chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Blood culture, Blood gases, Chills, Computerised tomogram abdomen, Computerised tomogram thorax
Clinical narrative: Fever, tachypnea, diarrhea, nausea vomiting and chills. Ceftriaxone 2 gm once, ciprofloxacin 500 mg BID, sodium chloride 1000 ml once.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Electrocardiogram, Full blood count, Hepatic enzyme, Laboratory test abnormal
Clinical narrative: Fever, tachypnea, diarrhea, nausea vomiting and chills. Ceftriaxone 2 gm once, ciprofloxacin 500 mg BID, sodium chloride 1000 ml once.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Occult blood, Pyrexia, Tachypnoea, Urine analysis
Clinical narrative: Fever, tachypnea, diarrhea, nausea vomiting and chills. Ceftriaxone 2 gm once, ciprofloxacin 500 mg BID, sodium chloride 1000 ml once.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Fever, tachypnea, diarrhea, nausea vomiting and chills. Ceftriaxone 2 gm once, ciprofloxacin 500 mg BID, sodium chloride 1000 ml once.
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and mild swelling 4.5cm diameter over right deltoid. Symptoms started a few hours after administration and lasted 4 days.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash papular
Clinical narrative: Mother called to office x1 week after imms given with concerns of rash to (L) leg. She reported temp 101.2 following imms admin. Relieved with dose of TYLENOL. Redness and raised area to bilat aspects of thighs. As of 3/4 on exam noted fine slightly erythematous papular rash - left leg greater than Rt. Impression maybe secondary to imms but cannot rule out eczema as well.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Electromyogram normal, Hypertrophy, Intervertebral disc protrusion, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Reported pain on 10/6/14 and evaluated in ER. Prednisone x 3 days. Occupational health on 10/8/14. Follows with own pain clinic and neurologist for pre existing medicals-saw neurologist (1) EMG done and negative kidney 1/20/15. (2) x ray 12/15/14=negative. (3) MRI shows small disc protrusion, joint hypertrophy and thyroid lesion 1/20/15. She is refusing PT. Has not missed work. Continues to complain s/s pain. No clear diagnosis. VAERS completed today.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Thyroid disorder, X-ray normal
Clinical narrative: Reported pain on 10/6/14 and evaluated in ER. Prednisone x 3 days. Occupational health on 10/8/14. Follows with own pain clinic and neurologist for pre existing medicals-saw neurologist (1) EMG done and negative kidney 1/20/15. (2) x ray 12/15/14=negative. (3) MRI shows small disc protrusion, joint hypertrophy and thyroid lesion 1/20/15. She is refusing PT. Has not missed work. Continues to complain s/s pain. No clear diagnosis. VAERS completed today.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Discomfort, Drug administered at inappropriate site, Immediate post-injection reaction, Joint range of motion decreased, Nuclear magnetic resonance imaging
Clinical narrative: Reported pain on 10/6/14 and evaluated in ER. Prednisone x 3 days. Occupational health on 10/8/14. Follows with own pain clinic and neurologist for pre existing medicals-saw neurologist (1) EMG done and negative kidney 1/20/15. (2) x ray 12/15/14=negative. (3) MRI shows small disc protrusion, joint hypertrophy and thyroid lesion 1/20/15. She is refusing PT. Has not missed work. Continues to complain s/s pain. No clear diagnosis. VAERS completed today.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Pain, X-ray normal
Clinical narrative: Reported pain on 10/6/14 and evaluated in ER. Prednisone x 3 days. Occupational health on 10/8/14. Follows with own pain clinic and neurologist for pre existing medicals-saw neurologist (1) EMG done and negative kidney 1/20/15. (2) x ray 12/15/14=negative. (3) MRI shows small disc protrusion, joint hypertrophy and thyroid lesion 1/20/15. She is refusing PT. Has not missed work. Continues to complain s/s pain. No clear diagnosis. VAERS completed today.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Electromyogram normal, Hypertrophy, Intervertebral disc protrusion, Nuclear magnetic resonance imaging spinal abnormal, Pain
Clinical narrative: Reported pain on 10/6/14 and evaluated in ER. Prednisone x 3 days. Occupational health on 10/8/14. Follows with own pain clinic and neurologist for pre existing medicals-saw neurologist (1) EMG done and negative kidney 1/20/15. (2) x ray 12/15/14=negative. (3) MRI shows small disc protrusion, joint hypertrophy and thyroid lesion 1/20/15. She is refusing PT. Has not missed work. Continues to complain s/s pain. No clear diagnosis. VAERS completed today.
