chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding an unknown age and gender (previously reported as child) patient with no pertinent medical history reported. On 14-NOV-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 23-JAN-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Rash erythematous, Skin warm
Clinical narrative: Large, red area on upper (Rt) arm, size of 1 1/2 softball. Area edematous and raised. Red rash on torso. (Rt) arm warm to touch. Took Ibuprofen and BENADRYL. Redness almost gone by 5/26/13 in morning.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a currently 14 years old, male patient with no pertinent medical history reported. On 01-MAR-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 11 years old, male patient with no pertinent medical history reported. On 29-AUG-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 31-DEC-2012 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: FLUX, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding an unknown age and gender, patient with no pertinent medical history reported. On 29-NOV-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). Concomitant medications included Influenza virus vaccine (manufacturer unknown) administered on 29-NOV-2012 (intramuscular in the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 16 years old, male patient with no pertinent medical history reported. On 27-FEB-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 0.5
Sex: U
Vaccine: HBHEPB
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a 6 month old infant of unknown gender. On 22-MAY-2013, the patient was vaccinated with 0.5 milliliter (ml) of COMVAX (lot number reported as 0807Z), intramuscularly that had expired on 14-APR-2013. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 9 years old, male patient with no pertinent medical history reported. On 21-DEC-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Seroconversion test negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a population of unspecified elderly patients. On an unknown date the patients were vaccinated with a second dose of ZOSTAVAX (0.65 ml) (lot number and expiration date not reported) subcutaneous. There was no concomitant medication reported. The registered nurse stated that she had no administer ZOSTAVAX as 2 separate doses on unspecified dates because the elderly patients did not serologically convert after the first dose of ZOSTAVAX on unspecified dates. The outcome of the event was unknown. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Injection site pain, Syncope
Clinical narrative: This spontaneous report as received from a consumer refers to her 18 year old daughter with hay fever and with no pertinent medical history, who on 22-MAY-2013, was vaccinated with a dose of GARDASIL (dose, route and lot # not reported) in her left arm. There was no concomitant medication. On 23-MAY-2013 morning, the patient fainted on the bathroom floor. The patient also had developed a headache and the injection site was sore and tender. The patient felt extremely tired. The reporter contacted the physician on 23-MAY-2013, by telephone, and was awaiting a response. No treatment was given for the events. The outcome of the events was reported as recovering. The causality was not reported. No laboratory diagnostic studies were performed. 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 registered nurse refers to a patient of unknown age. On 13-MAY-2013 the patient was vaccinated with an expired dose of GARDASIL, 0.5 ml, intramuscular (lot # 668261/1397AA, Exp 09-APR-2013). No adverse effect reported. This is one of several reports from the same reporter. 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 registered nurse refers to a patient of unknown age. On 17-MAY-2013 the patient was vaccinated with an expired dose of GARDASIL, 0.5 ml, intramuscular (lot # 668261/1397AA, Exp 09-APR-2013). No adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received as received from a registered nurse refers to about 20 patients of unknown age. From 20-APR-2013 until 17-MAY-2013 the patients were vaccinated with a dose of M-M-R II (HSA) (lot # H014646, exp. date: 03-AUG-2014) that was exposed to an unsupported temperature excursion of 50F for 16 hours. This temperature excursion occurred right before the first dose on 20-APR-2013. No known adverse effects. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 29-APR-2013 the patient was vaccinated with a dose of VAQTA 50/1.0 U/ML lot # 0628AE, expiration 26-JAN-2015 (dose and route unknown). The Healthcare worker reported that VAQTA had multiple excursions from 20-FEB-2013 to 13-MAY-2013. The lowest temperature the vaccines reached was 24F. The total time of hours for the excursions was 253 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Injection site pain, Joint range of motion decreased, X-ray limb normal
