chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Biopsy, Follicular mucinosis, Immunohistochemistry
Clinical narrative: This spontaneous report as received from a healthcare student refers to a 12 year old male patient. Patient's pertinent medical history and drug reactions/allergies were reported as none. On an unknown date in November 2012, the patient was vaccinated with GARDASIL, intramuscularly to prevent HPV. Concomitant medication was reported as none. On an unknown date in 2012, three weeks after onset of therapy, the patient experienced follicular mucinosis. Laboratory diagnostics performed included punch biopsy with amino histo-chemical test for which the result was not provided. The patient sought medical attention and on an unknown date, the patient started treatment with TAZORAC and dexamethasone (manufacturer unknown). The patient recovered from follicular mucinosis on an unspecified date in 2013 (reported as eight months later). The causality between follicular mucinosis and the suspect product was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number not reported). 1 sot, route reported as injection. The pharmacist reported that 6 months ago (in approximately February 2014), she saw the patient who asked her about ZOSTAVAX reaction described as a red line that looked like it originated from injection site, going across her neck (onset date of reaction was unknown). The pharmacist told the patient to go to the hospital, but did not know if the patient actually did visit the hospital. The reporting pharmacist did not administer ZOSTAVAX. Laboratory tests were not performed. The patient sought medical attention - went to pharmacy. The outcome of a red line that looked like it originated from injection site, going across her neck was unknown. The relatedness between the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other healthcare worker refers to an unknown number patients of unknown age and gender. The healthcare worker reported that less than 5 patients received (Oka-Merck) PROQUAD (0.5 ml, subcutaneously) that were exposed to temperatures of 34.8F for 5 hours. No advers effect was reported. It was unkonwn if the patient sought medical attention. At the time of report, the status of patient was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 10-JUN-2014 was vaccinated with (Oka/Merck) PROQUAD lot# J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 25-FEB-2014 was vaccinated (Oka-Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 09-JUL-2014 was vaccinated with (Oka/Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and does schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Heart rate abnormal, Hyperhidrosis, Myalgia
Clinical narrative: Muscle Pain, sweating, strong heartbeat.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Initial insomnia, Injection site pain, Pain in extremity
Clinical narrative: My arm hurt immediately after receiving the TDAP vaccination, which was expected, but the pain continues to this day nearly one month later. The pain is in my left shoulder and continues down my left arm, stopping at the elbow. It is noticeable throughout the entire day and causes problems for me when I try to sleep; I have problems falling asleep and often wake up in the middle of the night. I have just started my first week of graduate school and am extremely concerned at the difficulties this pain is causing me, especially in my inability to receive adequate rest.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other healthcare worker refers to an unknown number of patients of unknown age and gender. The healthcare worker reporter that less than 5 patients received does of PEDVAXHIB (dose, route and lot# not reported) that were exposed to temperatures of 50.7 F for 4 hours. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the status of the patient was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 30-JUL-2014 was vaccinated with (Oka/Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and does schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 23-MAY-2014 was vaccinated with (Oka/Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and does schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 31-JUL-2014 was vaccinated with (Oka/Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and does schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Culture, Staphylococcal infection
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old male patient with no pertinent medical history. On 27-JUN-2006, the patient was vaccinated with PROQUAD (Merck), subcutaneous. Lot number reported as 0770R, expiration date 04-AUG-2006. On 16-AUG-2014, the patient developed "a staph infection on the buttocks". On an unspecified date after this, the patient was started on prednisone 20mg daily for 3 days, and also BACTRIM. The patient recovered on 20-AUG-2014. A skin culture was performed (unknown date and results). The patient sought medical attention (went to see a physician). Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MEN
Symptoms: Abasia, Back pain, Blood test normal, Borrelia test negative, Computerised tomogram abdomen normal
Clinical narrative: Initial information received on 26 August 2014 from a consumer who is the patient's parent. A 17 year old female patient was vaccinated on 18 August 2014 into the deltoids with the following vaccines: MENACTRA (batch number, route and site of administration were not reported) and HPV vaccine (other manufacturer; batch, route and site of administration not reported). The patient was feeling well on the day of vaccination and had no pre-existing physician diagnosed allergies or medical conditions. On 19 August 2014, she developed a fever and severe low back pain near her coccyx. The patient is unable to walk. The mother took her to the emergency room this week and she had multiple tests. Mostly recently, "yesterday", she had a CT of the abdomen and pelvis which were all negative. Other lab tests were reported as Mono spot, Lymes, CBC, all Negative. "Lots of other blood work". A low spinal xray is pending. The mother is very concerned as her daughter is due to go to college next week. The fever and pain are continuing. The patient outcome is not recovered. Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MEN
