chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage, Uterine dilation and curettage, Vaginal haemorrhage
Clinical narrative: Noticed that morning sickness subsided about 1 week after 2010 flu shot required by hospital. 11/11/15 experienced spotting in the morning and had a miscarriage by early afternoon. D&C done due to uncontrollable hemorrhaging. Prior to this, I had no difficulty conceiving. After this, it took me one year to conceive my next child. I have been unsuccessfully trying to conceive for 2 years since her birth.
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Drug administered at inappropriate site, Pain in extremity, Rheumatoid arthritis
Clinical narrative: On Oct. 18, 2014, patient received her flu shot, but thought the pharmacist injected it too high on her arm, near the shoulder joint.  Two days later, she experienced sharp pain down her left arm and got a cortisone shot, thinking it was due to her RA.  She claims she is still getting the sharp pain, but not as frequently.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Infection, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient reported pain in right arm, unable to move it, went to physician who diagnosed infection and prescribed appropiate medication.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: FEBRILE SEIZURES, FEVER.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection area red, swollen, hot.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Erythema, inflammation around injection site.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Immune system disorder, Injection site atrophy, Injection site discolouration
Clinical narrative: Information has been received from a 69 year old female patient with allergy to latex gloves and morphine referring to herself. The patient's medical history included hysterectomy. On 08-NOV-2013 the patient was vaccinated with a dose of ZOSTAVAX on the left hip area, almost on the buttock (lot#, route and dose were unknown). Concomitant therapies unspecified estrogens and gabapentin. The patient described her ZOSTAVAX injection as "the nurse told the patient to get up against the wall, spread her fingers and extend her left hip". Around 03-JAN-2014, the patient developed "lypoatrophy" at the injection site. This "lypoatrophy" began as a dime size discolored mark that grew to the size of a golf ball, then a tennis ball and changed in color over time. It was under the skin. On 19-FEB-2015 it looked like a discolored indentation and had been diagnosed as "lypoatrophy/morphia" by an unspecified dermatologist. On 19-FEB-2015 the patient went to the physician's office and the physician took photos of this atrophy area. Two procedures were recommended: injected the patient's fat from the abdominal area or inject a synthetic. Patient opted for neither as she researched both and was not comfortable with other issues that could develop, and both procedures were only temporary fixes. She did choose to use a prescription Vitamin D cream which had changed the color of the skin and softened it. The patient was told by an unspecified physician that this could lead to scleroderma. She had been to 11 doctors. None had reported to her that this was a result of the vaccine, but rather, a result of a "bad batch" of the vaccine. The patient also was told that the physician's office had reported her adverse event, but no report was located. The physician's office was told that the patient must had this reaction from a KENALOG shot. The patient never had a KENALOG shot. This reaction had set off an immune disorder on an unknown date. The patient was scheduling to see an infectious disease specialist and a rheumatologist. There was no lab diagnostics studies performed. The outcome of the adverse events ws reported as not recovered/not resolved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Inflammation, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2015US017592, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 551604) website on 03 Feb 2015, with the follow-up information received from the Quality Assurance Department (reference number: 352186) on 16 Feb 2015. This report refers to a 65-year-old female patient. On an unknown date, she was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly and PNEUMOVAX (other manufacturer, batch number: K009809) intramuscularly, in the left arm. On an unknown date, after vaccination her arm became swollen, red, inflamed and warm. She went to emergency room and her physician diagnosed the events with cellulitis. She received a course of levofloxacin and recovered with no additional therapy. The events reported as non-serious. The causality of the events was not reported. Seriousness assessment of the events (cellulitis and its symptoms) was upgraded based on the available information in the source document. Upon follow-up from QA department, it stated that the reported FLUVIRIN batch number: 141101 is not a valid batch number. Hence QA investigation will be performed with unknown batch number. Follow-up information received from the Quality Assurance Department (reference number: 352186) on 16 Feb 2015: Updated QA comments and QA reference number.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Arthralgia, Blood test, Fatigue, Headache, Migraine
Clinical narrative: Tingling in hands, arms, feet, legs, toes. Weakness in arm and leg muscles. Chest pain with deep breaths. Joint pain in fingers, toes, elbows, shoulders, knees, ankles. Spine pain with pulsating feeling. Headaches and migraines. Fatigue and nausea, dry heaves.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Muscular weakness, Nausea, Painful respiration, Paraesthesia, Retching
