chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Expired product administered
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 19 year old female patient. The patient had no concomitant medications, no known allergies and pertinent medical history. On 02-DEC-1998, the patient was vaccinated with first dose of VARIVAX (strength, dose, route, site, lot#, expiry date were not reported). On 29-MAR-2007, the patient was vaccinated with second dose of VARIVAX (strength, dose, route, site, lot#, expiry date were not reported). ON 19-MAY-2015, the antibody test was drawn, and it was not reactive to varicella. Negative antibody test was the reason for administration on 15-JUL-2015, the third booster dose of VARIVAX (strength, site, route, dose were not reported) (lot # J008441, expiry date 09-JUL-2015). The reporter stated that it was expired dose of VARIVAX administered. The treatment for adverse event was not given. Therapy was not discontinued. The outcome of the adverse events was not reported. The relatedness between VARIVAX and the events was not 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 01-JUN-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: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL (dose: 0.5 ml, lot # K009902, expiration date 06-MAR-2017, route and a vaccination series were not reported). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown gender and age. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (strength, dose, route, lot# and expiration date unknown), which were improperly stored. No adverse experiences had been reported. This is one of several 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 as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL (dose: 0.5 ml, lot # K011325, expiration date 08-APR-2017, route and a vaccination series were not reported). There was no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown gender and age. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with doses of ROTATEQ orally (strength, dose, lot# and expiration date unknown), which were improperly stored. No adverse experiences had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refers to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 23-JUN-2015, the patient was inadvertently administered with improperly stored MMR II vaccine, lot # K002816, expire date: 25-FEB-2016 (dose, route, therapy type not reported). No adverse effects reported. No product quality complaint reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
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 12-JUN-15 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.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a patient of unknown age and gender. The patient's medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored ROTATEQ vial (route of administration default to oral, lot # K011952, expiration date 17-JUL-2016, dose and frequency were not reported). The patient's concomitant medication was not provided. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 29-JUN-2015, the patient was inadvertently administered with improperly stored MMR II vaccine, rHA therapy type, lot # K002816, expire date: 25-FEB-2016 (dose, route, therapy type not reported). No adverse effects reported. No product quality complaint reported. This is one of several reports received from the same source. Additional information has been requested.
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 of age. 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.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 18-JUN-2015, the patient was inadvertently administered with improperly stored MMR II vaccine, lot # K002816, expire date: 25-FEB-2016 (dose, route, therapy type not reported). No adverse effects reported. No product quality complaint reported. This is one of several reports received from the same source. Additional information has been requested.
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 01-MAY-2015, the patient was vaccinated with an improperly stored dose of (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: 1.39
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 16 months old. The patient demographics were updated. On 08-JUN-15 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 19-JUN-15 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: 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 04-MAY-2015, the patient was vaccinated with an improperly stored dose of (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.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On 14-JUL-2015 the patient was inadvertently vaccinated with a dose of improperly stored ROTATEQ (dose not reported, lot # K010325 with expiration date 10-MAY-2016, orally). Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse practitioner refers to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 22-JUN-2015, the patient was inadvertently administered with improperly stored MMR II vaccine, rHA type, lot # K002816, expire date: 25-FEB-2016 (dose, route, therapy type not reported). No adverse effects reported. No product quality complaint reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients who on an unknown date were vaccinated with improperly stored ROTATEQ lot # K013868, expiration date 27-MAY-2016, orally. No adverse effects were reported. The outcome of incorrect product storage was unknown. No further information was provided. Additional information has been requested.
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 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 06-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.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with VAQTA (lot # L009445 and expiration date 01-JUN-2017) (dose and route were not reported) that had been improperly stored. No concomitant therapies were reported. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information is not expected as the reporter did not wish further contact.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Haemoglobin normal, Hyperhidrosis, Pallor, Seizure, Skin discolouration
Clinical narrative: Patient fainted within 2 minutes of vaccine. She then appeared to have seizure activity shook for 1-2 minutes. Very pale and appeared to have a green hue to skin tone. O2 Sat 90% Pulse 40 B/P 60/42. Pt. sweating profusely. Transferred to Hosp ER.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Syncope, Tremor, Urine analysis normal
Clinical narrative: Patient fainted within 2 minutes of vaccine. She then appeared to have seizure activity shook for 1-2 minutes. Very pale and appeared to have a green hue to skin tone. O2 Sat 90% Pulse 40 B/P 60/42. Pt. sweating profusely. Transferred to Hosp ER.
Sex: U
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. The patient's medical history or concurrent condition was not provided. On 09-JUL-2015, the patient received a dose of improperly stored MMR II 0.5 ml (lot # J014876, expiration date 21-NOV-2015, therapy type rHA (recombinant human albumin)) subcutaneously. Concomitant drug was not reported. No adverse effects were reported. It was unknown whether the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
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 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.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with MMR II (lot# L009213 and expiration date 17-MAR-2017) (dose and route were not reported) that had been improperly stored. No concomitant therapies were reported. No adverse effects reported. No Product Quality Complaint (PQC0 was involved. This is one of the several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No pertinent medical history or concurrent condition were reported. On 22-JUL-2015, the patient was vaccinated with improperly stored VAQTA, strength 25/0.5 (units not specified), lot # K012457, expiration date 04-JUN-2017, through an unknown route. No adverse effects reported. The outcome of incorrect product storage was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
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 medical history, current conditions and concomitant therapies were reported. The nurse reported that on unknown dates unspecified number of doses of improperly stored (Merck) VARIVAX (lot # L003775, expiration date: 02-APR-2017 and lot # J014407, expiration date: 13-NOV-2015) had been administered to unspecified number of patients. No adverse effects reported. Additional information is not expected, as the reporter did not wish for any further contact.
