chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to patients of unknown age. On 25-JUL-2013 the patients were vaccinated with GARDASIL (lot # H020901, exp. 05-JUL-2015), 0.5 ml, subcutaneously. The vaccines were exposed to 79F for a maximum of 45 hours and were unspotted due to stability data not being available. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a patient of unknown age. On 23-JUL-2013 the patient was vaccinated with M-M-R II (lot # H010133, epx. 17-MAY-2014), 0.5 ml, subcutaneously. The vaccine was exposed to 79F for a maximum of 45 hours and was unsupported due to stability data not being available. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an adult patient of unknown age and gender. On 25-JUL-2013 the patient was vaccinated with an expired dose of M-M-R II, (lot number reported as 0870AA, Expiration date 06-JUN-2013), dose, route and anatomical location unspecified. Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of  patients of unknown age and gender. The pharmacist reported that unknown number of patients might have received ZOSTAVAX (lot number unspecified) that as improperly stored from 20-MAY-2013 to 05-JUN-2013. No adverse effects reported. IT was unknown if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Follow up information has been received from a health professional refers to a 62 (also reported as 63) year old female patient. On 26-FEB-2013 the patient vaccinated subcutaneously in left arm with ZOSTAVAX (lot number H017447, exp. date not reported) (dose not reported) which was incorrectly stored. No adverse reactions reported. This is one of several reports from same source. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with anxiety, hypertension and penicillin allergy. On 09-FEB-2010 the patient was vaccinated with ZOSTAVAX, (lot number reported as 0875Y and expiration date 20-DEC-2010, the reporter was not sure about lot number), (anatomical location unspecified), 1 dose via subcutaneous. Concomitant therapies included hydrochlorothiazide (manufacturer unknown) and ramipril (manufacturer unknown). On an unspecified date in July 2013 (reported as within the last 7 days) the patient experienced shingles. The patient sought medical attention and it was administered NORCO for pain. The outcome of shingles was unknown. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. The pharmacist reported that unknown number of patients might have received ZOSTAVAX (lot number specified) that was improperly stored from 20-MAY-2013 to 05-JUN-2013. No adverse effects reported. It was unknown if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Follow up information has been received from a health professional refers to a 67 (also reported as 68) year old male patient. On 09-NOV-2012 at 11:08 the patient vaccinated subcutaneously in left arm with a dose of ZOSTAVAX (lot number H011048, exp. date not reported) (dose not reported) which was incorrectly stored. No adverse reactions reported. This is one of several reports from same source. Additional information is not expected.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. The pharmacist reported that unknown number of patients might have received ZOSTAVAX (lot number unspecified) that was improperly stored from 20-MAY-2013 to 05-JUN-2013. No adverse effects reported. It was unknown if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Follow up information has been received from a health professional refers to a 63 (also reported as 64) year old patient (gender was unknown). On 08-NOV-2012 at 08:37 the patient vaccinated subcutaneously in right arm with a dose of ZOSTAVAX (lot number reported as H01148, exp. date not reported) (dose not reported) which was incorrectly stored. No adverse reactions reported. This is one of several reports from same source. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontanoeus report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. The pharmacist reported that unknown number of patients might have received ZOSTAVAX (lot number unspecified) that was improperly stored from 20-MAY-2013 to 05-JUN-2013. No adverse effects reported. It was unknown if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Follow up information has been received from a health professional refers to a 65 (also reported as 66) year old male patient. On 13-NOV-2012 at 16:36 the patient vaccinated subcutaneously in right arm with a dose of ZOSTAVAX (lot number H011048, exp. date not reported) (dose not reported) which was incorrectly stored. No adverse reactions reported. This is one of several reports from same source. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. The pharmacist reported that unknown number of patients might have received ZOSTAVAX (lot number unspecified) that as improperly stored from 20-MAY-2013 to 05-JUN-2013. No adverse effects reported. It was unknown if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Follow up information has been received from a health professional refers to a 62 (also reported as 63) year old female patient. On 15-NOV-2012 at 10:03 the patient vaccinated subcutaneously in left arm with a dose of ZOSTAVAX (lot number H011048, exp. date not reported) (dose not reported) which was incorrectly stored. No adverse reactions reported. This is one of several reports from the same source. Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Headache, Pain
