chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: 5-8-11 Clt states developed a sore arm where vaccine was given on 5-4-12. On 5-5-12 upper arm became red, hot, swollen & hard, the evening of 5-7-12 clt states developed flu like sx - HA, fatigue, sore throat. No fever. On 5-8-12 still has sore throat with pain in the shoulder blades & body aches. Advised clt to see health care provider & will f/u with phone call in two days. 5-11-12 T.C. to clt - clt went to doctor on 5-9-11. Per clt, doctor thought flu-like sx not R/T shot. Clt tested for pertussis (lab pending) & put on ZITHROMAX, client states is feeling better & the arm swelling has resolved.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Presyncope
Clinical narrative: Vasovagal event, approximately 2 min after administered. Came to approx. 2 min, went home after 15 min.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient started having cellulitis at the site of injection on 05/09/12. It was red & hot and 6 x 3 as described by the patient. Pt was painful as well. Patient seen the doctor on 05/10/12 & was given Cephalexin 500 mg to take tid.  Patient is getting better on 05/11/12.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Dyskinesia, Musculoskeletal stiffness, Tenderness
Clinical narrative: Pt reported that within 24 hrs post immunization on 08 May he was unable to open mouth. No hx of injury, no prior hx. Nml occlusion. Per PCM unable to open mouth more than a few mm. Denies fevers, pain, cramping. Reports stiffness of muscles about (R) angle of mandible with some assoc tenderness. Given cyclobenzaprine and methocarbamol. Was seen in follow up on 10 May and reports after taking the prescribed med, he has been able to open his mouth normally without pain or spasm since 2400 hours previous night. Currently, he has been feeling well without having jaw spasms, able to communicate clearly and normally.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Dyskinesia, Musculoskeletal stiffness, Myalgia, Trismus
Clinical narrative: Pt reported that within 24 hrs post immunization on 08 May he was unable to open mouth. No hx of injury, no prior hx. Nml occlusion. Per PCM unable to open mouth more than a few mm. Denies fevers, pain, cramping. Reports stiffness of muscles about (R) angle of mandible with some assoc tenderness. Given cyclobenzaprine and methocarbamol. Was seen in follow up on 10 May and reports after taking the prescribed med, he has been able to open his mouth normally without pain or spasm since 2400 hours previous night. Currently, he has been feeling well without having jaw spasms, able to communicate clearly and normally.
Sex: F
Vaccine: FLUX
Symptoms: Neuritis, Pain
Clinical narrative: October I got the flu vaccine in my left arm, I have had pain ever since. I reported this to my employer and my Dr. I then went online and sent to your web site. I have never heard back. I have neuritis now in my arm. Please contact me.
Age: 12.0
Sex: U
Vaccine: HPV4, IPV, MNQ, TDAP, HPV4, IPV, MNQ, TDAP
Symptoms: Haemoglobin normal, Loss of consciousness, Pallor, Posture abnormal
Clinical narrative: Pt got very pale & head back but woke up right away. Put head down bet. legs & doctor came & assisted pt to exam table & sit pt up reverse Trendelenburg. At the time of event pt also has Hgb 11.3. Pt went home in good spirit, walking fine. 5/15/12 TC to mom & pt doing well. No s/s of reaction after event 5/10/12.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Cellulitis, Rash
Clinical narrative: Rash, resulting in cellulitis. Asthma attack.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Pain, Painful respiration, Tearfulness
Clinical narrative: Client complained that it hurt to breathe to mother that night.  Denies injury.  Chest hurts to breathe and was in tears.  Mother gave ibuprofen.  Monday 5-14-12 it hurt to move but was better at rest. Instructed to call their doctor to follow up with.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles rash.
