chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Seizure like phenomena, Tremor, Vomiting, Weight increased
Clinical narrative: This spontaneous report as received from a 26 year old female consumer refers to herself. The patient's pertinent medical history included sickle cell. There were no concomitant medication and drug reactions/allergies reported. In August 2013 the patient was vaccinated with the first dose of GARDASIL (lot#, strength, dosage and route unknown) because she had HPV. And the patient got a little sick after vaccination. In October 2013 the patient was vaccinated with the second dose of GARDASIL (lot#, strength, dosage and route unknown). The patient also missed a menstrual period in "May". The patient got bloated, she got real big, she got rashes, she was getting fat and getting water in her leg and she was throwing up real bad. She got real sick one time, she was so sick that she tried to get out of bed she actually fell out of the bed. She was shaking real bad like she was having a seizure, her back was hurting so bad like someone was stabbing her, she had headaches, migraines, dizziness, the whole nine yards. The patient took a ton of pregnancy tests because she thought she was pregnant but they all came back negative. The patient kept going to the hospital and the doctors' office, almost every day, because she did not know what was going on. She never stayed there though. She also missed a menstrual period in "May" (probably May 2014). The patient did not receive treatment for the adverse events. The outcome of the events was reported as not recovered. Additional information is not expected.
Age: 0.9
Sex: M
Vaccine: MEN
Symptoms: Blindness, Brain death, Convulsion, Death, Gastrostomy
Clinical narrative: Initial report received from a consumer, who is also the patient's mother, on 14 August 2014. The following is verbatim from the report: "I lost my son at year and a half. But after 10 months. After he got the meningitis enoculation. He became brain dead blind dead outward posturing constant seizes. Gastrostomy tube and a shunt in his brain. Shot was what killed him. Panhandlers health." No further information was available at the time of the report. The patient outcome was fatal. Documents held by sender: None.
Age: 0.9
Sex: M
Vaccine: MEN
Symptoms: Posture abnormal, Ventriculo-peritoneal shunt
Clinical narrative: Initial report received from a consumer, who is also the patient's mother, on 14 August 2014. The following is verbatim from the report: "I lost my son at year and a half. But after 10 months. After he got the meningitis enoculation. He became brain dead blind dead outward posturing constant seizes. Gastrostomy tube and a shunt in his brain. Shot was what killed him. Panhandlers health." No further information was available at the time of the report. The patient outcome was fatal. Documents held by sender: None.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report was received on 15 August 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. This is one case in a series of 232 pertussis cases received during the surveillance period from 01 January 2010 to 15 August 2014. A case of pertussis disease in a four-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS). The subject had received four doses of PENTACEL on 17 December 2009, 17 February 2010, 20 April 2010 and 19 April 2011 (lot numbers, route and site of administration were not reported). Approximately three years after the last dose, on 20 July 2014, the subject developed a cough without a whoop. Seven days later on 27 July 2014, the subject developed a paroxysmal cough. The subject also experienced post-tussive vomiting and sleep disturbance (onset dates not reported). Cold-like symptoms were unknown (U). Laboratory testing included positive PCR on 27 July 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 27 July 2014 for "99" days. The subject was not hospitalized. At the time of final contact on 12 August 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pneumonia, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report was received on 15 August 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. This is one case in a series of 232 pertussis cases received during the surveillance period from 01 January 2010 to 15 August 2014. A case of pertussis disease in a four-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS). The subject had received four doses of PENTACEL on 17 December 2009, 17 February 2010, 20 April 2010 and 19 April 2011 (lot numbers, route and site of administration were not reported). Approximately three years after the last dose, on 20 July 2014, the subject developed a cough without a whoop. Seven days later on 27 July 2014, the subject developed a paroxysmal cough. The subject also experienced post-tussive vomiting and sleep disturbance (onset dates not reported). Cold-like symptoms were unknown (U). Laboratory testing included positive PCR on 27 July 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 27 July 2014 for "99" days. The subject was not hospitalized. At the time of final contact on 12 August 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. According to the investigator, this case was not epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as healthcare worker) refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of (Oka/Merck) VARIVAX lot number for Vaccines for Children (VFC) vaccines J013905, expiration date 30-OCT-2015 (dose and route were not reported) that had a temperature excursion. Patients were also vaccinated with improperly stored Tetanus-Diptheria vaccine (TD). No adverse effects were reported. The reporter was unable to provide any patient information or dates of vaccination. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Ageusia, Eye movement disorder, Facial asymmetry, Facial nerve disorder, Facial paresis
Clinical narrative: After vaccine, I had severe headaches for several weeks.  By December 6, I had weird facial disfigurement. I went to hospital on December 8 thinking I had stroke.  The emergency room diagnosed Bells Palsy with damage to the seven facial nerve.  Follow-up appointments with my practitioner, neurologist, and hospital neurology department confirmed I had permanent nerve damage which lead to disfigurement, loss of facial movement on left side of face including, chin, cheek, taste, nose, eye, and forehead.  I have regained maybe 30% but symmetry of my face is still not improved.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nerve injury, Nuclear magnetic resonance imaging, VIIth nerve paralysis
Clinical narrative: After vaccine, I had severe headaches for several weeks.  By December 6, I had weird facial disfigurement. I went to hospital on December 8 thinking I had stroke.  The emergency room diagnosed Bells Palsy with damage to the seven facial nerve.  Follow-up appointments with my practitioner, neurologist, and hospital neurology department confirmed I had permanent nerve damage which lead to disfigurement, loss of facial movement on left side of face including, chin, cheek, taste, nose, eye, and forehead.  I have regained maybe 30% but symmetry of my face is still not improved.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, swelling, redness, limited range of motion to right shoulder, warm to touch.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm under injection site was red and a little bit swollen.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: Lightheaded.
Sex: F
Vaccine: PPV
Symptoms: Local swelling
Clinical narrative: This spontaneous report was received from a female consumer of unknown age regarding herself. The patient's demographics were unknown. There was no information or pertinent medical history and drug reactions or allergies. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, units, product, lot#, expiry date, route not reported). The patient reported that after receiving PNEUMOVAX23 her entire arm swelled terribly. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 years old patient of unknown gender. On 11-JUL-2014 the patient was vaccinated with M-M-R II (therapy type: rHA, batch number: J005846, lot: 1681AA, expiry date: 17-APR-2015) that on 03/03/2014 was exposed at an unsupported temperature excursion (temperature range: 45F, time frame: 24h). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Inflammation, Pain in extremity, Rash
Clinical narrative: This spontaneous report as received from a male patient of unknown age who ws also pharmacist refers to  himself. On an unspecified date in approximately August 2011 (reported as 3 years ago), the patient ws vaccinated with ZOSTAVAX 19400 PFU (route of administration, lot # and expiration date were not reported). On an unspecified date in approximately August 2011, when he received ZOSTAVAX, the patient experienced soreness in his arm, inflammation and a rash. The patient reported that symptoms went away a week later in approximately August 2011 (also reported as 3 weeks ago). The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 3 years old patient of unknown gender. On 11-JUL-2014 the patient was vaccinated with M-M-R II (therapy type: rha, batch number: J005846, lot: 1681AA, expiry date: 17-APR-2015) that on 03/03/2014 ws exposed to at an unsupported temperature excursion (temperature range: 45F, time frame: 24h). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a consumer via a physician refers to a consumer's neighbor's child of unknown age and gender. On an unknown date the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot#, strength, dosage and route unknown). On an unknown date the patient experienced a rash after receiving (Oka/Merck) VARIVAX. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. On an unknown date, (Oka/Merck) VARIVAX underwent a temperature excursion and on an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX, lot number J014407 expiration date 13-NOV-2015, 0.5 ml, subcutaneous. No concomitant medication reported. No adverse effect report. The certified medical assistant was unable to offer patient identifiers or dates of vaccination, at the time of the report. At the time of the report the action taken with (Oka/Merck) VARIVAX was not reported. Causality was not reported. This case has been linked to Case # 1408USA008060 as same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 4 unspecified patients. The patient's current conditions or medical history were not reported. On an unknown date, the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (dose, route, lot number and expiration date not reported) that were improperly stored, exposed to six temperature excursions over two months for a maximum of 17F for a total of 19 hours. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patient were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 6 month old patient of unknown gender who on 23-JUL-2014 was vaccinated with improperly stored dose ROTATEQ oral, lot#K004480, expiration date 05-FEB-2016 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 7 unspecified patients. The patient's current conditions or medical history were not reported. On an unknown date, the patients were vaccinated with a dose of M-M-R II 0.5ml, subcutaneous injection (lot number and expiration date not reported) that were improperly stored, exposed to seven temperature excursions over two months for a maximum of 55 F for a total of 48 hours. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.48
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 5 month old patient of unknown gender who on 09-JUL-2014 was vaccinated with improperly stored dose of ROTATEQ oral, lot#K004468, expiration date 08-DEC-2015 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching and 10mm of redness around injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via Company Representative refers to a 60 year old female patient. Medical history and concurrent conditions were not reported. On 02-AUG-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous in the right arm, lot # K000330, expiration date 06-MAR-2015 (dose and strength were not reported) for prevention of shingles. Secondary and concomitant therapies were not reported. Pharmacist reported that on 05-AUG-2014, the patient presented after receiving ZOSTAVAX vaccine with a very red, swollen and itchy patch on her right arm. This was the same arm and location where the ZOSTAVAX vaccine was administered. The pharmacist suggested that patient could use MOTRIN and CLARITIN to relieve the reaction. The outcome of the events was reported as recovering. The pharmacist suggested to the patient to show her reaction to her physician for an evaluation. The patient had an follow up visit on 06-AUG-2014 with her primary care physician. Additional information has been requested.
Age: 1.06
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 12 month of patient. On 13-JUN-2014 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # J012818, 10-OCT-2015) dose and route not reported which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 10 unspecified patients. The patient's current conditions or medical history were not reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, route, lot number and expiration date not reported) that were improperly stored, exposed to seven temperature excursions over two months for a maximum of 55 F for a total of 48 hours. No adverse effects reported. This is one of several cases from the same source. Additional information has been requested.
Age: 1.05
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 12 month old patient. On 16-JUN-2014 the patient was vaccinated with a MMR II (lot # J011332, EXP date: 13-SEP-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from certified medical assistant (C.M.A) refers to a 4 year old patient of unknown gender. On an unknown date in 2014 (reported as "within last week"), the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot # J013730, exp. date 30-OCT-2015, (dose, route and site of administration were not reported) that was improperly stored. No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. In approximately August 2014, reported as "last week", the patient was vaccinated with PNEUMOVAX23 (dose, route and lot number were not provided). Concomitant medication was not reported. In approximately August 2014, after PNEUMOVAX23 administration, the patient experienced larger than expected swelling (a baseball size swelling) at the injection site. The outcome of larger than expected swelling (a baseball size swelling) at the injection site was unknown. Causality was not reported. This is one of two reports from the same reporter (MARRS# 1408USA011386). Additional information is not expected because the reporter refused further follow up.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, route and lot numbers were not provided). Concomitant medication was not reported. On unknown dates at unspecified time in the past, the patients experienced mild swelling at the injection site for PNEUMOVAX 23 vaccination. The outcome of mild swelling at the injection site was unknown. Causality was not reported. This is one of two reports from the same reporter (MARRS# 1408USA011463). Additional information is not expected because the reporter refused further follow up.