Clinical narrative: Information has been received from a pharmacist via a field employee concerning an approximately 53 years old female patient who on 18-JUL-2013 was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot# not reported) subcutaneously which was administered by the pharmacist. The patient called the pharmacy on 24-JUL-2013 to report that two hours after the injection on 18-JUL-2013, she developed painful headaches and felt fatigue for three days. The patient reported to the pharmacist that she brake out with painful blisters on one breast on an unknown date in July 2013, and had not yet sought treatment from a physician. No treatment has been given at this time. The pharmacist called unspecified physician to inform him of the adverse event. At the time of reporting, the outcome of events was unknown. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Decreased immune responsiveness, Immune complex assay, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a mother refers to her 12 month old male patient with drug allergy to penicillin and no pertinent medical history. On 29-JAN-207 the patient was vaccinated with M-M-R II (lot#,dose and route unknown). No other co-suspects were reported. There were no concomitant medications. About ten days after received M-M-R II, on approximately 08-FEB-2007 the patient experienced severe rash and fever of 106 degrees Fahrenheit. The patient was seen in the emergency room of an unspecified hospital, but was not admitted to the hospital. The patient's physician has run tests on the patient's immunity to M-M-R. "Three years ago," the patient was still immune to all three diseases. Presently, the patient was only immune to Measles and Rubella. The patient was treated with TYLENOL and MOTRIN. The outcome was reported as recovered/resolved on an unknown date. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date in 2007 the patient was vaccinated with the first dose of GARDASIL (route, dose and lot # were unknown) the second dose of GARDASIL (route, dose and lot # were unknown) on an unknown date in 2010. The patient was in the office today, 25-JUL-2013, was attempting to get the third dose of GARDASIL. No adverse reaction reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 2 year old female patient with sickle cell anemia and hernia, no drug reaction or allergies. On 19-JUN-2013 the patient was vaccinated with PNEUMOVAX23 (lot # J004058, 0.5 ml) because patient has sickle cell. Concomitant therapies included AMOXICILLIN 250mg twice per day. Within 24 hours, the patient experienced swelling, redness and pain of an unspecified leg. The patient's mother called and spoke with a nurse over the phone on 20-JUN-2013 to seek medical attention. Nurse informed patient's mother over the phone to give the patient MOTRIN. None lab diagnostics was performed. The outcome of the adverse events was reported as recovered/resolved. This is one of the three reports from the same source. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Drug administered to patient of inappropriate age, Erythema, Local swelling, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 2 year old female patient with sickle cell anemia and hernia, no drug reaction or allergies. On 19-JUN-2013 the patient was vaccinated with PNEUMOVAX23 (lot # J004058, 0.5 ml) because patient has sickle cell. Concomitant therapies included AMOXICILLIN 250mg twice per day. Within 24 hours, the patient experienced swelling, redness and pain of an unspecified leg. The patient's mother called and spoke with a nurse over the phone on 20-JUN-2013 to seek medical attention. Nurse informed patient's mother over the phone to give the patient MOTRIN. None lab diagnostics was performed. The outcome of the adverse events was reported as recovered/resolved. This is one of the three reports from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Gait disturbance, Osteomyelitis
Clinical narrative: Couldn't walk on right ankle at all for no reason and out of the blue.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Injection site nodule, Injection site pain, Muscle spasms, Musculoskeletal pain
