chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test normal, Migraine with aura, Nausea, Urine analysis normal, Vomiting
Clinical narrative: This spontaneous report was received from a medical assistant, refers to a 23 year old female patient. There were not pertinent medical history or drug reactions. On 05-JUN-2015 the patient was vaccinated with the first dose of GARDASIL 0.5 ml, in the left deltoid, lot # K023435, expiration date: 05-NOV-2016. There were not concomitant therapies. The medical assistant informed that on an unspecified date in June 2015, (reported as within 2-3 days), the patient experienced migraines with aura, nausea and vomiting. Also informed that the patient sought medical attention by visiting her primary care physician, who ran a blood work and urinalysis and the results were negative. Subsequently the physician suggested patient take unspecified "pain medication", at the moment of this report the patient was continuing with migraines but they are not at the severity that they first presented. The outcome of the migraine with aura was recovering. The outcome of migraine with aura was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 12-FEB-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 04-MAR-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 02-FEB-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 30-APR-2015 or 01-MAY-2015, the patient was vaccinated with either improperly stored VARIVAX (Merck) (strength, dosage, frequency and route unspecified) (Lot: reported as K015375 expiration date: 18-SEP-2016, Lot: reported as K018990 expiration date: 15-OCT-2016, Lot: reported as K011317 expiration date: 13-AUG-2016, Lot: reported as K016153 expiration date: 24-SEP-2016) or improperly stored M-M-R II (strength, dosage, frequency and route unspecified) (Lot: reported as K021930 expiration date: 10-NOV-2016, Lot: reported as K021487 expiration date: 03-NOV-2016, Lot: reported as L001329 expiration date: 13-JAN-2017). It was unspecified exactly which lot # of the vaccine the patient was given. No adverse effects were reported. Follow-up information has been received from the medical assistant on 24-JUN-2015 referring to a 4 year old female with one sibling. The patient's birth weight was 7 lb and 8 oz. The patient's weight was 49 (unit not provided) and height was 44.5 (unit not provided). On 01-MAY-2015 16:00, the patient received her second dose of M-M-R II (lot# K018990, expiration date and dose unspecified), subcutaneously in the right site. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested. Patient information, product, event and narrative were updated.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 02-JUN-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demographics. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, an unspecified number of patients were administered improperly stored doses of GARDASIL injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 06-FEB-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 07-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 19-MAR-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-JUN-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Age: 56.0
Sex: F
Vaccine: MMR, MNQ, PPV, MEN, MMR, PPV
Symptoms: Drug administered to patient of inappropriate age, Joint range of motion decreased, Musculoskeletal disorder, Myalgia, Pain
Clinical narrative: This spontaneous report was received from a currently 56-year-old female patient who was also the physician. The patient had no pertinent medical history, her allergies included allergy to ampicillin. The patient was left hand dominant. On 10-AUG-2014, the patient was intramuscularly vaccinated the first dose of PNEUMOVAX 23 (lot # J010396, expiration date: 16-FEB-2015; dose was not reported) in the left arm. On the same date, the patient also received an unspecified dose of M-M-R II (lot#J013316, expiration date was not reported, route of administration was not reported) and an unspecified meningococcal vaccine (dose and route of administration were not reported), in the right arm. At the time of vaccination the patient was 55 year and 11 months old. Concomitant treatment included unspecified multivitamin. On an unknown date, the patient experienced an achiness in her left arm. On an unknown date, the achiness turned into excruciating pain that lasted for a full month. The pain started to dissipate and then went away on an unspecified day in January 2015. After the pain went away, the patient was unable to move her arm above her head and no longer had the full movement potential in her left arm (date unknown in 2015). Therefore the patient visited an unspecified family physician on an unknown date. On 23-MAR-2015, the patient visited an internist. She was given a Magnetic Resonance Imaging (MRI) on 05-MAY-2015 and computerized tomogram (CT) scan on 01-JUN-2015. The results showed adhesive capsulitis. There was no rotator cuff damage. At the time of the report, the patient did not recover from adhesive capsulitis. It was reported that no treatment was given for the events. The relatedness between PNEUMOVAX 23 and the adverse events was not reported. The reporter stated that she considered the event of adhesive capsulitis to be a significant disability. She felt she was disabled to a degree since she was left hand dominant and she did not have full range of motion in her arm. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: MMR, MNQ, PPV, MEN, MMR, PPV
