chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Crying, Dyskinesia, Erythema, Photosensitivity reaction, Trichotillomania
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter of unknown age. The patient was vaccinated with VAQTA (route and strength unknown), vaccination site unknown on an unknown date. Concomitant medications included: H5N1 (manufacturer unknown), Pneumococcal vaccine (manufacturer unknown) and PEDVAXHIB. The patient's mother stated that, while on VAQTA on an unknown date, her daughter began to cry, was ripping her hair out, and her skin became red. She was rocking her body and forth. Her skin was still very sensitive to the sun. All adverse event responses are for VAQTA. The patient sought medical attention via doctor visit. No treatment was given. The outcomes were reported as not recovered/not resolved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 67 year old female consumer with scoliosis and no drug reactions/allergies who on 04-JUL-2012, was vaccinated SQ with a dose of ZOSTAVAX (lot# 90736). Concomitant medication included "propanol", "mitroval", "synthestaton (cholesterol)" and inhalers. The consumer stated that she received ZOSTAVAX vaccine and 5 days later "on 09-JUL-2012", she got a case of shingles. The consumer did not receive any treatment. She did not seek medical attention. At the time of the report, the consumer outcome was unknown. The relatedness for case of shingles is unknown for ZOSTAVAX. No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Choking, Underdose
Clinical narrative: This spontaneous report as received from a Medical assistant refers to a patient of unknown age. The patients was inadvertently administered an incomplete dose of ROTATEQ (dose and lot # not reported) on 29-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. An unspecified nurse was administering the dose of ROTATEQ when the patient started choking after receiving "about one or third dose". The patient did not regurgitate but the nurse did not administer the remainder of the ROTATEQ dose. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a medical assistant concerning patient who on unknown dates, was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). It was reported that on unknown dates, the patient might have developed a rash but medical assistant could not be sure of this. Patient sought unspecified medical attention. Patient's outcome was unknown at the time of report. Follow up information has been received from the physician, only contains the other patient's information. This is one of two reports from the same source. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Information has been received from a medical assistant concerning 2 patients who on unknown dates, were vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). It was reported that on unknown dates, 2 patients might have developed a rash but medical assistant could not be sure of this. Patients sought unspecified medical attention. Patients' outcomes were unknown at the time of report. This is one of two reports from the same source. Follow up information has been received from the physician refers to a 77 years old female patient with no known drug allergy, Gastrooesophageal reflux disease (GERD) and Hypertension (HTN). The patient was vaccinated with first dose PNEUMOVAX 23 (lot number 672781/1706AA; expire date 03-OCT-2012) intramuscularly at left deltoid at 10:01 am on 16-MAY-2012. No other co-suspects were reported. Concomitant medications included famotidine (manufacturer unknown) and hydrochlorothiazide (manufacturer unknown). On 16-MAY-2012 at 3:00 pm the patient experienced site of injection felt itchy night of injection then swelled the next day in 17-MAY-2012 with mild pain and no fever. In May 2012, exam showed erythema surrounding injection site about 6cm diameters with mild waterish or swelling. The patient was treated with AVELOX. The outcome of the event had been resolved by 21-MAY-2012. This is one of two reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a health professional concerning an unknown number of patients, who on unspecified dates were vaccinated with a dose of PNEUMOVAX 23 that had been exposed to temperatures between 22 32 degrees F, for about 5 months (doses, routes and lot numbers not reported). No adverse effect was reported. Attempts are being made to obtain additional identifying information to distinguish individual patients mentioned in this report. Additional information will be provided if available. Follow up information has been received from the health professional who indicated that patient identifiers could not be provided because no one experienced any adverse event. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose number, lot number, date of event, recovery status, healthcare provider name and contact information. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Scar