Clinical narrative: This spontaneous report was received from a 69 years old female consumer refers to herself with severe arthritis and narcolepsy. The patient was allergic to high doses of REMICADE, and some insulins. On 23-JUL-2013 the patient was vaccinated with a single standard dose of ZOSTAVAX (lot#batch# unspecified), unspecified route and location. No concomitant therapies included. The patient explained that within 27 hours of receiving ZOSTAVAX on approximately 24-JUL-2013, she developed muscle seizing in her arms, below her shoulders, and in her jaw. The pain occurred in her muscle and not in her joints. The patient was hospitalized for 2 days due to the event. The patient explained that the shot was mildly painful when received. She also stated that she had developed a small knot at the injection site that spawned the muscle pain when depressed; the effect had lessened over time but still sore to the touch. The pain was felt throughout her arm, shoulder, and jaw muscle upon touching the knot at injection to the point that her jaw seized on her left side during the night that clenched so hard that it left a bruise. The patient had sought medical attention via hospitalized. Treatment was given by morphine for events. At the time of report, the outcome of the events were recovering. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain in extremity, Pain in jaw, Trismus
Clinical narrative: This spontaneous report was received from a 69 years old female consumer refers to herself with severe arthritis and narcolepsy. The patient was allergic to high doses of REMICADE, and some insulins. On 23-JUL-2013 the patient was vaccinated with a single standard dose of ZOSTAVAX (lot#batch# unspecified), unspecified route and location. No concomitant therapies included. The patient explained that within 27 hours of receiving ZOSTAVAX on approximately 24-JUL-2013, she developed muscle seizing in her arms, below her shoulders, and in her jaw. The pain occurred in her muscle and not in her joints. The patient was hospitalized for 2 days due to the event. The patient explained that the shot was mildly painful when received. She also stated that she had developed a small knot at the injection site that spawned the muscle pain when depressed; the effect had lessened over time but still sore to the touch. The pain was felt throughout her arm, shoulder, and jaw muscle upon touching the knot at injection to the point that her jaw seized on her left side during the night that clenched so hard that it left a bruise. The patient had sought medical attention via hospitalized. Treatment was given by morphine for events. At the time of report, the outcome of the events were recovering. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Laboratory test, Medical device complication, Muscle spasms, Nodule
Clinical narrative: This spontaneous report was received from a 69 years old female consumer refers to herself with severe arthritis and narcolepsy. The patient was allergic to high doses of REMICADE, and some insulins. On 23-JUL-2013 the patient was vaccinated with a single standard dose of ZOSTAVAX (lot#batch# unspecified), unspecified route and location. No concomitant therapies included. The patient explained that within 27 hours of receiving ZOSTAVAX on approximately 24-JUL-2013, she developed muscle seizing in her arms, below her shoulders, and in her jaw. The pain occurred in her muscle and not in her joints. The patient was hospitalized for 2 days due to the event. The patient explained that the shot was mildly painful when received. She also stated that she had developed a small knot at the injection site that spawned the muscle pain when depressed; the effect had lessened over time but still sore to the touch. The pain was felt throughout her arm, shoulder, and jaw muscle upon touching the knot at injection to the point that her jaw seized on her left side during the night that clenched so hard that it left a bruise. The patient had sought medical attention via hospitalized. Treatment was given by morphine for events. At the time of report, the outcome of the events were recovering. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Trismus
Clinical narrative: This spontaneous report was received from a 69 years old female consumer refers to herself with severe arthritis and narcolepsy. The patient was allergic to high doses of REMICADE, and some insulins. On 23-JUL-2013 the patient was vaccinated with a single standard dose of ZOSTAVAX (lot#batch# unspecified), unspecified route and location. No concomitant therapies included. The patient explained that within 27 hours of receiving ZOSTAVAX on approximately 24-JUL-2013, she developed muscle seizing in her arms, below her shoulders, and in her jaw. The pain occurred in her muscle and not in her joints. The patient was hospitalized for 2 days due to the event. The patient explained that the shot was mildly painful when received. She also stated that she had developed a small knot at the injection site that spawned the muscle pain when depressed; the effect had lessened over time but still sore to the touch. The pain was felt throughout her arm, shoulder, and jaw muscle upon touching the knot at injection to the point that her jaw seized on her left side during the night that clenched so hard that it left a bruise. The patient had sought medical attention via hospitalized. Treatment was given by morphine for events. At the time of report, the outcome of the events were recovering. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: This spontaneous report was received from a female consumer of unknown age (reporting on herself). It was reported that around 1975, during childhood, the patient was vaccinated with a dose of M-M-R II (Lot # 9912202) (dose and route not reported) and did not report having had any booster doses since then. Concomitant therapy was not reported. On an unknown date an unspecified titer level test for the vaccine components showed that the patient was currently low in only the measles component of the vaccine. She sought medical attention for the low titer reading by talking to a couple of different unspecified healthcare professionals to see if she should be re-vaccinated. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 70 year old female patient with asthma, chronic obstructive pulmonary disease (COPD), Idiopathic thrombocytopenic purpura (ITP), sarcoidosis, drug allergy to aspirin, nonsteroidal anti-inflammatory drugs, penicillin, sulfa drugs, montelukast and nitrofurantoin and allergy to latex (specific allergic reactions were unknown). The patient was on many concomitant medications. On 01-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 dose not reported, lot# H013847, expiration date: 15-MAR-2014, intramuscularly. On 01-JUL-2013, in the evening, the patient developed redness and pain at the injection site, with swelling in the entire arm beyond the injection site, in addition it was so painful she could not lift her arm for 36 hours. Patient sought medical attention by calling the office. The outcome of adverse events was reported as recovered on an unknown date. The patient was treated with TYLENOL. No lab diagnostic studies were performed. The relatedness between PNEUMOVAX23 and adverse events was not reported. The same reporter and same mult-dose vial of PNEUMOVAX23 dose linked case: 1307USA011552. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse refers to a 70 year old female patient with asthma, chronic obstructive pulmonary disease (COPD), Idiopathic thrombocytopenic purpura (ITP), sarcoidosis, drug allergy to aspirin, nonsteroidal anti-inflammatory drugs, penicillin, sulfa drugs, montelukast and nitrofurantoin and allergy to latex (specific allergic reactions were unknown). The patient was on many concomitant medications. On 01-JUL-2013 the patient was vaccinated with a dose of PNEUMOVAX23 dose not reported, lot# H013847, expiration date: 15-MAR-2014, intramuscularly. On 01-JUL-2013, in the evening, the patient developed redness and pain at the injection site, with swelling in the entire arm beyond the injection site, in addition it was so painful she could not lift her arm for 36 hours. Patient sought medical attention by calling the office. The outcome of adverse events was reported as recovered on an unknown date. The patient was treated with TYLENOL. No lab diagnostic studies were performed. The relatedness between PNEUMOVAX23 and adverse events was not reported. The same reporter and same mult-dose vial of PNEUMOVAX23 dose linked case: 1307USA011552. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Eye penetration, Fall, Syncope
Clinical narrative: This spontaneous report was received from a physician, via field representative, refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. In approximately June 2013 reported as: (within past month) the patient fainted after administration her first dose of GARDASIL, had fallen and cut her eye. The outcome of both events was reported as recovering/resolving. The relatedness was not reported. Patient did not seek medical attention. Case is linked same reporter MARRS case # 1307USA015183, where 5 other patients fainting on GARDASIL are described. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site irritation
Clinical narrative: Irritated site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: 2 day after receiving vaccine pt had redness and tenderness at injection site. Pt went to clinic and was diagnosed w/cellulitis infection.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Pyrexia, Vomiting
Clinical narrative: Pt developed fever, chest pain and vomiting. Pt was seen in the ER, treated with PHENERGAN.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site swelling, Skin tightness
Clinical narrative: Pt received TDAP and MENACTRA in (R) deltoid on 7-25-13. Mom called the next day. She reported the patient's arm was very swollen at the injection site and the skin was tight. Pt was seen in ER, treated with Prednisone.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Convulsion, Loss of consciousness, Presyncope
Clinical narrative: Patient had 2 vaccination done in left arm directly after given her second immunization, patient passed out, upper extremities started convulsing. Patient went into vasovagal, came out of it within one minute.
