chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Blister, Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness of right arm from deltoid (injection site) down arm to about 1 inch below elbow. Warm to touch. No fever or other symptoms reported. Child's grandmother reports swelling started same day but got worse and brought child back to clinic 2 days later for evaluation (10/26/17).  Provider noted local reaction and instructed to ice, keep elevated, and prescribed Tylenol. Instructed parent on what to look for as far as worsening reaction and to return to clinic if symptoms did not subside. Child also had small blister on back of arm that appeared to be more likely from the band-aid that was applied at time of injection as outline of band-aid was still visible and blister was located at that site.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Local reaction, Skin warm, Swelling
Clinical narrative: Swelling and redness of right arm from deltoid (injection site) down arm to about 1 inch below elbow. Warm to touch. No fever or other symptoms reported. Child's grandmother reports swelling started same day but got worse and brought child back to clinic 2 days later for evaluation (10/26/17).  Provider noted local reaction and instructed to ice, keep elevated, and prescribed Tylenol. Instructed parent on what to look for as far as worsening reaction and to return to clinic if symptoms did not subside. Child also had small blister on back of arm that appeared to be more likely from the band-aid that was applied at time of injection as outline of band-aid was still visible and blister was located at that site.
Age: 24.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood test normal, Computerised tomogram normal, Electrocardiogram normal, Foaming at mouth, Generalised tonic-clonic seizure
Clinical narrative: Patient received vaccine around 8:45am 10/29/17  as did his mom, they both got into the car to head home when his mom noted patient to have a grand mal seizure, over all shaking, foaming at the mouth, unresponsive, incontinent of urine. Mom drove to Hospital ER (she was less then a mile away).  Mom asked them to make sure to fill out adverse vaccine report (at my request) and she was told that "they never do that because it's a waste of time". He was told to follow up with neurologist.
Age: 24.0
Sex: M
Vaccine: FLUC4
Symptoms: Tremor, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Patient received vaccine around 8:45am 10/29/17  as did his mom, they both got into the car to head home when his mom noted patient to have a grand mal seizure, over all shaking, foaming at the mouth, unresponsive, incontinent of urine. Mom drove to Hospital ER (she was less then a mile away).  Mom asked them to make sure to fill out adverse vaccine report (at my request) and she was told that "they never do that because it's a waste of time". He was told to follow up with neurologist.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with ZOSTAVAX, lot # N016185 expiration date on 31-JUL-2018, intramuscularly. No adverse effects were reported. Product quality complaint was not involved. Follow up information was received on 25-OCT-2017 from a pharmacist referring to a 68 years old female patient. The patient's medical history, concurrent conditions, drug allergies and concomitant medications were not reported. On 06-AUG-2017 the patient was vaccinated with ZOSTAVAX dose 1 (lot # N021171, Expiry date was not reported) (previously reported as lot # N016185 expiration date on 31-JUL-2018) intramuscular for prophylaxis (incorrect route of drug administration). Patient characteristics, product therapy details, event onset date and narrative updated.
