chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse concerning multiple unspecified patients of unknown age or gender. The patients' concurrent conditions, medical history or allergy/drug reaction were not reported. On an unknown date, the patients were vaccinated with improperly stored doses (24 hours) of GARDASIL 9 (lot # reported as K011562, exp. 08-APR-2017 (route, dose and frequency were not provided). There was no concomitant medications reported. No adverse effects were reported. Lot # K011562 is an invalid lot number for GARDASIL 9. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The patient received the GARDASIL 9 injection (exact dose, route of administration, lot # and expiration date were not provided) series as follows: the first dose on 07-JAN-2016, the second dose on 11-MAR-2016, and the third dose on 11-MAY-2016. There was no adverse effect reported. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 13-month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.13
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 13-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.05
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.04
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 12 months old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Inappropriate schedule of drug administration, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a Registered Nurse regarding a 19 year old female patient. The patient has no medical history and concurrent conditions. On an unknown date in 2002, patient was vaccinated with first dose of VARIVAX (Merck) lot details unknown, 0.5 milliliter (ml) subcutaneously. On 27-APR-2016, the patient was vaccinated with second dose of VARIVAX (Merck) (lot # L030158, expiry date 11-AUG-2017), 0.5 ml, subcutaneously (Inappropriate schedule of vaccine administration). On 29-APR-2016, the patient was seen at health department to obtain unspecified birth control and urine pregnancy test was positive. Nurse reported that patient was in good health. The last menstrual period (LMP) was reported as 03-JAN-2016. Estimated date of conception was 17-JAN-2016 and estimated date of delivery (EDD) was reported as 09-OCT-2016. The pregnancy outcome was pending and fetal outcome was unknown. It was reported that no treatment was given for the event. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-MAY-2016, the patient was vaccinated with M-M-R II injection, intramuscularly (exact dose, therapy type, lot # and expiration date were not reported). On 10-MAY-2016, the patient experienced pain at the injection site. The outcome of the event and causality assessment were not provided. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot #L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker professional referring to a unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients' were vaccinated with an improperly stored dose of GARDASIL 9 lot # L045711 with expiration date of 08-MAY-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. The healthcare worker stated, the GARDASIL 9 was exposed to a temperature excursion of 11.8 degrees C for a time frame of 2 hours and 35 minutes. I was called due to a data logger. Previous excursions also were reported, with a minimum of temperature of -0.3 degrees C for 15 hours and 42 minutes and a maximum of 11.8 degree C for 18 hours 55 minutes. Furthermore, no adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker professional referring to a unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients' were vaccinated with an improperly stored dose of PNEUMOVAX23 lot # L019836 with expiration date of 24-MAR-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. The healthcare worker stated, that PNEUMOVAX23 was exposed to a temperature excursion of 11.8 degrees C for a time frame of 2 hours and 35 minutes. It was called due to a data logger. Previous excursions also were reported, with a minimum of temperature of -0.3 degrees C for 15 hours and 42 minutes and a maximum of 11.8 degrees C for 18 hours 55 minutes. Furthermore, no adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 13 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 17 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 16 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot #L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 6 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-APR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot # L027076, expiration date 25-MAY-2017 (dose was not reported) and PEDVAXHIB lot # L035880, expiration date 11-AUG-2018 (dose and route of administration were reported). There was no adverse effect reported. No product quality issue was involved. Administered dose of vaccine experienced the temperature excursion of low - 28 degrees Fahrenheit for 5 hours on 22-APR-2016. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 12 months old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.04
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot #L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.19