Clinical narrative: This medically confirmed report (initial receipt 06-Feb-2013) concerns a 49-year-old female patient, who had no illness at time of vaccination nor any pre-existing allergies or medical conditions. On 17-Dec-2012, the patient received AFLURIA (batch number: P50908A) 0.5ml intramuscularly. On 17-Dec-2012, at 08:00am, after receiving AFLURIA the patient developed pain in the arm and very sore arm/shoulder which worsened by evening and limited range of motion. The patient had persistent shoulder pain with restricted range of motion, which was severe until late January and then decreased but still present during various daily activities. The patient sought medical attention by seeing a nurse. An x-ray was negative. The patient also saw an orthopedic surgeon and had a Magnetic Resonance Imaging (MRI) on 03-JAN-2013 and results were negative. The outcome for the event was recovering. Reporter comment: The health care practitioner stated that the patient experienced persistent disability/incapability (pain with activity). Follow-up (10-MAY-2013) : upgraded to serious, patient details, medical history/allergies, reporter seriousness, additional events, test/scan and results, HCP comments.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging normal, Pain in extremity, X-ray normal
Clinical narrative: This medically confirmed report (initial receipt 06-Feb-2013) concerns a 49-year-old female patient, who had no illness at time of vaccination nor any pre-existing allergies or medical conditions. On 17-Dec-2012, the patient received AFLURIA (batch number: P50908A) 0.5ml intramuscularly. On 17-Dec-2012, at 08:00am, after receiving AFLURIA the patient developed pain in the arm and very sore arm/shoulder which worsened by evening and limited range of motion. The patient had persistent shoulder pain with restricted range of motion, which was severe until late January and then decreased but still present during various daily activities. The patient sought medical attention by seeing a nurse. An x-ray was negative. The patient also saw an orthopedic surgeon and had a Magnetic Resonance Imaging (MRI) on 03-JAN-2013 and results were negative. The outcome for the event was recovering. Reporter comment: The health care practitioner stated that the patient experienced persistent disability/incapability (pain with activity). Follow-up (10-MAY-2013) : upgraded to serious, patient details, medical history/allergies, reporter seriousness, additional events, test/scan and results, HCP comments.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Licensed Visiting Nurse (L.V.N.) refers to a 50 year old female patient with allergies of skin rash/hives to SIMCOR, hypercholesterolemia and being a smoker. On 22-APR-2013 the patient was vaccinated with a dose of 0.65 ml of ZOSTAVAX lot # J000427 (Exp: 10-APR-2014), 0.65 ml, subcutaneous in the left arm. Concomitant therapies included LEXAPRO, NASONEX and VYTORIN. On 23-APR-2013, the nurse reported that the patient developed redness, swelling, warmth and pain of her left arm, at the injection site, after receiving ZOSTAVAX. The affected area of her left arm had increased in the past two days, and on 25-APR-2013 the area affected was from her shoulder down to her elbow. The patient sought medical attention by calling to physician's office. Treatment of BENADRYL and ADVIL or ALEVE was given. None lab diagnostics studies were performed. At the reporting time, the patient was not recovered. Follow-up information has been received from Licensed Vocational Nurse referring a 50 years old female patient, with hyperlipidaemia and anxiety, who on 22-APR-2013 at 8:00am was vaccinated with first dose of ZOSTAVAX. On 23-APR-2013, patient developed severe redness in whole arm below elbow. Patient was in office on 25-APR-2013. The patient was recovered on 28-APR-2013. Was reported that the patient required medical/surgical intervention to prevent the outcome of the event (medically significant by the nurse). Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Licensed Visiting Nurse (L.V.N.) refers to a 50 year old female patient with allergies of skin rash/hives to SIMCOR, hypercholesterolemia and being a smoker. On 22-APR-2013 the patient was vaccinated with a dose of 0.65 ml of ZOSTAVAX lot # J000427 (Exp: 10-APR-2014), 0.65 ml, subcutaneous in the left arm. Concomitant therapies included LEXAPRO, NASONEX and VYTORIN. On 23-APR-2013, the nurse reported that the patient developed redness, swelling, warmth and pain of her left arm, at the injection site, after receiving ZOSTAVAX. The affected area of her left arm had increased in the past two days, and on 25-APR-2013 the area affected was from her shoulder down to her elbow. The patient sought medical attention by calling to physician's office. Treatment of BENADRYL and ADVIL or ALEVE was given. None lab diagnostics studies were performed. At the reporting time, the patient was not recovered. Follow-up information has been received from Licensed Vocational Nurse referring a 50 years old female patient, with hyperlipidaemia and anxiety, who on 22-APR-2013 at 8:00am was vaccinated with first dose of ZOSTAVAX. On 23-APR-2013, patient developed severe redness in whole arm below elbow. Patient was in office on 25-APR-2013. The patient was recovered on 28-APR-2013. Was reported that the patient required medical/surgical intervention to prevent the outcome of the event (medically significant by the nurse). Additional information is not expected.