chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Tenderness
Clinical narrative: Erythematous, slightly raised area on deltoid surfaces bilaterally, (L) arm approx 4 in. diameter, (R) arm approx 3 in. diameter. Tender to palpation. Tx: BENADRYL, ice packs, ADVIL for fevers.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urticaria
Clinical narrative: Patient presented to the ER 2 days following his first set of immunizations. He had an acute urticaria. He was treated with PRELONE for 5 days.
Age: 1.52
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Convulsion, Emotional distress, Irritability, Unresponsive to stimuli
Clinical narrative: Mom thinks she had 2 seizures 1 day after her 18 month vaccines. Both episodes were episodes of unresponsiveness. The first time, mom found her lying face down on the floor, arms out to sides. Mom noticed that she was suddenly quiet. There was no sound of a fall. No bruises or bumps on face. She was normal in color, her eyes were open and seemed to be looking around. She would not alert to mom call her name, clapping, shook her food, and offered a cracker to her had, with no response. Suddenly she got up and was normal. The whole episode was about 30-40 secs. Later that night, aroun 7 pm, Dad was in the laundry room, next to the playroom, heard no noise, went to the playroom, and eventually found her after 1-2 minutes. She was laying under a small trampoline, with her hands in front of her face. Dad called her multiple times, with no reponse. 20-30 secs later she pulled her hands away, and then seemed to get back to normal. She had no fever. Since then she has been more sensitive and irritable, harder to soothe. She has more meltdowns.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Dysarthria, Muscular weakness
Clinical narrative: Went to emergency room with symptoms of CVA per client. Diagonses was Bells palsy per client. Right side of face "droopy". Weakness noted on right arms also per client. Slurred speech.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: VIIth nerve paralysis
Clinical narrative: Went to emergency room with symptoms of CVA per client. Diagonses was Bells palsy per client. Right side of face "droopy". Weakness noted on right arms also per client. Slurred speech.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Cough, Fatigue, Headache, Influenza virus test negative
Clinical narrative: SUDDEN ONSET OF FEVER WITH CHILLS, HEADACHE, FATIGUE. NO RUNNY NOSE, COUGH, SORE THROAT, NECK PAIN, VOMITINGS. WAS FEBRILE TEMP. 102.8, NO FOCUS FOR FEVER, VACCINE SITE NORMAL. RAPID FLU TEST WAS NEGATIVE.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Neck pain, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: SUDDEN ONSET OF FEVER WITH CHILLS, HEADACHE, FATIGUE. NO RUNNY NOSE, COUGH, SORE THROAT, NECK PAIN, VOMITINGS. WAS FEBRILE TEMP. 102.8, NO FOCUS FOR FEVER, VACCINE SITE NORMAL. RAPID FLU TEST WAS NEGATIVE.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness of lips and chin bilaterally, left greater than right. Lasted 1 hour.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Abnormal behaviour, Asthenia, Decreased activity, Dizziness, Pallor
Clinical narrative: Pale, weak, not herself, passive, sleepy, out of character; puked up lunch; fever 102.5; dizziness.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Personality change, Pyrexia, Somnolence, Vomiting
Clinical narrative: Pale, weak, not herself, passive, sleepy, out of character; puked up lunch; fever 102.5; dizziness.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pruritic
Clinical narrative: Itchy rash, possible hives, treated with allergy ointment and Benadryl.
Age: 0.16
Sex: F
Vaccine: DTAP
Symptoms: Abdominal distension, Crying, Rash
Clinical narrative: Rash on face down neck and lateral legs, more crying than usual, abdomen distended.
Age: 36.0
Sex: M
Vaccine: DTP
Symptoms: Erythema, Pain, Pain in extremity, Swelling
Clinical narrative: Redness, pain, swelling. Injection site is approx 2" below deltoid area. Arm has been painful since injection, swelling and redness developed soon after injection, reported this to spouse on 1/31/2013. Swollen area is about size of half-dollar. MD office called morning of 2/1/13, msg left for phone nurse with above info.
Age: 19.0
Sex: F
Vaccine: FLU3, HEPAB, MNQ, TDAP
Symptoms: Flushing, Pruritus, Throat tightness
Clinical narrative: FACIAL FLUSHING, ITCHING OF HANDS, TIGHTNESS IN THROAT. ITCHING OF FACE AND NECK.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Chills, Headache, Pyrexia
Clinical narrative: SUDDEN ONSET OF FEVER WITH CHILLS, HEADACHE, WHOLE BODY WEAKNESS.
