chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Bursa injury, Bursal fluid accumulation, Drug administered at inappropriate site, Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Extreme pain at time of needle piercing. Entry was too high up in the arm/shoulder area. Pierced Bursa. Pain in the entry area shortly afterwards.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Nasopharyngitis
Clinical narrative: The injection site was swollen/hard/red/tender to touch; patient treated with ice pack on Sunday.  Patient now has cold like symptoms (sinus/allergy - sore throat. Redness and tenderness have decreased today 4/6/15.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain
Clinical narrative: The injection site was swollen/hard/red/tender to touch; patient treated with ice pack on Sunday.  Patient now has cold like symptoms (sinus/allergy - sore throat. Redness and tenderness have decreased today 4/6/15.
Age: 0.21
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Coordination abnormal, Pyrexia, Seizure, Vomiting
Clinical narrative: He had convulsions and fever. He kept moving without coordination. He threw up. Warm bath to lower the fever and kept breast feeding.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: SHINGLES for the first time, then RECURRING SHINGLES.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient reported redness and soreness at injection site that has persisted but is going away.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Pt said developed redness on injection site, then started to spread.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Tenderness
Clinical narrative: Itching, Redness, Tenderness. I put ice on the arm. I also had to use anti-itch cream to stop the itching.
Age: 0.14
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Escherichia test positive, Pyrexia, Urinary tract infection
Clinical narrative: High fever with 4 hours of vaccines. TM 104 degrees. Hospitalized. Found to have UTI.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Cheilitis, Dyspnoea, Nausea, Rash
Clinical narrative: Patient received Zoster Vaccine 0.65ml in clinic and developed above described side effects. The patient received treatment in the ER and was subsequently discharged from ER to home. Patient symptoms eventually resolved. Rash and nausea, shortness of breath, sores on lips.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender who on 12-MAR-2015 was inadvertently vaccinated with an expired dose (expired product administered) of PNEUMOVAX23 (lot # K005957, expiration date 08-MAR-2015) (dose and route were not reported). No adverse effect reported. It was unkonwn if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored ROTATEQ Lot number was reported as: K010221, expiration date; 12-MAY-2016, oral. Concomitant medications were not reported. No adverse effects were reported and there was no product quality complaint involved. Follow up information has been received from the reporting nurse on 09-MAR-2015, who was available to provide the lot number and expiration date of the vaccine. The reporter also stated that the patient identification information was not available at the time of the call. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: FLU3, HEP, PNC13, RV5
Symptoms: Wrong drug administered
Clinical narrative: Accidentally administered Influenza vaccine (6-35 month) instead of PENTACEL.
Age: 52.0
Sex: M
Vaccine: IPV, MNQ, TDAP, TYP
Symptoms: Chills, Fatigue, Gait disturbance, Headache, Influenza A virus test negative
Clinical narrative: Severe body aches that affected pt's ability to sit and walk. Headache, nausea (no vomiting), fatigue, chills, temp 98.0. Symptoms started at 2300 on 04-02-15.
Age: 52.0
Sex: M
Vaccine: IPV, MNQ, TDAP, TYP
Symptoms: Influenza B virus test, Influenza virus test negative, Nausea, Pain
Clinical narrative: Severe body aches that affected pt's ability to sit and walk. Headache, nausea (no vomiting), fatigue, chills, temp 98.0. Symptoms started at 2300 on 04-02-15.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site rash, Laceration, Rash erythematous
Clinical narrative: Received ZOSTAVAX vaccine on 3-30-15. Developed site rash on 4-1-15, came to pharmacy on 4-3-15 with large red rash with blisters and a skin tear. Doctor monitoring for cellulitis due to being reddish-purple surrounding rash-told to cover rash.