Age: 65.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Client states woke up with diarrhea at 1:30 am and has continued since. Has vomited one time yesterday.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Induration
Clinical narrative: Large indurated, erythema area 9.5cm x 8cm.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Cold sweat, Decreased appetite, Emotional distress, Injection site discolouration, Injection site induration
Clinical narrative: Major discoloration, swelling, hardness, warm-to-the-touch, tenderness, and pain at injection site.  Vomiting.  Loss of appetite.  Cold sweats (dripping wet with sweat), no fever.  Inconsolable.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Vomiting
Clinical narrative: Major discoloration, swelling, hardness, warm-to-the-touch, tenderness, and pain at injection site.  Vomiting.  Loss of appetite.  Cold sweats (dripping wet with sweat), no fever.  Inconsolable.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: L arm became swollen, red, and painful. 5/9/2012 reports to clinic with c/o swollen, red, painful arm. L arm SQ injection site red, swollen, warm to touch, with darker red, raised center approx. 2 in x 0.5 in. L arm IM site slightly swollen and red. R arm SQ site slightly red. Mom reports using OTC pain reliever and cool compresses without much relief. Advised to see MD. 5/16/2012 f/u call made to mother. She reports MD prescribed Keflex. Before keflex had been started child c/o "itchy feet" and mom noticed "welts" on bottom of feet. Child saw MS again. Diagnosed as "hives." Claritin and a topical cream for feet was prescribed. Hives resolved in a couple of days. Reports little change to L arm. Site still red and swollen, raised area in center looks "red/purple, almost bruised like" not as tender. R arm is "fine" Denies any difficulty with breathing.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: L arm became swollen, red, and painful. 5/9/2012 reports to clinic with c/o swollen, red, painful arm. L arm SQ injection site red, swollen, warm to touch, with darker red, raised center approx. 2 in x 0.5 in. L arm IM site slightly swollen and red. R arm SQ site slightly red. Mom reports using OTC pain reliever and cool compresses without much relief. Advised to see MD. 5/16/2012 f/u call made to mother. She reports MD prescribed Keflex. Before keflex had been started child c/o "itchy feet" and mom noticed "welts" on bottom of feet. Child saw MS again. Diagnosed as "hives." Claritin and a topical cream for feet was prescribed. Hives resolved in a couple of days. Reports little change to L arm. Site still red and swollen, raised area in center looks "red/purple, almost bruised like" not as tender. R arm is "fine" Denies any difficulty with breathing.
Age: 64.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Decreased activity, Fatigue, Malaise, Muscle spasms, Myalgia
Clinical narrative: Significant generalized muscle pain, malaise, leg spasms at night.  More fatigued and less functional.  Continues at this time.  Will see PCP next week.
Age: 64.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Fatigue, Malaise, Muscle spasms, Pain
Clinical narrative: Significant generalized muscle pain, malaise, leg spasms at night.  More fatigued and less functional.  Continues at this time.  Will see PCP next week.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Lymphadenopathy
Clinical narrative: Patient had small left supra clavicular adenopathy without erythema following the administration of rabies vaccine.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Local reaction, Swelling, Vomiting
Clinical narrative: Local reaction-redness and swelling.  Also had vomiting.
Age: 0.4
Sex: U
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Biopsy skin abnormal, Blister, Blood creatinine, Dermatitis bullous, Histamine normal
Clinical narrative: This case was reported in a literature article and described the occurrence of severe bullous eruption in a 5-month-old subject of unspecified gender who was vaccinated with Hib (manufacturer unspecified), SYNFLORIX, poliomyelitis, unspecified, Rotavirus vaccine and DT absorbed. Concurrent medical conditions included Diffuse Cutaneous Mastocytosis diagnosed at 3 months based on the peau d?orange appearance of his skin with positive Darier sign. Total tryptase was 64ng/ml with mature fraction of 3.1ng/ml, urinary histamine 873 mcg/gr creatinine. Skin biopsy revealed a patchy band-like infiltrate of mononuclear cells in the dermis positive for tryptase and CD117. Concurrent medication included therapy with H1 and H2-antagonists and topical sodium cromoglycate. On an unspecified date, the subject received unspecified dose of Hib (unknown route, unknown manufacturer), unspecified dose of Pneumococcal vaccine (unknown route, unknown manufacturer), unspecified dose of Poliomyelitis vaccine (unknown route, unknown manufacturer), unspecified dose of Rotavirus vaccine (unknown route, unknown manufacturer) and unspecified dose of DT (unknown route, unknown manufacturer). 1 day after vaccination with DT, Hib, Pneumococcal vaccine, Poliomyelitis vaccine and Rotavirus vaccine, the subject experienced systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fevers and generalized malaise. A 5-day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. The author considered the events were life threatening. At the time of reporting the events were resolved.
Age: 0.4
Sex: U
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Malaise, Nausea, Pyrexia, Tryptase increased, Vomiting
Clinical narrative: This case was reported in a literature article and described the occurrence of severe bullous eruption in a 5-month-old subject of unspecified gender who was vaccinated with Hib (manufacturer unspecified), SYNFLORIX, poliomyelitis, unspecified, Rotavirus vaccine and DT absorbed. Concurrent medical conditions included Diffuse Cutaneous Mastocytosis diagnosed at 3 months based on the peau d?orange appearance of his skin with positive Darier sign. Total tryptase was 64ng/ml with mature fraction of 3.1ng/ml, urinary histamine 873 mcg/gr creatinine. Skin biopsy revealed a patchy band-like infiltrate of mononuclear cells in the dermis positive for tryptase and CD117. Concurrent medication included therapy with H1 and H2-antagonists and topical sodium cromoglycate. On an unspecified date, the subject received unspecified dose of Hib (unknown route, unknown manufacturer), unspecified dose of Pneumococcal vaccine (unknown route, unknown manufacturer), unspecified dose of Poliomyelitis vaccine (unknown route, unknown manufacturer), unspecified dose of Rotavirus vaccine (unknown route, unknown manufacturer) and unspecified dose of DT (unknown route, unknown manufacturer). 1 day after vaccination with DT, Hib, Pneumococcal vaccine, Poliomyelitis vaccine and Rotavirus vaccine, the subject experienced systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fevers and generalized malaise. A 5-day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. The author considered the events were life threatening. At the time of reporting the events were resolved.
