chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Significant pain to (R) shoulder where vaccine was administered. Lasted 3 days then resolved without treatment.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Decreased appetite, Injection site erythema, Pyrexia, Vomiting
Clinical narrative: Fever (100.3 max) x 1 day; vomiting; decreased appetite; redness to Rt. thigh at injection site - imm. given on 04-18-12.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red, itchy area at injection site, size of a softball - used BENADRYL cream on area. 4 day later says size has decreased & no longer itchy.
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Adult Pt was given DTaP by mistake when Tdap was ordered. Pt denies any adverse effects. Nurse and MA double checked vaccine but neither are familiar with vaccines and do not have a vast experience with them. Staff will be inserviced by both myself and the local Public Health Nurse in the hopes of educating new staff and preventing further errors.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Influenza, Injection site pain, Malaise, Nausea
Clinical narrative: Patient and brother both received vaccine, both with similar sx: headache, fever, nausea, malaise, L arm pain (site of injection) without swelling or redness to same.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia
Clinical narrative: Patient and brother both received vaccine, both with similar sx: headache, fever, nausea, malaise, L arm pain (site of injection) without swelling or redness to same.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Injection site pain, Malaise, Nausea, Pyrexia
Clinical narrative: Patient and brother both received vaccine, both with similar sx: headache, fever, nausea, malaise, L arm pain (site of injection) without swelling or redness to same.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Hypoaesthesia, Nuclear magnetic resonance imaging, Oedema, Paraesthesia
Clinical narrative: Noticed edema and tingling of "pins and needles" of right arm. The following day symptoms have changed to include numbness of the entire right hand with loss of strength and sensation.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Sensory loss, Ultrasound scan
Clinical narrative: Noticed edema and tingling of "pins and needles" of right arm. The following day symptoms have changed to include numbness of the entire right hand with loss of strength and sensation.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Computerised tomogram, Hypoaesthesia, Nuclear magnetic resonance imaging, Oedema peripheral
Clinical narrative: Noticed edema and tingling of "pins and needles" of right arm. The following day symptoms have changed to include numbness of the entire right hand with loss of strength and sensation.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Paraesthesia, Ultrasound scan
Clinical narrative: Noticed edema and tingling of "pins and needles" of right arm. The following day symptoms have changed to include numbness of the entire right hand with loss of strength and sensation.
Age: 49.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Lymphadenopathy, Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Swollen lymph nodes R arm, pain in R arm and swelling in R arm, tingling in fingers R hand.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Fever 102.7 Severe chills Muscle aches Severe muscle weakness
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt vaccinated at 10am. At 10pm pt noticed quarter size red circle located on lower area of deltoid near elbow. No pain. On 4-20 pt came into pharmacy presenting baseball size red raised 1 cm swelling. Told pt to contact Dr & we will do same. Pt. said no pain, itching at site, just annoying.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Mom states Lt arm warm, swollen, red, hard at injection site after 24h. Site itchy. Mom declined bringing child in TBS. 1st time vaccines have been given in deltoids.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling face
Clinical narrative: Patient has redness, itching, swelling on one side of face from cheek to under chin. Feels warm to touch.
Age: 59.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Ear pain, Herpes zoster, VIIth nerve paralysis
Clinical narrative: Severe left ear pain, Shingles in left ear, Left side facial paralysis, dizziness.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Severe pain & soreness in left arm where injection was given that extends upwards to the shoulder.
Age: 1.59
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Blood test normal, Decreased appetite, Dehydration, Diarrhoea, Fatigue
Clinical narrative: Constant vomiting since he woke up at 6:30AM, every 15 minutes or right after feeding him liquid. Tired and sleeping all the time, very fatigued. Tried Pedialyte and Emerol for nausea, still was getting dehydrated. Had to take him to emergency room at 4:30PM. Blood test was taken, and IV administered for 2 hours. On April 22, he has diarrhea, is sleepy and drinking only liquids since he vomited in the morning.
Age: 1.59
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Hypersomnia, Nausea, Vaccination complication, Vomiting
Clinical narrative: Constant vomiting since he woke up at 6:30AM, every 15 minutes or right after feeding him liquid. Tired and sleeping all the time, very fatigued. Tried Pedialyte and Emerol for nausea, still was getting dehydrated. Had to take him to emergency room at 4:30PM. Blood test was taken, and IV administered for 2 hours. On April 22, he has diarrhea, is sleepy and drinking only liquids since he vomited in the morning.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site oedema, Oedema
Clinical narrative: Approx 5-10 minutes after receiving vaccine, pt developed edema at injection site (upper (L) arm & to (L) wrist).