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Measles-like rash, fever.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Measles-like rash, fever.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Decreased appetite, Dyspepsia, Functional gastrointestinal disorder, Gastrointestinal hypomotility
Clinical narrative: Initial report was received on 22 May 2013 from a consumer who is also the patient. A 54 year-old female patient with no medical conditions and who had received the flu vaccine every year for the last seven years, had received on 12 December 2012 an intramuscular left deltoid injection of FLUZONE (lot number UH713AA) and 17 days later on 29 December 2012, reporter "my GI system stopped working" and had difficulty with digestion and intestinal motility. The patient reported on 30 December 2012 she had some relief however her abdomen was distended. The patient lost all appetite, had decreased food intake and lost 15 pounds. The patient reported that every two weeks since "then" she had some improvement in bowel movements, motility, digestion, appetite and abdominal distention. Tests included routine blood work (results not reported). The patient was referred to an allergy clinic for follow-up. The reporter "wonders if she has GBS but no doctor has verified". The patient's outcome was not recovered. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal distension, Blood test, Decreased appetite, Dyspepsia, Gastrointestinal disorder
Clinical narrative: Initial report was received on 22 May 2013 from a consumer who is also the patient. A 54 year-old female patient with no medical conditions and who had received the flu vaccine every year for the last seven years, had received on 12 December 2012 an intramuscular left deltoid injection of FLUZONE (lot number UH713AA) and 17 days later on 29 December 2012, reporter "my GI system stopped working" and had difficulty with digestion and intestinal motility. The patient reported on 30 December 2012 she had some relief however her abdomen was distended. The patient lost all appetite, had decreased food intake and lost 15 pounds. The patient reported that every two weeks since "then" she had some improvement in bowel movements, motility, digestion, appetite and abdominal distention. Tests included routine blood work (results not reported). The patient was referred to an allergy clinic for follow-up. The reporter "wonders if she has GBS but no doctor has verified". The patient's outcome was not recovered. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Gastrointestinal motility disorder, Hypophagia, Weight decreased
Clinical narrative: Initial report was received on 22 May 2013 from a consumer who is also the patient. A 54 year-old female patient with no medical conditions and who had received the flu vaccine every year for the last seven years, had received on 12 December 2012 an intramuscular left deltoid injection of FLUZONE (lot number UH713AA) and 17 days later on 29 December 2012, reporter "my GI system stopped working" and had difficulty with digestion and intestinal motility. The patient reported on 30 December 2012 she had some relief however her abdomen was distended. The patient lost all appetite, had decreased food intake and lost 15 pounds. The patient reported that every two weeks since "then" she had some improvement in bowel movements, motility, digestion, appetite and abdominal distention. Tests included routine blood work (results not reported). The patient was referred to an allergy clinic for follow-up. The reporter "wonders if she has GBS but no doctor has verified". The patient's outcome was not recovered. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Loss of consciousness, Tonic clonic movements