Age: 0.4
Sex: U
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Biopsy skin abnormal, Blister, Blood creatinine, Dermatitis bullous, Histamine level
Clinical narrative: This case was reported in a literature article and described the occurrence of severe bullous eruption in a 5-month-old subject of unspecified gender who was vaccinated with Hib (manufacturer unspecified), SYNFLORIX, poliomyelitis, unspecified, Rotavirus vaccine and DT absorbed. Concurrent medical conditions included Diffuse Cutaneous Mastocytosis diagnosed at 3 months based on the peau d?orange appearance of his skin with positive Darier sign. Total tryptase was 64ng/ml with mature fraction of 3.1ng/ml, urinary histamine 873 mcg/gr creatinine. Skin biopsy revealed a patchy band-like infiltrate of mononuclear cells in the dermis positive for tryptase and CD117. Concurrent medication included therapy with H1 and H2-antagonists and topical sodium cromoglycate. On an unspecified date, the subject received unspecified dose of Hib (unknown route, unknown manufacturer), unspecified dose of Pneumococcal vaccine (unknown route, unknown manufacturer), unspecified dose of Poliomyelitis vaccine (unknown route, unknown manufacturer), unspecified dose of Rotavirus vaccine (unknown route, unknown manufacturer) and unspecified dose of DT (unknown route, unknown manufacturer). 1 day after vaccination with DT, Hib, Pneumococcal vaccine, Poliomyelitis vaccine and Rotavirus vaccine, the subject experienced systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fevers and generalized malaise. A 5-day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. The author considered the events were life threatening. At the time of reporting the events were resolved.
Age: 0.4
Sex: U
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Keratosis follicular, Malaise, Nausea, Pathology test, Peau d'orange
Clinical narrative: This case was reported in a literature article and described the occurrence of severe bullous eruption in a 5-month-old subject of unspecified gender who was vaccinated with Hib (manufacturer unspecified), SYNFLORIX, poliomyelitis, unspecified, Rotavirus vaccine and DT absorbed. Concurrent medical conditions included Diffuse Cutaneous Mastocytosis diagnosed at 3 months based on the peau d?orange appearance of his skin with positive Darier sign. Total tryptase was 64ng/ml with mature fraction of 3.1ng/ml, urinary histamine 873 mcg/gr creatinine. Skin biopsy revealed a patchy band-like infiltrate of mononuclear cells in the dermis positive for tryptase and CD117. Concurrent medication included therapy with H1 and H2-antagonists and topical sodium cromoglycate. On an unspecified date, the subject received unspecified dose of Hib (unknown route, unknown manufacturer), unspecified dose of Pneumococcal vaccine (unknown route, unknown manufacturer), unspecified dose of Poliomyelitis vaccine (unknown route, unknown manufacturer), unspecified dose of Rotavirus vaccine (unknown route, unknown manufacturer) and unspecified dose of DT (unknown route, unknown manufacturer). 1 day after vaccination with DT, Hib, Pneumococcal vaccine, Poliomyelitis vaccine and Rotavirus vaccine, the subject experienced systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fevers and generalized malaise. A 5-day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. The author considered the events were life threatening. At the time of reporting the events were resolved.
Age: 0.4
Sex: U
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Pyrexia, Tryptase increased, Vomiting
Clinical narrative: This case was reported in a literature article and described the occurrence of severe bullous eruption in a 5-month-old subject of unspecified gender who was vaccinated with Hib (manufacturer unspecified), SYNFLORIX, poliomyelitis, unspecified, Rotavirus vaccine and DT absorbed. Concurrent medical conditions included Diffuse Cutaneous Mastocytosis diagnosed at 3 months based on the peau d?orange appearance of his skin with positive Darier sign. Total tryptase was 64ng/ml with mature fraction of 3.1ng/ml, urinary histamine 873 mcg/gr creatinine. Skin biopsy revealed a patchy band-like infiltrate of mononuclear cells in the dermis positive for tryptase and CD117. Concurrent medication included therapy with H1 and H2-antagonists and topical sodium cromoglycate. On an unspecified date, the subject received unspecified dose of Hib (unknown route, unknown manufacturer), unspecified dose of Pneumococcal vaccine (unknown route, unknown manufacturer), unspecified dose of Poliomyelitis vaccine (unknown route, unknown manufacturer), unspecified dose of Rotavirus vaccine (unknown route, unknown manufacturer) and unspecified dose of DT (unknown route, unknown manufacturer). 1 day after vaccination with DT, Hib, Pneumococcal vaccine, Poliomyelitis vaccine and Rotavirus vaccine, the subject experienced systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fevers and generalized malaise. A 5-day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. The author considered the events were life threatening. At the time of reporting the events were resolved.
