chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a female patient in her "early teens" (exact age was unspecified). No information regarding the patient's concurrent medical conditions and medical history was provided. On an unknown dates, the patient was vaccinated with three doses of GARDASIL (dose, route of administration and lot# were not reported) or three doses of GARDASIL 9 (dose, route of administration and lot# were not reported) (unknown which vaccine was administered). The patient's concomitant medications were not reported. On an unknown date, the patient experienced an unspecified reaction after the first dose of GARDASIL or GARDASIL 9, which worsened after each of the subsequent doses. The patient sought medical attention and was being evaluated by unspecified specialists due to this unspecified reaction. The outcome of the unspecified reaction was reported as not recovered. The relatedness between the unspecified reaction and GARDASIL or GARDASIL 9 was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K023863 with expiry date 03-APR-2016; dose and route were not reported). 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 an office manager referring to an unspecified multiple number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L016428, expiration date 30-JUL-2017 and/or lot# L006547, expiration date 04-MAR-2017, strength, dose and route not 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: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to 2 unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of MMR II injection (lot # K024036, expiration date 26-NOV-2016, therapy type, dose and route of administration were not 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: VARZOS
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. On 04-SEP-2015 the patient was vaccinated with improperly stored ZOSTAVAX (lot # L003216, expiration date 30-APR-2016, strength, dose and route were unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-NOV-2015, the patient was vaccinated with an expired dose of PROQUAD (Merck) (0.5 ml, subcutaneously, lot # K007158, expiration date 12-NOV-2015). No adverse effects were reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a 69 years old female patient. The patient received doses of PNEUMOVAX 23 (lot # K021030, expiration June 2016, dose was not reported) on the following dates: 16-SEP-2015 and 19-NOV-2015 (inappropriate schedule of vaccine administration). No adverse experience was reported. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 64 year old patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 11-NOV-2015 the patient was inadvertently vaccinated with ZOSTAVAX (lot # K011003, expiration date 07-NOV-2015, strength, dose and route were unknown), after the vaccine had expired. The patient's concomitant medication was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent and concomitant medications were not reported.  On unknown dates, the patients were vaccinated with the improperly stored doses of ROTATEQ (orally, lot # L000434 with expiration date 10-JUL-2016 and lot # K004795 with expiration date 11-FEB-2016; dose was not reported). No adverse effects were reported. It was also provided that during the previous call on 23-OCT-2015 (no adverse event were reported at that time), the  medical assistant reported a vaccine temperature excursion and inquired about the stability of M-M-R II, PROQUAD (Merck), VARIVAX (Merck) and ZOSTAVAX, but none of these vaccines have been administered to the patients. Additional information has been requested.
Age: 112.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia
Clinical narrative: This spontaneous report as received from a pharmacist, as a part of a marketing research program conducted by agency, refers to a 112 year old female patient. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. The patient was recommended to have the shot even at her age because she was in a really good health. However, she was very small and very frail and later, on an unknown date, she had a reaction from the shot. She was very weak for about a week afterwards. The patient was glad she had the shot and it was worth having the reaction knowing that she was protecting herself from getting shingles. The outcome of the event was not reported. The reporter considered the event to be related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates since 08-OCT-2015, the unspecified patients were vaccinated with doses of VAQTA (lot # L004743, expiration date 01-JUN-2017) (dosage, strength and route were not reported), which were exposed to temperature outside of the recommended range. There was no concomitant medication reported. No adverse experience had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a unspecified patients of unknown age and gender. On 05-MAY-2015, 19-MAY-2015, 11-JUN-2015, 16-JUN-2015 and 21-OCT-2015, the patients were vaccinated with improperly stored doses of Other suspect therapies included VAQTA (dose, frequency, route of administration and indication were not reported, lot # L023232 with expiration date: 27-FEB-2017). No adverse event was reported. This is one of the 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 licensed practical nurse, referring to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ by oral route, lot # K013410, expiration date 27-FEB-2016 (dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old female patient. The patient's concurrent condition included allergy to clindamycin and "penicillins". The patient had no pertinent medical history and did not take any concomitant medication. On 13-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX lot # J002865, expiry date 07-JUN-2014, intramuscularly in her unspecified arm (dose was not reported). On 13-SEP-2013, immediately following the