Age: 22.0
Sex: U
Vaccine: SMALL, TYP
Symptoms: Musculoskeletal discomfort, Paraesthesia, Rash, Skin lesion
Clinical narrative: Onset of discomfort in mid-back (R) side. The next day he noted lesions on his back that were still achy. Symptoms: Rash, other nonspecific skin eruption, Disturbance of skin sensation.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Dyskinesia, Fall, Syncope
Clinical narrative: Tdap and varicella given and seconds after varicella given to child his body fell back in chair with head jerk (fainted). This lasted about 30 sec. wet his face and fanned him and improved in seconds. Instructed mom to follow up with dr.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Injection site cellulitis
Clinical narrative: Local allergic reaction and cellulitis to injection site 2 days after administration. Pt. was given oral steroids, topical steroids and oral antibiotics.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Developed a wheal at injection site. No further reaction beyond that.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arteriogram carotid normal, Blood test normal, Brain scan normal, Electrocardiogram normal, Hypertension
Clinical narrative: Very high blood pressure.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Scan normal, Urine analysis normal
Clinical narrative: Very high blood pressure.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 57 year old female patient. On 18-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported). On 26-JUL-2013, the patient got shingles quickly after receiving ZOSTAVAX. The patient sought medical attention via calling the physician's clinic. At the time of reporting, the outcome of the event was unknown. This is one of several reports received from the same source (linked with Case # 1307USA017362). Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Chills, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Chills, dizziness, sweating, light headedness, nausea without vomiting. No syncope occurred.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Approx 3 weeks past vaccination develops case of shingles on left face.
Age: 38.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: Employee came in for a Varicella shot (Booster) was given in Lt. arm SQ on 7/18/13. EE came back in on 7/19/13 for a blood draw and was given a second varicella shot Rt. arm SQ. On 7/27 the site on the Lt. arm was painful, red, hot, swollen and a lesser reaction on the Rt. side. EE wand 2nd shot 7/19/13 APN. To Occ Health to be seen 7/29.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, warm, firm area to injection site.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Urticarial rash began day after vaccine. Still present 7/24/13.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Shot was given on 7/23/13, Pts mother called on 7/25/13 and stated that pt. had a big red circle that was swollen and warm at the touch on the (R) upper thigh.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt got shot on 7/23/13, pt's mother came in on 7/25/13 and stated that pt had a big red circle that was swollen and felt hot to the touch on the (R) upper thigh/deltoid.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Right arm had slight welling, redness, and warm to the touch. Symptoms began on the night of the injection.
Age: 1.3
Sex: M
Vaccine: HIBV, MMR
Symptoms: Rash
Clinical narrative: Pt. is a 16 mo old white male, who presents with the following sx, a rash. Both sisters and mother had chicken pox earlier this summer. 8 yr old sister dx'd 7-17-13 (15 days ago).
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 19 year old female patient. No medical history or current conditions were reported. On 02-MAY-1994, the patient was vaccinated with the 1st dose of RECOMBIVAX HB, (dose, route, lot # and exp date not reported). On 07-JUN-1994, the patient was vaccinated with the 2nd dose of RECOMBIVAX HB (dose, route, lot # and exp date not reported). On 10-JUL-2013, the patient was vaccinated with the 3rd dose of RECOMBIVAX HB, (dose, route, lot # and exp date not reported). Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Erythema, pain, edema at site. Use ice, Ibuprofen. PERCOCET as needed.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Diarrhoea, Injection site reaction, Malaise
Clinical narrative: Muscle soreness at injection site, myalgias/arthralgias, low-grade temp (99.5F, no fever), nausea, diarrhea and malaise developed after vaccine administration, supportive care.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia, Nausea
Clinical narrative: Muscle soreness at injection site, myalgias/arthralgias, low-grade temp (99.5F, no fever), nausea, diarrhea and malaise developed after vaccine administration, supportive care.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Vasovagal syncope after her HPV vaccine.
Age: 1.0
Sex: M
Vaccine: HEP, MMR, PNC13, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Large local reaction at site of injecton (L) 12 cm, red, slight tender. No specific treatment.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Loss of consciousness
Clinical narrative: MD ordered HPV-Injection given as noted below, with no sxs or reaction after leaving exam room. Mom called out for glass of water then approx 1 min after that mom called out needing help as pt had passed out she passed out for just a few seconds. She was alert and oriented immediately after. Glucose 89, BP 90/60, she was supine and recovered for a few min. Then given crackers and water and felt better a few in later BP 102/60.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 55 year old female patient with allergies to erythromycin, sulfa, codeine, KEFLEX and CELEBREX and no pertinent medical history. Sometime within the last week (approximately between 15-JUL-2013 to 19-JUL-2013), the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and route were not reported) on the triceps area at a pharmacy. Same day of the vaccination, the patient developed redness, induration, and severe tenderness at the injection site. The patient sought medical attention by seeing her physician. No treatment was given. No lab diagnostic studies were performed. At the time of reporting, the patient was recovering. This is one of several reports from the same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 24 year old female patient. On an unknown date the patient was vaccinated one dose of GARDASIL (lot# not reported) (dose, route, indication not reported). Concomitant therapies included IMPLANON. On an unknown date the patient was positive for an unspecified HPV type. It was unsure if the patient was diagnosed with a positive unspecified HPV type prior to receiving the GARDASIL or after. The outcome of the event was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm red, hot and swollen 4X3 inch.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site induration, Injection site pruritus
Clinical narrative: 5X6 CM INDURATION RIGHT POSTERIOR UPPER ARM WITH ITCHING.