Clinical narrative: Tingling in hands, arms, feet, legs, toes. Weakness in arm and leg muscles. Chest pain with deep breaths. Joint pain in fingers, toes, elbows, shoulders, knees, ankles. Spine pain with pulsating feeling. Headaches and migraines. Fatigue and nausea, dry heaves.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Spinal pain, Urine analysis normal
Clinical narrative: Tingling in hands, arms, feet, legs, toes. Weakness in arm and leg muscles. Chest pain with deep breaths. Joint pain in fingers, toes, elbows, shoulders, knees, ankles. Spine pain with pulsating feeling. Headaches and migraines. Fatigue and nausea, dry heaves.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Arthralgia, Blood creatine phosphokinase normal, Blood folate normal, Borrelia test negative, CSF cell count normal
Clinical narrative: Tingling in hands, arms, feet, legs, toes. Weakness in arm and leg muscles. Chest pain with deep breaths. Joint pain in fingers, toes, elbows, shoulders, knees, ankles. Spine pain with pulsating feeling. Headaches and migraines. Fatigue and nausea, dry heaves.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Computerised tomogram normal, Diplegia, Epstein-Barr virus test negative, Herpes simplex serology negative, Myalgia
Clinical narrative: Tingling in hands, arms, feet, legs, toes. Weakness in arm and leg muscles. Chest pain with deep breaths. Joint pain in fingers, toes, elbows, shoulders, knees, ankles. Spine pain with pulsating feeling. Headaches and migraines. Fatigue and nausea, dry heaves.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Spinal pain, Vitamin B12 normal
Clinical narrative: Tingling in hands, arms, feet, legs, toes. Weakness in arm and leg muscles. Chest pain with deep breaths. Joint pain in fingers, toes, elbows, shoulders, knees, ankles. Spine pain with pulsating feeling. Headaches and migraines. Fatigue and nausea, dry heaves.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Arthralgia, Dizziness, Muscular weakness
Clinical narrative: Tingling in hands, arms, feet, legs, toes. Weakness in arm and leg muscles. Chest pain with deep breaths. Joint pain in fingers, toes, elbows, shoulders, knees, ankles. Spine pain with pulsating feeling. Headaches and migraines. Fatigue and nausea, dry heaves.
Age: 0.88
Sex: M
Vaccine: DTAP
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site became swollen, red, bruised, and warm to the touch. It continued to get worse for 36 hours and then started healing in the third day.
Age: 0.81
Sex: M
Vaccine: HIBV, HPVX, IPV
Symptoms: Head banging, Screaming
Clinical narrative: Prolonged high pitched screaming; head banging.
Age: 1.39
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Bladder catheterisation, Chest X-ray abnormal, Ear infection, Lethargy, Pneumonia viral
Clinical narrative: The patient suffered a fever higher than 104 degrees and was extremely lethargic. This high fever lasted for a total of 5 days.
Age: 1.39
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: The patient suffered a fever higher than 104 degrees and was extremely lethargic. This high fever lasted for a total of 5 days.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Started with a headache on 02-26.  By that night, I was itching all over my body.  No rash, though.  By 02-27, headache was severe and ears were ringing.  Later that night, I was dizzy, had severe chills, was nauseated, was fatigued, and my joints and muscles ached so bad I could barely move. On 02-28, the symptoms started to subside, and by today (03-01), I'm just back to a regular headache.  Hopefully, that will be gone by tomorrow.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Mobility decreased, Myalgia, Nausea, Pruritus generalised, Tinnitus
Clinical narrative: Started with a headache on 02-26.  By that night, I was itching all over my body.  No rash, though.  By 02-27, headache was severe and ears were ringing.  Later that night, I was dizzy, had severe chills, was nauseated, was fatigued, and my joints and muscles ached so bad I could barely move. On 02-28, the symptoms started to subside, and by today (03-01), I'm just back to a regular headache.  Hopefully, that will be gone by tomorrow.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Blood glucose normal, Headache, Loss of consciousness, Pallor
Clinical narrative: My daughter received 4 year old vaccinations (Dtap, Polio, MMR, Varicella).  She was fine for about 5 minutes post vaccinations.  Then, she stated her head and stomach hurt.  I asked her dad to go ahead and take her to car.  She then got very pale.  He picked her up, but she vomited and proceeded to pass out.  After 20 minutes, she finally came back to normal.  We had to continuously call her name to wake her.  The doctor came back in the room.  She asked the nurses could one of the vaccinations possibly have one of her allergens, and they stated no.  Her blood glucose was tested, and it was completely normal.  I do feel like she had a strong allergic reaction to these vaccinations.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: My daughter received 4 year old vaccinations (Dtap, Polio, MMR, Varicella).  She was fine for about 5 minutes post vaccinations.  Then, she stated her head and stomach hurt.  I asked her dad to go ahead and take her to car.  She then got very pale.  He picked her up, but she vomited and proceeded to pass out.  After 20 minutes, she finally came back to normal.  We had to continuously call her name to wake her.  The doctor came back in the room.  She asked the nurses could one of the vaccinations possibly have one of her allergens, and they stated no.  Her blood glucose was tested, and it was completely normal.  I do feel like she had a strong allergic reaction to these vaccinations.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Blood glucose normal, Headache, Pallor, Somnolence
