chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX lot # L003774 and L013063 with expiration dater 04-FEB-2017 and 14-APR-2017, respectively (route was not provided). On an unknown date, there was an incorrect product storage as the unspecified number of patients received the improperly (Oka/Merck) VARIVAX. No adverse event was reported. It was unknown if the patients sought medical attention. At the time of the report, the patient's status was unknown.  This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a  Licensed Vocational Nurse (LVN) refers to a multiple unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. In unspecified dates during July 2015, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (dose and route were not reported), lot # L009203 expiry date 17-MAR-2017, L007225 expiry date 03-MAR-2017. There was no concomitant medication provided. No adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. Patient's medical history or concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX lot # K016318, expiration date 24-DEC-2015, (dose, dose number, route, anatomical location were unspecified). Concomitant therapies were not reported. No adverse symptoms reported. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old patient (unspecified gender). On 17-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.82 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received form the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11 year old patient (unspecified gender). On 18-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old patient (unspecified gender). On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In additional, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 year old patient (unspecified gender). On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 year old patient (unspecified gender). On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 68 year old female patient. The patient had no pertinent medical history or drug reactions or allergies. On 07-AUG-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # K023622; expiration date: 20-FEB-2016) (dose and route not provided). The patient's concomitant medications included unspecified medicines. On 09-AUG-2015, the patient reported having an unspecified red, bumpy rash on an unspecified side of her neck. The patient reported that it was itchy and a little painful. The patient was then seen at an unspecified urgent care center and was diagnosed with the shingles (herpes zoster) and was prescribed an unspecified medication. There were no laboratory tests of diagnostic studies performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 19 year old patient (unspecified gender). On 29-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18 year old patient (unspecified gender). On 29-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistant in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old patient (unspecified gender). On 29-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old patient (unspecified gender). On 29-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and rout were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 19 year old patient (unspecified gender). On 20-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 18 year old patient (unspecified gender). On 20-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 year old patient (unspecified gender). On 15-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11 year old patient (unspecified gender). On 20-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11 year old patient (unspecified gender). On 23-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling redness and soreness of left deltoid region.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant refers to a patient of unknown age and gender. Concurrent conditions and medical history were not provided. On 12-AUG-2013, the patient was vaccinated with the first dose of GARDAIL injection (expiration date and lot number were not provided). On 07-AUG-2014, the patient was vaccinated with the second dose of GARDASIL injection (expiration date and lot number were not provided). There was not concomitant medication provided. Not adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received from a nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. Reporter stated that, the patient received doses of GARDASIL injection on 24-JAN-2013, 30-DEC-2014 and 10-MAR-2015 (doses, strengths, route, lot number and expiration date not provided); which was an inappropriate schedule of drug administration. The nurse did not specify whether or not the patient experienced an adverse effect. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Throat tightness
Clinical narrative: Throat tightness.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional referring to multiple patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # J010668, expiration date 29-APR-2016; K003520, 20-NOV-2016; K006124, 02-FEB-2017) dose and route of administration were not provided. No adverse effect reported. This service request was first opened on 30-JUN-2015, when a pharmacist called to report a vaccine temperature excursion but any adverse event was reported at that time. However, this adverse event was reported on 11-AUG-2015, during a call back by this healthcare worker. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On 06-AUG-2015, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck), (dose and route of administration were not provided), (lot # L013545, expiration date 17-OCT-2016; lot # L019997, expiration date: 02-DEC-2016; lot # L011079, expiration date: 11-OCT-2016). No concomitant medications were reported. At the time of this report, no adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to 10 unspecified patients of unknown age and gender. The patient's pertinent medical history and drug reactions allergies were not reported. The nurse practitioner nurse reported that on unspecified dates, the patients received doses of improperly stored PROQUAD (Merck) (lot # K018142, exp. date 10-APR-2016). No concomitant therapies or adverse experiences were reported. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: RV5
