chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: PPV, TYP, YF
Symptoms: Back pain, Hypoaesthesia, Neurological examination normal, Pain in extremity, Paraesthesia
Clinical narrative: Called clinic at 6 P.M. stated numbness, tingling in Rt. foot. Seen in clinic 4/13/11, tingling in both feet. Neuro exam normal. Returned at 3:30pm stating arm very sore, back pain, continued numbness. Sent to Urgent Care.
Age: 1.63
Sex: F
Vaccine: FLU3, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 4x6 cm red indurated area on (L) thigh no tenderness.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Non stop crying > 3 hrs.
Age: 37.0
Sex: F
Vaccine: HIBV, MNQ, PPV
Symptoms: Chills, Headache, Hyperhidrosis, Injection site erythema, Pyrexia
Clinical narrative: Fever, chills, sweats, headache, redness to injection site.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: Arm pain, consistent, inability to lift arm, skeletal joint discomfort and site of administration very painful (as conveyed per patient) since the day of administration (1/20/2011).
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness, redness at injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Rash, Rash pruritic
Clinical narrative: 1 day after vaccine arm was red around entire tricep area. Patient also developed blistering rash that was still present on 4/12/11. Described as itchy and not painful. Located on both legs and some on arm. Described as round spots. This occurred 2-3 days after vaccine. Patient instructed to also call Dr. Dr. instructed to apply hydrocortisone and BENADRYL by mouth. 4/13/11 - Rash improving.
Age: 28.0
Sex: M
Vaccine: ANTH, TDAP, TYP
Symptoms: Chills
Clinical narrative: Pt reporting chills; 0.3 mg EPIPEN given. Decreased chills. BP prior 118/78, 18, 60, 97.9, 120 apical. VS after 100 apical.
Age: 17.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Dizziness, Pain, Swelling face
Clinical narrative: Body aches started 4 hours after injections, 12/15/10. On 12/16/10 facial swelling without itching or hives. C/O dizziness. Mother gave BENADRYL prior to calling office on 12/16/10.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt had ZOSTAVAX inj. Pt. reported case of shingles despite vaccine.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Urticaria
Clinical narrative: 4/6/11 - Rash/hives developed - improved with BENADRYL per PMD call to office. Reported sx to nurse 4/7/11. 4/8/11 - Rash, hives became worse - went to Urgent care on 4/11/11 - Rx Prednisone x 10 days. Reported to nurse on 4/13/11 - sx improving.
Age: 0.3
Sex: F
Vaccine: RV1
Symptoms: Accidental exposure, Expired drug administered, Nausea, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nausea in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included unspecified vaccine given on an unspecified date. On 15 March 2011 the subject inadvertently received an expired 2nd dose of ROTARIX. At an unspecified time after vaccination with ROTARIX, the subject experienced nausea and vomiting. It was noted that the subject had an unspecified gastrointestinal problem prior to vaccination with ROTARIX. At the time of reporting the outcome of the events was unspecified. Attribution of events to ROTARIX was not provided.
Sex: M
Vaccine: RV1
Symptoms: Lethargy, Motor dysfunction
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of lethargy in a male subject of unspecified age who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. There were no concurrent medications. In February 2005 the subject received unspecified dose of ROTARIX at 1.0 ml, orally. In February 2005, two days after receiving ROTARIX, the subject experienced lethargy which resolved 2 days later. Approximately 4 months after receiving ROTARIX, the subject developed decreased motor skills. This event was unresolved at the time of reporting. No additional details were provided.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH, FLU(H1N1), TYP
Symptoms: Anti-GAD antibody, Anti-insulin antibody, Anti-islet cell antibody, Antibody test, Dry mouth
Clinical narrative: Pt was in his usual state of excellent health prior to June 2010. Looking back, pt recalls developing symptoms of hyperglycemia sometime around June 2010. Initially, his symptoms were subtle and he did not feel "sick"; he was able to attribute most symptoms to his job and related temperature extremes, mission temp, as well as changes in diet, exercise, and sleep habits. His symptoms included polyuria, polyphagia, polydipsia, lack of energy, problems focusing his vision, and weight loss. During an evaluation in Feb 2011, a glucose level > 500 led to his diagnosis of T1DM. At that time, pt was voiding about every 30-60 minutes during the day and had lost 40 pounds from his pre employment weight of 190 pounds. He was admitted to urgent care treatment facility for 2-3 days. During his admission, insulin was initiated, as well as diabetes self management training. He was discharged on once daily LANTUS with additional premeal NOVOLOG and supplementation for hyperglycemia using NOVOLOG, which he continues today. Denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Pt denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. He does not recall a history of a recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active with sports and and weight and PT requirements prior to diagnosis. He has no family hx of T1DM.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH, FLU(H1N1), TYP
Symptoms: Glycosylated haemoglobin, Insulin C-peptide, Metabolic function test, Pollakiuria, Thirst