administration of ZOSTAVAX, the patient began to experience pain at the injection site. The patient continued to experience the pain at the injection site for "about a year" following the administration. At the time of the report, the patient still was experiencing the tenderness at the site "from time to time" but it was not as bad as it was during that year (outcome - recovering). No treatment was given for the adverse event. No laboratory diagnostics studies were performed. The patient sought medical attention by visiting the pharmacy. The relatedness between the pain at the injection site and the ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of PNEUMOVAX 23 (lot # L033707 with expiration date 18-MAY-2017 and lot # L014876 with expiration date 13-JAN-2017; dose and route of administration were not reported). No adverse effects were reported. It was also provided that during the previous call on 23-OCT-2015 (no adverse event were reported at that time), the medical assistant reported a vaccine temperature excursion and inquired about the stability of M-M-R II, PROQUAD , VARIVAX (Merck), but none of these vaccines have been administered to the patients. 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 an office manager referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L018500, expiration date 13-APR-2017, dose and route not provided). 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: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 19 year old patient. The patient's relevant medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the appropriate primary dose of VAQTA 25/0.5 (units not provided) (lot number, expiration date, dose and route were not reported). On an unspecified date, the patient received the booster dose of VAQTA Pediatric Formulation, second in the two-dose series (dose, route, lot# and expiry date were not reported). No adverse effect was 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 was received from a nurse refers to a unspecified patients of unknown age and gender. On 11-MAY-2015, 27-MAY-2015, 17-AUG-2015 and 24-AUG-2015 the patients were vaccinated with improperly stored doses of GARDASIL (dose, frequency, route of administration and indication were not reported, lot # J009788 with expiration date: 17-MAR-2016). No adverse event was reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates the unspecified patients was vaccinated with doses of improperly stored PNEUMOVAX 23 (lot # K020214, expiration date 25-MAR-2016) (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse effects were 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 unspecified patients of unknown age and gender. On unspecified dates, these patients were vaccinated with an unspecified number of improperly stored doses of oral, ROTATEQ (lot # K024700 with expiration 13-JUL-2016; lot # K011948 with expiration 07-JUN-2016; lot # L000569 with expiration 13-JUL-2016; dose and frequency were not reported) orally. No adverse effects were reported. This is one of several cases received 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 as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of GARDASIL 9 (lot # L027282 with expiration date 21-SEP-2017 and lot # reported as J006850 with expiration date 31-MAR-2016; dose and route of administration were not reported). No adverse effects were reported. It was also provided that during the previous call on 23-OCT-2015 (no adverse event were reported at that time), the medical assistant reported a vaccine temperature excursion and inquired about the stability of MMR II (Oka-Merck) PROQUAD, (Oka-Merck) VARIVAX and ZOSTAVAX, but none of these vaccines had been administered to the patients. 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 a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. In November 2015 (during that time frame of 05-NOV-2015 through 15-NOV-2015), the patients were vaccinated with improperly stored doses of M-M-R II (lot # K016153, expiry date 24-SEP-2016; dose and route were not reported). No adverse effects were 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: This spontaneous report was received from a nurse refers to a unspecified patients of unknown age and gender. On an unknown date, the patients were orally vaccinated with improperly stored doses of ROTATEQ (dose, frequency and indication were not reported, lot # K001716 with expiration date: 24-NOV-2015). No adverse event was reported. This is one of the 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 healthcare professional refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX injection (lot # L009206, expiration date 17-MAR-2017, dose and route of administration were not 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: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 09-NOV-2015, the patient was vaccinated with expired PNEUMOVAX 23 (strength, 25/0.5 (units not reported), dose number, route of administration were not reported, lot # K007824, expire date: 05-NOV-2015). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L028082 with expiry date 18-SEP-2017; dose and route were not reported). No adverse effects were reported. This one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Headache, Malaise