Symptoms: Lethargy, Listless, Pyrexia, Restlessness
Clinical narrative: Initial information has been received from a consumer concerning her daughter, a 1 year old female patient. The patient's medical history included high fever, listlessness, lethargy and abnormal restlessness after receiving multiple unspecified vaccinations according to the recommended dosing schedule, for her 2 and 4 month visits (unspecified dates in 2014). Concomitant medications were not reported. On 10-AUG-2015, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), oral for "booster" (dose, dose number, lot number and expiration date were unspecified). The mother stated that, on an unknown date in August 2015, the patient experienced again high fever (pyrexia), abnormal restlessness, lethargy and listlessness. The outcome of the events was reported as recovering/resolving. The reporter considered that the events were caused by rotavirus vaccine, live, oral, pentavalent (manufacturer unknown). Additional information is not expected because the reporter details were not provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot# L005297 with expired date 17-AUG-2016, dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not reported. On an unknown date in August 2015, the patients were vaccinated with improperly stored doses of (Merck) PROQUAD Lot# reported as "L008353", expiration date 11-SEP-2016 (administration routes was not reported). No concomitant therapies were reported. No adverse effects were reported. According to the reporting nurse, the doses were exposed to a temperature excursion from 12-AUG-2015 12:30 pm to 14-AUG-2015 5 pm for a total of 53 hours at 13.1 C. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with the improperly stored doses of GARDASIL (lot # K008931 with expired date 04-MAR-2017, dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not reported. On 13-AUG-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # K026386, expiration date: 15-DEC-2016 (administration route was not reported). No concomitant therapies were reported. No adverse effects were reported. According to the reporting nurse, the dose was exposed to a temperature excursion from 12-AUG-2015 to 13-AUG-2015, for a total of 17 hours at 5.5 C. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not reported. On an unknown date in August 2015, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX, lot # K021484, expiration date: 03-MOV-2016 and lot # reported as "L002868", expiration date 27-JAN-2017 (administration routes was not reported). No concomitant therapies were reported. No adverse effects were reported. According to the reporting nurse the doses were exposed to a temperature excursion from 12-AUG-2015 to 13-AUG-2015 for a total of 17 hours at 5.5C. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not reported. On 13-AUG-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX, lot # K026386, expiration date: 15-DEC-2016  (administration route was not reported). No concomitant therapies were reported. No adverse effects were reported. According to the reporting nurse the dose were exposed to a temperature excursion from 12-AUG-2015 to 13-AUG-2015 for a total of 17 hours at 5.5C. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not reported. On 13-AUG-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX, lot # L007227, expiration date: 03-MAR-2017  (administration route was not reported). No concomitant therapies were reported. No adverse effects were reported. According to the reporting nurse the dose were exposed to a temperature excursion from 12-AUG-2015 to 13-AUG-2015 for a total of 17 hours at 5.5C. This is one of several reports 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 registered nurse referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On an unspecified day, these patients were vaccinated with improperly stored RECOMBIVAX HB (lot # J014855, expiration date: 16-APR-2016; lot# K016005, expiration date: 27-AUG-2016; lot# K026666, expiration date: 22-OCT-2018; lot# L004754, expiration date: 11-OCT-2016; strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On an unspecified date, these patients were vaccinated with improperly stored GARDASIL (lot# K026246, expiration date: 28-JAN-2017; lot#K026247, expiration date: 29-JAN-2017; strength, dose and route unknown) (incorrect product storage). Lot # L004014 was not valid for GARDASIL. There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not reported. On 13-AUG-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX, lot # L007227, expiration date: 03-MAR-2016  (administration route was not reported). No concomitant therapies were reported. No adverse effects were reported. According to the reporting nurse the dose were exposed to a temperature excursion from 12-AUG-2015 to 13-AUG-2015 for a total of 17 hours at 5.5C. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with the first dose of PNEUMOVAX 23 (Lot number, expiration date, route and dose were not provided). Concomitant medication were not reported. The physician stated that, within 6 months of the first dose, the patient was administered a second dose of PNEUMOVAX 23 (Lot number, expiration date, route and dose were not provided). Then, after second dose, the patient experienced swelling at the injection site. The outcome of injection site swelling was unknown at the time of the report. The reporter did not assess the relatedness of PNEUMOVAX 23 to injection site swelling. Additional information is not expected because the physician had no further information to provide.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to two unspecified patients of unknown age and gender. No concurrent conditions and medical history were reported. In July 2015, the patients were vaccinated with doses of (Oka/Merck) VARIVAX lot # K006134, expiration date, route and dose were not provided). Concomitant medication were not provided. On an unknown date in 2015, the patients experienced injection site redness and itching. The patients did not seek for medical attention. Therefore, no treatment was given for the events. The outcome of injection site redness and itching was reported as recovered on an unspecified date in 2015. The reporter did not assess the relatedness of (Oka/Merck) VARIVAX to the events. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received fro ma pharmacist refers to an unspecified number of patients of unknown age and gender. No concurrent conditions and medical history were reported. On an unspecified date, the patients were vaccinated with doses of (Oka/Merck) VARIVAX lot number, expiration date, route and dose were not provided) as routine pre-employment vaccinations. Concomitant medication were not provided. On an unknown date, the patients experienced injection site redness and itching. The patients did not seek to medical attention. Therefore, no treatment was given for the events. The outcome of injection site redness and itching was reported as recovered on an unspecified date. The reporter did not assess the relatedness of (Oka/Merck) VARIVAX to the events. This is one of several reports 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 certified medical assistant refers to a multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of ROTATEQ, lot number K016314, expiration date 05-JUN-2016, orally, (dose was were not reported). There was no concomitant medication reported. No adverse effect was reported. No product quality complaint was involved. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL, lot number K026246, expiration date 28-JAN-2017, (dose and route were not reported). There was no concomitant medication reported. No adverse effect was reported. No product quality complaint was involved. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 1.16
Sex: F
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: Anaphylactic reaction, Blood test, Cyanosis, Pyrexia, Respiratory rate decreased
Clinical narrative: 45 min from shots, patient head was swollen, lips blue, nails blue and breathing slowing down. 106 fever.
Age: 1.16
Sex: F
Vaccine: DTAP, HIBV, MMR, PPV, VARCEL
Symptoms: Swelling
Clinical narrative: 45 min from shots, patient head was swollen, lips blue, nails blue and breathing slowing down. 106 fever.
Age: 15.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Fall, Lip injury, Swelling face, Syncope, Tooth fracture
Clinical narrative: Recieved HPV shot and fainted. The nurse didn't let me lay down although my mom had told her the doctor gave instructions to lay down and wait 15 minutes. I felt dizzy and started seeing purple and black lights. The next thing I knew I was on the tile floor bleeding from my mouth. I fell from the examination bed so based on my height it was a 5 foot fall. fractured nose, busted lip, cracked 2 teeth, bump on forehead. went to dentist and emergency room. started seeing face was swollen the following week. couldn't eat or drink anything because of the sensitive teeth. head pain as well. surgery on nose.
Age: 15.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Dizziness, Facial bones fracture, Fall, Feeding disorder, Fluid intake reduced
Clinical narrative: Recieved HPV shot and fainted. The nurse didn't let me lay down although my mom had told her the doctor gave instructions to lay down and wait 15 minutes. I felt dizzy and started seeing purple and black lights. The next thing I knew I was on the tile floor bleeding from my mouth. I fell from the examination bed so based on my height it was a 5 foot fall. fractured nose, busted lip, cracked 2 teeth, bump on forehead. went to dentist and emergency room. started seeing face was swollen the following week. couldn't eat or drink anything because of the sensitive teeth. head pain as well. surgery on nose.
Age: 15.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Headache, Lip injury, Mouth haemorrhage, Photopsia, Rhinoplasty
Clinical narrative: Recieved HPV shot and fainted. The nurse didn't let me lay down although my mom had told her the doctor gave instructions to lay down and wait 15 minutes. I felt dizzy and started seeing purple and black lights. The next thing I knew I was on the tile floor bleeding from my mouth. I fell from the examination bed so based on my height it was a 5 foot fall. fractured nose, busted lip, cracked 2 teeth, bump on forehead. went to dentist and emergency room. started seeing face was swollen the following week. couldn't eat or drink anything because of the sensitive teeth. head pain as well. surgery on nose.