Clinical narrative: Pt was in his usual state of excellent health prior to June 2010. Looking back, pt recalls developing symptoms of hyperglycemia sometime around June 2010. Initially, his symptoms were subtle and he did not feel "sick"; he was able to attribute most symptoms to his job and related temperature extremes, mission temp, as well as changes in diet, exercise, and sleep habits. His symptoms included polyuria, polyphagia, polydipsia, lack of energy, problems focusing his vision, and weight loss. During an evaluation in Feb 2011, a glucose level > 500 led to his diagnosis of T1DM. At that time, pt was voiding about every 30-60 minutes during the day and had lost 40 pounds from his pre employment weight of 190 pounds. He was admitted to urgent care treatment facility for 2-3 days. During his admission, insulin was initiated, as well as diabetes self management training. He was discharged on once daily LANTUS with additional premeal NOVOLOG and supplementation for hyperglycemia using NOVOLOG, which he continues today. Denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Pt denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. He does not recall a history of a recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active with sports and and weight and PT requirements prior to diagnosis. He has no family hx of T1DM.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH, FLU(H1N1), TYP
Symptoms: Anti-insulin antibody, Anti-islet cell antibody positive, Asthenia, Blood glucose increased, Blood immunoglobulin G
Clinical narrative: Pt was in his usual state of excellent health prior to June 2010. Looking back, pt recalls developing symptoms of hyperglycemia sometime around June 2010. Initially, his symptoms were subtle and he did not feel "sick"; he was able to attribute most symptoms to his job and related temperature extremes, mission temp, as well as changes in diet, exercise, and sleep habits. His symptoms included polyuria, polyphagia, polydipsia, lack of energy, problems focusing his vision, and weight loss. During an evaluation in Feb 2011, a glucose level > 500 led to his diagnosis of T1DM. At that time, pt was voiding about every 30-60 minutes during the day and had lost 40 pounds from his pre employment weight of 190 pounds. He was admitted to urgent care treatment facility for 2-3 days. During his admission, insulin was initiated, as well as diabetes self management training. He was discharged on once daily LANTUS with additional premeal NOVOLOG and supplementation for hyperglycemia using NOVOLOG, which he continues today. Denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Pt denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. He does not recall a history of a recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active with sports and and weight and PT requirements prior to diagnosis. He has no family hx of T1DM.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH, FLU(H1N1), TYP
Symptoms: Blood ketone body absent, Glucose urine present, Glycosylated haemoglobin increased, Hyperglycaemia, Hyperphagia
Clinical narrative: Pt was in his usual state of excellent health prior to June 2010. Looking back, pt recalls developing symptoms of hyperglycemia sometime around June 2010. Initially, his symptoms were subtle and he did not feel "sick"; he was able to attribute most symptoms to his job and related temperature extremes, mission temp, as well as changes in diet, exercise, and sleep habits. His symptoms included polyuria, polyphagia, polydipsia, lack of energy, problems focusing his vision, and weight loss. During an evaluation in Feb 2011, a glucose level > 500 led to his diagnosis of T1DM. At that time, pt was voiding about every 30-60 minutes during the day and had lost 40 pounds from his pre employment weight of 190 pounds. He was admitted to urgent care treatment facility for 2-3 days. During his admission, insulin was initiated, as well as diabetes self management training. He was discharged on once daily LANTUS with additional premeal NOVOLOG and supplementation for hyperglycemia using NOVOLOG, which he continues today. Denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Pt denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. He does not recall a history of a recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active with sports and and weight and PT requirements prior to diagnosis. He has no family hx of T1DM.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH, FLU(H1N1), TYP
Symptoms: Insulin C-peptide, Insulin C-peptide normal, Polydipsia, Polyuria, Red blood cell sedimentation rate
Clinical narrative: Pt was in his usual state of excellent health prior to June 2010. Looking back, pt recalls developing symptoms of hyperglycemia sometime around June 2010. Initially, his symptoms were subtle and he did not feel "sick"; he was able to attribute most symptoms to his job and related temperature extremes, mission temp, as well as changes in diet, exercise, and sleep habits. His symptoms included polyuria, polyphagia, polydipsia, lack of energy, problems focusing his vision, and weight loss. During an evaluation in Feb 2011, a glucose level > 500 led to his diagnosis of T1DM. At that time, pt was voiding about every 30-60 minutes during the day and had lost 40 pounds from his pre employment weight of 190 pounds. He was admitted to urgent care treatment facility for 2-3 days. During his admission, insulin was initiated, as well as diabetes self management training. He was discharged on once daily LANTUS with additional premeal NOVOLOG and supplementation for hyperglycemia using NOVOLOG, which he continues today. Denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Pt denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. He does not recall a history of a recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active with sports and and weight and PT requirements prior to diagnosis. He has no family hx of T1DM.