Clinical narrative: This spontaneous report as received from a registered nurse refers to her daughter: a 11 year old female patient. The patient's medical history included adenotonsillectomy and respiratory syncytial virus. No drug reactions/allergies. On 23-MAY-2013 the patient was vaccinated with her first dose of GARDASIL, in right deltoid (lot number not provided). Other suspect therapies included VARIVAX (Merck) in right deltoid, Tdap in left deltoid and an unspecified meningitis vaccine (manufacturer unknown) in left deltoid (lot numbers not provided). There were no concomitant medication. On 23-MAY-2013, the patient received her first dose of GARDASIL and immediately developed tonic clonic movements and passed out for ten seconds. Right before the patient received the 3 other vaccines. The physician recommended for the patient to get something to eat and drink after the patient passed out. The nurse reports her daughter is better and went to school afterwards. The outcome of passed out for 10 seconds and tonic clonic movements was reported as recovered on 23-MAY-2013. Passed out for 10 seconds was determined medically significant upon internal review. The relatedness for passed out for 10 seconds and tonic clonic movements was not reported for the suspect therapies. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Hemiparesis, VIIth nerve paralysis
Clinical narrative: This medically confirmed report (initial receipt: 14-May-2013) concerns a 60-year-old female patient. The patient had an allergy to MSG (monosodium glutamate). 3 years ago, exact date not specified, the patient received a flu shot (manufacturer and batch number not specified). 6 weeks after vaccination the patient developed Bell's palsy. The patient visited the emergency room but was not admitted to hospital. 3 years later the patient has not fully recovered, she continued to experience right side weakness. No further information was provided.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Local redness, swelling approximately 14.5 x 16cm.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old patient who was given a dose of (merck) VARIVAX (start date, dosage, route and lot# not reported) in one body site and a dose of (merck) PROQUAD (start date, dosage, route and lot# not reported) during one office visit. No adverse effect reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Onset of rash with multiple locations.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from a 74 year old female consumer refers to herself. On 16-APR-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number not reported). On an unspecified date, approximately in 2013 the patient experienced attack of the dreaded shingles. Treatment medicines included: antiviral medicine, pain medicine, antidepressants and topical creams given for her shingles outbreak, skin rash and blisters that accompanied it and for the pain and complications associated with it. Consumer also stated that doctor and emergency room visits were necessary when shingles occurred. She was concerned about she could get postherpetic neuralgia. The outcome of dreaded shingles wasn't reported by the consumer. The relatedness between ZOSTAVAX and dreaded shingles was not reported. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Sensory loss
Clinical narrative: Loss of sensation in the first 3 fingers of each hand and the soles of both feet up to about half way up the calves. Besides rehab, patient given NEURONTIN. Diagnosed with GBS.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Rash macular
Clinical narrative: Macular rash that developed within 24 hrs of application. T max 100.4 F, pt doing well feeding adequately.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Hallucination, Insomnia, Muscular weakness, Sleep disorder, Slow speech
Clinical narrative: Slowed speech - staring into space. Knees buckled. Collapsing. Arm tremors - shaking. Sleep problems. Insomnia - up every 1 hour. Having hallucinations.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Staring, Syncope, Tremor
Clinical narrative: Slowed speech - staring into space. Knees buckled. Collapsing. Arm tremors - shaking. Sleep problems. Insomnia - up every 1 hour. Having hallucinations.
Age: 1.13
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Expired drug administered
Clinical narrative: Was given expired Pentacel.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Axillary pain, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: At site of injection, large red area, hot and itchy, the next morning had pain in armpit area that radiated to the breast area.  Could not lay my arm down to my side due to pain. Could no sleep on my side due to pain. The extreme pain continued for two more days, missed work one day. Aleve did not relieve the pain, moist heat did help.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: At site of injection, large red area, hot and itchy, the next morning had pain in armpit area that radiated to the breast area.  Could not lay my arm down to my side due to pain. Could no sleep on my side due to pain. The extreme pain continued for two more days, missed work one day. Aleve did not relieve the pain, moist heat did help.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: MD diagnosed cellulitis at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Pyrexia, Rash
Clinical narrative: Patient was having itching at injection site with some redness. Patient developed a fever two days later and then began developing small rashes on her arms away from the injection site.
