chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Areflexia, Asthenia, Blood pressure fluctuation, Blood product transfusion, CSF glucose normal
Clinical narrative: Patient received Shingles vaccine on 5/21/08 - lot # 0295X, exp 7/25/09. Patient presented to hospital on 6/4/08 with 1 week history of progressive numbness and weakness. Exam notable for significant facial weakness, dysarthria proximal>distal weakness in an asymmetric pattern, areflexia and stocking glove sensory loss. Patient thought to have Guillain Barre syndrome. Subsequently noted to have autonomic dysfunction with labile BP - syncope X2, pulse and profuse diaphoresis. LP was done which showed cytoalbuminologic dissociation, confirming the diagnosis of GBS. Titers for other infectious causes pending but no history of recent illness. The presentation is quite consistent with a vaccine induced GBS. Patient is currently receiving IVIG, tolerating well with questionable improvement after 4th infusion. 7/30/08-records received for DOS 6/4-6/17/08-DC DX:Guillain-Barr syndrome. Presented with C/O 7 day history of numbness in hands, arms, feet, legs and tongue. Day after onset of symptoms felt better and played golf. Symptoms began 1 week after vaccine. PE: decreased temperature sensation cranial nerve 7 inability to close eyes.Positive Romberg decreased strength in extremities. Wide-based gait. No reflexes in upper or lower extremities. Treated with IVIG. Syncope.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: CSF immunoglobulin increased, CSF protein increased, CSF test abnormal, Dysarthria, Facial paresis
Clinical narrative: Patient received Shingles vaccine on 5/21/08 - lot # 0295X, exp 7/25/09. Patient presented to hospital on 6/4/08 with 1 week history of progressive numbness and weakness. Exam notable for significant facial weakness, dysarthria proximal>distal weakness in an asymmetric pattern, areflexia and stocking glove sensory loss. Patient thought to have Guillain Barre syndrome. Subsequently noted to have autonomic dysfunction with labile BP - syncope X2, pulse and profuse diaphoresis. LP was done which showed cytoalbuminologic dissociation, confirming the diagnosis of GBS. Titers for other infectious causes pending but no history of recent illness. The presentation is quite consistent with a vaccine induced GBS. Patient is currently receiving IVIG, tolerating well with questionable improvement after 4th infusion. 7/30/08-records received for DOS 6/4-6/17/08-DC DX:Guillain-Barr syndrome. Presented with C/O 7 day history of numbness in hands, arms, feet, legs and tongue. Day after onset of symptoms felt better and played golf. Symptoms began 1 week after vaccine. PE: decreased temperature sensation cranial nerve 7 inability to close eyes.Positive Romberg decreased strength in extremities. Wide-based gait. No reflexes in upper or lower extremities. Treated with IVIG. Syncope.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Hyperhidrosis, Hypoaesthesia, Nuclear magnetic resonance imaging abnormal, Sensory loss
Clinical narrative: Patient received Shingles vaccine on 5/21/08 - lot # 0295X, exp 7/25/09. Patient presented to hospital on 6/4/08 with 1 week history of progressive numbness and weakness. Exam notable for significant facial weakness, dysarthria proximal>distal weakness in an asymmetric pattern, areflexia and stocking glove sensory loss. Patient thought to have Guillain Barre syndrome. Subsequently noted to have autonomic dysfunction with labile BP - syncope X2, pulse and profuse diaphoresis. LP was done which showed cytoalbuminologic dissociation, confirming the diagnosis of GBS. Titers for other infectious causes pending but no history of recent illness. The presentation is quite consistent with a vaccine induced GBS. Patient is currently receiving IVIG, tolerating well with questionable improvement after 4th infusion. 7/30/08-records received for DOS 6/4-6/17/08-DC DX:Guillain-Barr syndrome. Presented with C/O 7 day history of numbness in hands, arms, feet, legs and tongue. Day after onset of symptoms felt better and played golf. Symptoms began 1 week after vaccine. PE: decreased temperature sensation cranial nerve 7 inability to close eyes.Positive Romberg decreased strength in extremities. Wide-based gait. No reflexes in upper or lower extremities. Treated with IVIG. Syncope.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Patient received Shingles vaccine on 5/21/08 - lot # 0295X, exp 7/25/09. Patient presented to hospital on 6/4/08 with 1 week history of progressive numbness and weakness. Exam notable for significant facial weakness, dysarthria proximal>distal weakness in an asymmetric pattern, areflexia and stocking glove sensory loss. Patient thought to have Guillain Barre syndrome. Subsequently noted to have autonomic dysfunction with labile BP - syncope X2, pulse and profuse diaphoresis. LP was done which showed cytoalbuminologic dissociation, confirming the diagnosis of GBS. Titers for other infectious causes pending but no history of recent illness. The presentation is quite consistent with a vaccine induced GBS. Patient is currently receiving IVIG, tolerating well with questionable improvement after 4th infusion. 7/30/08-records received for DOS 6/4-6/17/08-DC DX:Guillain-Barr syndrome. Presented with C/O 7 day history of numbness in hands, arms, feet, legs and tongue. Day after onset of symptoms felt better and played golf. Symptoms began 1 week after vaccine. PE: decreased temperature sensation cranial nerve 7 inability to close eyes.Positive Romberg decreased strength in extremities. Wide-based gait. No reflexes in upper or lower extremities. Treated with IVIG. Syncope.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Headache, Herpes zoster, Rash, Trigeminal neuralgia
Clinical narrative: Patient received Zostavax 2 1/2 weeks ago. She developed right sided head pain 2 weeks ago, right facial pain and sensitivity 1 week ago and rash on face 3 days ago consistent with a clinical case of Zoster -shingles- involving the trigeminal nerve 1st and second branch. No eye involvement thus far.  7/15/08 Reviewed PCP medical records of 5/12-6/9/08. FINAL DX:  Facial shingles w/trigeminal nerve involvement Records reveal patient w/left ear drainage & pain on 5/12 & tx w/topical & oral antibiotics.  RTC 6/9 with shooting pain right scalp x 2 wks which had progressively gotten worse.  Facial rash x 2-3 days w/burning sensation.  Exam revealed erythematous papules & vesicles on right face w/ulcerations, hemorrhagic crusts, increased touch sensitivity over face & right scalp.  Tx w/antibiotics & pain meds. Follow-up: The patient developed clinical zoster a few days after receiving the vaccine. The rash cleared after 3 weeks, but pain persisted despite Acyclovir and gabapentin initially. Gabapentin ongoing for about 6 more weeks. She had recurrence of similar pain mildly 6 months later which resolved after about 1 week without Rx. Today feels well.