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Arthralgia, Blood test normal, Burning sensation, Immediate post-injection reaction, Injection site pain
Clinical narrative: Information has been received from a consumer concerning her 24 year old daughter with sulfa allergy and a history of fibromyalgia and bleeding ulcer who on an unknown date was vaccinated with a dose of GARDASIL (route, dose and lot # not provided). Concomitant therapy included sertraline HCl 25 mg. It was reported that the patient was in constant pain while on GARDASIL. AE onset date reported as 24-JAN-2012. The patient could not walk and in February 2012, she went to inpatient rehabilitation and was admitted to the emergency room twice. She was in rehabilitation for a week. On an unspecified date a CAT scan, MRI of her brain and urine test were performed (results were not provided). The consumer indicated that her daughter had an arm tremor. At the time of the report, the patient was able to walk and had not recovered from constant pain and arm tremor. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Laboratory test normal, Neck pain, Nuclear magnetic resonance imaging normal, Pain in extremity, Vision blurred
Clinical narrative: Information has been received from a consumer concerning her 24 year old daughter with sulfa allergy and a history of fibromyalgia and bleeding ulcer who on an unknown date was vaccinated with a dose of GARDASIL (route, dose and lot # not provided). Concomitant therapy included sertraline HCl 25 mg. It was reported that the patient was in constant pain while on GARDASIL. AE onset date reported as 24-JAN-2012. The patient could not walk and in February 2012, she went to inpatient rehabilitation and was admitted to the emergency room twice. She was in rehabilitation for a week. On an unspecified date a CAT scan, MRI of her brain and urine test were performed (results were not provided). The consumer indicated that her daughter had an arm tremor. At the time of the report, the patient was able to walk and had not recovered from constant pain and arm tremor. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Arthralgia, Discomfort
Clinical narrative: Information has been received from a consumer concerning her 24 year old daughter with sulfa allergy and a history of fibromyalgia and bleeding ulcer who on an unknown date was vaccinated with a dose of GARDASIL (route, dose and lot # not provided). Concomitant therapy included sertraline HCl 25 mg. It was reported that the patient was in constant pain while on GARDASIL. AE onset date reported as 24-JAN-2012. The patient could not walk and in February 2012, she went to inpatient rehabilitation and was admitted to the emergency room twice. She was in rehabilitation for a week. On an unspecified date a CAT scan, MRI of her brain and urine test were performed (results were not provided). The consumer indicated that her daughter had an arm tremor. At the time of the report, the patient was able to walk and had not recovered from constant pain and arm tremor. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abasia, Computerised tomogram, Nuclear magnetic resonance imaging brain, Pain, Tremor
Clinical narrative: Information has been received from a consumer concerning her 24 year old daughter with sulfa allergy and a history of fibromyalgia and bleeding ulcer who on an unknown date was vaccinated with a dose of GARDASIL (route, dose and lot # not provided). Concomitant therapy included sertraline HCl 25 mg. It was reported that the patient was in constant pain while on GARDASIL. AE onset date reported as 24-JAN-2012. The patient could not walk and in February 2012, she went to inpatient rehabilitation and was admitted to the emergency room twice. She was in rehabilitation for a week. On an unspecified date a CAT scan, MRI of her brain and urine test were performed (results were not provided). The consumer indicated that her daughter had an arm tremor. At the time of the report, the patient was able to walk and had not recovered from constant pain and arm tremor. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Urine analysis
Clinical narrative: Information has been received from a consumer concerning her 24 year old daughter with sulfa allergy and a history of fibromyalgia and bleeding ulcer who on an unknown date was vaccinated with a dose of GARDASIL (route, dose and lot # not provided). Concomitant therapy included sertraline HCl 25 mg. It was reported that the patient was in constant pain while on GARDASIL. AE onset date reported as 24-JAN-2012. The patient could not walk and in February 2012, she went to inpatient rehabilitation and was admitted to the emergency room twice. She was in rehabilitation for a week. On an unspecified date a CAT scan, MRI of her brain and urine test were performed (results were not provided). The consumer indicated that her daughter had an arm tremor. At the time of the report, the patient was able to walk and had not recovered from constant pain and arm tremor. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Chills, Headache, Insomnia, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Monday evening headache started continues to have fever & chills, unable to sleep, stiffness neck & shoulders that has not resolved.
