chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with ROTATEQ orally (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA001256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011424, 1403USA011425, 1403USA011427 (same reporter link). Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a physician refers to a 45 year old male patient. The patient had no relevant medical history and past drug history were unknown. On 05-MAR-2014 ("3 days ago") the patient was vaccinated with PNEUMOVAX 23 (route and lot number were not provided). His concomitant medications were unknown. On 07-MAR-2014 the patient started to have symptoms which got progressively worse. On 08-MAR-2014 his left arm looked like it had cellulitis at the injection site and was about 6 inches in diameter. It was unknown if there was any relevant laboratory data. As of 08-MAR-2014 it was unknown if the patient would ever receive a PNEUMOVAX 23 injection again and his left arm continued to look like he had cellulitis that was about 6 inches in diameter. The outcome was reported as not recovered/not resolved. The relatedness was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with ROTATEQ (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (Same reporter link). Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with ROTATEQ (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363. 1403USA011380, 1403USA011414, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with VARIVAX (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. The case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424 and 1403USA011425 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with GARDASIL (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011427. (same reporter link) Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Muscular weakness, Musculoskeletal pain, Neuralgic amyotrophy
Clinical narrative: Onset of pain (R) shoulder followed by weakness. Pain for one month followed by lessening pain for two months with accompanied weakness in (R) arm and shoulder. Diagnosis as Parsonage-Turner Syndrome March 2014.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a male consumer of unknown age reporting on himself. The patient's current conditions or medical history were not reported. On an unknown date, reported as on an unspecified date years ago, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route, lot number and expiration date were not reported). On an unspecified date in November 2013, the patient developed shingles, the patient also reported he had developed a rash from the chest all the way around to his back. At the time of the report the patient was not recovered from the event. The patient was using CAPZASIN-P Creme (dosage, frequency, manufacturer unknown) to treat the rash but it was not helping him. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Pruritus, Rash
Clinical narrative: Rash on lower legs, arms - itchy. Mom applied hydrocortisone cream before bringing into office. Provider advised ZYRTEC 3/4 tsp. QD.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, VARCEL
Symptoms: Injection site erythema, Pyrexia, Skin warm, Vaccination complication
Clinical narrative: 03/06/2014 Pt has erythema to Lt arm at injection site measuring 6X5.5 in area with darker erythema at injection site measuring 1X1.5 in area. Hot to touch. Mother states that he has been sick with fever from vaccination. Dr. Dx as adverse vaccine reaction.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 03/06/2014 Pt has erythema to Lt arm at injection site measuring 6X5.5 in area with darker erythema at injection site measuring 1X1.5 in area. Hot to touch. Mother states that he has been sick with fever from vaccination. Dr. Dx as adverse vaccine reaction.
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient's current conditions or medical history were not reported. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route, lot and expiration date were not reported). On an unknown date, the medical assistant reported that an unspecified patient's mother reported to her that the daughter of the mother's friend experienced heavy menstrual bleeding after receiving GARDASIL. At the time of the report, outcome for heavy menstrual bleeding was unknown. This is one of two reports from the same source. Additional information is not expected.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood test normal, Brain scan normal, Hypoaesthesia, Joint stiffness, Lumbar puncture normal
Clinical narrative: A few days after I was let out of the hospital. I woke up and both of my legs from the thighs down to my toes were, numb, stiff, tight and painful. Went to the Emergency room on 11/ /13. Diagnosed w/ transverse myelitis. Went through steroid treatment and physical therapy.
Age: 31.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Muscle tightness, Musculoskeletal stiffness, Myelitis transverse, Pain in extremity
Clinical narrative: A few days after I was let out of the hospital. I woke up and both of my legs from the thighs down to my toes were, numb, stiff, tight and painful. Went to the Emergency room on 11/ /13. Diagnosed w/ transverse myelitis. Went through steroid treatment and physical therapy.