Symptoms: Computerised tomogram normal, Full blood count normal, Mononucleosis heterophile test negative, Pyrexia, Spinal X-ray
Clinical narrative: Initial information received on 26 August 2014 from a consumer who is the patient's parent. A 17 year old female patient was vaccinated on 18 August 2014 into the deltoids with the following vaccines: MENACTRA (batch number, route and site of administration were not reported) and HPV vaccine (other manufacturer; batch, route and site of administration not reported). The patient was feeling well on the day of vaccination and had no pre-existing physician diagnosed allergies or medical conditions. On 19 August 2014, she developed a fever and severe low back pain near her coccyx. The patient is unable to walk. The mother took her to the emergency room this week and she had multiple tests. Mostly recently, "yesterday", she had a CT of the abdomen and pelvis which were all negative. Other lab tests were reported as Mono spot, Lymes, CBC, all Negative. "Lots of other blood work". A low spinal xray is pending. The mother is very concerned as her daughter is due to go to college next week. The fever and pain are continuing. The patient outcome is not recovered. Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MEN
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Gait disturbance, Pain
Clinical narrative: Initial information received on 26 August 2014 from a consumer who is the patient's parent. A 17 year old female patient was vaccinated on 18 August 2014 into the deltoids with the following vaccines: MENACTRA (batch number, route and site of administration were not reported) and HPV vaccine (other manufacturer; batch, route and site of administration not reported). The patient was feeling well on the day of vaccination and had no pre-existing physician diagnosed allergies or medical conditions. On 19 August 2014, she developed a fever and severe low back pain near her coccyx. The patient is unable to walk. The mother took her to the emergency room this week and she had multiple tests. Mostly recently, "yesterday", she had a CT of the abdomen and pelvis which were all negative. Other lab tests were reported as Mono spot, Lymes, CBC, all Negative. "Lots of other blood work". A low spinal xray is pending. The mother is very concerned as her daughter is due to go to college next week. The fever and pain are continuing. The patient outcome is not recovered. Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MEN
Symptoms: Pyrexia
Clinical narrative: Initial information received on 26 August 2014 from a consumer who is the patient's parent. A 17 year old female patient was vaccinated on 18 August 2014 into the deltoids with the following vaccines: MENACTRA (batch number, route and site of administration were not reported) and HPV vaccine (other manufacturer; batch, route and site of administration not reported). The patient was feeling well on the day of vaccination and had no pre-existing physician diagnosed allergies or medical conditions. On 19 August 2014, she developed a fever and severe low back pain near her coccyx. The patient is unable to walk. The mother took her to the emergency room this week and she had multiple tests. Mostly recently, "yesterday", she had a CT of the abdomen and pelvis which were all negative. Other lab tests were reported as Mono spot, Lymes, CBC, all Negative. "Lots of other blood work". A low spinal xray is pending. The mother is very concerned as her daughter is due to go to college next week. The fever and pain are continuing. The patient outcome is not recovered. Documents held by sender: None.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Initial information was received on 25 August 2014 from a healthcare provider. It represents one of a cluster of four patients reported by the same reporter who each experienced an adverse event following administration of ADACEL, lot number U4902BA. The events for the other three patients are captured in case number 2014SA101259. A 12 year old male patient was vaccinated into the left deltoid on 25 July 2014 with a first dose of ADACEL, lot number U4902BA, route of administration not reported. On 26 July 2014, the patient experienced injection site cellulitis. The patient was not ill at the time of vaccination and had no pre-existing physician-diagnosed allergies or medical conditions. Other medications were reported as none. He was treated with antibiotics and was evaluated by a physician. The patient outcome is recovered on an unspecified date. Note: The other three unidentified patients are captured in case number 2014SA101259. Documents held by sender: None.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 26-JUN-2014 was vaccinated with (Oka/Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and does schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 10-JUN-2014 was vaccinated with (Oka/Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and does schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date these unknown number of patients were vaccinated with ROTATEQ (lot#, dose not reported, default route: oral) that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date these unknown number of patients were vaccinated with GARDASIL (lot#, dose, route not reported), that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms
Clinical narrative: Had minor back issue prior to vaccine.  Within 24 hours, lower back muscles began to severely spasm as well as the tops and bottoms of the feet.  Muscle relaxants were not effective until two days later when spasms began to subside.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date these unknown number of patients were vaccinated with VAQTA (lot#, dose, route not reported) that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 05-MAY-2014 was vaccinated with (Oka/Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and does schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date these unknown number of patients were vaccinated with PNEUMOVAX23 (lot#, dose, route not reported) that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 15-JUL-2014 was vaccinated with (Oka-Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 04-AUG-2014 was vaccinated with PROQUAD (Merck) lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F), (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 21-JUL-2014 was vaccinated with (Oka/Merck) PROQUAD lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F) (strength, dose and does schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Tender, erythema and hard at  (R) arm injection site. Ice and antihistamine ordered.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of unknown age and gender. No information on their medical history or concurrent conditions was provided. On an unknown date unspecified patients were vaccinated with VARIVAX (lot number, expiration date, dose route were not reported) that have been exposed to temperatures above 5F. No concomitant medications were reported. No adverse effects have been observed. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: VARZOS
Symptoms: Drug label confusion, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a other healthcare worker refers to a 13 month old patient. On 22-AUG-2014 the patient was vaccinated with ZOSTAVAX, (0.5 ml, route, dose number, dosage and lot number unknown). The reporter stated that the vials of ZOSTAVAX and VARIVAX "do look kind of similar" and they kept them next to each other in the freezer". No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Hypersensitivity, Induration
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 19 or 20 year old patient. On an unknown date the patient was vaccinated with one single shot of VARIVAX (dose, route and lot# not reported). On 25-AUG-2014 the patient experienced an allergic reaction and developed a red hard spot. The outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HIBV, MNQ, PPV
Symptoms: Cellulitis, Erythema, Local swelling, Pyrexia
Clinical narrative: Patient febrile with swollen, erythematous right upper extremity after receiving vaccination, diagnosed with cellulitis requiring a 10 day course of antibiotics.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of an unknown age and gender. On an unknown date, an unspecified number of patients were administered with improperly stored doses of (Oka/Merck) PROQUAD (dose, route of administration, lot# and expiration date were not provided). No adverse effects were reported. All telephone attempts to obtain follow up information have been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The medical assistant reported that the patient received the 1st dose of GARDASIL (dose and route not reported) on 25-OCT-2012, the 2nd dose of GARDASIL (dose and route not reported) on 06-MAY-2014 and was in the office "today", 22-AUG-2014, to receive the 3rd dose of GARDASIL (dose and route not reported). No adverse effects reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Cellulitis, Erythema, Pyrexia, Swelling
Clinical narrative: Patient febrile with swollen, erythematous left shoulder after receiving vaccination, diagnosed with cellulitis requiring a 10 day course of antibiotics.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Thyroid function test normal, Vitiligo
Clinical narrative: ALOPECIA, VITILIGO.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, 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. No information on their medical history or concurrent conditions was provided. On an unknown date unspecified patients were vaccinated with PROQUAD (Merck) (lot number, expiration date, dose route were not reported) that have been exposed to temperatures above 5F. No concomitant medications were reported. No adverse effects have been observed. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Fatigue, Hypoaesthesia, Migraine, Paraesthesia, Visual impairment
Clinical narrative: Pt given HPV (GARDASIL), Meningitis (MENACTRA), Hepatitis A vaccines on 8/5/2014. On 8/13/14, pt. was seen for new onset migraine type headache with tingling in hands, spots in vision, facial numbness. As of 8/28/14, headache continues and fatigue. No preceding illness. No chronic disease or meds.
Sex: U
Vaccine: FLUN3
Symptoms: Chills, Nausea
Clinical narrative: A report has been received from a literature source concerning an Adult, subject of unknown gender, who had been receiving FLUMIST (intranasal). FLUMIST started on an unknown date. The patient experienced nausea and chills. The outcome of the event of nausea and chills is unknown. The report was considered to be non-serious.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Nausea, Pain, Vomiting
Clinical narrative: One hour after receiving the influenza vaccine at the doctor's office (08/28/2014) I returned home. Almost immediately I started having severe nausea and vomiting. I vomited at least three times. I also had body aches. This lasted for several hours. Today (08/29/2014) I am feeling fine.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR
Symptoms: Asocial behaviour, Autism, Decreased eye contact, Speech disorder developmental
Clinical narrative: Loss of language, eye contact, responding to name. No social interaction, was in his own world.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No current condition was reported. No historical medication was reported. On 19-AUG-2014 the patient was vaccinated with PNEUMOVAX23 (dose strength was unknown) lot # J006921. No concomitant medication was reported. The pharmacist was reporting that the patient was inadvertently administered PNEUMOVAX23 lot J006921 on 19-AUG-2014 that had expired on 09-AUG-2014. No adverse event was reported. The outcome of inadvertently administered a lot which had expired was unknown. No PQC was involved. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose normal, Dizziness
Clinical narrative: Patient complained of dizziness. Finger stick for glucose was 100. Taken by ambulance to Emergency Room. BP was 190/84, 172/80.
