chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Blood test, Exposure during pregnancy, Nausea
Clinical narrative: This spontaneous prospective pregnancy report was received from a consumer's husband refers to his 32 year old wife. On 18-DEC-2013 the patient was vaccinated with MMR II (therapy route reported as injections, dose and frequency unspecified) and was 4 weeks pregnant. Estimated Last Menstrual Period date was 05-NOV-2013. Estimated date of delivery would be 12-AUG-2014. The patient was 7 weeks pregnant at the time of report. The reporter also stated that the patient was nauseated after receiving MMR II. On an unknown date, the patient underwent unspecified blood work test. The patient sought medical attention by visiting doctor. Outcome of the event and causality were not reported. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash erythematous
Clinical narrative: This spontaneous report as received from a 50 years old male (as reported) patient who was also the nurse via a company representative refers to himself. The patient had various past unspecified vaccine reactions. On 30-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# unspecified) (dose, frequency and route unspecified) at left arm for prevention of shingles. On 30-DEC-2013, the patient developed a raised, red, rash going down her left arm with a red spot at the injections site. The patient stated that the red spot was still presented at the insertion site, although the raised red rash had now ceased. Benadryl and Benadryl Spray were given as the treatment. The patient did not seek medical attention. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Dysphonia, Pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old female patient without drug allergies. On 02-JAN-2014 the patient was vaccinated with 0.5ml PNEUMOVAX23 (lot# H013399, expiration date 07-MAR-2014) injections, subcutaneous in the right arm. There was no concomitant therapy. On 03-JAN-2014 or 01-JAN-2014, approximately one to two days post vaccination with PNEUMOVAX23, patient developed itching, hives and hoarseness. The patient informed their unspecified physician of the adverse reactions by calling and the physician suggested that the patient use Benadryl and inform the pharmacist. The pharmacist reported that the patient was "doing better"; however, it was unspecified if the patient was completely recovered. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 50 year old female patient. On 27-DEC-2013 the patient was vaccinated subcutaneously with a dose of 0.65 ml ZOSTAVAX (lot # J008432, expired date: 11-OCT-2014) in the left arm. 4-5 days after vaccinations of ZOSTAVAX, approximately on 31-DEC-2013 the patient broke out with shingles. The patient had pain on the right side and underneath the right breast area and then a rash developed around the right breast and right side. Unspecified antiviral and unspecified topical compounded pain cream was given for the event. There was no lab diagnostics studied performed. At the time of reporting, the outcome of the event was unknown. The patient sought medical attention by visiting to unspecified physician and pharmacist. This is one of the several reports from the same reporter.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: Patient received FLUZONE. No paleness in skin. Felt nauseated and started to "vomit" (vomiting = spitting) and went back to the pharmacy - she spit several times into the trash. Encouraged her to lay down. Patient had cool cloth and fan on. Was turned to side when started spitting. Normal pulse, temp, breathing (approximately 20 min duration). Followed 911 instructions. Diag: fainted. Was taken to ER - labs pending 1-14-14 - patient discharged night of 1-13-14.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient received second dose of RECOMBIVAX HB "at least 12 months ago" and attempting to receive the third dose of RECOMBIVAX HB (dose, frequency, indication, route not reported) on 07-JAN-2014 (today). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to unspecified number of patients. On an unspecified dated the patients were vaccinated with ZOSTAVAX (dose, route and lot# not reported). It was reported that the patients experienced red at the injections site. The event went away in a few days. It was unknown if the patients sought medical attention. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to unspecified number of patients. On an unspecified dates the patients were vaccinated with ZOSTAVAX (dose, route and lot# not reported). It was reported that a few days later the patients experienced pain at the injection site. At the time of reporting, the outcome of the event was unknown. It was unknown if the patients sought medical attention. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness face and mouth, difficulty breathing, bad headache.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt received PPV23 in (L) deltoid, next day site was red, swollen, warm and tender. Sx worse on following day and pt went to ER. Dx cellulitis. Tx with 1 dose IV ROCEPHIN 1000 mg and discharged with rx for KEFLEX 500 mg x 7 days. Sx resolved.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Pt had a seizure about 5 minutes after vaccine administration, seizure lasted less than 30 seconds. EMS was called and took pt away to be checked out. Pt was responsive and aware of surrounding when she left.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with ZOSTAVAX (dose, strength, lot #, site and route of administration not reported). The reporter stated that ZOSTAVAX doses were exposed to 7F to 10F for a total excursion time of up to 504 hours from 01-DEC-2013 to 08-JAN-2014. The reporter was informed per stability data that this was supported as long as the overall average temperature remained between -5 degrees C and -15 degrees C (-58 degrees F and 5 degrees F). No adverse effects reported. The reporter stated that further evaluation would be needed to determine if overall average temperature remained at the recommended storage temperature of -58 degrees F and 5 degrees F. No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse regarding her 18 year old son. The patient's medical history, drug reactions or allergies were not provided. On 10-JAN-2014, the patient was vaccinated with an intramuscular dose of ZOSTAVAX, (dose and lot number were not provided) instead of GARDASIL as prescribed. No adverse effects were reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bacterial infection, Pain in extremity
Clinical narrative: Pt's right arm still sore from vaccination 5 days later.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Fainted in lobby approx 5 min after GARDASIL IZ. Taken back to room to rest on exam table x 10 min. Felt fine and left the clinic.