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 59 years old female patient with no drug reactions or allergies. The patient had never had a medical history of chickenpox before. The patient was vaccinated subcutaneously with, a 0.65 ml dose of ZOSTAVAX on 15-FEB-2012 (lot # not reported). No other co-suspects were reported and there was no concomitant medications. On an unknown date the patient developed pock marks that itched, on different parts of her body after receiving the vaccine. The pock marks come and the go away, so they did improve and she recover, but then she got then again. The patient contacted her physician, no treatment was given for the event and no lab diagnostics tests were performed. The outcome of pock marks that itch, on different parts of her body was unknown. The relatedness for pock marks that itch, on different parts of her body was not reported for ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 61 years old female patient with drug reactions/allergic to penicillin. The patient was vaccinated subcutaneously with a dose of 0.65 ml ZOSTAVAX (lot # 672868/0239AE) on 19-JUN-2012. On an unknown date the patient developed a case of shingles. The patient was not recovered. The patient sought medical attention by contacting physician. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood culture, Rash generalised, Rash papular
Clinical narrative: This spontaneous report as received from a physician referred to a 63 years old female patient. The patient was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (lot 1944AA; exp. 12-DEC-2013). No other co-suspects were reported. Concomitant medications included BENICAR, minocycline, metoprolol, cyclobenzaprine hydrochloride, paroxetine and doxycycline. The patient already had a rash under her breast at the time she received the vaccine. A week later, on 12-JUN-2012, the patient called the office because she had spread all over her body during the week after she got the vaccination. The doctor saw her and said that she had a papular rash all over her body. The patient sought unspecified medical attention. The patient was given prednisone, SARNA and KEFLEX as a treatment for the AE. On an unspecified date, blood cultures were performed (results not provided). The outcome of papular rash all over her body was unknown. The relatedness for papular rash all over her body was unknown for VARIVAX (Merck). Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV
Symptoms: Diarrhoea, Dry eye, Eating disorder, Hair texture abnormal, Motor dysfunction
Clinical narrative: This spontaneous report as received from the patient's mother refers to her son, a 6 months old male patient. The patient was vaccinated with a dose of VAQTA (Lot # not reported). Concomitant medications included PEDIARIX and PEDVAX HIB. In February 2004, while on the vaccine the patient experienced vomiting, diarrhea and had a slight body shake. His hair also became dry. He still had dry hair at the time of report. His eyes were dry and red at the time of report. He was a picky eater. His motor skills had also been affected. The patient sought for medical attention by visiting the doctor. The outcome was reported as not recovered. Additional information is not expected.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV
Symptoms: Ocular hyperaemia, Tremor, Vomiting
Clinical narrative: This spontaneous report as received from the patient's mother refers to her son, a 6 months old male patient. The patient was vaccinated with a dose of VAQTA (Lot # not reported). Concomitant medications included PEDIARIX and PEDVAX HIB. In February 2004, while on the vaccine the patient experienced vomiting, diarrhea and had a slight body shake. His hair also became dry. He still had dry hair at the time of report. His eyes were dry and red at the time of report. He was a picky eater. His motor skills had also been affected. The patient sought for medical attention by visiting the doctor. The outcome was reported as not recovered. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a healthcare worker concerning 2 patients who on an unknown date, were vaccinated with a dose of ZOSTAVAX (Merck) (doses, routes and lot numbers not reported). Two patients developed shingles "about 3-4 months" after receiving ZOSTAVAX (Merck). Acyclovir was given as a treatment for shingles. At the time of the report two patients recovered from shingles, date unspecified. The patients sought medical attention, were evaluated by their physicians (physicians unspecified). Follow-up information has been received via telephone call from a pharmacy clerk stated that she had spoken with the pharmacist and neither she nor the pharmacist could remember the patients. The pharmacy clerk stated that the patients developed shingles several months after receiving ZOSTAVAX (Merck). The pharmacy clerk was not able to provide any additional information at that time. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 75 year old female patient with high blood pressure and with no drug reaction or allergies. The patient was vaccinated subcutaneously with a single dose of ZOSTAVAX on 06-NOV-2008 (Lot# and dose not reported). No other co-suspects were reported. Concomitant medications were reported as blood pressure pill, name unknown. On 06-JUL-2012 the patient experienced shingles. The shingles started on her right upper hip and had gone around her mid section and back. The patient had contacted her physician and had a diagnosed case of the shingles. She had been treated with valacyclovir hydrochloride 1mg. No lab diagnostics studies performed. At the time of this report the patient was recovering. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old male patient with hydrocephalus and neurogenic bladder who in 2010 was vaccinated with a dose of MMR II, (dose route not reported), (Lot#664660/1016Y). Subsequently on an unknown date, the patient experienced anaphylactic reaction from MMR II. The patient was given was BENADRYL and "epinephrine shot" and sent to ER. It was unknown if the patient was hospitalized from the emergency room. The patient was recovered (recovery date was not reported). Anaphylactic reaction was considered to be immediately life-threatening. A lot check has been initiated. Follow up information has been received from registered nurse, concerning the 17 year old (previously reported as 19 year old) male patient, who on 28-JUN-2010 was vaccinated with a dose of MMR II (dose, route and Lot # not reported). It was reported that the patient did not receive any other vaccinations at that time. On 28-JUN-2010, within 5 minutes of receiving MMR II the patient experienced anaphylactic reaction. The patient was treated with BENADRYL and "epinephrine shot". The office called 911 and the patient was taken to the emergency room. The patient was hospitalised overnight from 28-JUN-2010 to 29-JUN-2010. The registered nurse stated that the patient recovered on 29-JUN-2010 and the patient was doing well at the time of the call. On 21-JUN-2012 the patient was due to received GARDASIL. The physician's office was told that the HPV vaccine was manufactured in the same facility as the MMR II, the physician decided against administering the HPV vaccine. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient with allergy to erythromycin. The patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (Lot#1716AA EXP 02-FEB-2013) on 25-JUN-2012. Concomitant medications included: LIPITOR (strength and manufacturer were unknown). Within 24 hours after onset of therapy the patient experienced rash at the injection site, reporter said "the rash looked like' bull's eye' rash". The patient south medical attention through going to pharmacy and physician's office, and got BENADRYL (strength and manufacturer were unknown) and triamcinolone cream (strength and manufacturer were unknown) to treat the AE. The outcome of "bull's eye" rash was reported as recovered/resolved. Additional information is not reported.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient with allergy to erythromycin. The patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (Lot#1716AA EXP 02-FEB-2013) on 25-JUN-2012. Concomitant medications included: LIPITOR (strength and manufacturer were unknown). Within 24 hours after onset of therapy the patient experienced rash at the injection site, reporter said "the rash looked like' bull's eye' rash". The patient south medical attention through going to pharmacy and physician's office, and got BENADRYL (strength and manufacturer were unknown) and triamcinolone cream (strength and manufacturer were unknown) to treat the AE. The outcome of "bull's eye" rash was reported as recovered/resolved. Additional information is not reported.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Inflammation, Muscle spasms, Pain in extremity, Paraesthesia
Clinical narrative: Pt reported completing a VAERS report, #E62329, as a follow up to a concern over a Tdap vaccine she believed to be administered to deeply or caused "nerved damage" per pat report. Pt described pain from her left shoulder to left fingertips.  Pt spoke with a nurse, unsure of name, approximately just over a week after the shot was given after the shot was given and per pt report the nurse explained a very sore arm may be a normal reaction to the immunization.  The pt reported that after she spoke with the nurse, she saw a doctor at the Urgicare center who  gave the pt an oral  steroid (during week 2) to help with pain or inflammation.  Since that time, she complains of developing numbness in hand and tingling in hand that restarted after steroid wore off (developed during week 3).   Pt spoke with another family physician after week 3 who stated is was nerve damage which the patient stated was from the immunization. Pt sought care during week 4 who gave Rx for a neuropathy med (Neurontin) and which pt states has not helped, but reports only being on for a couple of days.  The doctor also gave another round of steroid (prednisone taper down) and he felt it would be a little more effective at stopping pain per patient report.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Drug administration error, Hypoaesthesia, Musculoskeletal pain, Nerve injury, Pain in extremity
Clinical narrative: Pt reported completing a VAERS report, #E62329, as a follow up to a concern over a Tdap vaccine she believed to be administered to deeply or caused "nerved damage" per pat report. Pt described pain from her left shoulder to left fingertips.  Pt spoke with a nurse, unsure of name, approximately just over a week after the shot was given after the shot was given and per pt report the nurse explained a very sore arm may be a normal reaction to the immunization.  The pt reported that after she spoke with the nurse, she saw a doctor at the Urgicare center who  gave the pt an oral  steroid (during week 2) to help with pain or inflammation.  Since that time, she complains of developing numbness in hand and tingling in hand that restarted after steroid wore off (developed during week 3).   Pt spoke with another family physician after week 3 who stated is was nerve damage which the patient stated was from the immunization. Pt sought care during week 4 who gave Rx for a neuropathy med (Neurontin) and which pt states has not helped, but reports only being on for a couple of days.  The doctor also gave another round of steroid (prednisone taper down) and he felt it would be a little more effective at stopping pain per patient report.
