chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Pruritus, Rash erythematous
Clinical narrative: 44 y/o patient contacts Call Ctr on 06APR12 requesting waiver from all future vaccines. Reports "chills, felt warm, run down, tired, decreased appetite, general malaise" onset about 6 hours after receipt Tdap (LUE) & IPV (RUE) on Friday, 15JUL11. Stayed in bed all the next day (Saturday). Did not take any OTC medications for relief of sx. On Sunday, 17JUL11 felt like he was "hung over" but had not consumed any alcoholic beverages. Got up & around, but felt "off." Sx resolved spontaneously and he returned to work on Monday 18JUL11. On Monday, 25JUL11, he received AVA #5 in his left upper arm, IM. Arm got a little red at injection site and was sore, but denies large local reaction, erythema > 30 mm, warmth or induration at injection site. No adjacent joint pain or joint pain in any other part of body. No chronic HA's. States that AVA's # 1-4 all made his arm hurt, but no large local reactions or systemic malaise. On 29JUL11, patient received HEP B #1 IM in Lt arm on Friday, 29JUL11. Upon awakening on Saturday, 30JUL11, he noticed red spots, which looked like bug bites all over his body- face, neck, arms, chest, abdomen, genital area, back, legs, but not on palms of hands or soles of feet. The itching was not all that bad. By Sunday, 31JUL11, the red spots were quite a bit larger and merged together. His left eye was almost swollen shut, but he denied any lip swelling, tongue thickening, difficulty breathing or swallowing. He applied on OTC topical "anti-itch" medication (can't remember name) over all the affected areas. On Monday, 01AUG11, he returned to the Clinic and they gave him a Prednisone taper, which took effect right away. He has not received any other vaccines since the mentioned vaccines in July 2011. He will be mobilized for AD in June of 2012 x 2 weeks. He is not deploying and will remain in continent. He does Not want to receive another dose of HEP B or any other vaccines. PMH: No chronic disease, hospitalizations or surgeries. NKDA. No environmental, food, or chemical allergies. NO MEDS. SOCIAL Hx: Never has smoked. Very moderate Social ETOH. No illicit drug use. His MOS is currently Operational- sitting at desk, working at computer. His job during the week is as a Special Agent. He is married and has 2 boys. His 14-year-old son has Autism. His 12-year-old son is in good health, because they managed to "stop vaccines before he got damaged." Patient  expresses concern re + Family Hx of Auto-Immune Disease: Father (Deceased at 88) h/o RA since patient was born- as long as he can remember. Mother (Living, 83) in good health, no chronic disease. Likewise his elder Sister (Living, 47) is in good health, no chronic disease. Niece with asthma.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site swelling
Clinical narrative: Reported by Dr. office that patient had 17 x 15 cm raised area on left upper arm. Stated child did not have a temperature or other symptoms. Child was not seen by me with symptoms.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pruritus generalised
Clinical narrative: MOTHER STATED THAT CHILD HAD NO REACTION TO PREVIOUS VACCINES. PATIENT INSTRUCTED TO WAIT 15 MINUTES, PER MANUF. INSTRUCTIONS. AFTER 15 MINUTES, CLIENT C/O ITCHING THROUGHOUT BODY. NO VISIBLE RASH, DENIED DIFFICULTY BREATHING OR SWALLOWING. SUPERVISOR NOTIFIED. HE SPOKE WITH MOTHER AND INSTRUCTED ME TO GIVE 25 MG. BENADRYL PO. THIS WAS GIVEN AT 9:30 AM. CLIENT WAS OBSERVED FOR 30 MINUTES. SHE STATED THAT SHE FELT BETTER. MOM WAS INSTRUCTED TO OBSERVE PATIENT TODAY AND IF SYMPTOMS INCREASE, TO CALL FOR MEDICAL HELP.
Age: 1.65
Sex: F
Vaccine: MMR
Symptoms: Conjunctivitis, Cough, Ear infection, Rhinorrhoea
Clinical narrative: Runny nose, coughing, then 5/12/2012 developed conjunctivitis and 5/14/2012 developed ear infection.
Age: 19.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Convulsion, Dizziness, Hyperhidrosis, Musculoskeletal stiffness, Pallor
Clinical narrative: Pt sent to waiting room to wait customary 10 minutes after vaccination. Approx. 2 minutes later a support staff came looking for PHN stating that pt was sick. PHN went to waiting room where pt was found to be stiff with eyes unfocused. After several seconds he came out of it and said he was fine. At that time he was noted to be pale so 2L O2 was admin via non-rebreather mask. Pulse was noted to be weak, around 50bpm and unable to obtain BP. After several minutes pt was brought back into the exam room and layed on table. BP at that time was 100/62 with pulse in 50s. Back was noted to be sweaty and color was still pale. 911 was called. Rescue squad arrived approx 9:40. 9:45 BP was 110/70, pulse 60, PO2 99%, PERLA. Pt taken to ER for eval. Mom reported pt was feeling dizzy for 10-15 seconds then went into "seizure" for 10-15 seconds. She noted him to be pale in color and warm.