Sex: M
Vaccine: FLU4
Symptoms: Lethargy, Nasal congestion, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Initial report received from a non-healthcare professional (patient's parent) on 07 January 2014. A 34-year-old male patient whose medical history, concomitant medication were not reported, had received a dose of Quadrivalent Flu Vaccine (therapy dates, lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. It was reported that on an unspecified date, the patient experienced sore throat, 102 fever, chest and nasal congestion, lethargic. Laboratory investigation and corrective treatments were not reported. At the time of this report, the patient was recovering from events. Documents held by sender: none.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to ten unspecified patients of unknown age and gender. On an unknown date, the ten unspecified patients could have received improperly stored doses of VARIVAX (Merck) (Lot #, dose and route not provided). No adverse effects were reported. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Malaise, Pyrexia, Rash, Rash vesicular
Clinical narrative: HPI pt with rash x 2 days. Low grade fever, general malaise. Got varicella vaccine on 12/26 - presents today with rash (on an erythematous base of varying ages absolutely classic for varicella). Informed pt he is contagious until all lesions are dried/crusted, and none are forming. Pt to take FAMVIR 500 mg TID x 7 days. Symptomatic care. Remain home until no longer contagious. No contact with vaccinated children, pregnant pt's, and anyone immunocompromised.
Sex: F
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder, Headache
Clinical narrative: This spontaneous report as received from a registered Nurse refers to a female patient of unknown age. On 03-JAN-2014 the patient was vaccinated with single dose of ZOSTAVAX route reported as injection (dose, dose number and lot were not reported). On 04-JAN-2014, the patient woke up at 2 am and experienced headache and gastrointestinal issues (also reported as "G.I."). The patient did not receive any treatment. The patient did not see medical attention. On unspecified date in January 2014, the outcome of gastrointestinal issues and headache was reported as recovered/resolved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure decreased, Chest discomfort, Chills, Dry throat
Clinical narrative: Fainted within minutes of vaccines shot, then shivering, headache, chest tightness puffy face, fatigue, dry throat, strange sensation in tongue -> ER -> Epinephrine Blood pressure down to 86/33. Still very weak with fatigue 4 day course of prednisone. Immediate improvement after epinephrine.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Paraesthesia oral, Swelling face, Syncope
Clinical narrative: Fainted within minutes of vaccines shot, then shivering, headache, chest tightness puffy face, fatigue, dry throat, strange sensation in tongue -> ER -> Epinephrine Blood pressure down to 86/33. Still very weak with fatigue 4 day course of prednisone. Immediate improvement after epinephrine.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apnoea, Blood culture negative, CSF culture negative, Computerised tomogram head normal, Culture urine negative
Clinical narrative: Pt received 2 mo vaccinations on 1/3/2014. Presented to ER on 1/4/2014 at approx 2230 with "whole body jerking movements" vomiting x1, 1 period of apnea. No fever.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyskinesia, Viral test negative, Vomiting
Clinical narrative: Pt received 2 mo vaccinations on 1/3/2014. Presented to ER on 1/4/2014 at approx 2230 with "whole body jerking movements" vomiting x1, 1 period of apnea. No fever.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: DVT in Rt upper arm -> COUMADIN x 3 months. DVT resolved (by Doppler).
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Insomnia, Local swelling, Pain
Clinical narrative: Extended length of soreness in injection site and swelling. Pain, numbness and swelling in arm and hand that the shot was given in. Unable to sleep due to pain that is both a dull ache and a shooting pain. A cortisone shot was given and anti-inflammatories.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Extended length of soreness in injection site and swelling. Pain, numbness and swelling in arm and hand that the shot was given in. Unable to sleep due to pain that is both a dull ache and a shooting pain. A cortisone shot was given and anti-inflammatories.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pain
Clinical narrative: Complained of pain immediately - no visible redness or swelling. Saw PCP and was given MEDROL dose pak.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Patient presented with complaint of pain in left arm, shoulder to elbow (ache), which causes a sharp pain when attempting to raise arm above his head. Patient says this is ongoing from 10/23/13 to today, 1/8/14. Patient has not sought treatment.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Nausea, Skin warm
Clinical narrative: Arm redness and heat (redness began this morning, heat this afternoon), nausea since 3 pm.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Extreme swelling and pain at injection site.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Violent chills, headache, fever, muscle ache, fatigue.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Extreme nausea, chills, body aches, headache, tiredness, diarrhea for 4 days.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Pain
Clinical narrative: Extreme nausea, chills, body aches, headache, tiredness, diarrhea for 4 days.