Age: 0.4
Sex: U
Vaccine: DT, HIBV, IPV, PNC10, RVX, DT, HIBV, IPV, PPV, RV5, DTAP, HIBV, IPV, PPV, RVX
Symptoms: Blister, Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported in a literature article and described the occurrence of severe bullous eruption in a 5-month-old subject of unspecified gender who was vaccinated with Hib (manufacturer unspecified), SYNFLORIX, poliomyelitis, unspecified, Rotavirus vaccine and DT absorbed. Concurrent medical conditions included Diffuse Cutaneous Mastocytosis diagnosed at 3 months based on the peau d?orange appearance of his skin with positive Darier sign. Total tryptase was 64ng/ml with mature fraction of 3.1ng/ml, urinary histamine 873 mcg/gr creatinine. Skin biopsy revealed a patchy band-like infiltrate of mononuclear cells in the dermis positive for tryptase and CD117. Concurrent medication included therapy with H1 and H2-antagonists and topical sodium cromoglycate. On an unspecified date, the subject received unspecified dose of Hib (unknown route, unknown manufacturer), unspecified dose of Pneumococcal vaccine (unknown route, unknown manufacturer), unspecified dose of Poliomyelitis vaccine (unknown route, unknown manufacturer), unspecified dose of Rotavirus vaccine (unknown route, unknown manufacturer) and unspecified dose of DT (unknown route, unknown manufacturer). 1 day after vaccination with DT, Hib, Pneumococcal vaccine, Poliomyelitis vaccine and Rotavirus vaccine, the subject experienced systemic generalized life-threatening symptoms with clear-fluid-filled blisters associated with nausea, vomiting, fevers and generalized malaise. A 5-day course of 0.5 mg/kg oral steroids led to complete resolution with no residual skin changes. The author considered the events were life threatening. At the time of reporting the events were resolved.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Localized pain, swelling, warmth and redness, about 5 cm by 8 cm at vaccine location.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Discomfort, Injection site swelling, Pruritus, Swelling
Clinical narrative: Itching, swelling with blistering reported, observed on 5/16/2012, slight swelling at site with healing blister noted. No pain on 5/16/2012. Self treated with OTC meds to manage discomfort.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Nausea, Pain, Rash
Clinical narrative: Red, hot, sore, rash, painful, nausea.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain
Clinical narrative: Bruising at injection site, large area of pain/erythema (about 4in x 3in) around injection site.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Extreme swelling and redness of the leg at injection site. Went to ER for treatment and was prescribed an oral steroid along with Benadryl.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Hot flush, Injection site erythema, Injection site swelling, Pruritus generalised
Clinical narrative: 12/6/2011 - redness, swelling golf ball size, ice was applied to the site. 12/08/2011 faint redness, swelling approx orange size.  Also complained of hot flashes and generalized itching, not at injection site.  MD prescribed Benadryl.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Headache, Lethargy, Pain in extremity
Clinical narrative: Headache, lower back pain, soreness in the hands, lethargy.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Muscle injury, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Statement per email from patient: I had my flu shot in October and golfed the next day.  Within these 2 days the arm that I received my immunization in became very sore and began to stiffen up.  The long and short of it, I soon lost my range of motion and now am seeing my physical therapist to regain that motion.  PT said it is a "a traumatized muscle".
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Headache, nausea, vomiting x 2 episodes; pt advised to f/u with PCP, urgent care, ER if symptoms persisted.
Age: 49.0
Sex: F
Vaccine: FLUN3
Symptoms: Lacrimation increased, Malaise, Nasal congestion
Clinical narrative: EMPLOYEE STATES BECAME ILL, STUFFY NOSE, WATERY EYE, STAYED HOME, RESP TREATMENT NECESSARY, GIVEN BENADRYL AT MD OFFICE.