Age: 43.0
Sex: M
Vaccine: MMR
Symptoms: Chest discomfort, Swelling, Tremor, Vaccination complication
Clinical narrative: Received call from wife that employee was "shaking like a leaf". Having some chest tightness. Instructed to seek medical attention either ED or call 911 especially if symptoms worsen with difficulty breathing or chest pain. Did go to ED and was hospitalized. Supervisor came to report patient in hospital with swelling and is presently hospitalized. Stated he did have reaction to the MMR.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Decreased appetite, Hypersomnia, Somnolence
Clinical narrative: Patient states she got to school and walked into a wall, then went into class and starting "saying things" but she didn't think she was talking. She kept falling asleep in class, got home and didn't want to eat and then slept from 4pm until the next morning. She went to school on 1/25/2013 and said she felt better but still very sleepy and kept falling asleep in class.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Death
Clinical narrative: Patient deceased.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Convulsion, Crying, Eye movement disorder, Irritability, Muscle rigidity
Clinical narrative: Short seizure, approximately 10 seconds, not associated with fever occurred 24 hours following simultaneous immunization with Hepatitis A #1 and PROQUAD (MMR-Varicella), vaccinated 1/28/13, seizure on 1/29/13. Described as irritability/crying followed by stiffening of body x 10 sec. lateral eye movements followed by blank stare, 30 minute post-ictal period.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Postictal state, Staring
Clinical narrative: Short seizure, approximately 10 seconds, not associated with fever occurred 24 hours following simultaneous immunization with Hepatitis A #1 and PROQUAD (MMR-Varicella), vaccinated 1/28/13, seizure on 1/29/13. Described as irritability/crying followed by stiffening of body x 10 sec. lateral eye movements followed by blank stare, 30 minute post-ictal period.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea, Electrocardiogram, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Diagnosed with Guillain-Barre Syndrome. Received 5 doses of IVIG. Paralysis in extremities, trunk, and face. Loss of ability to swallow & extreme difficulty breathing.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture, Nerve conduction studies, Nuclear magnetic resonance imaging, Paralysis
Clinical narrative: Diagnosed with Guillain-Barre Syndrome. Received 5 doses of IVIG. Paralysis in extremities, trunk, and face. Loss of ability to swallow & extreme difficulty breathing.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Swelling/redness to upper rt arm pain at site. Advise elevation, ice x 24 hrs. Rev if no improvement 24-48 hrs.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Discomfort, Dizziness, Gait disturbance
Clinical narrative: New onset of dizziness lasting approx 1 day. Temp 101-102 degrees F. Reported difficulty walking comfortably. Twin w/same side effects.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with an improperly stored 0.5 ml dose of M-M-R II (lot # 671255/1002AA expiration date 28-JUN-2013) SQ on 29-JAN-2013. The nurse reported that the vaccine exposed to 49F for 18 hours. No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a 61 years old male consumer who refers to himself. It was reported that on 05-DEC-2012 the patient was vaccinated in upper left arm with a dose of live ZOSTAVAX (dose, route and lot# not reported). Concomitant medication included unspecified blood pressure drugs. The patient stated that his arm was painful at the injection site from the moment of insertion to 4-5days later before the pain subsided. To date the pain has completely stopped (recovery date was not reported). The patient did not seek medical attention and he did not get any treatment. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Body temperature increased, Dizziness, Gait disturbance
Clinical narrative: New onset of dizziness lasting 1 day (approx.). Temp 101 - 102 degrees F. Dizziness reported significant could not walk comfortably. TYLENOL/Ibu to bring temp. down.
Age: 32.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Client in clinic today states that a slight rash appeared on his arms, legs and upper body on 1-17-13. States that it itches really bad, but on SOB or any other problems. States that he has been putting calamine lotion no for the itching, informed client to seek medical help if any s/s of SOB noted or if rash get any worse. Client states that rash seem to be better today.
Age: 63.0
Sex: M
Vaccine: PER, TD
Symptoms: Chest X-ray, Computerised tomogram head, Dizziness, Electrocardiogram, Heart rate increased
Clinical narrative: Light heeadiness, fast heartbeat, dizziness.