Age: 19.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pulse pressure decreased, Skin warm, Vision blurred
Clinical narrative: Pt sent to waiting room to wait customary 10 minutes after vaccination. Approx. 2 minutes later a support staff came looking for PHN stating that pt was sick. PHN went to waiting room where pt was found to be stiff with eyes unfocused. After several seconds he came out of it and said he was fine. At that time he was noted to be pale so 2L O2 was admin via non-rebreather mask. Pulse was noted to be weak, around 50bpm and unable to obtain BP. After several minutes pt was brought back into the exam room and layed on table. BP at that time was 100/62 with pulse in 50s. Back was noted to be sweaty and color was still pale. 911 was called. Rescue squad arrived approx 9:40. 9:45 BP was 110/70, pulse 60, PO2 99%, PERLA. Pt taken to ER for eval. Mom reported pt was feeling dizzy for 10-15 seconds then went into "seizure" for 10-15 seconds. She noted him to be pale in color and warm.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Adverse drug reaction, Blood test normal, Computerised tomogram head normal, Convulsion, Disorientation
Clinical narrative: The first symptoms I experienced were myoclonic episodes. I would feel "twitchy". I would have involuntary twitching episodes that were violent enough to throw objects in my hand across the room. Shortly after these episodes began, I would lose consciousness for an unknown period of time, and would wake up with body aches, a headache and blood around my mouth due to biting my tongue and cheek. I would always be disoriented to the point of hardly knowing my name, year or location. The amount of blood and saliva present was quite excessive at times, and would always be scattered around me on the floor of which I fell. I was admitted to the hospital Emergency Room in March 2009 after describing these symptoms to my parents. I was admitted for approximately 4 days where all diagnostic testing proved negative. I was given a prescription for Topamax which was slowly tapered off due to intolerable side effects. I was then placed on Keppra 500mg daily. Since this time, I have had multiple seizures and have discovered that the "twitchy" sensation is the closest sign I have that resembles an aura. I have not been officially diagnosed with Epilepsy, yet I continue to have multiple seizures a year despite my medical regimen. My dose of Keppra has now reached is maximum limit of 1500mg daily and I have been seizure free for one month at this limit. I strongly feel that receiving the shot Gardasil had an adverse reaction that now causes me to have seizures. Over the past 3 years I have been unable to count the number of times I have had these seizure episodes and it has reached the point of severely interfering with my life in regards to losing driving privileges temporarily and countless doctors visits and trips to the hospital.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Fall, Headache, Impaired driving ability, Loss of consciousness, Mouth haemorrhage
Clinical narrative: The first symptoms I experienced were myoclonic episodes. I would feel "twitchy". I would have involuntary twitching episodes that were violent enough to throw objects in my hand across the room. Shortly after these episodes began, I would lose consciousness for an unknown period of time, and would wake up with body aches, a headache and blood around my mouth due to biting my tongue and cheek. I would always be disoriented to the point of hardly knowing my name, year or location. The amount of blood and saliva present was quite excessive at times, and would always be scattered around me on the floor of which I fell. I was admitted to the hospital Emergency Room in March 2009 after describing these symptoms to my parents. I was admitted for approximately 4 days where all diagnostic testing proved negative. I was given a prescription for Topamax which was slowly tapered off due to intolerable side effects. I was then placed on Keppra 500mg daily. Since this time, I have had multiple seizures and have discovered that the "twitchy" sensation is the closest sign I have that resembles an aura. I have not been officially diagnosed with Epilepsy, yet I continue to have multiple seizures a year despite my medical regimen. My dose of Keppra has now reached is maximum limit of 1500mg daily and I have been seizure free for one month at this limit. I strongly feel that receiving the shot Gardasil had an adverse reaction that now causes me to have seizures. Over the past 3 years I have been unable to count the number of times I have had these seizure episodes and it has reached the point of severely interfering with my life in regards to losing driving privileges temporarily and countless doctors visits and trips to the hospital.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Muscle twitching, Myoclonus, Nuclear magnetic resonance imaging normal, Pain, Quality of life decreased
Clinical narrative: The first symptoms I experienced were myoclonic episodes. I would feel "twitchy". I would have involuntary twitching episodes that were violent enough to throw objects in my hand across the room. Shortly after these episodes began, I would lose consciousness for an unknown period of time, and would wake up with body aches, a headache and blood around my mouth due to biting my tongue and cheek. I would always be disoriented to the point of hardly knowing my name, year or location. The amount of blood and saliva present was quite excessive at times, and would always be scattered around me on the floor of which I fell. I was admitted to the hospital Emergency Room in March 2009 after describing these symptoms to my parents. I was admitted for approximately 4 days where all diagnostic testing proved negative. I was given a prescription for Topamax which was slowly tapered off due to intolerable side effects. I was then placed on Keppra 500mg daily. Since this time, I have had multiple seizures and have discovered that the "twitchy" sensation is the closest sign I have that resembles an aura. I have not been officially diagnosed with Epilepsy, yet I continue to have multiple seizures a year despite my medical regimen. My dose of Keppra has now reached is maximum limit of 1500mg daily and I have been seizure free for one month at this limit. I strongly feel that receiving the shot Gardasil had an adverse reaction that now causes me to have seizures. Over the past 3 years I have been unable to count the number of times I have had these seizure episodes and it has reached the point of severely interfering with my life in regards to losing driving privileges temporarily and countless doctors visits and trips to the hospital.