chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Nuclear magnetic resonance imaging abnormal, Pericardial disease
Clinical narrative: This study case was received from the investigator on 24 May 2013. A 25-year-old male subject received the an injection of ACAM2000 (lot number, route and site of administration not reported) on 13 March 2013 and the following vaccinations on 12 March 2013: TYPHIM (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported). The subject was diagnosed with unspecified disease of pericardium on 26 March 2013 and other and unspecified acute myocarditis on 28 March 2013. Relevant laboratory data included abnormal Troponin I at 00.89 and an abnormal ECG on 26 March 2013, a normal echocardiogram on 27 March 2013 and an abnormal MRI (heart) on 28 March 2013. Treatments were not reported. The subject had no past medical history. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Troponin I increased
Clinical narrative: This study case was received from the investigator on 24 May 2013. A 25-year-old male subject received the an injection of ACAM2000 (lot number, route and site of administration not reported) on 13 March 2013 and the following vaccinations on 12 March 2013: TYPHIM (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number, route and site of administration not reported). The subject was diagnosed with unspecified disease of pericardium on 26 March 2013 and other and unspecified acute myocarditis on 28 March 2013. Relevant laboratory data included abnormal Troponin I at 00.89 and an abnormal ECG on 26 March 2013, a normal echocardiogram on 27 March 2013 and an abnormal MRI (heart) on 28 March 2013. Treatments were not reported. The subject had no past medical history. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Cardiac failure, Echocardiogram, Electrocardiogram abnormal, Pericardial disease, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013. A 24-year-old male subject with no past medical history was found to have unspecified disease of pericardium and heart failure, unspecified 11 days after receiving an injection of ACAM2000 (lot number, route and site of administration not reported) on 02 March 2013. The subject also received an injection of TYPHIM (lot number, route and site of administration not reported) on 23 February 2013. Relevant laboratory data included an abnormal ECG on 13 March 2013. Troponin I and echocardiogram were not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 43.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram abnormal, Hypertrophic cardiomyopathy, Nuclear magnetic resonance imaging, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013. A 43-year-old male subject was found to have hypertrophic obstructive cardiomyopathy 19 days after receiving an injection of ACAM2000 (lot number, route and site of administration not reported) on 31 January 2013. Relevant laboratory data included an abnormal echocardiogram on 28 February 2013. Treatments were not reported. Past medical history included elevated cholesterol, chest pressure, cardiomyopathy and abnormal ECG. Troponin I, ECG and MRI of the heart were unavailable. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 35.0
Sex: M
Vaccine: JEV1
Symptoms: Gait disturbance, Groin pain, Pain, Pain in extremity
Clinical narrative: Patient report approx. 3-4 hrs after having received his first dose of Ixiaro IM in his lt deltoid he started having constant, sharp pain radiates from above ankle to LT groin. Saw Pt on 6-4-13 leg pain persists. Able to have full weight-bearing. + limping w/ambulation d/t pain. Lt pedal pulse +3. No edema/erythema/overt signs of lt leg injuries during this visit. Full ROM of lt leg. Pt denied hx of sciatica or past back injuries.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Electrocardiogram, Pericarditis
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013. A 21-year-old male subject was found to have other acute pericarditis 11 days after receiving the following vaccines on 23 February 2013: an injection of ACAM2000 (lot number, route and site of administration not reported), TYPHIM (lot number, route and site of administration not reported) and Anthrax (manufacturer, lot number route and site of administration not reported). ECG was not available. Treatments were not reported. The subject had no past medical history. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 53.0
Sex: F
Vaccine: SMALL, TYP