Age: 17.0
Sex: F
Vaccine: HPV4, MMR, VARCEL
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: 15 mins post injection; rash, erythema, itching localized approximately 4 cm diameter with approximately 20 mm wheal. No systemic reactions. Benadryl 25 mg P.O. given. 30 mines later local reaction reduced by 75%. Told to repeat Benadryl at home.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: Back of left arm appears bruised from 4" above elbow to above injection site.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with M-M-R II and VAQTA (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (Same reporter link). Additional information has been requested.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Crying, Glassy eyes, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: High pitched crying. Fever. Intense swelling - entire upper leg - hard, swollen and red. Malaise, eyes glazed. Speech regressed for 2 years after this date.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Malaise, Pyrexia, Speech disorder
Clinical narrative: High pitched crying. Fever. Intense swelling - entire upper leg - hard, swollen and red. Malaise, eyes glazed. Speech regressed for 2 years after this date.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Developmental delay, Encephalopathy, Epistaxis, Lethargy, Mass
Clinical narrative: High pitched crying. Fever. Intense swelling - entire upper leg - hard, swollen and red. Malaise, eyes glazed. Speech regressed for 2 years after this date.
Age: 1.75
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA
Symptoms: Pyrexia, Screaming, Speech disorder developmental
Clinical narrative: High pitched crying. Fever. Intense swelling - entire upper leg - hard, swollen and red. Malaise, eyes glazed. Speech regressed for 2 years after this date.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chest X-ray, Chills, Cough, Fatigue
Clinical narrative: Given PNEUMOVAX 03/19/2014 - within 2 hours developed chills, fatigue, cough and body aches returned to office 3/20/14 - temp 101.6 injection site soreness, no erythema - WBC = 11 - CXR done.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain, White blood cell count increased
Clinical narrative: Given PNEUMOVAX 03/19/2014 - within 2 hours developed chills, fatigue, cough and body aches returned to office 3/20/14 - temp 101.6 injection site soreness, no erythema - WBC = 11 - CXR done.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Presyncope
Clinical narrative: Diarrhea a few hours after HPV. Light headed, dizzy, near syncope for approximately 48 hrs after vaccine.
Age: 0.34
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site movement impairment, Injection site pain
Clinical narrative: Severe leg pain, right leg. Pt. did not want to move leg.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Cycloplegic refraction, Fundoscopy normal, Neurological examination abnormal, Nuclear magnetic resonance imaging brain normal, Ophthalmological examination abnormal
Clinical narrative: This case was reported in a literature article and described the occurrence of partial paralysis of abducent nerve in a 4-day-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject was born at 39 weeks of gestation by caesarean section due to prolonged labour following an uncomplicated pregnancy. There was no reported history of febrile illness or trauma and a photography from day 1 of life showed normal eye abduction. A maternal uncle had a history of strabismus. No further information on his medical, family history or concurrent medication was available. On an unspecified date, at 2-day of life, the subject received 1st dose of ENGERIX B (administration site and route unknown, batch number not provided). 2 days after vaccination with ENGERIX B, the subject experienced partial paralysis of abducent nerve and esotropia. This case was assessed as medically serious by GSK. On ophthalmological examination, he showed marked limitation of abduction in the right eye (-3) and full ductions in the left eye. This was consistent with right lateral rectus paralysis. He blinked to light with each eye. Dilated fundus examination was normal. His paediatrician performed a neurological examination that was notable only for the abducens nerve palsy. MRI of the brain and orbits, with and without contrast, was performed and T1- and T2-weighted fluid attenuation inversion recovery (FLAIR) and diffusion-weighted images with fat suppression revealed no abnormalities. Diagnosis was isolated abducens nerve palsy. The treatment consisted of part-time occlusion therapy of his left eye. Examination on day 30 of life revealed a 60 degree right esotropia in primary gaze at near. Cycloplegic refraction revealed +13.25 D spherical error for each eye. He maintained fixation in adduction in the right eye and had central, steady, and maintained fixation in his left eye. At 2 months of age the esotropia had resolved and he was orthotropic in primary gaze, with full abduction of the right eye. Patching was discontinued at this visit. Examinations at 4, 12, and 18 months of age revealed orthotropia in primary gaze, with no limitation of abduction of the right eye. His vision was 9.8 cycles per degree (20/60, within normal range) in each eye using teller acuity cards at the 18-month of age follow-up examination. The author's conclusion stated that they believed that his sixth nerve palsy was caused by the vaccination, although other, less likely, possibilities include cryptogenic or unreported trauma. Presumed postimmunization abducens nerve palsy typically resolves spontaneously within 6 months, although it was often associated with a recurrence.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Strabismus, VIth nerve paralysis