Age: 15.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Sensitivity of teeth, Swelling face, Syncope, Tooth fracture
Clinical narrative: Recieved HPV shot and fainted. The nurse didn't let me lay down although my mom had told her the doctor gave instructions to lay down and wait 15 minutes. I felt dizzy and started seeing purple and black lights. The next thing I knew I was on the tile floor bleeding from my mouth. I fell from the examination bed so based on my height it was a 5 foot fall. fractured nose, busted lip, cracked 2 teeth, bump on forehead. went to dentist and emergency room. started seeing face was swollen the following week. couldn't eat or drink anything because of the sensitive teeth. head pain as well. surgery on nose.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 3 year old male patient. The patient's pertinent medical history and drug allergies were none. On 05-AUG-2015, the patient was vaccinated with VARIVAX (lot # J006695 and expiry date: 30-MAY-2015) (dose, frequency and route were not reported). This is one of the two reports from the same reporter. Additional information is not expected as the reporter did not wish to contact.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL, VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 3 year old male patient. The patient's pertinent medical history and drug allergies were none. On 05-AUG-2015, the patient was vaccinated with VARIVAX (lot # J006695 and expiry date: 30-MAY-2015) (dose, frequency and route were not reported). This is one of the two reports from the same reporter. Additional information is not expected as the reporter did not wish to contact.
Age: 4.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Blister, Injection site swelling
Clinical narrative: Large amount of swelling, ring surrounding injection site, small blisters.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash maculo-papular
Clinical narrative: Patient returned to clinic 45 minutes after immunization was administered with erythematous macular papular rash diffusely all over. No throat swelling, wheezing, or SOB noted. Child was playing and acting normal.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oral pruritus, Pruritus, Urticaria
Clinical narrative: Localized redness and hives later developed itchy limbs and mouth took Benadryl.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Chest pain, Dizziness, Headache, Oropharyngeal pain, Visual impairment
Clinical narrative: Dizziness, headache, vision change, throat and chest started to hurt.
Age: 1.24
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Within 5 mins of receiving the MMR patient experienced redness over entire right thigh, including swelling and hives.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Urticaria
Clinical narrative: Patients dad called and states was in last week 8-12-15 for a well child and received the Hep A and HPV, dad states that by Friday his son was broke out from head to toe with hives. His arms at the injection sides were very red, swollen like with some white lump like (Hives). Dad states they gave him Benadryl and didn't seem to help and did Claritin as well, he did state it was mint fest and was outside in heat as well. Took him to ER on Saturday where he was given a steroid shot, and medications as well. Dad said that was told by the doctors and nurses that these two vaccinations really shouldn't be given together for they can cause reactions together. Dad states he wanted us to be aware for he of his allergic reaction and would like a call back today to know if this is true on these two vaccinations, I told the dad I would call him after we called the Health Dept to see what there thoughts are on this.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, PPV
Symptoms: Decreased appetite, Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Fever of 102.8-oral/vomiting/loss of appetite/swelling & redness at injection site; 4-5 inches in diameter by the evening of 8/14/2015. Fever lasted until 08/16/2015 evening. Redness & swelling lasted until 8/17/2015. Vomiting subsided when temperature was stable.
Age: 0.23
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Apnoea, Apparent life threatening event, Cyanosis, Hypotonia
Clinical narrative: ALTE episode with limpness, cyanosis and apnea x 50 seconds.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Anaphylactic shock
Clinical narrative: within 10 minutes of vaccinations, went into anaphylactic shock.  Brought back to pediatrician's office when the EPIPEN was administered and he was taking by ambulance to the ER
Age: 0.54
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5, DTAP
Symptoms: Blood calcium, Blood electrolytes, Blood potassium, Computerised tomogram head, Dyskinesia
Clinical narrative: Patient jerked his head to the right and his mouth twisted down a few hours after receiving his vaccinations. Saturday, he had several episodes doing the same movements.The after hours nurse suggested he go to the ER. They tested calcium, potassium, and electrolytes. He also had a head CT. We were told to follow up with his pediatrician. On Sunday, he continued movements then changed from jerking the right side to shaking his head side to side. The nurse suggested we go back to ER. He was admitted for 3 days and given an EEG.