Symptoms: Cardiomyopathy, Echocardiogram abnormal, Electrocardiogram, Nuclear magnetic resonance imaging, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013. A 53-year-old female subject was found to have other primary cardiomyopathies 16 days after receiving the following vaccines on 11 March 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and TYPHIM (lot number, route and site of administration not reported). Relevant laboratory data included an abnormal echocardiogram on 27 March 2013. Troponin I, ECG and MRI of the heart were unavailable. Treatments were not reported. Past medical history included high blood pressure, elevated cholesterol, chest pain, cardiomyopathy, abnormal ECG, shortness of breath and headaches. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram abnormal, Myocarditis, Myocarditis septic, Pericardial disease, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 24 May 2013. A 36-year-old male subject was found to have other and unspecified acute myocarditis, septic myocarditis, unspecified disease of pericardium and non-specific myocarditis 12 days after receiving an injection of ACAM2000 (lot number, route and site of administration not reported) on 14 February 2013. Relevant laboratory data included abnormal troponin I of 07.55 on 26 February 2013 and an abnormal ECG on 08 March 2013. ECG was unavailable. Treatments were not reported. The subject had no past medical history. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Start 5/26/2013 and through 5/28/2013 she developed varicella-like rash on left side to: neck, upper arm, bend of elbow, forearm, wrist et top of hand. Total of approx. 13 lesions. No other c/o. Home tx with BENADRYL cream.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, heat around injection sites.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased, Pain in extremity, X-ray limb
Clinical narrative: Received vaccine at about 11AM, developed pain and swelling of site at about 4PM. Swelling improved but pain progressed with radiation down arm and inability to move shoulder joint.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Malaise, Pyrexia
Clinical narrative: Mom states - Son received T-dap vaccine on Tues 5/14/13 pm - Son woke around 11:30 AM and called her complaining of fever and SOB - Mom went home to check son - temp 102 and still having SOB - told mom to take son to ED. 6/3/13 attempted to f/u several times after report on 5/15/13. Spoke with mother on 5/23/13. Mother assistant patient was taken to ER on 5/15/13 - Temp 103 degrees, was retained in ER for 5 hours until fever resolved, was administered IV flds Lab work negative. Mother assistant patient went to work after receiving Tdap vaccine on 5/14/13, became ill after cutting grass. No other f/u reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a 1 year old patient (gender unknown). No medical history was reported. On 23-MAY-2013, the patient was vaccinated with an expired dose of M-M-R II (lot # 670619/0601AA, expiry: 26-APR-2013). This is 1 of 2 reports regarding twin patients (siblings) received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a 1 year old patient (gender unknown). No medical history was reported. On 23-MAY-2013, the patient was vaccinated with an expired dose of MMR II (lot # 670619/0601AA, expiry: 26-APR-2013). This is 1 of 2 reports regarding twin patients (siblings)received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Crying, Vomiting
Clinical narrative: On 3/22/13 client rec'd DTaP, IPV, Hib, HBV, PCV 13, et ROTATEQ. Mother reported to this RN that client cried for 24 h et had 3 episodes of emesis. Client received imm. at pvt. Dr's office.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a physician refers to a 18 year old male patient. No medical history was reported. The patient was vaccinated with dose 1 M-M-R II(lot #,expiry not reported) on 19-FEB-1996 and with dose 2 of M-M-R II (lot #,expiry not reported) on 31-MAR-2000, 0.5 ml, subcutaneously. No concomitant medications were reported. The physician reported that the patient who had received 2 doses of M-M-R II in the past and now (on an unknown date 2013) has an equivocal titer result (1.04) for mumps. The outcome of equivocal titer result (1.04) for mumps was unknown. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Diarrhoea, Erythema, Oedema peripheral, Skin warm
