chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (dosing regimen unspecified) (lot # L027733, expiry 13-SEP-2017). Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature: 31.55 F, Time frame: 45 seconds, there was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored ROTATEQ (dosing regimen unspecified) (lot # L013202, expiry 27-JAN-2017). Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature: 31.55 F, time frame: 45 seconds, there was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site urticaria, Loss of consciousness
Clinical narrative: Pt passed out after blood draw and vaccines HPV and MENVEO. 24 hrs later developed localized hives (L) upper arm down to elbow. PO BENADRYL and CLARITIN. Hydrocortisone topically.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 29-MAR-2016, the patient was vaccinated with a dose of ZOSTAVAX (strength, site of administration, dose, dose number, lot number and expiration date were not reported), which was inadvertently administered intramuscularly instead of the recommended subcutaneous route. On 29-MAR-2016 (also reported as the same day the injection was given), following ZOSTAVAX administration (reported as following that administration), the patient experienced a localized reddened area at the injection site. The patient sought medical attention (type was unknown). Product quality complaint was not involved. No further information was reported. The outcome of localized reddened area at the injection site and the relatedness between this event and ZOSTAVAX were not reported. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: TYP
Symptoms: Malaise, Pyrexia
Clinical narrative: Member started feeling sick and running a fever as high as 102 for about 4 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Large rash and itching at injection site.
Age: 22.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Abnormal behaviour, Diarrhoea, Influenza like illness, Learning disorder, Maternal exposure before pregnancy
Clinical narrative: I got severe flu like symptoms: vomiting, fever, nausea, diarrhea, ect.
Age: 22.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: I got severe flu like symptoms: vomiting, fever, nausea, diarrhea, ect.
Age: 22.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Diarrhoea, Exposure during pregnancy, Influenza like illness, Nausea, Pyrexia
Clinical narrative: I got severe flu like symptoms: vomiting, fever, nausea, diarrhea, ect.
Age: 22.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Vomiting
Clinical narrative: I got severe flu like symptoms: vomiting, fever, nausea, diarrhea, ect.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Fatigue, Feeling abnormal, Neck pain, Pyrexia
Clinical narrative: Daughter vomited 7 times within 6 hours. She had a low fever and was given acetaminophen. She complained of neck pain. She was not able to keep water down until after 7pm. She was misereable, tired and weak.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Daughter vomited 7 times within 6 hours. She had a low fever and was given acetaminophen. She complained of neck pain. She was not able to keep water down until after 7pm. She was misereable, tired and weak.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Blood test, Dyskinesia, Hypoaesthesia, Neurological examination
Clinical narrative: Severe head jerks, legs numb.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Death
Clinical narrative: None stated.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Paralysis
Clinical narrative: Information was received via an online newspaper article concerning a 26 year old female who alleged she was left partially paralyzed as a result of GARDASIL (see report # 1409CRI014823). The article also noted the following: "In 2008, documents obtained by the Freedom of Information Act revealed that during just that year, there were 6,723 adverse effects related to GARDASIL; of those 1,061 were "serious", 142 were considered life threatening and 28 deaths related to GARDASIL were recorded". This is one of several reports from the same reporter. Additional information is not expected.