Age: 27.0
Sex: M
Vaccine: ANTH, ANTH, FLU(H1N1), TYP
Symptoms: Type 1 diabetes mellitus, Urine ketone body present, Vision blurred, Weight decreased
Clinical narrative: Pt was in his usual state of excellent health prior to June 2010. Looking back, pt recalls developing symptoms of hyperglycemia sometime around June 2010. Initially, his symptoms were subtle and he did not feel "sick"; he was able to attribute most symptoms to his job and related temperature extremes, mission temp, as well as changes in diet, exercise, and sleep habits. His symptoms included polyuria, polyphagia, polydipsia, lack of energy, problems focusing his vision, and weight loss. During an evaluation in Feb 2011, a glucose level > 500 led to his diagnosis of T1DM. At that time, pt was voiding about every 30-60 minutes during the day and had lost 40 pounds from his pre employment weight of 190 pounds. He was admitted to urgent care treatment facility for 2-3 days. During his admission, insulin was initiated, as well as diabetes self management training. He was discharged on once daily LANTUS with additional premeal NOVOLOG and supplementation for hyperglycemia using NOVOLOG, which he continues today. Denies any unusual or prolonged reactions within the first week following vaccine receipt. He does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Pt denies a history of elevated glucose or blood pressure levels or history of hypertension prior to T1DM diagnosis. He does not recall a history of a recent infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis. He was active with sports and and weight and PT requirements prior to diagnosis. He has no family hx of T1DM.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Immediate post-injection reaction, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Periarthritis
Clinical narrative: immediate shoulder joint pain, improved for 2 wks then returned causing significant limited ROM, daignosed with adhesive capsulitis of L shoulder with MRI and u/s evidence of humeral head cortical reaction and supraspinatus tendon partial tear
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Rotator cuff syndrome, Ultrasound scan abnormal
Clinical narrative: immediate shoulder joint pain, improved for 2 wks then returned causing significant limited ROM, daignosed with adhesive capsulitis of L shoulder with MRI and u/s evidence of humeral head cortical reaction and supraspinatus tendon partial tear
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, VARCEL
Symptoms: Dehydration, Dizziness, Feeling hot, Laboratory test, Syncope
Clinical narrative: Patient felt hot & dizzy 5 minutes after vaccine, then syncopes for a few seconds approx 20 minutes after vaccines were administered.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Bacterial test, Rash pustular, Viral test
Clinical narrative: Sx.'s: pustules noted BILAT posterior lower extremities, anterior abdomen
Age: 41.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site macule, Injection site mass, Injection site urticaria
Clinical narrative: Within minutes of vaccination patient stated urticaria to the site with a "mosquito bite-sized" bump.  Persisted for four days and resolved.  States no other side effects or problems until 04/14/2011 when 4" flat, red ring appeared near site of immunization, no edema, no warmth, no c/o of constitutional symptoms.  Will to to PMD if persists or other problems develop.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site atrophy
Clinical narrative: Reported to pharmacist 04/14/2011 10am. Patient states muscle/tissue loss at site of injection which has caused indentation.  No infection or rash occured.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Muscle atrophy, Pain, Skin irritation
Clinical narrative: Reported to pharmacist 04/14/2011 10am. Patient states muscle/tissue loss at site of injection which has caused indentation.  No infection or rash occured.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient complaining of soreness to the injection site with redness that is spreading around injection site.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Was administered Varicella vaccine on 4/6/11 at 3:41 pm. Next day came in with little bit rash to chest area, was told to return end of day and did not. States on 4/9/11 started with itching took ATARAX. On 4/10/11 she had itching & rash throughout body and took BENADRYL. She went to MD on 4/11/11 and chickenpox were ruled out. She was prescribed a MEDROL pack (steroid) and ALLEGRA. 4-12-11 rash is better color changed. No fever.