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 09-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.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a physician concerning a patient of unknown gender and age. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route and lot # not provided). The physician reported that on an unspecified date, the patient experienced "an episode of dizziness" following administration of GARDASIL. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Erythema, Pain
Clinical narrative: Patient received vaccination of PCV 13 on 7/22/2015, then had dizziness, left arm erythema and getting bigger. Minimal pain, no fever.
Age: 1.52
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 have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 18 month 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: 84.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Immediate post-injection reaction, Injection site pain, Pain, Pain in extremity
Clinical narrative: Client reports feeling a burning sensation at time of injection and shooting pain down her arm. Developed a serious cough for weeks-was given cough syrup. Continues with constant burning (L) arm. "Real shooting pain" comes and & goes. Site still tender to the touch.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 27-JUL-2015, the patient received improperly stored PROQUAD (Merck) (lot # L002213, expiration date: 21-JUL-2016) dose and route were not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist 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 ZOSTAVAX vial, (dose, lot #, route and site of administration, expiration date were not reported). On an unknown date, the patient experienced warmth and swelling at the injection site and pain that was "going down the arm" (unspecified arm). The outcome of the events was unknown. The relatedness between ZOSTAVAX and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report from a healthcare worker refers to an unspecified patients of unknown age and gender. There was no information about concomitant medications, concurrent condition and medical history of patients reported. On an unknown date, improperly stored doses of VAQTA (dose, site, route of administration, lot# and expiry date were not reported) was administered to unspecified patients. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report 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 12-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. 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: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 66 year old female patient. The patient had no drug allergies/reactions. Patient's medical history and concomitant medications were unspecified. On 18-JUN-2015 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, 0.65 ml, lot# K024034, expiry date 20-FEB-2016). The patient developed an unspecified lump and bruise at the injection site "immediately" after receiving ZOSTAVAX. The patient had sought for medical attention by going into the pharmacy on 23-JUL-2015 and showed the pharmacist her injection site. No treatment was given for the adverse events. No lab diagnostics study was performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional (nurse) refers to a patient of unknown demographics. Patient's relevant medical history, concurrent conditions and drug reactions/allergies were not reported. On 23-JUL-2015 the patient was vaccinated with an improperly stored (Merck) VARIVAX (lot # L008270), expiry date: 11-MAR-2017), .5 ml, subcutaneous (incorrect product storage). Concomitant medications were unspecified. No adverse effects were reported. Additional information has been requested.
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 17-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.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. The medical assistant reported that on an unknown date in 2015, after second temperature excursion, the patients were administered an unspecified number of improperly stored doses of GARDASIL 9 (lot number reported as L004741, expiration date: 08-MAR-2017) (dose, route and frequency were not reported). No adverse effects were reported. Concomitant medications were not reported. The reporter was unable to provide any patient identifiers during a phone call. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Within 15 minutes of injection patient had complaint of numbness over suprasternal area then had pain. VS remained normal and physical exam. Didn't resolve after 1 hour sent to ED.
Age: 0.63
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a 7 month 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 concurrent 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: 0.34
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 old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-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 was 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: 0.33
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 16-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 12-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: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Computerised tomogram, Computerised tomogram head, Fall, Foaming at mouth, Full blood count
Clinical narrative: Pt. given immunization 7/21/15. Pt. seen in ER 7/25/2015 after he was found unresponsive and having fallen out of bed. He was limp, "foaming at the mouth." When ambulance arrived he was postictal.-Convulsion or seizure event.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hypotonia, Metabolic function test, Postictal state, Seizure, Toxicologic test
Clinical narrative: Pt. given immunization 7/21/15. Pt. seen in ER 7/25/2015 after he was found unresponsive and having fallen out of bed. He was limp, "foaming at the mouth." When ambulance arrived he was postictal.-Convulsion or seizure event.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Unresponsive to stimuli, Urine analysis
Clinical narrative: Pt. given immunization 7/21/15. Pt. seen in ER 7/25/2015 after he was found unresponsive and having fallen out of bed. He was limp, "foaming at the mouth." When ambulance arrived he was postictal.-Convulsion or seizure event.
Age: 0.55
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 17-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: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a 6 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-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. 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: 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 02-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: 29.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Rash macular, Skin warm
Clinical narrative: Swelling of upper arm. Redness, soreness. Whole upper arm became red and splotchy and was warm to touch. Placed on antibiotics by physician.
Sex: U
Vaccine: HPV4
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 GARDASIL lot # K009482, 06-MAR-2017. No adverse event was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with ROTATEQ (lot# L013188 and expiration date 02-NOV-2016) (dose and route were not reported) that had been improperly stored. No concomitant therapies were reported. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with GARDASIL (confirmed not GARDASIL 9) (lot# K016966 and expiration date 10-MAY-2017) (dose and route were not reported) that had been improperly stored. No concomitant therapies were reported. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (lot# L010595 and expiration date 12-NOV-2016) (dose and route were not reported) that had been improperly stored. No concomitant therapies were reported. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
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 of age. The patient demographics were updated. On 06-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 11-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: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Vomiting
Clinical narrative: Dizzy & past out after receiving shots. Client laid down until felt better. Prior to leaving clinic client vomited x 3.
Age: 0.34
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 old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-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: 0.32
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 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.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nausea, Pain, Skin warm, Swelling
Clinical narrative: Golf ball size raised red area warm to touch. Pt feels nausea "sick to stomach".
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Large red and swollen area measuring 6 in x 4 in wide, with induration. Warm to touch.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal tenderness, Blood test normal, Decreased appetite, Headache, Local swelling
Clinical narrative: Headaches daily, swollen lymph and neck, loss of appetite, nausea, tender belly. Blood tests reveal nothing. Chiropractic and lymph massage provides temporary relief. Can't afford neuro feedback treatment.