Age: 51.0
Sex: F
Vaccine: RUB, RUB
Symptoms: Arthralgia, Burning sensation, Joint swelling
Clinical narrative: Starting 6/3/08, employee started progressive multi-joint pain and swelling.  Also complained of "burning" along left side of throat.  Symptoms slowly resolving.  Advil taken on 6/7 and 6/8.  Employee reported symptoms on 6/9/08.
Age: 51.0
Sex: F
Vaccine: RUB, RUB
Symptoms: Arthralgia, Joint swelling, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: Starting 6/3/08, employee started progressive multi-joint pain and swelling.  Also complained of "burning" along left side of throat.  Symptoms slowly resolving.  Advil taken on 6/7 and 6/8.  Employee reported symptoms on 6/9/08.
Age: 51.0
Sex: F
Vaccine: RUB, RUB
Symptoms: Pain in extremity, Throat irritation
Clinical narrative: Starting 6/3/08, employee started progressive multi-joint pain and swelling.  Also complained of "burning" along left side of throat.  Symptoms slowly resolving.  Advil taken on 6/7 and 6/8.  Employee reported symptoms on 6/9/08.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: L posterior deltoid-to L arm a red, raised bump size of a pea (1/2 in diameter) -> no drainage, but a center felt to middle red raised area of L posterior deltoid.  No pain or warmth felt or noted to this area.
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Dyspnoea
Clinical narrative: Child received BOOSTRIX and HAVRIX during well child checkup. After returning home child developed SOB. Paramedics were called. B/P-ok, PO-98%, no further treatment needed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Neck pain, Pyrexia, Vomiting
Clinical narrative: Mom requested this be reported, but is aware that this is not a true contraindication to vaccine.  5 hrs. after vaccine, mom noted fever <105 degrees, vomiting x2, and child c/o neck pain.  No further vomiting today, fever 100 degrees today.  Child eating & drinking.  Mom was reluctant to get shots on the day of visit.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Dizziness, Gait disturbance, Pyrexia
Clinical narrative: Temperature increase 105, dizzy, gait off.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Patient got varicella with being vaccinated once at 12 months of age
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Lip swelling, Nausea, Oral pain, Pruritus
Clinical narrative: Received MMR, DTAP and IPV immunizations.  Within 10 minutes, child complained of itchy, red palms, blotchy rash, nausea, vomited x2.  Patient complained of mouth felt "funny", "it hurt."  Within 30 minutes - skin red over entire body, lips slightly swollen.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Rash macular, Stomatitis, Vomiting
Clinical narrative: Received MMR, DTAP and IPV immunizations.  Within 10 minutes, child complained of itchy, red palms, blotchy rash, nausea, vomited x2.  Patient complained of mouth felt "funny", "it hurt."  Within 30 minutes - skin red over entire body, lips slightly swollen.
Age: 10.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Confusional state, Wrong drug administered
Clinical narrative: Pt had immunization delay.  Tdap ordered.  DTaP administered.  Guardian was called to inform her of error & to monitor for increased pain, tenderness.  She stated since immunization a few hrs prior child "loopy" & confused-he asked her several times when he had to go back and couldn't remember answer.  She stated he was self now.  No seizure no fever.  Instructed to ED if any recurrence or any level of concern.