Age: 24.0
Sex: F
Vaccine: YF
Symptoms: Blood test, Chest X-ray normal, Chills, Dyspnoea, Headache
Clinical narrative: Initial report was received 28 February 2011 from a health care professional. A 24-year-old female patient had received a left arm injection (route not reported) of YF VAX, lot number UF802AA on 25 February 2011 and one day later, she developed a headache, body aches, fever of 100F, chills and sweating. She had no illness at the time of vaccination and no known allergies. Medical history was not reported. Concomitant medications consisted of LEXIPRO, TOPROMAX, ALTRAM and vicoprophen. She had not received any other vaccines within four weeks of YF VAX. At the time of the report, the patient's outcome was not recovered. Follow-up information received on 01 April 2011 from a health care professional who reported that the patient had additional symptoms of extreme shortness of breath and worsening symptoms. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. The patient had received a subcutaneous injection of the YF VAX at approximately 2:30 pm on 25 February 2011. On 28 February 2011 at 11:37 AM, the patient reported Flu-like symptoms and reported she recently had the flu (dates not provided). She reported her headache had improved with TYLENOL and body aches slightly improved with two Advil tablets. At 3:37 pm on 28 February 2011 the reporter called to "check" on the patient and stated the patient sounded better and more energetic. On 01 March 2011 at 8:30 am, the patient reported to the clinic with complaints of extreme shortness of breath and worsening symptoms. The patient was transported to the hospital emergency room (ER) for evaluation and treatment. Diagnostic and laboratory tests included a portable chest x-ray which was negative, oxygen saturation of 100% on room air (RA), blood draw with results not reported and a temperature of 99.1 degrees. She was treated with ATIVAN. The patient was discharged from the ER in stable condition with instructions to drink plenty of liquids and to be off from work 01-03 March 2011. No further information was available at the time of the report. The patient's outcome was reported as recovered on 02 March 2011. Documents held by sender; None.
Age: 24.0
Sex: F
Vaccine: YF
Symptoms: Hyperhidrosis, Influenza like illness, Pain, Pyrexia
Clinical narrative: Initial report was received 28 February 2011 from a health care professional. A 24-year-old female patient had received a left arm injection (route not reported) of YF VAX, lot number UF802AA on 25 February 2011 and one day later, she developed a headache, body aches, fever of 100F, chills and sweating. She had no illness at the time of vaccination and no known allergies. Medical history was not reported. Concomitant medications consisted of LEXIPRO, TOPROMAX, ALTRAM and vicoprophen. She had not received any other vaccines within four weeks of YF VAX. At the time of the report, the patient's outcome was not recovered. Follow-up information received on 01 April 2011 from a health care professional who reported that the patient had additional symptoms of extreme shortness of breath and worsening symptoms. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. The patient had received a subcutaneous injection of the YF VAX at approximately 2:30 pm on 25 February 2011. On 28 February 2011 at 11:37 AM, the patient reported Flu-like symptoms and reported she recently had the flu (dates not provided). She reported her headache had improved with TYLENOL and body aches slightly improved with two Advil tablets. At 3:37 pm on 28 February 2011 the reporter called to "check" on the patient and stated the patient sounded better and more energetic. On 01 March 2011 at 8:30 am, the patient reported to the clinic with complaints of extreme shortness of breath and worsening symptoms. The patient was transported to the hospital emergency room (ER) for evaluation and treatment. Diagnostic and laboratory tests included a portable chest x-ray which was negative, oxygen saturation of 100% on room air (RA), blood draw with results not reported and a temperature of 99.1 degrees. She was treated with ATIVAN. The patient was discharged from the ER in stable condition with instructions to drink plenty of liquids and to be off from work 01-03 March 2011. No further information was available at the time of the report. The patient's outcome was reported as recovered on 02 March 2011. Documents held by sender; None.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Flushing, Hypoaesthesia facial, Nausea, Paraesthesia
Clinical narrative: Patient returned post vaccine 2 hrs stating nausea, flushing approx 1/2 p. vaccine then stated she developed some numbness and tingling on facial area -> to ER.