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 14 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, lot # and expiration date were not reported). No adverse symptoms were reported. The administered doses were exposed to the temperature of 49.6 degrees Celsius for 1 hour and 20 minutes. There were no previous excursions. Data logger was involved. 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: This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported). No adverse effects were reported. The administered doses were exposed to the temperature of 49.6 degrees Celsius for 1 hour and 20 minutes. There were no previous excursions. Data logger was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX lot # L 024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Digital Data Logger (DLL) was used to capture the excursion. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 16 year old patient of unknown gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 25-APR-2016 (also reported as today) the reporter stated that 16 years old patient was inadvertently vaccinated with adult dose of VAQTA 1 ml (lot # L017757 expiry date 08-APR-2018) intramuscularly in the right deltoid. No adverse effects were reported. There was no product quality complaint involved. Additional information is not expected, as the reporter did not wish further contact.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Digital Data Logger (DDL) was used to capture the excursion. No previous temperature excursion was 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: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as receipt from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 10-MAY-2016, the patient was vaccinated with RECOMBIVAX HB lot # K008986, expiry date 01-APR-2016 (dose, route and site of administration were not reported) which was 10 days past its expiration date. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 19-NOV-2015, the patient was vaccinated with improperly stored VARIVAX lot # L024256, expiration date: 01-JUL-2017, (exact dose, route of administration and injection site were not reported). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Digital Data Logger (DDL) was used to capture the excursion. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 14-year-old patient (gender was not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4-year-old patient (gender was not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain
Clinical narrative: This study report was received from an unspecified source, as part of a marketing research study refers to a Caucasian female patient (age reported as 30). Concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufactured unknown) (dose and route not specified). Subsequently, the patient experienced injection site pain. At the time of the report the patient was recovering from the injection site pain. The investigator considered that injection site pain was related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(manufacturer unknown). Additional information is not expected as there is no consent to contact the patient nor the doctor.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of ROTATEQ (lot # L028645, expiration date 25-MAY-2017; dose was not reported). No adverse effects were reported. The vaccines were stored in 0.8 degrees of Celsius for 5 hours and 1 minute. Digital data logger was involved. No previous temperature excursion was reported. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Fatigue, pain at injection site, hot to touch at injection site, redness, swelling.
Age: 22.0
Sex: F
Vaccine: HPVX
Symptoms: Dizziness postural, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: High fever, severe head ache covering complete head, dizziness when standing, fatigue, lasting four hours, was given Motrin at 7 AM, fever reduced by 9 AM, headache was mild after this and lasted until 11 AM, today on 5/15 at 3:15 there is still pain at the injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Abasia, Fall, Hypotonia, Lethargy, Loss of control of legs
Clinical narrative: She did not cry upon injection. Approximately 10 minutes after the injection, patient became very lethargic and was not able to put weight on her leg, she said it did not hurt but that she could not walk. We left the office and went about 7 minutes away, as she stood up from her booster to get out of the car, she put weight on her leg and it buckled, causing her to collapse and fall down. Her back was to me so I could not tell if she briefly fainted or if it was a result of muscle weakness/nerve issues. This happened again once she got out of the car, I set her down and her leg buckled again, I shouted her name to her and then picked her up and carried her the rest of the day. She required that I carry her as a result of her limbs being floppy/weak until bedtime that night.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Muscular weakness, Syncope, Weight bearing difficulty
Clinical narrative: She did not cry upon injection. Approximately 10 minutes after the injection, patient became very lethargic and was not able to put weight on her leg, she said it did not hurt but that she could not walk. We left the office and went about 7 minutes away, as she stood up from her booster to get out of the car, she put weight on her leg and it buckled, causing her to collapse and fall down. Her back was to me so I could not tell if she briefly fainted or if it was a result of muscle weakness/nerve issues. This happened again once she got out of the car, I set her down and her leg buckled again, I shouted her name to her and then picked her up and carried her the rest of the day. She required that I carry her as a result of her limbs being floppy/weak until bedtime that night.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Information has been received from a physician via a field representative referring to a female patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dose, frequency, lot# and expiration date were not reported). Concomitant drug was not reported. On an unknown date after the vaccination, the patient broke out in a case of ophthalmic zoster and had to be treated by an ophthalmologist. The patient recovered on an unknown date. The causality was not reported. Upon internal review, the event of ophthalmic zoster was considered to be medically significant. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Red, tender, warm, and swollen Left arm hurts to touch. Started today (5/15/16) when she woke up, sent her to dr. care.