Clinical narrative: This case was reported in a literature article and described the occurrence of partial paralysis of abducent nerve in a 4-day-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject was born at 39 weeks of gestation by caesarean section due to prolonged labour following an uncomplicated pregnancy. There was no reported history of febrile illness or trauma and a photography from day 1 of life showed normal eye abduction. A maternal uncle had a history of strabismus. No further information on his medical, family history or concurrent medication was available. On an unspecified date, at 2-day of life, the subject received 1st dose of ENGERIX B (administration site and route unknown, batch number not provided). 2 days after vaccination with ENGERIX B, the subject experienced partial paralysis of abducent nerve and esotropia. This case was assessed as medically serious by GSK. On ophthalmological examination, he showed marked limitation of abduction in the right eye (-3) and full ductions in the left eye. This was consistent with right lateral rectus paralysis. He blinked to light with each eye. Dilated fundus examination was normal. His paediatrician performed a neurological examination that was notable only for the abducens nerve palsy. MRI of the brain and orbits, with and without contrast, was performed and T1- and T2-weighted fluid attenuation inversion recovery (FLAIR) and diffusion-weighted images with fat suppression revealed no abnormalities. Diagnosis was isolated abducens nerve palsy. The treatment consisted of part-time occlusion therapy of his left eye. Examination on day 30 of life revealed a 60 degree right esotropia in primary gaze at near. Cycloplegic refraction revealed +13.25 D spherical error for each eye. He maintained fixation in adduction in the right eye and had central, steady, and maintained fixation in his left eye. At 2 months of age the esotropia had resolved and he was orthotropic in primary gaze, with full abduction of the right eye. Patching was discontinued at this visit. Examinations at 4, 12, and 18 months of age revealed orthotropia in primary gaze, with no limitation of abduction of the right eye. His vision was 9.8 cycles per degree (20/60, within normal range) in each eye using teller acuity cards at the 18-month of age follow-up examination. The author's conclusion stated that they believed that his sixth nerve palsy was caused by the vaccination, although other, less likely, possibilities include cryptogenic or unreported trauma. Presumed postimmunization abducens nerve palsy typically resolves spontaneously within 6 months, although it was often associated with a recurrence.
Sex: M
Vaccine: DTAPIPV
Symptoms: Infection, Product contamination, Product quality issue, Surgery
Clinical narrative: This case was reported by a lawyer and described the occurrence of infection in a child male subject who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. According to the legal complaint received on 20 March 2014, on an unspecified date the subject received a dose of KINRIX (unknown). On 11 October 2013, less than one year after vaccination with KINRIX, the subject developed a serious infection following the vaccinations and was hospitalized and caused to undergo a procedure as a result of the infection. The claim raised concerns as to whether these lots were determined to contain contaminants [product complaint]. At the time of reporting the outcome of the events were unspecified.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old female patient. The patient's current conditions or medical history were not reported. On an unspecified date in 2011, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not provided). 17-MAR-2014, also reported as today, the patient reported a case of shingles. At the time of the report outcome for shingles was unknown. The patient went to the pharmacist for medical attention. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Rash
Clinical narrative: Redness around injection site and rashon legs and lower ABD, Pt was given Benadryl in the office and was watched for 30 minutes afterwards. The rash and redness were almost completely gone at the time the pt left.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Local reaction, Pruritus, Rash
Clinical narrative: Patient had a local reaction at injection site.  Redness, swelling and itch.  Marked margins of rash, applied ice and gave 25mg Benadryl.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Patient had a local reaction at injection site.  Redness, swelling and itch.  Marked margins of rash, applied ice and gave 25mg Benadryl.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Skin warm, Swelling
Clinical narrative: Swelling, continued to expand; hot; hard in center.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Induration, Injection site swelling, Local swelling, Pain in extremity
Clinical narrative: Severe swelling, pain, redness of left arm.  Swelling from shoulder to below elbow.  Very hard, red and hot to touch.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Skin warm
Clinical narrative: Severe swelling, pain, redness of left arm.  Swelling from shoulder to below elbow.  Very hard, red and hot to touch.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Local swelling
Clinical narrative: He received Kinrix and Proquad on the left arm and noted swelling redness for 3 days up to the elbow.  It has now resolved but noticed  redness on the bad aid site. No fever.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema
Clinical narrative: Bruising, and red streak from elbow to bicep.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Dyspnoea, Injection site erythema, Injection site rash, Rash erythematous
Clinical narrative: Red rashes on her neck, ears and injection site, slight dyspnea, given cortisone cream on the neck.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Local swelling, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from an unspecified other (Control #54417) concerning a 77 year old female patient. Medical history and concurrent conditions were not reported. Patient had no known allergies. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose and route were not reported) Lot # J011651; Expiration date: 22-AUG-2015 (reported as 31-AUG-2014). In 2014, the patient had swelling of the arm, body aches, weak and fever. Patient did not had any trouble breathing and have no known allergies. Once patient was put on antibiotics, patient got better. The outcome of the events was not reported. This is one of 4 reports from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Drooling, Hyperhidrosis, Laboratory test, Nausea, Pallor
Clinical narrative: Approximately 2-3 minutes following influenza and pneumococcal vaccine, pt. developed itching, throat tightness, tongue swelling diaphoresis, nausea, pallor and drooling.  EMS called and transported to hospital.