Age: 62.0
Sex: F
Vaccine: HEPA
Symptoms: Mobility decreased, Pain in extremity, Sensation of heaviness
Clinical narrative: Arm felt heavy, sore, and pain radiated down to her fingertips. She stated she could not raise her arm or hold the steering wheel while driving. She put ice on the injection site, and took Aleve, and went to bed. The following morning it was only a little sore.
Age: 64.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody, Mumps antibody test, Rash maculo-papular, Rubella antibody negative
Clinical narrative: Staff reported a fine maculopapular rash over both cheeks on face, chin, and forehead - no vesicles, induration or pruritus - afebrile (reported on 1-5-14). No treatment was ordered. Rash began to fade on 1-8-14 and was almost gone on 1-9-14.
Age: 66.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pain in elbow, hip and knee occasionally. Arm sore for few days then other s/s began. No treatment taken.
Age: 0.39
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability
Clinical narrative: After 2 month vaccines extreme night fussiness only x2 weeks. No other symptoms (same given at 4 mo except no HBV). After 4 month vaccines, same extreme night fussiness has occurred.
Age: 15.0
Sex: F
Vaccine: FLU3, FLUN3
Symptoms: Expired drug administered, Incorrect dose administered
Clinical narrative: Staff gave doctor vaccine that had expired. Doctor then administered proper vaccine.
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) arm swelling and red Rt deltoid.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: Severe case of shingles began 9/2/13. Still has neuropathy due to it. Several people in area had vaccine and still got shingles. Is vaccine any good or did he get water instead of medication?
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Localized red raised rash around the injection site.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Amnesia, Chills, Pyrexia
Clinical narrative: Pt experienced fever, chills, altered state of consciousness described as "being so out of it, I was past left field" short term memory loss. Lasted roughly 8 hours. No treatment.
Age: 56.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Activities of daily living impaired, Tremor
Clinical narrative: Pt. received Tdap immunization on 1/10/14. Pt RTC on 1/13/14 c/o tremors that were affecting ability to cut hair.
Age: 55.0
Sex: U
Vaccine: FLUX
Symptoms: Pain, Upper extremity mass
Clinical narrative: Patient experienced persistent pain and developed a lump on her left arm.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Blister, Erythema, Injection site warmth, Local reaction, Local swelling
Clinical narrative: Rt arm became red and swollen, pt had fever and warmth at the sight in rt arm. Developed blisters on her skin and was seen at a clinic by APRN (convenient care).
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: Rt arm became red and swollen, pt had fever and warmth at the sight in rt arm. Developed blisters on her skin and was seen at a clinic by APRN (convenient care).
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Immediately after injection a nickel sized bump formed in the RA at site of injection. Within a few min the area surrounded the site turned red, hot to touch, and the patient stated very itchy - called MD and prescribed and dispensed steroid cream.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site pruritus, Paraesthesia
Clinical narrative: Numbness, tingling starting at vaccine admin site and migrating down the left leg and up to left side of my face.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Haematoma, Pain
Clinical narrative: Jan 1, 2014. Pain, bruise 6 cm diameter. Pain is ache. Worse with movement. Current bruise/hematoma is 1.5 cm, throbbing pain.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Blood glucose normal, Cough, Diabetes mellitus, Glucose tolerance impaired, Increased upper airway secretion