Age: 0.56
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site reaction, Pyrexia, Rash pustular, Vomiting
Clinical narrative: Pt received vaccines on 8-18-14 and developed a T of 104, vomiting and pustular rash at injection sites within 24 hours. Fever lasted 48 hrs, rash persists today but is faded.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous retrospective pregnancy report was received from a medical assistant referring to approximately 25-year-old female patient. The patient's medical history included abnormal pap smear. On 21-NOV-2012, the patient received dose 1 of GARDASIL injection and on 06-FEB-2013 received dose 2 of GARDASIL. When the patient presented for third shot on 03-AUG-2013 the patient complained of feeling bad. On an unknown date in 2013 urine pregnancy test was performed which showed positive. On 27-DEC-2013, the patient underwent cesarean section (hospitalization) and delivered a large baby without any complications. Treatment was received for the adverse event. The patient sought medical attention. There was no intervention required to prevent serious criteria. There was no significant disability or incapacity. The event was not life-threatening. The causality of the events was unspecified. No PQC reported. Upon internal review, the event cesarean section was considered medically significant. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was given Zoster vaccine instead of Varicella. Pt reported no adverse events.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Vaccination site swelling
Clinical narrative: Pt. reported this adverse event today (8/25/14). Pt. reported a red, swollen, "larger than a golf ball sized" bump at vaccination site. This painful bump lasted approximately 2 weeks but lessened in size and pain over time. It is now completely gone.
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: This spontaneous report was received from a physician assistant, via a company representative, concerning a female patient of unknown age. Medical history and concurrent conditions were not reported. In approximately 2013 (reported as about a year ago) the patient was vaccinated with a dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The physician assistant reported to the representative, "about a year ago, approximately in 2013, 1 week after receiving GARDASIL the anonymous patient (demographics unknown) developed Guillain-Barre and was hospitalized". The outcome of "Guillain-Barre" was reported as recovered on an unknown date. Patient sought medical attention. The physician assistant considered the event as serious due the disability. Upon internal review the event "Guillain-Barre" was considered as Medically significant. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient complains of vomiting day of vaccine. Patient did receive follow up call on 08/20/14 AM, but patient did not return phone call.
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Erythema x 7 inches to (L) upper arm. Pain at injection site, ice to site, pt instructed to take OTC ibuprofen and BENADRYL.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urticaria
Clinical narrative: Hives abd and back.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. No current condition was reported. No historical medication was reported. On 21-AUG-2014 the patient was vaccinated with PNEUMOVAX23 (dose strength was reported). No concomitant medication was reported. Pharmacist reported that expired PNEUMOVAX23 was given to patient on 21-AUG-2014. No adverse effect was reported. The outcome of expired PNEUMOVAX23 was given to patient was unknown. No PQC was involved. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Abnormal faeces, Diarrhoea, Vomiting
Clinical narrative: Started with mucousy foul smelling diarrhea shortly after rotavirus vaccine. 2 days later developed few episodes of vomiting. Stools 8-10/day currently day 5 of diarrhea.
Age: 77.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient developed red raised rash around injection site which is no better after 5 days.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a Healthcare Student refers to a patient of unknown demographics. No current condition was reported. No historical medication was reported. On 21-AUG-2014 the patient was vaccinated with PNEUMOVAX23 lot# J0006242, intramuscular (dose strength not reported). No concomitant medication was J006242; expiration: 03-AUG-2014, patient received an expired dose of PNEUMOVAX23 (lot# J006242; expiration: 03-AUG-2014). No known adverse effects were reported. The outcome of received expired dose of PNEUMOVAX23 was unknown. No PQC was involved. Additional information has been requested.
Age: 1.71
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site scab, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, pink swollen area surrounding vaccine scab. No induration, right leg.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Medial surface (L) arm midway between elbow and shoulder has non raised light red area about 25 cent (quarter) sized. Tender to touch, smooth. Also 1 inch reddened line just below on same surface, not connected. Fatigue, headache.