Age: 6.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 6 year old patient. On 11-JUL-2014 the patient was vaccinated with MMR II (HSA, lot # J015503, EXP 05-DEC-2015 dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 year old male patient. On 18-AUG-2014 the patient received a dose of GARDASIL (lot# not reported), dose 0.5 ml, intramuscularly. Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a patient of unknown age and gender. There was no information pertinent medical history and drug reactions and allergies. On 12-AUG-2014, the patient was inadvertently vaccinated with MMR II (dose, units not reported) Product lot # H014650, subcutaneously which expired on 03-AUG-2014. No adverse effects reported. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified numbers of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-mintues. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 6 month old patient of unknown gender who on 23-JUL-2014 was vaccinated with improperly stored dose of ROTATEQ oral, lot#K004480, expiration ate 05-FEB-2016 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 13-AUG-2014 the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # J003808, expiration date: 03-JUL-2014). The nurse reported that the patient received an expired dose of ZOSTAVAX on 13-AUG-2014. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age and gender. On 05-AUG-2014, a medical assistant had inadvertently vaccinated a client with (Oka/Merck) VARIVAX (lot#, strength, dosage, route unknown) for vaccination instead of ZOSTAVAX. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a 15 year old female patient. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of PROQUAD (dose number, lot number, expiration date and route were not reported), 0.5 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The nurse reported that a patient received PROQUAD at 15 years of age. The nurse stated that the patient had received her first dose of M-M-R and VARIVAX (Merck) previously as separate vaccines. No adverse effects reported. Additional information has been reported.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 18 year old female patient. In 2008 the patient was vaccinated with her first dose of GARDASIL (lot#, dose, route not reported). In November 2013 the patient was vaccinated with her second dose of GARDASIL (lot#, dose, route not reported). In February 2014 the patient was vaccinated with her third dose of GARDASIL (lot#, dose, route not reported). Concomitant medications were not provided. No adverse effects were reported. Additional information is not expected because the reporter did not want to be contacted.
Age: 1.61
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported. It was unspecified whether the patient had sought any medical attention. There was no product quality complaint involved. Follow up information has been received from office manager, who stated she may call back or fax information as it becomes available. Also, reported that MMR II was not mentioned in the original call, but did not experience a temperature excursion. No further information was available at the time. Follow-up information as received from office manager refers to a 19 months old patient. On 13-JUN-2014 the patient was vaccinated with a dose of improperly stored MMR II (lot # J011332, expiration date 13-SEP-2015) (strength, dose and site of administration were not reported). This is one of several reports from the same course. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from certified medical assistant (C.M.A) refers to a 12 year old patient of unknown gender. On an unknown date in 2014 (reported as "within las weak"), the patient was vaccinated with a dose of (Oka/Merck) VARIVAX Lot # J013730, exp. date 30-OCT-2015, (dose, route and site of administration were not reported) that was improperly stored. No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Wrong technique in drug usage process
Clinical narrative: One diluent remained in box with no powder - 4 MENVEO immunizations given that day by 3 different nurses. Research did not provide which dose given incorrectly. All four clients notified to get revaccinated at no cost to client. Future use of meds with diluent will be banded to prevent future errors in their administration.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from certified medical assistant (C.M.A.) refers to approximately 3 year old patient of unknown gender. On an unknown date in 2014 (reported as "within last weak"), the patient was vaccinated with a dose of (Oka/Merck) VARIVAX Lot # J013730, exp. date 30-OCT-2015, (dose, route and site of administration were not reported) that was improperly stored. No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Hives; itching; redness above injection site.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Injection site warmth, Pruritus, Pyrexia, Swelling
Clinical narrative: Fever, erythema multiforme, urticaria, pruritus and swelling, warmth at injection site.  Acetaminophen.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Fever, erythema multiforme, urticaria, pruritus and swelling, warmth at injection site.  Acetaminophen.
Age: 1.03
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 months old patient. On 15-JUL-2014 the patient was vaccinated with MMR II (lot # J015503, EXP 05-DEC-2015 dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.09
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of RECOMBIVAX HB (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up information was received from the medical assistant on 06-AUG-2014. The M.A. stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 4 week old patient of unknown gender (lot# J012588, expiration date 29-AUG-2015) (dose and route of administration not reported). This is one of several reports received from the same source. Additional information is not expected.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site discharge, Purulent discharge
Clinical narrative: Patient called next day and said area around shot is filled with pus like material. Doesn't itch Patient iced it.
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 a patient of unknown age and gender. On an unknown date the patient was vaccinated with 0.5 ml dose of VARIVAX (Merck), subcutaneous (lot # and expiration date were not provided) that underwent temperature excursion. No adverse experienced reported. This is one of the several reports from the same reporter. Additional information has been requested.
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 a patient of unknown age and gender. On an unknown date the patient was vaccinated with 0.5ml dose of (Oka/Merck) VARIVAX, subcutaneous (lot # and expiration date were not provided) that underwent temperature excursion. No adverse experienced reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HEP, TD
Symptoms: Injection site induration
Clinical narrative: Pt received TD on 8-15-14 on R deltoid, returned to clinic on 8-19-14 with induration on R deltoid approx 6 inches . Seen by medical provider. No fever, no redness - pt advised to F/U if S/S becomes worse.