Age: 22.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus, Swollen tongue, Throat tightness
Clinical narrative: Approximately 2-3 minutes following influenza and pneumococcal vaccine, pt. developed itching, throat tightness, tongue swelling diaphoresis, nausea, pallor and drooling.  EMS called and transported to hospital.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Student fainted briefly after last vaccine (HPV) was given. She recovered immediately when laid on ground with feet elevated.
Age: 30.0
Sex: F
Vaccine: TTOX
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Pain in muscle at top of shoulder that did not go away and has become worse with passing weeks. Mobility is now limited.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Pt came in complaining of right arm swelling and feeling sore after receiving vaccine on Friday 3/21/2014. Given a prescription for Benadryl and Clindamycin with return appointment for 3/26/2014.
Age: 0.52
Sex: M
Vaccine: DTAP, RV5
Symptoms: Dermatitis diaper, Diarrhoea haemorrhagic, Eye infection, Irritability, Respiratory tract infection
Clinical narrative: Diarrhea, eye infection, congestion, bloody diaper rash, irritability.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site reaction, Rash, Rash maculo-papular
Clinical narrative: Macolopapular rash noted on abdomen spreding to back after vaccination.  At 11:20 nurse noted one maculopapular lesion on rt knee.  Mom said that was new.  At 11:21 Nurse noted 3 maculopapular lesions on right knee.  No SOB or color changes.  Baby alert and acting normally.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody, Arthralgia, Asthenia, C-reactive protein, Injection site pain
Clinical narrative: Severe pain beginning in shoulder of arm months of injection site. This was followed by pain and swelling in nearly every joint in body lasting for approximately 2 monthsWas seen by 4 different physicians the last of which prescribed 60 mg prednisone for 5 days resulting in relief of most pain. Since that time I have had 2 more episodes of the same symptoms. Doctor has advised consult with rheumatologist and possibly neurologist as I also have some weakness and tremor since this began. Latest bad episode began 03/21/2014 and continues. Currently treating with Naproxen with some relief.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Red blood cell sedimentation rate, Rheumatoid factor, Tremor
Clinical narrative: Severe pain beginning in shoulder of arm months of injection site. This was followed by pain and swelling in nearly every joint in body lasting for approximately 2 monthsWas seen by 4 different physicians the last of which prescribed 60 mg prednisone for 5 days resulting in relief of most pain. Since that time I have had 2 more episodes of the same symptoms. Doctor has advised consult with rheumatologist and possibly neurologist as I also have some weakness and tremor since this began. Latest bad episode began 03/21/2014 and continues. Currently treating with Naproxen with some relief.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia
Clinical narrative: Intermittent short term memory loss. Per mother, could not remember certain events for up to 1 month after vaccination.  Symptoms resolved.
Age: 58.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: NO HARM TO PATIENT. NO COMPLICATIONS NOTED.
Age: 24.0
Sex: M
Vaccine: HPV4, SMALL, SMALL
Symptoms: Cardiomegaly, Histology abnormal, Myocarditis, Sudden death, Toxicologic test
Clinical narrative: Sudden death.  Cardiomegally with four chamber dilation.  Histologic diagnosis of myocarditis.  At the time of this report toxicology is still pending.
Age: 24.0
Sex: M
Vaccine: HPV4, SMALL, SMALL
Symptoms: Autopsy, Blood ethanol normal, Cardiomegaly, Cardiovascular evaluation, Eosinophilic myocarditis
Clinical narrative: Sudden death.  Cardiomegally with four chamber dilation.  Histologic diagnosis of myocarditis.  At the time of this report toxicology is still pending.