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Salivary hypersecretion, Tongue biting, X-ray normal
Clinical narrative: The first symptoms I experienced were myoclonic episodes. I would feel "twitchy". I would have involuntary twitching episodes that were violent enough to throw objects in my hand across the room. Shortly after these episodes began, I would lose consciousness for an unknown period of time, and would wake up with body aches, a headache and blood around my mouth due to biting my tongue and cheek. I would always be disoriented to the point of hardly knowing my name, year or location. The amount of blood and saliva present was quite excessive at times, and would always be scattered around me on the floor of which I fell. I was admitted to the hospital Emergency Room in March 2009 after describing these symptoms to my parents. I was admitted for approximately 4 days where all diagnostic testing proved negative. I was given a prescription for Topamax which was slowly tapered off due to intolerable side effects. I was then placed on Keppra 500mg daily. Since this time, I have had multiple seizures and have discovered that the "twitchy" sensation is the closest sign I have that resembles an aura. I have not been officially diagnosed with Epilepsy, yet I continue to have multiple seizures a year despite my medical regimen. My dose of Keppra has now reached is maximum limit of 1500mg daily and I have been seizure free for one month at this limit. I strongly feel that receiving the shot Gardasil had an adverse reaction that now causes me to have seizures. Over the past 3 years I have been unable to count the number of times I have had these seizure episodes and it has reached the point of severely interfering with my life in regards to losing driving privileges temporarily and countless doctors visits and trips to the hospital.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: There was no adverse event, the patient was given a third dose of HPV at an invalid interval. There was not 12 weeks between the second and the third dose even though there was 24 weeks between dose one and three.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: There was no adverse event, the patient was given a third dose of HPV at an invalid interval. There was not 12 weeks between the second and the third dose even though there was 24 weeks between dose one and three.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Gardasil #3 given on 5/9/12 in right deltoid. Mother called 5/11/12 stating patients right deltoid was red, swollen, painful and hot to touch. Client states CC was pruritus. Mother gave Ibuprofen, ice pack and Benadryl cream. Advised to seek medical attention if worsens.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Culture wound, Drug administered at inappropriate site, Dyskinesia, Feeling cold
Clinical narrative: I began jerking cause I was cold, chills and breathing bad. Sweating Didn't take temp. Dr told me to go to Urgent care. Gave me prednisone and Benadryl 5-1-12, on Saturday 5/5/12 noticed a yellow spot around shot site hard and swollen tennis ball size. Called Dr. Sent us to Urgent care but went to ER. ER lance the site bloody watery drainage. Admitted to hospital for dressing changes and vancomycin until Tuesday. Skin dying around site. MD told me I might need a skin graft. Shot given in wrong spot 4 inch lower than other shot I have received in arm. Continue seeing my family doctor. Admitted to hospital.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Hyperhidrosis, Incisional drainage, Injection site discharge, Injection site discolouration, Injection site haemorrhage
Clinical narrative: I began jerking cause I was cold, chills and breathing bad. Sweating Didn't take temp. Dr told me to go to Urgent care. Gave me prednisone and Benadryl 5-1-12, on Saturday 5/5/12 noticed a yellow spot around shot site hard and swollen tennis ball size. Called Dr. Sent us to Urgent care but went to ER. ER lance the site bloody watery drainage. Admitted to hospital for dressing changes and vancomycin until Tuesday. Skin dying around site. MD told me I might need a skin graft. Shot given in wrong spot 4 inch lower than other shot I have received in arm. Continue seeing my family doctor. Admitted to hospital.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site necrosis, Injection site swelling, Respiration abnormal
Clinical narrative: I began jerking cause I was cold, chills and breathing bad. Sweating Didn't take temp. Dr told me to go to Urgent care. Gave me prednisone and Benadryl 5-1-12, on Saturday 5/5/12 noticed a yellow spot around shot site hard and swollen tennis ball size. Called Dr. Sent us to Urgent care but went to ER. ER lance the site bloody watery drainage. Admitted to hospital for dressing changes and vancomycin until Tuesday. Skin dying around site. MD told me I might need a skin graft. Shot given in wrong spot 4 inch lower than other shot I have received in arm. Continue seeing my family doctor. Admitted to hospital.