Symptoms: Pain in extremity, Periarthritis
Clinical narrative: This spontaneous report was received from a currently 56-year-old female patient who was also the physician. The patient had no pertinent medical history, her allergies included allergy to ampicillin. The patient was left hand dominant. On 10-AUG-2014, the patient was intramuscularly vaccinated the first dose of PNEUMOVAX 23 (lot # J010396, expiration date: 16-FEB-2015; dose was not reported) in the left arm. On the same date, the patient also received an unspecified dose of M-M-R II (lot#J013316, expiration date was not reported, route of administration was not reported) and an unspecified meningococcal vaccine (dose and route of administration were not reported), in the right arm. At the time of vaccination the patient was 55 year and 11 months old. Concomitant treatment included unspecified multivitamin. On an unknown date, the patient experienced an achiness in her left arm. On an unknown date, the achiness turned into excruciating pain that lasted for a full month. The pain started to dissipate and then went away on an unspecified day in January 2015. After the pain went away, the patient was unable to move her arm above her head and no longer had the full movement potential in her left arm (date unknown in 2015). Therefore the patient visited an unspecified family physician on an unknown date. On 23-MAR-2015, the patient visited an internist. She was given a Magnetic Resonance Imaging (MRI) on 05-MAY-2015 and computerized tomogram (CT) scan on 01-JUN-2015. The results showed adhesive capsulitis. There was no rotator cuff damage. At the time of the report, the patient did not recover from adhesive capsulitis. It was reported that no treatment was given for the events. The relatedness between PNEUMOVAX 23 and the adverse events was not reported. The reporter stated that she considered the event of adhesive capsulitis to be a significant disability. She felt she was disabled to a degree since she was left hand dominant and she did not have full range of motion in her arm. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: MMR, MNQ, PPV, MEN, MMR, PPV
Symptoms: Computerised tomogram abnormal, Injected limb mobility decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Periarthritis
Clinical narrative: This spontaneous report was received from a currently 56-year-old female patient who was also the physician. The patient had no pertinent medical history, her allergies included allergy to ampicillin. The patient was left hand dominant. On 10-AUG-2014, the patient was intramuscularly vaccinated the first dose of PNEUMOVAX 23 (lot # J010396, expiration date: 16-FEB-2015; dose was not reported) in the left arm. On the same date, the patient also received an unspecified dose of M-M-R II (lot#J013316, expiration date was not reported, route of administration was not reported) and an unspecified meningococcal vaccine (dose and route of administration were not reported), in the right arm. At the time of vaccination the patient was 55 year and 11 months old. Concomitant treatment included unspecified multivitamin. On an unknown date, the patient experienced an achiness in her left arm. On an unknown date, the achiness turned into excruciating pain that lasted for a full month. The pain started to dissipate and then went away on an unspecified day in January 2015. After the pain went away, the patient was unable to move her arm above her head and no longer had the full movement potential in her left arm (date unknown in 2015). Therefore the patient visited an unspecified family physician on an unknown date. On 23-MAR-2015, the patient visited an internist. She was given a Magnetic Resonance Imaging (MRI) on 05-MAY-2015 and computerized tomogram (CT) scan on 01-JUN-2015. The results showed adhesive capsulitis. There was no rotator cuff damage. At the time of the report, the patient did not recover from adhesive capsulitis. It was reported that no treatment was given for the events. The relatedness between PNEUMOVAX 23 and the adverse events was not reported. The reporter stated that she considered the event of adhesive capsulitis to be a significant disability. She felt she was disabled to a degree since she was left hand dominant and she did not have full range of motion in her arm. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Arm swollen by 2 inches, red skin, itching. no fever.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Injection site soreness, fever, aches and pain throughout body, headache.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Peripheral swelling, Pyrexia
Clinical narrative: ARM SWELLING. FEVER AND CHILLS.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13, RV1
Symptoms: Extra dose administered
Clinical narrative: Pt was given a Hepatitis B vaccine and a PEDIARIX.