Age: 46.0
Sex: F
Vaccine: FLU4, FLUX, FLU4, FLU3
Symptoms: Arthralgia, Injection site pain, Joint range of motion decreased, Limb discomfort, Musculoskeletal pain
Clinical narrative: Reported pain on 10/6/14 and evaluated in ER. Prednisone x 3 days. Occupational health on 10/8/14. Follows with own pain clinic and neurologist for pre existing medicals-saw neurologist (1) EMG done and negative kidney 1/20/15. (2) x ray 12/15/14=negative. (3) MRI shows small disc protrusion, joint hypertrophy and thyroid lesion 1/20/15. She is refusing PT. Has not missed work. Continues to complain s/s pain. No clear diagnosis. VAERS completed today.
Age: 37.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt had DTaP in (R) thigh and Flu >3 in the (L) thigh. On 3/17/15 parent's noticed a lg red swollen area to (R) outer thigh and a smaller swollen area to the left thigh.
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site extravasation, No adverse event
Clinical narrative: Information has been received from nurse concerning a patient of unknown age and gender. No known history condition and drug allergies. On 18-MAR-2015, the patient was vaccinated with MMR II (Oka/Merck) VARIVAX and VAQTA (dose, route, lot # and expiration date unknown). The reporter stated that after administering, some of the "vaccine dripped out of the injection site". No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from other source via pharmacist refers to 3 unspecified patients. On an unknown date, the patients were vaccinated with ZOSTAVAX. No concomitant medication was reported. On an unknown date, the patients developed shingles. The outcome of event was unknown. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports from the same reporter. Additional information is not expected, there was no consent for contact.
Sex: U
Vaccine: MMR
Symptoms: Adverse event
Clinical narrative: This spontaneous unconfirmed report as received from a consumer refers to unspecified number of children patients of unknown age and gender. On unknown dates, the patients were vaccinated with MMR II (dose, route, therapy type, lot# and expiration date were not reported). The reporter stated that she had heard some cases from "other people" about their children having "negative result" from receiving MMR II (dates unspecified). The reporter stated that those cases had been already reported to unspecified pediatricians. The outcome of the event was unknown. The relatedness between the event and MMR II was not reported. Additional information is not expected, because there was no contact details provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 13-MAR-2015, the patient was vaccinated with an expired dose of MMR II expiration date 12-MAR-2015, subcutaneous. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 13-OCT-2014, the patient was vaccinated with MMR II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a non pregnant female of unknown age. The patient's relevant medical history was not reported. On an unknown date, the patient was vaccinated subcutaneously with one dose of ZOSTAVAX (0.65 ml, lot# and expiration date were not reported). Information about the patient's concomitant medication was not reported. On an unknown date, the patient experienced shingles after receiving ZOSTAVAX. The patient was examined by her physician who prescribed CYCLOVIR (date unspecified). The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 13-MAR-2015 the patient was vaccinated with an expired dose of ZOSTAVAX, 19400 plaque forming unit (PFU) (lot # J013137, expiration date: 17-JAN-2015, route and dose were unknown). No adverse effects had been observed or reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. It was reported that the patient was on recurrent treatment with valacyclovir (indication unknown). On unknown date in November 2014 the patient was a dose of ZOSTAVAX (route of administration, indication, lot number were not reported) and on the same day, she took a dose of valacyclovir. No adverse events were unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-MAR-2015, the patient received a dose of expired ROTATEQ, lot # J008364, expiration date 27-Feb-2015, 2 ml, orally. Dose was supported. It was unspecified which dose number in the series this vaccination was. No adverse experience reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from the patient's husband referring to the 69 year old female patient. The patient's medical history included pacemaker and defibrillator implant insertion (dates were unknown). The patient had no drug reactions/allergies. "2 years ago, on an unspecified date in 2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, route not reported, 1 single shot). On 17-MAR-2015 the patient developed shingles. The patient had sought medical attention via speaking with physician. TYLENOL and codeine (dosages/frequencies/manufacturers unknown) were given for the event. No lab tests were performed. At time of this report, the patient did not recover from the event. The causality was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist regarding an approximately 61 year old female patient. The information on medical history and concurrent conditions were unknown. She did not have any drug reactions or allergies. On 21-MAR-2015, she was vaccinated with ZOSTAVAX 0.65 milliliter, Product lot # K020185, expiry date reported as 27-JAN-2016, taken subcutaneously. The information on concomitant medications was unknown. On an unknown date in March 2015, after receiving vaccination, she experienced a lump and itching around injection site. No treatment was given for the adverse events. The patient had spoke to pharmacist and sought medical attention. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 16-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of the several reports from the same source. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Facial pain, Gingival pain, Insomnia
Clinical narrative: Information has been received from an approximately 59 (reported as 59 1/2) year old male patient with drug allergies to Sulfa and "VYCATIN" concerning himself. No other relevant medical history was reported. On 20-FEB-2015, the patient was vaccinated with ZOSTAVAX (dose and frequency were reported as "1 time vaccine", route was reported as "right arm", lot number and expiration date unknown). Concomitant therapy included FLONASE. On 21-FEB-2015, the patient experienced intermittent "dull knife" pain that had moved to different areas of his body and insomnia. He stated the pain started in the ball of his right foot, to his left hip muscle, to the right side of his face and jaw, and his gums. He said it then was in his left shoulder muscle, to his left writ, to his left front thigh muscle. The pain lasted 3-4 days in each area, but he stated the pain was tolerable at time of the report. He performed blood tests, but nothing conclusive. At the time of reporting, outcome of the events was unknown. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pain in extremity, Pain in jaw
Clinical narrative: Information has been received from an approximately 59 (reported as 59 1/2) year old male patient with drug allergies to Sulfa and "VYCATIN" concerning himself. No other relevant medical history was reported. On 20-FEB-2015, the patient was vaccinated with ZOSTAVAX (dose and frequency were reported as "1 time vaccine", route was reported as "right arm", lot number and expiration date unknown). Concomitant therapy included FLONASE. On 21-FEB-2015, the patient experienced intermittent "dull knife" pain that had moved to different areas of his body and insomnia. He stated the pain started in the ball of his right foot, to his left hip muscle, to the right side of his face and jaw, and his gums. He said it then was in his left shoulder muscle, to his left writ, to his left front thigh muscle. The pain lasted 3-4 days in each area, but he stated the pain was tolerable at time of the report. He performed blood tests, but nothing conclusive. At the time of reporting, outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 10-OCT-2014, the patient was vaccinated with MMR II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant via company representative refers to a patient of unknown age and gender/ No information on their medical history or concurrent conditions was provided. On 19-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous, which expired on24-JAN-2015, lot/batch number not provided, expiration date 24-JAN-2015. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to unspecified patients of unknown demographics. Patients medical history and current condition was not reported. On an unspecified dates since 13-NOV-2014, unspecified patients were vaccinated with improperly stored VAQTA (strength and dose not reported). No adverse events reported. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 17x10 area of erythema/edema on right upper thigh. Rx's given for BENADRYL/ibuprofen/cephalexin.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via direct contact, Rash pruritic
Clinical narrative: This spontaneous report as received from a 42 year old female pharmacist refers herself. The patient's current conditions included dry skin and acetaminophen, PERCOCET allergy. The patient's medcal history included basal cell carcinoma and chickenpox (when she was younger). In 2014 (sometime between October and December 2014), after reconstituting ZOSTAVAX, the vaccine leaked and got on the patient's right hand. The patient washed both hands with soap and water. In approximately February 2015 (reported as 2 weeks ago), the patient experienced itchy rash on her lower back that might be spreading. The patient was reported as not recovered/not resolved (the patient's present status was reported as: rash on lower back). The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports from the same reporter. Additional information is not expected, there was no consent to contact.