Age: 1.07
Sex: M
Vaccine: MMRV
Symptoms: Aphasia, Autism, Blood test, Encephalopathy
Clinical narrative: A month after receiving the shot, his son could not speak anymore. Diagnosed with encephalopathy & severe Autism at 18 months of age by doctor.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Headache, Lymphadenopathy, Oedema peripheral, Pain in extremity
Clinical narrative: Thursday 5/10/12 I received a Tdap immunization at medical office on Friday 5/11/12 I started w/pain & redness in my right arm and a severe headache. Headache is still continuing even w/ taking ALEVE. Redness & swelling of Rt arm continued. Took BENADRYL & ZYRTEC over the weekend last night started w/ swollen lymph nodes under Rt arm.
Age: 1.29
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Measles, Measles post vaccine, Rash erythematous, Rash generalised, Viral rash
Clinical narrative: Vaccine given on 5-2-12, started with rash on 5-13-12. Generalized - fine - raised - red, diagnosed with Measles rash S/P vaccination - viral exanthem.
Age: 63.0
Sex: F
Vaccine: DPP
Symptoms: Blister, Diarrhoea, Herpes zoster, Upper respiratory tract congestion
Clinical narrative: Blisters on arms, legs, chest, hands after receiving Shingles Immunization.  Also diarrhea, and upper respiratory congestion.  Blisters continue to surface over past two weeks.  Worried if I can get reoccurring shingles now since this caused an outbreak on my body? I have never had shingles before. Since this is a realatively new immunization, I felt it important to report this negative affect.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Client was given BOOSTRIX (Tdap) on Wed. 5/9/12. By Thursday she noted a bump on her (R) deltoid site where the vaccine had been injected. By the weekend it was sore, tender and was the size of a dime. Today Monday, 5/14/12, it is still about dime-sized, red, raw at the vaccination site. She state it's still somewhat sore.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site discolouration, Injection site vesicles, Vaccination site pain, Vaccination site scab
Clinical narrative: Given on Friday, 5/11/12. States that by the next day there was a blister at the vaccination site. It has been sore. Today, Monday, 5/14/12 the blister is gone but there is reddened skin there with yellow scabbing. It still is sore.
Age: 48.0
Sex: M
Vaccine: HEPA, IPV, YF
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, raised, warm area 2-3" by 6 inches at the site of the injection of yellow fever vaccine. Adv palliative local treatment with cool compresses. No medical treatment at this time.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Hyponatraemia, Pyrexia, White blood cell count increased
Clinical narrative: Patient presented 9 hours post vaccinations to the ER with a fever of 102 untreated. Provider ordered TYLENOL. Baby not given TYLENOL, no fever upon admission. Pt tx for hyponatremia poor mixing of formula. Increased white ct high. Pt discharged the next day.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives developed 2 days after 12 mo. vaccines.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Diarrhoea, Incorrect route of drug administration, Vomiting
Clinical narrative: PREVNAR 13 inadvertently given orally instead of IM as advised. Pt given PENTACEL IM at the same time. Pt mother stated later that day pt had 2 episodes of diarrhea and 1 episode of vomiting. Pt mother denied any other symptoms and stated pt is "fine" today, 05/09/12.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reported injection site to be red & swollen. Observed area to approximately 2-3 in diameter. Informed Pt to take BENADRYL, pt reported marked improvement.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Shot 11:30 am. At 3 pm painful extension of arm. Swell area injection. Later area turned pink and continued to spread down and around arm. Second day large red area 2" above bend of arm, inside. Continued to swell & spread. Emergency in afternoon. IV treatment then 5 days of KEFLEX & hot compresses 5 days.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Oedema peripheral, Pyrexia, Vomiting
Clinical narrative: Report of fever, with vomiting, swollen arm with a blister. No report of fever on 5/3/12. Instructed to see provider. Pt. seen Dr.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Syncope
Clinical narrative: Well patient, in for well child care. Pt held breath then had syncopal episode shortly after vaccines had been given. Recovered quickly, normal exam.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Screaming
Clinical narrative: Unconsolable - uncontrollable crying/screaming for over 3 hours - started in late evening the day of vaccine. (That had never happened before or since).
Age: 1.53
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash -> varicella zoster of symphysis pubis. Rx with Acyclovir.
Age: 69.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema
Clinical narrative: Noted onset of redness on (L) forearm approximately 10 cm diameter. Given cephalexin on 5/13 by another physician. Today 5/15 site normal.
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Erythema, Feeling hot, Joint range of motion decreased, Oedema peripheral
Clinical narrative: Vaccine Tdap administered 5-7-12. Within 24 hrs, arm red, itchy, swollen. Some difficulty with range of motion. No previous adverse reaction to Td. Patient seen in clinic 5-11-12. Left arm had extensive swelling & redness - 3/4 lateral arm just above elbow to proximal arm. Some heat, some bruising.