Age: 84.0
Sex: F
Vaccine: DTP, VARZOS
Symptoms: Erythema, Oedema peripheral, Rash, Skin warm
Clinical narrative: WOKE UP WITH SWOLLEN UPPER ARM, RED, HOT TO TOUCH, RASHY.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: The swelling of May. By evening the swelling increased and became painful to move. Came into the clinc Wednesday morning seemed a little better. Pts right deltoid was swollen, red, and warm to touch. The swelling and redness messured about 3" by 3" and was tender to touch. She was treated with Benadryl 3x a day along with IBU 400mg 3x a day and to be ice/heat compress every hour for 20 mins. RTC tomorrow or sooner if worse.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Nodule
Clinical narrative: Localized swelling with redness and grape size knot under skin.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Cough, Full blood count normal, Headache, Metabolic function test normal
Clinical narrative: Myalgias, chills, vomiting, shivering. Went to emergency room and was given IV fluids and discharged.  Later, developed headache, subjective fever, cough. Still symptomatic as of 5/16/2012; further evaluation pending.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: Myalgias, chills, vomiting, shivering. Went to emergency room and was given IV fluids and discharged.  Later, developed headache, subjective fever, cough. Still symptomatic as of 5/16/2012; further evaluation pending.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cataplexy, Hallucination, Somnolence
Clinical narrative: Got extremely weak when provoked to laugh, almost fell down. I thought it was funny at the time, thinking my baby was pressing a nerve in my back. However, it progressed until I was getting cataplexy at any strong emotion. And the excessive sleepiness has progressed to the point of daily hallucinations at bedtime, micro-sleeping at work, and sleeping every time I am a passenger in a car. I have a 17-month-old baby now, and I fear holding her and having a strong emotion, not to mention losing my job for sleeping at work. I do not drive right now because I have no car, but when we do get one, I don't want to drive more than to work and back.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Lethargy, Pain, Pyrexia
Clinical narrative: Fever, soreness, fatigue, lethargy.
Age: 23.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Dizziness, Injection site joint movement impairment, Nausea, Pyrexia
Clinical narrative: Dizzy, nausea with standing, fever hard to move left shoulder. Both immunizations given in left arm 5/15/12. Sx started 5/15/12 evening and progressed in to today.
Age: 0.3
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of maladministration (asymptomatic/child too young) in a 4-month-old subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). On 14 May 2012 the subject received 2nd dose of KINRIX (unknown) and experienced maladministration (asymptomatic/child too young). The nurse reported two 4-month-old subjects were administered KINRIX on 14 May 2012. KINRIX is not indicated for this age (too young). The nurse reported the subjects were taken to the emergency room by the mother because "the mother was very concerned that something might happen". The nurse reported "that from her knowledge the subjects were fine, and they were not admitted". At the time of the report no other information was available. This is case one of two, for the second case see A0977580A.
Age: 0.3
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of maladministration in a 4-month-old subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). On 14 May 2012 the subject received 2nd dose of KINRIX (unknown) and experienced maladministration. The nurse reported two 4-month old subjects were administered KINRIX on 14 May 2012. KINRIX is not indicated for this age (too young). The nurse reported the subjects were taken to the emergency room by the mother because "the mother was very concerned that something might happen". The nurse reported "that from her knowledge the subjects were fine, and they were not admitted". At the time of the report no other information was available. This is the second case of two, for the first case see A0977550A.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyskinesia, Loss of consciousness
Clinical narrative: Mom reported that after vaccine was administered to child, child passed out while sitting on the exam table. Mom said she caught the child. On arrival at bedside child is held in mom's arm alert & stable. No distress. Mom said that child's arms jerked when she passed out.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, "burning" at injection site, pt states sx lasted 3 days or longer. Pt describes site as raised & "lumpy".
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: The day after injection, no problem or reaction. Several days after pt broke out in a rash. None at injection site. Started in neck area & went down. Most prominent on stomach, legs & feet. Family Dr prescribed prednisone for her on 5-14-12. Pt saw Dr no change in rash.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Patient reported injection site reaction 2" x 1" red/not raised/no pain or itching just slightly red area.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain, Pain, Pyrexia
Clinical narrative: Fever Tm 102 degrees F. Body aches & painful lymph node in neck on the side of the injection.
Age: 20.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Dyspnoea, Eye swelling, Hypersensitivity, Pruritus, Rash
Clinical narrative: Patient received MMR at time of positive Mantoux reading.  Patient went to gym later that afternoon and was working out and running strenuously and face and eyes became swollen and itchy.  Taken to ER.  Epinephrine given at ER.  Recovered fully by 01/09/2012.
Age: 20.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Eye pruritus, Eye swelling, Pruritus, Swelling face
Clinical narrative: Patient received MMR at time of positive Mantoux reading.  Patient went to gym later that afternoon and was working out and running strenuously and face and eyes became swollen and itchy.  Taken to ER.  Epinephrine given at ER.  Recovered fully by 01/09/2012.
Age: 23.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Open wound, Oropharyngeal blistering, Stevens-Johnson syndrome
Clinical narrative: Case number PHHY2012US038128 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 447858) on 07 May 2012 with a follow up received from the quality assurance department on 11 May 2012. This case refers to a 23-year-old female patient. Her preexisting condition included of allergy to BACTRIM, penicillin and mushrooms. She was vaccinated with MENVEO (batch number: M10126A) intramuscularly into her left arm on 05 Jan 2012. On 13 Jan 2012, the patient developed blisters in mouth and was diagnosed with Steven Johnson Syndrome in hospital. She also had finger wounds for which she was started on antibiotics. She had recovered completely on an unspecified date. Based on review, it was stated that the concerned MENVEO batch number M10126A was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the quality assurance department on 11 May 2012. Batch review report updated.