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 12 year old female patient. No medical history, concurrent conditions and concomitant medication was reported. On an unknown date in August 2015, the patient received her first dose of GARDASIL 9 with no complications reported. On 03-NOV-2015, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly, 0.5 ml, (lot # was not provided). Other suspect therapies included unspecified quadrivalent influenza virus vaccine (lot #, dose, manufacturer and route were not reported) given during the same vaccination session. On the same date, the patient experienced lightheadedness, dizziness and headache in the waiting room after her visit with the physician. The patient was monitored for 20 minutes after this episode of "lightheadedness and dizziness", and then was sent home. On 04-NOV-2015 (reported as the following day), she was examined by the physician in a follow-up appointment because she was still experiencing a headache, rated a 4 out of 10 on the pain scale. The physician recommended ibuprofen for the headache, but it "didn't seem to help the headache". On 06-NOV-2015, the patient still did not recovered, so the physician instructed family to consult her on Monday (09-NOV-2015), if the patient was still not feeling well on that day. The physician was assuming that since no further contact had been made since 06-NOV-2015, the patient had recovered. Relatedness between the events and suspect products was not specified. According to the representative this event had been reported to Vaccine Adverse Event Reporting System (VAERS). This is one of the several reports 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 medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. In November 2015 (during the time frame of 05-NOV-2015 through 15-NOV-2015), the patients were vaccinated with improperly stored doses of GARDASIL (lot # J006236, expiry date 25-FEB-2016; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) referring to a 28 year old female patient. The information of concurrent conditions, medical history and concomitant medications was not provided. On an unknown date the patient was vaccinated with the first dose of GARDASIL injection (dose and route were not provided). On an unknown date the patient was administered the second dose of GARDASIL series one month too early. This was outside the labeled recommendations in the GARDASIL prescribing information. No adverse effect was reported. The outcome of the event was unknown. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. On unspecified dates since 08-OCT-2015, the unspecified patients were vaccinated with doses of ROTATEQ (lot # K023157, expiration date 23-JUL-2016) (orally, dosage and frequency were not reported), which were exposed to temperatures outside of the recommended range. There was no concomitant medication reported. No adverse experience had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to an unspecified patient of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patient was inadvertently vaccinated with an improperly stored dose of VAQTA (lot number and expiration date were unspecified) dose, route and anatomical location were unknown. No concomitant medications were reported. No adverse experiences were reported. No further information was provided. No Product quality complaint was involved. Additional information is not expected because there is no reporter contact information.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse regarding unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On30-SEP-2015, the patient were vaccinated with ZOSTAVAX lot # L006381, 25-MAY-2016 which were exposed to temperatures outside of the recommended range. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Scar, Skin exfoliation, Urticaria
Clinical narrative: This spontaneous report was received from a physician (patient's mother) via field representative refers to a 13 year old male patient. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 21-AUG-2015 the patient was vaccinated with the first dose of GARDASIL. No concomitant medications were reported. Reporting physician stated that she observed severe hives all over the patient's body after he woke up on 22-AUG-2015. Hives were seen in the ears, nose and on his feet, everywhere on his body. The patient did not have any swelling of the mouth or throat. The patient did not require medical attention as his mother was the treating physician. She treated him with unspecified KENALOG. It was reported that it took approximately two weeks for the hives to resolve. The patient still had scars from the peeling skin as of the date of this report. Reporting physician did not assess the causality of the event with respect to vaccination with GARDASIL. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L033707 with expiry date 18-MAY-2017; dose and route were not reported). No adverse effects were reported. This one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a female physician of unknown age refers to herself. The patient's relevant medical history and concomitant medications were not reported. On an unknown date in approximately 2009 (reported as about six years ago), the patient was vaccinated with a pediatric dose of VAQTA 25/0.5 (units not provided) (lot number, expiration date, dose and route not reported) and the patient was 19 years of age or older at that time). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter declined to provide any additional information.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a multiple patients of unknown age and gender. On an unknown dates (reported as multiple unspecified dates), the patient were vaccinated with improperly stored doses of VARIVAX (Merck) injection, lot # L008273 with expiry date 11-MAR-2017, lot # L001330 with expiry date 13-JAN-2017, lot # L010146 with expiry date 24-MAR-2017, lot # L000456 with expiry date 06-JAN-2017 and lot # L001330 with expiry date 13-JAN-2017 (dose and route of administration not provided). No adverse events were reported. Lot number L008273 has been verified to be a valid lot number for VARIVAX (Merck). Follow-up information has been received on 13-NOV-2015. All telephone attempts to obtain follow-up information had been unsuccessful. This is one of the two reports from the same source. Additional information has been requested. Narrative was updated.