Age: 33.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, Extra dose administered, Urine analysis
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 33 year old pregnant female patient. The patent had no pertinent medical history. No drug reactions or allergies were reported. On 27-FEB-2015, the patient was inadvertently vaccinated with a dose of M-M-R II (therapy type was not reported) (dose, frequency and route of administration were not provided, indication was reported as "vaccination") (lot # was reported as K007982 and expiration date: 03-JUN-2016) and a dose of VARIVAX (Merck) (dose, frequency and route of administration were not provided, indication was reported as "vaccination") (lot # was reported as K007982 and expiration date: 03-JUN-2016). Concomitant medication was not reported. The patient became pregnant with last menstrual period (LMP) reported as 12-FEB-2015 and estimated date of delivery (EDD) calculated as 19-NOV-2015. The patient did not know she was pregnant at the time of vaccination. Unspecified urine test was performed on an unknown date (results were not provided), The patent sought medical attention. She visited physician on an unknown date (approximately in 2015). No product quality complaint (PQC) was involved. The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 14-OCT-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to about 20 unspecified patients. On an unknown date, about 20 patients received improperly stored doses of VARIVAX (Merck) (lot #, expiration date, dose, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 02-FEB-2015, the patient was inadvertently vaccinated with an improperly stored single dose of ZOSTAVAX, subcutaneous (dose and lot number were not reported). No adverse effects were reported. Additional information is not expected because the reporter did not wish to be contacted.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Pruritus immediately after shot. Developed redness within the next 24 hrs and extends out 10cm diameter. Persists one week after shot. This is all at location of injection site (R) deltoid.
Age: 68.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: After about 3 days after shot pt developed redness, itching, and feverish to the area.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Hypoaesthesia oral, Rash, Sensation of foreign body, Swelling
Clinical narrative: Swelling, rash on arms, chest, face and neck. Pain in joints, lips and tongue numb, knot in throat.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pharyngeal oedema, Rash
Clinical narrative: Rash on thighs, chest, abdomen. Feeling of throat swelling. Dexamethasone ordered.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a female physician of unknown age reporting on herself via company representative. Medical history and concurrent conditions were not reported. When the physician was over the age of 26 (unspecified date), was self-vaccinated with the first dose of GARDASIL (dose, route, lot number and expiry date were not reported). No adverse reported. There was no concomitant medication provided. This is one of two reports received from the same reporter. Additional information is not expected, because the reporter refused additional contact.