Age: 42.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia
Clinical narrative: Pt reported completing a VAERS report, #E62329, as a follow up to a concern over a Tdap vaccine she believed to be administered to deeply or caused "nerved damage" per pat report. Pt described pain from her left shoulder to left fingertips.  Pt spoke with a nurse, unsure of name, approximately just over a week after the shot was given after the shot was given and per pt report the nurse explained a very sore arm may be a normal reaction to the immunization.  The pt reported that after she spoke with the nurse, she saw a doctor at the Urgicare center who  gave the pt an oral  steroid (during week 2) to help with pain or inflammation.  Since that time, she complains of developing numbness in hand and tingling in hand that restarted after steroid wore off (developed during week 3).   Pt spoke with another family physician after week 3 who stated is was nerve damage which the patient stated was from the immunization. Pt sought care during week 4 who gave Rx for a neuropathy med (Neurontin) and which pt states has not helped, but reports only being on for a couple of days.  The doctor also gave another round of steroid (prednisone taper down) and he felt it would be a little more effective at stopping pain per patient report.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Flushing, Syncope, Vomiting
Clinical narrative: This case was reported by the grandmother of a consumer and described the occurrence of could not breathe properly in a 4-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), MMR vaccine. A physician or other health care professional was not verified this report. Concurrent medical conditions included asthma. Concurrent medications included FLOVENT. On 5 July 2012 at 14:00 the subject received booster dose of INFANRIX in an unknown arm as well as an unspecified dose of MMR vaccine. On 5 July 2012, 5 minutes after vaccination with INFANRIX and MMR vaccines, the subject experienced could not breathe properly, cough, itchy feet, collapse unspecified, injection site burning, increased heart rate, jerking, tremor, skin red, coldness in body (cold body temperature but no fever) vomiting and staring after the episode. The events were considered to be medically serious by GlaxoSmithKline. The subject was taken back to the clinic that administered the injections and then he was sent to his pediatrician's office for observation. The subject was treated with BENADRYL and all of the events resolved within about 3 hours after receiving the vaccinations.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Cough, Dyskinesia, Dyspnoea, Erythema, Feeling cold
Clinical narrative: This case was reported by the grandmother of a consumer and described the occurrence of could not breathe properly in a 4-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), MMR vaccine. A physician or other health care professional was not verified this report. Concurrent medical conditions included asthma. Concurrent medications included FLOVENT. On 5 July 2012 at 14:00 the subject received booster dose of INFANRIX in an unknown arm as well as an unspecified dose of MMR vaccine. On 5 July 2012, 5 minutes after vaccination with INFANRIX and MMR vaccines, the subject experienced could not breathe properly, cough, itchy feet, collapse unspecified, injection site burning, increased heart rate, jerking, tremor, skin red, coldness in body (cold body temperature but no fever) vomiting and staring after the episode. The events were considered to be medically serious by GlaxoSmithKline. The subject was taken back to the clinic that administered the injections and then he was sent to his pediatrician's office for observation. The subject was treated with BENADRYL and all of the events resolved within about 3 hours after receiving the vaccinations.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Heart rate increased, Injection site pain, Pruritus, Staring, Syncope
Clinical narrative: This case was reported by the grandmother of a consumer and described the occurrence of could not breathe properly in a 4-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), MMR vaccine. A physician or other health care professional was not verified this report. Concurrent medical conditions included asthma. Concurrent medications included FLOVENT. On 5 July 2012 at 14:00 the subject received booster dose of INFANRIX in an unknown arm as well as an unspecified dose of MMR vaccine. On 5 July 2012, 5 minutes after vaccination with INFANRIX and MMR vaccines, the subject experienced could not breathe properly, cough, itchy feet, collapse unspecified, injection site burning, increased heart rate, jerking, tremor, skin red, coldness in body (cold body temperature but no fever) vomiting and staring after the episode. The events were considered to be medically serious by GlaxoSmithKline. The subject was taken back to the clinic that administered the injections and then he was sent to his pediatrician's office for observation. The subject was treated with BENADRYL and all of the events resolved within about 3 hours after receiving the vaccinations.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Tremor, Vomiting