Clinical narrative: This case was reported by a consumer and described the occurrence of diabetes in a male subject aged between 60 and 69 years old who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified), pneumonia vaccine (non-gsk) and ADVAIR multi dose powder inhaler for lung congestion. A physician or other health care professional has not verified this report. Concurrent medical conditions included acid reflux, allergy to animals, allergy to citrus, dairy allergy, iodine allergy, osteoporosis, peanut allergy, shellfish allergy and walnut allergy. Concurrent medications included Metformin, Vitamin D, Multivitamin and NEXIUM. On an unspecified date the subject received a dose of Influenza vaccine unspecified (unknown) and unspecified dose of Pneumonia vaccine (Non-GSK) (unknown). Within months of vaccination with Influenza vaccine unspecified and Pneumonia vaccine (Non-GSK), the subject experienced serum sickness and lung congestion. On 15 November 2013 the patient started Fluticasone propionate+salmeterol xinafoate (inhaled) 500/50, prescribed to be taken 1 puff, twice daily for lung congestion secondary to serum sickness. The patient reported that he suffered from serum sickness after a pneumonia and flu shot. He was prescribed ADVAIR diskus and he started taking the ADVAIR 500/50 on 15 November 2013. He was concerned about taking a steroid medication so he reduced his dose to ADVAIR 250/50 on 24 November 2013 and would take the medication on an as needed basis. He would take the product one puff at night before bedtime when he would feel a buildup in his chest of phlegm and he would start to cough. The ADVAIR product allowed him to sleep and he was pleased with the medication. In "late" December 2013, the patient experienced diabetes and borderline diabetes. The patient "was diagnosed with diabetes in late December 2013" but also stated that his doctor said he was "right on the edge of having diabetes". Two weeks prior to this report (approximately 23 December 2013), he received a blood test and his blood sugar numbers increased to 5.8 during treatment with ADVAIR diskus. No further information was available at this time. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the not sleeping well resolved. The outcome of diabetes, borderline diabetes and increased blood sugar were unresolved. The outcome of serum sickness, lung congestion, mucus increased in chest and cough were unspecified.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Insomnia, Pulmonary congestion, Serum sickness
Clinical narrative: This case was reported by a consumer and described the occurrence of diabetes in a male subject aged between 60 and 69 years old who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified), pneumonia vaccine (non-gsk) and ADVAIR multi dose powder inhaler for lung congestion. A physician or other health care professional has not verified this report. Concurrent medical conditions included acid reflux, allergy to animals, allergy to citrus, dairy allergy, iodine allergy, osteoporosis, peanut allergy, shellfish allergy and walnut allergy. Concurrent medications included Metformin, Vitamin D, Multivitamin and NEXIUM. On an unspecified date the subject received a dose of Influenza vaccine unspecified (unknown) and unspecified dose of Pneumonia vaccine (Non-GSK) (unknown). Within months of vaccination with Influenza vaccine unspecified and Pneumonia vaccine (Non-GSK), the subject experienced serum sickness and lung congestion. On 15 November 2013 the patient started Fluticasone propionate+salmeterol xinafoate (inhaled) 500/50, prescribed to be taken 1 puff, twice daily for lung congestion secondary to serum sickness. The patient reported that he suffered from serum sickness after a pneumonia and flu shot. He was prescribed ADVAIR diskus and he started taking the ADVAIR 500/50 on 15 November 2013. He was concerned about taking a steroid medication so he reduced his dose to ADVAIR 250/50 on 24 November 2013 and would take the medication on an as needed basis. He would take the product one puff at night before bedtime when he would feel a buildup in his chest of phlegm and he would start to cough. The ADVAIR product allowed him to sleep and he was pleased with the medication. In "late" December 2013, the patient experienced diabetes and borderline diabetes. The patient "was diagnosed with diabetes in late December 2013" but also stated that his doctor said he was "right on the edge of having diabetes". Two weeks prior to this report (approximately 23 December 2013), he received a blood test and his blood sugar numbers increased to 5.8 during treatment with ADVAIR diskus. No further information was available at this time. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the not sleeping well resolved. The outcome of diabetes, borderline diabetes and increased blood sugar were unresolved. The outcome of serum sickness, lung congestion, mucus increased in chest and cough were unspecified.