Age: 0.34
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Decreased eye contact, Grunting, Insomnia, Irritability
Clinical narrative: Screaming for hours, threw up through nose and mouth, irritable, restless. Symptoms for the next six days: loss of eye contact, loss of babbling noises, loss of smile, loss of care for interaction with parents, only sleeping 2-3 hours at night, throwing up, not wanting to be held, arching back, grunting for hours.
Age: 0.34
Sex: M
Vaccine: DTAP
Symptoms: Opisthotonus, Restlessness, Screaming, Vomiting
Clinical narrative: Screaming for hours, threw up through nose and mouth, irritable, restless. Symptoms for the next six days: loss of eye contact, loss of babbling noises, loss of smile, loss of care for interaction with parents, only sleeping 2-3 hours at night, throwing up, not wanting to be held, arching back, grunting for hours.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Feeling hot, Hyperhidrosis, Induration, Musculoskeletal stiffness, Oedema peripheral
Clinical narrative: Pt began feeling hot, feverish, sweaty with swelling in arm and right side of neck stiff. Large indurated area on posterior arm/deltoid on right (nondominant).  Referred to facility on 1 Aug 13.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Pt began feeling hot, feverish, sweaty with swelling in arm and right side of neck stiff. Large indurated area on posterior arm/deltoid on right (nondominant).  Referred to facility on 1 Aug 13.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Localised oedema
Clinical narrative: This spontaneous report as received from a family nurse practitioner refers to a 18 year old female patient. The patient's medical history included constipation and diarrhea. The patient had no allergy. Recent the patient did not exposure to chickenpox and shingles. On 03-JUN-2013 the patient was vaccinated with second dose of VARIVAX (lot # was reported as 6016512, dose was not reported), subcutaneous in the left arm. The rash did not occur at the site of injection post vaccination. Concomitant therapies included DOXYCYCLINE. On 05-JUN-2013, the patient experienced local edema and erythema 7cmx4cm and 4c vesicles. The maximum temperature was 98.1. The outcome of events was unknown. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Blister, Pain, Paraesthesia, Pruritus
Clinical narrative: 7/28/13 tingling/itch in back then 7/31/13 pain and then 8/1/13 breaking out with blisters.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test normal, Computerised tomogram normal, Electroencephalogram normal, Gaze palsy, Seizure like phenomena
Clinical narrative: ED visit- Admission 7/23-7/24/13. Patient had his 2 mos wcv the morning of 7/23/13 at which time he was healthy with no recent history of sick symptoms including fever. He received his 2 mos immunizations. Mother drove to a store after the visit and when she stopped in the parking lot she noticed that patient was shaking and his eyes were rolling in the back of his head. He did not lose tone. Mother thinks the seizure like activity lasted for about 30 seconds. She call 911 and EMS came, but mother decided to observe and not got to the ED. 1 hr later she was at Grandma's house and he had the same episode that mother estimates lasted 60 seconds. They took him to hospital. He had no temperature on arrival. Per mother all blood and urine tests were negative. CT scan WNL. They kept him over night for observation and did an EEG in the morning which was normal.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Tremor, Urine analysis normal
Clinical narrative: ED visit- Admission 7/23-7/24/13. Patient had his 2 mos wcv the morning of 7/23/13 at which time he was healthy with no recent history of sick symptoms including fever. He received his 2 mos immunizations. Mother drove to a store after the visit and when she stopped in the parking lot she noticed that patient was shaking and his eyes were rolling in the back of his head. He did not lose tone. Mother thinks the seizure like activity lasted for about 30 seconds. She call 911 and EMS came, but mother decided to observe and not got to the ED. 1 hr later she was at Grandma's house and he had the same episode that mother estimates lasted 60 seconds. They took him to hospital. He had no temperature on arrival. Per mother all blood and urine tests were negative. CT scan WNL. They kept him over night for observation and did an EEG in the morning which was normal.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Diarrhoea, Erythema, Injection site induration, Injection site mass
Clinical narrative: Swelling at site increasing to size of palm, large hard lump very warm, chills and fever, diarrhea, aching all over throughout the night and next day swelling and redness still present one week later.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Pyrexia, Swelling
Clinical narrative: Swelling at site increasing to size of palm, large hard lump very warm, chills and fever, diarrhea, aching all over throughout the night and next day swelling and redness still present one week later.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Shoulder and upper arm very sore and aches. Anti inflammatory medicine doesn't help much with the pain. It has hurt since the day of the shot.