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. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of the improperly stored VARIVAX (Merck) (lot # K005427, expiration date 15-APR-2016; dose and route of administration were not reported). No adverse effects were reported. The reporter also inquired about the stability of M-M-R II and PNEUMOVAX 23, but neither of these vaccines have been administered to the patients. In addition, the registered nurse also reported another temperature excursion for the other lot # and expiration date of VARIVAX (Merck) (lot # K020760 and expiration date 31-OCT-2016), but this lot # of VARIVAX (Merck) had not been administered to the patients after temperature excursion. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 10-NOV-2015 the patient was vaccinated with expired dose of ZOSTAVAX (strength, dose, frequency and route were not reported) lot # K010732 with an expiry date of 31-OCT-2015. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse and pharmacist refers to a patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. From an unknown date in September 2015 to 15-NOV-2015, an unspecified number of patients have been administered doses of RECOMBIVAX HB lot# reported as L022261 exp. 01-APR-2015 (route and site of administration, dose were not reported), which were improperly stored. There was no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L013428, expiration date 03-FEB-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of several 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 was received from a register nurse, refers to an unknown number of patients, of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored doses of ZOSTAVAX, (lot #, expiration date, dosage and route were not reported). Concomitant therapy was not reported. No adverse effects reported. No product quality complaint was involved. 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 was received from a Licensed Practical Nurse concerning a patient of unknown age and gender. Information about concurrent condition and medical history was not provided. On 22-OCT-2015, the patient was vaccinated with an improperly stored dose VARIVAX (lot # L013063, expiration date 14-APR-2015 or lot # L026408, expiration date 15-JUL-2015) (dose and route were unspecified). Concomitant therapy was not reported. No adverse effect was informed. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age (also reported as in her "late 50s or early 60s") with diabetes. The patient's medical history was not provided. Approximately in 2015 (reported as "for about a month"), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route were not reported). Concomitant therapies included insulin. Approximately in 2015 (reported as "for about a month"), the patient experienced dermatitis on her face "a few days or a week" after she received ZOSTAVAX. There was no labs diagnostics studies performed. The patient was treated with BENADRYL (OTC) in unspecified dosages. The outcome of dermatitis was reported as not recovered. The reporter considered dermatitis to be not related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the registered nurse refers to multiple unspecified patients of unknown age and unknown gender. No medical history and concurrent conditions of the patients were reported. On an unknown date, multiple unspecified patients were administered improperly stored GARDASIL 9 (L013429, expiry date 21-JUL-2017, L014415, expiry date 25-JUL-2017, L028083 expiry date: 03-SEP-2017) (dose, route, therapy type not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Culture, Herpes zoster, Rash, Rash pruritic, Sleep disorder
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 63 year old female patient. The patient had drug allergies or drug reactions to pneumonia shot, tricyclic, penicillin, codeine, latex sensitive and sulfur containing medications. The patient had no pertinent medical history. On an unknown date (at least 5-8 years ago) the patient was vaccinated with ZOSTAVAX, (subcutaneous, injection). Concomitant medications included armour thyroid, pravastatin and XANAX. On 01-NOV-2015 the patient experienced shingles. On 02-NOV-2015, the patient underwent smear test from location of shingles. The smear test results were not provided. On an unknown date in 2015, the patient sought medical attention. The patient was prescribed with anti-viral, also LYRICA for pain, hydrocodone and Phenergan. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Smear test