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Autopsy, Confusional state, Congestive cardiomyopathy, Death
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient. On or about 02DEC2011, the patient received PNEUMOVAX23 for its intended purpose: the prevention of invasive pneumococcal disease. On or about 04DEC2011, the patient experienced fever, dizziness, weakness, vomiting, confusion, shortness of breath, and jaundice. On or about 04DEC2011 the patient was transported via ambulance to the hospital. On or about 04DEC2011, approximately 3 hours after his arrival, the patient died. On or about 06DEC2011, an autopsy revealed suggested pneumonia. The patient's cause of death was dilated cardiomyopathy. As a direct and proximate result of PNEUMOVAX23 the patient died on 04DEC2011 (conflicting information received from the lawyer indicates that the patient died on 06DEC2011, therefore there are two different dates of death). Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Dyspnoea, Jaundice, Pneumonia, Pyrexia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient. On or about 02DEC2011, the patient received PNEUMOVAX23 for its intended purpose: the prevention of invasive pneumococcal disease. On or about 04DEC2011, the patient experienced fever, dizziness, weakness, vomiting, confusion, shortness of breath, and jaundice. On or about 04DEC2011 the patient was transported via ambulance to the hospital. On or about 04DEC2011, approximately 3 hours after his arrival, the patient died. On or about 06DEC2011, an autopsy revealed suggested pneumonia. The patient's cause of death was dilated cardiomyopathy. As a direct and proximate result of PNEUMOVAX23 the patient died on 04DEC2011 (conflicting information received from the lawyer indicates that the patient died on 06DEC2011, therefore there are two different dates of death). Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient. On or about 02DEC2011, the patient received PNEUMOVAX23 for its intended purpose: the prevention of invasive pneumococcal disease. On or about 04DEC2011, the patient experienced fever, dizziness, weakness, vomiting, confusion, shortness of breath, and jaundice. On or about 04DEC2011 the patient was transported via ambulance to the hospital. On or about 04DEC2011, approximately 3 hours after his arrival, the patient died. On or about 06DEC2011, an autopsy revealed suggested pneumonia. The patient's cause of death was dilated cardiomyopathy. As a direct and proximate result of PNEUMOVAX23 the patient died on 04DEC2011 (conflicting information received from the lawyer indicates that the patient died on 06DEC2011, therefore there are two different dates of death). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Burning sensation, Erythema, Pruritus, Tenderness, Urticaria
Clinical narrative: In 24 hrs pt had a red welt approx 3 ins long x 21 ins wide that was itching, burning and tender to touch.
Age: 1.01
Sex: M
Vaccine: VARZOS
Symptoms: Influenza, Influenza virus test positive, Rash, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 12 month old male patient. On 30-DEC-2013 the patient received a dose of ZOSTAVAX in error, rather than the VARIVAX (Merck) that was indicated for him. The patient presented to the physician's practice today to be evaluated for a skin rash. On an unknown date, influenza skin test by skin swab was performed: it was determined to be influenza. The physician, a dermatologist, stated that the rash was not varicella. He did not have much information about the patient at because the patient was new to him. He did not know at which healthcare provider's office the child received ZOSTAVAX. The patient's outcome was reported as not recovered. The patient sought unspecified medical attention. The causal relationship was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug 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. On 09-JAN-2014 the patient was vaccinated with GARDASIL (dose and route not reported, lot # 1073AA, expiration date 11-OCT-2013). There was no concomitant medication reported. The nurse reported that the patient was administered an expired dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: HEPA, IPV, VARCEL
Symptoms: Herpes zoster, Pruritus
Clinical narrative: Pt states she had an area on her thigh that was itchy. No rash no fever. Kept itching so she went to her dr 12/30/13 and he said it was shingles as a result of varicella vaccine given 7 years post stem cell transplant. Pt treated with acyclovir.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Sore/throbs and loss range of motion due to pain - still as of today 1/14/14. Saw Dr > 1 month after - given hot/cold packs. Have an Rx ointment 7 wks after inj. Now acupuncture treatments and arnica.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Mom states site was swollen. Went to ER.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Injection site pain, Injection site rash
Clinical narrative: On 1-10-14 pneumo was given. Patient noticed symptoms 1-11-14 rash and pain on injection site. Patient also has chest pain.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Skin warm
Clinical narrative: (L) deltoid redness, swelling/inflammation. Hot to area.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Allergy to animal, Antinuclear antibody, Arthralgia, Blood aluminium
