted. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound uterus, Vaginitis bacterial
Clinical narrative: This is in follow-up to report(s) previously submitted on 1/16/2007. Initial and follow-up information has been received from a physician through the Merck pregnancy registry concerning a 17 year old female with episodic reflux and dyspepsia and no known drug allergies and no previous pregnancies who on 16-Oct-2006 was vaccinated intramuscularly with the first dose of GARDASIL (0.5 ml) (lot # 653735/0688F). Concomitant therapy included PRILOSEC OTC and prenatal vitamins. From 20-Oct-2006 to 26-Oct-2006 the patient was placed on therapy with FLAGYL 500 mg twice daily for bacterial vaginitis. On 31-Oct-2006 the patient was found to have a positive pregnancy test. LMP was 11-Sep-2006. Unspecified medical attention was sought and the patient was placed on prenatal vitamins. On 19-Dec-2006, an ultrasound revealed gestational age 24.7 weeks which was not consistent with the estimated date of last menstrual period (LMP). On an unspecified date a Cystic Fibrosis carrier screen was performed, results were negative. On 22-MAR-2007 she delivered a normal, healthy male baby weighing 6 pounds 3 ounces and 18 1/2" long, with a head circumference of 33.5 cm, and APGAR scores of 9 at one and five minutes. The patient's labor and delivery was uncomplicated. No other symptoms were noted. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Sneezing
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated intramuscularly with 0.5 ml of Gardasil vaccine (yeast). Subsequently, the patient sneezed consistently for 12 hours. The patient sought unspecified medical attention. It was reported that the patient recovered "12 hours after it started" (date unknown). Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007.  Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated intramuscularly with 0.5 mL of GARDASIL (lot # not reported).  Subsequently, the patient sneezed consistently for 12 hours.  The patient sought unspecified medical attention.  It was reported that the patient recovered "12 hours after it started" (date unknown).  Additional information was received from the physician who reported that the patient did not return for follow-up.  The reaction was not typical (sneezing/runny nose for about 24 hours).  The events may or may not be related to therapy with GARDASIL.  No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Dizziness, Nausea
Clinical narrative: This is in follow-up to report(s) previously submitted on 1/16/2007. Information has been received from a "nurse" via a company representative and follow up information has been received from a licensed practical nurse concerning an 18 year old female student who on 26-OCT-2006, was vaccinated in the arm with a first dose of GARDASIL (Lot# 653735/0688F). The nurse reported that the patient experienced nausea and dizziness the same day as the vaccination. Follow up information from the nurse also indicated that the patient had experienced nausea, shaking and a "stoned feeling" on 26-OCT-2006. The patient returned to the office and was stable with no urticaria, no erythema, no swelling. Her blood pressure was 118/62, pulse 92 and respiration 20. It was reported that the patient had "blood work" done (results not reported). It was not known whether the patient recovered. The patient sought unspecified medical attention. Subsequently, on the same day, 26-OCT-2006, the patient recovered. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 22 year old female who was vaccinated with a dose of Gardasil vaccine (yeast). Subsequently, after receiving the vaccination, the patient developed red lesions around the injection site on her arm. On an unspecified date, the patient recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Hypotension, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 13-Dec-2006 was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil vaccine (yeast) (0.5 ml) (lot#654389/0961F). There was no concomitant medication. On 13-Dec-2006, shortly after vaccination, the patient fainted and her skin color was pale. The patient was aroused by shaking her right arm and with smelling salts. The patient's vital signs were found to be normal upon discharge from the office. No further details were provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2007. Follow up information received from the physician stated that on 13-DEC-2006 the injection of GARDASIL was administered by a medical assistant. It was reported that immediately after receiving the vaccination the patient had a syncopal episode. It was reported that the patient became hypotensive (actual blood pressure measurement not provided) and diaphoretic and responded to ammonia salts, being placed in the Trendelenburg and hydration, taken by mouth. It was reported that patient recovered from the event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a nurse at a physician's office concerning a female patient with a history of hepatitis C who on 11-Dec-2006 was vaccinated with Gardasil vaccine (yeast). On 12-Dec-2006 the patient reported that she had developed swelling of her hands. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Epstein-Barr virus test positive, Infectious mononucleosis
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female patient with asthma, penicillin allergy, sulfonamide allergy and a history of infectious mononucleosis in December 2005, who on 21-Oct-2006 was vaccinated with the second dose of Gardasil vaccine (yeast) (lot# 654540/0800F). There was no concomitant medication. It was reported by the patient's mother that one week following vaccination, on approximately 28-Oct-2006 the patient developed mononucleosis which had been confirmed by a blood test taken at the university the patient attended. Unspecified medical attention was sought, however the patient received no treatment. At the time of this report the patient had not yet recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007.  Information has been received from a registered nurse concerning an 18 year old female student with asthma, penicillin allergy, sulfonamide allergy and a history of infectious mononucleosis in December 2005, who on 26-OCT-2006 was vaccinated in the left arm with the second dose of GARDASIL (lot #654540/0800F).  There was no concomitant medication and no illnessess at the time of vaccination.  It was reported that on 31-OCT-2006 the patient tested positive for mononucleosis at the university she attended.  Unspecified medical attention was sought, however the patient received no treatment.  At the time of this report, the outcome of the event was unknown.  No further information is expected.