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Vaccine Tdap administered 5-7-12. Within 24 hrs, arm red, itchy, swollen. Some difficulty with range of motion. No previous adverse reaction to Td. Patient seen in clinic 5-11-12. Left arm had extensive swelling & redness - 3/4 lateral arm just above elbow to proximal arm. Some heat, some bruising.
Age: 1.01
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever started 5/14/12 into 5/15/12.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TYP, YF, HEPA, HPV4, MNQ, TYP, YF
Symptoms: Flushing, Laboratory test normal, Muscle twitching, Musculoskeletal stiffness, Pallor
Clinical narrative: Pt face color turned pale, nonresponsive, upper body stiffened, rt hand twitched. RN applied smelling salts to nasal area & pt. responsive post-3 seconds. Face became flushed. Post-10 seconds pt's face became pale, pt. again nonresponsive, entire body stiffened and upper & lower body in seizure posturing position. Applied smelling salts & pt responsive post 7 seconds. Face flushed once again. Pt stated "I don't know what happened but I think I just wet my pants". Pt. lost urinary control during seizure and urinated on self. Observed pt for 30 minutes. RN offered to contact family member, pt declined. Once pt stable escorted pt out of immunization room & pt insistent on ambulating out of building by self. Pt again declined RN repeated offer to contact emergency contact.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TYP, YF, HEPA, HPV4, MNQ, TYP, YF
Symptoms: Posture abnormal, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Pt face color turned pale, nonresponsive, upper body stiffened, rt hand twitched. RN applied smelling salts to nasal area & pt. responsive post-3 seconds. Face became flushed. Post-10 seconds pt's face became pale, pt. again nonresponsive, entire body stiffened and upper & lower body in seizure posturing position. Applied smelling salts & pt responsive post 7 seconds. Face flushed once again. Pt stated "I don't know what happened but I think I just wet my pants". Pt. lost urinary control during seizure and urinated on self. Observed pt for 30 minutes. RN offered to contact family member, pt declined. Once pt stable escorted pt out of immunization room & pt insistent on ambulating out of building by self. Pt again declined RN repeated offer to contact emergency contact.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TYP, YF, HEPA, HPV4, MNQ, TYP, YF
Symptoms: Convulsion, Flushing, Laboratory test normal, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: Pt face color turned pale, nonresponsive, upper body stiffened, rt hand twitched. RN applied smelling salts to nasal area & pt. responsive post-3 seconds. Face became flushed. Post-10 seconds pt's face became pale, pt. again nonresponsive, entire body stiffened and upper & lower body in seizure posturing position. Applied smelling salts & pt responsive post 7 seconds. Face flushed once again. Pt stated "I don't know what happened but I think I just wet my pants". Pt. lost urinary control during seizure and urinated on self. Observed pt for 30 minutes. RN offered to contact family member, pt declined. Once pt stable escorted pt out of immunization room & pt insistent on ambulating out of building by self. Pt again declined RN repeated offer to contact emergency contact.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TYP, YF, HEPA, HPV4, MNQ, TYP, YF
Symptoms: Pallor, Posture abnormal, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Pt face color turned pale, nonresponsive, upper body stiffened, rt hand twitched. RN applied smelling salts to nasal area & pt. responsive post-3 seconds. Face became flushed. Post-10 seconds pt's face became pale, pt. again nonresponsive, entire body stiffened and upper & lower body in seizure posturing position. Applied smelling salts & pt responsive post 7 seconds. Face flushed once again. Pt stated "I don't know what happened but I think I just wet my pants". Pt. lost urinary control during seizure and urinated on self. Observed pt for 30 minutes. RN offered to contact family member, pt declined. Once pt stable escorted pt out of immunization room & pt insistent on ambulating out of building by self. Pt again declined RN repeated offer to contact emergency contact.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Red induration at injection site slight swelling, painful.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Drug administered at inappropriate site, Immediate post-injection reaction, Injection site pain, Joint manipulation
Clinical narrative: Unusual discomfort when receiving injection.  Shot was administered by RN who was standing while I was standing and seemed to be too high up on the deltoid.  Felt like it "hit bone" or something.  Sore immediately, then within one week could not sleep on left shoulder.  Progressed to adhesive capsulitis that required 2 depot steroid injections, a interscalene block, and manipulation under general anesthesia followed by one month of CPM therapy.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis, X-ray therapy to joint
Clinical narrative: Unusual discomfort when receiving injection.  Shot was administered by RN who was standing while I was standing and seemed to be too high up on the deltoid.  Felt like it "hit bone" or something.  Sore immediately, then within one week could not sleep on left shoulder.  Progressed to adhesive capsulitis that required 2 depot steroid injections, a interscalene block, and manipulation under general anesthesia followed by one month of CPM therapy.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Headache, Injection site erythema, Injection site swelling, Muscle twitching
Clinical narrative: Mother state patient awoke 5/12/12 with Nausea, severe headache, Dizziness, and fever.  States she also noted "twitching" in patient's thumb and back.  And noted swelling and redness to injection areas.  Was given Ibuprofen which gave little relief.  Saw private MD on 5/14/2012.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Nausea, Pyrexia
Clinical narrative: Mother state patient awoke 5/12/12 with Nausea, severe headache, Dizziness, and fever.  States she also noted "twitching" in patient's thumb and back.  And noted swelling and redness to injection areas.  Was given Ibuprofen which gave little relief.  Saw private MD on 5/14/2012.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and Induration at site of injection.