Sex: M
Vaccine: DTP
Symptoms: Apparent life threatening event, Convulsion, Immunodeficiency, Learning disability
Clinical narrative: Initial report was received 05 April 2011 via a company sponsored web site from a consumer, who is the patient's mother.  A male infant, had received a first full dose of DTP in 1982 (manufacturer unknown, lot number, route, site and exact date of administration not reported).  The reporter indicated that the DTP vaccine manufacturer may have been Eli Lilly.  Within one hour after receiving the vaccine, the mother felt there was something desperately wrong with the infant (unspecified).  Within the first three years of the patient's life, the patient had immune deficiency and seizure disorder and came close to death (also reported as almost died) several times.  He suffered for many months and years with learning disabilities and seizures.  He required medical care (unspecified), counseling and special education services.  The reporter stated that she finally found help (unspecified) for her son at a hospital (it was not reported if the patient had been hospitalized).  The patient's outcome was not reported.  No additional information was provided at the time of the report.  Upon review of this case, it was determined that the event of "close to death several times" met the seriousness criteria of life threatening.  Documents held by sender: None.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injected limb mobility decreased, Injection site warmth, Pain in extremity
Clinical narrative: Pt's arm very sore (L) - had a hard time lifting it. SQ site warm to touch - no elevated temperature. Red around site 1 1/2" - slightly firm. No drainage from site. Encouraged TYLENOL & cool compress to area. Should go to clinic if gets worse. It was better 4 days later.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Injection site pain, Pain, Pain in extremity, Radiculitis brachial
Clinical narrative: Initial report was received 11 April 2011 from a consumer, who is also the patient.  A 57-year-old female patient who had a history of Hashimoto's disease and hyperparathyroidism, had received a right deltoid intramuscular injection of ADACEL, lot number C3828AA on 25 March 2011 and two days later, she developed an intense burning from the injection site to her shoulder.  She also experienced pain shooting down her arm and pain in the back of her arm.  The event required an emergency room visit and doctor's visit.  The patient was seen by a neurologist and diagnosed with brachial neuritis.  Corrective treatments consisted of Tramadol for pain.  The patient had no illness and no known allergies at the time of vaccination.  Concomitant therapies consisted of Levoxyl 100 mg.  The patient had not received any other vaccines within four weeks of ADACEL and she denied any history of adverse events following prior vaccinations.  Outcome was not recovered.  Documents held by sender: None.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Activities of daily living impaired, Headache, Injection site pain, Lymphadenopathy, Mobility decreased
Clinical narrative: Initial report was received 11 April 2011 from a consumer, who is also the patient.  A 57-year-old female patient who had a history of Hashimoto's disease and hyperparathyroidism, had received a right deltoid intramuscular injection of ADACEL, lot number C3828AA on 25 March 2011 and two days later, she developed an intense burning from the injection site to her shoulder.  She also experienced pain shooting down her arm and pain in the back of her arm.  The event required an emergency room visit and doctor's visit.  The patient was seen by a neurologist and diagnosed with brachial neuritis.  Corrective treatments consisted of Tramadol for pain.  The patient had no illness and no known allergies at the time of vaccination.  Concomitant therapies consisted of Levoxyl 100 mg.  The patient had not received any other vaccines within four weeks of ADACEL and she denied any history of adverse events following prior vaccinations.  Outcome was not recovered.  Documents held by sender: None.
Age: 57.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Muscular weakness, Musculoskeletal stiffness, Pain
Clinical narrative: Initial report was received 11 April 2011 from a consumer, who is also the patient.  A 57-year-old female patient who had a history of Hashimoto's disease and hyperparathyroidism, had received a right deltoid intramuscular injection of ADACEL, lot number C3828AA on 25 March 2011 and two days later, she developed an intense burning from the injection site to her shoulder.  She also experienced pain shooting down her arm and pain in the back of her arm.  The event required an emergency room visit and doctor's visit.  The patient was seen by a neurologist and diagnosed with brachial neuritis.  Corrective treatments consisted of Tramadol for pain.  The patient had no illness and no known allergies at the time of vaccination.  Concomitant therapies consisted of Levoxyl 100 mg.  The patient had not received any other vaccines within four weeks of ADACEL and she denied any history of adverse events following prior vaccinations.  Outcome was not recovered.  Documents held by sender: None.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Anaphylactic reaction, Rhinorrhoea, Swelling face, Urticaria, Wheezing
Clinical narrative: Anaphylaxis within 20 minutes after vaccines given - facial swelling, rhinorrhea, wheezing, urticaria.
Age: 33.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Fever, erythema & induration at Tdap site.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Dyskinesia, Pyrexia, Staring
Clinical narrative: She received the MMR shot on 3-18-11 and on 2 separate days within a week of that she had a 104 degree temperature which was very difficult to bring down - and she had fever seizures (stares - jerking).