Age: 43.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: Information has been received from a pharmacist referring to a currently 43 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. On unknown dates the patient was vaccinated with two doses of M-M-R II (dose, route, lot # and expiration date were unknown). There was no concomitant medication. The patient was seen for a routine examination by an unspecified physician on an unknown date. The patient was informed by the physician that his titers were low for measles, mumps, and rubella. No treatment was given for the adverse events. Outcome of the events was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse concerning a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 27-APR-2016 the patient was vaccinated with the second dose of VAQTA (route not reported, lot # L045713 and expiration date 14-JAN-2017) inadvertently (Extra dose administered). Concomitant therapies included M-M-R II and VARIVAX. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about concurrent condition, medical history and concomitant therapy was not reported. The physician stated that many years ago the patient was vaccinated with a dose of VARIVAX (lot#, dose and route not reported). Many years later the patient had a red rash that resembled shingles. The physician stated that this was a previous event that happened 3 to 4 years ago. At the time of reporting, the outcome of red rash that resembled shingles was unknown. The physician did not provide the causality. Additional information has been requested.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Feeling abnormal, Malaise, Myalgia
Clinical narrative: Case number PHEH2015US013965 is a spontaneous report initially received from a consumer on 15 Jul 2015. This report refers to an adult female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1205401) at a dose of 0.5 ml intramuscularly in Jan 2013. Since the vaccination in Jan 2013, she felt like there was cement throughout her body. She was active and agile before the vaccination but not since the shot. She also experienced myalgia, malaise and fatigue after vaccination. It was reported that from an unknown date after vaccination, the patient has not been able to walk (for 02 years now) and has been diagnosed with Parkinson's Disease. The outcome of the events not been able to walk and Parkinson's disease was reported as unknown and for other it was reported as ongoing. The seriousness of the events not been able to walk and Parkinson's disease was reported as serious (disability) and for other events it was not reported. The causality of the events was not reported. Consent to contact reporter was not provided hence case was considered as lost to follow up.  Follow up report from the consumer received on 20 Aug 2015: Added patient's age group and events (malaise, myalgia and fatigue. Follow up report received from a consumer on 05 May 2016: Added dose of FLUVIRIN and events (not been able to walk and Parkinson's Disease).
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Fatigue, Feeling abnormal, Malaise, Myalgia
Clinical narrative: Case number PHEH2015US013965 is a spontaneous report initially received from a consumer on 15 Jul 2015. This report refers to an adult female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1205401) at a dose of 0.5 ml intramuscularly in Jan 2013. Since the vaccination in Jan 2013, she felt like there was cement throughout her body. She was active and agile before the vaccination but not since the shot. She also experienced myalgia, malaise and fatigue after vaccination. It was reported that from an unknown date after vaccination, the patient has not been able to walk (for 02 years now) and has been diagnosed with Parkinson's Disease. The outcome of the events not been able to walk and Parkinson's disease was reported as unknown and for other it was reported as ongoing. The seriousness of the events not been able to walk and Parkinson's disease was reported as serious (disability) and for other events it was not reported. The causality of the events was not reported. Consent to contact reporter was not provided hence case was considered as lost to follow up.  Follow up report from the consumer received on 20 Aug 2015: Added patient's age group and events (malaise, myalgia and fatigue. Follow up report received from a consumer on 05 May 2016: Added dose of FLUVIRIN and events (not been able to walk and Parkinson's Disease).
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Parkinson's disease, Sensation of foreign body
Clinical narrative: Case number PHEH2015US013965 is a spontaneous report initially received from a consumer on 15 Jul 2015. This report refers to an adult female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1205401) at a dose of 0.5 ml intramuscularly in Jan 2013. Since the vaccination in Jan 2013, she felt like there was cement throughout her body. She was active and agile before the vaccination but not since the shot. She also experienced myalgia, malaise and fatigue after vaccination. It was reported that from an unknown date after vaccination, the patient has not been able to walk (for 02 years now) and has been diagnosed with Parkinson's Disease. The outcome of the events not been able to walk and Parkinson's disease was reported as unknown and for other it was reported as ongoing. The seriousness of the events not been able to walk and Parkinson's disease was reported as serious (disability) and for other events it was not reported. The causality of the events was not reported. Consent to contact reporter was not provided hence case was considered as lost to follow up.  Follow up report from the consumer received on 20 Aug 2015: Added patient's age group and events (malaise, myalgia and fatigue. Follow up report received from a consumer on 05 May 2016: Added dose of FLUVIRIN and events (not been able to walk and Parkinson's Disease).