Age: 33.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Chapped lips, Full blood count normal, Liver function test normal, Pain of skin, Rash
Clinical narrative: Rash/Hives on extremities. Painful bumps on hands and feet. Extreme chapped lips. Lasted 9 days.
Age: 33.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Urticaria
Clinical narrative: Rash/Hives on extremities. Painful bumps on hands and feet. Extreme chapped lips. Lasted 9 days.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Pallor
Clinical narrative: S/p administration of vaccine 24hr later pt developed erythema (blanching) itchy, and small area of induration at site.
Age: 14.0
Sex: F
Vaccine: HPV2
Symptoms: Amenorrhoea
Clinical narrative: This case was reported by a physician, via a sales representative, and described the occurrence of amenorrhea in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 19 December 2011 the subject received 1st dose of CERVARIX (details unknown). On 19 December 2011, less than one day after vaccination with CERVARIX, the subject experienced amenorrhea. The physician reported that the subject received her first dose of CERVARIX and had experienced amenorrhea since that time. The vaccination series was delayed. At the time of reporting the event was unresolved. The physician considered the event was possibly related to vaccination with CERVARIX. Follow-up information was received on 27 March 2012. It was reported that CERVARIX was administered intramuscularly in the left arm of the female subject on 19 December 2011. At that time, the subject was having menses. The subject experienced an absence of menses in January 2012 and February 2012. This resolved in March 2012 with the return of menses. In the reporter's opinion, the event was possibly related to vaccination with CERVARIX. No concurrent medications were noted. The subject returned for her 2nd dose of CERVARIX in March 2012. It was not known if the event recurred.
Age: 14.0
Sex: F
Vaccine: HPV2
Symptoms: Amenorrhoea, Ovarian cyst, Ultrasound scan abnormal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of amenorrhea in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included BACTRIM allergy, epigastric pain and sore throat. On 13 April 2011 at 14:30 the subject received 1st dose of CERVARIX (.5 ml, unknown route, right arm). In April 2011, less than one month after vaccination with CERVARIX, the subject experience amenorrhea and on 01 February 2012 experienced an ovarian cyst. The subject was administered the CERVARIX on 13 April 2011. In July 2011, the subject was seen by the healthcare professional and did not mention the amenorrhea. In November 2011, the subject was seen by the healthcare professional and the subject's mother reported that the subject had not had her period since April 2011. The subject was referred to Obstetrics and Gynecology who found a right ovarian cyst on 01 February 2012 by ultrasound. At the time of reporting the outcome of the events was unspecified. The vaccination course with CERVARIX was discontinued. On 06 March 2012, updated lot number information was received from a safety review. The lot number was reported as AHPV096AD from the reporter; however, based on safety lot number review, the lot was updated to APVA096AD. Follow up information received from the healthcare professional on 14 March 2012. The healthcare professional reported that the subject experienced the events on 13 April 2011 and the events resolved on 05 February 2012. The healthcare professional noted that the events were not serious. According to the healthcare professional, the CERVARIX immunization series has been delayed until the subject's parent decides to continue.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site is red, swollen, warm to the touch, itchy and painful. Symptoms occurred after injection. Patient was counseled by doctor and pharmacist to take ibuprofen and BENADRYL.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Abasia, Abdominal pain, Hiccups, Mobility decreased, Myalgia
Clinical narrative: This case was reported by a consumer (also the subject's mother) and described the occurrence of myalgia in a 14-year-old female subject who was vaccinated with HPV vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included epilepsy. Concurrent medications included DEPAKOTE, KEPPRA, Risperidone and Omeprazole. On 6 February 2012 at 13:15 the subject received 3rd dose of HPV vaccine (unknown route, right arm). On 7 February 2012, 1 day after vaccination with HPV vaccine, the subject experienced myalgia, "hurts to move her feet so barely ambulatory" (could not walk because of pain in foot), abdominal pain and hiccups. At the time of reporting the events were unresolved.