Clinical narrative: Patient developed a rash approx 10/1/13 and was seen for this on 10/14/13, at this time she also received her 2nd HPV vaccine. In addition she requested referral to dermatology. I diagnosed her with folliculitis and treated her on 10/14 with topical triamcinolone and Benadryl. She then saw a dermatologist in Nov who treated her with addition of oral prednisone and did a punch biopsy showing spongiotic dermatitis. The rash got better but more recently worsened after discontinuation of steroids. She has also continued with oral antihistamine, hydroxyzine. She saw an allergist in Nov and had extensive skin testing done which revealed allergies to cats, grasses, weeds and molds. Recommendation was to use Zyrtec. She was then seen here 11/17/13 for abdominal pain and had been to the hospital for this complaint a few days prior. I felt that the pain was primarily due to dysmenorrhea but entertained a broad differential, this pain improved but has returned off and on. Patient sought care at ED on 1/7/14 for myriad of concerns including pruritis, rash, fatigue, abdominal pain, joint pain, heavy and irregular periods, attention and memory difficulties, dizziness, tingling of R arm and leg, chest pain, difficulty walking, almost impossible to get up stairs. She had been visiting father who has PhD in organic chemistry and he became concerned that her symptoms are due to Gardasil. Specifically he thinks she could have poisoning or reaction to the aluminum or boric acid used in the vaccine or that she is having a reaction to the active components of the vaccine. MOC also feels her daughter's symptoms are due to the vaccine.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood thyroid stimulating hormone, C-reactive protein, Chest pain, Disturbance in attention, Dizziness
Clinical narrative: Patient developed a rash approx 10/1/13 and was seen for this on 10/14/13, at this time she also received her 2nd HPV vaccine. In addition she requested referral to dermatology. I diagnosed her with folliculitis and treated her on 10/14 with topical triamcinolone and Benadryl. She then saw a dermatologist in Nov who treated her with addition of oral prednisone and did a punch biopsy showing spongiotic dermatitis. The rash got better but more recently worsened after discontinuation of steroids. She has also continued with oral antihistamine, hydroxyzine. She saw an allergist in Nov and had extensive skin testing done which revealed allergies to cats, grasses, weeds and molds. Recommendation was to use Zyrtec. She was then seen here 11/17/13 for abdominal pain and had been to the hospital for this complaint a few days prior. I felt that the pain was primarily due to dysmenorrhea but entertained a broad differential, this pain improved but has returned off and on. Patient sought care at ED on 1/7/14 for myriad of concerns including pruritis, rash, fatigue, abdominal pain, joint pain, heavy and irregular periods, attention and memory difficulties, dizziness, tingling of R arm and leg, chest pain, difficulty walking, almost impossible to get up stairs. She had been visiting father who has PhD in organic chemistry and he became concerned that her symptoms are due to Gardasil. Specifically he thinks she could have poisoning or reaction to the aluminum or boric acid used in the vaccine or that she is having a reaction to the active components of the vaccine. MOC also feels her daughter's symptoms are due to the vaccine.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Eczema, Electrocardiogram normal, Fatigue, Full blood count
Clinical narrative: Patient developed a rash approx 10/1/13 and was seen for this on 10/14/13, at this time she also received her 2nd HPV vaccine. In addition she requested referral to dermatology. I diagnosed her with folliculitis and treated her on 10/14 with topical triamcinolone and Benadryl. She then saw a dermatologist in Nov who treated her with addition of oral prednisone and did a punch biopsy showing spongiotic dermatitis. The rash got better but more recently worsened after discontinuation of steroids. She has also continued with oral antihistamine, hydroxyzine. She saw an allergist in Nov and had extensive skin testing done which revealed allergies to cats, grasses, weeds and molds. Recommendation was to use Zyrtec. She was then seen here 11/17/13 for abdominal pain and had been to the hospital for this complaint a few days prior. I felt that the pain was primarily due to dysmenorrhea but entertained a broad differential, this pain improved but has returned off and on. Patient sought care at ED on 1/7/14 for myriad of concerns including pruritis, rash, fatigue, abdominal pain, joint pain, heavy and irregular periods, attention and memory difficulties, dizziness, tingling of R arm and leg, chest pain, difficulty walking, almost impossible to get up stairs. She had been visiting father who has PhD in organic chemistry and he became concerned that her symptoms are due to Gardasil. Specifically he thinks she could have poisoning or reaction to the aluminum or boric acid used in the vaccine or that she is having a reaction to the active components of the vaccine. MOC also feels her daughter's symptoms are due to the vaccine.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Memory impairment, Menorrhagia, Menstruation irregular, Mononucleosis heterophile test