Age: 24.0
Sex: M
Vaccine: HEPAB
Symptoms: Rash
Clinical narrative: Rash to both antecubitals, behind both knees & entire back which persisted for 2 weeks.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Severe body ache, fever.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Induration, Injection site swelling, Swelling, Tenderness
Clinical narrative: Redness with slight induration, swelling and mild tenderness. Swelling 5cm x 5cm on extensor upper left arm surrounding injection site. No fluctuation noted. No streaking. Able to move forarm well. Treatment Augmentin, Benadryl and avoid scratching. ER warnings given. Follow up in 3 days for recheck.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Oedema peripheral, Pyrexia, Rash
Clinical narrative: Pt experienced swollen arm (entire bicep), rash & fever. Extreme headache not recovering by migraine meds, chills, & tremors.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Albumin CSF abnormal, Electromyogram abnormal, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness
Clinical narrative: 26 y/o male admitted for ascending neuromuscular weakness with CSF remarkable for albuminocytologic dissociation, and EMG c/w Acute inflammatory demyelinating polyradiculoneuropathy (AIDP).  He recieved his final dose of the Anthrax vaccine on 7 Jan 2013.  He developed progressive ascending paresthesias around 1/16/2013. He would go on to have ascending neuromuscular weakness and was admitted to Medical Center on 20 Jan 2013. EMG and CSF were c/w the diagnosis of AIDP. He has no recent history of infection, and is undergoing infectious workup at this time.  He also recieved the influenza vaccine on 2 Oct 2012.  He is currently being treated with IVIG and is doing well clinically.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Paraesthesia
Clinical narrative: 26 y/o male admitted for ascending neuromuscular weakness with CSF remarkable for albuminocytologic dissociation, and EMG c/w Acute inflammatory demyelinating polyradiculoneuropathy (AIDP).  He recieved his final dose of the Anthrax vaccine on 7 Jan 2013.  He developed progressive ascending paresthesias around 1/16/2013. He would go on to have ascending neuromuscular weakness and was admitted to Medical Center on 20 Jan 2013. EMG and CSF were c/w the diagnosis of AIDP. He has no recent history of infection, and is undergoing infectious workup at this time.  He also recieved the influenza vaccine on 2 Oct 2012.  He is currently being treated with IVIG and is doing well clinically.
Age: 29.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Oropharyngeal pain, Sinus headache
Clinical narrative: Headache, sinus pain, sore throat.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test abnormal, Bone pain, Malaise
Clinical narrative: I felt like I only had days to live...bones hurts so bad.  Generally felt ill all over.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue
Clinical narrative: Extreme fatigue, worse the last few days, (today is Feb 01) started about the time of the injection.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Hysterectomy, Rash
Clinical narrative: This spontaneous report was received from a Nurse Practitioner refers to a 67 years old female patient with allergy to penicillin, allergy to MACROBID, endometrial carcinoma and hemochromatosis. On 07-DEC-2012, the patient was vaccinated subcutaneously (SQ) with a 0.65 ml dose of ZOSTAVAX (lot # not reported). No other co-suspects were reported. Concomitant medications included: COLACE. The Nurse practitioner reported that a patient who received ZOSTAVAX had developed a rash on her abdomen and back. It was on both sides of the body (it was not limited to one side). The patient had a hysterectomy on 12-JAN-2013 and the rash developed approximately 2 days after the surgery (approximately on 14-JAN-2013). Patient's outcome was reported as recovering. The patient was treated with BENADRYL. The patient sought Medical Attention by visiting office. No lab diagnostics were performed. The Nurse Practitioner said the rash looked like contact dermatitis and she did not think it was related to ZOSTAVAX. The relatedness for hysterectomy was unknown for ZOSTAVAX. Upon internal review the event hysterectomy was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. In 2011, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not provided) which had expired a year earlier, the vaccine expired some time in 2010. No adverse effect reported. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site pruritus, Injection site swelling
Clinical narrative: Pt initially presented with a round swollen, itchy area on her right deltoid at the site of injection. She came back 2/1/2013 complaining of area still itching & swollen & bleeding.
Age: 15.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: Client had vaso vagal response 10 minutes after vaccinations when standing to leave clinic room. Client was seated on the floor when he briefly lost consciousness. Pulse/blood pressure monitored. Given orange juice upon regaining consciousness. Remained stable, regained color and strength.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Local reaction, Swelling
Clinical narrative: Induration/swelling - local rxn.
Age: 37.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Left arm swollen w/ redness. Pt. received Tdap in left arm. Pt states fever of 100.9 w/ soreness swollen and redness on left arm.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Allergy to vaccine, Rash, Respiratory arrest
Clinical narrative: Patient stopped breathing developed rash.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site nodule
Clinical narrative: Knots on bilateral thighs - refilled TYLENOL.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Indurated erythematous knots to all sites. Hydrocortisone cream twice a day to affected area (prescribed).