Age: 1.27
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Contusion, Oedema peripheral, Swelling, Urticaria
Clinical narrative: Full body welts and swelling. Feet swollen. Face, arms, trunk, legs, back, neck all with welts. Looked bruised as they faded. Lasted 7 days.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Dysphagia, Eye irritation, Feeling abnormal, Insomnia
Clinical narrative: Came down with a mild fever Sunday evening.  The next day it seemed to subside, but the fever returned again Monday night and was higher--around 102 to 103 degrees.  Fever broke again in the morning and returned Tuesday evening.  For three days she had fever, difficulty sleeping, decreased appetite, and generally seemed not to feel very well, though she was still active.  Wednesday morning she seemed to have trouble swallowing (she was rolling her tongue around in her mouth as if uncomfortable all morning), and she vomited three times during meals.  Took her to see the pediatrician.  She was given a strep test (negative).  The doctor said during the exam that her ears and lungs looked good, but her throat appeared red.  Was advised to keep watching for another 48 hours to see if symptoms persisted.  The fever did not return that night. However, she developed a rash that evening and continued to feel poorly (lack of appetite, rubbing eyes, crankiness).  The rash and other symptoms (except for fever) lasted another 4 days.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Irritability, Malaise, Pharyngeal erythema, Pyrexia, Rash
Clinical narrative: Came down with a mild fever Sunday evening.  The next day it seemed to subside, but the fever returned again Monday night and was higher--around 102 to 103 degrees.  Fever broke again in the morning and returned Tuesday evening.  For three days she had fever, difficulty sleeping, decreased appetite, and generally seemed not to feel very well, though she was still active.  Wednesday morning she seemed to have trouble swallowing (she was rolling her tongue around in her mouth as if uncomfortable all morning), and she vomited three times during meals.  Took her to see the pediatrician.  She was given a strep test (negative).  The doctor said during the exam that her ears and lungs looked good, but her throat appeared red.  Was advised to keep watching for another 48 hours to see if symptoms persisted.  The fever did not return that night. However, she developed a rash that evening and continued to feel poorly (lack of appetite, rubbing eyes, crankiness).  The rash and other symptoms (except for fever) lasted another 4 days.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Streptococcus test negative, Vomiting
Clinical narrative: Came down with a mild fever Sunday evening.  The next day it seemed to subside, but the fever returned again Monday night and was higher--around 102 to 103 degrees.  Fever broke again in the morning and returned Tuesday evening.  For three days she had fever, difficulty sleeping, decreased appetite, and generally seemed not to feel very well, though she was still active.  Wednesday morning she seemed to have trouble swallowing (she was rolling her tongue around in her mouth as if uncomfortable all morning), and she vomited three times during meals.  Took her to see the pediatrician.  She was given a strep test (negative).  The doctor said during the exam that her ears and lungs looked good, but her throat appeared red.  Was advised to keep watching for another 48 hours to see if symptoms persisted.  The fever did not return that night. However, she developed a rash that evening and continued to feel poorly (lack of appetite, rubbing eyes, crankiness).  The rash and other symptoms (except for fever) lasted another 4 days.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Muscular weakness
Clinical narrative: During visit in April with me, he reports having received Zostavax at local pharmacy in December 2012. States next day had eye pain and leg weakness lasting about one day.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Erythema, Rash
Clinical narrative: Patient's parent stated she noticed redness around the patient's face around 0900. Notified technician at 0905. Patient taken in back office for further evaluation. Rash/redness noted on face, lower back, neck and chest. No other signs or symptoms noted. PA evaluated child/listened to breath sounds. Gave instructions for patient to be observed for additional 30 minutes to ensure no progression. Patient's viatls taken and observed by clinic personnel. Patient recovered and released at 1000. No other interventions needed. Patient advised to follow up with doctor if symptoms returned.
