chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 13-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L026602, expiration date: 19-OCT-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event, Product use issue
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates in November 1989 and December 1989, respectively, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot #, expiration date, dose and route were unknown). In January 1990, the patient was vaccinated with the third dose of RECOMBIVAX HB (lot #, expiration date, dose and route were unknown) (Extra dose administration). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected as the reporter did not want to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA which had lot # M002268 and expiry date: 20-SEP-2017 (dose and route not reported). No adverse effects and no product quality complaint (PQC) was reported. No further information provided. Is one of the three reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 24-year-old patient of an unknown gender. The patient's medical  history, concurrent conditions and concomitant therapies were not reported. On 26-APR-2016 (reported as 26-APR-20106), the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L026602, expiration date: 19-OCT-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: F
Vaccine: HPV9
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a female patient of unknown age. There were unspecified heart conditions run in the patient's family. On an unknown date, the patient the second dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). On an unknown date, soon after administration of GARDASIL 9, the patient experienced chest pain. On an unknown date, the patient was given an electrocardiogram (EKG) and "echo", which were negative for any heart disease. The patient sought medical attention (unspecified). It was reported that therapy was discontinued. On an unknown date, the patient recovered from the event. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical histories, concurrent conditions and concomitant therapies were not reported. On an unspecified dates, the patients received an improperly stored doses of VAQTA (dose and route of administration were not provided) (lot numbers: J005081, expiration date: 22-OCT-2015; K009506, expiration date: 22-SEP-2016; K007791, expiration date: 22-AUG-2016; K024697, expiration date: 28-APR-2017; J005713 expiration date: 25-OCT-2015; reported as "K010535" expiration date: unknown; K015827, expiration date: unknown; L004743, expiration date: unknown). No adverse effect were reported. No product quality complaint (PQC) was involved. Lot # K010535 is an invalid lot # for hepatitis A vaccine, inactivated. 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: This spontaneous report as received from a medical assistant refers to unspecified number of unknown patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # M020103, expiry date 15-FEB-2018 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced temperature excursion ranged from 1.8 to -1.5 degrees Celsius for cumulative time of 11 hours and 30 minutes. Data logger was involved. There was no previous excursions reported. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner and refers to a 15 year old male patient. The patient did not suffer from any illnesses at the time of the vaccination and did not have any preexisting allergies, birth defects or medical conditions. On 07-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017, intramuscularly in the left arm (dose not reported). The vaccine administered to the patient was improperly stored as it underwent temperature excursion for an unspecified cumulative period of time since January 2016 at 0.5 degrees Celsius. There had been no previous temperature excursion and the aforementioned one was identified due to a data logger. No adverse symptoms or reactions occurred. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a 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 12-JUL-2016, the patient was vaccinated with the improperly stored dose of (wistar 27-3) M-M-R II (lot # L026553, albumin status rHA; dose, route, expiration date were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a 5 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was inadvertently administered two extra doses of RECOMBIVAX HB after the three dose series had already been completed. No adverse effects reported. Additional information has been requested.
Age: 23.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 23-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 11-MAY-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot number: L026602, expiration date: 19-OCT-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There were no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as al the data was already obtained.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of unknown patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # M000592, expiry date 12-OCT-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced temperature excursion ranged from 1.8 to -1.5 degrees Celsius for cumulative time of 11 hours and 30 minutes. Data logger was involved. There was no previous excursions reported. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a 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-JUL-2016, the patient was vaccinated with the improperly stored dose of M-M-R II (lot # L026553, albumin status rHA; dose, route, expiration date were not reported). This is one of several reports received from the same reported. Additional information has been requested.
Age: 80.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an 80 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 11-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L012521 and expiration date 01-FEB-2017 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. 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
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age and gender. On 01-AUG-2016, the patient was vaccinated with improperly stored dose of (wistar ra 27-3) M-M-R II lot # L029266 (dose, route of administration and lot# were not provided). This is one of several reports received from the same source. Additional information has been requested.