Age: 24.0
Sex: M
Vaccine: HPV4, SMALL, SMALL
Symptoms: Histology abnormal, Left ventricular hypertrophy, Pathology test, Sudden death, Unresponsive to stimuli
Clinical narrative: Sudden death.  Cardiomegally with four chamber dilation.  Histologic diagnosis of myocarditis.  At the time of this report toxicology is still pending.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: This spontaneous report as received from a physician via Company representative refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and lot number were not reported). Secondary and concomitant therapies were not reported. Physician reported that a patient no longer experienced having her period after receiving the GARDASIL (unspecified dose in the series) (date unspecified): it was also report that the patient was not pregnant. It was reported that the patient sought medical attention by seeing the physician. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients may had been vaccinated with a dose of PEDVAXHIB, (strength, dose unit, route, lot# and expiry date unknown). On an unknown date, PEDVAXHIB were improperly stored. Registered nurse reported that she was unsure if improperly stored vaccines were administered and no adverse effects reported, but she does not think so. Registered nurse also reported that another nurse at VFC handles the issue. The outcome of unsure if improperly stored vaccines; GARDASIL, VAQTA, PEDVAX HIB, were administered and no adverse effects reported was unkown. This is one of several reports from the same source. Follow up information was received on 11/MAR/2014. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Mobility decreased, Pain
Clinical narrative: Pt received Tdap to (L) deltoid on 2/12/14. Pt called to report pain at 5 days had not subsided. Reported numbness on radial aspect of (L) hand. Pain w/ sleeping. Decreased functionality of (L) hand. Pt see by FNP on 2/19 and prescribed Abx for ? of abscess (7 day) pt stopped treatment on day 4 "not working". Referred to neurology/PT/ ok'd for acupuncture. Still having decreased function/numbness/pain.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Dizziness, Dyspnoea, Paraesthesia
Clinical narrative: SOB, chest pain, dizziness, tingling in legs that started one hour after receiving Hepatitis B vaccine #2.
Age: 0.59
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Syncope. LOC less than 1 minute. Treatment: patient placed in supine position, knees elevated.
Age: 1.59
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMRV
Symptoms: Rash generalised
Clinical narrative: Mild rash on total body - started day after received immunizations.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient noticed soreness in arm 3 days post injection (3/24) and small bump and pink skin around injection site. Called pharmacy and reported on 3/25 AM.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever above 106.4 after vaccines given 1/9/14. After this reaction mother informed us that child had fever of 104.2 given at previous Dr. office.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients may have been vaccinated with a dose of GARDASIL (strength, dose unit, route, lot# and expiry date unknown). On an unknown date GARDASIL was improperly stored. Registered nurse reported that she was unsure if improperly stored vaccines were administered and no adverse effects reported, but she does not think so. Registered nurse also reported that another nurse at facility handles the issue. The outcome of unsure if improperly stored vaccines; GARDASIL, VAQTA, PEDVAX HIB, were administered and no adverse effects reported was unknown. This is one of several cases from same source. Follow up information was received on 11/MAR/2014. All telephone attempts to obtain follow up information has been unsuccessful. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus
Clinical narrative: Injection site rash, itching covering back of upper arm.
Age: 18.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a License Practical Nurse (LPN) refers to an 18 year old patient. On 13-MAR-2014 the patient was vaccinated with an expired dose of VARIVAX (lot # H006536, exp date 09-MAR-2014) 0.5 ml dose, subcutaneous route. Concomitant therapy was not reported. No adverse events reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product label confusion, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient who on 17-MAR-2014, was vaccinated intramuscularly with a 0.65 ml dose of VARIVAX (Merck) (lot number not reported). The patient was supposed to receive ZOSTAVAX but due to the product confusion was vaccinated with a dose of VARIVAX (Merck). No adverse effects were reported. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dry throat, Dysphagia, Dyspnoea, Erythema, Feeling hot
Clinical narrative: Evening of 2/26/14 - throat "tickled" or "itchy" and dry. Arm a little red. Given Tylenol. Mom busy and forgot to check arm Thurs 2/27/14. Child went to school. Friday 2/28/14 after school found shot area red, raised 1/2", arm "on fire" elbow to shot area below deltoid. Face and neck that lt side patchiness dots of red and hot. Throat itchy, dry, hard time swallowing, hard time breathing, rare wheeze. Gave Benadryl and went to ER. Mostly resolved by 3/3/14.