Age: 30.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Rash
Clinical narrative: Patient complains of left arm redness, rash-like and slight swelling. Patient states arm is a lot better than at onset. Patient was seen in the clinic by doctor.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Oedema peripheral, Skin discolouration, Skin warm
Clinical narrative: SWELLING AND HEAT IN THE LEG. RED MARKS FROM THE LEG UP THE BACK
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Barium enema, Crying, Decreased appetite, Intussusception
Clinical narrative: Crying episode, decrease in appetite, unconsolable, decrease in distal pulses in lower extremities, Dx. probable intussuseption at ER.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Peripheral pulse decreased
Clinical narrative: Crying episode, decrease in appetite, unconsolable, decrease in distal pulses in lower extremities, Dx. probable intussuseption at ER.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Allodynia, Erythema, Induration
Clinical narrative: 19 cm area of erythema with 40 cm area of induration.  Allodynia in entire upper arm.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood test, Computerised tomogram, Dyskinesia, Electroencephalogram, Epilepsy
Clinical narrative: Got stiff and started flexing hands. Progressed into jerking of legs. Takes Keppra.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Musculoskeletal stiffness, Nuclear magnetic resonance imaging
Clinical narrative: Got stiff and started flexing hands. Progressed into jerking of legs. Takes Keppra.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Decreased appetite, Diarrhoea, Irritability, Pyrexia
Clinical narrative: Diarrhea 7X's a day for 1 to 2 weeks, fever-103.5 at onset, decrease in appetite, fussiness.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Approximately on 23-NOV-2013 (8 months ago) the patient was vaccinated with first dose of VARIVAX (Merck). Approximately on 23-JUL-2013 the patient was vaccinated with second dose of VARIVAX (Merck). Vaccine lot number was not reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 52 year old female patient with allergies to Codeine and Penicillin and no pertinent medical history. On an unknown date the patient was vaccinated with a does of ZOSTAVAX (dose, lot # and route were reported) on the triceps at a pharmacy. There was no concomitant therapy. The nurse reported "couple days after the vaccination", the patient developed redness, induration, and mild tenderness at the injection site. The patient sought medical attention by seeing a physician. No treatment was given. No lab diagnostics studies were performed. At the time of reporting, the patient's outcome was reported as recovering. This is one of several reports from the same reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. The pharmacist reported that unknown number of patients might have received ZOSTAVAX (lot number unspecified) that was improperly stored from 20-MAY-2013 to 05-JUN-2013. No adverse effects reported. It was unknown if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Follow up information has been received from a health professional refers to a 64 year old male patient. On 12-FEB-2013 at 08:40 the patient vaccinated subcutaneously in left arm with a dose of ZOSTAVAX (lot number H017447, exp. date not reported) (dose not reported) which was incorrectly stored. No adverse reactions reported. This is one of several reports from same source. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a physician, as part of a marketing research program conducted refers to a pre-adolescent female patient. On an unknown date the patient was vaccinated with the fist dose of GARDASIL dose, route and lot # not reported. On an unknown date, reported as when administering GARDASIL, the patient experienced injection site reaction. Action taken for GARDASIL was reported as unknown. The outcome of injection site reaction was reported as recovering/resolving. The reporter considered injection site reaction to be related to GARDASIL. The reporter considered injection site reaction to be a non serious adverse event. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age (gender not reported). The patient was vaccinated with the first, second and third dose of GARDASIL (lot #, route, dose not reported) on 12-JUN-2007, 13-AUG-2007 and 17-OCT-2007 respectively. No adverse effects reported. It was unspecified if the patient seek medical attention or not. 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 multiple unspecified patients of unknown age or gender. From 15-MAY-2013 to 25-JUL-2013, the patients were vaccinated with GARDASIL (dose, frequency, route, lot # and expired date unspecified) that were subjected to multiple unsupported temperature excursions. It was reported that it was at most 20 doses. No adverse effect reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Knot at injection site 1-2 days after arm red, warm to touch, swollen, painful from shoulder to elbow 7-10 days after shot; Tx with KEFLEX 500 mg QID for 17 days.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Chest X-ray normal, Dyspnoea, Electrocardiogram normal, Pulmonary congestion
Clinical narrative: 7/29/13 given MENVEO (had MENVEO 7-9-07). C/O chest congestion, SOB that evening. Worked out 5PM wt lifting, only ate soup that PM.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Papule, Rash
Clinical narrative: Rash on thigh, 1-2mm papules.