Age: 0.87
Sex: F
Vaccine: HIBV, IPV, PNC13, TDAP
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Epistaxis, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Small pinpoint bruising on legs neck and arms, nosebleeds.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Epistaxis, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Small pinpoint bruising on legs neck and arms, nosebleeds.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Convulsion, Gaze palsy, Tremor, Wheelchair user
Clinical narrative: After vaccination given, Pt. began to seize, eyes rolled back, limbs shook for aprox. 30 sec.  Pt. was in padded wheelchair, monitored by RN, clerk, mother.  Mother wanted to take Pt. home.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient was feeling itchy on Thursday, 23 May 2013 and thought it was bug bites. By Saturday morning, 25 May 2013 he noticed hives/rashes on legs and arms. He did not go to the hospital or ER. Pt is being evaluated at the facility.
Age: 1.86
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Rash, Urticaria
Clinical narrative: HIVES AND RASH.
Age: 1.86
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Rash, Urticaria
Clinical narrative: Rash and hives.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Embolia cutis medicamentosa, Injection site discolouration, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling and purple discoloration of right leg. Diagnosed with Nicolau's Syndrome.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Pain, Retching
Clinical narrative: Began feeling very achy, nausea with dry heves, dizziness, took 4 hours till patient began to feel better.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Cough, Dizziness, Fatigue, Headache
Clinical narrative: Dizzy, severe headache, cough, 100.8 temp, very tired, lethargic, nausea, shooting pains up right arm, stiff neck, noise bothering him.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hyperacusis, Lethargy, Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: Dizzy, severe headache, cough, 100.8 temp, very tired, lethargic, nausea, shooting pains up right arm, stiff neck, noise bothering him.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Rash
Clinical narrative: Red spot an injection sight. Spread to small red, hard spots on rt leg, back and stomach with small white spots in the middle.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: Patient has a silver dollar size red irritated area on his arm with several small fluid filled blisters.  Patients states no pain, but occasional itching.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site scab, Injection site vesicles
Clinical narrative: Patient has a silver dollar size red irritated area on his arm with several small fluid filled blisters.  Patients states no pain, but occasional itching.
Age: 31.0
Sex: F
Vaccine: TTOX
Symptoms: Burning sensation, Pain, Pain in extremity
Clinical narrative: Donor's left arm hurt the whole time but she noticed it becoming worse on the 5th day and is now burning and stinging. Applied cold pack last night.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Fall, Mental status changes
Clinical narrative: Pt with hx of seizure disorder (last seizure last year) seen in ER on 5/25/13 after unwitnessed ? of seizures. Mom heard him fall went in to room on ground with altered mental status EMS brought to ER had missed several days of KEPPRA. Dischg home after observation. Had rec'd 4 yo immuns on 5/24.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Periorbital oedema, Urticaria, Wheezing
Clinical narrative: Child received the vaccines listed below. Within about 5 min, he developed periorbital edema and parents brought him back to the office for eval (from parking lot). He developed wheezing but no swallowing difficulty. He received DECADRON, BENADRYL, and Albuterol jet neb with good results. We watched him for 2 hrs. He developed facial hives but no reoccurrence of wheezing or cough. Sent home on Prednisolone, BENADRYL and instructions to use jet neb if needed.
Sex: U
Vaccine: PPV
Symptoms: Death
Clinical narrative: This spontaneous report as received from a consumer refers to the consumer's neighbor of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23 (strength, dose, via, indication, lot number and expiration date not reported). There was no concomitant medication reported. The reporter stated that the unspecified neighbor died on an unknown date from PNEUMOVAX23. This is one of several reports from the same source (MARRS case # 1305USA014871). Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness, Faecal incontinence, Loss of consciousness, Muscular weakness, Musculoskeletal disorder
Clinical narrative: Received vaccine 5/16 and 5/17 had dizziness and seizure like activity. Loss of consciousness and loss of bowel control for approximately 1 minute. Continues to have muscle weakness and instability of lower extremities currently being worked up at hospital.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Seizure like phenomena
Clinical narrative: Received vaccine 5/16 and 5/17 had dizziness and seizure like activity. Loss of consciousness and loss of bowel control for approximately 1 minute. Continues to have muscle weakness and instability of lower extremities currently being worked up at hospital.