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 24-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number reported as M003629, expiration date: 02-SEP-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursions of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother states on the night of 9/8 arm started swelling and redness was all over upper left arm.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Lightheaded/ Woozy/ Fog Headed - Symptoms not listed on CDC website as reaction. Generalized weakness/Fatigue.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Chest discomfort, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Approximately one hour after receiving vaccine patient noted onset fatigue and lightheadedness. Approximately six hours after receiving vaccine he noted onset of back spasms (upper greater than lower) and chest tightness which he felt caused him to feel shortness of breath. He reports feeling anxious, skin crawling, hot and cold flashes, racing heart rate, and sweating. These symptoms lasted for several hours and slowly resolved without treatment. He denies cutaneous, laryngeal, and GI symptoms.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling cold, Formication, Hot flush, Hyperhidrosis, Muscle spasms
Clinical narrative: Approximately one hour after receiving vaccine patient noted onset fatigue and lightheadedness. Approximately six hours after receiving vaccine he noted onset of back spasms (upper greater than lower) and chest tightness which he felt caused him to feel shortness of breath. He reports feeling anxious, skin crawling, hot and cold flashes, racing heart rate, and sweating. These symptoms lasted for several hours and slowly resolved without treatment. He denies cutaneous, laryngeal, and GI symptoms.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Palpitations
Clinical narrative: Approximately one hour after receiving vaccine patient noted onset fatigue and lightheadedness. Approximately six hours after receiving vaccine he noted onset of back spasms (upper greater than lower) and chest tightness which he felt caused him to feel shortness of breath. He reports feeling anxious, skin crawling, hot and cold flashes, racing heart rate, and sweating. These symptoms lasted for several hours and slowly resolved without treatment. He denies cutaneous, laryngeal, and GI symptoms.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Soreness at injection site, erythema/warmth just distal to injection site on mid upper arm.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a medical assistant concerning a 13-year-old patient of an unknown gender. the patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L037339, expiration date: 09-FEB-2018, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (strength, dose and frequency were unknown; subcutaneous, lot # L051101, expiration date 17-JUN-2017; lot # L040415, expiration date 13-APR-2017 and lot # reported as M015475 which was not valid, expiration date 01-SEP-2017). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt received PREVNAR 13 vaccine IM in right deltoid 8/8/16 at 0900. On f/u visit 8/10/16, patient c/o redness and warmth at right arm (deltoid area). She able to move her arm but does cause some pain. Area is swollen to size of grapefruit, warm and tender, with no drainage. Also noticed small nodule to area. Has not applied cold pack or taken OTC pain meds. Advised to apply ice pack to injection site for 20 mins every 2 hrs throughout a 24hr period to help reduce swelling and discomfort and to take OTC pain medication (aspirin, acetaminophen, or ibuprofen) as needed.
Age: 42.0
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Pt received PREVNAR 13 vaccine IM in right deltoid 8/8/16 at 0900. On f/u visit 8/10/16, patient c/o redness and warmth at right arm (deltoid area). She able to move her arm but does cause some pain. Area is swollen to size of grapefruit, warm and tender, with no drainage. Also noticed small nodule to area. Has not applied cold pack or taken OTC pain meds. Advised to apply ice pack to injection site for 20 mins every 2 hrs throughout a 24hr period to help reduce swelling and discomfort and to take OTC pain medication (aspirin, acetaminophen, or ibuprofen) as needed.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Musculoskeletal pain, Tenderness
Clinical narrative: Patient received PNEUMOVAX IM in Left deltoid at PCP on 8/9/16 at 1100. Pt reported that the evening after the PNEUMOVAX was administered, her chronic (since 2009) right shoulder pain worsened. Patient tried ice packs, tramadol with no relief. Patient presented to emergency department on 8/10/16, where physician reported physical exam: Right shoulder - no swelling/redness/warmth, but tender to palpation generalized even on simple touch. Her PCP had written for NORCO 7.5 mg and pt wanted to go with that and continue heat/ice packs TID prn. Physician informed pt. that pain may be related to shoulder surgery in 2009 (rotator cuff repair, arthritis in AC joint, decompression). Discharged home in stable condition. On follow up call on 8/11, pt. reported pain is less sharp, is taking tramadol, hydrocodone and muscle relaxers, doing ice packs. Symptoms: and Right shoulder pain. Treatment: Tramadol 50 mg TID, Acetaminophen/hydrocodone 7.5mg/325mg mg TID, Tizanidine 4 mg TID.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received form a Nurse Practitioner and refers to a 16 year old female patient. The patient did not suffer from any illnesses at the time of the vaccination and did not have any preexisting allergies, birth defects or medical conditions. On 10-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017, intramuscularly in the left arm (dose not reported). The vaccine administered to the patient was improperly stored as it underwent temperature excursion for an unspecified cumulative period of time since January 2016 at 0.5 degrees Celsius. There had been no previous temperature excursion and the aforementioned one was identified due to a data logger. No adverse symptoms or reactions occurred. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner and refers to a 16 year old male patient. The patient did not suffer from any illnesses at the time of the vaccination and did not have any preexisting allergies, birth defects or medical conditions. On 07-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017, intramuscularly in the left arm (dose not reported). The vaccine administered to the patient was improperly stored as it underwent temperature excursion for an unspecified cumulative period of time since January 2016 at 0.5 degrees Celsius. There had been no previous temperature excursion and the aforementioned one was identified due to a data logger. No adverse symptoms or reactions occurred. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Inappropriate schedule of drug administration, Paraesthesia, Paralysis
Clinical narrative: Information has been received from a nurse practitioner via a company representative referring to a 12 years old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On 26-MAR-2015, the patient was vaccinated with the first dose of HPV vaccine (it was unknown whether the patient received GARDASIL or GARDASIL 9) (lot number, strength, dose and route unknown). On 18-AUG-2016, the patient was vaccinated with the second dose of GARDASIL 9 0.5 ml, (lot # L024993, expiration date: 17-OCT-2017) intramuscularly in the right deltoid (Inappropriate schedule of vaccine administered). On approximately 03-SEP-2016 (reported as "2 or 3 days ago"), the patient developed tingling and numbness. On an unspecified date in 2016, the patient also felt paralysis in her hands. The patient had scheduled a follow up visit with the Nurse Practitioner on 06-SEP-2016 for a "neurological" evaluation. The outcome of felt paralysis in her hands, tingling and numbness was unknown. The causal relationship between the events and GARDASIL 9 was unknown. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 66 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L018503, expiration date: 16-MAR-2017) (dose and route of administration were not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 80.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistance refers to a 80 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L012521, expiration date: 01-FEB-2017 (dose and route of administration were not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
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. Pertinent medical history, drug reactions or allergies were not reported. On 22-AUG-2016, the patient was inadvertently administered an expired dose of vaccinated with M-M-R II, albumin status of rHA, lot # K011189 (expiration date 12-AUG-2016) (dose, frequency and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L012521, expiration date: 01-FEB-2017) (dose and route of administration were not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Headache, Pyrexia
Clinical narrative: Student called 9/7/16 at 8:30 am - reported fever and headache; RN called student 9/8/16 at 2:45 pm - she reports feeling better with no fever or HA.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of unknown patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB lot # M014926, expiry date 17-FEB-2019 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced temperature excursion ranged from 1.8 to -1.5 degrees Celsius for cumulative time of 11 hours and 30 minutes. Data logger was involved. There was no previous excursions reported. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 65 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L018503, expiration date: 16-MAR-2017) (dose and route of administration were not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Hot to touch, rash, itching.
Age: 73.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistance refers to a 73 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L012521, expiration date: 01-FEB-2017) (dose and route of administration were not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Clavicle fracture, Fall, Syncope
Clinical narrative: Following administration of vaccines (approximately 10-15 min) patient fainted, fell to floor and sustained a right clavicular fracture.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistance refers to a 66 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L018503, expiration date: 16-MAR-2017) (dose and route of administration were not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: This solicited report has been received from a 71 years old female consumer referring to herself. The patient's medical history, concurrent condition and concomitant medication were not reported. The patient was fine before. On an unknown date the patient was vaccinated with PNEUMOVAX (lot#, dose and route were not reported). On unknown dates, the patient experienced general muscular pain/sore, chills and fever which was reported as probable side effects of PNEUMOVAX. The outcome of the events were unknown. Additional information is not expected since no contact details was provided.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient received PNEUMOVAX vaccine at 1 pm 9/8/16. Patient called at 6 pm same day stating right arm was throbbing and hurt when she moved it. Patient took ALEVE.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Severe inflammation at injection site. Hard, red, swollen, hot, painful. Began 1 day post administration. Possible cellulitis being treated with CEFDINIR. Was 2nd dose (1 mo).