Age: 25.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Pt had a vasovagal syncopal episode and was unresponsive for about 15 minutes, slowly started responding after extensive fluids (water) and eating glucose candy. Last BP 96/60.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site pustule, Rash pustular
Clinical narrative: Pox like lesions at site of injection and subsequently spread to trunk.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Moderate cellulitis of the left arm/started on oral BACTRIM, recovering.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 16-MAR-2015, the patient was vaccinated with a dose of expired PNEUMOVAX23 strength: 25/0.5 DG, 0.5 ml/once, intramuscular, lot # K004930, expiry date 16-MAR-2015 also reported as 06-MAR-2015. No adverse effects reported. There was no concomitant medication provided. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. On 03-APR-2015, the patient was vaccinated with ZOSTAVAX 19400 PFU, intramuscularly (dose and lot number not provided). No co-suspect or concomitant therapies were provided. The pharmacist reported that on 03-APR-2015 the patient was inadvertently administered ZOSTAVAX intramuscularly rather than subcutaneously. The pharmacist also reported that the patient was anxious because ZOSTAVAX was administered by the wrong route. At the time of the report, the outcome of the events was unknown. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Mother called and reported that "couple of hrs after child received shots, he developed several hives near injection site (right upper arm and on the front chest area). She gave him BENADRYL po with mild improvement. Mother will call to report any improvement or actions. Mother was advised by this nrsg. superv. to proceed to the nearest ED.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash
Clinical narrative: Pt had rash develop at injection site which spread down arm. Rash was diagnosed as shingles.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Headache, Nausea, Vomiting
Clinical narrative: Client reports temp of 103.5 degrees F, headache, chills, nausea, vomiting 12 hours after receiving TDP. He took TYLENOL and Ibuprofen, applied cold compresses to armpits. Temp came down. No temp after 24 hours. No complaint of redness, swelling, pain at injection site.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, hot patch at injection site.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site rash, Injection site reaction, Pallor
Clinical narrative: Integumentary exam: (L) leg anterior thigh blanchable, erythematous area with small papules in the middle 3.5 cm x 2 cm (R) anterior thigh rash 2.5 cm x 1.5 cm, blanches, erythematous 1 papule in center-per Dr.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Chest pain, Dizziness, Erythema, Nausea
Clinical narrative: 4-1-15 Called (husband) 2:35 pm-patient vomiting, dizziness, lightheaded, nausea-with some chest pain states like weight-did not call earlier-to see if she would feel better. Nausea, vomiting a little less-chest pain not as hard. Last meal-burrito from wagon at around 5:30 pm-everything started happening around 10 pm last night. Spoke with husband-checked Lt arm-slight redness-small amount swelling less than quarter size. Due to chest pain-to ER-has no regular medical doctor. Given name nurse and clinic and personal phone #. Call after ER visit. To let ER know about Tdap booster 3/31/15 and meal last pm.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling, Vomiting
Clinical narrative: 4-1-15 Called (husband) 2:35 pm-patient vomiting, dizziness, lightheaded, nausea-with some chest pain states like weight-did not call earlier-to see if she would feel better. Nausea, vomiting a little less-chest pain not as hard. Last meal-burrito from wagon at around 5:30 pm-everything started happening around 10 pm last night. Spoke with husband-checked Lt arm-slight redness-small amount swelling less than quarter size. Due to chest pain-to ER-has no regular medical doctor. Given name nurse and clinic and personal phone #. Call after ER visit. To let ER know about Tdap booster 3/31/15 and meal last pm.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: Erythema, warmth within few minutes of injection. 8cm x 7cm erythema. Took BENADRYL 50mg-observed. Erythema decreased 2.5cm x 5cm. No systemic effects. Continue BENADRYL x 24 hrs.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Red, warm rash at site of injection. Bigger than 1 inch. Itching with a little pain. Started 1 day after injection was given (3/26/15) BENADRYL and Hydrocortisone crm recommended pt did not buy it.
Age: 90.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt seen in office 3/27/15 for other reason and asked to have left injection site checked-slight redness at site and approx baseball sized area around site. By Sunday 3/29/15 entire arm (posterior) from shoulder to elbow red and warm to touch. Instructed to use BENADRYL 25mg Q 4 hours and ice to area. On 3/30/15 seen in office and given script for cephalexin 500 3x/d for 10 days.
Age: 15.0
Sex: F
Vaccine: TYP, YF
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Tachycardia, Throat tightness
Clinical narrative: Red eyes, sore throat, throat tightness, tachycardia lasting 10-15 min treated with BENADRYL, ALLEGRA with resolution.