Age: 0.54
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5, DTAP
Symptoms: Electroencephalogram
Clinical narrative: Patient jerked his head to the right and his mouth twisted down a few hours after receiving his vaccinations. Saturday, he had several episodes doing the same movements.The after hours nurse suggested he go to the ER. They tested calcium, potassium, and electrolytes. He also had a head CT. We were told to follow up with his pediatrician. On Sunday, he continued movements then changed from jerking the right side to shaking his head side to side. The nurse suggested we go back to ER. He was admitted for 3 days and given an EEG.
Age: 0.54
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5, DTAP
Symptoms: Abnormal behaviour, Dyskinesia, Eye movement disorder, Hypokinesia, Laboratory test
Clinical narrative: Patient jerked his head to the right and his mouth twisted down a few hours after receiving his vaccinations. Saturday, he had several episodes doing the same movements.The after hours nurse suggested he go to the ER. They tested calcium, potassium, and electrolytes. He also had a head CT. We were told to follow up with his pediatrician. On Sunday, he continued movements then changed from jerking the right side to shaking his head side to side. The nurse suggested we go back to ER. He was admitted for 3 days and given an EEG.
Age: 0.54
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV5, DTAP
Symptoms: Musculoskeletal stiffness
Clinical narrative: Patient jerked his head to the right and his mouth twisted down a few hours after receiving his vaccinations. Saturday, he had several episodes doing the same movements.The after hours nurse suggested he go to the ER. They tested calcium, potassium, and electrolytes. He also had a head CT. We were told to follow up with his pediatrician. On Sunday, he continued movements then changed from jerking the right side to shaking his head side to side. The nurse suggested we go back to ER. He was admitted for 3 days and given an EEG.
Age: 1.3
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Papule, Rash
Clinical narrative: Patient developed rash within 24 hours of receiving Pentacel Vaccine. Provider noted small erythematous papules to her legs, arms and back of her neck. Provider prescribed Cetirizine.
Age: 1.1
Sex: M
Vaccine: HEPA, MMR
Symptoms: Abdominal pain, Agitation, Asthenia, Ataxia, Dizziness
Clinical narrative: Agitation, ataxia, dizziness, sneezing, flatulence, abdominal pain, weakness.
Age: 1.1
Sex: M
Vaccine: HEPA, MMR
Symptoms: Flatulence, Sneezing
Clinical narrative: Agitation, ataxia, dizziness, sneezing, flatulence, abdominal pain, weakness.