Age: 15.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: At site of vaccine (Varicella) developed erythema & induration. Erythema border outlined, grew 5 x 4 cm -> 13 x 10 cm in 24 hrs. No drainage. Prescribed Amoxicillin x 10 days.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: After receiving her third dose of GARDASIL approx. 30 seconds after vaccine, patient had a syncopal episode. Patient fell off exam table hitting her head - LOC approx 30 sec. Pt. was examined by doctor & ice applied to head & observed for 30 min.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Area of injection (upper arm) became reddened and somewhat hard to the touch about 24 hrs post injection. No itching, no discomfort. Pt applied mild heat to area and over the course of 6 days the area had softened and much less red. No ill effects were noted. This was probably a normal reaction - no allergic signs noted.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, PNC13
Symptoms: Injection site swelling, Lymphadenopathy
Clinical narrative: Swelling 10 x 8cm (L) deltoid with erythema. (L) axillary node 3 x 5 cm.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pruritus, Ocular hyperaemia, Respiratory tract congestion, Throat irritation
Clinical narrative: Flu vaccine given at 2:15 pm. By 4:15 pm, pt. reports throat "scratchy/itchy", eyes, "red & itchy" feeling of congestion. No respiratory distress. All symptoms resolved by 9:00 pm. No fever. No vomiting.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Abdominal discomfort, Injection site pain, Pain in extremity, Somnolence, Vomiting
Clinical narrative: Wed -> less than 24 hrs later, (L) leg pain in entire leg all the way to the foot w/moments of intense foot pain. Also upset belly and took a 1.5 hr. nap, which is unusual. This lasted about full 24 hours. Fri -> belly still upset & random vomiting 2x's in a row at 10am.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood creatine phosphokinase, Headache, Neuralgia, Presyncope
Clinical narrative: Extreme head pain, nerve ending pain-all over-preceded by nearly losing consciousness on the street while walking my dog-several hours after the vaccine was given.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Facial pain, Feeling abnormal, Feeling cold, Headache
Clinical narrative: Extreme head pain, nerve ending pain-all over-preceded by nearly losing consciousness on the street while walking my dog-several hours after the vaccine was given.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inflammation, Pain, Pyrexia
Clinical narrative: Extreme head pain, nerve ending pain-all over-preceded by nearly losing consciousness on the street while walking my dog-several hours after the vaccine was given.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: 3/29/11 - loose stool, decreased appetite x 7 days. 4/7/11 - red lump (L) thigh - warm to touch. 4/10/11 - rash on stomach, hands, arms, back, head, papules on sides, neck and ears. Afebrile.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Papule, Rash
Clinical narrative: 3/29/11 - loose stool, decreased appetite x 7 days. 4/7/11 - red lump (L) thigh - warm to touch. 4/10/11 - rash on stomach, hands, arms, back, head, papules on sides, neck and ears. Afebrile.
Age: 18.0
Sex: F
Vaccine: HEP, MEN
Symptoms: Headache, Rash generalised
Clinical narrative: Had headache night of 04/13/2011 which resolved. Noticed on day of 04/14/2011 to have full body rash. No difficulty with breathing, fever, or neuro symptoms. Gave Benadryl and discussed reasons to go to ER.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HIBV, PNC
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swollen.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, HIBV, PNC
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swollen.
Age: 13.0
Sex: F
Vaccine: HPV4, MMR, MNQ, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Clts was living with father, recently moved back to mother's care.  HD called provider for IMMs record at which time there was 1 sheet received, with 1 Gardasil recorded. There was only the 1 recorded on MICR. This RN administered HPV on 4/12/2011 as 2nd dose.  There was a subsequent fax that came to the HD after clt's visit that 3 doses of HPV vacc. recorded.  The 4/12/2011 dose was then clts. 4th dose.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid red, warm to touch and swollen to the size of an egg. Pt stated area was also burning. Pt given ice packs and told to take Tylenol or Motrin. If symptoms persisted or got worse to return to clinic or Emergency Department.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Screaming
Clinical narrative: Uncontrolable screaming for 24 hours
Age: 3.0
Sex: M
Vaccine: MMR, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at site right leg, size about 4 inch
Age: 19.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP
Symptoms: Dysarthria, Paraesthesia oral, Tongue paralysis
Clinical narrative: TONGUE FELT STRANGE TONGUE MOVEMENT WAS WEIRD, VOICE SLURRED. GIVEN 0.3 MG OF 1:1000 EPI R ARM IM
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness, swelling, pain at injection site
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local swelling
Clinical narrative: Patient has red swollen area, size of an egg on the back of the left arm. No fever, no rash. Taking Advil.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Faeces discoloured, Frequent bowel movements
Clinical narrative: 2 weeks of green frothy bubbly stools with up to 20 times per day.  Was not fussy.  Fed well the whole time.  Was Breastfed.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Pts mother called office on 3/25/11 to report red bump/rash.  Mom gave pt Claritin and Bendaryl. No difficulty breathing at this time. Neg n/v. Was seen at the Urgent Care on 3/29/11 and given an epi injection.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Computerised tomogram normal, VIIth nerve paralysis
Clinical narrative: Bell's Palsy, affecting right side of face
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Child broke out with chickenpox blisters all over body. Mother called physcian who diagnosed chickenpox over the phone.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Two inch wheal, six inch flare began within 24 hours after injection.  Peaked around 48-72 hrs after injection. Treated with topical ice, cortisone and antihistamine.