Age: 8.0
Sex: M
Vaccine: UNK
Symptoms: Autism
Clinical narrative: "Patient" was a perfectly healthy child until he received standard vaccines, most of which I have heard have been recalled. As a result, "patient" has and now suffers from extreme Autism.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: C/O headache.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: C\O severe headache
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: Complained of severe headache
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain upper, Headache, Nausea
Clinical narrative: 15 mins post vaccination c/o nausea, headache, stomach ache.  Not resolved after 35 mins. Child seen by school nurse parent called to take child home.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: C\O light headiness, dizziness (monitored, sent home with guardian)
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache
Clinical narrative: Complained of dizziness/headache.  Monitored/given lunch/sent home with parent 1:00 pm.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache
Clinical narrative: Headache, dizziness.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Respiratory distress
Clinical narrative: C/O Respiratory Distress Hx of asthma, no inhaler available, 911 phoned taken to ER
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: C/O  localized redness, itching, swelling which spread down R arm with progressive worsening.  No shortness of breath.  Given 50 mg IM BENADRYL per Dr.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Complained of scattered red raised bumps to right forearm. Slight itching; monitored for signs and symptoms of respiratory distress; parent notified; Sent home with parents and instructions for po. Benadryl; follow up with MD.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: C\O headache, nausea/vomiting, monitored x2 hours, sent home with guardian. TC made to parent just getting over sore throat/sinus infection.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache
Clinical narrative: Complained of dizziness and headache, monitored for 1 hour, parent notified, sent back to class.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Heart rate normal, Respiratory rate
Clinical narrative: C/O dizziness (monitored pulse 83 resp 17) x1 hour symptoms did not improve 911 called sent to ER.
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Swelling
Clinical narrative: C/O small red raised bump to R wrist. Pre-existing red raised bump on R upper eyelid with swelling.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature, Headache, No reaction on previous exposure to drug
Clinical narrative: Spoke with mother of 15 yo who states "took child to ER for c/o terrible headache.  No nausea/vomiting slight temperature 99.4.  Per mom has taken childhood immunizations OK in the past (still has not been seen by MD).
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Vomiting
Clinical narrative: Headache and vomiting
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: Complained of pain injection site and radiating up the left shoulder, neck, and occipital.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Erythema, Head injury, No reaction on previous exposure to drug
Clinical narrative: Child stated felt weak post vaccination, states hit head on handrail on stairs, no bleeding, redness noted B/P taken by school nurse 110/70 P 80. Will notify Pt MD if need. States grandmother. Grandmother came to pick up child. Mother called stated no previous reaction to vaccination.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Nausea
Clinical narrative: Complained of nausea and dizziness.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Complained feeling dizzy - PHS
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: Complained of left temporal headache, getting better (10:50 AM).  Denies skipping breakfast.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: L temporal lobe scale of 4 (0-10) headache
Age: 13.0
Sex: M
Vaccine: MNQ, UNK
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Complained of headache, nausea, and vomiting. Denied eating breakfast. Refused orange juice and doughnut
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache
Clinical narrative: Complained of dizziness with beginning headache.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Dry skin, Fatigue, Skin warm
Clinical narrative: Pt c/o of feeling tired, no pain, slight dizziness, no headache, no SOB. Pain score is 0. Pt is alert and oriented x3. Skin warm and dry. Walks with steady gait.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: Complained of headache (frontal). Ate doughnut, apple before shot
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache, Musculoskeletal pain, Neck pain
Clinical narrative: C/O Dizziness and L shoulder pain radiating to neck and occipital lobe - recovering from dizziness after 30 min. Sent home with recommends to take TYLENOL for pain and warm compress to shoulder.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Grip strength decreased, Headache, Injected limb mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Patient complained of increased left hand swelling, "turned purple" and pain in hand - thumbs and 1st finger, after receiving vaccine in left deltoid (0.5mL of meningococcal vaccine). Physical exam: no circulatory deficits, no swelling, no sensory deficits of left arm. * See attached: Patient complained of feeling pain in her left hand, swelling of left hand, and that her left hand turned "purple" soon after receiving her meningococcal vaccine, IM in her left deltoid. She also stated that she had a headache - she denied photosensitivity. Exam revealed 2+ radial pulses bilaterally, no circulatory deficits to left hand, no sensory deficits to left hand (simple touch). Patient was reluctant to strong left grip, to abduction of her left arm more than 110 degrees of elevation, because she complained of pain her left deltoid with these activities. Left deltoid (site of vaccination) had no swelling, warmth or erythema, and was somewhat tender to palpation. Patient stated she thought she would be okay during her last class, and had friends to walk her home. She stated she could not take pills, and usually takes pain medicine in liquid form. Since we had no liquid pain medicine available on site, she was instructed to take some pain medication (ibuprofen, acetaminophen) when she arrived home, and to inform her parent(s) and family doctor if she had worsening or persisting pain or discomfort.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Palpitations, Skin discolouration, Tenderness
Clinical narrative: Patient complained of increased left hand swelling, "turned purple" and pain in hand - thumbs and 1st finger, after receiving vaccine in left deltoid (0.5mL of meningococcal vaccine). Physical exam: no circulatory deficits, no swelling, no sensory deficits of left arm. * See attached: Patient complained of feeling pain in her left hand, swelling of left hand, and that her left hand turned "purple" soon after receiving her meningococcal vaccine, IM in her left deltoid. She also stated that she had a headache - she denied photosensitivity. Exam revealed 2+ radial pulses bilaterally, no circulatory deficits to left hand, no sensory deficits to left hand (simple touch). Patient was reluctant to strong left grip, to abduction of her left arm more than 110 degrees of elevation, because she complained of pain her left deltoid with these activities. Left deltoid (site of vaccination) had no swelling, warmth or erythema, and was somewhat tender to palpation. Patient stated she thought she would be okay during her last class, and had friends to walk her home. She stated she could not take pills, and usually takes pain medicine in liquid form. Since we had no liquid pain medicine available on site, she was instructed to take some pain medication (ibuprofen, acetaminophen) when she arrived home, and to inform her parent(s) and family doctor if she had worsening or persisting pain or discomfort.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Blood glucose increased, Blood pressure decreased, Loss of consciousness, Oxygen supplementation
Clinical narrative: After the patient received TDAP and MENACTRA, he passed out. It took a while for him to come around. He received O2 til recovered. The patient went home 1 1/2 - 2 hrs after episode.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: Patient was to receive HPV vaccine. The bottle that was available did not look like the usual vaccine that is given. Consult made with medical director of immunization and technician instructed by MD to give the immunization. It was discovered the next day that this was in fact HPV antibody reagent given to the patient. Patient was by the medical director and had no symptoms. Unable to contact manufacturer until the next business day. Manufacturer contacted and MSDS obtained. Poison Control Center contacted. Per Poison Control, no adverse effects are expected.
