chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medication were reported. No adverse effect had been observed or 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. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years old. The patient demographics were updates. On 04-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or 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. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years old. The patient demographics were updated. On 03-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Age: 1.01
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or 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. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 12 months old. The patient demographics were updated. On 03-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergies/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or 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. Follow up information has been received from 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years old. The patient demographics were updated. On 08-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Age: 1.02
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or 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. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 12 months old. The patient demographics were updated. On 05-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. NO concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly store VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or 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. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years old. The patient demographics were updated. On 19-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Age: 1.11
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or 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. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 13 months old. The patient demographics were updated. On 18-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. On 22-JUL-2015, the patient was vaccinated with an improperly stored doe of PROQUAD (Merck) (dose and route were not reported, lot# reported as L005296, expiration date 17-AUG-2016). There was no adverse effects reported. This is one of several reports from the same reporter. Lot number L005296 has been verified to be a valid lot number for PROQUAD (Merck). Additional information has been requested.
Age: 0.26
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a 3 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot #' K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or 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 has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to an 8 weeks old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or 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 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 refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 15-JUN-2015, the patient was vaccinated with improperly stored doses of VAQTA with one of the following lot numbers: K014696 with expiration date: 11-NOV-2015, L001445 with expiration date: 15-FEB-2016 and L004439 with expiration date: 15-FEB-2016, (Strength, dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. Lot numbers K014696, L001445 and L004439 have been verified to be valid lot numbers for VAQTA. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Seroconversion test negative
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. On an unkonwn date the patient was vaccinated with M-M-R II injection, dose 1 and dose (dose, route and lot # unspecified). No concomitant medications were reported. On an unknown date the patient experienced seroconversion test negative. Pharmacist confirms after two doses of M-M-R II, the patient, in the military, failed to seroconvert to mumps and rubella. Antibody blood test was drawn, unspecified when. No adverse effects reported. Pharmacist states she does not have any other information since patient was vaccinated elsewhere. The outcome of seroconversion test negative was unknown. Causality assessment was not reported. Additional information is not expected. Pharmacist does not want to be contacted about this report.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unkonwn age and gender. Information about patient's concurrent conditions and medical history was not reported. On 25-JUL-2015 the patient was inadvertently vaccinated with a dose of PNEUMOVAX23 (dose, route not reported, lot # K005402 with expiration date 07-NOV-2015) that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. Additional information is not expected because the physician did not want to be contacted.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the nurse refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On unspecified dates, the patients were vaccinat4edd with improperly stored doses of ROTATEQ vial (oral, lot number and dose not reported). No adverse effects were reported. The outcome of improperly stored product was unknown. There was no product quality complaint involved. Upon telephonic follow up, the nurse stated that no additional information was available. This is one of the two reprots received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 29-APR-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist referring to a 52 year old female patient. The patient was allergic to erythromycin, morphine, penicillin, tetracycline, VALIUM. On 29-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # K007988, expiration date: 03-SEP-2015; Strength, route and dose unknown) for shingles prevention. There was no information about concomitant therapy. On an unspecified date after administration of ZOSTAVAX, the patient developed a raised rash at the injection site. It was reported that the patient's rash had been present for about a month. The patient had called the pharmacy for medical attention. No treatment was given to the patient. The outcome of injection site rash was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. Information regarding concurrent conditions and medical history was not provided. The pharmacist reported that the patient received her first dose of GARDASIL on an unspecified date one year ago (in 2014) and was in her pharmacy today, 27-JUL-2015, to receive dose number two (strength, dose, lot #, route and application site were not reported) (inappropriate schedule of drug administration). Concomitant therapy was not reported. No adverse experience reported. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a 6 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or 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 has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated intramuscularly with an unknown dose of GARDASIL 9 (lot# and expiry date were not reported). Concomitant medication included PPD test, which was performed on the same day as vaccination. On an unknown date, after the procedures were completed, the patient experienced syncope. The patient was observed for an unspecified amount of time and was released. The patient did not seek medical attention. It was unknown if the subsequent doses of GARDASIL 9 would be continued. The outcome of syncope was unknown. The relatedness between syncope and GARDASIL 9 was not reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 years old patient of unknown gender. On 23-JUL-2015, the patient was vaccinated with a improperly stored dose of PROQUAD (Merck) (dose and route were not reported, lot # reported as L005296, expiration date 17-AUG-2016). There was no adverse effects reported. This is one of several reports received from the same reporter. Lot number L005296 has been verified to be a valid lot number for PROQUAD (Merck). Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a six years old patient of unknown gender. On 17-JUL-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose and route were not reported, lot # reported as L007224, expiration date 03-MAR-2017). There were no adverse effects reported. This is one of several reports received from the same reporter. Lot L007224 has been verified to be a valid lot number for VARIVAX (Merck). Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: Information has been receiving from a registered nurse via field representative referring to several female patients that had recently given birth of unknown age and gender. On unknown dates the patients were vaccinated with M-M-R II (dose 1, route, dose and lot# were unknown). On unknown dates, it indicated that the titer for Rubella was showing negative. So the patients had to revaccinated with M-M-R II. The hospital's protocol required that the patients who had recently given birth had to demonstrate Rubella Immunity before leaving. The patient's didn't seek medical attention for the adverse event. 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 registered nurse referring to two patients of unknown gender and age. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot# K025002 and expiration date 20-JUL-2017, strength, dose and route unknown). NO adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unknown dates, the patients received doses of improperly stored GARDASIL, lot # J003727, expiration date 07-NOV-2015 (dose, route of administration and indication were not reported). No adverse effect was reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 63 year old female patient with lupus and diabetes mellitus. There was none of the drug reactions or allergies reported. On 24-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # L012476, exp. date: 10-JUL-2016) 0.65 ml injection, subcutaneously in the left arm. Concomitant therapies included ENBREL. On 24-JUL-2015, the patient developed an injection site reaction 15 minutes after ZOSTAVAX administration. The injection site area became pink and the affected area was the size of a dime. The patient reported to the pharmacist that during the past two days the injection site reaction has become red and looked like "a burn". The affected area had also increased in size (the specific size was unspecified). No treatment was given for the adverse events. None of the lab diagnostics studies were performed. The outcome of the patient's events was reported as not recovered/not resolved. The relatedness between vaccination with ZOSTAVAX and the patient's events was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to 2 patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On 13-JUL-2015, the patients were vaccinated with expired doses of GARDASIL (lot# reported as H020921, expiry date 05-JUL-2015; strength, dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. It has been determined that lot # H020921 is an invalid lot # for GARDASIL. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 29-APR-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a physician's office manager via a company representative refers to a female patient of unknown age. Concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, injection (dose, route of administration, lot number and expiration date were not reported). There was not concomitant medication provided. On an unspecified date, the patient experienced swelling from the point of injection to the shoulder, the reporter stated that the swelling was only in the arm where the ZOSTAVAX was given. The outcome of injection site swelling was not reported. No product quality complaint (PQC) was involved. The reporter did not assess the relatedness of injection site swelling with ZOSTAVAX. 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 02-JUL-2015 concerning a patient of an unknown age and gender. On 22-MAY-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 159 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist referring to an adult patient of unknown gender and age. On an unknown date the patient was vaccinated with RECOMBIVAX HB injection, 0.5 ml, intramuscular, unknown frequency. It was reported that the patient was an unspecified adult and therefore, RECOMBIVAX HB was administered outside the prescribing information. It was unspecified as to which dose that was in the RECOMBIVAX HB vaccination series. No adverse effect was reported. No further information was available. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a 6 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 05-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or 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 has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient woke up at 3AM Wednesday 7/22/15 with moderate pain at injection site, hard, red 1/2 dollar size area which increased to softball size. Patient also had nausea, dizziness and felt "out of it". Felt better in afternoon, saw Dr at 3PM, was given doxycycline, redness area has softened but is increasing in size down to elbow, patient felt that it was disseminating but improving.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Patient woke up at 3AM Wednesday 7/22/15 with moderate pain at injection site, hard, red 1/2 dollar size area which increased to softball size. Patient also had nausea, dizziness and felt "out of it". Felt better in afternoon, saw Dr at 3PM, was given doxycycline, redness area has softened but is increasing in size down to elbow, patient felt that it was disseminating but improving.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient's pertinent medical history includes anxiety, headaches, bowel spasm, nausea, and allergies for iodine contrast media, ADVIL, ELAVIL, penicillin, NSAIDs, MEDROL, DILAUDID, epinephrine, vitamin C and citrus. On 20-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # K020186, exp. date: January 2016) 0.65 ml injection, subcutaneously in the left arm. Concomitant therapies included AMBIEN, diazepam and atenolol. The patient called to nurse's (physician's) office and told that she had a small red swollen bump at the injection site of left arm, where she was vaccinated with ZOSTAVAX. In addition, the bump was warm to the touch and was getting bigger. The nurse stated that there was no rash. No treatment was given for adverse event. The nurse asked the patient to use cool compress as comfort measure and to observe the area. There was no lab diagnostics studies performed. The outcome of the patient's events was reported as not recovered/not resolved. The relatedness between vaccination with ZOSTAVAX and the patient's events 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 02-JUL-2015, concerning a patient of an unknown age and gender. On 03-JUN-2015, the patient was vaccinated with a dose of PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 159 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On an unknown date in 2009 the patient was vaccinated with the first dose of GARDASIL (dose, strength, lot # and route were not reported). On 15-MAY-2015 the patient was vaccinated with the second dose of GARDASIL (dose, strength, lot # and route were not reported). No adverse effects were reported. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 28-MAY-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised, Rash morbilliform
Clinical narrative: Measle like rash on patient's body.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, MMRV, PNC13
Symptoms: Eye movement disorder, Muscle contracture, Musculoskeletal stiffness, Postictal state, Seizure
Clinical narrative: Within a few minutes after receiving vaccines ? seizure-sent to ER. Pt was witnessed to have a clonic tonic seizure during the appointment. Pt had been given her immunizations and appeared to be doing well. Provider was speaking about the need for possible blood drawn when pt appeared to become nervous. Pt suddenly contracted. Her arms became rigid and then her whole body became stiff as her eyes rolled back in her head. The pt was standing at the time in her mother's arms. Pt was then transferred to the exam table. The seizure lasted approx 30 seconds. She then remained in a postictal state for 4-5 minutes. She gradually became more responsive. Pt's mother agreed to take her to ER for further evaluation. Pt was in stable condition when she left the clinic. The ER was notified of pt's arrival. Report given to RN.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain
Clinical narrative: Patient has shoulder pain.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Blood test, Computerised tomogram, Joint contracture, Malaise, Posture abnormal
Clinical narrative: 5-10 minutes after injection, patient was not feeling well. Her head dropped and fist clenched and she started shaking for 2-3 minutes. 911 was called and patient taken to local ER for treatment. She was also referred to Neuro.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Tremor
Clinical narrative: 5-10 minutes after injection, patient was not feeling well. Her head dropped and fist clenched and she started shaking for 2-3 minutes. 911 was called and patient taken to local ER for treatment. She was also referred to Neuro.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Feeling abnormal, Seizure
Clinical narrative: 5-10 minutes after injection, patient was not feeling well. Her head dropped and fist clenched and she started shaking for 2-3 minutes. 911 was called and patient taken to local ER for treatment. She was also referred to Neuro.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 28-MAY-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a 6 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or 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 has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Fall
Clinical narrative: Patient received 2nd dose HPV, became dizzy, light headed, fell to floor.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives on arms, legs and abdomen 5-6.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 7/24 Raised area, warm, tender to touch at site of Tdap. Treated with BACTRIM -> 7/29, site improved (injection 7/23, site tender 7/24, Saturday 7/25 bump).