Age: 71.0
Sex: M
Vaccine: MENB
Symptoms: Muscular weakness, Pain, Rash
Clinical narrative: Got meningococcal vaccine on 3/10/15. Rash (band across arm formed on day 2. Pain formed day 2, worsened to affect muscle strength with pain (no numbness or tingling). Pain noticeable Kw/use. Sore/weaker today. Sent doctor email today. No other tx.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Developed pruritic rash within 24 hours exam otherwise unremarkable.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Depression, Fatigue, Feeling cold, Feeling hot
Clinical narrative: Headache until 3/9/15. The first 3 days I was cold w/chills. Extreme tiredness; fell asleep during day and evening. I could not stay awake day and evening. From 3/6-10 then I went into deep depression from 10/11-3/16/15. One day I did 3 loads of wash. And later wonder how I did that.??? I slept Saturday night Sunday, Sunday night. Left cheek swelling with sharp sinus pain. In 1973 by accident left side fracture sinus and shatter and crack bone. At times my body heated up. Not a hot flash.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Sinus headache, Somnolence, Swelling face
Clinical narrative: Headache until 3/9/15. The first 3 days I was cold w/chills. Extreme tiredness; fell asleep during day and evening. I could not stay awake day and evening. From 3/6-10 then I went into deep depression from 10/11-3/16/15. One day I did 3 loads of wash. And later wonder how I did that.??? I slept Saturday night Sunday, Sunday night. Left cheek swelling with sharp sinus pain. In 1973 by accident left side fracture sinus and shatter and crack bone. At times my body heated up. Not a hot flash.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On an unknown dates these patients were vaccinated with doses of improperly stored PEDVAXHIB (dose, frequency, route and lot# were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unkonwn age and gender. On an unknown dates these patients were vaccinated with doses of improperly stored GARDASIL (dose, frequency, route and lot# were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Paraesthesia, Swelling face
Clinical narrative: Patient received GARDASIL number 3 on 3/21/15 mother states patient has swelling and tingling of the face after immunization.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered nurse refers to her currently 69 year old boyfriend with diabetes, hypertension, blind in one unspecified eye, deaf in one unspecified ear, with no drug reactions or allergies and pertinent medical history of traumatic brain injury who on unknown date in 2012 was vaccinated with ZOSTAVAX (dose, lot #, expiration date and route were not reported). Concomitant therapies included insulin, lisinopril (manufacturer unknown), baby aspirin and unspecified vitamins. Since he received ZOSTAVAX had developed shingles "about 6 times per year". So he was seen by unspecified physician in August 2013 and was treated with acyclovir (manufacturer unknown) for unspecified amount of time. The nurse stated that her boyfriend's last episode of shingles was in February 2015 which resolved on unknown date in 2015. No laboratory diagnostic tests were performed. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker (also reported as office manager) refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On 17-MAR-2015 the patient was inadvertently vaccinated with ZOSTAVAX lot # J014812, dose 0.65 ml, subcutaneously that expired on 20-FEB-2015. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information is not expected as the reporter refused additional contact.
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Cough, Pyrexia, Rash, Rash generalised
Clinical narrative: Client states has never had varicella vaccine or chicken pox disease. Is attending nursing school and varicella vaccine required for clinical experiences. Received varicella vaccine on 3/6/15. Started slight fever and rash on face an generalized on body 3/28/2005 (21-22 days after vaccine). Presented at HD on 3/30/15 for cough. Fever has resolved . Rash is mild and drying. Out at school and at home until rash is crusted and dry.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm began to hurt and he had swelling and redness from around the injection site (2/20/15), he noticed the swelling, redness, and discomfort to have spread. He denied any wheezing or dyspnea. No itching or hives. Per doctor exam and note 2/20/15 (L) arm with irregular, warm, erythematous, patch over upper arm only. Mild tenderness. No e/o urticaria or excoriation. Skin rash and pain. Hydrocortisone BID, ibuprofen TID.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Rash, Swelling
Clinical narrative: Arm began to hurt and he had swelling and redness from around the injection site (2/20/15), he noticed the swelling, redness, and discomfort to have spread. He denied any wheezing or dyspnea. No itching or hives. Per doctor exam and note 2/20/15 (L) arm with irregular, warm, erythematous, patch over upper arm only. Mild tenderness. No e/o urticaria or excoriation. Skin rash and pain. Hydrocortisone BID, ibuprofen TID.