Clinical narrative: This spontaneous report was received from a consumer refers to herself as a 63 year old female patient. The patient had drug allergies or drug reactions to pneumonia shot, tricyclic, penicillin, codeine, latex sensitive and sulfur containing medications. The patient had no pertinent medical history. On an unknown date (at least 5-8 years ago) the patient was vaccinated with ZOSTAVAX, (subcutaneous, injection). Concomitant medications included armour thyroid, pravastatin and XANAX. On 01-NOV-2015 the patient experienced shingles. On 02-NOV-2015, the patient underwent smear test from location of shingles. The smear test results were not provided. On an unknown date in 2015, the patient sought medical attention. The patient was prescribed with anti-viral, also LYRICA for pain, hydrocodone and Phenergan. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect therapy. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Rash
Clinical narrative: Information has been received from a physician via a field representative referring to a 65 year old male patient. The patient's medical history included genital herpes, erectile dysfunction, supraventricular tachycardia (PSVT), pulmonary hypertension (HTN) and varicella (as child). He had no known allergies. The patient did not have recent VZV exposure of chickenpox or shingles. He did not have a prior history of herpes zoster of herpes zoster ophthalmicus. On 06-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous in the right deltoid, lot number # reported as 013475). Concomitant therapies included TOPROL XL TABLETS, pantoprazole, metoprolol succinate, LEVITRA, vitamin d (unspecified), aspirin and AMBIEN. On 07-NOV-2015, full shingles broke out left side front to back with left thoracic herpes zoster. The patient had a rash the day after receiving ZOSTAVAX vaccine injection. On 09-NOV-2015, the patient was seen by the physician and diagnosed with shingles. On 16-NOV-2015, the specimen sample was collected from blister on left side. The vesicle was drained and swabbed with steric cotton swab. The patient contacted physician and no treatment was given for shingles. The patient was not on oral antivirals prior to specimen collection. At the time of reporting, the patient currently still had lesions and scabs. Lot number# 013475 is not valid for ZOSTAVAX on 19-NOV-2015. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Scab, Skin lesion
Clinical narrative: Information has been received from a physician via a field representative referring to a 65 year old male patient. The patient's medical history included genital herpes, erectile dysfunction, supraventricular tachycardia (PSVT), pulmonary hypertension (HTN) and varicella (as child). He had no known allergies. The patient did not have recent VZV exposure of chickenpox or shingles. He did not have a prior history of herpes zoster of herpes zoster ophthalmicus. On 06-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous in the right deltoid, lot number # reported as 013475). Concomitant therapies included TOPROL XL TABLETS, pantoprazole, metoprolol succinate, LEVITRA, vitamin d (unspecified), aspirin and AMBIEN. On 07-NOV-2015, full shingles broke out left side front to back with left thoracic herpes zoster. The patient had a rash the day after receiving ZOSTAVAX vaccine injection. On 09-NOV-2015, the patient was seen by the physician and diagnosed with shingles. On 16-NOV-2015, the specimen sample was collected from blister on left side. The vesicle was drained and swabbed with steric cotton swab. The patient contacted physician and no treatment was given for shingles. The patient was not on oral antivirals prior to specimen collection. At the time of reporting, the patient currently still had lesions and scabs. Lot number# 013475 is not valid for ZOSTAVAX on 19-NOV-2015. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Abdominal distension, Arthralgia, Catheterisation cardiac normal, Chest discomfort
