chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Injection site swelling, Insomnia, Neck pain, Photosensitivity reaction
Clinical narrative: Per patient's mother: He had swelling of the Left deltoid injection site. He had a "sleepless" night on Monday evening (3/21/16). He stated his head hurt, his neck hurt, and he had back pain. He also felt chills. He was photosensitive on 3/22/16. He felt weak and tired. Symptoms continued through 3/23/16.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness and swelling at injection site, extreme fatigue.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Blood test, Guillain-Barre syndrome, Headache, Hyperaesthesia
Clinical narrative: Headaches , back pain, heightened sensations in tongue, fingertips, with numbness in the hands and feet: Bell's Palsy and GBS.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Lumbar puncture, Sensory disturbance, VIIth nerve paralysis
Clinical narrative: Headaches , back pain, heightened sensations in tongue, fingertips, with numbness in the hands and feet: Bell's Palsy and GBS.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient notices redness and mild soreness of injection site, appr. 2" square in size.
Age: 68.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Dermatitis contact, Pruritus, Rash, Rash erythematous, Rash generalised
Clinical narrative: Rash began on left arm (same arm Zostavax was administered).  Rash became widespread, was red and blotchy similar to a contact dermititis reaction (poison ivy).  Rash also caused itching.  Rash began to subside on 3/21/16 but itching remained.
Age: 68.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Rash macular
Clinical narrative: Rash began on left arm (same arm Zostavax was administered).  Rash became widespread, was red and blotchy similar to a contact dermititis reaction (poison ivy).  Rash also caused itching.  Rash began to subside on 3/21/16 but itching remained.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 24-FEB-2016, the patient received an unspecified pneumococcal vaccine. On 16-MAR-2016, three weeks late the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L003227, expiration date: 13-OCT_2016, route and dose were unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ orally, L029617 exp. 19-MAY-2017 (dose and site of administration were not reported). There were no adverse effects reported. The temperature of the storage was 47 Fahrenheit degree for 135 minutes. There was no previous temperature excursion. The reporter was call because of a "data logger". No product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot# reported as L0333423 exp. 13-SEP-2017 (dose, route and site of administration were not reported). There were no adverse effects reported. The temperature of the storage was 47 Fahrenheit degree for 135 minutes. There was no previous temperature excursion. The reporter was call because of a "data logger". No product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Several small areas of pruritus on chest, under (R) arm on back and (L) side of forehand. Followed up 3/25 and pt reported symptoms were "getting better."
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 64 year old female patient. The patient historical medications included BACTRIM. The patient was allergic to BACTRIM. The patient's concomitant medications included fluvoxamine maleate and quetiapine fumarate. On 02-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX, (0.65, subcutaneous, lot # and expiration date were not reported). On an unknown date, unspecified time after receiving the ZOSTAVAX, the patient developed red patches at the injection site. The patient sought medical attention by calling the pharmacist. The outcome of red patches at the injection site was reported as recovery/resolving. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # L043213 exp. 28-AUG-2017 (dose, site and route of administration were not reported). There were no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Respiratory disorder
Clinical narrative: This spontaneous report as received from a nurse via other company letter Pfizer, refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23. Approximately in 2012 (reported as four years ago), the patient had a reaction, respiratory issues. The outcome of respiratory issues was unknown. The causality of the event was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies reported. On an unknown dates, the patients were vaccinated with an improperly stored M-M-R II recombinant human albumin status (lot# L024267, expiration date 01-JUL-2017, dose, anatomical location and route of administration were not reported). No adverse event reported. There was no temperature excursion. The temperature and time frame was 11.7 Celsius degree for 1 hour, 30 minutes; -1 Celsius degree for 2 hours, 50 minutes; 11.6 Celsius degree for 4 hours, 20 minutes and -2.3 Celsius degree for 63 hours, 10 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies reported. On an unknown dates, the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L003227, expiration date 13-OCT-2016, dose, anatomical location and route of administration were not reported). No adverse event reported. There was no temperature excursion. The time frame was 11.7 Celsius degree for 1 hour, 30 minutes; -1 Celsius degree for 2 hours, 50 minutes; 11.6 Celsius degree for 4 hours, 20 minutes and -2.3 Celsius degree for 63 hours, 10 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies reported. On an unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (lot# L043213, expiration date 28-AUG-2017, dose, anatomical location and route of administration were not reported). No adverse event reported. There was no temperature excursion and the time frame was 11.7 Celsius degree for 1 hour, 30 minutes; -1 Celsius degree for 2 hours, 50 minutes; 11.6 Celsius degree for 4 hours, 20 minutes and -2.3 Celsius degree for 63 hours, 10 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical histories, concomitant medications and drug reactions or allergies reported. On an unknown date, the patients were vaccinated with an improperly stored dose of PEDVAXHIB (lot# L035880, expiration date 11-AUG-2018, dose, anatomical location and route of administration were not reported). No adverse event reported. There was no temperature excursion and time frame was 11.7 Celsius degree for 1 hour, 30 minutes; -1 Celsius degree for 2 hours, 50 minutes; 11.6 Celsius degree for 4 hours, 20 minutes and -2.3 Celsius degree for 63 hours, 10 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding unspecified patients of unknown age and gender. Medical history and concurrent conditions of the patients were not reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (Merck) lot # L008270 expiry date 11-MAR-2017, L032391 expiry date 26-AUG-2017, lot 035127 expiry date 14-SEP-2017 (dose, route and site of administration not reported. This was following first temperature excursion of -7.4C for 8 hours. No adverse effects were reported. Temperature: 0.05C. Time frame: 9 hours 20 minutes. Based on these supportive parameters the improperly stored vaccines were administered after first excursion. No doses were administered after second excursion. There was previous temperature excursion (-7.4C for 8 hours). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 15-MAR-2016, the patient was vaccinated with improperly stored VARIVAX (Merck) lot # L011084 with Expiration Date of 01-APR-2017 (dose, dose number, vaccination site and route not provided), which was exposed to the following temperature: 18.71 F for 15.5 hours. The previous temperature excursions were 15.71F for 36 hours and 29.85 F for 24 hours. No adverse symptoms reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unspecified age and gender. The patients concurrent conditions and medical history was not reported. The healthcare worker reported that, on an unspecified dates, an unspecified number of unspecified patients were administered with improperly stored doses of ROTATEQ with lot# L037924 and expiration date: 22-JUN-2017; with lot # L039297 and expiration date: 19-JUN-2017; with lot # L008578 and expiration date: 14-DEC-2016; with lot # L027726 and expiration date: 10-MAY-2017 (strength, dose number and dosage unspecified) via oral route. The vaccine was exposed to temperature of 10.1 degree C for time frame of 1 hour, there was no previous temperature excursion. No adverse effect was reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Lumbar puncture, Mass, Muscular weakness, Nerve conduction studies
Clinical narrative: In late Oct or Nov I felt lump under right toes left. Pin and needles in feet. Lower legs weak couldn't walk as far w/o rest. Painful "shocking" hand shakes, coffee cup got too heavy to lift with right hand. Burned hand on broiler. Paralysis started 2-28-16.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Paraesthesia, Paralysis, Thermal burn, Tremor
Clinical narrative: In late Oct or Nov I felt lump under right toes left. Pin and needles in feet. Lower legs weak couldn't walk as far w/o rest. Painful "shocking" hand shakes, coffee cup got too heavy to lift with right hand. Burned hand on broiler. Paralysis started 2-28-16.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Weight bearing difficulty
Clinical narrative: In late Oct or Nov I felt lump under right toes left. Pin and needles in feet. Lower legs weak couldn't walk as far w/o rest. Painful "shocking" hand shakes, coffee cup got too heavy to lift with right hand. Burned hand on broiler. Paralysis started 2-28-16.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on concurrent condition, pertinent medical history and drug allergies of the patient were not reported. On 01-NOV-2011 the patient was vaccinated with first dose of HPV-2 (lot, expiry date, route, dose and anatomical location were not reported) 1 dosage. On 06-JUN-2014, the patient was vaccinated with first dose of GARDASIL lot # J011272, expiry date 21-MAY-2017, 0.5 ml, intramuscular. On 22-JUN-2014, the patient was vaccinated with third dose of GARDASIL lot/batch # K009282, expiry date 06-MAR-2017, 0.5 ml, intramuscular. Concomitant medication were not reported. No adverse effects were reported. There was no Product Quality Concern (PQC) involved. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Borrelia test negative, Epistaxis, Fatigue, Headache, Hypersomnia