Age: 38.0
Sex: F
Vaccine: DTP
Symptoms: Agitation
Clinical narrative: Agitation.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema
Clinical narrative: Redness on arm.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer referring to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (route, lot#, dose and frequency were unknown). On unknown dates the patient developed 4 cases of shingles. The outcome of the adverse event was unknown. The relationship of the adverse event and ZOSTAVAX was not reported. Additional information is not expected as there was no specific contact information.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients. Sometime between 28-FEB-2015 and 11-MAR-2015, these patients were vaccinated with ZOSTAVAX (lot#, expiration date, dose and route not provided) which were post supported temperature excursion(s) (incorrect storage of drug). No adverse effects reported. The patients' present status was unknown. This is one of several reports received from te same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse via a company representative referring to patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On 31-MAR-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot#, expiration date, dose and route were unknown) instead of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a healthcare worker referring to a 16 year old female patient who was pregnant. The patient had no pertinent medical history and drug reactions/allergies. On 20-JAN-2015 the patient was vaccinated with her first dose of GARDASIL (lot # K006124, expiry date: 02-FEB-2017) 0.5 ml, intramuscularly. No concomitant medication was reported. The patient found out "last Wednesday (18-MAR-2015)" that she became pregnant (Vaccine exposure during pregnancy). The mother of the patient reported that she thought her daughter was "at least three months" pregnant since an unspecified date. The Last Menstrual Period (LMP) and expected date of delivery (EDD) was not known. The patient sought medical attention. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Incorrect product storage, Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a79 year old male patient. on 19-MAR-2015, the patient was vaccinated with ZOSTAVAX (dose, strength and frequency were not reported) intramuscular and PNEUMOVAX23 (dose, strength, frequency and route were not reported) both in the physician's office (medication error). The pharmacist reported that the ZOSTAVAX was being stored in the refrigerator (also reported as "incorrect storage of the ZOSTAVAX") and was administered via the intramuscular route (incorrect route of administration). The pharmacist was very concerned as to the efficacy of the vaccine considering the incorrect storage of the ZOSTAVAX as well as the incorrect route of administration. No adverse effects were reported. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: RAB
Symptoms: Learning disability, Nervous system disorder
Clinical narrative: Learning Disabilites, brain issues..
Age: 1.01
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Haemorrhage, Injection site reaction, Rash, Rash pruritic
Clinical narrative: 12 month old shots. Caused painful bumps on legs, these bumps have not resolved and the patient will scratch them until they bleed per mom.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Arthralgia, Blood test, Fatigue, Headache, Migraine
Clinical narrative: 1 day after MENACTRA vaccine given pt developed severe arthralgias, spinal pain, and myalgias. She was then paralyzed arms and legs.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Muscular weakness, Nausea, Painful respiration, Paraesthesia, Retching
Clinical narrative: 1 day after MENACTRA vaccine given pt developed severe arthralgias, spinal pain, and myalgias. She was then paralyzed arms and legs.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Spinal pain, Urine analysis normal
Clinical narrative: 1 day after MENACTRA vaccine given pt developed severe arthralgias, spinal pain, and myalgias. She was then paralyzed arms and legs.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Arthralgia, Blood creatine phosphokinase normal, Blood folate normal, Borrelia test negative, CSF cell count normal
Clinical narrative: 1 day after MENACTRA vaccine given pt developed severe arthralgias, spinal pain, and myalgias. She was then paralyzed arms and legs.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Computerised tomogram normal, Diplegia, Epstein-Barr virus test negative, Herpes simplex serology negative, Myalgia
Clinical narrative: 1 day after MENACTRA vaccine given pt developed severe arthralgias, spinal pain, and myalgias. She was then paralyzed arms and legs.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Spinal pain, Vitamin B12 normal
Clinical narrative: 1 day after MENACTRA vaccine given pt developed severe arthralgias, spinal pain, and myalgias. She was then paralyzed arms and legs.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, HPV4
Symptoms: Arthralgia, Dizziness, Muscular weakness
Clinical narrative: 1 day after MENACTRA vaccine given pt developed severe arthralgias, spinal pain, and myalgias. She was then paralyzed arms and legs.
Age: 80.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Pain, rednessm swellin to right deltoid noted on the day after immunization. Given steroid cream for symptoms.