Clinical narrative: This non-medically confirmed report (initial receipt 21-May-2013) concerns a female patient. On an unspecified date the patient received AFLURIA (batch number not specified) and PNEUMOVAX (batch number not specified), both in the left arm. On the 3rd day the patients arm began to swell, was red and felt hot. She also experienced episodes of diarrhoea. She visited the hospital and was diagnosed with cellulitis. She was prescribed antibiotics. The outcome for the event was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical history was reported. On 28-MAY-2013 the patient was vaccinated with an expired dose of ZOSTAVAX lot # 671020/0746AA, expiry 15-JUL-2011 (reported as 18-AUG-2012). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 5 year old female patient. No medical history was reported. On 28-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J000445, expiry:11-APR-2014) 0.65 ml, subcutaneously instead of VARIVAX. No concomitant medications were reported. No adverse effect were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 19-MAY-2013 the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # J000494, exp. date: 14-APR-2014) as doctor recommendation. Concomitant medication included "couple of medications". It was reported that patient received ZOSTAVAX and 1-2 days after vaccination on approximately 20-MAY-2013 the patient experienced itchy and redness at the injection site. The patient was given topical CORTAID for the events. At the time of report, the patient was recovering from the events. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report was received from a physician refers to an unknown umber of patients of unknown age and gender. No medical history was reported. On unknown dates, the patients probably were vaccinated with MMR II (lot #, expiry, dose, route not reported). No concomitant medications were reported. The physician reported that there have been outbreaks of mumps in unspecified colleges in his area, in patients that he stated probably had received MMR II. The outcome of mumps was unknown. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 66 year old male patient. The patient has unspecified reaction and sulfa allergy. On 08-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). Concomitant therapies included ASPIRIN, ATENOLOL, LISINOPRIL and SPIRONOLACTONE. ON 18-MAY-2013, patient experienced a case of shingles on the right neck and ear after he received ZOSTAVAX. It was unspecified if the patient had laboratory diagnostics. The patient was treated with FAMVIR 500mg, one tablet, three times a day for 7 days starting from 22-MAY-2013 and GABAPENTIN 100mg, one tablet, three times daily. The outcome of the event was reported as recovering. On 20-MAY-2013, the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patient experienced pain, redness and swelling at the injection site. The outcome of pain, redness and swelling at the injection site was unknown. The patient wanted to know exactly how long this adverse event would last. The patient was advised to speak further with her healthcare provider. The relatedness for all the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Electrocardiogram, Imaging procedure, Laboratory test, Malaise
Clinical narrative: Patient is a 64 year old male. Sx began day after the Tdap. Aching, myalgias, malaise, very sore arm, then a cough which he still has. No exposures, no pmh of pertussis, no rash. No is tired and has a cough. No sx with yard work. I have reviewed all pertinent lab, EKG, imaging studies and advised and discussed appropriate diet and exercise. Reaction to DTaP immunization prednisone 20 mg tablet.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Patient is a 64 year old male. Sx began day after the Tdap. Aching, myalgias, malaise, very sore arm, then a cough which he still has. No exposures, no pmh of pertussis, no rash. No is tired and has a cough. No sx with yard work. I have reviewed all pertinent lab, EKG, imaging studies and advised and discussed appropriate diet and exercise. Reaction to DTaP immunization prednisone 20 mg tablet.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an approximately 18 year old female patient. No information regarding the patient's medical history was provided. On 13-JAN-2011 the patient was vaccinated with the first dose of GARDASIL injection. On 20-AUG-2012 the patient received the second dose. No concomitant medication was reported. It was reported that the patient received GARDASIL off schedule. The patient asked to receive the third dose in the near future. No adverse effects were reported. No outcome was reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. On 30-MAY-2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous in the posterior left upper arm, lot # was unknown inadvertently instead of VARIVAX (Merck). No adverse reaction reported. The patient did not sought medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Fainted post vaccination. Recovered almost immediately. Cool compresses to neck/face, head placed between knees. Moved to cot when safe to do so. Observed x 30 min without further incident. (Seated at time of vaccination).