Age: 36.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Chest discomfort, Dyspnoea, Flushing, Headache, Lip swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling of tongue in a 36-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergic to compazine, allergy to demerol and allergy to VISTARIL. Concurrent medications included SYNTHROID, CYMBALTA, CORTISOL and Migraine medication. On 6 April 2012 at 09:00 the subject received 1st dose of HAVRIX in the left arm. On 6 April 2012, immediately after vaccination with HAVRIX, the subject experienced swelling of tongue, lip swelling, hand and leg swelling and feeling woozy. Fifteen minutes after HAVRIX injection, at 09:15 on 06 April 2012, the subject developed nausea and a headache. Forty-five minutes after HAVRIX administration, at 09:45 on 06 April 2012, the subject had difficulty breathing. One hour after receiving 1st dose of HAVRIX, at 10:00 on 06 April 2012, the subject experienced arm heaviness and was unable to lift her arm. The subject also reported flushing and rash on her face, arm and chest with onset the same day of HAVRIX vaccination, 06 April 2012. The subject was hospitalized on 06 April 2012, and elevated body temperature, low blood pressure and increased heart rate were noted at that time. One day following 1st dose of HAVRIX, on 07 April 2012, the subject reported a biphasic reaction. The subject was discharged on 07 April 2012, after one day of hospitalization. Arm heaviness and inability to lift arm resolved on 06 April 2012 and feeling woozy resolved as of 08 April 2012. Flushing and rash on face, arm and chest, difficulty breathing, nausea and headache, as well as biphasic reaction were improved at the time of reporting. Swelling of tongue, lips, legs and hands was unresolved at the time of reporting. Outcome of elevated body temperature, low blood pressure and increased heart rate were not reported. The lot number for HAVRIX was reported as AHAUB538AA from the reporter; however, based on GlaxoSmithKline batch numbering guidelines, the lot number was updated to AHAVB538AA.
Age: 36.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Paraesthesia oral
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling of tongue in a 36-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergic to compazine, allergy to demerol and allergy to VISTARIL. Concurrent medications included SYNTHROID, CYMBALTA, CORTISOL and Migraine medication. On 6 April 2012 at 09:00 the subject received 1st dose of HAVRIX in the left arm. On 6 April 2012, immediately after vaccination with HAVRIX, the subject experienced swelling of tongue, lip swelling, hand and leg swelling and feeling woozy. Fifteen minutes after HAVRIX injection, at 09:15 on 06 April 2012, the subject developed nausea and a headache. Forty-five minutes after HAVRIX administration, at 09:45 on 06 April 2012, the subject had difficulty breathing. One hour after receiving 1st dose of HAVRIX, at 10:00 on 06 April 2012, the subject experienced arm heaviness and was unable to lift her arm. The subject also reported flushing and rash on her face, arm and chest with onset the same day of HAVRIX vaccination, 06 April 2012. The subject was hospitalized on 06 April 2012, and elevated body temperature, low blood pressure and increased heart rate were noted at that time. One day following 1st dose of HAVRIX, on 07 April 2012, the subject reported a biphasic reaction. The subject was discharged on 07 April 2012, after one day of hospitalization. Arm heaviness and inability to lift arm resolved on 06 April 2012 and feeling woozy resolved as of 08 April 2012. Flushing and rash on face, arm and chest, difficulty breathing, nausea and headache, as well as biphasic reaction were improved at the time of reporting. Swelling of tongue, lips, legs and hands was unresolved at the time of reporting. Outcome of elevated body temperature, low blood pressure and increased heart rate were not reported. The lot number for HAVRIX was reported as AHAUB538AA from the reporter; however, based on GlaxoSmithKline batch numbering guidelines, the lot number was updated to AHAVB538AA.