Age: 67.0
Sex: M
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 67-year-old male patient with diabetes. No information regarding the patient's medical history was provided. On 26-SEP-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # N020854 with expiration date on 31-JUL-2018, 0.65 ml, via intramuscular route in the left arm. The dose of the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) lot # N021894 with expiration date on 28-NOV-2019. Concomitant vaccinations included PREVNAR 13 and FLUARIX QUADRIVALENT. The patient had no illness at the time of the vaccination. He experienced no adverse events. The reporter stated that the patient was checked again on 27-SEP-2017, and he still did not develop any adverse reaction.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: This non-valid spontaneous report was received from a pharmacist via a company representative and refers to two non-pregnant patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. In approximately September 2017, reported as "within the last month", the patients were vaccinated with PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported). The patients were administered PNEUMOVAX 23 with the same lot number. In approximately September 2017, both patients experienced swelling, which lasted two to three days. The pharmacist reported that the patients followed up with him for the swelling and he recommended that they "ice" the swollen area. The pharmacist received no follow up after this. The outcome of the event of swelling was reported as recovered/resolved (in approximately September 2017). The relatedness between the event of swelling and PNEUMOVAX 23 was not assessed by the reporter.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer mother refers to a 17 year old female patient with pregnancy. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 25-SEP-2017, the patient was vaccinated with the dose of GARDASIL 9, intramuscular in the left deltoid (lot #, expiration date and dose were not provided) for prevent HPV. Other suspect therapies (reporter was not sure which one was administered) included GARDASIL intramuscular in the left deltoid (lot #, expiration date and dose were not provided) for prevent HPV. The patient became pregnant with LMP of JUN-2017. On 02-OCT-2017 the patient performed a positive pregnancy test. At the time of initial exposure to GARDASIL 9 or GARDASIL patient was about 15 weeks pregnant. The exposure to vaccine occurred in the second trimester of patient's pregnancy. The pregnancy outcome was pending at the time of the report and the fetal outcome was unknown. The outcome of the vaccine exposure during pregnancy was unknown. The patient did not seek any medical attention.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Discomfort, Menstrual disorder
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring a 12 year old female patient. The patient's medical history, concomitant medications were not reported. The reporting physician stated that the patient was "often seen for various unspecified illnesses".  On an unknown date, the patient was vaccinated with GARDASIL 9 dose 1, intramuscular (strength, frequency, lot number and expiration date were not provided) for prophylaxis. The physician stated that when it was time to receive the second dose of GARDASIL 9, the patient's mother refused to allow the patient to receive the injection because her daughter did not experience a "normal menstrual cycle" (abnormal menstrual cycle) which lasted for 6 months. On an unspecified date, the abnormal menstrual cycle became normal again. Also it was reported that the patient experienced severe cramping (abdominal pain) and discomfort. At the reporting time, the outcome of abdominal pain and discomfort was not mentioned. The patient's mother, believes that all of her daughter's issues were a result of vaccination with GARDASIL 9, however the physician considered menstrual disorder, discomfort and abdominal pain to be not related to GARDASIL 9.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 20-year-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 04-OCT-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB lot # M023892, expiration date: 15-SEP-2017, intramuscularly in the right deltoid for prophylaxis. At the same day, the patient was also vaccinated with tuberculin purified protein derivative reported as "PPD". Other concomitant therapies included sertraline hydrochloride (ZOLOFT), sulfamethoxazole (+) trimethoprim (BACTRIM DS), sulfamethoxazole (+) trimethoprim (SEPTRA DS). The patient tolerated vaccination with RECOMBIVAX HB well at date it was given. On 06-OCT-2017, the patient came back to the office for tuberculosis test (reported as ""TB") read. No reactions from RECOMBIVAX HB was noted.  No adverse event was reported.
Age: 1.25
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Lethargy
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 15 months old female patient. No information on the patient's pertinent medical history and concurrent conditions was provided. The patient had no drug reactions or allergies. On an unspecified date in approximately 2013 (reported as: "approximately 4 years ago"), the patient was vaccinated with VARIVAX, 0.5 ml, once, for prevention of chickenpox (route of administration, lot# and expiry date were not reported). Concomitant therapies included PREVNAR and hepatitis A vaccine, inactivated (manufacturer unknown). On an unspecified date in approximately 2013, after getting these vaccines, the patient became lethargic. The patient's parents sought medical attention and consulted the physician. Lab diagnostic or studies were not performed. The patient recovered after 4 days (exact date was not provided). The patient's physician believed that this event occurred because of VARIVAX, because since the event occurred, the patient had received PREVNAR and hepatitis A vaccine, inactivated (manufacturer unknown) with no adverse event. Product quality complaint (PQC) was not involved. The reporting nurse did not provide her causality assessment.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of an unknown age. No information regarding the patient's pertinent medical history, concomitant therapies, drug reactions and allergies were reported. On 06-OCT-2017, the patient was vaccinated with diluted with sterile diluent, expired M-M-R II injection powder (dose, route of administration were not reported; lot # L034730, expiration date 09-SEP-2017) for prophylaxis. Reporter stated that M-M-R II was supported by post expiry memo and did not have a previous temperature excursions. No adverse effects reported.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Peripheral coldness