Age: 93.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Erythema, Local swelling, Pain
Clinical narrative: Red swollen area shoulder anterior chest axilla, 2/3 down to elbow, 1 inch approx area of white color, red area sore, bruising appearance in part of upper arm appears various stages. Ordered ZPAK one course.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody positive, Mumps antibody test positive, No therapeutic response, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse, via a company representative, refers to a 23 year old female patient. The patient's medical history and concurrent conditions were not reported. On an unspecified date approximately in 1993 (reported as: "At one year of age"), the patient was vaccinated with a dose of MMR II (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The reporter stated that the patient was vaccinated again at kindergarten age on an unknown date. Subsequently antibody titers were drawn on an unspecified date, and the patient failed to seroconvert. The patient was recently revaccinated with a dose of MMR II, and other antibody test was drawn, and this time the patient failed to seroconvert the rubella portion of the vaccine, the measles and mumps titers were high. The patient contacted the doctors office on an unknown date in regards to this problem. The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 24.0
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 14-OCT-2014, the patient was vaccinated with MMR II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. 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 a nurse practitioner refers to a female patient of unknown age. Concurrent or medical conditions were not reported. On 10-OCT-2014, the patient was vaccinated with the first dose of GARDASIL, on 20-DEC-2014, the patient was vaccinated with the second dose of GARDASIL and on 11-MAR-2015, less than 3 months after the second dose, the patient received the third dose of GARDASIL (dose, strength, route and lot number were not reported). No adverse effects were reported. No product quality complain (PQC) reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with no drug allergies. The patient's concurrent conditions and medical history were not reported. On 09-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX dose and route were not reported (lot# reported as K024031, expiration date: 20-FEB-2016). Concomitant therapies included fluoxetine, glimepiride, lisinopril (manufacturer unknown) and metformin. The pharmacist reported, that the patient came back to the pharmacy on 12-MAR-2015 with a red, hot, 6 inch lump at the injection site (onset date of the event: unspecified date in March 2015). The reporter stated, that there was no rash or itching present. The patient did not seek medical attention. No treatment was given for the event. The outcome of the event was reported as recovering/resolving. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified number of patients of unknown age and gender. Since on unknown dates, the patients had been vaccinated with unspecified doses of VARIVAX (route, lot # and expiration date were not provided). It was reported that the vaccines underwent supported defrost cycling. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were provided. The healthcare professional reported that an unspecified number of improperly stored VARIVAX doses (dose, route and lot numbers not provided) have been administered to unspecified patients on unspecified dates. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 10-MAR-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (route subcutaneous, dose 0.65 ml, lot # K000995, expiration date reported as 06-MAR-2015, expiration date after lot verification 16-MAR-2015). No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a other health professional (reported as immunization coordinator) referring to ten patients of unknown age and gender. On an unknown date(s), the ten patients were vaccinated with VARIVAX (Merck) (dose, strength, route were not reported, lot # reported as K003411, expiration date: 06-MAR-2016) which were stored improperly. There were no adverse event reported since the administration of the vaccinations. This is one of two cases (MARRS# 1503USA011471 and MARRS#1501USA010212) from the same source. Additional information has been requested.
Age: 1.27
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Musculoskeletal stiffness, Tremor
Clinical narrative: Shaking and stiffening of the body. Admitted in hospital for evaluation.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: Patient came in to inform us of a swollen arm the day after the vaccine was administered. Arm was swollen down to and including the hand.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were inadvertently vaccinated with GARDASIL (Lot #, expiration date, dose and route of administration not reported) that had been improperly stored. No adverse events reported. Additional information is not expected, because the reporter did not wish to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. Patient's medical history and concurrent condition were not reported. On 24-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # K003596, Expiry date: 12-MAR-2015), (dose was not reported), subcutaneous, that expired on 12-MAR-2015. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected due to no consent for follow up.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen area approx size of 50 cent piece at injection site - iced and reduced within 15 min assessed by physician with good report and released home with mother.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Postictal state, Tonic convulsion
Clinical narrative: Tonic seizure within 3-5 min of vaccine administration followed by 1 hr postictal state.
Age: 59.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Administration site pain, Administration site swelling, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient developed general pain and fever. On (R) arm site administration developed pain, redness and swelling. Pt is taking APAP and ice for the (R) arm pain.