Age: 36.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Adverse reaction, Body temperature increased, Dizziness, Dyspnoea, Flushing
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling of tongue in a 36-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergic to compazine, allergy to demerol and allergy to VISTARIL. Concurrent medications included SYNTHROID, CYMBALTA, CORTISOL and Migraine medication. On 6 April 2012 at 09:00 the subject received 1st dose of HAVRIX in the left arm. On 6 April 2012, immediately after vaccination with HAVRIX, the subject experienced swelling of tongue, lip swelling, hand and leg swelling and feeling woozy. Fifteen minutes after HAVRIX injection, at 09:15 on 06 April 2012, the subject developed nausea and a headache. Forty-five minutes after HAVRIX administration, at 09:45 on 06 April 2012, the subject had difficulty breathing. One hour after receiving 1st dose of HAVRIX, at 10:00 on 06 April 2012, the subject experienced arm heaviness and was unable to lift her arm. The subject also reported flushing and rash on her face, arm and chest with onset the same day of HAVRIX vaccination, 06 April 2012. The subject was hospitalized on 06 April 2012, and elevated body temperature, low blood pressure and increased heart rate were noted at that time. One day following 1st dose of HAVRIX, on 07 April 2012, the subject reported a biphasic reaction. The subject was discharged on 07 April 2012, after one day of hospitalization. Arm heaviness and inability to lift arm resolved on 06 April 2012 and feeling woozy resolved as of 08 April 2012. Flushing and rash on face, arm and chest, difficulty breathing, nausea and headache, as well as biphasic reaction were improved at the time of reporting. Swelling of tongue, lips, legs and hands was unresolved at the time of reporting. Outcome of elevated body temperature, low blood pressure and increased heart rate were not reported. The lot number for HAVRIX was reported as AHAUB538AA from the reporter; however, based on GlaxoSmithKline batch numbering guidelines, the lot number was updated to AHAVB538AA.
Age: 36.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Headache, Heart rate increased, Hypotension, Immediate post-injection reaction, Lip swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling of tongue in a 36-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergic to compazine, allergy to demerol and allergy to VISTARIL. Concurrent medications included SYNTHROID, CYMBALTA, CORTISOL and Migraine medication. On 6 April 2012 at 09:00 the subject received 1st dose of HAVRIX in the left arm. On 6 April 2012, immediately after vaccination with HAVRIX, the subject experienced swelling of tongue, lip swelling, hand and leg swelling and feeling woozy. Fifteen minutes after HAVRIX injection, at 09:15 on 06 April 2012, the subject developed nausea and a headache. Forty-five minutes after HAVRIX administration, at 09:45 on 06 April 2012, the subject had difficulty breathing. One hour after receiving 1st dose of HAVRIX, at 10:00 on 06 April 2012, the subject experienced arm heaviness and was unable to lift her arm. The subject also reported flushing and rash on her face, arm and chest with onset the same day of HAVRIX vaccination, 06 April 2012. The subject was hospitalized on 06 April 2012, and elevated body temperature, low blood pressure and increased heart rate were noted at that time. One day following 1st dose of HAVRIX, on 07 April 2012, the subject reported a biphasic reaction. The subject was discharged on 07 April 2012, after one day of hospitalization. Arm heaviness and inability to lift arm resolved on 06 April 2012 and feeling woozy resolved as of 08 April 2012. Flushing and rash on face, arm and chest, difficulty breathing, nausea and headache, as well as biphasic reaction were improved at the time of reporting. Swelling of tongue, lips, legs and hands was unresolved at the time of reporting. Outcome of elevated body temperature, low blood pressure and increased heart rate were not reported. The lot number for HAVRIX was reported as AHAUB538AA from the reporter; however, based on GlaxoSmithKline batch numbering guidelines, the lot number was updated to AHAVB538AA.
Age: 36.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Mobility decreased, Nausea, Oedema peripheral, Rash, Sensation of heaviness
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling of tongue in a 36-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergic to compazine, allergy to demerol and allergy to VISTARIL. Concurrent medications included SYNTHROID, CYMBALTA, CORTISOL and Migraine medication. On 6 April 2012 at 09:00 the subject received 1st dose of HAVRIX in the left arm. On 6 April 2012, immediately after vaccination with HAVRIX, the subject experienced swelling of tongue, lip swelling, hand and leg swelling and feeling woozy. Fifteen minutes after HAVRIX injection, at 09:15 on 06 April 2012, the subject developed nausea and a headache. Forty-five minutes after HAVRIX administration, at 09:45 on 06 April 2012, the subject had difficulty breathing. One hour after receiving 1st dose of HAVRIX, at 10:00 on 06 April 2012, the subject experienced arm heaviness and was unable to lift her arm. The subject also reported flushing and rash on her face, arm and chest with onset the same day of HAVRIX vaccination, 06 April 2012. The subject was hospitalized on 06 April 2012, and elevated body temperature, low blood pressure and increased heart rate were noted at that time. One day following 1st dose of HAVRIX, on 07 April 2012, the subject reported a biphasic reaction. The subject was discharged on 07 April 2012, after one day of hospitalization. Arm heaviness and inability to lift arm resolved on 06 April 2012 and feeling woozy resolved as of 08 April 2012. Flushing and rash on face, arm and chest, difficulty breathing, nausea and headache, as well as biphasic reaction were improved at the time of reporting. Swelling of tongue, lips, legs and hands was unresolved at the time of reporting. Outcome of elevated body temperature, low blood pressure and increased heart rate were not reported. The lot number for HAVRIX was reported as AHAUB538AA from the reporter; however, based on GlaxoSmithKline batch numbering guidelines, the lot number was updated to AHAVB538AA.