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Hypotension
Clinical narrative: Lightheaded & dizzy. Checked blood pressure, patient stated it was lower than normal. Had patient sit w/ feet elevated. Blood pressure returned to normal after approx 20 min.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 months old patient. The patient was accidentally received two doses of live (Merck) VARIVAX (lot number unspecified) on 29-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The patient's outcome was unknown. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Paraesthesia
Clinical narrative: This spontaneous report as received from a female pharmacist in her early 50's, reporting on herself, with pertinent historical condition of shingles outbreak. On an unknown date, the patient was vaccinated with one dose of live ZOSTAVAX (lot # and expiration date were not reported) (0.65 ml, subcutaneous route). No other co-suspects or concomitant medications were reported. The reporter stated that two days after immunization felt very lethargic and described it as that feeling up on her shoulder where she previously had a shingles outbreak, a tingling sensation, and then it went away the next day. The patient did not sought medical attention. The patient was reported as recovered on an unspecified date. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 years old female patient with no known relevant medical history or drug allergies. The patient was vaccinated with lot # (0172AE, Exp. 18-APR-2013), 0.65 ml live ZOSTAVAX subcutaneously on 10-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 10-NOV-2012 ("a month later") the patient developed cold sore, which has reoccurred at least once a month on unspecified dates since receiving ZOSTAVAX vaccination. The pharmacist noted that the patient showed her the location of the healed cold sores and that there was an indentation where the cold sore had healed. No treatment was given for the event. The patient contacted pharmacist for medical attention. No lab test was performed. Final outcome of patient's cold sores is unknown. The relatedness for cold sores is unknown for live ZOSTAVAX. Additional information is not expected.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Rash, Urticaria
Clinical narrative: Patient presented to the ER with a rash 3 days after receiving vaccines. He was diagnosed with acute urticaria. He was treated with Prednisone for 5 days & BENADRYL for 3 days.
Age: 32.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Activities of daily living impaired, Hypersomnia, Impaired driving ability, Sleep study, Somnolence
Clinical narrative: Shortly after receiving the H1N1 vaccination I just could not get enough sleep.  I began sleeping through my alarm at 5:00am and not being able to get out of bed until 12:00 or 1:00pm.  I would nod off while driving to work, even though it is only a 30 minute drive and I had only been awake less than 2.5 hours.  I actually drove my car off the side of the road once, I woke up and I was just sitting in my car....  I would fall asleep at the light at the exit ramp of the freeway to work.  I would be so overcome with the need to sleep, I would shut my office door and sleep on the floor at 9am.  I would sleep in my car instead of eating lunch.  I came home from work and took 3-4 hour naps.  On the weekends, I would sleep 15-19 hours a day.  I tried to drink caffeine (I usually don't) and it did not help me stay awake.  In mid-December I went to see my gynecologist, thinking maybe I was anemic.  She woke me up (I fell asleep in the exam chair!) and told me that there was no way the extreme sleepiness was caused by my cycle. She ordered a multiple sleep latency test - I averaged 5 minutes to fall asleep for each nap.  Since then I have been in an out of doctor's offices, trying a variety of pills, lifestyle changes, anything to get my life back.  I used to be able to function daily, not since November 2009.
Age: 32.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Activities of daily living impaired, Blood test, Insomnia, Sleep study, Somnolence
Clinical narrative: Shortly after receiving the H1N1 vaccination I just could not get enough sleep.  I began sleeping through my alarm at 5:00am and not being able to get out of bed until 12:00 or 1:00pm.  I would nod off while driving to work, even though it is only a 30 minute drive and I had only been awake less than 2.5 hours.  I actually drove my car off the side of the road once, I woke up and I was just sitting in my car....  I would fall asleep at the light at the exit ramp of the freeway to work.  I would be so overcome with the need to sleep, I would shut my office door and sleep on the floor at 9am.  I would sleep in my car instead of eating lunch.  I came home from work and took 3-4 hour naps.  On the weekends, I would sleep 15-19 hours a day.  I tried to drink caffeine (I usually don't) and it did not help me stay awake.  In mid-December I went to see my gynecologist, thinking maybe I was anemic.  She woke me up (I fell asleep in the exam chair!) and told me that there was no way the extreme sleepiness was caused by my cycle. She ordered a multiple sleep latency test - I averaged 5 minutes to fall asleep for each nap.  Since then I have been in an out of doctor's offices, trying a variety of pills, lifestyle changes, anything to get my life back.  I used to be able to function daily, not since November 2009.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Visual impairment
Clinical narrative: Pt states about 2 hours after receiving vaccine he started seeing spots and losing vision in both eyes. He reported this to me 6 days later.  Stated it had improved about 90% but still had some vision disturbances.  He did not contact his family physician or ophthalmologist.  I encouraged him to do so.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Electromyogram abnormal, Injection site pain, Musculoskeletal pain, Neuralgic amyotrophy
Clinical narrative: Sudden onset of pain in left shoulder with accompanying weakness that also involved the right shoulder the following day. Symptoms persisted and patient was eventually diagnosed as having brachial plexitis (Parsonage-Turner syndrome).  Patient is currently undergoing treatment with IV steroids and gabapentin for pain
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Emotional distress, Screaming
Clinical narrative: 4 hours after immunizations he began to scream and was inconsolable for 3 hours.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Screaming
Clinical narrative: Inconsolable screaming for 2 hours beginning 4 hours after immunization.