Sex: U
Vaccine: MNQ
Symptoms: Abnormal behaviour, Seizure, Seizure like phenomena
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (consumer) on 07 August 2015. A patient (age and gender not reported), whose medical history and concomitant medications were not reported, had received dose of MENACTRA (batch number, expiry date, route and site of administration not reported) on an unspecified date. On an unknown date, few days after the vaccination, the patient was acting funny and then at five days post vaccination developed convulsions and seizure type behavior. The patient was taken to the hospital (dates not specified). Laboratory investigations and corrective treatments were not reported. At the time of this report the outcome of the events was not reported. Documents held by sender: none.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dehydration, Herpes zoster, Hyperhidrosis, Pyrexia
Clinical narrative: This spontaneous report was received from a consumer on behalf of her husband as a 66 year old male patient with penicillin allergy. On 07-JUL-2014, the patient was vaccinated with ZOSTAVAX 1 single shot (frequency and lot # unspecified (exp. 29-FEB-2014)). Concomitant medication included Teratozon y Alperanal (therapies unspecified). After vaccination, the patient developed shingles on the patient's inner left thigh, leg, front of the chest and neck and was hospitalized for 12 days (unspecified dates). On 26-JUL-2015, the patient developed the second case of shingles on the patient's inner left thigh, leg, front of the chest and neck. On an unspecified date in July 2015, the patient experienced sweating and dehydration and was admitted to the hospital due to a low grade fever (specific date and duration of hospitalization were unknown). At the time of this report, the outcome of second case of shingles on the patient's inner left thigh, leg, front of the chest and neck, sweating, dehydration and low grade fever was reported as recovering. The outcome of the patient's first case of shingles was unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Upper arm swelling and redness, pruritis.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Syncope
Clinical narrative: Fainting and jerking motion of hands. Lasted 1-3 seconds.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain at site of injection.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Throat tightness
Clinical narrative: PATIENT REPORTED SLIGHT TIGHTNESS IN HER THROAT.  NEVER EXPERIENCED LOSS OF CONSCIOUSNESS OR CONSTRICTION OF AIRWAY.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Blood in Stool.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: This spontaneous report was received from a pharmacist via company representative, concerning her 48 year old her husband. Patient's concurrent condition included immune system "so low". On an unknown date within ten years, the patient was vaccinated with two doses of PNEUMOVAX 23 (dose, route, lot # and expiration date were not reported) for chronic obstructive pulmonary disease (COPD). On unspecified dates, the patient "almost died from his COPD". The patient sought medical attention through an unspecified source. Upon internal review, the event "almost died from his COPD" was considered as a life threatening. At the time of the report, the outcome of event was unknown. Additional information is not expected because the physician cannot be contacted.
Age: 27.0
Sex: F
Vaccine: HEP, IPV, JEV1, MENB, RAB
Symptoms: Headache, Injected limb mobility decreased, Injection site erythema, Injection site warmth, Muscular weakness
Clinical narrative: Patient called that night stating her right arm was very sore, she was unable to make a fist, deltoid immunization site was red and very hot. She also complained of nausea and headache. She stated that her arm was immediately hot and sore after her shots but she went to play Ultimate frisbee. During this game she became nauseous. She was advised to take 600 Ibuprofen if stomach could tolerate it, put hot compresses on arm and rest. A nurse called her back an hour later - her nausea was gone, still had a headache and arm was a little better. She could then make a fist but could not lift her arm above her head. She stated the heat helped a lot. She agreed to call if things get worse.
Age: 27.0
Sex: F
Vaccine: HEP, IPV, JEV1, MENB, RAB
Symptoms: Nausea, Pain in extremity
Clinical narrative: Patient called that night stating her right arm was very sore, she was unable to make a fist, deltoid immunization site was red and very hot. She also complained of nausea and headache. She stated that her arm was immediately hot and sore after her shots but she went to play Ultimate frisbee. During this game she became nauseous. She was advised to take 600 Ibuprofen if stomach could tolerate it, put hot compresses on arm and rest. A nurse called her back an hour later - her nausea was gone, still had a headache and arm was a little better. She could then make a fist but could not lift her arm above her head. She stated the heat helped a lot. She agreed to call if things get worse.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Photophobia
Clinical narrative: Light sensitivity, extreme headache.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Arm really and then the next day, 8/8, it was very swollen and hurt. Went Sunday afternoon to ER to have checked. Gave something for pain and nausea.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Blood creatine phosphokinase normal, Injection site pain, Muscle twitching
Clinical narrative: 60 yo female s/p Prevnar 13 vaccine c/o severe pain at injection site with twitching of arm muscles.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Breath holding, Confusional state, Crying, Glassy eyes, Hypotonia
Clinical narrative: After injection of Varicella child was holding breath, body became limp, moving slowly with glazed look in eyes as if she was confused.  Picked up child and called for Dr, at which time he did a full body assessment, child was crying and in mothers arms.  Child and mother were placed in another room for observation for 10 minutes at which time Dr allowed them to go home.  I called VFC and spoke with Dr she said this was not a typical reaction and to wait at least 4 weeks before giving the next set of immunizations.