Clinical narrative: This case was reported by the grandmother of a consumer and described the occurrence of could not breathe properly in a 4-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), MMR vaccine. A physician or other health care professional was not verified this report. Concurrent medical conditions included asthma. Concurrent medications included FLOVENT. On 5 July 2012 at 14:00 the subject received booster dose of INFANRIX in an unknown arm as well as an unspecified dose of MMR vaccine. On 5 July 2012, 5 minutes after vaccination with INFANRIX and MMR vaccines, the subject experienced could not breathe properly, cough, itchy feet, collapse unspecified, injection site burning, increased heart rate, jerking, tremor, skin red, coldness in body (cold body temperature but no fever) vomiting and staring after the episode. The events were considered to be medically serious by GlaxoSmithKline. The subject was taken back to the clinic that administered the injections and then he was sent to his pediatrician's office for observation. The subject was treated with BENADRYL and all of the events resolved within about 3 hours after receiving the vaccinations.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Cough, Dyskinesia, Erythema, Feeling jittery, Hyperhidrosis
Clinical narrative: This case was reported by the grandmother of a consumer and described the occurrence of could not breathe properly in a 4-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), MMR vaccine. A physician or other health care professional was not verified this report. Concurrent medical conditions included asthma. Concurrent medications included FLOVENT. On 5 July 2012 at 14:00 the subject received booster dose of INFANRIX in an unknown arm as well as an unspecified dose of MMR vaccine. On 5 July 2012, 5 minutes after vaccination with INFANRIX and MMR vaccines, the subject experienced could not breathe properly, cough, itchy feet, collapse unspecified, injection site burning, increased heart rate, jerking, tremor, skin red, coldness in body (cold body temperature but no fever) vomiting and staring after the episode. The events were considered to be medically serious by GlaxoSmithKline. The subject was taken back to the clinic that administered the injections and then he was sent to his pediatrician's office for observation. The subject was treated with BENADRYL and all of the events resolved within about 3 hours after receiving the vaccinations.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR, DTAP, MMR
Symptoms: Pruritus, Staring, Syncope, Vomiting
Clinical narrative: This case was reported by the grandmother of a consumer and described the occurrence of could not breathe properly in a 4-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), MMR vaccine. A physician or other health care professional was not verified this report. Concurrent medical conditions included asthma. Concurrent medications included FLOVENT. On 5 July 2012 at 14:00 the subject received booster dose of INFANRIX in an unknown arm as well as an unspecified dose of MMR vaccine. On 5 July 2012, 5 minutes after vaccination with INFANRIX and MMR vaccines, the subject experienced could not breathe properly, cough, itchy feet, collapse unspecified, injection site burning, increased heart rate, jerking, tremor, skin red, coldness in body (cold body temperature but no fever) vomiting and staring after the episode. The events were considered to be medically serious by GlaxoSmithKline. The subject was taken back to the clinic that administered the injections and then he was sent to his pediatrician's office for observation. The subject was treated with BENADRYL and all of the events resolved within about 3 hours after receiving the vaccinations.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pain
Clinical narrative: Pt presented with symptoms of pain, one-sided redness, blister and excruciating pain. Pt admitted to the ER, diagnosed with shingles.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, tender to touch around the area of DTaP/IPV and MMR injections imm. after. These symptoms increased over next 4 days, and slowly reduced with BENADRYL. Full recovery by 7/10/12.
Age: 19.0
Sex: M
Vaccine: HEP, HEPA, IPV, TD, VARCEL
Symptoms: Congestive cardiomyopathy, Death, Excessive exercise, Unresponsive to stimuli
Clinical narrative: No previous problems known. Pt was found unresponsive in rec room of home with treadmill running.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Computerised tomogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Patient has been having abdominal pain x 3 months. Mom thinks it might be the HPV vaccine.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Urticaria
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 59 years old female patient. The patient was vaccinated with a dose lot # (669863/0365AA), exp. date (09-JUN-2012) ZOSTAVAX (dose and route not reported) on 18-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 18-MAY-2012, the patient experienced a reaction after ZOSTAVAX was administered. The patient broke out in hives all over her body that were very painful. The patient was treated at the hospital for 2 days. At the time of the report, the patient's outcome was unknown. The relatedness to the events was unknown for ZOSTAVAX. No further information is available.
Sex: M
Vaccine: HEP
Symptoms: Breath holding, Crying, Cyanosis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of turned blue in a 1-day-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the 1 day old subject received a dose of ENGERIX B while already in the hospital. Soon after vaccination, the subject experienced excessive crying, breath holding and he turned blue. This case was assessed as medically serious by GSK. The healthcare provider gave the subject oxygen and suction. The subject was discharged from the hospital as it was planned which was the day after vaccination. It was reported that the baby was doing fine at the time of reporting; however, the outcome of the events was not specified.