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix abnormal, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician (M.D.) via a company representative refers to a 22 year old female patient. On unknown dates the patient was vaccinated intramuscularly with dose of GARDASIL, 3 doses respectively, (date, dose, frequency, lot# not provided). The patient had tested positive for high risk HPV after completing the 3 doses series of GARDASIL. The patient had her annual pap smear done at the physician's office on 20-MAY-2013 and also had  a colpo biopsy done on an unspecified date and location. The patient was not hospitalized and alive. Her adverse event improvement and present status was unknown. Therapy with GARDASIL was reported as not discontinued. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Skin discolouration, Skin papilloma, Swelling
Clinical narrative: This spontaneous report was received from a mother refers to approximately 12 year old daughter. The patient had no pertinent medical history or drug reactions or allergies. On an unknown date between nov -2012 and jan-2013, the patient was vaccinated with dose 1 of GARDASIL,(lot number, expiry date and route was not reported). On an unknown date in MAY-2013, the patient was vaccinated with dose 2 of GARDASIL,(lot number, expiry date and route was not reported). The patient was scheduled for dose 3 in September 2013. There was no concomitant medications reported. On an unknown date (reported as days after dose 1), the patient complained that her feet hurt. The bottom of her feet had raised areas and were discolered at that time. Yesterday the patient went to the physician with 5 to 8 warts on the bottom of each of her feet. She was seeing a dermatologist today. The patient was also administered with an unspecified dose of unspecified hepatitis vaccine(manufacturer unknown) along with first dose of GARDASIL. There was no laboratory diagnostics performed. There was no treatment rendered for the events. The outcome of the reported events were not recovered at the time of this report. The patient sought medical attention. Additional information has been attention.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pustular
Clinical narrative: Pt began developing small pustules on the right side of the neck, chest and behind the right ear around 6:00 PM the day he recieved the smallpox vaccine. The pustules behind the right ear grew larger and the pustules on the neck and chest were about 1/2 centimeter in clusters. Pt is being evaluated at the facility.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction, Dyspnoea, Eye swelling, Hyperhidrosis, Nausea
Clinical narrative: Felt nauseated first, vomiting started, eye swelling, red eyes, sweating - worsened as night progressed, went to ED around 11pm because of vomiting and shortness of breath.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Ocular hyperaemia, Vomiting
Clinical narrative: Felt nauseated first, vomiting started, eye swelling, red eyes, sweating - worsened as night progressed, went to ED around 11pm because of vomiting and shortness of breath.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Folliculitis, Injection site rash
Clinical narrative: On 5/17/2013 rec'd Prevnar, Dtap and Hib as well as oral Rotateq. See OU 05/24/2013. Parents reported after vaccines at sites of injections skin colored rash c/w folliculitis diagnosis. No hives no respiratory distress.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Allergy test, Full blood count, Hepatobiliary scan, Laboratory test abnormal
Clinical narrative: Mid upper abd pain since September 2012 (intermittent). Box 9: Possible gallbladder removal.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Metabolic function test, Red blood cell sedimentation rate, Urinary system X-ray
Clinical narrative: Mid upper abd pain since September 2012 (intermittent). Box 9: Possible gallbladder removal.
Age: 62.0
Sex: F
Vaccine: HEPAB
Symptoms: Urticaria
Clinical narrative: Client developed hives on back, chest, arms and legs. Took 2 seperate doses of oral Benadryl 25mg on 5/29 and on 5/30 without relief. Topical steoiod applied to area on back without improvement.
Age: 29.0
Sex: M
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 29 year old male patient. No medical history was reported. On 11-APR-2013, the 29 year old patient was vaccinated with a dose of PROQUAD (merck) (lot#, expiry, dose, route not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. It was reported that on an unknown date an unknown number of patients were vaccinated with GARDASIL or VAQTA (information captured in MARRS#1305USA013384) (dose, route, lot number and expiration date not reported). Medical assistant reported that the vaccine was stored lower than -1C (Celsius degrees) from July 2012 until the present. No adverse effect was reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: PPV