Age: 80.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, rednessm swellin to right deltoid noted on the day after immunization. Given steroid cream for symptoms.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Local swelling, Pain, Pruritus generalised
Clinical narrative: Localized swelling, redness that wrapped around the arm starting at injection site.  Body aches that started the next day.  Generalized itching that lasted 2 days.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Foaming at mouth, Immediate post-injection reaction, Incomplete course of vaccination, Seizure like phenomena, Syncope
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 19 year old male patient. Patient's pertinent medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL, injection, 0.5 ml, intramuscularly. No concomitant medications were reported. On an unknown date the patient experienced an episode of syncope, accompanied by seizure-like activity (medically significant) and foaming at mouth which lasted briefly for only 10 seconds immediately after receiving the first dose of GARDASIL. At the time of the events, patient was in office and hence sought medical attention. No laboratory studies were performed. Patient lifted legs up to increase blood flow to head, as treatment for the events. It was decided that the patient would not continue the series of vaccination due to the events and hence he did not receive any additional doses of GARDASIL. Patient recovered from all the events. Causality assessment was not provided. Upon internal assessment seizure was considered to be medically significant. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Mother reports a pruritic rash that began on his face within hours of receiving the immunizations, the rash then spread to the remainder of his body. No other issues reported. Arrived 4/7/15 for treatment of the rash.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Blood test normal, Disorientation, Dizziness, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: She was at school.  In the class that she was in, the teacher turned off the lights and put an audio only video on for the class to listen to.  A couple minutes into it she had sitting at her desk.  Her hands fell forward and hit the child in front of her.  He turned around thinking she was trying to get her attention.  Her eyes were very wide open and staring to the right.  She did not respond to him.  The teacher can to her and she started swaying back and forth and still not responding to anyone.  They helped her to the floor, with no response.   About after 4 minutes she started responding.  She was very sleepy.  She did not know where she was or what had just happened for another 2-3 minutes following that.  After she figured out where she was, her mother can and picked her up from school and took her to ER.  EKG, EEG and blood work all normal
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Somnolence, Staring, Unresponsive to stimuli
Clinical narrative: She was at school.  In the class that she was in, the teacher turned off the lights and put an audio only video on for the class to listen to.  A couple minutes into it she had sitting at her desk.  Her hands fell forward and hit the child in front of her.  He turned around thinking she was trying to get her attention.  Her eyes were very wide open and staring to the right.  She did not respond to him.  The teacher can to her and she started swaying back and forth and still not responding to anyone.  They helped her to the floor, with no response.   About after 4 minutes she started responding.  She was very sleepy.  She did not know where she was or what had just happened for another 2-3 minutes following that.  After she figured out where she was, her mother can and picked her up from school and took her to ER.  EKG, EEG and blood work all normal
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Bursal fluid accumulation, Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Paraesthesia
Clinical narrative: Numbness, tingling, weakness of the left arm where vaccine was given lasting now for 3 weeks.
Age: 0.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site movement impairment, Injection site pain, Irritability
Clinical narrative: Parents complain that they noticed pain/decrease left lower extremity use since vaccinations. Increased fussiness 2 days after vaccines. Full ROM noted by MD, not standing on both legs, appears to be due to pain. Left leg pain, neurologically intact. No treatment, follow up in 1 week.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed vocational nurse (L.V.N.) referring to an unspecified number of patients of unknown age. On 01-APR-2015 the patients were vaccinated with an unspecified number of improperly stored dose of (Oka/Merck) VARIVAX, 0.5 ml/one time dose, subcutaneously for routine vaccination. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a patient of unknown age. On 06-JAN-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # J011342, expiration date 29-MAY-2015, dose unknown). No adverse effect was reported. This is one of several report received from same source. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Computerised tomogram normal, Disability, Immediate post-injection reaction, Impaired work ability, Lumbar puncture normal