Age: 71.0
Sex: M
Vaccine: PER
Symptoms: Nerve conduction studies abnormal, Neuralgic amyotrophy
Clinical narrative: Parsonage Turner Syndrome (Brachial plexis neuritis)
Age: 15.0
Sex: M
Vaccine: MEN
Symptoms: Abasia, Bacterial test negative, Borrelia test negative, Eye irritation, Facial pain
Clinical narrative: Patient had severe pain in his legs on Friday April 8th. He woke early in the morning, and could not walk for a few hours. The pain subsided by afternoon, though mild soreness persisted for the day. He was ok, and relaxed for the weekend and stayed off his legs for the most part. On Monday April 11th, patient woke up with a facial droop like that of Bells palsy. His face was swollen on his right side. His right eye was pink, tearing up and felt irritated. His face both mildly hurt and felt numb in some places. This persisted all day. The next day patient experienced the same symptoms, but to a lesser degree. On April 13th, patient woke more umcomfortable and swollen. His left eye had a pink stripe across it, and both eyes felt irritated. Today is April 14th. The swelling had gone down and he is experiencing less discomfort, but is not symptom free yet. Patient has never experienced any of these symptoms before, including the pain in his legs. He did not do any strenuous activities that week, and he had no illnesses for months prior to this event.
Age: 15.0
Sex: M
Vaccine: MEN
Symptoms: Hypoaesthesia facial, Lacrimation increased, Pain in extremity, Swelling face, VIIth nerve paralysis
Clinical narrative: Patient had severe pain in his legs on Friday April 8th. He woke early in the morning, and could not walk for a few hours. The pain subsided by afternoon, though mild soreness persisted for the day. He was ok, and relaxed for the weekend and stayed off his legs for the most part. On Monday April 11th, patient woke up with a facial droop like that of Bells palsy. His face was swollen on his right side. His right eye was pink, tearing up and felt irritated. His face both mildly hurt and felt numb in some places. This persisted all day. The next day patient experienced the same symptoms, but to a lesser degree. On April 13th, patient woke more umcomfortable and swollen. His left eye had a pink stripe across it, and both eyes felt irritated. Today is April 14th. The swelling had gone down and he is experiencing less discomfort, but is not symptom free yet. Patient has never experienced any of these symptoms before, including the pain in his legs. He did not do any strenuous activities that week, and he had no illnesses for months prior to this event.
Age: 15.0
Sex: M
Vaccine: MEN
Symptoms: Viral test negative
Clinical narrative: Patient had severe pain in his legs on Friday April 8th. He woke early in the morning, and could not walk for a few hours. The pain subsided by afternoon, though mild soreness persisted for the day. He was ok, and relaxed for the weekend and stayed off his legs for the most part. On Monday April 11th, patient woke up with a facial droop like that of Bells palsy. His face was swollen on his right side. His right eye was pink, tearing up and felt irritated. His face both mildly hurt and felt numb in some places. This persisted all day. The next day patient experienced the same symptoms, but to a lesser degree. On April 13th, patient woke more umcomfortable and swollen. His left eye had a pink stripe across it, and both eyes felt irritated. Today is April 14th. The swelling had gone down and he is experiencing less discomfort, but is not symptom free yet. Patient has never experienced any of these symptoms before, including the pain in his legs. He did not do any strenuous activities that week, and he had no illnesses for months prior to this event.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Oedema peripheral, Pruritus, Tenderness
Clinical narrative: swollen, red shoulder, mildly itchy and tender
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix
Clinical narrative: I GOT THE GARDASIL SHOT AND IT PERMANENTLY GAVE ME THE HPV VIRUS, I NOR MY DOCTORS KNOW IF IT WILL GET WORSE, BUT IT IS NOT CURABLE. I AM STUCK WITH THIS VIRUS FOR THE REST OF MY LIFE. BECAUSE OF THE GARDASIL SHOT THAT WAS SUPPOSED TO PREVENT ME FROM GETTING HPV.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Cold sweat, Erythema, Gaze palsy, Hypotonia, Loss of consciousness
Clinical narrative: After 5-6min after injection pt c/o nausea then face turned red eyes rolled back lost consciouness and became pale, flaccid, and clammy. Ambulance was called and pt was taken to the ER.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Pallor
Clinical narrative: After 5-6min after injection pt c/o nausea then face turned red eyes rolled back lost consciouness and became pale, flaccid, and clammy. Ambulance was called and pt was taken to the ER.
Age: 1.35
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: High fever 103 for two days (Thursday, Friday and broke Saturday), followed by a rash (like chickenpox on Saturday night then all of Sunday, began to go away Monday afternoon) followed by another rash - bigger bumps, more clustered all over his body.