Clinical narrative: My daughter received 4 year old vaccinations (Dtap, Polio, MMR, Varicella).  She was fine for about 5 minutes post vaccinations.  Then, she stated her head and stomach hurt.  I asked her dad to go ahead and take her to car.  She then got very pale.  He picked her up, but she vomited and proceeded to pass out.  After 20 minutes, she finally came back to normal.  We had to continuously call her name to wake her.  The doctor came back in the room.  She asked the nurses could one of the vaccinations possibly have one of her allergens, and they stated no.  Her blood glucose was tested, and it was completely normal.  I do feel like she had a strong allergic reaction to these vaccinations.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Unresponsive to stimuli, Vomiting
Clinical narrative: My daughter received 4 year old vaccinations (Dtap, Polio, MMR, Varicella).  She was fine for about 5 minutes post vaccinations.  Then, she stated her head and stomach hurt.  I asked her dad to go ahead and take her to car.  She then got very pale.  He picked her up, but she vomited and proceeded to pass out.  After 20 minutes, she finally came back to normal.  We had to continuously call her name to wake her.  The doctor came back in the room.  She asked the nurses could one of the vaccinations possibly have one of her allergens, and they stated no.  Her blood glucose was tested, and it was completely normal.  I do feel like she had a strong allergic reaction to these vaccinations.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Lip blister, Pain
Clinical narrative: Pt. is a 58 year old physician with no preexisting medical conditions  Presented for elective vaccination with Zostavax.  Chickenpox as child and one herpetic (presumed) upper lip lesion at age 13.  Subcutaneous injection was painless.  6 hours later, pt. noted erythema with 3 inches of induration at injection site, which was left covered.  Pain and induration persist at 5 days post vaccine. At 48 hours post vaccine, pt. noted onset of viral blister on lower lip involving the mucosa and adjacent skin.  Blister persists at 72 hours post vaccine. There is no warning in the labeling or the store about the potential for outbreaks of Herpes simplex post Zostavax.  However, internet search reveals numerous complaints on bulletin boards and elsewhere regarding this complication.
Age: 1.08
Sex: F
Vaccine: FLUX, MMR, UNK, VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash on most of body.
Sex: U
Vaccine: PPV, PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a pharmacist via Pfizer (manufacturer control# 2015058208) referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (route, lot#, dose and frequency were unknown). On an unknown date the patient experienced allergic reaction after being administered PNEUMOVAX 23. The symptoms of the allergic reaction were unknown. It was unspecified if the patient sought for medical attention. The outcome of allergic reaction was unknown. The relationship between the adverse event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Pt reported soreness of (R) upper arm. Mobility to raise arm to a reasonable height after 1 month, small bump at immunization site. Notified MD over phone. Pt has been sick w/ flu-like symptoms more than usual this year.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood culture, Computerised tomogram, Culture urine, Disorientation, Electroencephalogram
Clinical narrative: Son was unresponsive 01/30/2015 and was very disoriented. After numerous tests administered by hospital, neurologist attributed mental status to adverse reaction to MMR vaccine.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Gram stain, Mental status changes, Nuclear magnetic resonance imaging, Unresponsive to stimuli, Vaccination complication
Clinical narrative: Son was unresponsive 01/30/2015 and was very disoriented. After numerous tests administered by hospital, neurologist attributed mental status to adverse reaction to MMR vaccine.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Paraesthesia oral, Sensory disturbance
Clinical narrative: Approximately 3 hr post vaccination pt called to report "feels like someone grabbing my chin", "lips tingle" and then "nauseous" - pt went to urgent care given epi, BENADRYL, loratadine, prednisone.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, Rash
Clinical narrative: Pt was administer ZOSTAVAX with noted HIV which is contraindicated. Pt stated got a rash about 3-4 months after vaccination. Doing well and hasn't had any problem.
Age: 60.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced redness, swelling and pain from the shoulder to the elbow in the arm vaccine was given. Lasted for about 4 days. Patient used APAP and BENADRYL.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. Since 2012 the patient was vaccinated with 4 doses of GARDASIL injection (dosage, lot# and route unspecified). No adverse effects were reported. This is one of two report received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Information has been received from a male consumer of unknown age via Pfizer referring to himself. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown)(reported as "PPSV23 Pneumonia shot"). (lot#, dose, and route not reported). On an unknown date the patient experienced side effects (unspecified). The outcome of the side effects was unknown. The causality was not provided by reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to four patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot number, dose and route were unknown). No adverse events were reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Allodynia
Clinical narrative: Mechanical Allodynia legs.