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 (gender unspecified). On 30-MAY-2013 the patient was vaccinated with an expired PNEUMOVAX23 lot # 671615/1170AA, exp date. 10-MAY-2013, 0.5 ml once, intramuscularly. No adverse effect reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 year old female patient with no known drug reactions or allergies. On 10-MAY-2013 the patient was vaccinated subcutaneously with ZOSTAVAX, 0.65 ml (lot number reported as: J001005; exp. date 24-APR-2014). Concomitant therapies included losartan potassium (+) hydrochlorothiazide (manufacturer unknown) (dose, frequency were not reported), ADVAIR and generic montelukast sodium (manufacturer unknown). In May 2013, the patient subsequently developed shingles on her torso. She was diagnosed with shingles by her physician on 15-MAY-2013. VALTREX and Triamcinolone topical cream were given as a treatment for shingles. The outcome of developed shingles on her torso was unknown. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse. The nurse reported that on 17-MAY-2013 expired dose of PNEUMOVAX23 (dose and route were not reported) (lot number 671615/1170AA, expiration date: 10-MAY-2013) was administered to the 9 year old patient of unknown gender. No adverse events were reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Mumps, Pyrexia, Urticaria
Clinical narrative: This spontaneous report was received from a patient's mother, who is a former company representative, from an unspecified pharmaceutical company and refers to her current teenaged male son. On an unknown date the patient, (who was at that time 18-months old) was vaccinated with M-M-R II (dose, route of administration, lot number and exp. date were not provided). On an unknown date the patient developed a high fever, 107 degrees (unspecified), and broke out in welts that looked very similar to a mumps outbreak. Patient's mother called to determine his risk for developing a similar reaction from a booster dose of M-M-R II, before going overseas. The outcome of a high fever and welts that looked very similar to a mumps outbreak was unknown. The relatedness between high fever and welts that looked very similar to a mumps outbreak and M-M-R II was not reported. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. It was reported that on an unknown date an unknown number of patients were vaccinated with GARDASIL (information captured in MARRS # 1305USA010598) or VAQTA (dose, route, lot number and expiration date not reported) for prophylaxis. Medical assistant reported that the vaccine was stored lower than -1C (Celsius degrees) from July 2012 until the present. No adverse effect was reported. Additional information has been requested.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Angioedema, Urticaria
Clinical narrative: Urticarial rash started on abdomen 3-4 days after DTaP and HIB, extended to arms and face with slight angioedema. Responds to BENADRYL. Had similar reaction after 12 month vaccines (MMR, VARIVAX, PCV).
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (Lot number, expiry date, route and dose were not reported). The time frame between doses 1 and 2 of GARDASIL was 8 months and the time frame between doses 2 and 3 was 6 months. On an unknown date, the patient experienced condyloma acuminatum, external genital warts. Patient sought medical attention for the same (details unspecified). The outcome of condyloma acuminatum, external genital warts was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, No adverse event, Product quality issue
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a female patient of unknown age. The medical assistant reported that while the patient was withdrawing a dose of ZOSTAVAX (Lot number J001006, expiration date 24-APR-2014), on 28-MAY-2013, a portion of the vaccine was sprayed in her eye. No adverse effect reported. A Product quality complaint was reported. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Rash, Rash maculo-papular
Clinical narrative: On 6/2/13 patient started with rash around her torso and back. After waking up the next day rash continued to spread to arms and legs and neck and face. No fever per mom.  No itching.  Patient was, aside from extensive maculopapular rash spread diffusely about body, asymptomatic.
Age: 1.02
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Rash, Rash morbilliform
Clinical narrative: Measles like rash started on face, extended to trunk, then arms and legs. Benadryl given, did not help.