Age: 14.0
Sex: F
Vaccine: HPVX
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer (also the subject's mother) and described the occurrence of myalgia in a 14-year-old female subject who was vaccinated with HPV vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included epilepsy. Concurrent medications included DEPAKOTE, KEPPRA, Risperidone and Omeprazole. On 6 February 2012 at 13:15 the subject received 3rd dose of HPV vaccine (unknown route, right arm). On 7 February 2012, 1 day after vaccination with HPV vaccine, the subject experienced myalgia, "hurts to move her feet so barely ambulatory" (could not walk because of pain in foot), abdominal pain and hiccups. At the time of reporting the events were unresolved.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Papule, Rash macular
Clinical narrative: Shortly after receiving immunizations, child developed red blotchy fleshy papules on face. No airway obstruction, no wheezing. Observed for 25 mins. Rash faded.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: 6 cm bright red area w/ 10x11 induration at injection site. HA, body aches, anorexia, lassitude, swelling & fatigue lasting 5-7d.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: 6 cm bright red area w/ 10x11 induration at injection site. HA, body aches, anorexia, lassitude, swelling & fatigue lasting 5-7d.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Flushing, Nausea, Vomiting
Clinical narrative: After receiving vaccine, patient stood up to leave when she suddenly felt flushed and nauseous. She vomited x1. BP checked (100/60). Had patient lay down for 20 min. Patient felt better. Checked BP again (102/64). Released to go home.
Age: 18.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis around injection site.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Soreness, heat, swelling, redness continued to be becoming larger and larger. On 3rd day size was over 3 inch in diameter and on 5th, it passed over elbow. On 7th day, it went down. Feel warmth to touch, blistering round spot appeared below injection site the night she got injected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Soreness, heat, swelling, redness continued to be becoming larger and larger. On 3rd day size was over 3 inch in diameter and on 5th, it passed over elbow. On 7th day, it went down. Feel warmth to touch, blistering round spot appeared below injection site the night she got injected.
Age: 1.62
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Blister, Erythema, Exposure to communicable disease, Pain, Rash
Clinical narrative: Mom stated pt began having a rash with blistery type lesions to left lower extremity and buttocks. Pt did not have fever - blisters became red and then popped. Pt complained they hurt but did not itch. Mom stated pt did not act sick & played with other children and ate as usual. Lesions have improved at time of visit - per Mom. Mom denies problem at injection site. Pt had been exposed to caregiver with history of MRSA.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness
Clinical narrative: Pt. passed out after rec. BOOSTRIX - BP 80/40. No adverse reaction from previous doses. Pt given Pepsi & snack. BP 120/84. P RRR A & O. Girlfriend driving him home.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Dizziness, Erythema, Muscle spasms, Nausea
Clinical narrative: Beginning on morning after vaccination, expected swelling, redness & itching began and lasted 5 days. On day after vaccination, I developed severe cramping in upper abdomen. This lasted 24 hours and, I feel was result of shot. 2 days after shot, I developed a severe cramp in same arm's forearm. Lasted 1 hour. Also there was slight nausea & dizziness. All gone now.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: Beginning on morning after vaccination, expected swelling, redness & itching began and lasted 5 days. On day after vaccination, I developed severe cramping in upper abdomen. This lasted 24 hours and, I feel was result of shot. 2 days after shot, I developed a severe cramp in same arm's forearm. Lasted 1 hour. Also there was slight nausea & dizziness. All gone now.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Unevaluable event
Clinical narrative: None reported.
Age: 25.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Incorrect drug dosage form administered, Pain in extremity, Tenderness, Vaccination site infection
Clinical narrative: Case number PHEH2012US007908 is an initials spontaneous report received from a nurse on 06 Apr 2012 with a follow up information received on 07 May 2012. This case refers to a 25-year-old female patient. She was vaccinated with only the MenCWY-135 liquid conjugate component of MENVEO (batch number: M11061) intramuscularly on 05 Apr 2012 and did not receive the MenA lyophilized conjugate. This maladministration was noted on 06 Apr 2012 and MENVEO (batch number: M11041) was re-administered through unspecified route and site on 11 Apr 2012. It was reported that on an unspecified date, her arm became sore, tender and red. She was advised to visit the primary care provider and was diagnosed with an infection at the vaccination site. She was treated with antibiotics. The outcome of the event was reported as recovered with sequelae. The causality of the events was assessed as suspected to vaccine administration. Follow up received on 07 May 2012: Batch number of MENVEO updated, infection at vaccine site, sore, tender and red arm coded as events. Re-vaccination details updated.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Exanthema subitum
Clinical narrative: Roseola rash.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic, Trigeminal neuralgia