Age: 36.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Swollen tongue
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling of tongue in a 36-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergic to compazine, allergy to demerol and allergy to VISTARIL. Concurrent medications included SYNTHROID, CYMBALTA, CORTISOL and Migraine medication. On 6 April 2012 at 09:00 the subject received 1st dose of HAVRIX in the left arm. On 6 April 2012, immediately after vaccination with HAVRIX, the subject experienced swelling of tongue, lip swelling, hand and leg swelling and feeling woozy. Fifteen minutes after HAVRIX injection, at 09:15 on 06 April 2012, the subject developed nausea and a headache. Forty-five minutes after HAVRIX administration, at 09:45 on 06 April 2012, the subject had difficulty breathing. One hour after receiving 1st dose of HAVRIX, at 10:00 on 06 April 2012, the subject experienced arm heaviness and was unable to lift her arm. The subject also reported flushing and rash on her face, arm and chest with onset the same day of HAVRIX vaccination, 06 April 2012. The subject was hospitalized on 06 April 2012, and elevated body temperature, low blood pressure and increased heart rate were noted at that time. One day following 1st dose of HAVRIX, on 07 April 2012, the subject reported a biphasic reaction. The subject was discharged on 07 April 2012, after one day of hospitalization. Arm heaviness and inability to lift arm resolved on 06 April 2012 and feeling woozy resolved as of 08 April 2012. Flushing and rash on face, arm and chest, difficulty breathing, nausea and headache, as well as biphasic reaction were improved at the time of reporting. Swelling of tongue, lips, legs and hands was unresolved at the time of reporting. Outcome of elevated body temperature, low blood pressure and increased heart rate were not reported. The lot number for HAVRIX was reported as AHAUB538AA from the reporter; however, based on GlaxoSmithKline batch numbering guidelines, the lot number was updated to AHAVB538AA.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Insomnia, Joint range of motion decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Extreme pain limiting range of motion which is not relieved by OTC pain medication. After six months it is getting worse - keeping me awake at night and radiating to my shoulder, neck with numbness all the way to my fingers.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Extreme pain limiting range of motion which is not relieved by OTC pain medication. After six months it is getting worse - keeping me awake at night and radiating to my shoulder, neck with numbness all the way to my fingers.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Movement disorder, Oedema peripheral, Vaccination site pain
Clinical narrative: Extremely sore arm in area of vaccination. Not able to move upper arm. Rapid swelling of upper arm.
Age: 61.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Sixty one yrs old female presented to foreign travel clinic at local health dept. Client requesting Hepatitis A and Typhoid vaccines. Client was given a 1.0 cc dose of Typhoid VI vaccine and a 1.0cc dose of HepA vaccine. Error noted immediately after administering the extra dose of typhoid. Client was given Typhoid VI lot number G1121-1 in rt deltoid muscle. Failed to re check dosage amount and re check name of vaccine being administered. Typhoid VI was provided in multi dose vial. Client is doing well. Steps to prevent future error slow down and follow re checking steps when administer any vaccines.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Eyelid oedema, Nausea, Sensation of foreign body
Clinical narrative: Information has been received from a physician concerning a 25 year old female patient with no pertinent medical history and allergy to meningococcal vaccine (unspecified) and plum's allergy who on 04-OCT-2011, was vaccinated with the first dose of GARDASIL, 0.5 mL, IM (lot # 670048/0963AA, expiration date 09-NOV-2013) and the second dose of GARDASIL, 0.5 mL, IM (lot # 668261/1397AA, expiration date 09-APR-2012) administered on 06-DEC-2011. In December 2011, the patient experienced nausea after receiving the second dose of GARDASIL. On 09-APR-2012, the patient received the third dose of GARDASIL 0.5 mL, IM (lot # 1745AA, expiration date 13-DEC-2014). Concomitant therapy included contraceptive pills (unspecified). On 09-APR-2012 "within 2 hours of administration of the third dose of GARDASIL", the patient experienced foreign body sensation in her throat and nausea. The patient was administered BENADRYL oral, a nebulizer (unspecified) treatment and epinephrine intramuscular, in the physician's office. The patient went to the emergency room and was given prednisone 60 mg oral (dosage was titrated over a few days) and released without admission to the hospital. On 10-APR-2012, the patient went to the physician's office and was found to have puffy upper eyelids as well as persistence of the foreign body sensation in her throat. The patient was given ZYRTEC and prednisone while in the office. No laboratory tests were performed. The patient was continued on ZYRTEC. At the time of the report, the patient continued to experience a foreign body sensation in her throat and the outcome for nausea and puffy upper eyelids was unknown. Upon internal review the use of epinephrine IM was determined to be an other important medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Tenderness
Clinical narrative: (L) arm - extensive erythema, tenderness. KEFLEX x P.O. Topical Triamcinolone oint.