Age: 68.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Urticaria
Clinical narrative: Urticaria within 12 hrs of vaccination - pt rec'd antihistamine/IV Solemedrol (120g) in ER given RX for PREDNISONE but did not take it we discontinued it. Urticaria persists at day 6.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pyrexia, Rash generalised
Clinical narrative: Symptoms appeared evening of 5/30/08 - sore arm.  Morning of 5/31/08 arm severely swollen, red and hot, fever (100 F) and rash over body.  Symptoms lasted until 6/3/08.  Treatment - Tylenol and heat pack.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Symptoms appeared evening of 5/30/08 - sore arm.  Morning of 5/31/08 arm severely swollen, red and hot, fever (100 F) and rash over body.  Symptoms lasted until 6/3/08.  Treatment - Tylenol and heat pack.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Limb discomfort, Muscle twitching
Clinical narrative: Patient reported his muscles felt "twitchy" and he felt like he needed to stretch.  Then after he was uncomfortable while sitting in a meeting from feeling in leg muscles.  By 3 days post-vaccination all symptoms resolved per T.U. to patient.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Nasopharyngitis, Neuralgia, Pharyngolaryngeal pain
Clinical narrative: Red rash on R great toe with hives. No scabbing, sore throat and cold symptoms at same time, Nerve pain. Ibuprophen and ABSORBINE Jr. Healed in 2-2 1/2 wks. (Pt thinks shingles).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Red rash on R great toe with hives. No scabbing, sore throat and cold symptoms at same time, Nerve pain. Ibuprophen and ABSORBINE Jr. Healed in 2-2 1/2 wks. (Pt thinks shingles).
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Erythema, Rash, Rash macular
Clinical narrative: Red splotchy rash appeared on face, neck, and shoulders.  She had cried before and during immunization injections.  Rash appeared approximately 3-5 minutes after administration of vaccines.  No respiratory distress, she stated she had no problem breathing.  She was monitored for 30 minutes at the office.  After 15 minutes rash on face had disappeared and only light reddish on neck and shoulders.  Released after 30 minutes with only one red spot below left ear approximately 1 1/2 circular inch.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Blood pressure normal, Heart rate normal, Loss of consciousness
Clinical narrative: Passed out after giving MENACTRA. Dr called to room. Pulse and BP monitored vital signs stable. Color improved. Left without incident.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash developed within 24 hrs. Lower abdomen, across buttocks and right leg. Within 3 days, antibiotic treatment started; rash gone in 7 days; Percocet and Gabapentum for pain--no appetite
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Grand mal convulsion
Clinical narrative: Employee reports that she "had a grand mal seizure" at approx 7:15 pm last evening. She states that she did not seek treatment, she "went to bed". States that she "is fine" today. Last TD vaccine was 205, Medical DX: AVM, Seizure disorder.
Age: 11.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Headache, Injection site pain, Injection site swelling, Oedema peripheral, Pyrexia
Clinical narrative: Fever 101, vomiting, headache, swollen, tender injection site and upper arm.
Age: 11.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Vomiting
Clinical narrative: Fever 101, vomiting, headache, swollen, tender injection site and upper arm.
Age: 49.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Patient given vaccine 5/27/08 - returned to clinic 5/29/08 - had no complaints. Over weekend developed itchy red raised "hive" appearance rash. Seen by MD 6/2/08 - Benadryl ordered and cold compresses
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: In for routine physical. Was given three vaccinations. ADACEL, MENACTRA, and VARIVAX which caused a reaction-per parents.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Vaccination complication
Clinical narrative: In office for routine visit. Given 3 vaccines - Adacel Tdap), MCV4, Varicella. The Varicella caused a reaction, per Dr..