Age: 19.0
Sex: M
Vaccine: FLUC3
Symptoms: Feeling abnormal, Influenza, Influenza like illness, Vaccination failure
Clinical narrative: Case number PHEH2016US008149, is an initial spontaneous report received from a health care professional on 31 Mar 2016. This report also associated with product quality complaint (QA reference number: 1013962). This report refers to a 20 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173906) intramuscular on Sep 2015. The patient caregiver stated he had been feeling bad for about a month with flu like symptoms and was recently diagnosed with influenza. The seriousness, outcome and causality of the events were not reported. The seriousness assessment of influenza, vaccination failure and influenza like illness were upgraded based on information in the source document.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a healthcare worker concerning an unknown number of patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On 21-MAR-2016, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L048236; expiration date: 32-MAR2-18 and lot# L048849; expiration date: 04-FEB-2018) (dose and route not provided). The patients' concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 18 degrees C for 22.5 hours. No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Paralysis
Clinical narrative: Information was received via an online newspaper article concerning a 26 year old female who alleged she was left partially paralyzed as a result of GARDASIL (see report # 1409CRI014823). The article also noted the following: "A number of other cases of partial or complete paralysis in girls and young women shortly after having receiving the vaccine have also been reported by the media since the vaccine was introduced in 2006". Upon internal review, partial or complete paralysis was considered medically significant. This is one of several reports from the same reporter. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative referring to a 11 year old female patient. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 0.5 ml (concentration, dose number, anatomical site of vaccination, lot # and expiration date were not reported) for routine vaccination. Concomitant therapies included TDAP and MENACTRA. On an unknown date (reported as "within the last couple of days") and after the vaccination with GARDASIL 9, the patient "almost passed out". The patient was attended to at the office and was kept there for 45 minutes before she was allowed to leave. She was "fine" at the time she left. There was no cancer, the patient did not die, there was no significant disability or hospitalization and the event was not life-threatening. No product quality complaint was involved. Subsequently (also reported as "within the last couple of days"), the patient recovered of the loss of consciousness. The reporter did not provide a causality assessment between GARDASIL 9. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Dizziness, Extra dose administered
Clinical narrative: This spontaneous report was received from a currently 18 year old female patient of unknown age. No pertinent medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with GARDASIL, dose route and frequency unknown. No concomitant medications were reported. On an unknown date, the patient experienced being dizzy and light headed while on GARDASIL. The patient reported that on an unknown date, she received a fifth dose of GARDASIL. The patient sought medical attention with the health professional via. The outcome of being dizzy and light headedness was unknown. The reporter did not assess the causality of the events with GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patient of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. The patients were vaccinated with the doses of VAQTA injection, lot # K026529 with expiration date 02-JUN-2017 and lot# L048460 with expiration date 14-JAN-2017 (dose and route of administration were not reported), which were exposed to temperatures outside of the recommended range for much longer than originally realized, and had been administered to the patients since these excursions began to occur on an unspecified date in July 2015. The refrigerator, in which the vaccine was stored, had been "losing power" each night for 8 hours since an unspecified date in July, 2015. The vaccine was exposed to temperatures as high as 66 Fahrenheit (F) for as long as long as 8 hours each night since an unspecified date in July 2015. The reporter's facility started to use a data logger, which was how the daily (also reported as each night) power interruption was discovered. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 16 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 24-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # L004014 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 6 patients of unknown age and gender. There was no information about the patients' concomitant medications, drug reaction/allergies and pertinent medical history reported. On multiple unknown dates, 6 patients were administered improperly stored (72 F for 4 hours and 30 minutes) PROQUAD (Merck) lot # L046509, expiry date 17-MAY-2017 (dose, strength, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A) concerning multiple unspecified patients of unknown age and gender. On unknown dates the patient were inadvertently vaccinated with improperly stored GARDASIL 9, lot # L018351 with expiration date 11-AUG-2017 (dose and route unspecified), which was exposed to temperature excursion 47.78 Fahrenheit degree (F) for 22 hours 44 minutes or 15 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A.) concerning multiple unspecified patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with improperly stored RECOMBIVAX HB, lot # K008986 with expiration date 01-APR-2016 (dose and route unspecified), which was exposed to temperature excursion 47.78 Fahrenheit degree (F) for 22 hours 44 minutes or 15 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A.) concerning multiple unspecified patients of unknown age and gender. On unknown dates, the patients were inadvertently vaccinated with improperly stored PEDVAXHIB, lot # J010385 with expiration date 28-MAY-2016, lot# L030871 with expiration date 10-JUN-2018 (dose and route unspecified), which was exposed to temperature excursion 47.78 Fahrenheit degree (F) for 22 hours 44 minutes or 15 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. ROTATEQ (lot # L027719 with expiration date 28-APR-2017) was actually exposed to the following temperature excursions on the following dates: 46.01 Fahrenheit degree (F) for 20 minutes on 01-FEB-2016, 47.62 F for 8 hours 45 minutes on 12-FEB-2016; 47.78 