Age: 12.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Acoustic stimulation tests, Dizziness, Headache, Influenza virus test negative, Lethargy
Clinical narrative: There were no reactions or signs of distress at time of administration of vaccine. Patient discharged from clinic without complaints. Accompanied by mother. See ER report.
Age: 12.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pallor, Pyrexia, Rash, Sensation of foreign body, Streptococcus test negative
Clinical narrative: There were no reactions or signs of distress at time of administration of vaccine. Patient discharged from clinic without complaints. Accompanied by mother. See ER report.
Age: 12.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Tinnitus, Urticaria
Clinical narrative: There were no reactions or signs of distress at time of administration of vaccine. Patient discharged from clinic without complaints. Accompanied by mother. See ER report.
Age: 12.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Unevaluable event
Clinical narrative: There were no reactions or signs of distress at time of administration of vaccine. Patient discharged from clinic without complaints. Accompanied by mother. See ER report.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Muscle ache in both arms and chest after mild activity.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, half dollar in size to right thigh.  Warm to touch.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Cough, Ear infection, Nasopharyngitis, Pyrexia, Rash
Clinical narrative: Pinpoint rash started on trunk (front and back) developed into full measles-type rash covering entire body. Also, pt had cold-like symptoms (congestion and coughing) with fever started on 2/10/15, and R ear infection dx'd 2/20/15, started on amoxicillin 2/20/15 x 10 days BID. Rash and cold-type symptoms almost resolved on this date (3/2/15).
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Rash generalised, Rash morbilliform, Respiratory tract congestion
Clinical narrative: Pinpoint rash started on trunk (front and back) developed into full measles-type rash covering entire body. Also, pt had cold-like symptoms (congestion and coughing) with fever started on 2/10/15, and R ear infection dx'd 2/20/15, started on amoxicillin 2/20/15 x 10 days BID. Rash and cold-type symptoms almost resolved on this date (3/2/15).
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Pallor, Rash, Rash morbilliform, Rash papular
Clinical narrative: Pinpoint rash started on trunk (front and back) developed into full measles-type rash covering entire body. Also, pt had cold-like symptoms (congestion and coughing) with fever started on 2/10/15, and R ear infection dx'd 2/20/15, started on amoxicillin 2/20/15 x 10 days BID. Rash and cold-type symptoms almost resolved on this date (3/2/15).
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Cerebrovascular accident, Convulsion, Electrocardiogram, Electroencephalogram, Hemiparesis
Clinical narrative: NONE RESPONSIVE, VOMITING, SEIZURE, SLIGHT REDNESS AT SIGHT. BILATERAL CEREBRAL STROKE WITH RIGHT SIDE WEAKNESS.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Unresponsive to stimuli, Vomiting
Clinical narrative: NONE RESPONSIVE, VOMITING, SEIZURE, SLIGHT REDNESS AT SIGHT. BILATERAL CEREBRAL STROKE WITH RIGHT SIDE WEAKNESS.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and itching at the injection site with swelling and hard lump approximately 2 by 3 inches.
Age: 13.0
Sex: F
Vaccine: TDAP, TYP, YF
Symptoms: Hypersensitivity, Lip swelling, Sensation of foreign body
Clinical narrative: About 20 hours after vaccine administration, patient had lip swelling and felt like there was a ball in her throat. No respiratory involvement. Went to ER and received EPIPEN, IV BENADRYL, IV steroids. Vital signs and respiratory status all remained normal. Admitted for observation overnight and had no further allergic reaction symptoms.
Sex: F
Vaccine: DTAP
Symptoms: Bordetella test positive, Pertussis
Clinical narrative: Initial unsolicited case received from a healthcare professional on 17 February 2015. An 8-year-old female patient received 5 doses of DAPTACEL (lot number and dates of vaccination not reported) as per immunization schedule, and was subsequently diagnosed in 2014 with pertussis. According to the reporter, the patient had completed the full schedule of doses. The patient was seen in the office on 06 November 2014, and the diagnosis was laboratory-confirmed. Outcome was reported as recovered. Documents held by sender: None.
Age: 1.13
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Blood culture, Chest X-ray, Computerised tomogram head, Febrile convulsion, Full blood count
Clinical narrative: Febrile seizures, rash.
Age: 1.13
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Metabolic function test, Rash
Clinical narrative: Febrile seizures, rash.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid and posterior lateral fat of upper left arm golf ball size bump with red, hot, itching and burning.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Pyrexia
Clinical narrative: Right deltoid and posterior lateral fat of upper left arm golf ball size bump with red, hot, itching and burning.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pruritus, Rash, Rash erythematous, Rash pustular
Clinical narrative: Injection site was sore that afternoon.  About a week later I started noticing red bumps coming up one at a time.  They are mostly on arms and torso, itchy and some puss filled.  Some are still itchy.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Anal haemorrhage, Anal ulcer, Surgery
Clinical narrative: Went to have bowel movement and started bleeding profusely from anal area. No prior symptoms.