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 a patient of unknown age and gender. On an unknown date the patient was vaccinated with 0.5 ml dose of VARIVAX (Merck), subcutaneous (lot # and expiration date were not provided) that underwent temperature excursion. No adverse experience reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist regarding a 39 year old male patient. Current conditions and medical history were not reported. On an unknown date the patient started the therapy with MMR II. On 06-AUG-2014 the patient was vaccinated with MMR II lot # H014649, subcutaneous in the left arm. Concomitant medications were not reported. On 06-AUG-2014, after the injection, the pharmacist realized that the vaccine had expired on 03-Aug-2014 (also reported as 06-AUG-2014). At the time of reporting the patient did not experience any adverse events. The outcome of receiving expired vaccine was unknown. Causal relation of the event with the suspect drug was not reported. At the time of reporting it was unknown if the patient would continue to take MMR II. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Incorrect dose administered, Pyrexia
Clinical narrative: Two doses of varicella vaccine were given. One single dose and a dose in the PROQUAD vaccine. Child had prolonged subjective fever which resolved with time. No rash on other complications.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 61 year old female patient. Patient's current conditions included type 2 diabetes, hypertension, hypothyroidism, fibromyalgia, dysthymic disorder, hyperlipidemia and osteoarthritis. Patient had no drug reactions/allergies. On n13-AUG-2014 the patient was vaccinated with ZOSTAVAX lot # J016259, expiry date 27-FEB-2015, (dose and frequency unknown), subcutaneous for vaccination. Concomitant therapies included metformin, HYZAAR, WELLBUTRIN, CYMBALTA, ZOCOR, NORCO, TESSALON PERLES, FLEXERIL, ATIVAN. The reporter stated that since receipt of the ZOSTAVAX, on 13-AUG-2014, the patient had complained of an injection site reaction, described as red, warm to touch, growing in size, tender and causing her pain on the right side of her body. Patient sought medical attention-the reporter stated that when the patient came to the office on 15-AUG-2014, the nurse practitioner noted redness, warmth and swelling at the site which was getting worse and diagnosed the patient as having an allergic reaction to the ZOSTAVAX. No laboratory studies were performed. The nurse practitioner treated the patient with a prescription for halobetasol (topical) and prednisone. The outcome of allergic reaction was not recovered/not resolved. Reporter's causality assessment was not provided. Product quality complaint was not involved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 61 year old female patient. Patient's current conditions included type 2 diabetes, hypertension, hypothyroidism, fibromyalgia, dysthymic disorder, hyperlipidemia and osteoarthritis. Patient had no drug reactions/allergies. On n13-AUG-2014 the patient was vaccinated with ZOSTAVAX lot # J016259, expiry date 27-FEB-2015, (dose and frequency unknown), subcutaneous for vaccination. Concomitant therapies included metformin, HYZAAR, WELLBUTRIN, CYMBALTA, ZOCOR, NORCO, TESSALON PERLES, FLEXERIL, ATIVAN. The reporter stated that since receipt of the ZOSTAVAX, on 13-AUG-2014, the patient had complained of an injection site reaction, described as red, warm to touch, growing in size, tender and causing her pain on the right side of her body. Patient sought medical attention-the reporter stated that when the patient came to the office on 15-AUG-2014, the nurse practitioner noted redness, warmth and swelling at the site which was getting worse and diagnosed the patient as having an allergic reaction to the ZOSTAVAX. No laboratory studies were performed. The nurse practitioner treated the patient with a prescription for halobetasol (topical) and prednisone. The outcome of allergic reaction was not recovered/not resolved. Reporter's causality assessment was not provided. Product quality complaint was not involved. 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 registered nurse refers to an unknown number of patients of unknown age and gender. The reporter stated that since May 2014 (exact date unspecified) an unknown number of patients had received doses of ROTATEQ (oral vaccine, dosage details, lot # and expiration date were not reported) which underwent temperatures which fell outside the prescribing information and which were supported. No adverse events were reported. No PQC (product quality complaint) was involved. This is the one of several reports received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Screaming