Age: 23.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Patient called pharmacy c/o nausea, vomiting, diarrhea. Told patient -if symptoms continue or worsen seek medical attention at nearest emergency room.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Cold sweat, Feeling cold, Hyperhidrosis, Syncope, Vision blurred
Clinical narrative: Patient fainted twice after vaccines received, diaphoretic, cool, clammy, and blurred vision.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, itching and pain at injection site.  By 06/06/2013 3 pm the right upper arms was erythematous as well. Ice to the area, Tylenol prn for pain.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site dermatitis, Injection site dryness, Injection site erythema, Injection site pain
Clinical narrative: Presents for INJECTION SITE REACTION. Skin: Skin is warm and dry. Rash noted. There is erythema. Hive like rash over R deltoid, about 1 cm from vaccines sites? Tender, erythematous (pink) and slightly raised 682.9 CELLULITIS (primary encounter diagnosis) 502079 VACCINES ADVERSE REACTION 692.9 DERMATITIS, ALLERGIC.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site rash, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Presents for INJECTION SITE REACTION. Skin: Skin is warm and dry. Rash noted. There is erythema. Hive like rash over R deltoid, about 1 cm from vaccines sites? Tender, erythematous (pink) and slightly raised 682.9 CELLULITIS (primary encounter diagnosis) 502079 VACCINES ADVERSE REACTION 692.9 DERMATITIS, ALLERGIC.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Dermatitis allergic, Injection site cellulitis, Injection site dryness, Injection site urticaria, Injection site warmth
Clinical narrative: Presents for INJECTION SITE REACTION. Skin: Skin is warm and dry. Rash noted. There is erythema. Hive like rash over R deltoid, about 1 cm from vaccines sites? Tender, erythematous (pink) and slightly raised 682.9 CELLULITIS (primary encounter diagnosis) 502079 VACCINES ADVERSE REACTION 692.9 DERMATITIS, ALLERGIC.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Presents for INJECTION SITE REACTION. Skin: Skin is warm and dry. Rash noted. There is erythema. Hive like rash over R deltoid, about 1 cm from vaccines sites? Tender, erythematous (pink) and slightly raised 682.9 CELLULITIS (primary encounter diagnosis) 502079 VACCINES ADVERSE REACTION 692.9 DERMATITIS, ALLERGIC.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Inflammation, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Kinrix and MMR-V were given in the Left deltoid and SubQ arm. Redness, warm to touch and swelling and pain at injection sites reported by Mother and PCP, states that "he cannot move his left arm" and that he had vomiting and diarrhea and fever at the time of immunizations. Mom told me that he had a little runny nose but no fever. Dr. gave a SoluMedrol injection for the inflammation.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth
Clinical narrative: Kinrix and MMR-V were given in the Left deltoid and SubQ arm. Redness, warm to touch and swelling and pain at injection sites reported by Mother and PCP, states that "he cannot move his left arm" and that he had vomiting and diarrhea and fever at the time of immunizations. Mom told me that he had a little runny nose but no fever. Dr. gave a SoluMedrol injection for the inflammation.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Feeling cold, Flushing, Hyperhidrosis, Pain in extremity
Clinical narrative: Arm very painful early in AM.  Became very cold and could not get warm.  Even with several blankets and heating pad.  Husband said I was very flushed.  Took ibuprofen and went to bed.  Next day became very weak and sweaty when trying to get dressed.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Red 2-3mm papular rash concentrated over extremities.  Pruritic.  Approx 30 lesions total.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Abnormal behaviour, Dissociative disorder, Hypoacusis, Psychomotor hyperactivity
Clinical narrative: Disassociative behavior, hyperactivity, not hearing well/obeying.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture negative, CSF culture negative, CSF virus no organisms observed, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Patient vaccinated 4/10/13. Developed (L)-sided facial palsy (Bell's palsy) 2 days later. Admitted to hospital, received acyclovir, ceftriaxone. Discharged 4/15/13.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: VIIth nerve paralysis
Clinical narrative: Patient vaccinated 4/10/13. Developed (L)-sided facial palsy (Bell's palsy) 2 days later. Admitted to hospital, received acyclovir, ceftriaxone. Discharged 4/15/13.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chemotherapy, Colon cancer, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 71 year old female patient. In approximately Jun 2007 ("in mid 2007"), the patient was vaccinated with ZOSTAVAX (lot number was not reported), single dose 0.65 ml, once subcutaneous injection. Concomitant therapies included VALTREX. In approximately Jun 2007 ("in mid 2007"), the patient experienced lower trunk pain and "shingle like symptoms" since her ZOSTAVAX injection in mid-2007. The patient stated that the pain was not as bad in the past two days. No treatment was received for the events. On 28-MAY-2013 (two days ago), the patient was diagnosed with colon cancer and was receiving chemotherapy. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered from the events. Upon internal review colon cancer was considered to be medically significant. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red area around injection site swelling.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Decreased appetite, Rash, Throat lesion
Clinical narrative: Had MMR4 varicella shots 5/20/13. On 5/29/2013 mother noted rash (non vesicular) at abdominal area slowly progressing to the trunk and extremities. No fever, no itchiness, no vomiting. No tenderness/pain. Positive decreased appetite because of lesion at throat. Advised fluids, BENADRYL and mouth wash (wash x1, BENADRYL).