Sex: U
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: This spontaneous report as received from a physician who heard about the experience from another physician, via company representative refers to a patient of unknown age and gender. There was no information about concomitant medications and pertinent medical history reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (first dose) intramuscular (dose, lot#, expiration date were not reported). On an unknown date, reported as "within seconds after being administered the first dose of GARDASIL 9 the patient experienced a full onset seizure. The outcome of seizure was unknown. The relatedness between GARDASIL 9 and the event was not reported. Upon internal review, the event of a full onset seizure was considered to be medically significant. Additional information is not expected as there were no patient's or physician's contact details.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash lower underside of arm, not at site of injection no vesicles-may not be related.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Day 17 post vaccine. Developed classic varicella rash. No culture taken.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 01-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients received improperly stored VARIVAX (Merck) (lot #K002922, expiration date: 26-FEB-2016, lot# reported as L006386, expiration date: 25-FEB-2017, lot# K004652, expiration date: 11-FEB-2017, route and dose were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 04-FEB-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: M
Vaccine: HEP
Symptoms: Pain in extremity, Product closure removal difficult, Product quality issue
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a male patient of unknown age who was a physician. On an unknown date, the physician had extreme difficulty removing the yellow caps off of the RECOMBIVAX HB vials, to the point where it started to hurt his fingers. The physician always had issues removing the yellow caps and they always seemed to bother his fingers. Product quality issue was reported. The outcome of the event was not reported. The relatedness between the event and the RECOMBIVAX HB was not reported. 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 healthcare worker refers to unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unspecified dates, the patients were vaccinated with improperly stored, ROTATEQ, oral (unknown strength). Concomitant medications were not reported. No adverse symptoms were reported. The outcome of the event was unknown. There was no product quality complaint involved. This one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 30-JAN-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demographics. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, an unspecified number of patients were administered improperly stored, Oral, ROTATEQ injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 27-APR-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 28-APR-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and concomitant medications were reported. On 12-JUN-2015, the patient received improperly stored MMR II, injection (dose, route of administration, albumin status, lot # and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 03-MAR-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, exp date 03-JUL-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 19-FEB-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 21-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to a child patient of unknown age and gender. The patient's medical history was not reported. On 22-APR-2015 the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown) via vaccines for children (VFC) program. Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 27-MAY-2015 the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Extra dose of vaccines were administered within 2 days.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 11-MAR-2015 the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 18-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K016425, expiration date 26-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 20-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K016425, expiration date 26-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 20-APR-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 17-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K016425, expiration date 26-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K016425, expiration date 26-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 06-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K016425, expiration date 26-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reported. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as Healthcare Prof-other) refers to a patient of unknown age and gender. On 13-MAY-2015 the patient was vaccinated with an improperly stored VAQTA 25/0.5, injection (lot 3 K018181, expiry date 04-JUN-2017) (route, dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. There was no product quality complaint reported. The action taken with the therapy with VAQTA. The outcome of the events was unknown. The relatedness of the events to the therapy with VAQTA was unknown. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 13-FEB-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K016425, expiration date 26-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event following immunisation, Seizure like phenomena
Clinical narrative: This spontaneous report was received from a registered nurse, via field representative and refers to a female patient of unknown age. Medical history of the patient was not reported. On an unknown date the patient was vaccinated with GARDASIL. Concomitant medications were not reported. After receiving the first dosed of GARDASIL, the patient experienced sycophancy (adverse event following immunization) and "seizure like activity" while still in the physician's office. No treatment was given for the events. No laboratory studies were performed. The outcome of the events was reported as recovered. Causality assessment was not provided. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 20-MAY-2015, the patent was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K016425, expiration date 26-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 17-MAR-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as Healthcare Prof-other) refers to a patient of unknown age and gender. On 03-JUN-2015 the patient was vaccinated with an improperly stored dose of VAQTA 25/0.5, injection (lot # K018181, expiry date 04-JUN-2017) (route, dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. There was no product quality complaint reported. The action taken with the therapy with VAQTA was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VAQTA. This is one of the many reports form the same source. 