Age: 29.0
Sex: M
Vaccine: FLU3, HEP, MMR, TDAP
Symptoms: Chest pain, Computerised tomogram, Dyspnoea, Electrocardiogram abnormal, Exercise electrocardiogram
Clinical narrative: After receiving vaccines listed, pt c/o CP/SOB. Pt appeared in NAD. Breathing even & unlabored. Pulse 76 & regular. BP 142/88, interpreter used to help assess pt. Pain a 5 (scale 1-10). Reports he had CT 2 days prior with exercise & hx of CP. Assessed by nurse practitioner. O2 given via nasal canula. Transported to ER via rescue squad.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site swelling, Oedema peripheral
Clinical narrative: Mom states gradual increase in swelling in left upper arm - getting as large as a grapefruit - 24 hours post vaccination. 48 hr post vaccination - arm still enlarged but decreasing in size. Client has been taking MOTRIN for pain - per mom via phone.
Age: 1.07
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister
Clinical narrative: MOM CALLED CLINIC DESCRIBING 20 "ERUPTIONS OF BLISTERS" OVER BODY THAT LOOK LIKE CHICKEN POX.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling, redness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Localized inflammation and redness L thigh size of quarter at first but doubled in size by next day, eventually whole lateral thigh red.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling from shoulder to elbow on Right arm.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Localized swelling, redness left thigh. Where shots were given & itchiness.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Deafness, Musculoskeletal pain, Neck pain, Spinal operation
Clinical narrative: Information has been received from a physician concerning her 81 year old female friend having meningitis at age 2 years and hearing loss from the disease who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# and route not reported). Subsequently the patient developed pain in her neck and both shoulders and hearing loss. The neck and shoulder pain resulted in cervical spine surgery which requested hospitalization. The patient's hearing loss was worse since vaccination with ZOSTAVAX (Merck). At the time of reporting, the patient was not recovered. Upon internal review, worsening of hearing loss was determined to be an other important medical event. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: RASH, ITCHING.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: Information has been received from a registered pharmacist concerning a 69 year old female patient with sulfa and amoxicillin allergies who on 26-MAR-2012, was vaccinated with a dose of ZOSTAVAX (Merck) (dose and route not provided) (lot # 671144/1269AA, expiration date 05-NOV-2012). The pharmacist informed that the patient died approximately on 02-APR-2012 "around 1 week after receiving the ZOSTAVAX (Merck)". The pharmacist indicated that no adverse reaction was reported or any physical symptoms other than the death and that the patient did not seek medical attention. The cause of death was not provided. A lot check has been initiated. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: TTOX
Symptoms: Cold sweat, Hypotension, Loss of consciousness, Pallor, Thirst
Clinical narrative: LOC FOR APPROX. 10 SECONDS, LOW B/PS, PALE, CLAMMY, EXTREME THIRST.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in face.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Face oedema, Heart rate increased, Immediate post-injection reaction, Urticaria, Vomiting
Clinical narrative: Immediately after immunizations child vomited and became urticarial, mild facial edema. HR increased to 170's RR increased to 50's and Pulse OX to 93% --> gave ZYRTEC - vomited that but HR decreased to 146, hives began fading pulse ox to 96% EMS transported to ED - BENADRYL, EPI PEN for home use and f/u 1 wk.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Right deltoid red, raised, and inflamed.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Dizziness, Injection site swelling, Nausea, Throat tightness
Clinical narrative: Swelling in the injection site, pt had a tight chest/throat with nausea and light headed. BENADRYL 50 mg IM
Age: 85.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Full blood count normal, Metabolic function test normal, Swelling, Tenderness
Clinical narrative: Significant - along (R) posterior/radial upper ext for swelling, erythema and mild tenderness lasting > 4 days since injection.