Clinical narrative: Excessive fatigue and nosebleeds, headaches, some nausea sleeping more than 13 hours straight through, several times per wk. Sometimes sleeping more than 20 hrs. straight through.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Laboratory test normal, Mononucleosis heterophile test negative, Nausea
Clinical narrative: Excessive fatigue and nosebleeds, headaches, some nausea sleeping more than 13 hours straight through, several times per wk. Sometimes sleeping more than 20 hrs. straight through.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Arthrogram, Blood test, Immediate post-injection reaction, Mobility decreased, Nerve conduction studies
Clinical narrative: Immediate pain severe in right arm - lasted 2 days since then sleepless night - can not sleep on right side. Shooting pain when lifting arm uncertain ways can not lift heavy objects. Limited movement and use since shot on 10-27-`5.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain, Sleep disorder, Weight bearing difficulty, X-ray
Clinical narrative: Immediate pain severe in right arm - lasted 2 days since then sleepless night - can not sleep on right side. Shooting pain when lifting arm uncertain ways can not lift heavy objects. Limited movement and use since shot on 10-27-`5.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cold sweat, Feeling cold, Hypopnoea, Pallor
Clinical narrative: On 3/23 - received shots and while at daycare that same afternoon, (5 PM) he got really pale, no color in hands or lips, clammy, ice cold. Shallow breathing 24 hours admit to hospital.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Intervertebral disc degeneration, Muscle injury, Nuclear magnetic resonance imaging, Rotator cuff syndrome
Clinical narrative: Within 24 hours I experienced left shoulder pain. (Rotator cuff). Several visits to primary care, x-rays, MRI, medication for pain, physical therapy and scheduled for treatment with surgeon orthopedic.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Within 24 hours I experienced left shoulder pain. (Rotator cuff). Several visits to primary care, x-rays, MRI, medication for pain, physical therapy and scheduled for treatment with surgeon orthopedic.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Paraesthesia
Clinical narrative: Left deltoid with 4" x 5" red, warm, swollen area, distal to injection site. Symptoms started 1 day post injection worsened overnight into day 2 post injection. Some tingling in fingers with certain positions. Recommended ice, evaluation, ibuprofen, and BENADRYL
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Painful right thigh, swelling, redness, and hot to touch site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness at injection site. Severe arm pain near injection site.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Back pain, Chills, Malaise, Musculoskeletal stiffness, Night sweats
Clinical narrative: Vaccine administered 2/24/16; 3/2/16 - stiff and sore low back, pain in back; 3/5/16 - fever 100.8, chills, night sweat, general feeling unwell w/body aches through 3/9/16; 3/8/16 - Rash developed on abdomen, back, spread to legs, chest, face.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Vaccine administered 2/24/16; 3/2/16 - stiff and sore low back, pain in back; 3/5/16 - fever 100.8, chills, night sweat, general feeling unwell w/body aches through 3/9/16; 3/8/16 - Rash developed on abdomen, back, spread to legs, chest, face.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warm, erythematous deltoid at the area.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Malaise, Pain
Clinical narrative: Patient noted lump on (L) deltoid area yesterday from where immunization (TDAP) shot was administered on 3/10/16. Area tender to touch, (+) erythema, no drainage, lump measured 3x3cm. 46 y/o female presents for reaction to DTAP that was given 6 days. Pt noted last night that she had a lump that was sore to the point that every time she lifts arm was painful in last 24 hours. Today massaged which help. Pt here today for eval. No fever, chills. Circular raised and tender to touch over site w/vascular appearance and pt had malaise. Pt also had pain w/ROM 6 days after injection.
Age: 1.18
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt given PEDIARIX instead of DTAP. Father of pt notified on 03/18/2016. Father of pt reports no adverse reactions. "He is doing fine." Father voiced understanding of calling 911 or coming into Urgent Care if there are any reactions to the vaccination.