Age: 7.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Throat irritation, Wheezing
Clinical narrative: Evening of 2/26/14 - throat "tickled" or "itchy" and dry. Arm a little red. Given Tylenol. Mom busy and forgot to check arm Thurs 2/27/14. Child went to school. Friday 2/28/14 after school found shot area red, raised 1/2", arm "on fire" elbow to shot area below deltoid. Face and neck that lt side patchiness dots of red and hot. Throat itchy, dry, hard time swallowing, hard time breathing, rare wheeze. Gave Benadryl and went to ER. Mostly resolved by 3/3/14.
Age: 1.95
Sex: M
Vaccine: HEP
Symptoms: Joint swelling, Pyrexia, Urticaria
Clinical narrative: Fever, urticaria, transient joint swelling.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Injection site pain, Local swelling, Pain
Clinical narrative: Pt has swelling and redness in arm that patient received HPV vacc. Patient reports pain with movement. (R Deltoid) Treated with 60 mg Benadryl BID for 2 days.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Injection site pain, Neck pain
Clinical narrative: Dizziness, weakness, sweating, right shoulder pain radiating to neck.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Left deltoid area red and warm to touch and tender.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site
Clinical narrative: Immunization given in the gluteus IM instead of deltoid IM.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pt called and stated that after she had a lot of pain in the arm that the PNEUMOVAX was administered. Pt will go see Dr and also will take Naproxen.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Pyrexia, Urticaria
Clinical narrative: This spontaneous report was received from a physician via other company (GlaxoSmithKline, manufacturer control number: A1063242A) and referred to a 2 month old male patient born premature (born at 31 weeks gestation). Per the physician, the patient "was tested along with several consultation to different doctors". No details were provided as to the tests performed. The subject had "routine referral to cardiologist, pulmonary and eye doctor due to premature birth." On 15-AUG-2013 the patient was vaccinated with unspecified dose of ROTATEQ (lot #, expiration date, strength, dose number and frequency were not reported), orally. Other suspect therapies that were administered on the same day (15-AUG-2013) included: unspecified dose of ACTHIB and PREVNAR 13 (dose number unknown) as well as first dose of PEDIARIX (lot # 749CT, 0.5 ml, unknown route, left arm). Concomitant therapies included vitamins (unspecified) and CHILDRENS TYLENOL (also reported as paracetamol). On 17-AUG-2013, 2 days after vaccination with ROTATEQ, ACTHIB and PREVNAR 13 and PEDIARIX the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and was sent home on prednisone (manufacturer unknown). On 18-AUG-2013, 3 days after vaccination with ROTATEQ, ACTHIB, PREVNAR 13 and PEDIARIX the rash worsened and the patient was taken to hospital "with a pediatric ward". Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged on an unspecified date with a diagnosis of erythema multiforme. The patient was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccine to this child." The patient was treated with prednisone (manufacturer unknown). The outcome of erythema multiforme and allergic rash was reported as recovered/resolved on an unspecified date. The physician considered events of allergic rash and erythema multiforme to be life threatening. The relatedness between events of allergic rash and erythema multiforme and ROTATEQ was not reported. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Drug administered at inappropriate site, Erythema multiforme, Laboratory test, Rash
Clinical narrative: This spontaneous report was received from a physician via other company (GlaxoSmithKline, manufacturer control number: A1063242A) and referred to a 2 month old male patient born premature (born at 31 weeks gestation). Per the physician, the patient "was tested along with several consultation to different doctors". No details were provided as to the tests performed. The subject had "routine referral to cardiologist, pulmonary and eye doctor due to premature birth." On 15-AUG-2013 the patient was vaccinated with unspecified dose of ROTATEQ (lot #, expiration date, strength, dose number and frequency were not reported), orally. Other suspect therapies that were administered on the same day (15-AUG-2013) included: unspecified dose of ACTHIB and PREVNAR 13 (dose number unknown) as well as first dose of PEDIARIX (lot # 749CT, 0.5 ml, unknown route, left arm). Concomitant therapies included vitamins (unspecified) and CHILDRENS TYLENOL (also reported as paracetamol). On 17-AUG-2013, 2 days after vaccination with ROTATEQ, ACTHIB and PREVNAR 13 and PEDIARIX the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and was sent home on prednisone (manufacturer unknown). On 18-AUG-2013, 3 days after vaccination with ROTATEQ, ACTHIB, PREVNAR 13 and PEDIARIX the rash worsened and the patient was taken to hospital "with a pediatric ward". Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged on an unspecified date with a diagnosis of erythema multiforme. The patient was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccine to this child." The patient was treated with prednisone (manufacturer unknown). The outcome of erythema multiforme and allergic rash was reported as recovered/resolved on an unspecified date. The physician considered events of allergic rash and erythema multiforme to be life threatening. The relatedness between events of allergic rash and erythema multiforme and ROTATEQ was not reported. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dermatitis allergic, Drug administered at inappropriate site, Erythema multiforme
Clinical narrative: This spontaneous report was received from a physician via other company (GlaxoSmithKline, manufacturer control number: A1063242A) and referred to a 2 month old male patient born premature (born at 31 weeks gestation). Per the physician, the patient "was tested along with several consultation to different doctors". No details were provided as to the tests performed. The subject had "routine referral to cardiologist, pulmonary and eye doctor due to premature birth." On 15-AUG-2013 the patient was vaccinated with unspecified dose of ROTATEQ (lot #, expiration date, strength, dose number and frequency were not reported), orally. Other suspect therapies that were administered on the same day (15-AUG-2013) included: unspecified dose of ACTHIB and PREVNAR 13 (dose number unknown) as well as first dose of PEDIARIX (lot # 749CT, 0.5 ml, unknown route, left arm). Concomitant therapies included vitamins (unspecified) and CHILDRENS TYLENOL (also reported as paracetamol). On 17-AUG-2013, 2 days after vaccination with ROTATEQ, ACTHIB and PREVNAR 13 and PEDIARIX the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and was sent home on prednisone (manufacturer unknown). On 18-AUG-2013, 3 days after vaccination with ROTATEQ, ACTHIB, PREVNAR 13 and PEDIARIX the rash worsened and the patient was taken to hospital "with a pediatric ward". Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged on an unspecified date with a diagnosis of erythema multiforme. The patient was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccine to this child." The patient was treated with prednisone (manufacturer unknown). The outcome of erythema multiforme and allergic rash was reported as recovered/resolved on an unspecified date. The physician considered events of allergic rash and erythema multiforme to be life threatening. The relatedness between events of allergic rash and erythema multiforme and ROTATEQ was not reported. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC, RV1, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Band neutrophil count, Blood alkaline phosphatase increased, Blood bicarbonate normal, Blood chloride normal, Blood creatinine normal
Clinical narrative: This spontaneous report was received from a physician via other company (GlaxoSmithKline, manufacturer control number: A1063242A) and referred to a 2 month old male patient born premature (born at 31 weeks gestation). Per the physician, the patient "was tested along with several consultation to different doctors". No details were provided as to the tests performed. The subject had "routine referral to cardiologist, pulmonary and eye doctor due to premature birth." On 15-AUG-2013 the patient was vaccinated with unspecified dose of ROTATEQ (lot #, expiration date, strength, dose number and frequency were not reported), orally. Other suspect therapies that were administered on the same day (15-AUG-2013) included: unspecified dose of ACTHIB and PREVNAR 13 (dose number unknown) as well as first dose of PEDIARIX (lot # 749CT, 0.5 ml, unknown route, left arm). Concomitant therapies included vitamins (unspecified) and CHILDRENS TYLENOL (also reported as paracetamol). On 17-AUG-2013, 2 days after vaccination with ROTATEQ, ACTHIB and PREVNAR 13 and PEDIARIX the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and was sent home on prednisone (manufacturer unknown). On 18-AUG-2013, 3 days after vaccination with ROTATEQ, ACTHIB, PREVNAR 13 and PEDIARIX the rash worsened and the patient was taken to hospital "with a pediatric ward". Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged on an unspecified date with a diagnosis of erythema multiforme. The patient was referred to an allergist to do allergy testing "to determine which vaccine may have caused" the reaction "before they go forward with administering any vaccine to this child." The patient was treated with prednisone (manufacturer unknown). The outcome of erythema multiforme and allergic rash was reported as recovered/resolved on an unspecified date. The physician considered events of allergic rash and erythema multiforme to be life threatening. The relatedness between events of allergic rash and erythema multiforme and ROTATEQ was not reported. Additional information has been requested.