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 22-APR-2015, the patient was vaccinate4d with an improperly stored dose of VARIVAX (Merck) lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Sex: U
Vaccine: HEP
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. On an unknown date, the patients were vaccinated with an improperly stored RECOMBIVAX HB lot # J004700, Expiry date, 20-NOV-2015, K019502, expiry date 04-FEB-2016. No adverse event was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA, IPV, MNQ
Symptoms: Unevaluable event
Clinical narrative: None.
Sex: M
Vaccine: HEP
Symptoms: C-reactive protein increased, Leukoplakia oral, Oropharyngeal pain, Pallor, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a physician concerning to a male subject in his 30's with no pertinent medical history. The subject who was participating in an unspecified clinical trial developed an itchy, sore throat which was "progressively worsening," and a "tiny, pale spot" on the roof of his mouth, all "within two days" after receiving on an unknown date, "within the past few weeks", his first dose of RECOMBIVAX HB (dose and lot number not reported), intramuscular. Physician also reported the subject had bloodwork done on unspecified dates after receiving the dose of RECOMBIVAX HB, which showed his "EFR" increased to 35, then increased to 38, from a pre-vaccination baseline of 21. The bloodwork also showed his C-reactive protein (CRP) increased to 0.9 from a pre-vaccination baseline of 0.7. No treatment was given. There was no intervention to prevent serious criteria. No significant disability or incapacity, hospitalization, cancer, overdose or life threatening were reported. The outcome of leukoplakia oral, pruritus and oropharyngeal pain was unknown. Relationship between leukoplakia oral, pruritus, pain and vaccination with RECOMBIVAX HB was not reported. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Throat irritation
Clinical narrative: Information has been received from a physician concerning to a male subject in his 30's with no pertinent medical history. The subject who was participating in an unspecified clinical trial developed an itchy, sore throat which was "progressively worsening," and a "tiny, pale spot" on the roof of his mouth, all "within two days" after receiving on an unknown date, "within the past few weeks", his first dose of RECOMBIVAX HB (dose and lot number not reported), intramuscular. Physician also reported the subject had bloodwork done on unspecified dates after receiving the dose of RECOMBIVAX HB, which showed his "EFR" increased to 35, then increased to 38, from a pre-vaccination baseline of 21. The bloodwork also showed his C-reactive protein (CRP) increased to 0.9 from a pre-vaccination baseline of 0.7. No treatment was given. There was no intervention to prevent serious criteria. No significant disability or incapacity, hospitalization, cancer, overdose or life threatening were reported. The outcome of leukoplakia oral, pruritus and oropharyngeal pain was unknown. Relationship between leukoplakia oral, pruritus, pain and vaccination with RECOMBIVAX HB was not reported. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site reaction, Rash erythematous
Clinical narrative: Pt was give Tdap on 7/17/2015 and was seen back in our office on 7/20/2015 with a indurated erythematous rash 11 by 18 cm at site of injection. Evaluated at our office by Dr.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Injection site pain, Pain, Skin warm
Clinical narrative: ZOSTAVAX administered 7/17/15. The next day pt noted pain at site. On 7/21 noted area of redness/warmth/pain and expanded in 24hrs seen 7/22 by me. Exam: 14 cm x 5.5 cm area of erythema/warmth/tenderness dx's with cellulitis-> tx'd with KEFLEX 500,g QID x 7d. Pt has f/w with PCP 7/24/15.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: ZOSTAVAX administered 7/17/15. The next day pt noted pain at site. On 7/21 noted area of redness/warmth/pain and expanded in 24hrs seen 7/22 by me. Exam: 14 cm x 5.5 cm area of erythema/warmth/tenderness dx's with cellulitis-> tx'd with KEFLEX 500,g QID x 7d. Pt has f/w with PCP 7/24/15.