Age: 62.0
Sex: M
Vaccine: FLUC3
Symptoms: Blood test, Gait disturbance, Injection site pain, Nuclear magnetic resonance imaging, Oedema peripheral
Clinical narrative: Pain in right shoulder radiate down arm swollen finger can't close hand extreme pain. Pain in both legs hard to walk.
Age: 62.0
Sex: M
Vaccine: FLUC3
Symptoms: Pain in extremity, X-ray
Clinical narrative: Pain in right shoulder radiate down arm swollen finger can't close hand extreme pain. Pain in both legs hard to walk.
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: Received Tdap tetanus shot on Wednesday, January 30, 2013 and developed a reddened area around injection site right deltoid area.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This spontaneous repot as received from a consumer refers to her 12 years old daughter. The patient did not have any drug reactions/allergies. The patient's medical history included anxiety. Immediately after getting the first shot of GARDASIL (route, dose and lot3 were unknown) in late summer 2012 and again after the second shot, the patient complained of extreme pain at injection site. Concomitant medications included: sertraline hydrochloride. She is now terrified to get the third shot in the series. This pain does subside within days of each shot. Treatment ibuprofen was given after both shots. The outcome of event was reported as recovered/resolved. The relatedness for event is unknown for GARDASIL. No lab diagnosis studies performed. The patient did not sought medical attention. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Oedema peripheral, Pain in extremity
Clinical narrative: Patient's spouse called and said patient was complaining of pain and swelling ("like a balloon") in the left arm. Also said patient had a headache, no hives or rash at this time.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Rash
Clinical narrative: Developed burning pain on the left posterior side of her chest going down front the chest four days after ZOSTAVAX. Rash began about 7 days after ZOSTAVAX. Treated with valacyclovir 1 g TID x 7 days and hydrocodone/APAP 5/325.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse refers to a 13 years old patient, who on an unknown date, was vaccinated with PROQUAD (dose, route and lot not reported). No adverse effect was reported. No concomitant medications were reported. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Amnesia, Dry skin, Fatigue, Injection site pruritus, Mental disorder
Clinical narrative: NO TREATMENT-
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Muscle spasms, Pain, Paranoia, Pruritus, Pyrexia
Clinical narrative: NO TREATMENT-
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Shoulder stiff and red raised spot half dollar size at point of injection.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Insomnia, Musculoskeletal pain
Clinical narrative: Excruciating pain in upper left arm; shoulder, radiating down to elbow. Headaches. Can't sleep. Can't lift arm or exert any pressure using arm. Originally thought was part of normal pain associated with shot but never got better.
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Seizure like phenomena, Vomiting
Clinical narrative: Vomited while sleeping seizure like symptoms high fever.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Fatigue, Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: "Lost 3 days of work due to fatigue". Also reports "sore throat, stuffy nose, muscle aches, runny nose." Patient did not seek medical care or have symptoms documented but is now refusing annual flu shots required by facility. Please advise.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: "Lost 3 days of work due to fatigue". Also reports "sore throat, stuffy nose, muscle aches, runny nose." Patient did not seek medical care or have symptoms documented but is now refusing annual flu shots required by facility. Please advise.
Age: 1.27
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Decreased appetite, Diarrhoea, Injection site pain, Lethargy, Pain
Clinical narrative: Sore need of whole right side of the body, including arm and leg where shot was given. Lethargy and paleness followed around 1pm and fever came on by 3pm. Fever was not brought down by Advil and 3 hours after first dose of Advil fever was still 102. Child was restless that night and fever continues for 3 days. Also lack of appetite and diarrhea throughout the 3 days.
Age: 1.27
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Pain in extremity, Pallor, Pyrexia, Restlessness
Clinical narrative: Sore need of whole right side of the body, including arm and leg where shot was given. Lethargy and paleness followed around 1pm and fever came on by 3pm. Fever was not brought down by Advil and 3 hours after first dose of Advil fever was still 102. Child was restless that night and fever continues for 3 days. Also lack of appetite and diarrhea throughout the 3 days.
Age: 12.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Headache, Laboratory test normal, Lumbar puncture normal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal
Clinical narrative: Fever (101), congestion, headache. Fever rose to 103.3 on 1/22/2013. On 1/28/2013 patient complained of severe pain in feet. On 1/30/2013 patient was hospitalized for 4 days with severe foot pain of unknown origin Treated with Toradol.