Clinical narrative: Patient reported chest pain, went to hospital, no cardiac reason found for chest pain, possibly from vaccine. Given cardiac meds to treat just in case.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Computerised tomogram normal, Nausea, Pyrexia
Clinical narrative: Patient reported chest pain, went to hospital, no cardiac reason found for chest pain, possibly from vaccine. Given cardiac meds to treat just in case.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain
Clinical narrative: Patient reported chest pain, went to hospital, no cardiac reason found for chest pain, possibly from vaccine. Given cardiac meds to treat just in case.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Pain, Pain in extremity, X-ray
Clinical narrative: Patient complaints of shooting pain down the left arm intermittently. Patient stated that her left arm is not swollen, not inflamed, and no discharge.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity, X-ray
Clinical narrative: Patient complaints of shooting pain down the left arm intermittently. Patient stated that her left arm is not swollen, not inflamed, and no discharge.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Delirium, Erythema, Eyelid oedema, Lip swelling, Peripheral swelling
Clinical narrative: On date of vaccination, started with fevers to 102 and ?delirious, then on 11/20/15 had lip swelling and eyelid swelling-treated with Benadryl, now presently with left arm swelling and redness.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: On date of vaccination, started with fevers to 102 and ?delirious, then on 11/20/15 had lip swelling and eyelid swelling-treated with Benadryl, now presently with left arm swelling and redness.
Sex: F
Vaccine: FLU3
Symptoms: Abnormal dreams, Dehydration, Electrocardiogram, Fatigue, Fear
Clinical narrative: This medically confirmed spontaneous report (initial receipt 09-Nov-2015) concerns a female patient who had received the flu shot for the past 7 years and had never had a reaction. She did not know if she had received Afluria in the past. On 06-Nov-2015 at 11am, the patient received Afluria vaccine (Influenza virus vaccine polyvalent, batch number 10849211A) 0.5 mL via the intramuscular route for the prevention of influenza. On 06-Nov-2015 at 8pm, the patient began shaking uncontrollably and her mouth felt sore and swollen. She also had garbled speech, the temperature was above 103 degrees Fahrenheit, tongue swelling, very irritable, and was not feeling well. The shaking was severe. The patient had strange dreams, which was out of the ordinary for her. The patient was scared and described the experience as frightening. She thought she was having a stroke. She had visited the emergency room and had an IV (intravenous) in her.  When she was asked about her diet, she reported that she had not tried anything new. The hospital did an EKG (electrocardiogram) and reported that she had an unspecified fever, dehydration and an upper respiratory infection. She may had a viral infection. Yesterday was the first time she felt 100% better. About 2 days ago, she started feeling nausea but she attributed this to not eating because she was feeling exhausted. She will follow-up with her primary care doctor on 13-Nov-2015. The outcome was recovering. Reporter's Comments: Reporter comments: The hospital would not say if the reaction was due to the Afluria. Sender's Comments: Company comments: Seriousness criterion/criteria: Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus vaccine and the Afluria PI, upper respiratory tract infection and all other events are unlisted. Fever, malaise and nausea are listed. Causality: Possible. Time to onset is same day of vaccination. Event onset on same day is suggestive of combination of systemic events (fever, malaise), autonomic reaction (shaking) and or hypersensitivity (tongue swelling, sore swollen mouth). Dehydration may have resulted from inadequate intake due to other symptoms; collectively all events are causally attributable to vaccination due to temporal association. Neurological event (stroke) is considered to be suspected and not confirmed diagnosis, hence causality unassessable.