Clinical narrative: Patient developed a rash approx 10/1/13 and was seen for this on 10/14/13, at this time she also received her 2nd HPV vaccine. In addition she requested referral to dermatology. I diagnosed her with folliculitis and treated her on 10/14 with topical triamcinolone and Benadryl. She then saw a dermatologist in Nov who treated her with addition of oral prednisone and did a punch biopsy showing spongiotic dermatitis. The rash got better but more recently worsened after discontinuation of steroids. She has also continued with oral antihistamine, hydroxyzine. She saw an allergist in Nov and had extensive skin testing done which revealed allergies to cats, grasses, weeds and molds. Recommendation was to use Zyrtec. She was then seen here 11/17/13 for abdominal pain and had been to the hospital for this complaint a few days prior. I felt that the pain was primarily due to dysmenorrhea but entertained a broad differential, this pain improved but has returned off and on. Patient sought care at ED on 1/7/14 for myriad of concerns including pruritis, rash, fatigue, abdominal pain, joint pain, heavy and irregular periods, attention and memory difficulties, dizziness, tingling of R arm and leg, chest pain, difficulty walking, almost impossible to get up stairs. She had been visiting father who has PhD in organic chemistry and he became concerned that her symptoms are due to Gardasil. Specifically he thinks she could have poisoning or reaction to the aluminum or boric acid used in the vaccine or that she is having a reaction to the active components of the vaccine. MOC also feels her daughter's symptoms are due to the vaccine.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Mycotic allergy, Paraesthesia, Rash, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Patient developed a rash approx 10/1/13 and was seen for this on 10/14/13, at this time she also received her 2nd HPV vaccine. In addition she requested referral to dermatology. I diagnosed her with folliculitis and treated her on 10/14 with topical triamcinolone and Benadryl. She then saw a dermatologist in Nov who treated her with addition of oral prednisone and did a punch biopsy showing spongiotic dermatitis. The rash got better but more recently worsened after discontinuation of steroids. She has also continued with oral antihistamine, hydroxyzine. She saw an allergist in Nov and had extensive skin testing done which revealed allergies to cats, grasses, weeds and molds. Recommendation was to use Zyrtec. She was then seen here 11/17/13 for abdominal pain and had been to the hospital for this complaint a few days prior. I felt that the pain was primarily due to dysmenorrhea but entertained a broad differential, this pain improved but has returned off and on. Patient sought care at ED on 1/7/14 for myriad of concerns including pruritis, rash, fatigue, abdominal pain, joint pain, heavy and irregular periods, attention and memory difficulties, dizziness, tingling of R arm and leg, chest pain, difficulty walking, almost impossible to get up stairs. She had been visiting father who has PhD in organic chemistry and he became concerned that her symptoms are due to Gardasil. Specifically he thinks she could have poisoning or reaction to the aluminum or boric acid used in the vaccine or that she is having a reaction to the active components of the vaccine. MOC also feels her daughter's symptoms are due to the vaccine.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Seasonal allergy, Skin test positive, Thyroxine, Toxicologic test, Urine analysis
Clinical narrative: Patient developed a rash approx 10/1/13 and was seen for this on 10/14/13, at this time she also received her 2nd HPV vaccine. In addition she requested referral to dermatology. I diagnosed her with folliculitis and treated her on 10/14 with topical triamcinolone and Benadryl. She then saw a dermatologist in Nov who treated her with addition of oral prednisone and did a punch biopsy showing spongiotic dermatitis. The rash got better but more recently worsened after discontinuation of steroids. She has also continued with oral antihistamine, hydroxyzine. She saw an allergist in Nov and had extensive skin testing done which revealed allergies to cats, grasses, weeds and molds. Recommendation was to use Zyrtec. She was then seen here 11/17/13 for abdominal pain and had been to the hospital for this complaint a few days prior. I felt that the pain was primarily due to dysmenorrhea but entertained a broad differential, this pain improved but has returned off and on. Patient sought care at ED on 1/7/14 for myriad of concerns including pruritis, rash, fatigue, abdominal pain, joint pain, heavy and irregular periods, attention and memory difficulties, dizziness, tingling of R arm and leg, chest pain, difficulty walking, almost impossible to get up stairs. She had been visiting father who has PhD in organic chemistry and he became concerned that her symptoms are due to Gardasil. Specifically he thinks she could have poisoning or reaction to the aluminum or boric acid used in the vaccine or that she is having a reaction to the active components of the vaccine. MOC also feels her daughter's symptoms are due to the vaccine.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased, Malaise, Nervousness
Clinical narrative: About one hour after receiveing flu shot developed rapid heart rate, feeling "shakey", SOB, heaviness in her chest, and general not feeling well.  Followed up in ED for evaluation and treatment of symptoms that resolved over about 4 hour period.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance
Clinical narrative: Could hardly walk.
Age: 51.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Arm pain and muscle soreness but no swelling or fever.
Age: 15.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness, tenderness, swelling at pectoral muscle.
Age: 33.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Dizziness, Dyspnoea, Immediate post-injection reaction, Musculoskeletal pain
Clinical narrative: Facility, as provided by employer, provided on-site flu shots administered by other healthcare.  As soon as the shot was administered, an immediate reaction occurred. Extremely difficult to breathe, paleness, dizziness and incapabable of walking.  Two Epi Pens were administered by the technician.  911 was dispatched.  Once they arrived, an additional Epi Pen was administered along with oxygen.  After about an hour, some stabilization was realized.  I was hospitilized until about 7pm.  Hives were observed and extreme soreness was felt in the arm/shoulder area.  The doctor prescribed Oxycodone and an Epi Pen.