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Injection site warmth
Clinical narrative: Severe inflammation at injection site. Hard, red, swollen, hot, painful. Began 1 day post administration. Possible cellulitis being treated with CEFDINIR. Was 2nd dose (1 mo).
Age: 78.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Asthenia, Pain, Pyrexia
Clinical narrative: Pt called clinic 9/8/16 to report that had fever 9/2/16-9/3/16, body aches and weakness. Starting with arms and shoulders spreading to entire body, not able to get out of bed; feeling better today able to be up.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Warts.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from an unspecified person via a company employee referring to unknown number of patients of unknown age and gender. the patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, lot #, expiration date and route not reported). the reporter stated that on unknown dates, the patients experienced pain and injury which caused by GARDASIL. Some patients also died due to the vaccine. the reporter stated that so many patient's lives had been literally stolen from them due to GARDASIL. They could no longer play sports, dance, have fun and act like kids. the outcome of the events was unknown. the reporter considered the GARDASIL was related to the events. Upon internal review, the event of death was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (exact dose and route of administration were not reported, lot # M018644, expiration date 20-SEP-2017). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 1.5 degrees Celsius (C) for 2 hours 54 minutes on 13-AUG-2016, 1.4 C for 4 hours 2 minutes on 14-AUG-2016 and 1.5 C for 1 hour 24 minutes on 15-AUG-2016. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a female patient of unknown age. It was reported that patient had gone under some type of surgery for unspecified cancer prior to ZOSTAVAX administration and patient experienced swelling of her wrist post-surgery, prior to ZOSTAVAX administration. Date of surgery was unspecified. On an unknown date in June 2016 the patient was vaccinated with ZOSTAVAX lot # M001747/expiration date-07-APR-2017 with no issue. No concomitant medication was reported. It was reported that pharmacist saw patient in July 2016 and patient was doing fine with no problem. However, in August 2016, pharmacist received a call from patient's physician (name unspecified) and physician told pharmacist that patient had been experiencing swelling of arm and leg, on one side of body (did not specify left or right side but same side as ZOSTAVAX, and physician thought that swelling was due to ZOSTAVAX getting into patient's vein from administration. Patient visit physician to seek medical attention. It was unknown if any treatment was given for event. The outcome of event was unknown. Causality was unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Blister, Erythema, Rash erythematous
Clinical narrative: Large red blister the size of nickel on leg. Small red dots on arms. All appeared approximately 10-14 days after injection.
Sex: U
Vaccine: MMRV
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. On 11-JUL-2016 the patient received an improperly stored dose of PROQUAD (lot # L040412, expiry date: 13-APR-2017). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one several reports received from the same reporter. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt got shot ADACEL on 9/6/12. She comes back today 9/8/16 with redness swollen arm 4x4 inches size of reaction. Pt is looking for advice. I advice her to go urgent care.
Age: 18.0
Sex: F
Vaccine: HEP, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Erythema, Joint stiffness, Joint swelling, Lip swelling, Paraesthesia oral
Clinical narrative: Presented 48  hrs after vaccination at office with complaint of red swollen ankle with stiffness for several hours. Rash also present on ankles. Occurred that evening along with swelling and tingling of the lips; which resolved and symptoms now subsided. MD advised BENADRYL that night. T/C client day- states improvement.