Age: 0.26
Sex: M
Vaccine: RV5
Symptoms: Abnormal faeces
Clinical narrative: Information has been received from a physician refers to a 3 month old male patient. The patient had no pertinent medical history and no drug reactions/allergies. On 19-FEB-2015 the patient was vaccinated with his first dose of ROTATEQ (lot# reported as K010222, expiry date dose unspecified) orally. No concomitant medication reported. On 20-FEB-2015 (reported as "about 1 to 2 days" following the administration), the patient began to produce stool that smelled like metal. The outcome of the event was not resolved at the time of report. Patient sought medical attention via phone call to physician's office. There was no treatment given for event and no lab diagnostics studies performed. No product quality complaint (PQC) was involved. The reporter did not assessed the relationship between ROTATEQ and the event. Additional information has been requested.
Age: 0.78
Sex: F
Vaccine: HEP
Symptoms: Agitation, Crying, Emotional distress, Muscle twitching, Sleep disorder
Clinical narrative: My daughter cried and twitched for a month straight. She was inconsolable and agitated. I could not get her to sleep normally after that doctor visit.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site injury, Injection site pain
Clinical narrative: I am an RN and therefore am knowledgable in respect of proper/safe IM injection technique. I could tell that the vaccinator was nervous & can remember the feeling so I looked away in hopes of taking some pressure off of him. After the initial stick, I could tell something was wrong and turned to look at what was happening. This is when I noticed the worried look on the administrator's face before he proceeded to withdraw the needle a little bit and then inject the vaccine. I myself was very worried once I realized how very high up on my arm the injection was placed. It felt as if he had administered the shot directly into my joint & completely missed any sliver of muscle tissue altogether. After receiving the vaccine, I instantly/constantly experienced extreme pain in shoulder w/ any movement, range of motion, stretching, weight bearing, etc. The pain has since caused me to wake up in the middle of the night and is only somewhat relieved with high doses of NSAIDS.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Middle insomnia, Nuclear magnetic resonance imaging, Pain, Weight bearing difficulty
Clinical narrative: I am an RN and therefore am knowledgable in respect of proper/safe IM injection technique. I could tell that the vaccinator was nervous & can remember the feeling so I looked away in hopes of taking some pressure off of him. After the initial stick, I could tell something was wrong and turned to look at what was happening. This is when I noticed the worried look on the administrator's face before he proceeded to withdraw the needle a little bit and then inject the vaccine. I myself was very worried once I realized how very high up on my arm the injection was placed. It felt as if he had administered the shot directly into my joint & completely missed any sliver of muscle tissue altogether. After receiving the vaccine, I instantly/constantly experienced extreme pain in shoulder w/ any movement, range of motion, stretching, weight bearing, etc. The pain has since caused me to wake up in the middle of the night and is only somewhat relieved with high doses of NSAIDS.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Influenza virus test negative, Myalgia, Pyrexia, Rash, Rash papular
Clinical narrative: Low grade fever, myalgias within 24 hours developed soft pink papular rash on forehead & cheeks with gradual spread down abdomen anterior/posteriorly. Non itchy rash.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Streptococcus test negative
Clinical narrative: Low grade fever, myalgias within 24 hours developed soft pink papular rash on forehead & cheeks with gradual spread down abdomen anterior/posteriorly. Non itchy rash.
Age: 20.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, PPV
Symptoms: Cough, Dysphagia, Dyspnoea, Fatigue, Headache
Clinical narrative: Excessive pain, redness and swelling near injection site the day it was given; hard, painful red lumps developed surrounding and well below the injection sight for 3 days, headache, difficulty breathing, fatigue, sore throat, sneezing, dry cough, difficulty swallowing. Self treated with Benadryl.
Age: 20.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Excessive pain, redness and swelling near injection site the day it was given; hard, painful red lumps developed surrounding and well below the injection sight for 3 days, headache, difficulty breathing, fatigue, sore throat, sneezing, dry cough, difficulty swallowing. Self treated with Benadryl.