Age: 38.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Asthenia, Headache, Nausea, Pharyngeal oedema, Swelling face
Clinical narrative: Approximately 20-30 min. after receiving vaccines felt nauseated. Then she cx of headache, weakness and vomiting. She called her father who took her to the hospital ER. States her face began to swell and throat too. Was given BENADRYL and ZOFRAN.
Age: 38.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Vomiting
Clinical narrative: Approximately 20-30 min. after receiving vaccines felt nauseated. Then she cx of headache, weakness and vomiting. She called her father who took her to the hospital ER. States her face began to swell and throat too. Was given BENADRYL and ZOFRAN.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Hypoaesthesia, Lumbar puncture, Nerve conduction studies
Clinical narrative: Flu shot on 10/17/13, achy body 10/18/13, skin pain 10/26/13, unable pee 10/27/13, hospitalized 10/28/13, loss in leg feeling, treatment and test begin 10/29/13, 10 plasma treatments, rehab.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain of skin, Plasmapheresis, Urinary retention
Clinical narrative: Flu shot on 10/17/13, achy body 10/18/13, skin pain 10/26/13, unable pee 10/27/13, hospitalized 10/28/13, loss in leg feeling, treatment and test begin 10/29/13, 10 plasma treatments, rehab.
Age: 0.63
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Culture urine, Middle ear effusion, Pyrexia, Urine analysis
Clinical narrative: Fever starting 3 days after imms (6 mo) Tmax 103, persistent 3 days. TSs serious fluids and slightly thickened.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Bone pain, Chills, Headache, Injection site erythema, Nausea
Clinical narrative: On 8/27/14 Tdap vaccine given in (L) deltoid per pt. developed localized redness, quarter sized at injection site. (L) arm feels painful. Denies swelling, did c/o some systemic sx of chills, body aches, bone aches, headache and nausea - worst symptoms Thursday NOC.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: On 8/27/14 Tdap vaccine given in (L) deltoid per pt. developed localized redness, quarter sized at injection site. (L) arm feels painful. Denies swelling, did c/o some systemic sx of chills, body aches, bone aches, headache and nausea - worst symptoms Thursday NOC.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Vomiting
Clinical narrative: 5 hours after flu injection, pt complained of headache. 2 hours later pt vomited x1.  15 min later pt. vomited again. Pt. immediately felt better afterwards.  Pt is now fine.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Patient reports slight pain in her arm, and she says the area around the injection site is itchy, swollen, hot, and burning. She has not treated the localized reaction, but she was counseled on how to treat such reactions.
Age: 1.03
Sex: M
Vaccine: MMRV
Symptoms: Injection site reaction
Clinical narrative: Site reaction.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Site reaction-redness.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site reaction-redness, swelling.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site reaction-redness and swelling.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, MMRV
Symptoms: Injection site reaction, Swelling
Clinical narrative: Site reaction-redness and swelling.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Local reaction, Local swelling
Clinical narrative: Patient reported raised and red localized reaction on the evening on 8/27/14. Patient took some Benadryl and kept ice packs on the location. Patient went to the doctor and received an antibiotic (Keflex 500mg TID x 10d) for possible cellulitis.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Patient reported raised and red localized reaction on the evening on 8/27/14. Patient took some Benadryl and kept ice packs on the location. Patient went to the doctor and received an antibiotic (Keflex 500mg TID x 10d) for possible cellulitis.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Induration, Local swelling, Pain
Clinical narrative: Swelling, redness, induration and pain in local area (L arm).