Age: 85.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: X-ray normal
Clinical narrative: Significant - along (R) posterior/radial upper ext for swelling, erythema and mild tenderness lasting > 4 days since injection.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Erythema, edema, & tenderness at site of injection.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Pain, Pruritus, Rash
Clinical narrative: Patient advised that noticed rash at bedtime (11:30 PM) on 4/14/12 with itching. Woke up at 2AM 4/15/12 with burning pain on right side between hip joint & wrist. Burning pain has become worse. Pain localized to right side. Advised patient to see physician - was going to MD evening of 4/19/12. MD's office was also called approx 5:45 on 4/19/12 & incident reported to employee in MD's office.
Age: 43.0
Sex: F
Vaccine: HEPAB, IPV, TYP, YF
Symptoms: Muscle strain
Clinical narrative: Pt. c/o pulled muscle in (R) lower leg x 3 since receiving vaccinations on 3/13/12. Pt. states she was told by her private MD that vaccines can cause muscle tears (??). Pt referred to ortho specialist for further evaluation.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: 30 min to 45 min after leaving - returned with swelling eyes - itching, no wheezing, no hives. Given PO BENADRYL - PRELONE - improved.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: GBS.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Cough, Oropharyngeal pain, Pain
Clinical narrative: Reports to HD that two weeks ago had flu shot intradermal - and 2 days later developed sore throat, body aches, and upper respiratory cough, chills - for 2 days. Respiratory symptoms ("joints hurt so bad." cough occasional) Reports "this happens every year."
Age: 59.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Areflexia, Ataxia, Balance disorder, CSF protein increased, Diplopia
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 59-year-old male patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 influenza vaccine (manufacturer is unknown). 2 weeks after receiving H1N1 influenza vaccine the patient developed his first symptom of Guillain-Barre syndrome (GBS). Sensory symptoms included diplopia and imbalance. Motor symptoms included ophthalmoplegia and gait ataxia. A neurological examination revealed right ptosis, bilateral vertical (upward and downward) and horizontal (abduction and adduction) ophthalmoplegia, absent vestibulo-ocular reflex, generalized areflexia and severe ataxia on finger-to-nose and heel-to-shin maneuvers. The patient's cerebrospinal fluid (CSF) protein was 48mg/dl which was considered elevated. 18 days after receiving H1N1 influenza vaccine electrodiagnostic findings revealed normal nerve conduction studies of the upper and lower extremities, the facial nerve and blink reflexes. Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. One week after receiving IVIG there was a slow improvement in eye movements, ataxia of gait and hands however areflexia was persistent. After 6 months the patient resumed their baseline activities. Reporter's comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient fulfilled level 1 diagnostic certainty criteria outlined by the work group. A relationship between the vaccine and GBS was not necessarily established.
Age: 59.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Eye movement disorder, Eyelid ptosis, Guillain-Barre syndrome, Imaging procedure, Immunoglobulin therapy
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 59-year-old male patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 influenza vaccine (manufacturer is unknown). 2 weeks after receiving H1N1 influenza vaccine the patient developed his first symptom of Guillain-Barre syndrome (GBS). Sensory symptoms included diplopia and imbalance. Motor symptoms included ophthalmoplegia and gait ataxia. A neurological examination revealed right ptosis, bilateral vertical (upward and downward) and horizontal (abduction and adduction) ophthalmoplegia, absent vestibulo-ocular reflex, generalized areflexia and severe ataxia on finger-to-nose and heel-to-shin maneuvers. The patient's cerebrospinal fluid (CSF) protein was 48mg/dl which was considered elevated. 18 days after receiving H1N1 influenza vaccine electrodiagnostic findings revealed normal nerve conduction studies of the upper and lower extremities, the facial nerve and blink reflexes. Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. One week after receiving IVIG there was a slow improvement in eye movements, ataxia of gait and hands however areflexia was persistent. After 6 months the patient resumed their baseline activities. Reporter's comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient fulfilled level 1 diagnostic certainty criteria outlined by the work group. A relationship between the vaccine and GBS was not necessarily established.