Age: 23.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Oral mucosal blistering, Stevens-Johnson syndrome, Wound
Clinical narrative: Case number PHHY2012US038128 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 447858) on 07 May 2012 with a follow up received from the quality assurance department on 11 May 2012. This case refers to a 23-year-old female patient. Her preexisting condition included of allergy to BACTRIM, penicillin and mushrooms. She was vaccinated with MENVEO (batch number: M10126A) intramuscularly into her left arm on 05 Jan 2012. On 13 Jan 2012, the patient developed blisters in mouth and was diagnosed with Steven Johnson Syndrome in hospital. She also had finger wounds for which she was started on antibiotics. She had recovered completely on an unspecified date. Based on review, it was stated that the concerned MENVEO batch number M10126A was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the quality assurance department on 11 May 2012. Batch review report updated.
Age: 0.57
Sex: F
Vaccine: HIBV, IPV, PNC, RV5, DT, HIBV, IPV, PNC13, RV5
Symptoms: Hypotonia, Pyrexia
Clinical narrative: Given shots staring spell off & on for a day, fever to 104 degrees, not active, screaming spells.
Age: 0.57
Sex: F
Vaccine: HIBV, IPV, PNC, RV5, DT, HIBV, IPV, PNC13, RV5
Symptoms: Decreased activity, Pyrexia, Screaming, Staring
Clinical narrative: Given shots staring spell off & on for a day, fever to 104 degrees, not active, screaming spells.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, MNQ
Symptoms: Fatigue, Myalgia
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 14 February 2012. An 18-year-old female patient had received a dose one intramuscular injection in the left deltoid of MENACTRA, sanofi pasteur Inc., lot number U3678AA on 18 January 2012. On 27 January 2012, the patient was taken to the emergency room (ER) for severe fatigue, excess menstrual bleeding and has had soreness of 8/10 (on a scale of 10) both arms and legs since then and increased sensitivity in arms and legs. The patient's physician ran tests for mono and muscle breakdown which were negative. The patient had a mono (T&B) titer within the last 18 months. The patient had no illness at the time of vaccination and had no reported adverse events to prior vaccinations. The patient had no known allergies (NKA) and a past medical history of Willebrand Type I. The patient's outcome was not recovered. Follow-up information was received from a health care professional on 07 May 2012. Based upon the new information provided, this case has been upgraded to serious. The diagnosis was possible fibromyalgia. The patient did not receive any treatment but was evaluated by rheumatology and neurology for migraines. The patient's mono titer showed recent past mono infection (in past 4-18 months) but not currently. The patient's outcome remained not recovered. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, MNQ
Symptoms: Fatigue, Hyperaesthesia, Laboratory test normal, Menorrhagia, Migraine
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 14 February 2012. An 18-year-old female patient had received a dose one intramuscular injection in the left deltoid of MENACTRA, sanofi pasteur Inc., lot number U3678AA on 18 January 2012. On 27 January 2012, the patient was taken to the emergency room (ER) for severe fatigue, excess menstrual bleeding and has had soreness of 8/10 (on a scale of 10) both arms and legs since then and increased sensitivity in arms and legs. The patient's physician ran tests for mono and muscle breakdown which were negative. The patient had a mono (T&B) titer within the last 18 months. The patient had no illness at the time of vaccination and had no reported adverse events to prior vaccinations. The patient had no known allergies (NKA) and a past medical history of Willebrand Type I. The patient's outcome was not recovered. Follow-up information was received from a health care professional on 07 May 2012. Based upon the new information provided, this case has been upgraded to serious. The diagnosis was possible fibromyalgia. The patient did not receive any treatment but was evaluated by rheumatology and neurology for migraines. The patient's mono titer showed recent past mono infection (in past 4-18 months) but not currently. The patient's outcome remained not recovered. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, MNQ
Symptoms: Mononucleosis heterophile test negative, Pain in extremity
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 14 February 2012. An 18-year-old female patient had received a dose one intramuscular injection in the left deltoid of MENACTRA, sanofi pasteur Inc., lot number U3678AA on 18 January 2012. On 27 January 2012, the patient was taken to the emergency room (ER) for severe fatigue, excess menstrual bleeding and has had soreness of 8/10 (on a scale of 10) both arms and legs since then and increased sensitivity in arms and legs. The patient's physician ran tests for mono and muscle breakdown which were negative. The patient had a mono (T&B) titer within the last 18 months. The patient had no illness at the time of vaccination and had no reported adverse events to prior vaccinations. The patient had no known allergies (NKA) and a past medical history of Willebrand Type I. The patient's outcome was not recovered. Follow-up information was received from a health care professional on 07 May 2012. Based upon the new information provided, this case has been upgraded to serious. The diagnosis was possible fibromyalgia. The patient did not receive any treatment but was evaluated by rheumatology and neurology for migraines. The patient's mono titer showed recent past mono infection (in past 4-18 months) but not currently. The patient's outcome remained not recovered. Documents held by sender: None.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Oedema peripheral, Pain in extremity, Rash pruritic
Clinical narrative: Redness, swelling, pain on skin and below from injection site on upper arm to the elbow. Pt could not sleep for the first two nights because of pain. Solid red rash.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Redness, swelling, pain on skin and below from injection site on upper arm to the elbow. Pt could not sleep for the first two nights because of pain. Solid red rash.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash erythematous, Swelling
Clinical narrative: Redness, swelling, pain on skin and below from injection site on upper arm to the elbow. Pt could not sleep for the first two nights because of pain. Solid red rash.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Petechiae, Platelet count decreased, Platelet morphology abnormal
Clinical narrative: PRESENTED ON 5/14 WITH PETECHIAE AND PLATELET COUNT OF 1,000.  CLINICALLY STABLE BUT REQUIRED URGENT MEDEVAC DURING OVERSEAS DEPLOYMENT.