Age: 0.76
Sex: M
Vaccine: PNC
Symptoms: Insomnia, Irritability, Pyrexia, Skin warm
Clinical narrative: Son had fever of 101-103.6 was very irritable could not be consoled. Did not sleep through the night. Sleepless, cranky, skin warm to the touch.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Local reaction in left deltoid, pain, hardness swelling 10cm x 12cm approximately 12 hours post vaccine.
Age: 1.51
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Sudden death
Clinical narrative: Sudden unexplained death.
Age: 1.08
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Soon after Imms given urticarial rash over neck area only. No progression noted, on observation for 15 min. BENADRYL 4ml given. Clear chest, no distress, no fever on exam before child left the office. Advised Mom to call us at the clinic if rash progresses or still concerned. An oncall Dr. would call her back. RN called Mom at 5:30pm, rash all gone, didn't repeat BENADRYL at home.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Pallor
Clinical narrative: Pt. turned white, had trouble breathing & almost passed out. Was transported to ER by paramedics. Was discharged from hospital with no known symptoms 30 mins later.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Patient has large rash on left deltoid warm to the touch, patient states it itches a lot. No fever or other complaints.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (L) upper arm (elbow to shoulder) with tight swelling & redness; increased warmth; tender to palpation. ? Large local reaction-vs-cellulitis. Tx with BENADRYL q 6 hours; MOTRIN q 6 hours x 24 hours & DURICEF 500mg/5ml Sig > 3ml po BID x 10d.
Age: 57.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain
Clinical narrative: Pain in a linear form on (L) upper arm. No eryth or swelling.
Age: 1.36
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Rash erythematous, Rash pustular
Clinical narrative: Mom reports that a rash appeared on his buttocks approx 2 hrs. after vaccinations. Rash has progressed to being papular & pustular. It is diffuse in location, on lower extremities & diaper area & is red in color.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Erythematous 10x4 cm patch (L) upper arm. Warm to touch.
Age: 1.05
Sex: F
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Rash erythematous, Vaccination site reaction
Clinical narrative: Red bumps around vaccination site.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) leg at injection site with redness, swelling & warm to touch 1 day after vaccine given.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Patient developed whelps over most of her body. Reaction was a few hours after shot was given.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Patient seen with about 15-20 lesions most c/w varicella.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Patient describes adverse event as 2" long x 1" wide bump at site of injection. She states that the bump is red, hot, hard, & itchy (but not painful).
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration
Clinical narrative: 6 cm x 7.5 cm erythema with induration; non-tender to palpation; no warmth at site. Imm. administered 4/12/11; seen in office r/t reaction 4/14/11. Tx: ice pack to arm & Ibuprofen.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Headache, Injection site urticaria, Papule
Clinical narrative: Given Varicella vaccine on 3-25-11, advised by PCP following titer showing no immunity - never had illness or vaccine. On 4-11-11, 2 weeks following vaccine developed headache, urticaria (hive) at injection site and several vesicles/papules scattered to scalp, face, back, chest, arms.
Age: 61.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Chills, Cough, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: Initial report received from vaccine adverse event reporting system website (VAERS reference number 379710) on 01 Feb 2011: This patient with an unknown medical history was vaccinated with S-OIV FLUVIRIN (batch number: 1021173P) in one arm and influenza vaccine (manufacturer and batch number: unknown) in another arm on 26 Jan 2010. The patient experienced congestion, sore throat, aches, chills, exhaustion, and cough on 01 Feb 2010. The patient was concomitantly using FOSAMAX and atorvastatin calcium. The outcome was not reported.
Age: 61.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Respiratory tract congestion
Clinical narrative: Initial report received from vaccine adverse event reporting system website (VAERS reference number 379710) on 01 Feb 2011: This patient with an unknown medical history was vaccinated with S-OIV FLUVIRIN (batch number: 1021173P) in one arm and influenza vaccine (manufacturer and batch number: unknown) in another arm on 26 Jan 2010. The patient experienced congestion, sore throat, aches, chills, exhaustion, and cough on 01 Feb 2010. The patient was concomitantly using FOSAMAX and atorvastatin calcium. The outcome was not reported.
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Pyrexia
Clinical narrative: This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced high fever. The patient received a dose on 07-May-2010. Patient received PREVNAR therapy on 07-May-2010. It was reported on 10-May-2010, that the patient over the weekend had been treated at the hospital or was hospitalized with a high fever. Outcome was not provided. See related cases(s): US-WYE-H15094610 (adverse event, expedited) and US-WYE-H15094510 (adverse event, expedited). Follow-up (07Dec2010): Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up report may indicate in the appropriate field that this is an initial report. New information received from a contactable physician included event outcome of recovered. Follow-up attempts completed. No further information expected.