Age: 1.02
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Apnoea, Body temperature increased, Crying, Generalised tonic-clonic seizure, Hypotonia
Clinical narrative: Eight hours after receiving MMR/Varicella/PREVNAR 13 vaccine patient went for a one hr sleep with crying/screaming and then a grandmal seizure- lasted 1-2 min. and went limp and apneic -called 911. Taken to ER and she was stable and Rx TYLENOL 101.8 degrees C.
Age: 1.02
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Screaming
Clinical narrative: Eight hours after receiving MMR/Varicella/PREVNAR 13 vaccine patient went for a one hr sleep with crying/screaming and then a grandmal seizure- lasted 1-2 min. and went limp and apneic -called 911. Taken to ER and she was stable and Rx TYLENOL 101.8 degrees C.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Chest X-ray normal, Dyspnoea, Feeling abnormal, Malaise, Sinus tachycardia
Clinical narrative: Patient had shot, left office and started to experience illness (like my body was tearing it apart from the inside) and called this office - she was advised to go to ER - no difficulty breathing. Hospice nurse arrived at her home and advised calling ambulance c/o SOB. Treated with Epi, SOLU-MEDROL and BENADRYL en route to ER.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: White blood cell count increased
Clinical narrative: Patient had shot, left office and started to experience illness (like my body was tearing it apart from the inside) and called this office - she was advised to go to ER - no difficulty breathing. Hospice nurse arrived at her home and advised calling ambulance c/o SOB. Treated with Epi, SOLU-MEDROL and BENADRYL en route to ER.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Pt complains of arm pain like a normal vaccine but lasting a lot longer than normal (one week vs 2-3 days).
Age: 48.0
Sex: F
Vaccine: HEPA, MEN, MMR, TDAP
Symptoms: Dizziness, Headache, Lower respiratory tract infection, Malaise
Clinical narrative: Severe dizziness, headache, but symptoms have not gone away. I feel horrible. Like I have a severe chest cold.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS AND SWELLING FROM 10 INCHES ABOVE AND BELOW SITE OF INJECTION -severe soreness. Site of injection looked fine no discharge or redness arounfd injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: "A bump/knot on my arm where I got the shot" customer said site is painful. I suggested ibuprofen/Benadryl/and a cool compress, if difficulty breathing/swallowing call 911.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Pain in extremity, Periarthritis, X-ray
Clinical narrative: Slight pain in arm that medication was administered in (left arm) that did not go away. By late December less use of left arm. Visited orthopedic Feb and was diagnosed with Adhesive Capsulitis, frozen shoulder. Have been in Physical Therapy for 4 weeks.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: Patient received vaccine, had no problems in store. Left to drive home, started to feel faint, pulled over on side of road and had fainting spell. Patient stated no other problems occurred. Followed up w/PCP w/in 24 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, 0.65 ml (lot# and expiration date were not reported), subcutaneously. Concomitant drug was not reported. On an unknown date after receiving the vaccination the patient came down with a case of shingles. Outcome and the causality were not reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Decreased appetite, Migraine, Mobility decreased, Nausea
Clinical narrative: FEVER 103, SEVERE JOINT PAIN IN SHOULDERS-SPINE-HIPS-KNEES-ANKLES CAUSING TEMPORARY IMMOBILITY, MIGRAINE, NAUSEA, TACHYCARDIA, LOSS OF APPETITE, SORE THROAT.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pyrexia, Tachycardia
Clinical narrative: FEVER 103, SEVERE JOINT PAIN IN SHOULDERS-SPINE-HIPS-KNEES-ANKLES CAUSING TEMPORARY IMMOBILITY, MIGRAINE, NAUSEA, TACHYCARDIA, LOSS OF APPETITE, SORE THROAT.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMRV, PNC13
Symptoms: Abnormal faeces, Aphasia, Appetite disorder, Asterixis, Autism spectrum disorder
Clinical narrative: Stopped communication (had been talking since 7 months) started hand flapping became disconnected with people regressed with potty training developed sandy or grainy bowel movements stopped all eye contact stopped all playing using imagination developed very picky appetite got very routine oriented started physical therapy and development therapy occupation therapy and speech therapy.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMRV, PNC13
Symptoms: Childhood disintegrative disorder, Decreased eye contact, Social avoidant behaviour, Stereotypy
Clinical narrative: Stopped communication (had been talking since 7 months) started hand flapping became disconnected with people regressed with potty training developed sandy or grainy bowel movements stopped all eye contact stopped all playing using imagination developed very picky appetite got very routine oriented started physical therapy and development therapy occupation therapy and speech therapy.