Age: 20.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, PPV
Symptoms: Oropharyngeal pain, Sneezing
Clinical narrative: Excessive pain, redness and swelling near injection site the day it was given; hard, painful red lumps developed surrounding and well below the injection sight for 3 days, headache, difficulty breathing, fatigue, sore throat, sneezing, dry cough, difficulty swallowing. Self treated with Benadryl.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, HEP, HEPA, MMRV
Symptoms: Asthenia, Pyrexia
Clinical narrative: Fever and lack of energy up to 104 - 5  days.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M increased, Otitis media, Pharyngitis, Rash
Clinical narrative: Onset of rash, nasal drainage, congestion on 2-22. Parents brought child to an urgent care on 2-24-15. He was diagnosed with otitis media and pharygitis. The physician also ordered IgG and IgM for measles and a viral swab was sent for viral culture.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Respiratory tract congestion, Rhinorrhoea, Viral test
Clinical narrative: Onset of rash, nasal drainage, congestion on 2-22. Parents brought child to an urgent care on 2-24-15. He was diagnosed with otitis media and pharygitis. The physician also ordered IgG and IgM for measles and a viral swab was sent for viral culture.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Eczema, Erythema, Food allergy, Milk allergy
Clinical narrative: Inconsolable crying lasted about 2 hours, hive appearance rash on face, red whelps around the mouth. Rash continued for 2 weeks scheduled appointment with doctor. Doctor diagnosed eczema and said to use steroid cream on face. Still had issues with rash/hives/eczema on face. Dr recommended an allergen specialist to be seen. Allergens diagnosed as egg, dairy, and peanuts. Span/Time of events-2 months from the date of adverse event onset.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Rash, Skin test positive, Urticaria
Clinical narrative: Inconsolable crying lasted about 2 hours, hive appearance rash on face, red whelps around the mouth. Rash continued for 2 weeks scheduled appointment with doctor. Doctor diagnosed eczema and said to use steroid cream on face. Still had issues with rash/hives/eczema on face. Dr recommended an allergen specialist to be seen. Allergens diagnosed as egg, dairy, and peanuts. Span/Time of events-2 months from the date of adverse event onset.
Age: 0.61
Sex: M
Vaccine: PNC13
Symptoms: Condition aggravated, Eczema, Rash, Urticaria
Clinical narrative: Rash/Hives around the face area. Eczema patches on the body.
Age: 1.26
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Onset approximately 10 days after shot with fever to 101.7 and rash.
Age: 13.0
Sex: F
Vaccine: HPV2
Symptoms: Pharyngeal oedema, Throat irritation
Clinical narrative: Minor throat swelling/irritation.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Injection site nodule, Pain, Pruritus
Clinical narrative: Large welt (larger than 2 quarters side-to-side), knot under site, redness, heat, pain, severe itching.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Large welt (larger than 2 quarters side-to-side), knot under site, redness, heat, pain, severe itching.
Age: 0.72
Sex: M
Vaccine: PNC13
Symptoms: Allergy test positive, Food allergy, Hypersensitivity, Tic
Clinical narrative: Child developed involuntary head tics.  Within 24 hours of receiving Prevnar 13 vaccine. He would intermittently shake his head back and forth and in all directions while sitting or crawling.  The involuntary head tics were the most pronounced within the first weeks of receiving the vaccine.  It was startling, as our child had NEVER done this motion before.  We were afraid it might be permanent. After a few weeks, the tics appeared to subside. After receiving previous vaccinations, between the ages of 3 months and 9 months, he had eczema and was later diagnosed with a nut allergy.  He had his first allergic reaction to nuts at 12 months and then again at age 3 (11/12/2013).  He was officially diagnosed with a nut allergy at age 3 (11/2013).
Age: 1.04
Sex: M
Vaccine: MMRV
Symptoms: Injection site rash, Rash generalised, Rash vesicular
Clinical narrative: Blister type rash around inner thighs, upper arms, ear lobes, face and chest.
Age: 1.1
Sex: M
Vaccine: HIBV
Symptoms: Abasia, Body temperature increased, Crying, Decreased appetite, Eye movement disorder
Clinical narrative: Took nap at noon, would not wake up at 2pm when I tried to wake him by calling his name and rubbing his back (normally he wakes up if I touch the door knob).  I thought he was just very tired and had a babysitter come over while I got my daughter from school.  He woke up at 3:30p, crying, acted lethargic, wouldn't walk, was not happy to see his dad like usual. Had a low grade temp but no fever.  Figured the injection site hurt. At dinner he would not eat, did not look well, would not smile, eyes rolled back and he slumped over. Temp 103.8 and Motrin given. Figured eyes rolling were from being very sleepy.  Slept 6-9p (took temp while he slept at 8p and it was 103.4. Gave more Motrin at 10p and he slept until 7a. At 8am on 1/16/14 temp 102.3, slept 8:15-8:45, then 11-12, at 1p temp 100.4.  Called Dr's office, told them what was going on with child and paper given to me on HiB from CDC said to call MD if moderate or severe reaction occurs but it does not quantify "high fever."  Nurse first said "I'm sure he'll be fine."  Then she asked if I was giving Motrin and Tylenol round the clock since shot, I said how would I know if he had a reaction if I gave him the meds constantly? She said his fever got that high because I let it.  I insisted that it would be covering up a vaccine reaction, and I want it documented and reported, like in the paper they gave me.  She asked me how I took his temp. and said tympanic is not accurate...I explained that room air is not 103.8 so it couldn't be a false high but it could potentially be an even higher temp if she thinks I didn't get it all the way in his ear.  Then I asked for the doctor to call me instead. I explained to the doctor that he was not sick at all before the shot, not one in our house was sick, and he woke up like this hours after the single HiB shot, with no other cold symptoms.  She said he was probably getting sick and since he isn't fully vaccinated we can't be sure what he has.  It is a coincidence.  If the fever is not gone by Friday (would be 72 hours from start) and he does not develop other cold symptoms she would do a straight cath because he is uncircumcised.  He slept 3-5:30pm, then by 4pm on Friday his temp was 99.2.  He never got any cold symptoms and neither did anyone else in the household. He did not eat for 3 days following the injection of HiB and when he started eating again he was very picky and still is.  Previous to that he would eat ANYTHING.