Age: 18.0
Sex: F
Vaccine: HEP, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Rash
Clinical narrative: Presented 48  hrs after vaccination at office with complaint of red swollen ankle with stiffness for several hours. Rash also present on ankles. Occurred that evening along with swelling and tingling of the lips; which resolved and symptoms now subsided. MD advised BENADRYL that night. T/C client day- states improvement.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: 4 x 4.5 in area of erythema with warmth and tenderness.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Moderate to severe redness and swelling of approximately 8 inch diameter. Moderate pain. Fever spike 102. Fever reduced with acetaminophen, but all symptoms lasing 4 days.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (exact dose and route of administration were not reported, lot # L043704, expiration date 04-NOV-2017). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 1.5 degrees Celsius (C) for 2 hours 54 minutes on 13-AUG-2016, 1.4 C for 4 hours 2 min minutes on 14-AUG-2016 and 1.5 C for 1 hour 25 minutes on 15-AUG-2016. This is one 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 medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (2 ml, orally, lot # M005733, expiration date 01-OCT-2017; lot reported as # M007124, expiration date 05-OCT-2017). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 1.5 degrees Celsius (C) for 2 hours 54 minutes on 13-AUG-2016, 1.4 C for 4 hours 2 min minutes on 14-AUG-2016 and 1.5 C for 1 hour 24 minutes on 15-AUG-2016. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Drug dose omission, No adverse event, Product colour issue
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The nurse reported that four vials of M-M-R II did not show the color as indicated in the prescribing information after reconstitution. Once the product was reconstituted, the color was more clear than light yellow. As a result of this, on an unknown date, the patient missed a dose. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 20-JUN-2016, the patient was vaccinated with an incorrectly stored dose of VARIVAX lot # L045953 (dose and route of administration were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka-Merck) PROQUAD (dose and route were unknown) lot # M015698 with expiration date 26-SEP-2017, lot # M000998 (and invalid lot number) with expiration date 07-JAN-2018 and lot # M006724 (an invalid lot number) with expiration date 08-FEB-2018. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 15-year-old male patient. The patient's medical history included syncope (the patient had fainted from giving blood before). It was reported that concomitant medications included "Hep A". The patient's drug reactions or allergies were unknown. On approximately 30-JUN-2016 (reported as 2 months ago), the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (dose and lot number not reported). On an unknown date in 2016, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly (dose and lot number not reported). The reported stated that the patient was administered the second dose of GARDASIL 9 and fainted. The patient recovered and then he fainted again. The patient sought medical attention and received unspecified treatment. The outcome of the events was reported as recovered/resolved. The relationship between vaccination with GARDASIL 9 and the events was not provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Excessive eye blinking, Tic
Clinical narrative: Tic developed - Repetitive quick eye blinking.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Induration
Clinical narrative: 11x13cm with red area middle induration.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Approximately three hours post-vaccine administration, patient's spouse reported "excruciating" pain in both of patient's arms (left arm was Fluzone-HD, right arm was PPSV23), particularly in right arm, with inability to move the arms. Patient was given ibuprofen but it did not help. Patient and spouse were concerned re: history of stroke. They proceeded to urgent care, at which point patient was transported by ambulance to a local hospital. At hospital, it was determined that patient did not suffer a stroke, but was given Dilaudid for pain, which helped significantly. Patient was released home with a prescription for Vicodin. The next morning, patient's spouse reported patient was feeling much better; the left arm had typical, but non-significant soreness, and the right arm was still in pain, but not nearly as much as before.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Pain and itching at injection site without any visible skin reaction.  Pain and itching worsens at nighttime and OTC diphenhydramine does not lessen.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: PATIENT COMPLAINED OF SWELLING, REDNESS, WHITE RAISED RASH AT INJECTION SITE.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site macule, Injection site swelling, Injection site warmth
Clinical narrative: 3 macular, pink-erythematous, areas on right deltoid. No itching. Mild warmth. Mild swelling underneath middle area in location of 2 injections.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: RED, SWOLLEN, PAIN.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient states she had a rash, swelling and pain at the injection site for 3 to 4 days after vaccination.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling of right upper extremity from below shoulder and biceps muscle insertion to elbow, nml ROM without pain, nml sensation, pulses, reflexes. Very warm to touch. No fever.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: On the afternoon of 9/7/16 patient develop itchy welts to both arms, chest, back and both legs.  They continued through 9/8 and resolved with no intervention.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L038018 with expiry date on 13-SEP-2017, lot# L048848 with expiry date on 09-AUG-2018 and lot# M010671 with expiry date on 02-JUN-2018) (dose and route of administration were not reported). No adverse symptoms were reported. No product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 65 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 01-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX lot # L012521 and expiration date 01-FEB-2017 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 69 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L018503 and expiration date 16-MAR-2017 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site urticaria, Pyrexia
Clinical narrative: Few scattered hives around the site of injection, low grade fever. Fever resolved with TYENOL. Hives disappeared in the morning.
Age: 73.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 73 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 29-JAN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L012521 and expiration date 01-FEB-2017 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: (L) arm erythema, swelling, induration tenderness and hot to touch on day 2. Erythema: 13cm x 12cm, Fever 101.2, circumference: 17.5cm (L) (R) 15cm.