Sex: F
Vaccine: FLU3
Symptoms: Irritability, Malaise, Mouth swelling, Nausea, Oral pain
Clinical narrative: This medically confirmed spontaneous report (initial receipt 09-Nov-2015) concerns a female patient who had received the flu shot for the past 7 years and had never had a reaction. She did not know if she had received Afluria in the past. On 06-Nov-2015 at 11am, the patient received Afluria vaccine (Influenza virus vaccine polyvalent, batch number 10849211A) 0.5 mL via the intramuscular route for the prevention of influenza. On 06-Nov-2015 at 8pm, the patient began shaking uncontrollably and her mouth felt sore and swollen. She also had garbled speech, the temperature was above 103 degrees Fahrenheit, tongue swelling, very irritable, and was not feeling well. The shaking was severe. The patient had strange dreams, which was out of the ordinary for her. The patient was scared and described the experience as frightening. She thought she was having a stroke. She had visited the emergency room and had an IV (intravenous) in her.  When she was asked about her diet, she reported that she had not tried anything new. The hospital did an EKG (electrocardiogram) and reported that she had an unspecified fever, dehydration and an upper respiratory infection. She may had a viral infection. Yesterday was the first time she felt 100% better. About 2 days ago, she started feeling nausea but she attributed this to not eating because she was feeling exhausted. She will follow-up with her primary care doctor on 13-Nov-2015. The outcome was recovering. Reporter's Comments: Reporter comments: The hospital would not say if the reaction was due to the Afluria. Sender's Comments: Company comments: Seriousness criterion/criteria: Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus vaccine and the Afluria PI, upper respiratory tract infection and all other events are unlisted. Fever, malaise and nausea are listed. Causality: Possible. Time to onset is same day of vaccination. Event onset on same day is suggestive of combination of systemic events (fever, malaise), autonomic reaction (shaking) and or hypersensitivity (tongue swelling, sore swollen mouth). Dehydration may have resulted from inadequate intake due to other symptoms; collectively all events are causally attributable to vaccination due to temporal association. Neurological event (stroke) is considered to be suspected and not confirmed diagnosis, hence causality unassessable.
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Speech disorder, Swollen tongue, Tremor, Upper respiratory tract infection
Clinical narrative: This medically confirmed spontaneous report (initial receipt 09-Nov-2015) concerns a female patient who had received the flu shot for the past 7 years and had never had a reaction. She did not know if she had received Afluria in the past. On 06-Nov-2015 at 11am, the patient received Afluria vaccine (Influenza virus vaccine polyvalent, batch number 10849211A) 0.5 mL via the intramuscular route for the prevention of influenza. On 06-Nov-2015 at 8pm, the patient began shaking uncontrollably and her mouth felt sore and swollen. She also had garbled speech, the temperature was above 103 degrees Fahrenheit, tongue swelling, very irritable, and was not feeling well. The shaking was severe. The patient had strange dreams, which was out of the ordinary for her. The patient was scared and described the experience as frightening. She thought she was having a stroke. She had visited the emergency room and had an IV (intravenous) in her.  When she was asked about her diet, she reported that she had not tried anything new. The hospital did an EKG (electrocardiogram) and reported that she had an unspecified fever, dehydration and an upper respiratory infection. She may had a viral infection. Yesterday was the first time she felt 100% better. About 2 days ago, she started feeling nausea but she attributed this to not eating because she was feeling exhausted. She will follow-up with her primary care doctor on 13-Nov-2015. The outcome was recovering. Reporter's Comments: Reporter comments: The hospital would not say if the reaction was due to the Afluria. Sender's Comments: Company comments: Seriousness criterion/criteria: Medically significant. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus vaccine and the Afluria PI, upper respiratory tract infection and all other events are unlisted. Fever, malaise and nausea are listed. Causality: Possible. Time to onset is same day of vaccination. Event onset on same day is suggestive of combination of systemic events (fever, malaise), autonomic reaction (shaking) and or hypersensitivity (tongue swelling, sore swollen mouth). Dehydration may have resulted from inadequate intake due to other symptoms; collectively all events are causally attributable to vaccination due to temporal association. Neurological event (stroke) is considered to be suspected and not confirmed diagnosis, hence causality unassessable.