Age: 12.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Pain in extremity, Pyrexia, Respiratory tract congestion, White blood cell count normal
Clinical narrative: Fever (101), congestion, headache. Fever rose to 103.3 on 1/22/2013. On 1/28/2013 patient complained of severe pain in feet. On 1/30/2013 patient was hospitalized for 4 days with severe foot pain of unknown origin Treated with Toradol.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling of the vaccination site the size of a half dollar with redness and soreness. Pt said onset was within 24 hrs of the vaccination but did not report to the pharmacist until 2 days later.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Eye irritation, Nausea, Ocular hyperaemia, Vomiting
Clinical narrative: Patient experienced burning eyes, bloodshot eyes, nausea, vomiting & diarrhea 3-4 hours after administration.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Within the first 3 sec. of administering the FLUZONE intraderm 2012-13 syringe -> patient got lightheaded and was sweating and hot.
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Back pain, Musculoskeletal stiffness
Clinical narrative: Severe pain and stiffness of lower back/sacral area could not bend to put shoes on. Saw Dr after a week and was given a steroid shot and shot for inflammation. Cont. to have pain for a week. Dr advised use ice and got better Dr reminded pt she had Td 3 years ago and had same complaint.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient. The patient was vaccinated with live ZOSTAVAX (route, dose and lot # were unknown) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient broke out with shingles on her left arm at the injection site 1 week after injection. No treatment was reported. The outcome of event is unknown. The relatedness for event is unknown for live ZOSTAVAX. The patient sought medical attention via seeing her doctor. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Erythema, Insomnia, Local swelling, Pain
Clinical narrative: This spontaneous report was received from a 68 year old female patient regarding herself. On 01-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiration date and route was subcutaneous). Concomitant medications included: KLONOPIN. On 02-OCT-2012, the patient experienced a red puffy ring near the injection site, swelling and pain, her arm felt paralyzed and she could not sleep at night. On an unknown date in 2012 (reported as last year), blood work was performed and results were unknown. The patient visited her doctor and he prescribed unspecified medications, cold packs and therapy as treatment for the events. At the time of this report the patient had not recovered from the reported events. The patient sought medical attention. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Sensory disturbance
Clinical narrative: This spontaneous report was received from a 68 year old female patient regarding herself. On 01-OCT-2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiration date and route was subcutaneous). Concomitant medications included: KLONOPIN. On 02-OCT-2012, the patient experienced a red puffy ring near the injection site, swelling and pain, her arm felt paralyzed and she could not sleep at night. On an unknown date in 2012 (reported as last year), blood work was performed and results were unknown. The patient visited her doctor and he prescribed unspecified medications, cold packs and therapy as treatment for the events. At the time of this report the patient had not recovered from the reported events. The patient sought medical attention. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: VARCEL
Symptoms: Immunoglobulin therapy, Polymerase chain reaction, Varicella, Varicella virus test positive
Clinical narrative: This spontaneous report was received from a physician concerning a 54 year old male patient with no drug reactions or allergies. Current conditions of the patient included myelofibrosis. On an unknown date in October 2012, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number, expiry date unspecified), subcutaneously. Concomitant medications included low dose (unspecified) prednisone and JAKAFI started on an unknown date, approximately in October 2012 (just after the vaccination). On an unknown date in November 2012 (reported as mid November 2012), the patient was diagnosed with disseminated varicella (chickenpox) for which he was hospitalized for an unspecified amount of time. He was treated with acyclovir and intravenous immunoglobulins IVIG). While in the hospital, the physician reported that they sampled the vesicles of the patient and submitted them to the Centers for Disease Control (CDC) who identified the strain as Merck strain VZV. The physician was adamant about not receiving packet as strain was already identified. The physician was unsure about whether or not this event was previously reported to the company, but no documentation was located. The outcome of disseminated varicella (chickenpox) was reported as resolved on an unknown date. The relatedness for disseminated varicella (chickenpox) was unknown for ZOSTAVAX. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Significant swelling and itching, very symmetric, mostly face but also little bit on the upper extremities.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, MNQ, TDAP, VARCEL
Symptoms: Pruritus, Swelling
Clinical narrative: Significant swelling and itching, very symmetric, mostly face but also little bit on the upper extremities.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Mass