Clinical narrative: Information received on 26MAR2015 from a consumer. A 39 year old male experienced migraine-like headaches following the administration of BIOTHRAX. Around May or June of 1995, patient believes he received seven doses of BIOTHRAX. He stated that all doses were administered two weeks apart. He reported he experienced an immediate adverse event which consisted of a knot on his right arm. In 1996, he began to experience constant migraine-like headaches which persist still. He has tried a number of therapies (not specified) none of which helped. he has had medical work-ups that included two spinal taps (June 2014) and numerous computed tomography scans (CT) and magnetic resonance imaging (MRI) (dates not provided) all of which were reported as negative. Patient noted that spinal taps made headaches worse. He stated that he has not been hospitalized for the headaches; however, he also stated that the headaches could be nearly incapacitating at times and that he did receive a 30 percent disability from work because of the headaches. Patient also reported currently experiencing occasional muscle aches, which he attributed to getting older. Treatments included number of unspecified therapies. Medical history included hypertension and exposure to tuberculosis (TB). Concomitant medications included isoniazid for exposure to TB. Relevant laboratory/diagnostics: Numerous CT scans and MRIs dates not provided. Two spinal taps, the last in June 2014. All reported as negative. Medical records have been requested. Additional information is expected.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Migraine, Myalgia, Nodule, Nuclear magnetic resonance imaging normal
Clinical narrative: Information received on 26MAR2015 from a consumer. A 39 year old male experienced migraine-like headaches following the administration of BIOTHRAX. Around May or June of 1995, patient believes he received seven doses of BIOTHRAX. He stated that all doses were administered two weeks apart. He reported he experienced an immediate adverse event which consisted of a knot on his right arm. In 1996, he began to experience constant migraine-like headaches which persist still. He has tried a number of therapies (not specified) none of which helped. he has had medical work-ups that included two spinal taps (June 2014) and numerous computed tomography scans (CT) and magnetic resonance imaging (MRI) (dates not provided) all of which were reported as negative. Patient noted that spinal taps made headaches worse. He stated that he has not been hospitalized for the headaches; however, he also stated that the headaches could be nearly incapacitating at times and that he did receive a 30 percent disability from work because of the headaches. Patient also reported currently experiencing occasional muscle aches, which he attributed to getting older. Treatments included number of unspecified therapies. Medical history included hypertension and exposure to tuberculosis (TB). Concomitant medications included isoniazid for exposure to TB. Relevant laboratory/diagnostics: Numerous CT scans and MRIs dates not provided. Two spinal taps, the last in June 2014. All reported as negative. Medical records have been requested. Additional information is expected.
Sex: U
Vaccine: DTAP
Symptoms: Feeding disorder, Jaundice neonatal, Maternal exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a physician and described the occurrence of jaundice in a unk neonate exposed to INFANRIX (batch number F43Z7, expiry date 31st October 2016) in utero. The mother received the product. On 6th November 2014, the 24-year-old mother received INFANRIX .5 ml. The mother's last menstrual period was on 20th May 2014 and estimated date of delivery was 24th February 2015. The neonate was exposed to INFANRIX at week 24 of gestation and during the second trimester of pregnancy. At 37 weeks and 4 days, the neonate was born via unknown delivery. The neonate was diagnosed with jaundice (serious criteria hospitalization), feeding disorder and maternal exposure during pregnancy, second trimester. On an unknown date, the outcome of the jaundice, feeding disorder and maternal exposure during pregnancy, second trimester were unknown. It was unknown if the reporter considered the jaundice, feeding disorder and maternal exposure during pregnancy, second trimester to be related to INFANRIX. See case US2014GSK023695 for details regarding the mother case.
Age: 1.25
Sex: F
Vaccine: DTAP, MMRV, VARCEL
Symptoms: Blood test normal, Chest X-ray normal, Febrile convulsion, Rash generalised, Respiratory syncytial virus test negative
Clinical narrative: SHE HAD A FEBRILE SEIZURE DUE TO FEVER.  PLUS A RASH ALL OVER HER BODY. SHE HAD A COUPLE FEVERS BEFORE AND NEVER EXPERIENCED THIS UNTIL AFTER THIS VACCINATION.