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare worker refers to unknown number of patients of unknown age and gender. Approximately in 2013 the patients were vaccinated with MMR II (manufacturer unknown) (lot # and expiration date unspecified) (dose, route and anatomical location unspecified) for prophylaxis. The Healthcare worker reported that an unknown number of patients received doses of MMR II (manufacturer unknown) that were exposed to temperatures of 53F for 68 hours beginning on 29-MAR-2013, and then exposed to temperatures of 52F for 68 hours beginning on 12-APR-2013. All doses were administered after 29-MAR-2013. No adverse effect reported. This is one of two reports from the same source (MARRS 1306USA001249). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Feeling abnormal, Injection site erythema, Injection site swelling, Rash
Clinical narrative: Large red swollen area at site. Joints ached - rash on torso and legs - felt so bad couldn't go to school per mom.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: After DTAP, HAP, IPV, MMR and VZV were administered pt c/o of stomache ache the vomitted moderate amt of breakfast intake.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Nodule, Urticaria
Clinical narrative: Large red wheal - 6 x 6 cm with hard knot. Redness now decreased after 1 wk, still 1 nodule.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Dermatitis allergic, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Localized allergic skin reaction after subcutaneous administration of PNEUMOVAX in (R) upper arm - pain, swelling, redness and itching. Starting after 1 day of vaccine.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare worker refers to unknown number of patients of unknown age and gender. Approximately in 2013 the patients were vaccinated with ROTATEQ (lot # and expiration date unspecified) (dose, route and anatomical location unspecified). The Healthcare worker reported that an unknown number of patients received ROTATEQ that were exposed to temperatures of 53F for 68 hours beginning on 29-MAR-2013, and then exposed to temperatures of 52F for 68 hours beginning on 12-APR-2013. All doses were administered after 29-MAR-2013. No adverse effect reported. This is one of two reports from the same source (MARRS 1306USA001991). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 3 patients of unknown age and gender. The pharmacist reported that on an unknown date the patients were vaccinated with ZOSTAVAX (lot # and expiration date unspecified) 0.65 ml, once, subcutaneous injection (anatomical location unspecified). Pharmacist reported that he had 3 patients over the past four months (approximately in 2013) reporting a mild case of the shingles after receiving ZOSTAVAX. Patients did not seek medical attention. At the time of the report the outcome of patients was unknown. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Blood test, Headache, Injection site bruising, Nausea, Spinal pain
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old female patient with no pertinent medical history allergies. On 20-MAY-2013 the patient was vaccinated with GARDASIL dose 1, intramuscular in the right arm. Concomitant medication were reported as none. On 20-MAY-2013, the patient experienced black bruised mark on the right arm where she received the vaccine. Ten days later, on 30-MAY-2013 the patient complained of toothaches, headaches, and pain radiating down to her spine. She also felt like vomiting and developed right hand and left leg tremors. She was taken to an emergency room and released after treated with ATIVAN. The patient is scheduled to see a neurologist that night. The outcome of black bruised mark on the right arm, left leg tremors, developed right hand tremors, felt like vomiting, pain radiating down to the spine, toothaches and headaches was reported as not recovered. X-ray and Blood work were performed. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Toothache, Tremor, X-ray
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old female patient with no pertinent medical history allergies. On 20-MAY-2013 the patient was vaccinated with GARDASIL dose 1, intramuscular in the right arm. Concomitant medication were reported as none. On 20-MAY-2013, the patient experienced black bruised mark on the right arm where she received the vaccine. Ten days later, on 30-MAY-2013 the patient complained of toothaches, headaches, and pain radiating down to her spine. She also felt like vomiting and developed right hand and left leg tremors. She was taken to an emergency room and released after treated with ATIVAN. The patient is scheduled to see a neurologist that night. The outcome of black bruised mark on the right arm, left leg tremors, developed right hand tremors, felt like vomiting, pain radiating down to the spine, toothaches and headaches was reported as not recovered. X-ray and Blood work were performed. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old male patient. The pharmacist reported that on an unknown date the patient was vaccinated with GARDASIL (lot # and expiration date unspecified) (dose, route and anatomical location unspecified) for prophylaxis. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative concerning a female patient of unknown age. On an unknown date, the patient was vaccinated with 0.65 milliliter (reported as standard) of ZOSTAVAX (lot number, expiry date and route unspecified).No concomitant medications were reported. Approximately on an unknown date in April 2013 (reported as approximately with the last month), the patient developed a rash after receiving ZOSTAVAX. The patient sought medical attention at a local urgent care. It was unspecified if any treatment was given or if any lab tests were performed. The outcome of rash was unknown. The relatedness for rash was unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to an unspecified number of patients. On unknown dates, the patients were vaccinated with doses of ZOSTAVAX (route and lot # not reported). The pharmacist reported that on an unknown dates, the patients had experienced redness and swelling at the injection site. The outcome of redness at and swelling at the injection site was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an advanced practice nurse refers to a female patient of unknown age. On 03-JUN-2013, the patient was vaccinated with the third dose of GARDASIL (route and lot # not reported) after received her first 2 doses of GARDASIL (route and lot # not reported) on unspecified dates "more than a year ago". No adverse effect was reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Swelling and hives of arm where vaccine was administered.
Age: 24.0
Sex: M
Vaccine: ADEN_4_7, ANTH, BCG, DTAPH
Symptoms: Headache
Clinical narrative: Headache.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Physician ordered a TDAP instead of an HPV, patient had a TDAP last year.  The TDAP was administered as part of the orders. No harm done. Just an honest mistake.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Nausea, Oedema peripheral, Pain in extremity
Clinical narrative: Tues - red, swollen, sore back left arm. Wed - nauseous. Thurs - fine.
Age: 0.22
Sex: M
Vaccine: PNC13
Symptoms: Irritability, Screaming
Clinical narrative: Baby started to get very irritable, screaming uncontrollably and wanted to nurse every hour but would eat and throw up right away, and get even more upset, this lasted for 48 hours before baby could hold milk down.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Post vaccination autoinoculation, Skin lesion
Clinical narrative: Diffuse lesions to anterior aspect of trunk.  Appear to be self inoculation sites of smallpox patient had received on 29 May 2013.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling
Clinical narrative: Swelling around injection site, headache. Told to apply cold compress 15min on 15min off. Next day the swelling around the sight doubled. Dr said take 1 Benadryl every 6 hrs.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dyspnoea, Injection site pain, Musculoskeletal pain, Pyrexia
Clinical narrative: Client reported fever up to 104.1, weakness, shortness of breath, and severe pain in limb where shot was given, extending into her shoulder. Was inst. to go to nearest ER- never went for evaluation.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 48 year old male patient who on 29-MAR-2013, was vaccinated with a dose of PNEUMOVAX 23 (lot # H017759, expiration date 04-JUL-2014) 0.5 ml, subcutaneously. On 02-JUN-2013, the patient called the physician's office to report a high fever, redness and swelling at injection site and shortness of breath. Because of the shortness of breath, the physician's office advised this patient to go further information evaluation by the emergency room staff. It was unknown if the patient would be admitted to the hospital after the emergency room evaluation. The outcome of shortness of breath, redness and swelling at injection site and high fever was reported as not recovered/not resolved. Causal relationship between PNEUMOVAX 23 and shortness of breath, redness and swelling at injection site and high fever was unknown. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test, Computerised tomogram, Electromyogram, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Parsonage Turners Syndrome right arm. Guillain Barre. Symptoms began Feb/8/19, right arm first, followed by numbness, etc. Ongoing through today - 5/19/13. Being treated by multiple doctors.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Nerve conduction studies, Neuralgic amyotrophy, Nuclear magnetic resonance imaging
Clinical narrative: Parsonage Turners Syndrome right arm. Guillain Barre. Symptoms began Feb/8/19, right arm first, followed by numbness, etc. Ongoing through today - 5/19/13. Being treated by multiple doctors.