Clinical narrative: Information has been received from a physician concerning an 80 year old male (physician's friend) who on 06-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck). A few days after the vaccine was given (also reported as 3 days later) the patient had the prodromal phase with symptoms of pain over the trigeminal nerve. Physician stated he saw his friend "last night" on 07-MAY-2012 and it looked like a case of ocular shingles. The patient sought medical attention by asking physician. At the time of report, the patient was not recovered. The patient's ocular shingles was considered to be disabling. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, C-reactive protein increased, CSF culture negative, Coronary artery dilatation, Culture urine negative
Clinical narrative: This is a spontaneous report based on information from the FDA's VAERS database. Regulatory authority report number (VAERS-ID 395496). A 6-month-old male patient received the second dose of PREVENAR 13 (Lot E57642) intramuscularly in the left leg, the third dose of PEDIARIX (Lot AC21B248CA) intramuscularly in the right leg, a dose of ROTATEQ (Lot 0510Z) orally, and the third dose of ACTHIB (Lot UH045AB) intramuscularly in the right leg. All vaccines were administered on 26July2010. Relevant medical history was reported as none. The patient's concomitant medications were not reported. On 04Aug2010 the patient experienced Kawasaki's disease. Relevant laboratory data included the following: leukocytosis with platelet count increasing to 922K, CRP greater than 300, and erythrocyte sedimentation rate max at 130 mm/hr. A urine analysis on an unspecified date revealed leukocytosis. Cultures of the blood, urine, and CSF on an unspecified date were negative. An echocardiogram on an unspecified date demonstrated coronary artery ectasia with a clinical picture of Kawasaki's disease. Therapeutic measures were taken as a result of the event Kawasaki's disease and included treatment with  two rounds of intravenous immunoglobulin (IVIG). The clinical outcome of the events was reported as recovered. Follow-up (11May2011): This follow-up is submitted to amend previously reported information trade name for non-Pfizer suspect vaccines.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Echocardiogram abnormal, Immunoglobulin therapy, Kawasaki's disease, Leukocytosis, Platelet count increased
Clinical narrative: This is a spontaneous report based on information from the FDA's VAERS database. Regulatory authority report number (VAERS-ID 395496). A 6-month-old male patient received the second dose of PREVENAR 13 (Lot E57642) intramuscularly in the left leg, the third dose of PEDIARIX (Lot AC21B248CA) intramuscularly in the right leg, a dose of ROTATEQ (Lot 0510Z) orally, and the third dose of ACTHIB (Lot UH045AB) intramuscularly in the right leg. All vaccines were administered on 26July2010. Relevant medical history was reported as none. The patient's concomitant medications were not reported. On 04Aug2010 the patient experienced Kawasaki's disease. Relevant laboratory data included the following: leukocytosis with platelet count increasing to 922K, CRP greater than 300, and erythrocyte sedimentation rate max at 130 mm/hr. A urine analysis on an unspecified date revealed leukocytosis. Cultures of the blood, urine, and CSF on an unspecified date were negative. An echocardiogram on an unspecified date demonstrated coronary artery ectasia with a clinical picture of Kawasaki's disease. Therapeutic measures were taken as a result of the event Kawasaki's disease and included treatment with  two rounds of intravenous immunoglobulin (IVIG). The clinical outcome of the events was reported as recovered. Follow-up (11May2011): This follow-up is submitted to amend previously reported information trade name for non-Pfizer suspect vaccines.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Red blood cell sedimentation rate increased, Urine analysis abnormal, White blood cells urine positive
Clinical narrative: This is a spontaneous report based on information from the FDA's VAERS database. Regulatory authority report number (VAERS-ID 395496). A 6-month-old male patient received the second dose of PREVENAR 13 (Lot E57642) intramuscularly in the left leg, the third dose of PEDIARIX (Lot AC21B248CA) intramuscularly in the right leg, a dose of ROTATEQ (Lot 0510Z) orally, and the third dose of ACTHIB (Lot UH045AB) intramuscularly in the right leg. All vaccines were administered on 26July2010. Relevant medical history was reported as none. The patient's concomitant medications were not reported. On 04Aug2010 the patient experienced Kawasaki's disease. Relevant laboratory data included the following: leukocytosis with platelet count increasing to 922K, CRP greater than 300, and erythrocyte sedimentation rate max at 130 mm/hr. A urine analysis on an unspecified date revealed leukocytosis. Cultures of the blood, urine, and CSF on an unspecified date were negative. An echocardiogram on an unspecified date demonstrated coronary artery ectasia with a clinical picture of Kawasaki's disease. Therapeutic measures were taken as a result of the event Kawasaki's disease and included treatment with  two rounds of intravenous immunoglobulin (IVIG). The clinical outcome of the events was reported as recovered. Follow-up (11May2011): This follow-up is submitted to amend previously reported information trade name for non-Pfizer suspect vaccines.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Feeling of body temperature change, Pyrexia, Rash
Clinical narrative: "Slight" fever for 2 days following immunization, feeling hot then cold. Then approximately 4 days after immunization blister/bumps appeared on right leg (some but not many) then a couple of days later blister/bumps appeared on left leg (many), still on both legs.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red & hot at injection site. Rash starting to form.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm, tender, little swollen (L) thigh.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Bordetella test, Erythema, Fatigue, Feeling hot, Headache
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: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Influenza like illness, Injection site pain, Musculoskeletal pain, Oedema peripheral
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.