Age: 9.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chills, Pyrexia, Rash, Rash macular
Clinical narrative: Patient received 2nd dose of HPV. 2 hrs after receiving 2nd dose pt. broke out with blotchy rash on trunk, arms, and upper thighs. Had chills. Fever started and was highest at 102.5. Mother gave TYLENOL and fever resolved by 10 pm. Pt. woke the am of 05/17 and felt better.
Age: 9.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chills, Pyrexia, Rash macular
Clinical narrative: Patient received 2nd dose of HPV. 2 hrs after receiving 2nd dose pt. broke out with blotchy rash on trunk, arms, and upper thighs. Had chills. Fever started and was highest at 102.5. Mother gave TYLENOL and fever resolved by 10 pm. Pt. woke the am of 05/17 and felt better.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Swelling
Clinical narrative: Patient has a purple bruise on her right arm, swelling has gone down. Pt has no pain. Patient will apply warm compress.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Induration, Pain
Clinical narrative: Redness, warmth, induration + 10mm., soreness. No temp. Tx: Prednisone 40 mg STAT. May apply ice as tolerated. Hydrocortisone cr. BID. BENADRYL 50 mg QHS x 3 nights.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Cardiac monitoring, Confusional state, Dizziness, Echocardiogram
Clinical narrative: Weakness in left arm where injection was given (about 15 minutes after injection). (20 mins to 1/2 hr.) Paleness, confusion, dizzy, heart palpitations, shaking and high B/P.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Electrocardiogram, Hypertension, Muscular weakness, Pallor, Palpitations
Clinical narrative: Weakness in left arm where injection was given (about 15 minutes after injection). (20 mins to 1/2 hr.) Paleness, confusion, dizzy, heart palpitations, shaking and high B/P.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Weakness in left arm where injection was given (about 15 minutes after injection). (20 mins to 1/2 hr.) Paleness, confusion, dizzy, heart palpitations, shaking and high B/P.
Sex: F
Vaccine: DTAP
Symptoms: Dysstasia, Muscular weakness, Rash generalised, Vomiting
Clinical narrative: Initial report was received on 07 May 2012 from another manufacturer national service center (service request number 1-5116970150), who received the report from a consumer, who is also the patient's parent. A female patient who was a "four to five month-old" infant at the time of the event (date of birth not report) with an unreported past medical history had received a first dose of "DTAP" vaccine (manufacturer, lot number, route, site and date of administration were not reported) and an unspecified amount of time later, lost of use of her legs, could not stand, was throwing up and experienced a rash all over. No further information was provided at the time of the report. The patient did not die, no further outcome was reported. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: Shot given 4-16-12. 2 days later had pain below right ear behind jaw. Went away after about 3 days. Lump started developing behind right ear about 4-24. Didn't hurt. 4-30-12 woke up in severe pain with right arm. Couldn't raise up arm more than 6". Red spots around shot area about 2-3 in area (not raised rash) swelling, hot to touch. Lump behind ear about size of nickel. (Lymph node). No fever. Pain severe in arm. At ER, given script for 1, 500 mg of Penicillin a day for 10 days. Pain med - tramadol HCL 50 mg (every 6 hours). Which didn't alleviate pain hot pad didn't help either.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Neck pain, Pain in extremity, Rash erythematous
Clinical narrative: Shot given 4-16-12. 2 days later had pain below right ear behind jaw. Went away after about 3 days. Lump started developing behind right ear about 4-24. Didn't hurt. 4-30-12 woke up in severe pain with right arm. Couldn't raise up arm more than 6". Red spots around shot area about 2-3 in area (not raised rash) swelling, hot to touch. Lump behind ear about size of nickel. (Lymph node). No fever. Pain severe in arm. At ER, given script for 1, 500 mg of Penicillin a day for 10 days. Pain med - tramadol HCL 50 mg (every 6 hours). Which didn't alleviate pain hot pad didn't help either.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Arm extremely sore.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: CD4 lymphocytes decreased, Contraindication to vaccination
Clinical narrative: Improper screening for ZOSTAVAX ie: HIV/AID.