Age: 40.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of drug administration, Pain, Secondary transmission, Varicella
Clinical narrative: Patient developed headache, body aches and occasional pox 2 days after injection. His 4yr daughter developed chicken pox (dx by pedi) 1 week after his symptom began. She had been vaccinated so had a very mild case
Age: 34.0
Sex: F
Vaccine: ANTH, HEP, TYP
Symptoms: Arthralgia, Joint swelling, Rash, Rash pruritic, Vision blurred
Clinical narrative: About 3 weeks after the vaccines she developed small pink bumps on her arms and legs, more severe on the legs. The rash was intensely pruritic and as she scratched it, it enlarged. The pruritis kept her awake at night and lasted 1 month. She took Benadryl which provided minimal relief. Calamine lotion and lavender all were also soothing. She noticed minimal benefit from the application of flucinonide cream 0.05% or Triamcinolone acetonide cream 0.5%- she used these creams for about 1 week. She was offered and declined use of a Medrol dose pack. She denies any new detergents, skin cleansers, lotions, or other skin care products. No new clothing or bedding. No new foods. No travel, gardening or other household chemical use around the time the rash started. No new pets. No history of eczema/atopic dermatitis or other skin rashes/reactions. No associated wheezing or swelling. The rash was confined to her extremities- no facial/scalp/trunk involvement. Currently without rash (6/9/08). In the past she was had mild seasonal allergies (itchy throat, sneezing watery eyes) in the spring and summer months, but reports that this year's season was quite mild for her. She denies any unusual or prolonged symptoms at injection sites (all vaccines received on R) upper arm). She denies any viral-type symptoms within the 1st 2 weeks following vaccine receipt - no fever, chills, fatigue, myalgias or headaches. She did note her left elbow felt/looked swollen compared to her right "early on" with the rash. She has since noted some minor aching pain of her elbows and ankles. (No joint swelling, redness, or warmth.) Joint pain is tolerable and does not interfere with duties. Notes pain is worse upon awakening. Pain in ankles increases with weight bearing activities and pain in elbows increases after push-ups. Has taken Tylenol when pain at its worst with some improvement. She also noted some aching type pain around her right eye with some visual "fogginess' but no significant visual changes (resolved)
Age: 34.0
Sex: F
Vaccine: ANTH, HEP, TYP
Symptoms: Weight bearing difficulty
Clinical narrative: About 3 weeks after the vaccines she developed small pink bumps on her arms and legs, more severe on the legs. The rash was intensely pruritic and as she scratched it, it enlarged. The pruritis kept her awake at night and lasted 1 month. She took Benadryl which provided minimal relief. Calamine lotion and lavender all were also soothing. She noticed minimal benefit from the application of flucinonide cream 0.05% or Triamcinolone acetonide cream 0.5%- she used these creams for about 1 week. She was offered and declined use of a Medrol dose pack. She denies any new detergents, skin cleansers, lotions, or other skin care products. No new clothing or bedding. No new foods. No travel, gardening or other household chemical use around the time the rash started. No new pets. No history of eczema/atopic dermatitis or other skin rashes/reactions. No associated wheezing or swelling. The rash was confined to her extremities- no facial/scalp/trunk involvement. Currently without rash (6/9/08). In the past she was had mild seasonal allergies (itchy throat, sneezing watery eyes) in the spring and summer months, but reports that this year's season was quite mild for her. She denies any unusual or prolonged symptoms at injection sites (all vaccines received on R) upper arm). She denies any viral-type symptoms within the 1st 2 weeks following vaccine receipt - no fever, chills, fatigue, myalgias or headaches. She did note her left elbow felt/looked swollen compared to her right "early on" with the rash. She has since noted some minor aching pain of her elbows and ankles. (No joint swelling, redness, or warmth.) Joint pain is tolerable and does not interfere with duties. Notes pain is worse upon awakening. Pain in ankles increases with weight bearing activities and pain in elbows increases after push-ups. Has taken Tylenol when pain at its worst with some improvement. She also noted some aching type pain around her right eye with some visual "fogginess' but no significant visual changes (resolved)
Age: 1.02
Sex: M
Vaccine: HEPA, PNC
Symptoms: Full blood count abnormal, Inappropriate schedule of drug administration, Injection site erythema, Irritability, Local reaction
Clinical narrative: Patient received vaccine on 06/10/08 - Returned to office with fever 100deg, restless at night and extreme irritability and local reaction 4.5x6.5cm site of injection redness.
Age: 1.02
Sex: M
Vaccine: HEPA, PNC
Symptoms: Platelet count normal, Pyrexia, Restlessness
Clinical narrative: Patient received vaccine on 06/10/08 - Returned to office with fever 100deg, restless at night and extreme irritability and local reaction 4.5x6.5cm site of injection redness.
Sex: U
Vaccine: TTOX
Symptoms: Borrelia burgdorferi serology negative, Cytomegalovirus antibody negative, Epstein-Barr virus test, Immunology test, Medical device complication
Clinical narrative: When attaching a needle to syringe, the syringe snapped at the junction of the barrel and luer-lock end. The product was Tetanus-Diphtheria syringes LOT#U2287AA EXP: 02JUL09.
Age: 1.0
Sex: M
Vaccine: MEA, PNC, VARCEL
Symptoms: Anorexia, Erythema, Erythema infectiosum, Immediate post-injection reaction, Irritability
Clinical narrative: He had an immediate fever for 2-3 days with a rash starting at neck and working over entire body on 6th day after shot.  He was very irritable and showed signs of lost appitite through out the week.  Revisited the doctor 10 days after vaccination showing signs of redness in ears and a more developed rash over entire body.  Prescribed w/ Immoxicelin @ 6.25ml 2 twice a day. After 8 days a more prominant rash returned over entire body. Dr diagnosis of B19 (fifths desease) virus on 6/11 without blood test and told to stop medication. Patient had not previously been sick other than a small fever from previous vaccinations. Rash and irritablity still present 6/13/08.