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 66 year old female patient. The patient's medical history included injection site reaction. On 14-JAN-2013, the patient was vaccinated with 0.65 ml live ZOSTAVAX (lot number reported as H018092, expiration date 04-JAN-2014). No other co-suspects were reported. No concomitant medications were reported. The nurse practitioner reported that after receiving live ZOSTAVAX, the patient developed a 1 cm by 1 cm reddened area at the injection site. The nurse practitioner directed the patient to use cold compresses, over the counter MOTRIN and over the counter cortisone cream. Patient returned on 17-JAN-2013 because the injection site had become redder, and she had a hard lump underneath the skin. The patient reported also feeling headache and malaise, but she had no fever. The nurse practitioner gave her KEFLEX for cellulitis. The patient returned to her physician (unspecified) and was diagnosed with shingles. The patient reported that 20-JAN-2013 she had a non-vesicular rash on her inner thighs. The onset date of the adverse event was reported as 15-JAN-2013. The outcome of shingles is unknown. The relatedness for shingles is unknown live ZOSTAVAX. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Headache, Herpes zoster, Injection site erythema, Injection site mass
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 66 year old female patient. The patient's medical history included injection site reaction. On 14-JAN-2013, the patient was vaccinated with 0.65 ml live ZOSTAVAX (lot number reported as H018092, expiration date 04-JAN-2014). No other co-suspects were reported. No concomitant medications were reported. The nurse practitioner reported that after receiving live ZOSTAVAX, the patient developed a 1 cm by 1 cm reddened area at the injection site. The nurse practitioner directed the patient to use cold compresses, over the counter MOTRIN and over the counter cortisone cream. Patient returned on 17-JAN-2013 because the injection site had become redder, and she had a hard lump underneath the skin. The patient reported also feeling headache and malaise, but she had no fever. The nurse practitioner gave her KEFLEX for cellulitis. The patient returned to her physician (unspecified) and was diagnosed with shingles. The patient reported that 20-JAN-2013 she had a non-vesicular rash on her inner thighs. The onset date of the adverse event was reported as 15-JAN-2013. The outcome of shingles is unknown. The relatedness for shingles is unknown live ZOSTAVAX. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 66 year old female patient. The patient's medical history included injection site reaction. On 14-JAN-2013, the patient was vaccinated with 0.65 ml live ZOSTAVAX (lot number reported as H018092, expiration date 04-JAN-2014). No other co-suspects were reported. No concomitant medications were reported. The nurse practitioner reported that after receiving live ZOSTAVAX, the patient developed a 1 cm by 1 cm reddened area at the injection site. The nurse practitioner directed the patient to use cold compresses, over the counter MOTRIN and over the counter cortisone cream. Patient returned on 17-JAN-2013 because the injection site had become redder, and she had a hard lump underneath the skin. The patient reported also feeling headache and malaise, but she had no fever. The nurse practitioner gave her KEFLEX for cellulitis. The patient returned to her physician (unspecified) and was diagnosed with shingles. The patient reported that 20-JAN-2013 she had a non-vesicular rash on her inner thighs. The onset date of the adverse event was reported as 15-JAN-2013. The outcome of shingles is unknown. The relatedness for shingles is unknown live ZOSTAVAX. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC, MMRV
Symptoms: Papule, Rash vesicular
Clinical narrative: Information has been received from a Licensed Practical Nurse regarding a 12 months old female patient with no pertinent medical history, drug reactions or allergies. On 17-JAN-2013, the patient was vaccinated with 0.5 ml dose of PROQUAD (merck), subcutaneous, (Lot number H015778, expiration date 24-FEB-2014). No other co-suspects were reported. No concomitant medications were reported. On 23-JAN-2013, the patient started amoxicillin therapy for otitis media. On 29-JAN-2013 evening, the patient developed a fever and then developed a mild rash on 30-JAN-2013. The physician was not sure if the rash was from a reaction to the amoxicillin or if the rash was chickenpox. The patient received with BENADRYL as treatment for the adverse events. Laboratory test was not performed. The patient sought medical attention, at office visit. At the time of the report, the patient not recovered from the adverse events. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC, MMRV
Symptoms: Otitis media, Pyrexia, Rash
Clinical narrative: Information has been received from a Licensed Practical Nurse regarding a 12 months old female patient with no pertinent medical history, drug reactions or allergies. On 17-JAN-2013, the patient was vaccinated with 0.5 ml dose of PROQUAD (merck), subcutaneous, (Lot number H015778, expiration date 24-FEB-2014). No other co-suspects were reported. No concomitant medications were reported. On 23-JAN-2013, the patient started amoxicillin therapy for otitis media. On 29-JAN-2013 evening, the patient developed a fever and then developed a mild rash on 30-JAN-2013. The physician was not sure if the rash was from a reaction to the amoxicillin or if the rash was chickenpox. The patient received with BENADRYL as treatment for the adverse events. Laboratory test was not performed. The patient sought medical attention, at office visit. At the time of the report, the patient not recovered from the adverse events. Additional information is not expected.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Adverse reaction, Guillain-Barre syndrome, Lumbar puncture, Paralysis
Clinical narrative: Pt wife came into pharmacy on 2-2-13 and said that after her husband received a flu shot he had a severe reaction. She said pt got shot on 1-10-13 & on 1-17-13 pt went to hospital where they discovered that he developed Guillain- Barre after performing a spinal tap. Pt has MS but has had flu shots before no reaction. Pt has been in hospital about 16 days. Pt wife says pt is paralyzed from waist down & will need rehab.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN3