Clinical narrative: Immunizations given at 1130 am - screamed till 8:00 pm.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. The reporter stated that since May 2014 (exact date unspecified) an unknown number of patients had received doses of RECOMBIVAX HB (dosage details, route, lot# and expiration date were not reported) which underwent temperatures which fell outside the prescribing information. Among these improperly stored RECOMBIVAX HB vaccines were these that were supported and these that were not supported. No adverse events were reported. No PQC (product quality complaint) was involved. This is the one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician, as part of a ZOSTAVAX marketing research program conducted by marketing agency, refers to a patient of unknown age and gender. Medical history and concomitant medication were unknown. On an unknown date, the patient was vaccinated with a single dose of ZOSTAVAX (dose, route, lot# and expiration date were no reported). On an unknown date, the patient experienced shingles. The patient got shingles a few weeks after getting the vaccine. The outcome of the events was unknown. The reporter considered events to be related to ZOSTAVAX. The reporter considered the event of shingles to be other medical event. (Also reported that it was unknown by reporter if the case was serious). This is one of several reports from the same source. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Dyspnoea, Rash, Swelling
Clinical narrative: Swelling, rash, SOB 30 min after immunization. DECADRON 8mg IM/BENADRYL 12.5mg IM. O2 sats x2 improved with meds.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash on neck, ear and forehead.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Balance disorder, Dizziness, Nausea, Nightmare, Pain
Clinical narrative: Began to feel feverish, achy, dizzy, nauseated off balance "like I was going to fall", disturbed sleep and nightmares. At time of this report, is better, but still a little dizzy.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Began to feel feverish, achy, dizzy, nauseated off balance "like I was going to fall", disturbed sleep and nightmares. At time of this report, is better, but still a little dizzy.
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Drug hypersensitivity, Urticaria
Clinical narrative: I got hives all over both of my legs the day after the shot. I came back to the office to ask them why I was had all these hives and they told me that I probably is allergic to the medication and to take Benadryl.
Age: 74.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Fatigue, Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: Pneumococcal R. Arm- Sore, low fever 1 day 99-100 deg. Better- no fever after 1 day. Sore about 3 or 4 days. Tired and not feeling great for 1-4 days.
Age: 0.79
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of RECOMBIVAX HB (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up information was received from the medical assistant on 06-AUG-2014. The M.A. stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 9 month old patient who on 09-JUL-2014 was vaccinated with improperly stored dose of RECOMBIVAX HB (lot# J007946, expiration date 24-MAR-2016) (dose and route of administration not reported). This is one of several reports received from the same source. Additional information is not expected.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 years old patient of unknown gender. On 10-APR-2014 the patient was vaccinated with M-M-R II (therapy type: rHA, batch number: J005846, lot: 1681AA, expiry date: 17-APR-2015) that on 03/03/2014 was exposed at an unsupported temperature excursion (temperature range: 45F, time frame: 24h). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse via the representative refers to a 18 year old female patient. In June 2008 the patient was vaccinated with the first dose of GARDASIL (lot#, strength, dosage and route unknown). The patient received the second dose in June 2014, and then got a third dose of GARDASIL in August 2014. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients. On an unknown date over the "past year", the patients were vaccinated with (Oka/Merck) VARIVAX which were improperly stored (lot#, strength, dosage and route unknown). No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 4 years old patient of unknown gender. On 10-APR-2014 the patient was vaccinated with M-M-R II (therapy type: rHA, batch number: J005846, lot: 1681AA, expiry date: 17-APR-2015) that on 03/03/2014 was exposed at an unsupported temperature excursion (temperature range: 45F, time frame: 24h). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as healthcare worker) refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of M-M-R II HSA, lot number for Vaccines for Children (VFC) Vaccines J004204, expiration date 12-APR-2015 (dose and route were not reported) that had a temperature excursion. Patients were also vaccinated with improperly stored Tetanus-Diphtheria vaccine (TD). No adverse effects were reported. The reporter was unable to provide any patient information or dates of vaccination. This is one of several reports received from the same reporter. Additional information has been requested.