Age: 1.0
Sex: M
Vaccine: MEA, PNC, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: He had an immediate fever for 2-3 days with a rash starting at neck and working over entire body on 6th day after shot.  He was very irritable and showed signs of lost appitite through out the week.  Revisited the doctor 10 days after vaccination showing signs of redness in ears and a more developed rash over entire body.  Prescribed w/ Immoxicelin @ 6.25ml 2 twice a day. After 8 days a more prominant rash returned over entire body. Dr diagnosis of B19 (fifths desease) virus on 6/11 without blood test and told to stop medication. Patient had not previously been sick other than a small fever from previous vaccinations. Rash and irritablity still present 6/13/08.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intestinal obstruction, Intussusception, Surgery
Clinical narrative: Acute bowel obstruction due to irreducible intussusception, required surgery at hospital. Tissue samples sent to CDC Atlanta for testing. Child recovered and discharged home on 5/28/08.  6/24/08 Reviewed hospital medical records of 5/24-5/28/2008. FINAL DX: bowel obstruction secondary to nonreducible intussusception Records reveal patient had been transferred from outlying ER.  Patient experienced bilious vomiting x 2 days, acute blood per rectum, abdominal tenderness & distention.  Emergent laparotomy for abdominal exploration, ileal resection w/primary anastomosis, appendectomy & CVP placement.  Did well post operatively, tolerating oral feeds well & d/c to home
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Hypersomnia, Injection site induration, Irritability, Lethargy
Clinical narrative: Received Pediarix, PRP-T, PCV7, and RV on 6-11-2008, at approximately 10:00am.  Fever started June 11, 2008 after the vaccines were administered, fever was as high as 105 during the night.  Baby was fussy and lethargic as reported by the Day Care the morning of June 12th, sleeping more than usual, feeding okay, cried hard for about one hour and was difficult to console. Mom and baby presented in the office June 12, 2008. Vaccination sites were hard to the touch, temperature was 100.9, rectally.  General exam was negative, baby was not lethargic or irritable during the office exam.  Baby also had a fever at about 2 months of age.  At the time the fever occurred, the baby had not yet received her 2 month vaccines.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Received Pediarix, PRP-T, PCV7, and RV on 6-11-2008, at approximately 10:00am.  Fever started June 11, 2008 after the vaccines were administered, fever was as high as 105 during the night.  Baby was fussy and lethargic as reported by the Day Care the morning of June 12th, sleeping more than usual, feeding okay, cried hard for about one hour and was difficult to console. Mom and baby presented in the office June 12, 2008. Vaccination sites were hard to the touch, temperature was 100.9, rectally.  General exam was negative, baby was not lethargic or irritable during the office exam.  Baby also had a fever at about 2 months of age.  At the time the fever occurred, the baby had not yet received her 2 month vaccines.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Gaze palsy, Hypotonia, Tremor
Clinical narrative: After 3rd shot given, client slumped over, lowered to floor, eyes rolled back, began shaking, lasted approx 5 seconds.  Client came to stand shaky lco, vs stable wnl, ems called - determined client stable to go to physician ofc.  Ice pack, juice given.  Clients physician notified.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site erythema, Rash erythematous, Swelling
Clinical narrative: 50mm x 48mm red, erythemic spot on left upper arm where vaccine was given. Very difficult contacting as reported by mother of child-parents and onset reported as 24-48 hours-red raised bumps, rash. No open lesions, no blisters. Resolved without medical intervention.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Left deltoid swollen from shoulder to elbow all the way around arm.  Deltoid area hard, red, warm to the touch.  Child ran low grad fever.  Symptoms began 5/29/08.  Given Tylenol and Motrin.  Dr. called, suggested Benadryl
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Confusional state, Dysarthria, Dysphonia, Eye swelling, Fall
Clinical narrative: Patient received her vaccine then sat in a chair while her 14 year old brother got his second chicken pox shot, she was laughing and goofing around with her 12 year old brother. Then within minutes she was on the floor, her body started shaking and she started making noises.  The nurse stated that this never happened before and ran out of the room to get Dr.  After he was in the room a short time patient came to and he helped her back into the chair.  He tried telling me that it was probably 'cause her blood sugar was low from not eating, not true she ate two hours before she got her vaccine.  She was pale, confussed and talking slowly.  Dr.  then gave her some water and put an ice pack on the back of her neck, told me she'd be fine.  For the next three hours at home patient was hoarse, had slurred speech and responded to everything very slowly.  Her face ended up swollening as did her eyes, her face and eyes are still somewhat swollen today.  She hurt her right thumb when she fell, Dr. said it is probably sprained, but never took an x-ray.  We  went back to see Dr. yesterday, patient still swollen and slow.  She stated that maybe Patient just fainted because of being worked up about getting a shot but she has no idea why her speech would be slurred or why she would be hoars.  I tried to explain to her that patient was not worked up about the shot and her and her brother were goofing around when patient ended up on the floor but she wouldn't listen.  She said that when people have a siezure they will pee and poop their pants, however I have friends that have siezures and they never have done that. The paper I received after patient's reaction states that a reaction can happen within minutes to a few hours of the vaccine and the doctor keeps telling me it can't happen that fast. Patient is still swollen this morning,she just got up so I am not sure how her reactions are.  Patient gets almost all staight A+'s in school I am worried how this will effect her.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Limb injury, Nervousness, Pallor, Speech disorder, Swelling face