Age: 1.89
Sex: F
Vaccine: DTAP, HEPA, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Injection site reddened with warmth and intermittent pain.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Warmness to touch, hardness at site of injection, pain.
Age: 1.52
Sex: F
Vaccine: HIBV, IPV, MNQ
Symptoms: Hypersomnia, Irritability, Rhinorrhoea
Clinical narrative: Prolonged nap more than normal for our child, woke up very irritable and cranky..Continued fussiness with runny nose.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: 7/30/2013, my baby received 3 kinds of vaccine including Hepatitis A, Hib and Pneumococcal. He got a low fever at the night of 7/30/2013 but his body temperature came to the normal at the second day. However, the skins on the shots became swelling and redness. At the third day, the area of red skins developed into 10X 15 cm.
Age: 1.4
Sex: F
Vaccine: DTAP, HEP, HEPA, HIBV, MMR, OPV, PPV, VARCEL
Symptoms: Local swelling, Pyrexia
Clinical narrative: Localized swelling to thigh, low grade fever.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Dysuria, Fatigue, Maternal exposure before pregnancy, Nausea, Papilloma viral infection
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer refers to her 27 year old daughter. On an unknown date, "several years ago", the patient was vaccinated with a dose of GARDASIL (dose, route and lot # not reported). The consumer reported that "recently", the patient became pregnant. The patient underwent an urine and bloodwork pregnancy tests that were positive. The LMP and EDD were not known. The patient was recently diagnosed with HVP. The patient was experiencing a heavy discharge with a distinct odor accompanied with a slight fever, burning when urinating, extreme tiredness and nausea. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test positive, Pregnancy test urine positive, Pyrexia, Vaginal discharge
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer refers to her 27 year old daughter. On an unknown date, "several years ago", the patient was vaccinated with a dose of GARDASIL (dose, route and lot # not reported). The consumer reported that "recently", the patient became pregnant. The patient underwent an urine and bloodwork pregnancy tests that were positive. The LMP and EDD were not known. The patient was recently diagnosed with HVP. The patient was experiencing a heavy discharge with a distinct odor accompanied with a slight fever, burning when urinating, extreme tiredness and nausea. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 1.48
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Low grade fever, vomiting starting 1 hour after vaccine.
Age: 49.0
Sex: F
Vaccine: TYP, YF
Symptoms: Headache, Malaise, Mental impairment, Nausea
Clinical narrative: 1/2 hour after taking oral typhoid vaccine, patient felt sick with extreme nausea (no vomiting) headache and she was unable to think clearly. Rested and went to bed early. OK today.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Irritability, Pyrexia
Clinical narrative: Fever, loss of appetite, irritability.
Age: 0.62
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site rash, Local reaction
Clinical narrative: Patient rec'd vaccines 7-31-13, returned to clinic 8-1-13 with local reaction (red rash extending from injection site to knee and up thigh) mom states she noticed reaction around 10am this morning. Pt. sent home with Rx ATARAX and instructed to return for follow up 8-3-13.