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 16-year-old female patient. The patient's pertinent medical history, drug reactions, allergies and information about concomitant medications were not reported. On 01-AUG-2017, the patient was vaccinated with the GARDASIL 9, 0.5 ml, intramuscularly (lot # and expiration date were not reported) for prevention of Human Papillomavirus. On 04-OCT-2017, the patient was vaccinated with second dose of GARDASIL 9, 0.5 ml, intramuscularly (lot # reported as N016832, expiration date were not reported) for prevention of Human Papillomavirus. On 04-OCT-2017, the patient experienced cold hands and cold feet. The patient had to be picked up from school. The patient sought a medical attention, she contacted the physician's office. No laboratory diagnostic studies were performed. No treatment was given for the adverse events. The patient recovered from the adverse event on an unknown date, approximately in October 2017. The relatedness between the adverse event and GARDASIL 9 was not reported. Lot number N016832 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 06-OCT-2017, the patient received an expired dose of VARIVAX injection, subcutaneously, one vial/ once (exact dose was not reported), lot # L034368 with expiration date on 08-SEP-2017. The VARIVAX was reconstituted with sterile diluent (lot # M020945 with expiration date on 05-DEC-2018). The pharmacist reported that both VARIVAX and sterile diluent were stored according to prescribing information. No adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 15 year old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-NOV-2001, 29-JAN-2002 and 04-FEB-2003, the patient was vaccinated with three separate doses of RECOMBIVAX HB (dose, concentration, route of administration, lot# and expiration dates were not reported). The patient was also vaccinated with an adult dose of RECOMBIVAX HB on 10-OCT-2017 (intramuscular, lot# M041384, expiration date 07-JUN-2019). No adverse effects were reported. The outcome of inappropriate schedule of drug administration was unknown.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient. No information regarding the patient's pertinent medical history and concomitant therapies was provided. Her drug reactions or allergies included: sulfa, letrozole (reported also as letrozol) and nickel. On an unspecified date in 2016, the patient was vaccinated with PNEUMOVAX 23 to prevent pneumonia (dose, route and site of administration, lot # and expiration date were not reported). On an unknown date, the patient developed redness and swelling at the injection site. On an unknown date, the patient developed drug reaction or allergy to PNEUMOVAX 23, which was listed as an allergy on the patient's file. Therefore, the reporter called to find out the ingredients in the suspect vaccine to see if a patient might have been allergic to a component of the vaccine. The outcome of injection site erythema and injection site swelling was reported as recovered/resolved. The outcome of allergy to vaccine was unknown. The reporter considered allergy to vaccine to be related to PNEUMOVAX 23 whereas, relationship between redness, swelling at the injection site and suspect vaccine was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Contraindicated product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies included ENBREL which the patient started in approximately 27-SEP-2017 (also reported as "two weeks before"). On 11-OCT-2017, the patient was vaccinated with ZOSTAVAX lot # N009777 with an expiration date 04-MAR-2018 for prophylaxis. (Dose, route of administration an anatomical location were not reported) which was reconstituted with sterile diluent lot# L037794 with an expiration date 03-MAY-2018. There was no side effects reported.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. Concomitant therapies included sterile diluent. On 10-OCT-2017, the patient was inadvertently vaccinated with expired dose of M-M-R II lot # L023385, expiration date 25-JUN-2017 (concentration and route of administration were not reported). No adverse effects were reported. The outcome of expired product administered was unknown.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-OCT-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 lot number M007768 with expiration date on 27-JUN-2017 (dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: This spontaneous report has been received from a physician, via a field representative, concerning an over 65 year old male patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, dose number, anatomical location, lot number and expiration date were not provided) administered for active immunization for the prevention of pneumococcal disease. The vaccine's route of administration was reported as intramuscular or subcutaneous injection. On an unknown date (reported as after receiving the injection of the PNEUMOVAX 23), the patient's arm "completely blew up in a rash". It was reported that the patient saw the physician, however no treatment was given for the event. At the time of reporting, the patient had recovered from rash and the causal relationship between PNEUMOVAX 23 and the event was unknown.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from an office manager, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in October 2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, once, intramuscularly, lot # N014946 with expiration date on 01-FEB-2019 (anatomical location was not reported) for prophylaxis. No adverse effects were reported. It was reported that on 10-OCT-2017, the vaccine had a temperature excursion of 32°Fahrenheit (°F) to 35°F (32F) for 24 hours and later on 12-OCT-2017, the temperature excursion was 32°F to 35°F (34F) for 9.5 hours. The reporter stated that no previous temperature excursions occurred and no digital data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with one dose of ZOSTAVAX, and on 08-OCT-2017, the patient received a second dose of ZOSTAVAX 19400 pfu (dose, route, lot number and expiration date were not reported) both for prophylaxis (extra dose administered). Other suspect therapies included sterile diluent (MERCK STERILE DILUENT). No adverse events were reported.