Age: 24.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Breast swelling
Clinical narrative: Information has been received from a physician concerning a 24 year old female with no pertinent medical history or drug reactions/allergies, who on 08-Dec-2006 was vaccinated intramuscularly with Gardasil vaccine (yeast) (0.5 ml) (lot#653736/0868F). Concomitant vaccination given on an unspecified date included influenza virus vaccine (unspecified). Other concomitant medication included hormonal contraceptives (unspecified).On 09-Dec-2006, one day after receiving the Gardasil vaccine (yeast), the patient experienced breast swelling. It was reported that there was no significant pain, however the patient could not lie on her breast. Unspecified medical attention was sought. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on approximately 27-Nov-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (0.5 ml) (lot#653650/0641F). Concomitant vaccination the same day included Fluvirin vaccine. It was reported that " a few days after receiving the vaccination", on approximately 01-Dec-2006, the patient experienced dizziness when standing and walking and experienced a headache. Unspecified medical attention was sought. Subsequently, the patient recovered from the dizziness and headache on an unspecified date. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site irritation
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter who on 26-Oct-2006 was vaccinated IM with "one shot" of Gardasil vaccine (yeast). The patient felt like it was burning. She is recovering on an unspecified therapy. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: Information has been received from a pharmacist concerning her 13 year old daughter who in approximately October 2006 was vaccinated intramuscularly in the upper deltoid of left arm with the first dose if Gardasil vaccine (yeast). On an unspecified date, the patient developed lots of pain and tenderness in her arm around the injection site for a few days after receiving Gardasil vaccine (yeast). The pharmacist reported that her daughter developed three swollen and tender lymph nodes on her left side of her neck. The lymph nodes were really swollen for about three weeks and the tenderness lasted for about two weeks. The pharmacist was planning to have her daughter vaccinated again with the second of Gardasil vaccine (yeast) some time around 25-Dec-2006. At the time of this report, the patient had recovered from the events "about three weeks after the first dose". Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Headache, Lymphadenopathy, Neck pain, Pyrexia
Clinical narrative: This is in follow-up to report(s) previously submitted on 1/16/2007. Information has been received from a certified medical assistant concerning a 19 year old female with a mold allergy who on 13-Dec-2006 was vaccinated IM into the left deltoid with a 0.5 ml dose of Gardasil vaccine (yeast) (lot# 654540/0800F). Concomitant therapy included Advair, Allegra, montelukast sodium, Ortho-Tri-Cyclen Lo and Lexapro. Illness at the time of vaccination included a cold. On 13-Dec-2006 the patient experienced a fever of 101.4 degrees F, head pain, neck pain and swollen glands. Her fever decreased to 99.1 degrees F. On 14-Dec-2006, she called the office to report these events. The patient was seen in the office and was diagnosed with sinusitis and the doctor said it was not related to the vaccine. Unspecified medical attention was sought. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Sinusitis
Clinical narrative: This is in follow-up to report(s) previously submitted on 1/16/2007. Information has been received from a certified medical assistant concerning a 19 year old female with a mold allergy who on 13-Dec-2006 was vaccinated IM into the left deltoid with a 0.5 ml dose of Gardasil vaccine (yeast) (lot# 654540/0800F). Concomitant therapy included Advair, Allegra, montelukast sodium, Ortho-Tri-Cyclen Lo and Lexapro. Illness at the time of vaccination included a cold. On 13-Dec-2006 the patient experienced a fever of 101.4 degrees F, head pain, neck pain and swollen glands. Her fever decreased to 99.1 degrees F. On 14-Dec-2006, she called the office to report these events. The patient was seen in the office and was diagnosed with sinusitis and the doctor said it was not related to the vaccine. Unspecified medical attention was sought. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female with no medical history or allergies, who on 30-Nov-2006 was vaccinated IM with a 0.5 ml dose of Gardasil vaccine (yeast). Concomitant therapy included an unspecified hormonal contraceptives (unspecified). On 30-Nov-2006, the patient experienced severe injection site pain. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with no medical history or allergies, who was vaccinated IM with 0.5 ml dose of Gardasil vaccine (yeast). Concomitant therapy included unspecified hormonal contraceptives (unspecified). Subsequently, the patient experienced severe injection site pain at the time of immunization. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Acne
Clinical narrative: Information has been received from a physician concerning a 22 year old female who on an unknown date was vaccinated with a first dose of Gardasil vaccine (yeast). Subsequently, the patient broke out with acne all over her face. Unspecified medical attention was sought. No diagnostic studies were performed. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007.  Information has been received from a physician concerning a 22 year old female student with a recent upper respirtatory infection and no allergies, who on 24-NOV-2006 was vaccinated IM into the left arm with a first dose of GARDASIL (lot # 653938/0954F).  On 25-NOV-2006, the patient broke out with acne all over her face.  It was noted that the patient and her mother stated that the patient does not usually suffer from acne.  Unspecified medical attention was sought.  No diagnostic studies were performed.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Allergy to vaccine