Age: 25.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Dizziness, Exposure during pregnancy, Nerve injury, Palpitations
Clinical narrative: I was 7 months pregnant when I received the flu shot. Within 10 minutes after getting the flu shot, I was extremely dizzy and my heart was racing. It took hours for it to subside. In the weeks that followed I got dizzy spells and developed chronic dizziness and damage to the nerve in my inner ear. I am still dizzy to this day.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Influenza, Pain in extremity, Pyrexia, Rash
Clinical narrative: My arm hurts and has a rash. I had a fever chills all the symptoms of the flu.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Injection site pain
Clinical narrative: Erythema, induration, pain at site of injection to ~ 30 cm x 15 cm at right deltoid PPSV23 3/25/16 PCV 13 given 2/10/16.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Abdominal pain upper, Back pain, Chest pain, Headache, Oropharyngeal pain
Clinical narrative: Sore throat, headache, chest and back pain, stomach pain.
Age: 25.0
Sex: F
Vaccine: HPVX
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Body aches, overall tiredness, chills.
Age: 22.0
Sex: M
Vaccine: BCG
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching approximately 1 1/2 in diameter at injection site. Pt. reports mild swelling 3/26/16 a.m. and increased swelling 3/27/16 a.m. Given ibuprofen and ice. to continued as needed until swelling resolves.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 24-MAR-2016 the patient was vaccinated with an expired dose of ZOSTAVAX (strength: 19400 PFU; dose and route were not reported, lot # K021624 with expiration 07-FEB-2016) (expired vaccine used). The patient had not reported any adverse effects, Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was unspecified. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX which might have underwent a temperature excursion (lot number, expiration date, temperature, time frame, dose and route were unknown). No adverse effects reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abasia, Rash, Wheelchair user
Clinical narrative: I was given the shingles shot along with AUGMENTIN for a skin issue along the bottom portion of my right leg. After this event happen, I broke out into a severe rash all over my body with the exception of the head. After going to a dermatologist I was given methotrexate. This resulted in a loss of weight (45 pounds) from 125 to 80 pounds. After this my legs had a tingling feeling and the nerves and/or nerve covering were damaged. I currently am confined to a wheelchair and cannot walk.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abasia, Nerve injury, Pruritus, Rash generalised, Rash vesicular
Clinical narrative: I was given the shingles shot along with AUGMENTIN for a skin issue along the bottom portion of my right leg. After this event happen, I broke out into a severe rash all over my body with the exception of the head. After going to a dermatologist I was given methotrexate. This resulted in a loss of weight (45 pounds) from 125 to 80 pounds. After this my legs had a tingling feeling and the nerves and/or nerve covering were damaged. I currently am confined to a wheelchair and cannot walk.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Wheelchair user
Clinical narrative: I was given the shingles shot along with AUGMENTIN for a skin issue along the bottom portion of my right leg. After this event happen, I broke out into a severe rash all over my body with the exception of the head. After going to a dermatologist I was given methotrexate. This resulted in a loss of weight (45 pounds) from 125 to 80 pounds. After this my legs had a tingling feeling and the nerves and/or nerve covering were damaged. I currently am confined to a wheelchair and cannot walk.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abasia, Laboratory test normal, Nerve injury, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: I was given the shingles shot along with AUGMENTIN for a skin issue along the bottom portion of my right leg. After this event happen, I broke out into a severe rash all over my body with the exception of the head. After going to a dermatologist I was given methotrexate. This resulted in a loss of weight (45 pounds) from 125 to 80 pounds. After this my legs had a tingling feeling and the nerves and/or nerve covering were damaged. I currently am confined to a wheelchair and cannot walk.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash generalised, Skin disorder, Weight decreased, Wheelchair user
Clinical narrative: I was given the shingles shot along with AUGMENTIN for a skin issue along the bottom portion of my right leg. After this event happen, I broke out into a severe rash all over my body with the exception of the head. After going to a dermatologist I was given methotrexate. This resulted in a loss of weight (45 pounds) from 125 to 80 pounds. After this my legs had a tingling feeling and the nerves and/or nerve covering were damaged. I currently am confined to a wheelchair and cannot walk.