Age: 21.0
Sex: F
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Reported fever 101, myalgias, nausea on May 25, 2013; symptoms self resolved on f/u phone contact 05/28/2013.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Pt was given Tdap on 5-14-13 as ordered by nurse practitioner. Pt returned to clinic on 5-17-13 and asked us to look at her arm. Pt stated arm was red, warm and had large knot where injection given. I looked at injection site and the injection was not given in correct location. It was given in deltoid muscle - was given too low and therefore SQ. It had quarter sized knot but redness had subsided. Told pt to monitor area but the knot would be present for several weeks. Also had NP look at her arm with same instructions. Nurse that administered injections was counseled and re-taught correct IM placement for injection.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Varicella post vaccine
Clinical narrative: None stated.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, Varicella virus test
Clinical narrative: None stated.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Eye swelling
Clinical narrative: Pt. returned to clinic 2 hours later with swelling of eyes L > R. No rash.
Age: 1.51
Sex: F
Vaccine: DTAP
Symptoms: Incorrect dose administered
Clinical narrative: Patient came to us for 18 mo WCC. No records transferred or hand carried. Mom stated UTD and wanted to continue with 18 mo shots. Vaccine given. Records received later on and patient already had immunization at 15 mo WCC: Mom and doctor aware no harm done.
Age: 47.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL, HEPAB, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm, Swelling
Clinical narrative: Varicella vaccine given 5/22/13 and 0n 5/23/13 noticed swollen and red in PM and by noon on 5/24/13 it had extended to her elbow and around her arm and was red, swollen and warm. Saw PMD and was started on AUGMENTIN and improved each day with minimal redness by 5/28.
Age: 47.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL, HEPAB, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Varicella vaccine given 5/22/13 and 0n 5/23/13 noticed swollen and red in PM and by noon on 5/24/13 it had extended to her elbow and around her arm and was red, swollen and warm. Saw PMD and was started on AUGMENTIN and improved each day with minimal redness by 5/28.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received MCV4 around 10-11 AM on 5/20/13 in (L) deltoid - that night child woke parent up - complaining his (L) upper arm hurt - felt a little hard (but admits was half asleep). Not day no complaints and didn't look at it. Last evening - after shower - Mom noted area -was very red, swollen and hot to touch - covered 2/3 of upper arm -called for appt. Today states it looks a lot better - less red, less swollen. Still feels hard and warm to touch - but again less than yesterday. Able to move arm. Mark for injection (IM) in correct place.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: After PNEUMOVAX 23 on 5/17/2013 he developed a fever and chills with T 101 degrees and sore, red swollen left arm.
Age: 0.16
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Apnoeic attack, Blood culture, Cardiac monitoring, Electrocardiogram, Electroencephalogram
Clinical narrative: Stopped breathing, apneic vs unresponsive episodes, to ER then admitted. Pale, limp, eating less vigorous - home symptoms non responsive at 1230.
Age: 0.16
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Feeding disorder of infancy or early childhood, Full blood count, Hypotonia, Metabolic function test, Pallor
Clinical narrative: Stopped breathing, apneic vs unresponsive episodes, to ER then admitted. Pale, limp, eating less vigorous - home symptoms non responsive at 1230.
Age: 0.16
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Unresponsive to stimuli
Clinical narrative: Stopped breathing, apneic vs unresponsive episodes, to ER then admitted. Pale, limp, eating less vigorous - home symptoms non responsive at 1230.