Sex: U
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, drug reactions/allergies,concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was inadvertently vaccinated a dose of PREVNAR 13 lot # S35324 with expiration date August 2018 (dose, strength, frequency, route of administration and anatomical location were not provided), for prophylaxis instead of the intended dose of PNEUMOVAX 23 (dose, strength, frequency, route of administration, anatomical location, lot# and expiraiton date were not provided), for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site rash, Injection site vesicles
Clinical narrative: This spontaneous report as received from a nurse refers to a 60 year old female patient. The patient did not have concurrent conditions, medical history, historical drugs or concomitant therapies. On 10-OCT-2017, the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneously, once, lot # N016185 expiration date 31-JUL-2018 (anatomical application was not reported) for prophylaxis, reconstituted with sterile diluent (MERCK) lot number M005906, expiration date 14-AUG-2018. On 11-OCT-2017, the patient experienced itching at the injection site. On 12-OCT-2017, she had the injection site tender and hard. On the same date (might have started earlier), she had a blister "like rash" at the injection site. The patient was in a clinic at the time of reporting, but not treatment was given for the events. The outcome of the events was not reported. The causal relationship between the events and ZOSTAVAX and sterile diluent (MERCK) was not reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Pruritus, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist, regarding a currently 53 year old female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 11-OCT-2017, the patient was vaccinated with ZOSTAVAX, subcutaneously for prophylaxis. Concomitant therapies included minocycline, tramadol hydrochloride and QVAR. Following vaccination the patient developed itchiness on the arm opposite to where she received the ZOSTAVAX, and had developed "redness and a red dot rash" at the site where she experienced the itch during the following night. The patient had not received any treatment for the rash at this time. The outcome of pruritus, rash and erythema was reported as not recovered/not resolved. The relatedness between the event and vaccination with ZOSTAVAX was not reported.
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare business professional refers to a 14 year old female patient. The patient did not have concurrent conditions or medical history. The patient's historical drugs and concomitant therapies were not reported. On an unknown date, the patient was prescribed with PROQUAD, and on 12-OCT-2017, the patient was vaccinated with PROQUAD in the left arm, first dose, lot # N019253, expiration date 20-DEC-2018 (dose and route were not reported) for prophylaxis. It was reported that the patient never had vaccines before, and that she was recovered. No adverse events were reported.
Sex: M
Vaccine: PPV
Symptoms: Nervousness, Pain
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 66 year old male patient. The patient's medical history and concurrent conditions were not reported. On 12-OCT-2017, the patient was vaccinated with one dose of PNEUMOVAX 23, (lot # N022703, expiry date 27-FEB-2019) intramuscular for prevention of pneumonia. A couple of weeks ago the patient received a dose of influenza virus vaccine and a dose of PREVNAR 13. On 12-OCT-2017, approximately 10 minutes after vaccination, the patient felt shaky (tremor), and began experiencing pain all over his body. The staff had to assist the patient to sit down in the front of the store. No treatment was given to the patient at the time of reporting. The outcome of tremor and pain was reported as not recovered/not resolved. No causality assessment between the events and the PNEUMOVAX 23 therapy was provided by the reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary tract infection
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 61 year old female patient. The patient's historical drugs included penicillin. The patient's concurrent conditions included penicillin allergy, anxiety, unspecified respiratory problems and unspecified urinary problems. On 12-OCT-2017 at 09:15, the patient was vaccinated with a dose of ZOSTAVAX lot # N021170 with expiration date 27-OCT-2018, subcutaneously, for prophylaxis (dose was not reported). Concomitant therapies included nortriptyline 25 mg, vitamin D, LEXAPRO, "cholecystramine powder", and albuterol. On the same day at 12:30, the patient developed "symptoms of urinary tract infection". No treatment was provided for the adverse event. At the time of reporting the outcome of the event was reported as not recovered. A product quality complaint was not involved. The causality assessment between urinary tract infection and ZOSTAVAX was not provided.