F for 15 hours 24 minutes on 26-FEB-2016 and 46.73 F for 15 hours on 15-MAR-2016. Then (at an unspecified time later in the days) on 15-MAR-2016, after all of the above temperature excursions had occurred, the patient was inadvertently vaccinated with an improperly stored dose of ROTATEQ listed above (dose unspecified) orally. No known adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Information has been received from a nurse referring to a female patient of unknown age. Concurrent conditions and medical history of the patient were not reported. On 14-MAR-2016 (reported as "nine days ago"), the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route unspecified) (also reported as the patient received PREVNAR 13), but we have limited information due to the call was ended abruptly. On 23-MAR-2016 (reported as "now") the patient's arm was red and swollen. The outcome of the events was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 12 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 11-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 14 year old, male patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 10-AUG-2015, patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to an 18 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 14-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the left arm (reported as LD), lot # L004014 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 16 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 14-JUL-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the left arm (reported as LD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all schedule follow up information has been received.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 13 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 14-JUL-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a healthcare worker concerning an unknown number of patients (demographics unknown). The patient's pertinent medical history and concurrent conditions were not provided. On 21-MAR-2016, the patients were vaccinated with doses of improperly stored ROTATEQ (Lot # L037574; expiration date: 01-JUL-2017 and L038536; expiration date: 19-AUG-2017) oral. The patients' concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 18 degree C for 22.5 hours. No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Hyperhidrosis, Pallor, Presyncope
Clinical narrative: Near syncope with paleness and sweating. No treatment required.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a healthcare worker concerning an unknown number of patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On 21-MAR-2016, the patients were vaccinated with doses of improperly stored doses of VAQTA (Lot # L042486; expiration date: 12-DEC-2016 and Lot # L045713; expiration date: 14-JAN-2017) (dose and route not provided). The patients' concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 18 degrees C for 22.5 hours. No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Client needed varicella vaccine as well as MMR vaccine for work. ZOSTAVAX given in place of VARIVAX in error. No adverse effects reported. Client had 2 doses VARIVAX in childhood but negative varicella titer.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Tender, red swelling of 6 cm diameter developed approximately 24 hours after injection. Seen at 48 hours and local supportive care with cold compress then warm compress.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Febrile convulsion, Influenza virus test negative, Respiratory syncytial virus test negative
Clinical narrative: Patient had febrile seizure in office 2 days after vaccine administration.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 19 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 11-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the left arm (reported as LD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 17 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 26-JUN-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 14 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 01-SEP-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # L004014 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Joint swelling, Nausea, Pain, Peripheral swelling, Vomiting
Clinical narrative: This retrospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of swollen joints in a adult female patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX (intramuscular). The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced swollen joints, vomiting, general body pain and nausea. On an unknown date, the outcome of the swollen joints, vomiting, general body pain and nausea were unknown. The pregnancy outcome was unknown. It was unknown if the reporter considered the swollen joints, vomiting, general body pain and nausea to be related to BOOSTRIX. Additional details were received as follows: The patient experienced swelling in her arm, from her elbow to her shoulder, when receiving BOOSTRIX in 2009 at the time of her last pregnancy. The patient was pregnant again at the time of reporting, at the age of 34 and would like a recommendation regarding whether or not she could receive BOOSTRIX during this pregnancy. The date of last menstrual period was 12th September 2015 and estimated date of delivery was 27th June 2016 for this pregnancy. The reporter's call was escalated to Medical Information Scientist for requested information.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients (unknown age and gender). The patients current conditions, medical history and concomitant medications were not reported. On unknown dates, unspecified number of patients received improperly stored doses of ROTATEQ (lot # L029617 and expiry date 19-MAY-2017, lot # L020859 and expiry date 19-JAN-2017), which was exposed to temperature of 51 degree Fahrenheit (F) for 3 hours of time (incorrect product storage). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patient of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. The patients were vaccinated with the doses of PNEUMOVAX 23 injection, lot # L003227, expiration date 13-OCT-2016 (dose and route of administration were not reported), which were exposed to temperatures outside of the recommended range for much longer than originally realized, and had been administered to the patients since these excursions began to occur on an unspecified date in July 2015. The refrigerator, in which the vaccine was stored, had been "losing power" each night for 8 hours since an unspecified date in July, 2015. The vaccine was exposed to temperatures as high as 66 Fahrenheit (F) for as long as 8 hours each night since an unspecified date in July, 2015. The reporter's facility started to use a data logger, which was the daily  (also reported as each night) power interruption was discovered. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 21 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 11-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the left arm (reported as LD), lot # L004014 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 19 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 11-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the left arm (reported as LD), lot # L004014 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Blood test normal, Computerised tomogram normal, Hypoaesthesia, Immunoglobulin therapy, Paraesthesia