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Td given to client d/t injury. Client refused encouraged Tdap d/t cost difference. Td administered IM in (R) UOQGM. This nurse has now been educated and understands not to give immunizations in the GM d/t absorption. Client called 5/29/13 AM to come back in today to get Tdap IM in delt per CDC recommendation. No adverse reactions reported by client at this time.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Injection site reaction, Local reaction, Tenderness
Clinical narrative: Telephone call from mother 5/23/13 reports significant local reaction to left arm at injection site of KINRIX (Dtap-UPV). Mom reports area oval shape approx 2" x 3", no fever; arm red, slightly tender, offered appt. Mom decided to wait, apply cold compresses, call with additional concerns.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Disorientation, Middle insomnia, Screaming, Sleep terror
Clinical narrative: Patient rec'd VARIVAX on 5/20/13. That evening and though to early a.m. Kept waking up screaming and disoriented seemed to be a night terror. No fever. On 5/21 on exam completely nl.
Age: 26.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema
Clinical narrative: Left arm with quarter size area of redness. Began 1 day ago. Treatment consisted of instructing pt to use ice or TYLENOL for pain and to notify us if any further symptoms.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Pain at the site.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Injection site pruritus, Pain, Pyrexia, Tenderness
Clinical narrative: Baseball size lump at vacc. site - body aches all over, fever, itching at site. Arm very tender.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Computerised tomogram normal, Fatigue, Hepatic cyst, Hypoaesthesia
Clinical narrative: Developed Immune Peripheral Neuropathy in both hands and feet with numbness and tingling that has not gone away. Easily fatigued and more sensitive to warm temperatures. Development of cysts on liver and kidneys with dull aching pain in Rt. upper side of abdomen since Dec. 2012.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Neuropathy peripheral, Nuclear magnetic resonance imaging normal, Paraesthesia, Renal cyst, Temperature intolerance
Clinical narrative: Developed Immune Peripheral Neuropathy in both hands and feet with numbness and tingling that has not gone away. Easily fatigued and more sensitive to warm temperatures. Development of cysts on liver and kidneys with dull aching pain in Rt. upper side of abdomen since Dec. 2012.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Fever, leg, arm muscle pain, nausea, baseball size welt - very hot to touch.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Fever, leg, arm muscle pain, nausea, baseball size welt - very hot to touch.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Inflammation, Skin discolouration, Skin warm
Clinical narrative: Large local inflammatory reaction over right deltoid. Pink discoloration, warmth, no tenderness.
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Induration, Local swelling
Clinical narrative: Localized swelling, induration of entire shoulder. Treated w/BENADRYL.
Age: 0.22
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Patient was oral receiving ROTATEQ when she started spitting it out then she proceeded to vomit. Mom stated she had eaten a couple of hours before. No other vaccines had been administered prior to this one.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Culture wound negative, Erythema, Induration, Inflammation
Clinical narrative: Cellulitis -> more likely inflammatory reaction. 10 cm region erythema 5 cm of which indurated and no purulence but serous drainage - sterile cx.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Secretion discharge
Clinical narrative: Cellulitis -> more likely inflammatory reaction. 10 cm region erythema 5 cm of which indurated and no purulence but serous drainage - sterile cx.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varicella like rash a 10-15 lesion scattered at body.
Sex: U
Vaccine: MNQ
Symptoms: Atrial fibrillation, Electrocardiogram abnormal, Electrocardiogram ambulatory, Heart rate increased, Heart rate irregular
Clinical narrative: Pt RTC 5/29/13 830 am - Informed NP exp fast/irregular HR approx 24 hrs post vaccination of MENACTRA at the clinic. Resulted to ER Dx. Atrial fibrillation. Now Holter monitor in use to follow up with PCP and cardiologist.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) upper arm swollen, sore, warm from shoulder to elbow - began 8 hrs after vax - using ice and will start Ibuprofen and call MD no fever, no h/a, no rash, not itchy. Also used BENADRYL.
Age: 0.74
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site mass
Clinical narrative: (R) thigh with lump not red not tender. Plan: TYLENOL, MOTRIN, and massage.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Unevaluable event
Clinical narrative: None stated.