Age: 52.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Blood test normal, Malaise, Pyrexia, Rash erythematous
Clinical narrative: Six days post vaccination pt reported high fevers (peak 102.6) and red diffuse body rash. Reports fever persisted 5 days and was controlled by analgesia. Saw PCP and had blood work which per patient was normal. Pt continues to have rash, and general malaise, but no fevers. Says he has f/u with Infectious Disease Monday 8/3/15.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt. had vaccine (Tdap) given at 3:30 pm and two hours after shot she started feeling pain on site. That night she stated feeling site of vaccine warm, red and a little swollen. Ibuprofen 600mg TID x 3 days, BID x 3 days-ice, BENADRYL.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Rash started yesterday on the back then spread to legs/arm.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: C-reactive protein normal, Full blood count normal, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mild pain to (L) upper arm with swelling and redness after vaccination 2 days ago. Patient was seen at ER yesterday. Seen at office 7/23/15 swelg of (L) upper arm redness warmth.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site warmth, Red blood cell sedimentation rate normal
Clinical narrative: Mild pain to (L) upper arm with swelling and redness after vaccination 2 days ago. Patient was seen at ER yesterday. Seen at office 7/23/15 swelg of (L) upper arm redness warmth.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker and a medical assistant refers to a patient of unknown and gender. Concurrent conditions and medical history were not reported. The healthcare worker mentioned that on 13-JUL-2015, the patient was vaccinated with an expired dose of MMR II (HSA). The medical assistant reported that Lot number was reported as J010158, expiration date 11-JUL-2015, 0.5 ml subcutaneously (dose was not reported) in preparation for a trip. Concomitant medication was not reported. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender with no pertinent medical history, drug reaction or allergies reported. On 28-JUL-2015, the patient was vaccinated with an expired dose of GARDASIL lot # H017698, expiration date: 02-JUL-2015, dose 1, 0.5 ml, intramuscular. Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old patient gender not reported. On 27-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # reported as L010145 exp date 24-MAR-017) (dose and route not reported) that was exposed to a temperature outside the recommended range. The patient had not reported an adverse experience. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year  old patient gender not reported. On 27-JUL-2015, the patient was vaccinated with a dose of M-M-R II (lot # K016153 exp date 24-SEP-2016) (dose and route not reported) that was exposed to a temperature outside the recommended range. The patient had not reported an adverse experience. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
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. On an unknown date, the patients were vaccinated with an improperly stored PNEUMOVAX23 (lot # K009107, 21-JAN-2016, K010523, expiry date K019502). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HPV4, MMRV
Symptoms: Product preparation error
Clinical narrative: This spontaneous report was received from a radiology technician refers to a 12 month old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided. On 15-JUL-2015, the 12 month old patient was vaccinated with a dose of PROQUAD (Merck) which was reconstituted with GARDASIL instead of sterile diluent (route, lot numbers and expiration dates were not provided). So, there was a wrong technique in drug usage process and inappropriate schedule of drug administration. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. In 2010 the patient was vaccinated with a first (only one) dose of M-M-R II (lot #, strength and dose were not reported). ON an unspecified date, the patient has serologic testing completed which was negative for two (unspecified) of the three components of the M-M-R II. The outcome of the patient's event was not reported. The relatedness between vaccination and M-M-R II and the patient's event was not reported. Additional information has been requested.
Age: 0.37
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a 4 months patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-JUN-2015, the patient was vaccinated with an improperly stored dose ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of th 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 has been requested.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Lymphadenopathy, Oropharyngeal pain, Pain, Rash
Clinical narrative: Body aches, sore joints, swollen glands, mild sore throat, rash-covering almost entire body-rash-started on arms, spread to legs, then to trunk.