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever (<102.8), chills, general body and head ache and soreness, lasting until morning of August 26. Fatigue gradually lessening as of 8/29.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Convulsion, Dizziness
Clinical narrative: As soon as vaccine was administered client stated she felt faint. PHN immediately instructed client to put head down between her knees as she was sitting down. Client then had seizure episode. Seizure lasted for approx 5-10 seconds and client recovered. After resting for a few minutes, client stated she felt fine to walk and left with her mother. Mother stated she will let clients doctor know.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Asthenia, Dizziness, Dyspnoea, Neurological examination normal, Pallor
Clinical narrative: About 45 minutes after the vaccine patient reported starting to feel crummy, as the day went on symptom got worse, blurred vision, overall feeling of weakness, dizziness, feeling like it was hard to breathe, pale skin, heart thumping in chest and temples.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Palpitations, Vision blurred
Clinical narrative: About 45 minutes after the vaccine patient reported starting to feel crummy, as the day went on symptom got worse, blurred vision, overall feeling of weakness, dizziness, feeling like it was hard to breathe, pale skin, heart thumping in chest and temples.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Crying, Decreased appetite, Insomnia, Irritability, Pain
Clinical narrative: Child got very fussy, sore and had a fever of 101.6o F gave him Tylenol on the same day he got his shots. The next day 02/26/14 no appetite, he was very fussy woe not want to be put down and still had a fever of 100.2 gave him Tylenol again. On the 27th still no appetite, he was still crying cried for 2 hours he did not want to sleep finally got him to bed around 11:30 PM. The 28th he would cry every time I sat him down. Like he is suffering separation anxiety and still would not sleep. Today the 29th he still is very fussy and does not want to sit! Cries unless being held in my arms while standing.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Pyrexia
Clinical narrative: Child got very fussy, sore and had a fever of 101.6o F gave him Tylenol on the same day he got his shots. The next day 02/26/14 no appetite, he was very fussy woe not want to be put down and still had a fever of 100.2 gave him Tylenol again. On the 27th still no appetite, he was still crying cried for 2 hours he did not want to sleep finally got him to bed around 11:30 PM. The 28th he would cry every time I sat him down. Like he is suffering separation anxiety and still would not sleep. Today the 29th he still is very fussy and does not want to sit! Cries unless being held in my arms while standing.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Nodule, Skin warm
Clinical narrative: Prevnar (PCV-13) Injection given IM Right anterior Lateral Thigh. A reddened raised nodule appeared opposite to and inferior to the injection site. Warm to the touch. No fever noted. Otherwise doing fine per parents.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Bed rest, Chills, Hypoacusis, Pyrexia, Tinnitus
Clinical narrative: Chills, high fever near 102 degrees, severe tinnitus;  Treated with acetaminophen and bedrest; Fever resolved within 24 hrs, but diminished hearing and tinnitus have persisted as of this date.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction
Clinical narrative: Per child's mother. Child had a reaction to vaccine injection site. Child was taken to Urgent Care to be evaluated. Per mother child was placed on antibiotics for infection to injection site. Mother states (today) child has been on antibiotics for approx. 2 days and is doing better.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Miliaria
Clinical narrative: Mother noted rash that looked like heat rash on the injection sites and around it.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Hypoaesthesia, Injection site pain, Muscle spasms, Neck pain
Clinical narrative: Patient received her a flu vaccine in the left deltoid area.  After receiving the flu vaccine patient complained of an extreme sharp pain in her arm at the area of injection.  Then later felt nerve related pain in her arm that traveled through her upper back/neck then eventually to the opposite arm. Her pain later turned to numbness in both arms and neck and has remained for 1 week with accompanying muscle spasms and numbness from left to right side of her upper back.  No specific error in injection technique was described by either the intern or the patient during the administration of the flu vaccine.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Neuralgia, X-ray
Clinical narrative: Patient received her a flu vaccine in the left deltoid area.  After receiving the flu vaccine patient complained of an extreme sharp pain in her arm at the area of injection.  Then later felt nerve related pain in her arm that traveled through her upper back/neck then eventually to the opposite arm. Her pain later turned to numbness in both arms and neck and has remained for 1 week with accompanying muscle spasms and numbness from left to right side of her upper back.  No specific error in injection technique was described by either the intern or the patient during the administration of the flu vaccine.
Age: 21.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth, Type III immune complex mediated reaction
Clinical narrative: Pt reported swelling, redness, and warmth to the back of her left upper arm where she received the injection. Pt also c/o fatigue.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Swollen, hot to touch, itchy and pain.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt reported swelling, redness, and warmth to the back of her left upper arm where she received the injection. Pt also c/o fatigue.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Constipation, Hypophagia, Intussusception, Small intestinal obstruction
Clinical narrative: The patient has had vomiting for the past 5 days. He had not had a bowel movement for 3 days with the exception of a small bowel movement after rectal temperature at ED from which the patient is presenting. He has had no flatus as well. He has had no fevers. He has had decreased urinary output and decreased p.o. intake. The patient's abdominal x-ray at outside showed a small-bowel obstruction. The patient otherwise healthy.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urine output decreased, Vomiting, X-ray abnormal
Clinical narrative: The patient has had vomiting for the past 5 days. He had not had a bowel movement for 3 days with the exception of a small bowel movement after rectal temperature at ED from which the patient is presenting. He has had no flatus as well. He has had no fevers. He has had decreased urinary output and decreased p.o. intake. The patient's abdominal x-ray at outside showed a small-bowel obstruction. The patient otherwise healthy.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.8
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Leg hard to touch, red where vaccine given.