Age: 41.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 41-year-old an immunocompromised patient of an unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. According to the reporter, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, anatomical location, route of administration, lot# and expiration date were not reported) on an unknown dates (also reported as "at 41 years and 47 years"). No adverse symptoms reported.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 16-OCT-2017, the patient was vaccinated with an expired dose of ROTATEQ lot # M007125 with an expiration date 06-OCT-2017, 2 ml, orally for prophylaxis. Primary reporter denied any adverse effects occurred.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and a pharmacist and refers to a 4-year-old male patient. The patient had no pre-existing physician-diagnosed allergies, birth defects or medical conditions. There was no event following a prior vaccination. He had no illness at the time of vaccine administration. On 16-OCT-2017, the patient was vaccinated with the second dose of properly stored PROQUAD (rHA) lot # M018638, intramuscularly (dose was not provided), which expired on 11-OCT-2017. Sterile diluent (STERILE DILUENT) used for reconstitution of vaccine was properly stored. Concomitant vaccine, given on the same date, included KINRIX. It was also reported, that there was unspecified error in preparation for administration. No adverse events were reported (also reported that it was prescription drug treatment required for the experience). The reporter would wait 2 months and then reimburse the cost of vaccine.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-OCT-2017, the patient was vaccinated with an expired dose of GARDASIL 9 lot # M004116, expiry date 12-OCT-2017 (dose, route of administration were not reported).
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 64-year-old female patient. The patient's historical drugs included acetaminophen (+) hydrocodone bitartrate (NORCO), to which the patient was allergic. The patient did not have any pertinent medical history and did not take any concomitant medications. On 09-OCT-2017, the patient was vaccinated with ZOSTAVAX injection, via subcutaneous route, lot # M036296 with expiration date on 14-NOV-2017 (dose was not reported). The vaccine was reconstituted with sterile diluent (manufacturer, dose, lot # and expiration date were not reported). In October 2017, the patient experienced overall body itching for about a week. The patient did not experience a rash. No laboratory diagnostics were performed. It was unknown if the patient received any treatment. The outcome of overall body itching was reported as not recovered/not resolved. The relatedness between the event and the suspect therapies was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 18-OCT-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (dose and route of administration were not reported) lot # M000555, expiration date: 27-MAR-2017. The vaccine was reconstituted with properly stored sterile diluent lot# M013219, expiration date: 15-NOV-2018. No adverse effects was reported.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 25-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054:
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 06-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 3 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 01-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 11-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Age: 1.08
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 02-OCT-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Age: 1.0
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 11-SEP-2017, the patient was vaccinated with improperly stored VAQTA lot # N017094, expiry date: 31-AUG-2018, and M-M-R II lot # M045392, expiry date: 17-NOV-2018; dosing details were not reported, both for prophylaxis. The lot# of M-M-R II was reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Age: 1.0
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 26-SEP-2017, the patient was vaccinated with improperly stored VAQTA lot # N017094, expiry date: 31-AUG-2018, and M-M-R II lot # M045401, expiry date: 14-NOV-2018; dosing details were not reported, both for prophylaxis (incorrect product storage). The lot# of M-M-R II was reconstituted with properly stored sterile diluent (STERILE DILUENT MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000054:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 28-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Age: 4.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 12-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054:
Age: 5.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 05-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Age: 1.58
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 07-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Age: 1.0
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 26-SEP-2017, the patient was vaccinated with improperly stored VAQTA lot # N017094, expiry date: 31-AUG-2018, and M-M-R II lot # M045401, expiry date: 14-NOV-2018; dosing details were not reported, both for prophylaxis. The lot# of M-M-R II was reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 07-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054:
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 11-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Age: 1.0
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 27-SEP-2017, the patient was vaccinated with improperly stored VAQTA lot # N017094, expiry date: 31-AUG-2018, and M-M-R II lot # M045401, expiry date: 14-NOV-2018; dosing details were not reported, both for prophylaxis. The lot# of M-M-R II was reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Age: 10.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 10 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 21-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Age: 16.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 16 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 06-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.