Age: 12.0
Sex: M
Vaccine: RAB
Symptoms: Abnormal behaviour, Fatigue, Feeling abnormal, Pyrexia, Vision blurred
Clinical narrative: Initial unsolicited report received from a physician on 11-Aug-2015. A 12 years old male patient, had received a third dose of IMOVAX RABIES intramuscularly (batch number, expiry date, dose details and site of administration were not provided) on 04-Aug-2015. There was no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not provided. It was reported that 18 children were treated as a precaution due to exposure to a bat while sleeping. On 04-Aug-2015, few hours post-vaccination, the patient was not acting right and seemed very tired. After midnight, on 05-Aug-2015 he developed fever of 102 degree F with blurry vision and his arms and legs felt funny. His mother took him to the emergency room and they found no cause for the issue as he was no longer febrile after OTC treatment and felt better. It was reported that he was still tired and rested the whole next day. Laboratory investigations were unknown. On an unspecified date, the patient had recovered from the events. Follow-up information received from a physician on 18 September 2015. The patient had received third dose of Imovax rabies (batch number: 565011A) in left deltoid on 04 August 2015 at 14:00 hours. It was reported that the patient did not have a bat bite at camp but had multiple exposure to bats in cabin while sleeping for multiple days. The patient was vaccinated at private doctors office and vaccine purchased with private funds. The patient's illness at time of vaccination reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as asthma (2 years ago-no medications). Any other vaccinations within four weeks of vaccinations was reported as none. Concomitant medications were reported as none. The patient had received two previous doses of Imovax rabies. On 04 August 2015 at 22:00 hours, eight hours following the vaccination, the patient was not acting right. On 04 August 2015 at 23:30 hours, nine hours thirty minutes following the vaccination, the patient had blurry vision, arms and legs felt funny and had fever of 102 degree Fahrenheit. On 05 August 2015, one day following the vaccination, the patient seemed very tired. Laboratory investigations were not done. The patient was treated with Tylenol. On 06 August 2015, the patient had completely recovered from all the events. Documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Diarrhoea, Fatigue, Gastroenteritis, Injection site erythema, Injection site swelling
Clinical narrative: Initial unsolicited report received from a nurse on 05-Nov-2015. This case involves an 26-month-old male patient who was vaccinated with an intramuscular dose DAPTACEL (batch number: C4887AA, expiry date16-Jul-2016) in left thigh on 28-Oct-2015 and a dose of DTaP/Hib(manufacturer: unknown, batch number: 2031030, route and site of administration was not reported) on 22-Oct-2015. History of previous allergies was reported as none. No illness at the time of vaccination was reported. Patient's medical history includes maternal narcotic use and Neonatal Abstinence Syndrome. Concomitant medications were not reported. On 28-Oct-2015, within a couple of hours after vaccination with DAPTACEL, the patient experienced redness and swelling at injection site. On 29-Nov-2015, one day after vaccination the patient felt tired, irritable, and began vomiting. The patient continued to vomit 3 to 4 times a day. On 01-Nov-2015 patient developed diarrhea. It was reported that the patient was diagnosed with viral infection. Patient required an ER visit on 01-Nov-2015. No Laboratory investigations were reported. Corrective treatments were not reported. The outcome of the event vomiting was reported as resolved and the outcome of all other events were reported as not recovered. Documents held by sender: none. Follow up information received from physician on 14 March 2016. The patient's concurrent conditions includes viral illness. On 07 November 2015, nine days following the vaccination, the patient had experienced gastroenteritis. On 07 November 2015, the patient was recovered from events. The illness was not related to vaccine.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Irritability, Viral infection, Vomiting