Age: 1.25
Sex: F
Vaccine: DTAP, MMRV, VARCEL
Symptoms: Streptococcus test negative, Urine analysis normal, Viral infection
Clinical narrative: SHE HAD A FEBRILE SEIZURE DUE TO FEVER.  PLUS A RASH ALL OVER HER BODY. SHE HAD A COUPLE FEVERS BEFORE AND NEVER EXPERIENCED THIS UNTIL AFTER THIS VACCINATION.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: RED/SWOLLEN RT DELTOID. NO EVIDENCE OF INFECTION NOTED BY DR, BENADRYL AND IBUPROFEN PRESCRIBED AND TO RETURN IF NOT BETTER OR WORSE.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Abnormal behaviour, Dizziness, Hypoaesthesia, Hypotension, Vomiting
Clinical narrative: Pt reported dizziness, low Blood Pressure, Vomiting, Behavioral changes, numbness.  NP ordered bloodwork, Medrol Dose Pack, Loratidine, topical hydrocortizone.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: 2/23: Tetanus vaccine given L upper arm. 2/24: very painful, hot to touch, red, swollen L arm injection site. Area of redness about the size of a quarter. 2/26: redness and swelling now encompassing entire L upper arm. Still painful and hot. Saw PCP. Diagnosed with cellulitis.  Antibiotics prescribed and began taking that day. 3/3: Intense itching of L upper arm, swelling slightly decreased, but now area of redness has taken on a hexagonal pattern made up of many small itchy red dots encompassing L bicep. Consulted Dr again and she prescribed topical steroid cream. 3/13: redness finally fading away.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Injection site swelling, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: 2/23: Tetanus vaccine given L upper arm. 2/24: very painful, hot to touch, red, swollen L arm injection site. Area of redness about the size of a quarter. 2/26: redness and swelling now encompassing entire L upper arm. Still painful and hot. Saw PCP. Diagnosed with cellulitis.  Antibiotics prescribed and began taking that day. 3/3: Intense itching of L upper arm, swelling slightly decreased, but now area of redness has taken on a hexagonal pattern made up of many small itchy red dots encompassing L bicep. Consulted Dr again and she prescribed topical steroid cream. 3/13: redness finally fading away.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess, Cellulitis
Clinical narrative: Cellulitis with abscess. Seen by Dr (Occ. Med) and treated successfully with Bactrim DS.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Arthralgia, Arthropathy, Asphyxia, Back disorder, Fatigue
Clinical narrative: Fatigue, nausea, vomiting, respiratory problems, asphyxiating attacks, mental health problems, chronic headaches, back problems, muscle spasms, neuritis, joint disorders, chronic pain on entire left side of the body, blackouts, joint pain, muscle pain, scoliosis, vitamin deficiencies.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Headache, Hypovitaminosis, Loss of consciousness, Mental disorder, Muscle spasms
Clinical narrative: Fatigue, nausea, vomiting, respiratory problems, asphyxiating attacks, mental health problems, chronic headaches, back problems, muscle spasms, neuritis, joint disorders, chronic pain on entire left side of the body, blackouts, joint pain, muscle pain, scoliosis, vitamin deficiencies.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Myalgia, Nausea, Neuritis, Pain, Respiratory disorder
Clinical narrative: Fatigue, nausea, vomiting, respiratory problems, asphyxiating attacks, mental health problems, chronic headaches, back problems, muscle spasms, neuritis, joint disorders, chronic pain on entire left side of the body, blackouts, joint pain, muscle pain, scoliosis, vitamin deficiencies.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Respiratory failure, Scoliosis, Vomiting
Clinical narrative: Fatigue, nausea, vomiting, respiratory problems, asphyxiating attacks, mental health problems, chronic headaches, back problems, muscle spasms, neuritis, joint disorders, chronic pain on entire left side of the body, blackouts, joint pain, muscle pain, scoliosis, vitamin deficiencies.
Age: 21.0
Sex: F
Vaccine: FLU3, IPV, JEV1, TYP
Symptoms: Dysgeusia, Hirsutism, Immediate post-injection reaction, Laboratory test abnormal, Peripheral swelling
Clinical narrative: Noticed a weird rash on her right arm /unsure if it had been there longer. Did notice after receiving the Typhoid vaccine in the right arm it felt swollen and persisted until 03/26 also noticed a metallic taste in back of her throat right after the shot but unsure which vaccine it was that only lasted briefly.
Age: 21.0
Sex: F
Vaccine: FLU3, IPV, JEV1, TYP
Symptoms: Rash, Vitamin D deficiency
Clinical narrative: Noticed a weird rash on her right arm /unsure if it had been there longer. Did notice after receiving the Typhoid vaccine in the right arm it felt swollen and persisted until 03/26 also noticed a metallic taste in back of her throat right after the shot but unsure which vaccine it was that only lasted briefly.