Clinical narrative: Patient received her vaccine then sat in a chair while her 14 year old brother got his second chicken pox shot, she was laughing and goofing around with her 12 year old brother. Then within minutes she was on the floor, her body started shaking and she started making noises.  The nurse stated that this never happened before and ran out of the room to get Dr.  After he was in the room a short time patient came to and he helped her back into the chair.  He tried telling me that it was probably 'cause her blood sugar was low from not eating, not true she ate two hours before she got her vaccine.  She was pale, confussed and talking slowly.  Dr.  then gave her some water and put an ice pack on the back of her neck, told me she'd be fine.  For the next three hours at home patient was hoarse, had slurred speech and responded to everything very slowly.  Her face ended up swollening as did her eyes, her face and eyes are still somewhat swollen today.  She hurt her right thumb when she fell, Dr. said it is probably sprained, but never took an x-ray.  We  went back to see Dr. yesterday, patient still swollen and slow.  She stated that maybe Patient just fainted because of being worked up about getting a shot but she has no idea why her speech would be slurred or why she would be hoars.  I tried to explain to her that patient was not worked up about the shot and her and her brother were goofing around when patient ended up on the floor but she wouldn't listen.  She said that when people have a siezure they will pee and poop their pants, however I have friends that have siezures and they never have done that. The paper I received after patient's reaction states that a reaction can happen within minutes to a few hours of the vaccine and the doctor keeps telling me it can't happen that fast. Patient is still swollen this morning,she just got up so I am not sure how her reactions are.  Patient gets almost all staight A+'s in school I am worried how this will effect her.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Left deltoid  with two areas of redness, warmth and induration. The first area measured 9 x 5.5 cm. with a smaller area directly underneath measuring 2.5 cm. in diameter. Both areas tender to touch. Patient was placed on doxycycline 100mg. BID x 10 days to cover unlikely cellulitis.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cardiac arrest, Death, Upper respiratory tract infection
Clinical narrative: Ex 29-week premature infant presented for routinue post NICU follow-up on 6/5/08 for 2mo.  Relatively nml Pexam (hx of RDS,Apnea, R/o spesis, anemia, hyperbilirubinemia, cholestatic jaundice, murmur, bilat inguinal hernia)  Of note only jaundice and murmur were present at time of discharge.  Patient recieved 4 vaccines on 6/5/08.  Patient presented with URI symptoms on 6/9/08 diagnoses with URI and sent home.  The baby reportedly had a cardiac arrest later that evening and did not survive. ****please note submission of similar patient of similar event with ALTE diagnosis and hospitalization (survived).  6/27/08 Link w/317530 per direction of FDA.  9/24/08 ER record received for DOD 6/10/08.  DX:  Sudden Death.  CPR unsuccessful.  Infant last seen alive at 1800. EMS on scene at 22:35. Pt found cold, stiff and puple in color.  CPR attempted but unsuccessful. Pt in rigor upon arrival in ED and prounounced. PMH: 28 wk premie. In NICU from DOB 3/29/08 until 4/29/08 with DX: Respiratory Distress syndrome.  Apnea of Prematurity.  R/O Sepsis x3.  R/O NEC. Jaundice.  Nutritional support. R/O IVH and PVL.  Temperature Support. Infant on CPAP and NC O2. Had apnea, bradycardia and O2 desats.  3 episodes of sepsis w/u. Had physiologic jaundice requiring phototherapy. On parenteral feeds with intermittant enteral feeds. D/C on O2 and monitoring./pc 9/29/08 ME's report received.  Probable COD Acute Bronchopneumonia.  DX:  Acute bronchopnemonia, moderate.  Cholestasis. Microscopic exam of the lungs reveals moderate acute bronchopneumonia present w/in the major and minor bronchi and alveolar spaces.  Focal atelectasis. Liver shows diffuse cholestasis with bile plugs present.  Slight chronic inflammation.  Severe autolysis.  10/30/08 PCP records received which include d/c summary for 2+month NICU stay with D/C 6/4/08. Seen in f/u 6/5/08-cholestatic jaundice, anemia, ROP and scrotal masses (hydroceles) noted. Otherwise normal premie exam. Vax given. Seen again 6/9/08 for cough and congestion with Impression URI. RR 60. P ox 95%. Wet cough, wheeze and rhonchi noted (clear A/P/L). Nasal saline and suction as sympromatic care. To f/u in 1-2 days or to ER PRN.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cardiac arrest, Cough, Death, Nasopharyngitis