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who was "positive for one strain of papilloma viral infection". On an unspecified date, the patient was vaccinated intramuscularly with the first "single dose vial" of Gardasil vaccine (yeast). Subsequently, the patient developed an "allergic reaction". The patient was sought unspecified medical attention. The patient was treated with a "steroid dose pack". At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Acne, Dry skin, Hypersensitivity, Rash pruritic
Clinical narrative: Information has been received from the mother of a 14 year old female who on 27 Sep 2006 was vaccinated with a dose of Gardasil. Vaccination the same day included a dose of influenza virus vaccine (unspecified). Concomitant therapy included Allegra. On 28 Sep 2006, the next day, the patient developed little, itchy bumps on her legs and pimple like bumps on her back. The patient's mother reported that it may or may not have been an allergic reaction, or it "could have been" dry skin. The patient takes therapy with Allegra every day, although, the mother was unsure if the patient had taken it the day of the vaccination. Unspecified medical attention was sought. Subsequently, the patient fully recovered the same day. No other vaccinations have been given. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site haemorrhage
Clinical narrative: Information has been received from a physician concerning a female who on 12 Dec 2006 was vaccinated with a "full" dose of Gardasil. At the time of administration, a small amount of bleeding was reported at the injection site. The bleeding was controlled prior to the patient leaving the physician's office on 12 Dec 2006. The patient called the office the day (13 Dec 2006) and reported that she had bled from the injection site and that the "blood had run down her arm". The patient feels that she did not get the full vaccination because of the bleeding problem. It was reported that the patient sought unspecified medical attention. As of 13 Dec 2006, the patient had recovered from bleeding at the injection site. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site oedema, Smear cervix, Smear cervix abnormal, Smear cervix normal
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female with an allergy to penicillin who on 21 Oct 2006 was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil (Lot #653650/0702F).  Concomitant therapy included hormonal contraceptives (unspecified). On 21 Oct 2006 the patient experienced minor redness and swelling at the injection site, which later resolved. On 08 Dec 2006 the patient presented with bacterial vaginosis and had a positive pap smear test for high risk HPV types. It was noted that on an unspecified date in November 2006 and on 09 Dec 2005 the patient's pap smear tests were negative. Subsequently, unspecified medical attention was sought and the patient had not recovered from positive pap smear test. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginitis bacterial
Clinical narrative: Information has been received from a nurse practitioner concerning a 19 year old female with an allergy to penicillin who on 21 Oct 2006 was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil (Lot #653650/0702F).  Concomitant therapy included hormonal contraceptives (unspecified). On 21 Oct 2006 the patient experienced minor redness and swelling at the injection site, which later resolved. On 08 Dec 2006 the patient presented with bacterial vaginosis and had a positive pap smear test for high risk HPV types. It was noted that on an unspecified date in November 2006 and on 09 Dec 2005 the patient's pap smear tests were negative. Subsequently, unspecified medical attention was sought and the patient had not recovered from positive pap smear test. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil. Subsequently, the patient developed an "adverse reaction". No details were given of the adverse experience. At the time of this report, the outcome of the event was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007.  Initial and follow up information has been received from a licensed practical nurse (previously reported as registered nurse) and the mother of a 15 year old female student.  On 19-OCT-2006, the patient was vaccinated in the left deltoid with the first dose of GARDASIL (Lot # 653736/0689F).  The mother reported that on 14-DEC-2006, her daughter had been ill since the shot.  The patient sought unspecified medical attention.  It was reported that the primary care physician (PCP) had advised against getting another shot.  At the time of this report, the patient had recovered from the event (date unknown).  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 15 year old female patient who was vaccinated with her first dose of Gardasil. Subsequently, the patient experienced prolonged dizziness. Medical attention was required. The patient recovered. The nurse practitioner reported that she was unsure if the 2nd dose of Gardasil should be administered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female (NOS) who on approximately 07-Dec-2006 was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided). Immediately after receiving the injection on approximately 07-Dec-2006 the patient developed hives in the same arm where she received the injection. The patient sought unspecified medical attention. At the time of this report it was unknown if the patient had recovered from the hives.