Clinical narrative: Initial unsolicited report received from a nurse on 05-Nov-2015. This case involves an 26-month-old male patient who was vaccinated with an intramuscular dose DAPTACEL (batch number: C4887AA, expiry date16-Jul-2016) in left thigh on 28-Oct-2015 and a dose of DTaP/Hib(manufacturer: unknown, batch number: 2031030, route and site of administration was not reported) on 22-Oct-2015. History of previous allergies was reported as none. No illness at the time of vaccination was reported. Patient's medical history includes maternal narcotic use and Neonatal Abstinence Syndrome. Concomitant medications were not reported. On 28-Oct-2015, within a couple of hours after vaccination with DAPTACEL, the patient experienced redness and swelling at injection site. On 29-Nov-2015, one day after vaccination the patient felt tired, irritable, and began vomiting. The patient continued to vomit 3 to 4 times a day. On 01-Nov-2015 patient developed diarrhea. It was reported that the patient was diagnosed with viral infection. Patient required an ER visit on 01-Nov-2015. No Laboratory investigations were reported. Corrective treatments were not reported. The outcome of the event vomiting was reported as resolved and the outcome of all other events were reported as not recovered. Documents held by sender: none. Follow up information received from physician on 14 March 2016. The patient's concurrent conditions includes viral illness. On 07 November 2015, nine days following the vaccination, the patient had experienced gastroenteritis. On 07 November 2015, the patient was recovered from events. The illness was not related to vaccine.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Based on additional information received on 9 February 2016 and 12 February 2016, this case became medically confirm. Initial unsolicited report received from a non-healthcare professional on 17 December 2015. This case involves an adult female patient (age not reported) who was vaccinated with first dose of Adacel (batch number- U5292AA) intramuscularly on right arm on 04 December 2015. The patient's medical history of illness at time of vaccination was reported as unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as no known allergy. The patient's concomitant medications were not reported. On an unspecified date, few days following the vaccination, the patient had experienced cellulitis at the injection site from the point of injection down the arm. The patient required ER/doctor visit. Laboratory data and corrective treatment were not reported. It was reported that, the patient was not recovered from the event. List of documents held by sender: none. Follow up information received from physician on 9 February 2016 and additional information on 12 February 2016. This case involves 51-year-old patient. On 05 December 2015, one day following the vaccination, the patient had experienced cellulitis at the injection site from the point of injection down the arm. The patient was recovered from the event after receiving some treatment (details were not provided).
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HPV9, HEPA, HPV9
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 15 year old female patient with asthma exercise induced and no drug reactions or allergies. On 01-FEB-2016, the patient was vaccinated with a dose of GARDASIL 9, dose 1 (dose, anatomical place of vaccination, lot# and expiration date were not provided). Other suspect therapies included HAVRIX 2 dose (dose, anatomical place of vaccination, lot# and expiration date were not provided). Concomitant therapies included LORYNA. On the same date, the patient developed urticarial. Subsequently, on an unknown date, the patient sought for medical attention via telephone call and then on an unknown date, started treatment with BENADRYL indicated for the adverse event. At the time of the report, the outcome of the urticarial was reported as not recovered. The reporter did not provide a causality assessment and no product quality complaint was involved. Follow-up information was received from physician on 23-MAR-2016. The concurrent condition included penicillin allergy (PCN). On 01-FEB-2016 at 08:07 AM, the patient was vaccinated with a dose of GARDASIL 9, dose 1 (lot number L018351) intramuscularly on left arm (dose and expiration date not reported). The patient was not ill at the time of vaccination. On 02-FEB-2016 at 08:54 AM, the patient experienced red, swollen, itching areas on left wrist twice, left knee area, left upper thigh and right ankle. Hives lasted 3-4 days after treatment with BENADRYL, SOLU-MEDROL injection and MEDROL dose pack 4 mg (21 tablets) and the patient recovered on 05-FEB-2016. Upon internal review, the events were determined to be medically significant as they required medical/surgical intervention. Additional information has been requested. Patient, product, event and narrative updated.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, HPV9, HEPA, HPV9
Symptoms: Erythema, Joint swelling, Pruritus, Swelling, Urticaria