Age: 59.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Nerve conduction studies normal, Neurological examination abnormal, Ophthalmoplegia, Serology normal
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 59-year-old male patient. The patient had no clinical or laboratory evidence suggestive of any precipitating conditions. In 2010/2011 the patient received H1N1 influenza vaccine (manufacturer is unknown). 2 weeks after receiving H1N1 influenza vaccine the patient developed his first symptom of Guillain-Barre syndrome (GBS). Sensory symptoms included diplopia and imbalance. Motor symptoms included ophthalmoplegia and gait ataxia. A neurological examination revealed right ptosis, bilateral vertical (upward and downward) and horizontal (abduction and adduction) ophthalmoplegia, absent vestibulo-ocular reflex, generalized areflexia and severe ataxia on finger-to-nose and heel-to-shin maneuvers. The patient's cerebrospinal fluid (CSF) protein was 48mg/dl which was considered elevated. 18 days after receiving H1N1 influenza vaccine electrodiagnostic findings revealed normal nerve conduction studies of the upper and lower extremities, the facial nerve and blink reflexes. Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. One week after receiving IVIG there was a slow improvement in eye movements, ataxia of gait and hands however areflexia was persistent. After 6 months the patient resumed their baseline activities. Reporter's comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient fulfilled level 1 diagnostic certainty criteria outlined by the work group. A relationship between the vaccine and GBS was not necessarily established.
Age: 76.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Areflexia, Asthenia, Balance disorder, CSF protein increased, Dysphagia
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 76-year-old female patient. The patient had no clinical or laboratory evidence suggestive of precipitating conditions. In 2010/2011 the patient received H1N1 (manufacturer is unknown). 4 weeks after receiving H1N1 the patient developed her first symptom of Guillain-Barre syndrome (GBS). Sensory symptoms included paresthesias and numbness in bilateral toes progressing to both legs, and then to bilateral fingers and loss of balance. Motor symptoms included loss of dexterity and dysphagia and no weakness. A neurological examination revealed generalized weakness (graded to 4/5), decreased pinprick, joint position and vibration in both lower extremities, unsteady upon stance and gait, deep tendon reflexes 1+ in both upper extremities and absent patellar and ankle reflexes. The patient's cerebrospinal fluid (CSF) protein was 78mg/dl which was considered elevated. 7 weeks after receiving H1N1 electrodiagnostic findings revealed sural sparing, prolonged distal latencies and absent or abnormal F responses which was highly suggestive of acute inflammatory demyelinating polyradiculoneuropathy. Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. One week after receiving treatment with IVIG the patient showed improved sensations and slow improvement of weakness and dysphagia. The patient resumed their baseline level of activities by 6 months. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient did not have one of the diagnostic certainty criteria recommended by the working group however the working group recognised that their case definitions might not include some rare and atypical clinical variants of GBS. A relationship between the vaccine and GBS was not necessarily established.
Age: 76.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dysstasia, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Imaging procedure
Clinical narrative: This literature report (initial receipt 10-Apr-2012) concerns a 76-year-old female patient. The patient had no clinical or laboratory evidence suggestive of precipitating conditions. In 2010/2011 the patient received H1N1 (manufacturer is unknown). 4 weeks after receiving H1N1 the patient developed her first symptom of Guillain-Barre syndrome (GBS). Sensory symptoms included paresthesias and numbness in bilateral toes progressing to both legs, and then to bilateral fingers and loss of balance. Motor symptoms included loss of dexterity and dysphagia and no weakness. A neurological examination revealed generalized weakness (graded to 4/5), decreased pinprick, joint position and vibration in both lower extremities, unsteady upon stance and gait, deep tendon reflexes 1+ in both upper extremities and absent patellar and ankle reflexes. The patient's cerebrospinal fluid (CSF) protein was 78mg/dl which was considered elevated. 7 weeks after receiving H1N1 electrodiagnostic findings revealed sural sparing, prolonged distal latencies and absent or abnormal F responses which was highly suggestive of acute inflammatory demyelinating polyradiculoneuropathy. Clinical history, neurological exam, imaging studies, and serological and CSF markers excluded other etiologies of acute neuropathy such as vasculitis, vitamin deficiency, toxic neuropathy and porphyria. Treatment included intravenous immunoglobulin (IVIG) 0.4kg/day for 5 days. One week after receiving treatment with IVIG the patient showed improved sensations and slow improvement of weakness and dysphagia. The patient resumed their baseline level of activities by 6 months. Reporters comment: Clinical history, serological studies and CSF findings did not point to any other precipitating conditions except for the H1N1-influenza vaccination. The Brighton Collaborative Working Group established criteria for GBS in association with vaccine. The patient did not have one of the diagnostic certainty criteria recommended by the working group however the working group recognised that their case definitions might not include some rare and atypical clinical variants of GBS. A relationship between the vaccine and GBS was not necessarily established.