Age: 1.1
Sex: M
Vaccine: HIBV
Symptoms: Lethargy, Posture abnormal, Somnolence
Clinical narrative: Took nap at noon, would not wake up at 2pm when I tried to wake him by calling his name and rubbing his back (normally he wakes up if I touch the door knob).  I thought he was just very tired and had a babysitter come over while I got my daughter from school.  He woke up at 3:30p, crying, acted lethargic, wouldn't walk, was not happy to see his dad like usual. Had a low grade temp but no fever.  Figured the injection site hurt. At dinner he would not eat, did not look well, would not smile, eyes rolled back and he slumped over. Temp 103.8 and Motrin given. Figured eyes rolling were from being very sleepy.  Slept 6-9p (took temp while he slept at 8p and it was 103.4. Gave more Motrin at 10p and he slept until 7a. At 8am on 1/16/14 temp 102.3, slept 8:15-8:45, then 11-12, at 1p temp 100.4.  Called Dr's office, told them what was going on with child and paper given to me on HiB from CDC said to call MD if moderate or severe reaction occurs but it does not quantify "high fever."  Nurse first said "I'm sure he'll be fine."  Then she asked if I was giving Motrin and Tylenol round the clock since shot, I said how would I know if he had a reaction if I gave him the meds constantly? She said his fever got that high because I let it.  I insisted that it would be covering up a vaccine reaction, and I want it documented and reported, like in the paper they gave me.  She asked me how I took his temp. and said tympanic is not accurate...I explained that room air is not 103.8 so it couldn't be a false high but it could potentially be an even higher temp if she thinks I didn't get it all the way in his ear.  Then I asked for the doctor to call me instead. I explained to the doctor that he was not sick at all before the shot, not one in our house was sick, and he woke up like this hours after the single HiB shot, with no other cold symptoms.  She said he was probably getting sick and since he isn't fully vaccinated we can't be sure what he has.  It is a coincidence.  If the fever is not gone by Friday (would be 72 hours from start) and he does not develop other cold symptoms she would do a straight cath because he is uncircumcised.  He slept 3-5:30pm, then by 4pm on Friday his temp was 99.2.  He never got any cold symptoms and neither did anyone else in the household. He did not eat for 3 days following the injection of HiB and when he started eating again he was very picky and still is.  Previous to that he would eat ANYTHING.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Diabetes mellitus, Laboratory test abnormal
Clinical narrative: Vaccine given 3/1/2012 - diagnosed with diabetes 4/9/2012.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Diabetes mellitus
Clinical narrative: Vaccine given 3/1/2012 - diagnosed with diabetes 4/9/2012.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Vaccine give to left upper arm 11/05/14 at 16:30 at Health Dept. to HU on 11/06/14 left upper arm red from shoulder to elbow, hot, and hard to touch at 08:44 ice pack applied. Parent contacted. Verbal MD referral given. Appt made for 11:00 on 11/06/14.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Myalgia, Pain
Clinical narrative: Pt complained of muscle pain after influenza shot, described like she was given a tetanus shot. 2 days later she felt more of an ache, she went to a physician 2/12/15 who said she could have bursitis and referred her to an orthopedic surgeon and MRI. She was given tramadol, NSAIDS and told to ice. She has follow up in March.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myalgia, Pain
Clinical narrative: Pt complained of muscle pain after influenza shot, described like she was given a tetanus shot. 2 days later she felt more of an ache, she went to a physician 2/12/15 who said she could have bursitis and referred her to an orthopedic surgeon and MRI. She was given tramadol, NSAIDS and told to ice. She has follow up in March.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Aching (L) arm, neck, shoulder, then the aching went into legs, hip. Returned to normal by 2/3/15.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyskinesia, Electroencephalogram normal
Clinical narrative: Infant developed jerking movement, as starting in all extremities within hours of receiving PEDIARIX, Hib, PREVNAR and ROTATEQ. He was having one jerk every 3-4 minutes but slowed down and last one was about 2 hours prior to visit today.