Age: 72.0
Sex: M
Vaccine: HEPA, TD, TYP
Symptoms: Acute hepatic failure, Hepatic failure, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of acute hepatic failure in a 72-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine (manufacturer unspecified) and tetanus and diphtheria toxoids adsorbed (manufacturer unspecified) both given on 27 January 2012. On 27 January 2012 at 14:15 the subject received 1st dose of HAVRIX at 1 ml in the left arm as a travel vaccination. Three months after vaccination with HAVRIX, in April 2012, the subject experienced acute hepatic failure. Additional information received indicated that the subject had experienced liver failure following vaccination with HAVRIX: however, an onset date for the event was not provided. The event occurred within months of receiving the 1st dose of HAVRIX. This report was also associated with a product complaint as the reporter questioned if there was a problem with this lot (AHAVB493BA exp. 26 August 2013) of HAVRIX. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Age: 26.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Abnormal behaviour, Anger, Fatigue, Memory impairment, Neuropathy peripheral
Clinical narrative: This case was reported by a consumer (patient) and described the occurrence neuropathy in a 26-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to sulfa drugs. Concurrent vaccination included typhoid vaccine (non-gsk);non-GSK manufacturer;unknown;unknown given on 26 September 2008. On 26 September 2008 the subject received 1st dose of TWINRIX (unknown route, route arm) and on unspecified dates the subject received 2nd dose and 3rd dose of TWINRIX (details unknown) and experienced poor quality vaccine administered with the 1st dose. The subject believed that his symptoms might be caused by his vaccine not being refrigerated properly because an internet search turned up a recall for the reported lot number by an agency in his state. On 26 September 2008, about 1 month after vaccination with TWINRIX 1st dose, at an unspecified time after vaccination with TWINRIX 2nd dose and 3rd dose, the subject experienced paresthesia, neuropathy "that felt like his nerves were on fire", memory problem, "irrational" anger/rage, "relapsing fever where he would feel feverish" and exhausted. He explained the fever would go away and recur. While he was hospitalized for these symptoms, but "they did not know the cause". Everyone in his family and at work noticed that "something was wrong because he acted very differently from before the vaccination" (acted as a different person). The subject was seeing a neurologist for these symptoms. The subject reported that the first and second vaccination doses were received at the same office and the third dose was received at a different office, but did not know the exact dates. It could not be determined if the events got worse from subsequent TWINRIX doses or if the problem, was just progressing, thus all doses were considered suspect. The subject was hospitalised. At the time of reporting the paresthesia and "relapsing fever where he would fell feverish" and exhausted were unresolved and the neuropathy "that felt like his nerves were on fire, memory problem and "irrational" anger/rage were worse. The outcome for acted as a different person was unknown. The subject reported an event for his father. See case A0984842A for details.
Age: 26.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Paraesthesia, Poor quality drug administered, Pyrexia, Thinking abnormal
Clinical narrative: This case was reported by a consumer (patient) and described the occurrence neuropathy in a 26-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to sulfa drugs. Concurrent vaccination included typhoid vaccine (non-gsk);non-GSK manufacturer;unknown;unknown given on 26 September 2008. On 26 September 2008 the subject received 1st dose of TWINRIX (unknown route, route arm) and on unspecified dates the subject received 2nd dose and 3rd dose of TWINRIX (details unknown) and experienced poor quality vaccine administered with the 1st dose. The subject believed that his symptoms might be caused by his vaccine not being refrigerated properly because an internet search turned up a recall for the reported lot number by an agency in his state. On 26 September 2008, about 1 month after vaccination with TWINRIX 1st dose, at an unspecified time after vaccination with TWINRIX 2nd dose and 3rd dose, the subject experienced paresthesia, neuropathy "that felt like his nerves were on fire", memory problem, "irrational" anger/rage, "relapsing fever where he would feel feverish" and exhausted. He explained the fever would go away and recur. While he was hospitalized for these symptoms, but "they did not know the cause". Everyone in his family and at work noticed that "something was wrong because he acted very differently from before the vaccination" (acted as a different person). The subject was seeing a neurologist for these symptoms. The subject reported that the first and second vaccination doses were received at the same office and the third dose was received at a different office, but did not know the exact dates. It could not be determined if the events got worse from subsequent TWINRIX doses or if the problem, was just progressing, thus all doses were considered suspect. The subject was hospitalised. At the time of reporting the paresthesia and "relapsing fever where he would fell feverish" and exhausted were unresolved and the neuropathy "that felt like his nerves were on fire, memory problem and "irrational" anger/rage were worse. The outcome for acted as a different person was unknown. The subject reported an event for his father. See case A0984842A for details.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope, Visual acuity reduced
Clinical narrative: After receiving vaccine patient fainted. Patient also complained of not being able to see after vaccine.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Face injury, Syncope
Clinical narrative: After receiving vaccine, patient walked down hallway stopping at check-out desk, while standing at desk area patient fainted hitting nose on door handle.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Urticaria
Clinical narrative: On day two after vaccine given, a 2 inch wheal developed and remained until day 6, red and itching at site.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Began itching "1 day after shot" - continued to 4 days has raised dots on chest with the rash. Treated with BENADRYL 50mg every  4 hours as needed for this. Prednisone treatment offered patient refused.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Denervation atrophy, Electromyogram abnormal, Motor dysfunction, Musculoskeletal pain, Nuclear magnetic resonance imaging spinal cord abnormal
Clinical narrative: Pain in right scapular area and into right posterior arm. Associated with paresthesia.  Pain lasted 4 months and was followed by loss of motor function to right triceps and pectoralis muscles.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia, Spinal osteoarthritis
Clinical narrative: Pain in right scapular area and into right posterior arm. Associated with paresthesia.  Pain lasted 4 months and was followed by loss of motor function to right triceps and pectoralis muscles.