Age: 0.54
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Blood culture, Body temperature increased, Chest X-ray, Culture urine, Diarrhoea
Clinical narrative: Vomiting and diarrhea on Saturday. Sunday temp was 105.5.
Age: 0.54
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Differential white blood cell count, Full blood count, Urine analysis, Vomiting
Clinical narrative: Vomiting and diarrhea on Saturday. Sunday temp was 105.5.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Feeling hot, Pain, Pruritus
Clinical narrative: 50 cent piece area on RA with increased warmth, erythema & pain/itching.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Area of erythema & slight induration approximately 3 cm diameter around injection site (L) arm. Warm & tender.
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives - BENADRYL.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site induration, Myosclerosis
Clinical narrative: 4 x 4.5 induration left deltoid (KINRIX site). 4 x 4 induration left trapezius.
Age: 37.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: In 2009 she received her 8th AVA while out of the country. In the next couple of days her arm became swollen from shoulder to elbow accompanied by pain (9/10), heat, erythema and tender axilla. She also developed a red, splotchy, papular rash along that side of her trunk from axilla to waist. She does not recall any systemic symptoms such as fever, chills, malaise, but the pain was severe. She was seen by the medic and the symptoms resolved after a couple of weeks. There are no sequelae. Lot # not known.
Age: 37.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Rash erythematous, Rash macular, Tenderness
Clinical narrative: In 2009 she received her 8th AVA while out of the country. In the next couple of days her arm became swollen from shoulder to elbow accompanied by pain (9/10), heat, erythema and tender axilla. She also developed a red, splotchy, papular rash along that side of her trunk from axilla to waist. She does not recall any systemic symptoms such as fever, chills, malaise, but the pain was severe. She was seen by the medic and the symptoms resolved after a couple of weeks. There are no sequelae. Lot # not known.
Age: 37.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Erythema, Oedema peripheral, Rash macular
Clinical narrative: In 2009 she received her 8th AVA while out of the country. In the next couple of days her arm became swollen from shoulder to elbow accompanied by pain (9/10), heat, erythema and tender axilla. She also developed a red, splotchy, papular rash along that side of her trunk from axilla to waist. She does not recall any systemic symptoms such as fever, chills, malaise, but the pain was severe. She was seen by the medic and the symptoms resolved after a couple of weeks. There are no sequelae. Lot # not known.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Bone pain, Chills, Pain
Clinical narrative: Pt says he experienced severe chills, body ache, bone pain and has been off work because of this.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site anaesthesia, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Patient states that she is experiencing pain, numbness and swelling at injection site. She also feels nauseous and have sore joints.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Death
Clinical narrative: Pt received vaccines on 5/3/12. Died on 5/4/12.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site. MD wants pt to ice site TID. Ibuprofen OTC TID. Contact MD in 5 days.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: VIIth nerve paralysis
Clinical narrative: Right-sided facial Bell's Palsy.
Age: 23.0
Sex: M
Vaccine: YF
Symptoms: Chest discomfort, Rash
Clinical narrative: 5/15/12 6:00 PM, Tightness in chest and rash on trunk & extremities. 5/16/12 7:30 AM, TX with Solucortef 100mg IV, Diphenhydramine 50mg IV, Prednisone PO, & Diphenhydramine PO.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt's rt shoulder found with large reddened area. Warm and tender to touch at the injection site. Size of reddened area is 8cm x 7cm. Ice pack placed on area. Kpad ordered by physician.
Age: 1.16
Sex: F
Vaccine: VARCEL
Symptoms: Ear tube insertion, Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash
Clinical narrative: Mother reporting 3 spots at the varicella injection site last night and that patient was itching at them.  No fever and child okay otherwise per mother.  Today the site became red and "hard" and about the size of a plum per mother. Still denies a fever and denies child still itching it.  The child had tubes placed this morning, so fussy for other reasons.  Mother stated that she would follow up with Dr. today and would try to put a cool compress to the site.
Age: 1.16
Sex: F
Vaccine: VARCEL
Symptoms: Irritability
Clinical narrative: Mother reporting 3 spots at the varicella injection site last night and that patient was itching at them.  No fever and child okay otherwise per mother.  Today the site became red and "hard" and about the size of a plum per mother. Still denies a fever and denies child still itching it.  The child had tubes placed this morning, so fussy for other reasons.  Mother stated that she would follow up with Dr. today and would try to put a cool compress to the site.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Diarrhoea, Malaise, Myalgia, Pyrexia
Clinical narrative: Acute arthralgias in large joints, diffuse myalgias, diarrhea, fever and malaise.
Age: 21.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt seen in at student Health Services for right upper arm swelling (5cm), pain and redness, S/P Tdap and Pneumococcal injection on 05/11/12.