Clinical narrative: Ex 29-week premature infant presented for routinue post NICU follow-up on 6/5/08 for 2mo.  Relatively nml Pexam (hx of RDS,Apnea, R/o spesis, anemia, hyperbilirubinemia, cholestatic jaundice, murmur, bilat inguinal hernia)  Of note only jaundice and murmur were present at time of discharge.  Patient recieved 4 vaccines on 6/5/08.  Patient presented with URI symptoms on 6/9/08 diagnoses with URI and sent home.  The baby reportedly had a cardiac arrest later that evening and did not survive. ****please note submission of similar patient of similar event with ALTE diagnosis and hospitalization (survived).  6/27/08 Link w/317530 per direction of FDA.  9/24/08 ER record received for DOD 6/10/08.  DX:  Sudden Death.  CPR unsuccessful.  Infant last seen alive at 1800. EMS on scene at 22:35. Pt found cold, stiff and puple in color.  CPR attempted but unsuccessful. Pt in rigor upon arrival in ED and prounounced. PMH: 28 wk premie. In NICU from DOB 3/29/08 until 4/29/08 with DX: Respiratory Distress syndrome.  Apnea of Prematurity.  R/O Sepsis x3.  R/O NEC. Jaundice.  Nutritional support. R/O IVH and PVL.  Temperature Support. Infant on CPAP and NC O2. Had apnea, bradycardia and O2 desats.  3 episodes of sepsis w/u. Had physiologic jaundice requiring phototherapy. On parenteral feeds with intermittant enteral feeds. D/C on O2 and monitoring./pc 9/29/08 ME's report received.  Probable COD Acute Bronchopneumonia.  DX:  Acute bronchopnemonia, moderate.  Cholestasis. Microscopic exam of the lungs reveals moderate acute bronchopneumonia present w/in the major and minor bronchi and alveolar spaces.  Focal atelectasis. Liver shows diffuse cholestasis with bile plugs present.  Slight chronic inflammation.  Severe autolysis.  10/30/08 PCP records received which include d/c summary for 2+month NICU stay with D/C 6/4/08. Seen in f/u 6/5/08-cholestatic jaundice, anemia, ROP and scrotal masses (hydroceles) noted. Otherwise normal premie exam. Vax given. Seen again 6/9/08 for cough and congestion with Impression URI. RR 60. P ox 95%. Wet cough, wheeze and rhonchi noted (clear A/P/L). Nasal saline and suction as sympromatic care. To f/u in 1-2 days or to ER PRN.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Peripheral vascular disorder, Sleep disorder, Thrombosis, Weight decreased
Clinical narrative: This case is poorly documented. Information has been received from a consumer report which appeared in a television bulletin on 27-MAY-2008. It was reported by the mother of the patient that her 18 year old daughter was vaccinated with the first dose of GARDASIL on an unspecified date and was well tolerated. The second dose of GARDASIL, lot #, route and administration site not reported, was given in May-2007. Subsequently on an unknown date, the patient developed a thrombosis (not otherwise specified) and complained about weight loss, sleeping and circulatory disorder. Outcome was not reported. The reporter considered thrombosis, insomnia, circulatory disorder peripheral, and weight loss to be other important medical event. Additional information has been requested. Other business partner numbers include E2008-05381.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash vesicular, Serology negative, Varicella
Clinical narrative: Patient was given varicella vacination on May 30, 2008. On June 12, 2008 called c/o itching varicella like pox on arms and scalp.  Was advised to f/u with ER if symptoms worsen and to come in to our office on June 13, 2008. She was then diagnosed with what seems to be chicaken pox.
Age: 70.0
Sex: F
Vaccine: FLU3, MNQ, PPV
Symptoms: Inappropriate schedule of drug administration, Injection site erythema
Clinical narrative: redness at injection site at day 7 after injection
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blister, Erythema, Induration, Local reaction, Secretion discharge
Clinical narrative: About 27 hours after vaccine about 3 inch diameter local redness. 28 hours after there was some scant serous discharge from the center of the redness.  By about 32 hours after vaccination there was redness and induration that had largely covered her anterior thigh. By 42 hours after vaccination there were a 4 inch diameter patch of vesicles (blisters) the redness and induration had somewhat improved. There were no fevers or systemic symptoms.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Abnormal behaviour, Body temperature increased, Cough, Heat rash, Injection site erythema
Clinical narrative: Local at injection site:erythematous rash x7+days, 1 week post injection elevated temp > 103, difficult to respond to oral NSAID's, temp has lasted over 5+ days, prickly heat type rash on back and neck (remains evident at time of report), muscle aches, malaise, cough, behavior changes (argumentative and combative even when temp was < 100), URI symptoms runny nose and congestion...URI symptoms are still evident at time of this report. Was seen by pediatrician who diagnosed this as a viral syndrome...
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Local reaction, Malaise, Myalgia, Respiratory tract congestion
Clinical narrative: Local at injection site:erythematous rash x7+days, 1 week post injection elevated temp > 103, difficult to respond to oral NSAID's, temp has lasted over 5+ days, prickly heat type rash on back and neck (remains evident at time of report), muscle aches, malaise, cough, behavior changes (argumentative and combative even when temp was < 100), URI symptoms runny nose and congestion...URI symptoms are still evident at time of this report. Was seen by pediatrician who diagnosed this as a viral syndrome...
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rhinorrhoea, Upper respiratory tract infection, Viral infection
Clinical narrative: Local at injection site:erythematous rash x7+days, 1 week post injection elevated temp > 103, difficult to respond to oral NSAID's, temp has lasted over 5+ days, prickly heat type rash on back and neck (remains evident at time of report), muscle aches, malaise, cough, behavior changes (argumentative and combative even when temp was < 100), URI symptoms runny nose and congestion...URI symptoms are still evident at time of this report. Was seen by pediatrician who diagnosed this as a viral syndrome...