Age: 33.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Pallor, Urticaria
Clinical narrative: Facility, as provided by employer, provided on-site flu shots administered by other healthcare.  As soon as the shot was administered, an immediate reaction occurred. Extremely difficult to breathe, paleness, dizziness and incapabable of walking.  Two Epi Pens were administered by the technician.  911 was dispatched.  Once they arrived, an additional Epi Pen was administered along with oxygen.  After about an hour, some stabilization was realized.  I was hospitilized until about 7pm.  Hives were observed and extreme soreness was felt in the arm/shoulder area.  The doctor prescribed Oxycodone and an Epi Pen.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood alkaline phosphatase increased, Blood glucose increased, Blood urea increased, Dysphagia, Haematocrit decreased
Clinical narrative: The patient complained that her left arm (where the pneumonia vaccine was given) became very tight, and then she noticed it was difficult to swallow.  She was seen in the ED.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Haemoglobin decreased, Injection site reaction, Laboratory test abnormal, Skin tightness, Troponin
Clinical narrative: The patient complained that her left arm (where the pneumonia vaccine was given) became very tight, and then she noticed it was difficult to swallow.  She was seen in the ED.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Confusional state, Fall, Gait disturbance, Injection site reaction
Clinical narrative: Confusion, mumbling, unsteady gait, multiple falls, urinary incontinence, localized reaction at injection site, chills, feverish.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Local reaction, Pyrexia, Speech disorder, Urinary incontinence
Clinical narrative: Confusion, mumbling, unsteady gait, multiple falls, urinary incontinence, localized reaction at injection site, chills, feverish.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Confusional state, Conjunctivitis, Delirium, Encephalopathy
Clinical narrative: Confusion, mumbling, unsteady gait, multiple falls, urinary incontinence, localized reaction at injection site, chills, feverish.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Fall, Gait disturbance, Injection site reaction, Local reaction, Pneumonitis
Clinical narrative: Confusion, mumbling, unsteady gait, multiple falls, urinary incontinence, localized reaction at injection site, chills, feverish.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia, Speech disorder, Urinary incontinence, Vaccination complication
Clinical narrative: Confusion, mumbling, unsteady gait, multiple falls, urinary incontinence, localized reaction at injection site, chills, feverish.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown ages who on an unknown date, might have been vaccinated with a dose of VARIVAX (Merck) (lot number 0690Y) (dose and route not reported) that was expired. The lot reported had expiration date on 15-MAY-2011. No adverse symptoms were reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal, VIIth nerve paralysis
Clinical narrative: Pt developed Bell's palsy in 24 hours after flu vaccine.
Age: 6.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Abnormal behaviour, Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood creatinine decreased, Blood culture negative
Clinical narrative: Onset of strange behavior - acting withdrawn but not confused per family. Then developed nausea / vomiting / headache / fever and admitted for evaluation. No infectious etiology identified. Felt to be vaccine reaction vs. viral infection.
Age: 6.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: C-reactive protein increased, CSF culture negative, CSF glucose normal, CSF protein normal, CSF white blood cell count increased
Clinical narrative: Onset of strange behavior - acting withdrawn but not confused per family. Then developed nausea / vomiting / headache / fever and admitted for evaluation. No infectious etiology identified. Felt to be vaccine reaction vs. viral infection.
Age: 6.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Culture urine negative, Enterovirus test negative, Epstein-Barr virus antibody negative, Epstein-Barr virus antibody positive, Epstein-Barr virus test positive
Clinical narrative: Onset of strange behavior - acting withdrawn but not confused per family. Then developed nausea / vomiting / headache / fever and admitted for evaluation. No infectious etiology identified. Felt to be vaccine reaction vs. viral infection.
Age: 6.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Gram stain negative, Headache, Lymphocyte percentage, Nausea, Neutrophil percentage
Clinical narrative: Onset of strange behavior - acting withdrawn but not confused per family. Then developed nausea / vomiting / headache / fever and admitted for evaluation. No infectious etiology identified. Felt to be vaccine reaction vs. viral infection.
Age: 6.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Nuclear magnetic resonance imaging brain normal, Polymerase chain reaction, Pyrexia, Red blood cells CSF positive, Social avoidant behaviour
Clinical narrative: Onset of strange behavior - acting withdrawn but not confused per family. Then developed nausea / vomiting / headache / fever and admitted for evaluation. No infectious etiology identified. Felt to be vaccine reaction vs. viral infection.
Age: 6.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Vaccination complication, Viral infection, Viral test negative, Vomiting
Clinical narrative: Onset of strange behavior - acting withdrawn but not confused per family. Then developed nausea / vomiting / headache / fever and admitted for evaluation. No infectious etiology identified. Felt to be vaccine reaction vs. viral infection.
Age: 14.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccine given to 14 year old. Manufacturer approval is for 18 years and over.
Age: 71.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Injection site swelling
Clinical narrative: Large swollen area at site of flu shot. Left arm upper area.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting and diarrhea.