Age: 1.1
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, PNC13
Symptoms: Pyrexia
Clinical narrative: Patient was given KINRIX. 3/17/15 at 8:12 am spoke with mother. She reports patient had "a little fever" last night but no other symptoms or reaction.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Patient received ZOSTAVAX injection in her left arm and immediately had a hard lump appear about 1 inch from site of injection. Bump was surrounded by redness no pain or discomfort. Patient sat for additional time no further progression and remained for 30 min.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pts arm was red, swollen, and hot around injection site. Pt saw PCP and PCP prescribed azithromycin, and MEDROL D.P.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Injection site erythema, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Patient developed hives at site, redness, itching, warmth, and shortness of breath, Saturday. Took BENADRYL and symptoms mostly resolved. Still some mild redness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Unevaluable event
Clinical narrative: None reported
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Pruritus
Clinical narrative: About 3 days after vaccination given, I developed a rash around injection sire. It covered approximately 1/3 of out upper arm, itched intensely, and spread to about 1/2 of upper arm. Lasted about 1 week, still itches occasionally.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: This spontaneous report as received from a 73 year old female consumer reporting on herself with bronchitis, drug hypersensitivity to tramadol and codeine. The patient's medical history included myocardial infarction, gallbladder operation and knee operation in 2013. On 20-JAN-2015, the patient was vaccinated with ZOSTAVAX 1 time vaccine in the left arm, triceps area. Concomitant therapies included aspirin 81 mg 1 time daily, levothyroxine sodium (manufacturer unknown) 50 mg, COREG 3.12 mg twice daily, "prevastatin", niacin, PLAVIX 75 mg, zenix, LASIX 20 mg, NEXIUM and unspecified stool softener once daily. On 20-FEB-2015, the patient developed a red area "1 1/2 inches by 3 inches", on her left insertion arm. The patient stated that it was warm, but not hot to the touch, and it was not painful. She also stated that the red area was subsiding. It was reported that the patient sought unspecified medical attention but did not receive treatment for the adverse events. No Product Quality Complaint (PQC) reported. Additional information has been requested.
Age: 1.53
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site urticaria
Clinical narrative: Had urticarial reaction on (Lt) thigh just distal to injection site right after administration. Treated with ice and BENADRYL.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Nausea, Pyrexia, Rash
Clinical narrative: 8 hours after injection patient experienced fever rash (6 inches), nausea. (Patient is a retired doctor he decided not to go to his doctor).
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. It was reported that on an unspecified dates in 2015, since 05-FEB-2015, an unspecified number of patients were vaccinated with an unspecified number of doses of M-M-R II, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were incorrect stored. No adverse effects were reported and no product quality complaint (PQC) was filled. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse (also reported as a healthcare worker) refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. Since 04-FEB-2015, an unspecified number of patients were vaccinated with a dose of oral, ROTATEQ, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were incorrect stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not consent further follow up.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse (also reported as healthcare worker) refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. Since 04-FEB-2015, an unspecifed number of patients were vaccianted with a dose of RECOMBIVAX HB, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were incorrect stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional infromation has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse (also reported as healthcare worker) refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. Since 04-FEB-2015, an unspecified number of patients were vaccinated with a dose of PEDVAXHIB, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were incorrect stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse (also reported as healthcare worker) refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. Since 04-FEB-2015, an unspecified number of patients were vaccinated with a dose of M-M-R II, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were incorrect stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Information has been received from a female patient referring to herself. The patient's current condition and medical history were not reported. On 18-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route were unknown). Concomitant therapies were not reported. On an unknown in March 2015 the patient had severe adverse event. The outcome of adverse event was unknown. Additional information is not expected as there was no patient's contact information.