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 15 year old female patient with asthma exercise induced and no drug reactions or allergies. On 01-FEB-2016, the patient was vaccinated with a dose of GARDASIL 9, dose 1 (dose, anatomical place of vaccination, lot# and expiration date were not provided). Other suspect therapies included HAVRIX 2 dose (dose, anatomical place of vaccination, lot# and expiration date were not provided). Concomitant therapies included LORYNA. On the same date, the patient developed urticarial. Subsequently, on an unknown date, the patient sought for medical attention via telephone call and then on an unknown date, started treatment with BENADRYL indicated for the adverse event. At the time of the report, the outcome of the urticarial was reported as not recovered. The reporter did not provide a causality assessment and no product quality complaint was involved. Follow-up information was received from physician on 23-MAR-2016. The concurrent condition included penicillin allergy (PCN). On 01-FEB-2016 at 08:07 AM, the patient was vaccinated with a dose of GARDASIL 9, dose 1 (lot number L018351) intramuscularly on left arm (dose and expiration date not reported). The patient was not ill at the time of vaccination. On 02-FEB-2016 at 08:54 AM, the patient experienced red, swollen, itching areas on left wrist twice, left knee area, left upper thigh and right ankle. Hives lasted 3-4 days after treatment with BENADRYL, SOLU-MEDROL injection and MEDROL dose pack 4 mg (21 tablets) and the patient recovered on 05-FEB-2016. Upon internal review, the events were determined to be medically significant as they required medical/surgical intervention. Additional information has been requested. Patient, product, event and narrative updated.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Joint range of motion decreased, Myalgia
Clinical narrative: Left deltoid. Chronic muscle aching moderate weakness, reduced range of motion upper arm.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site movement impairment, Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: Left deltoid. Chronic muscle aching moderate weakness, reduced range of motion upper arm.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site induration, Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site tenderness in a 17-year-old female patient who received BEXSERO (batch number 149001, expiry date 30th September 2016). On 10th March 2016, the patient received the 1st dose of BEXSERO .5 ml. On 10th March 2016, less than a day after receiving BEXSERO, the patient experienced injection site tenderness and injection site induration. On an unknown date, the outcome of the injection site tenderness and injection site induration were not recovered/not resolved. It was unknown if the reporter considered the injection site tenderness and injection site induration to be related to BEXSERO. Additional details provided were as follows: The patient received the 1st dose of the BEXSERO vaccine in the left field. The patient has been experiencing side effects for the past 10 days prior reporting. The reporter wanted to know if she should administer the second dose.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Pain
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 75 year old female patient with no medical pertinent history, drug reactions or allergies. On 14-MAR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (route, dose, dose number and anatomical location of vaccination were not provided) lot # L018503, expiration date 16-MAR-2017. There were no concomitant therapies. On 15-MAR-2016, the patient experienced headache and generalized body aches, so she called to the physician office and started treatment with TYLENOL for the events but no lab diagnostic studies were performed. At the time of the report, the outcome of pain and headache was unknown. The reporter did not provide a causality assessment between PNEUMOVAX 23 and the events. The reporter asked for a lot check but no product quality complaint was involved. This is one of several case from the same reporter. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Headache, Pain
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 75 year old female patient with no medical pertinent history, drug reactions or allergies. On 14-MAR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (route, dose, dose number and anatomical location of vaccination were not provided) lot # L018503, expiration date 16-MAR-2017. There were no concomitant therapies. On 15-MAR-2016, the patient experienced headache and generalized body aches, so she called to the physician office and started treatment with TYLENOL for the events but no lab diagnostic studies were performed. At the time of the report, the outcome of pain and headache was unknown. The reporter did not provide a causality assessment between PNEUMOVAX 23 and the events. The reporter asked for a lot check but no product quality complaint was involved. This is one of several case from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Streptococcal infection
Clinical narrative: Chronic Strep.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: Received a shingles booster shot this Friday into the back of the left arm.  Experienced localized swelling and redness that progressed over the last 2 days.  Redness progressing down the elbow.