Age: 47.0
Sex: F
Vaccine: DTP
Symptoms: Injection site reaction, Pruritus, Rash erythematous
Clinical narrative: Stated had an itch and looked and found a rash. Rash red clusted at injection site to 5 inches around site.
Age: 5.0
Sex: M
Vaccine: DTAP, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) upper arm 2" x 5" area of erythema, area is warm & swollen. No induration, no tenderness, no d/c from injection site.
Age: 69.0
Sex: F
Vaccine: RAB
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: This patient has had 3 doses (7/10, 7/13, 7/17/12) of rabies post exposure vaccine. Within a few hours of receiving each vaccination this patient complained of "severe neck pain with stiffness". She takes her migraine medicine to relieve it with good results.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Syncope episode (fainting after post Vaccination).
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Convulsion
Clinical narrative: Pt had short <2 minute seizure.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Death, Endotracheal intubation, Resuscitation, Unresponsive to stimuli
Clinical narrative: Found unresponsive by parents just after midnight 6/30/12, transported to local hospital with external CPR by EMS.  ER able to intubate and establish HR, then transferred to another hospital.  Died at 2148 on 6/30/12.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Angiotensin converting enzyme, Antinuclear antibody, Blood folate, Blood thyroid stimulating hormone, Borrelia test
Clinical narrative: Dizziness; headache; tingling around the lips; tingling in all four extremities (upper and lower); left arm and left hand numbness, and fatigue for nine months with tongue twitching for three months.  Continues to have on and off numbness in left arm and left hand.  No treatment prescribed.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Electromyogram, Fatigue, Glucose tolerance test, Headache
Clinical narrative: Dizziness; headache; tingling around the lips; tingling in all four extremities (upper and lower); left arm and left hand numbness, and fatigue for nine months with tongue twitching for three months.  Continues to have on and off numbness in left arm and left hand.  No treatment prescribed.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Immunology test, Muscle twitching, Nerve conduction studies, Nuclear magnetic resonance imaging brain
Clinical narrative: Dizziness; headache; tingling around the lips; tingling in all four extremities (upper and lower); left arm and left hand numbness, and fatigue for nine months with tongue twitching for three months.  Continues to have on and off numbness in left arm and left hand.  No treatment prescribed.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Paraesthesia oral, Red blood cell sedimentation rate, Treponema test, Urine analysis
Clinical narrative: Dizziness; headache; tingling around the lips; tingling in all four extremities (upper and lower); left arm and left hand numbness, and fatigue for nine months with tongue twitching for three months.  Continues to have on and off numbness in left arm and left hand.  No treatment prescribed.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Vitamin B12
Clinical narrative: Dizziness; headache; tingling around the lips; tingling in all four extremities (upper and lower); left arm and left hand numbness, and fatigue for nine months with tongue twitching for three months.  Continues to have on and off numbness in left arm and left hand.  No treatment prescribed.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Angiotensin converting enzyme, Antinuclear antibody, Blood folate, Blood thyroid stimulating hormone, Borrelia test
Clinical narrative: Dizziness; headache; tingling around the lips; tingling in all four extremities (upper and lower); left arm and left hand numbness and fatigue for nine months with tongue twitching for three months.  Continues to have on and off numbness in left arm and hand.  No treatment prescribed.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Electromyogram, Fatigue, Glucose tolerance test, Headache
Clinical narrative: Dizziness; headache; tingling around the lips; tingling in all four extremities (upper and lower); left arm and left hand numbness and fatigue for nine months with tongue twitching for three months.  Continues to have on and off numbness in left arm and hand.  No treatment prescribed.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Hypoaesthesia, Immunology test, Muscle twitching, Nerve conduction studies, Nuclear magnetic resonance imaging brain
Clinical narrative: Dizziness; headache; tingling around the lips; tingling in all four extremities (upper and lower); left arm and left hand numbness and fatigue for nine months with tongue twitching for three months.  Continues to have on and off numbness in left arm and hand.  No treatment prescribed.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia, Paraesthesia oral, Red blood cell sedimentation rate, Treponema test, Urine analysis
Clinical narrative: Dizziness; headache; tingling around the lips; tingling in all four extremities (upper and lower); left arm and left hand numbness and fatigue for nine months with tongue twitching for three months.  Continues to have on and off numbness in left arm and hand.  No treatment prescribed.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Vitamin B12
Clinical narrative: Dizziness; headache; tingling around the lips; tingling in all four extremities (upper and lower); left arm and left hand numbness and fatigue for nine months with tongue twitching for three months.  Continues to have on and off numbness in left arm and hand.  No treatment prescribed.