Age: 32.0
Sex: M
Vaccine: JEV1
Symptoms: Paraesthesia
Clinical narrative: Patient states he felt tingling sensation down right arm after Japanese Encephalitis vaccine. Patient was administered vaccine in the same arm.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient developed erythema at injection site, irregular border, 1 inch x 2 inches.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 4 months old patient, gender not reported. On 03-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K009181, orally. It was reported that the administered vaccine was subjected to temperature excursion. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 4 months old infant, gender not reported. On 03-DEC-2014, the patient was vaccinated with ROTATEQ, Lot # K004620, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported fort he patients. On an unknown date the patients were inadvertently administered with unknown number of doses of improperly stored ROTATEQ (dose strength unspecified). No adverse effects reported. The outcome of events reported is unknown. No product complaint was involved. This is one of the several reports from the same source. Additional infromation has been requested.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 4 months old infant, gender not reported. On 03-DEC-2014, the patient was vaccinated with ROTATEQ, Lot # K010642, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 8 week old infant, gender not reported. On 12-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K009181, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 9 weeks old infant, gender not reported. On 05-DEC-2014, the patient was vaccinated with ROTATEQ, Lot # K010642, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.26
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Electroencephalogram normal, Fatigue, Hyperhidrosis, Mental impairment, Muscle twitching
Clinical narrative: Became almost stuck in mental lapse.  Seizure activity.  Blank stare.  Lip twitching.  Body stiff.  Lasted approximately 1-2 minutes.  Stopped breathing or it was so light undetectable.  Skin would turn grey.  Once it was over his head would be burning up and sweating as well as body.  Would become very tired.  We had EEG done approximately 1 month after onset which didn't show anything (Dr said this happens a lot even if seizures are present).  No course of treatment at this time as no more seizures after a run of approx 20 in 10 days and discontinuation of vaccines.
Age: 0.26
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Musculoskeletal stiffness, Respiratory arrest, Seizure, Skin discolouration, Skin warm
Clinical narrative: Became almost stuck in mental lapse.  Seizure activity.  Blank stare.  Lip twitching.  Body stiff.  Lasted approximately 1-2 minutes.  Stopped breathing or it was so light undetectable.  Skin would turn grey.  Once it was over his head would be burning up and sweating as well as body.  Would become very tired.  We had EEG done approximately 1 month after onset which didn't show anything (Dr said this happens a lot even if seizures are present).  No course of treatment at this time as no more seizures after a run of approx 20 in 10 days and discontinuation of vaccines.
Age: 0.26
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Staring
Clinical narrative: Became almost stuck in mental lapse.  Seizure activity.  Blank stare.  Lip twitching.  Body stiff.  Lasted approximately 1-2 minutes.  Stopped breathing or it was so light undetectable.  Skin would turn grey.  Once it was over his head would be burning up and sweating as well as body.  Would become very tired.  We had EEG done approximately 1 month after onset which didn't show anything (Dr said this happens a lot even if seizures are present).  No course of treatment at this time as no more seizures after a run of approx 20 in 10 days and discontinuation of vaccines.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 30 year old female patient with no drug reactions or allergies and no other pertinent medical history. The patient, who was 31 weeks pregnant at the time of the report, was vaccinated by mistake with a dose of GARDASIL (intramuscular, 0.5 ml, once, lot# and expiration date were not reported) on 09-MAR-2015 (also reported as "yesterday"). Concomitant therapies included prenatal vitamins. The patient became pregnant with LMP (last menstrual period) of approximately 05-AUG-2014 and EDD (estimated date of delivery) of approximately 12-MAY-2015. The pregnancy outcome was pending at the time of the report. The patient was not treated for the event. The patient did not have any laboratory test performed. The patient sought medical attention via office visit in March 2015. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug administered to patient of inappropriate age, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 30 year old female patient with no drug reactions or allergies and no other pertinent medical history. The patient, who was 31 weeks pregnant at the time of the report, was vaccinated by mistake with a dose of GARDASIL (intramuscular, 0.5 ml, once, lot# and expiration date were not reported) on 09-MAR-2015 (also reported as "yesterday"). Concomitant therapies included prenatal vitamins. The patient became pregnant with LMP (last menstrual period) of approximately 05-AUG-2014 and EDD (estimated date of delivery) of approximately 12-MAY-2015. The pregnancy outcome was pending at the time of the report. The patient was not treated for the event. The patient did not have any laboratory test performed. The patient sought medical attention via office visit in March 2015. Additional information has been requested.
Age: 0.16
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 8 weeks old infant, gender not reported. On 17-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K004620, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.36
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 4 months old infant, gender not reported. On 12-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K009181, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to 9 weeks old infant, gender not reported. On 17-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K009181, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.