Age: 16.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Computerised tomogram head normal, Drug screen negative, Dyspnoea, Full blood count normal, Metabolic function test normal
Clinical narrative: Fainted around 4 pm at softball practice-she was having hard time breathing before fainting afterwards. She was acting "normal".
Age: 16.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Pregnancy test urine negative, Syncope, Troponin normal, Urine alcohol test negative
Clinical narrative: Fainted around 4 pm at softball practice-she was having hard time breathing before fainting afterwards. She was acting "normal".
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Vomiting
Clinical narrative: Shoulder pain and reduced range of motion in arm where shot was given immediately after given. Had chills 4 hrs. later. Pain still cont and can't lay on shoulder in bed. Also, vomited w/chills.
Age: 11.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Pain in extremity
Clinical narrative: Ever since she got flu shot left arm is painful and red while exercises (school gym class). Otherwise she feels normal.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Eye movement disorder, Seizure, Tremor
Clinical narrative: He had a Tmax of 102.5 on 2/28 and had a 10-15 min seizure episode of shaking arms and legs w/ rolling of eyes.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of expired vaccine used in a 27-year-old female patient who received BOOSTRIX (batch number unknown, expiry date 21st June 2014). In July 2014, the patient received BOOSTRIX. In July 2014, an unknown time after receiving BOOSTRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: Per HCP: an expired dose of BOOSTRIX was administered to a patient back in July.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Chills, Fatigue, Pain, Rash
Clinical narrative: 2/25/15-C/o fatigue, body aches and chills. 2/26/15-C/0 with these symptoms and rash to hand-rash worsening both hands/chest. 2/27/15-rash worsening and took BENADRYL x 3. Rash "burned" no itch. 2/28/15-went to urgent care-rx steroids.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Fibromyalgia, Headache, Hyperhidrosis, Influenza like illness, Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 54-year-old female patient who received Flu vaccine. Concurrent medical conditions included systemic lupus erythematous and fibromyalgia. In October 2012, the patient received Flu vaccine (intramuscular). In 2012, less than a month after receiving Flu vaccine, the patient experienced nausea, sweating and headache. In October 2012, the patient experienced influenza-like symptoms and feeling unwell. The patient was treated with OTC nausea medication and vitamin D nos. In January 2013, the outcome of the influenza-like symptoms, feeling unwell, nausea, sweating and headache were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, feeling unwell, nausea, sweating and headache to be related to Flu vaccine. Additional information: This patient received an unknown flu vaccination and developed flu-like symptoms that came and went several times. She described the symptoms as sweating, nausea, headache and just not feeling good. She stated that the symptoms would last about 1.5 days and then come and go. In July 2013, she was diagnosed with Lupus and fibromyalgia so she believes it is possible the symptoms were actually caused by these conditions and not related to the flu vaccination.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Systemic lupus erythematosus
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 54-year-old female patient who received Flu vaccine. Concurrent medical conditions included systemic lupus erythematous and fibromyalgia. In October 2012, the patient received Flu vaccine (intramuscular). In 2012, less than a month after receiving Flu vaccine, the patient experienced nausea, sweating and headache. In October 2012, the patient experienced influenza-like symptoms and feeling unwell. The patient was treated with OTC nausea medication and vitamin D nos. In January 2013, the outcome of the influenza-like symptoms, feeling unwell, nausea, sweating and headache were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, feeling unwell, nausea, sweating and headache to be related to Flu vaccine. Additional information: This patient received an unknown flu vaccination and developed flu-like symptoms that came and went several times. She described the symptoms as sweating, nausea, headache and just not feeling good. She stated that the symptoms would last about 1.5 days and then come and go. In July 2013, she was diagnosed with Lupus and fibromyalgia so she believes it is possible the symptoms were actually caused by these conditions and not related to the flu vaccination.
Age: 48.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist via Center referring to a 48 year old female patient. The patient did not have any relevant medical or drug history. On 06-FEB-2015 the patient was vaccinated with a dose of MMR II, lot# was reported as H018945 that expired on 18-OCT-2014 (dose, dose number, application site and route were not reported). The patient did not take any concomitant medications. The patient did not report any problems and no tests had been done. As of 06-FEB-2015 it was unknown if the patient would get another MMR II vaccine and the outcome of receiving an expired vaccine was unknown. This pharmacist stated that the lot number and expiration dates on the cartons were very hard to read and she did not known if the lot number and expiration date given was accurate. Product quality complaint (PQC) involved (also reported as "emergency PQD: No"). This is one of several reports received from the same source. Additional information has been requested.