Age: 1.32
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Convulsion, Electroencephalogram normal, Hypotonia, Pyrexia, Screaming
Clinical narrative: Patient was febrile to 102, unresponsive, atonic and screaming for 4-5 hours. 20 minutes after she stopped screaming, had a generalized seizure lasting 45 seconds which resolved spontaneously.
Age: 1.32
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient was febrile to 102, unresponsive, atonic and screaming for 4-5 hours. 20 minutes after she stopped screaming, had a generalized seizure lasting 45 seconds which resolved spontaneously.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Pt was seen in the clinic for a rash that started 10 days after MMR shot.  The doctor that saw him gave him a course of steroids.  The rash lasted about 11-12 days.
Age: 0.34
Sex: F
Vaccine: DTAP, OPV, PPV
Symptoms: Abnormal behaviour, Grunting
Clinical narrative: Approx 2-3 days after receiving standard 4 month vaccinations patient stopped babbling/baby talk completely and started grunting.  The grunting got progressively worse occurring in bursts of 15-30 seconds every 1-2 minutes she was awake.  Patient had previously been very interactive and talkative.  The reaction got progressively worse for 1-1.5wks then subsided and her talking was back.
Age: 25.0
Sex: F
Vaccine: IPV, JEV1, TYP
Symptoms: Abdominal pain, Abdominal tenderness, Back pain, Headache, Laboratory test
Clinical narrative: Feeling nauseated/sick to stomach even when waking up. Also had a really bad headache and a rash on stomach. Severe pain with tenderness on her abdomen to the right of her navel along with c/o backpain.
Age: 25.0
Sex: F
Vaccine: IPV, JEV1, TYP
Symptoms: Nausea, Rash
Clinical narrative: Feeling nauseated/sick to stomach even when waking up. Also had a really bad headache and a rash on stomach. Severe pain with tenderness on her abdomen to the right of her navel along with c/o backpain.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Fatigue, Headache, Nausea, Vomiting
Clinical narrative: I played in a softball game beginning at 7:30 PM. I felt tired and nauseous at the beginning of the game, and 15 minutes later I vomited. I felt very weak, drowsy, tired, and nauseous throughout the rest of the evening. I was sure to drink plenty of fluids including a Gatorade and lots of water. Tiredness, mild headache, and periodic nausea continued over the next 60 hours.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Dizziness, Headache, Malaise, Myalgia
Clinical narrative: Headache, extreme dizziness, nauseous, stomach pains, muscle aches.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea
Clinical narrative: Headache, extreme dizziness, nauseous, stomach pains, muscle aches.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Dizziness, Headache, Myalgia, Restlessness
Clinical narrative: Headache, extreme dizziness, nauseous, stomach pains, muscle aches.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Localized swelling, deep red center about 2" across at injection site surrounded by a less swollen, less red area about 4" in diameter.  Extreme heat, itching, and sensitivity at injection area.  Continuous pain.  Low fever and low energy.  After four days contacted pharmacist who recommended OTC allergy pills and ibuprofen.  Took for three weeks.  Low fever went away in several days.  Stopped when the other symptoms had subsided.  One month after inoculation there is discoloration of the skin the same size as the 4" original discoloration.  No other symptoms.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Local swelling, Pyrexia, Skin discolouration
Clinical narrative: Localized swelling, deep red center about 2" across at injection site surrounded by a less swollen, less red area about 4" in diameter.  Extreme heat, itching, and sensitivity at injection area.  Continuous pain.  Low fever and low energy.  After four days contacted pharmacist who recommended OTC allergy pills and ibuprofen.  Took for three weeks.  Low fever went away in several days.  Stopped when the other symptoms had subsided.  One month after inoculation there is discoloration of the skin the same size as the 4" original discoloration.  No other symptoms.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth in left thigh at and around injection site.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug hypersensitivity, Erythema, Skin warm, Tenderness
Clinical narrative: 3 days after, Pt. arm was red and tender - 2 in. in diameter and warm to touch. Pt. went to clinic, and received BACTRIM DS for 10 days to cover a possible skin infection. Pt. Allergic to PCN.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Fatigue, Oedema peripheral, Pain
Clinical narrative: Fever, shortness of breath, tired, achy right arm red & swollen, wheezing.