Clinical narrative: 2 weeks after vaccination tingling and numbness in tips of fingers and toes - gradually spreading up hands and feet over course of several months - eventually started IVIG treatments that reduce symptoms temporarily.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 15 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 25-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 16 year old, male patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 03-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash
Clinical narrative: This spontaneous report was received from a pharmacist referring to a currently 61 years old female patient. The patient had no pertinent medical history besides a sulfa allergy. On 23-MAR-2016, the patient was vaccinated with ZOSTAVAX 19400 PFU lot # L032399 expiration date 26-NOV-2016 in the arm (route and dose unknown). The patient's concomitant medications included PROTONIX, levocetirizine, vitamin D, venlafaxine hydrochloride and Naproxen. On an unknown date, patient developed a localized reaction on her arm where ZOSTAVAX was administered. The patient also stated, she had a rash on both legs following the administration of ZOSTAVAX. On an unspecified date, the patient sought for attention with the pharmacist but no treatment was provided for the adverse event. Laboratory diagnostics studies were not performed and no product quality issue was involved. At the time of report, the outcome of vaccination site reaction and rash was reported as not recovered and relatedness between the adverse event and vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 18 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 11-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the left arm (reported as LD), lot # L004104 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 14 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 03-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the left arm (reported as LD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 31-MAR-2016, the patient received an improperly stored dose of (Oka/Merck) VARIVAX (lot# reported as L044525, expiration date: 31-MAR-2016, dose, route of administration and injection site were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concurrent conditions and concomitant medications was reported. On an unknown dates, the patients were vaccinated with ZOSTAVAX (dose, lot #, expiry date, route of administration and anatomical location were not specified). The pharmacist reported that when he administered ZOSTAVAX to multiple unspecified patients of unspecified dates, some of the patients, who received the ZOSTAVAX, complained that it hurt when ZOSTAVAX was administered. The outcome of the event was unknown. The reporter did not provide the causality assessment. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 11 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 21-JUL-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the left arm (reported as LD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with M-M-R II. It was reported that unspecified patient was administered 4 dose of M-M-R II. The reporter stated that the patient was currently in the pharmacy and will be administered fifth dose of M-M-R II on 11-MAR-2016. No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 19 year old, male patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 08-SEP-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # L011846 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patient of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. The patients were vaccinated with the doses of RECOMBIVAX HB injection, lot # L003193 with expiration date 10-NOV-2016 and lot# reported as L038499 with expiration date 26-JUN-2017 (dose and route of administration were not reported), which were exposed to temperature outside of the recommended range for much longer than originally realized, and had been administered to the patients since these excursions began to occur on an unspecified date in July 2015. The refrigerator, in which the vaccine was stored, had been "losing power" each night for 8 hours since an unspecified date in July, 2015. The vaccines was exposed to temperatures as high as 65 Fahrenheit (F) as long as 8 hours each night since an unspecified date in July, 2015. The reporter's facility started to use a data logger, which was how the daily (also reported as each night) power interruption was discovered. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patient of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. The patients were vaccinated with the doses of GARDASIL 9 injection, lot # L006547, expiration date 04-MAR-2017 (dose and route of administration were not reported), which were exposed to temperatures outside of the recommended range for much longer than originally realized and had been administered to the patients since these excursions began to occur on an unspecified date in July 2015. The refrigerator, in which the vaccine was stored, had been "losing power" each night for 8 hours since an unspecified date in July 2015. The vaccine was exposed to temperatures as high as 66 Fahrenheit (F) for as long as 8 hours each night since an unspecified date in July 2015. The reporter's facility started to use a data logger, which was how the daily (also reported as each night) power interruption was discovered. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm swelling and pain on 3/30/16. On 3/31/16 left arm began with redness and swelling and heat around shot site. Redness on upper back with mottling of the skin of the torso.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Skin discolouration
Clinical narrative: Right upper arm swelling and pain on 3/30/16. On 3/31/16 left arm began with redness and swelling and heat around shot site. Redness on upper back with mottling of the skin of the torso.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives spread to neck and arms 15 mins after receiving the vaccine.