Age: 62.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events reported. Just documenting the vaccine was given on 04/07/2015 and the expiration date was 03/2015.  7 days after expiration date.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Malaise, Nausea, Vomiting
Clinical narrative: Friday 9/26/2014: 3 pm High dose influenza injection, 10 pm symptoms, 11:59 pm not digesting, nausea. 9/27/2014: throwing up and diarrhea every 20 minutes for 3 hours.  Stopped after 4 hours.  Weak for 24 hours.  5 1/2 pound weight loss. Weak throughout Saturday and Sunday. Patient reported being "deathly ill". Pt stated that he had received high dose influenza vaccine 11 years prior and was extremely sick after that vaccination as well.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Weight decreased
Clinical narrative: Friday 9/26/2014: 3 pm High dose influenza injection, 10 pm symptoms, 11:59 pm not digesting, nausea. 9/27/2014: throwing up and diarrhea every 20 minutes for 3 hours.  Stopped after 4 hours.  Weak for 24 hours.  5 1/2 pound weight loss. Weak throughout Saturday and Sunday. Patient reported being "deathly ill". Pt stated that he had received high dose influenza vaccine 11 years prior and was extremely sick after that vaccination as well.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: The patient called on this day and reported a blistering rash on her torso, neck, arms and legs. Described as red and itchy.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Acute lung injury, Bronchoscopy, Computerised tomogram, Cough, Diffuse alveolar damage
Clinical narrative: No fever. Yes cough. Diagnosed on 12/20/2012 with Pneumonia in one lung.  Followed with pneumonia in other lung one month later. 12/1/2014- diagnosis "DAD" from single acute injury to lung; 4/1/2015 patient on 24/7 oxygen and referred for evaluation to lung transplant team. No recovery as yet.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: No fever. Yes cough. Diagnosed on 12/20/2012 with Pneumonia in one lung.  Followed with pneumonia in other lung one month later. 12/1/2014- diagnosis "DAD" from single acute injury to lung; 4/1/2015 patient on 24/7 oxygen and referred for evaluation to lung transplant team. No recovery as yet.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Intussusception, Pain, Pallor, Syncope
Clinical narrative: Intussusception: multiple hours' worth of sudden and severe waves of extreme pain (causing syncope), diarrhea, pallor.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Ultrasound abdomen
Clinical narrative: Intussusception: multiple hours' worth of sudden and severe waves of extreme pain (causing syncope), diarrhea, pallor.
Age: 1.59
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Electroencephalogram normal, Seizure
Clinical narrative: 3 episodes of seizure the day after - getting vaccines - went to ER - NL EEG, KEPPRA and VALIUM given in hospital. No seizures since.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a nurse, for (Oka/Merck) VARIVAX, a Pregnancy Registry product, concerning a female patient of unknown age. The patient's medical history and relevant past drug history was unknown. On 16-MAR-2015, the patient was vaccinated with (Oka/Merck) VARIVAX injection (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. On an unknown date in 2015, the patient was pregnant after receiving (Oka/Merck) VARIVAX. The patient's pregnancy had not been confirmed at the HCP office. The last menstrual period (LMP) and expected date of delivery (EDD) was not known. The pregnancy outcome was unknown. No adverse effects reported. Additional information is not expected as there is no reporter's contact information.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist via company representative referring to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX, (dose and lot number not provided) and months after, on an unknown date, the patient developed a mild case of shingles. The patient spoke to pharmacist for seeking medical attention. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician concerning unspecified number of unspecified patients. On unspecified dates since 30-JAN-2015, the unspecified number of unspecified patients were administered an unspecified number of improperly stored doses of VAQTA (dose, strength and lot# were not reported, intramuscular). No adverse effects were reported. This case was one of the three cases received from the same reporter. (Other two cases were 1504USA002464 and 1503USA010732). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a patient of unknown age. On 09-MAR-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # J011342, expiration date 29-MAY-2015, dose unknown) orally. No adverse effect was reported. This is one of several report received from same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 27-MAR-2015 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K000326, expiration date 27-FEB-2015; dose and route were not reported). No adverse effects were reported. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 16-JUL-2013  the patient was inadvertently administered a 4th dose of GARDASIL (lot#, expiration date, dose and route not reported). No adverse effects were reported. It was unspecified if the patient sought any medical attention. 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 certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. On 19-MAR-2015, the patients were vaccinated with improperly stored dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. 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 certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. On 19-MAR-2015, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.