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 healthcare worker (also reported as Healthcare Prof- other) refers to a patient of unknown age and gender. On 23-APR-2015 the patient was vaccinated with an improperly stored dose of VAQTA 25/0.5, injection (lot # K018181, expiry date 04-JUN-2007) (route, dosing regimen and frequency unknown). No concomitant medications were reported. No adverse events were reported. There was no product quality complaint reported. The action taken with the therapy with VAQTA was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VAQTA was unknown. This is one of the many reports from the same source. 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 healthcare worker (also reported as Healthcare Prof- other) refers to a patient of unknown age and gender. On 23-APR-2015 the patient was vaccinated with an improperly stored dose of VAQTA 25/0.5, injection (lot # K018181, expiry date 04-JUN-2017) (route, dosing regimen and frequency unknown). No concomitant medications were reported. No adverse events were reported. There was no product quality complaint reported. The action taken with the therapy with VAQTA was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VAQTA was unknown. This is one of the many reports from the same source. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test positive
Clinical narrative: This spontaneous report as received from a nurse refers to a 40 year old female patient. The patient's medical history included positive PPD. On 05-FEB-2010, the patient was vaccinated with the first does of (Oka/Merck) VARIVAX injection, 0.5 ml, subcutaneous. On an unspecified date, the patient was vaccinated with the second dose of (Oka/Merck) injection, 0.5 ml, subcutaneous. Concomitant therapies included bupropion hydrochloride and quetiapine fumarate. On 27-JUL-2012, a varicella zoster antibody IGG test was 1.39 (positive indication). On 13-FEB-2015, a varicella IGG antibody test was negative. The outcome of the event 'Varicella virus test positive' was reported as not recovered. The patient did not seek any medical attention. There were no product quality complaint (PQC) involved. The relatedness of the event was not reported for VARIVAX (Oka/Merck). No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as Healthcare Prof-other) refers to a patient of unknown age and gender. On 04-JUN-2015 the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # K008878, expiry date 23-MAR-2017) (route, dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. There was no product quality complaint reported. The action taken with the therapy with LIQUID PEDVAXHIB was unknown. The outcome of the events was unknown. The relatedness of the events of the therapy with LIQUID PEDVAXHIB was unknown. This is one of the many reports from the same source. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B surface antigen negative
Clinical narrative: Information has been received from a registered nurse referring to a 29 year old female patient. The patient was allergy to morphine, VICODIN and penicillin. The patient's concurrent condition included arthritis of the knees. The patient's medical history included gastric bypass surgery. Concomitant therapies included ZOCOR and aspirin. On unspecified dates in "late 1996 or early 1997", the patient was administered with three-dose series of an unspecified hepatitis B vaccine (manufacturer unknown) (lot#, dose and route were not reported) which were not documented in the patient's medical record and it could not be determined whether the unspecified hepatitis B vaccine was RECOMBIVAX HB. On 19-SEP-1997, the patient had blood tests for hepatitis B surface antigen, which was negative; patient also had hepatitis B antibody titers drawn on this date, which were undetectable. As a result, patient was administered a two-dose series of ENGERIX-B (both doses from lot# 2429A4, expiry date unspecified): one dose on 25-NOV-1997 and one dose on 13-JAN-1998, which were her fourth and fifth doses of hepatitis B vaccine. When patient began working at a new facility, she had repeat hepatitis B antibody titers drawn on 17-APR-2015, which were also undetectable, described as "less than 3.0". As a result, patient was administered two 0.5 mL doses of RECOMBIVAX HB (both doses from lot # K010535, expiry date 27-AUG-2016) on 22-APR-2015 to equal one 1 ml dose. Patient had repeat hepatitis B antibody titers drawn on 26-MAY-2015, which were also undetectable, described as "less than 3.0". No treatment was given for the adverse events. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant on 15JUN2015 concerning a patient (age and gender not specified). The medical assistant reported that on 04JUN-2015 the patient received a dose of improperly stored LIQUID PEDVAXHIB. The outcome is unknown. No adverse effects were reported. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as Healthcare Prof-other) refers to a patient of unknown age and gender. On 02-MAY-2015 the patient was vaccinated with an improperly stored dose of VATA 25/0.5, injection (lot # K018181, expiry date 04-JUN-2017) (route, dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. There was no product quality complaint reported. The action taken with the therapy with hepatitis a vaccine, inactivated was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with hepatitis a vaccine, inactivated was unknown. This is one of the many reports from the same source. 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 healthcare worker (also reported as Healthcare Prof-other) refers to a patient of unknown age and gender. On 07-MAY-2015 the patient was vaccinated with an improperly stored dose of VAQTA 25/0.5, injection (lot # K018181, expiry date 04-JUN-2017) (route, dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. There was no product quality complaint reported. The action taken with the therapy with hepatitis a vaccine, inactivated was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with hepatitis a vaccine, inactivated was unknown. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as Healthcare Prof-other) refers to a patient of unknown age and gender. On 27-MAY-2015 the patient was vaccinated with an improperly stored dose of VAQTA 25/0.5, injection (lot # K018181, expiry date 04-JUN-2017) (route, dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. The action taken with the therapy with VAQTA was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VAQTA was unknown. This is one of the many reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K020749, expiration date 30-APR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-JUN-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K026385, exp date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demographics. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, an unspecified number of patient were administered improperly stored doses of (Oka/Merck) VARIVAX injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 08-APR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 31-MAR-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.