Symptoms: Injection site swelling, Pain, Pyrexia, Type III immune complex mediated reaction
Clinical narrative: Swelling to (L) upper arm started within 24 hrs. Went to ER 1/23/13, follow up with pediatrician 1/24/13 AM. Went to ER again later in day 1/24/13 and was admitted overnight. Discharged 1/25/13. Reported fever on 1/24/13. ER visit with severe pain. NO abscess was seen. Called an arthus reaction by MD treating in hospital.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apnoea, Chest X-ray, Grunting, Laboratory test, Nasal flaring
Clinical narrative: Dad recounts events. Pt ran fever all day after vaccines. At 9:00pm, pt started having grunting, nasal flaring, and periods of apnea with respiration. Parents took pt to ER, and she was admitted. Pt received IV fluids and was discharged 1/25/13 in the evening.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Respiratory syncytial virus test, Urine analysis
Clinical narrative: Dad recounts events. Pt ran fever all day after vaccines. At 9:00pm, pt started having grunting, nasal flaring, and periods of apnea with respiration. Parents took pt to ER, and she was admitted. Pt received IV fluids and was discharged 1/25/13 in the evening.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Dizziness, Dysstasia, Electrocardiogram, Erythema
Clinical narrative: Severe swelling, redness, dizziness, motion sickness, inability to control movement of both legs, could not stand. Treatment: taken to ER by ambulance. Overnight observe.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of control of legs, Motion sickness, Swelling
Clinical narrative: Severe swelling, redness, dizziness, motion sickness, inability to control movement of both legs, could not stand. Treatment: taken to ER by ambulance. Overnight observe.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Apparent death, Convulsion, Herpes zoster
Clinical narrative: The vaccine was administered on Jan 4, he was healthy - no high blood pressure or cholesterol - not sick at all. He had seizures Jan 9th - almost died - then broke out with mild shingles on his back.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Pyrexia, Shift to the left, White blood cell count increased
Clinical narrative: Fever, sight of vaccine (right deltoid) sore 1/29 onset. 1/31/13 admit to hospital. 1/31/13 wbc=28.5 with left shift.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, TDAP, VARCEL
Symptoms: Activities of daily living impaired, Cardiac disorder, Headache, Loss of consciousness, Migraine
Clinical narrative: This spontaneous report as received from a patient's mother reporting on her 11 year old female daughter (currently 16 year old) with no drug reactions or allergies and no pertinent medical history. In March 2007, the patient was vaccinated with the first dose, on an unknown date with the second dose, and in November 2009 with the third dose of GARDASIL, shot in the arm (doses, routes, lot numbers not reported) respectively. No other co-suspects were reported. Concomitant medications included: ibuprofen. From the beginning, from March 2007, the patient passed out, got migraine, headaches and need to see a heart specialist. The patient got "all of the side effects listed". The patient had been missing a lot of school because of this and had been detained by one year as well. There was no treatment given for adverse events. No laboratory tests were performed. At the time of the report the patient's outcome was unknown. Missing a lot of school was related to GARDASIL. The relatedness for passing out, migraine, headaches, need to see a heart specialist and all of the side effects listed was not reported for GARDASIL. The patient sought medical attention. Upon internal review, missing a lot of school by the patient was determined to be disabling. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, TDAP, VARCEL
Symptoms: Electrocardiogram, Loss of consciousness, Migraine, Tremor
Clinical narrative: This spontaneous report as received from a patient's mother reporting on her 11 year old female daughter (currently 16 year old) with no drug reactions or allergies and no pertinent medical history. In March 2007, the patient was vaccinated with the first dose, on an unknown date with the second dose, and in November 2009 with the third dose of GARDASIL, shot in the arm (doses, routes, lot numbers not reported) respectively. No other co-suspects were reported. Concomitant medications included: ibuprofen. From the beginning, from March 2007, the patient passed out, got migraine, headaches and need to see a heart specialist. The patient got "all of the side effects listed". The patient had been missing a lot of school because of this and had been detained by one year as well. There was no treatment given for adverse events. No laboratory tests were performed. At the time of the report the patient's outcome was unknown. Missing a lot of school was related to GARDASIL. The relatedness for passing out, migraine, headaches, need to see a heart specialist and all of the side effects listed was not reported for GARDASIL. The patient sought medical attention. Upon internal review, missing a lot of school by the patient was determined to be disabling. Additional information has been requested.
Age: 1.06
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to her 1 years old daughter. The patient was vaccinated with VAQTA (0.7 ml, Intramuscular, right leg, lot # was unknown) on 24-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. Physician assistant states she thought the healthcare worker withdrew too much vaccine from the vial, 0.7ml. No adverse effects reported at this time. The outcome of event is unknown. Additional information has been requested.