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Chills, Headache, Injection site erythema, Pain, Pyrexia
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. An 18-year-old other ethnic group male patient received the first dose of TRUMENBA, intramuscular at 0.5 ml single in the left arm on 28Dec2015. Relevant medical history and concomitant medications were unknown. On 28Dec2015, the patient experienced chills, pain. On 29Dec2015, he developed slight pinkness around the site, large redness from elbow up to point of injection, slight fever at 99.8 degrees Fahrenheit, and headache. The adverse events, chills, pain, vaccination site erythema, erythema and slight fever were assessed as serious (hospitalization required) while the event, headache, was assessed as non-serious. Therapeutic measures taken for headache included ibuprofen. No treatment was received for other events. The patient recovered from the events on an unspecified date. Follow-up (13Apr2016): Follow-up attempts are completed. No further information is expected. Follow-up (09May2016): New information reported from the same contactable consumer includes: patient details, reaction data and case seriousness changed from non-serious to serious (hospitalization required).
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Chills, Headache, Pain, Pyrexia, Vaccination site erythema
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. An 18-year-old other ethnic group male patient received the first dose of TRUMENBA, intramuscular at 0.5 ml single in the left arm on 28Dec2015. Relevant medical history and concomitant medications were unknown. On 28Dec2015, the patient experienced chills, pain. On 29Dec2015, he developed slight pinkness around the site, large redness from elbow up to point of injection, slight fever at 99.8 degrees Fahrenheit, and headache. The adverse events, chills, pain, vaccination site erythema, erythema and slight fever were assessed as serious (hospitalization required) while the event, headache, was assessed as non-serious. Therapeutic measures taken for headache included ibuprofen. No treatment was received for other events. The patient recovered from the events on an unspecified date. Follow-up (13Apr2016): Follow-up attempts are completed. No further information is expected. Follow-up (09May2016): New information reported from the same contactable consumer includes: patient details, reaction data and case seriousness changed from non-serious to serious (hospitalization required).
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Local swelling, Tenderness, Urticaria
Clinical narrative: This spontaneous report as received from a 73 year old female patient, reporting on herself. The patient did not present any pertinent medical history or drug reaction/allergies. On 23-MAR-2016, the patient was vaccinated with PNEUMOVAX23 (strength, dose, route, anatomical site and lot number were not reported). Concomitant therapies included LISINOPRIL (Manufacture unknown), SIMVASTATIN (manufacturer unknown) and metformin. Later on 23-MAR-2016, the patient's arm where the vaccine shot was administered got very swollen and she developed hives all over her body "from head to toe". She also stated a few days later on 27-MAR-2016, she started itching and scratching all over and she wasn't able to sleep at night because the itching got so bad. The patient sought medical attention via visiting her physician on 28-MAR-2016, where she received ATARAX as treatment for her itching and hives. Patient also said she ended up seeing her doctor "3 or 4 more times" after that initial follow up visit because of her severe itching. Non lab diagnostic studies were reported. In April 2016 (reported as about two weeks ago), the outcome of insomnia, urticarial, peripheral swelling and pruritus was reported as recovered. The relatedness between the events and vaccination with PNEUMOVAX23 was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling, Pruritus, Scratch, Sleep disorder, Urticaria
Clinical narrative: This spontaneous report as received from a 73 year old female patient, reporting on herself. The patient did not present any pertinent medical history or drug reaction/allergies. On 23-MAR-2016, the patient was vaccinated with PNEUMOVAX23 (strength, dose, route, anatomical site and lot number were not reported). Concomitant therapies included LISINOPRIL (Manufacture unknown), SIMVASTATIN (manufacturer unknown) and metformin. Later on 23-MAR-2016, the patient's arm where the vaccine shot was administered got very swollen and she developed hives all over her body "from head to toe". She also stated a few days later on 27-MAR-2016, she started itching and scratching all over and she wasn't able to sleep at night because the itching got so bad. The patient sought medical attention via visiting her physician on 28-MAR-2016, where she received ATARAX as treatment for her itching and hives. Patient also said she ended up seeing her doctor "3 or 4 more times" after that initial follow up visit because of her severe itching. Non lab diagnostic studies were reported. In April 2016 (reported as about two weeks ago), the outcome of insomnia, urticarial, peripheral swelling and pruritus was reported as recovered. The relatedness between the events and vaccination with PNEUMOVAX23 was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Chest X-ray normal, Chest discomfort, Chest pain
Clinical narrative: Patient complained of 24+ hrs of dull substernal chest tightness/pain with shortness of breath described as difficulty takin in deep breaths with subjective fevers and chills, mild sweating, sore throat, and intermittent cough to clear mucus.  Initially he was found to have an elevated troponin of 7.46 and had an ECHO conducted showing normal function and repeat troponin to 11.  All symptoms resolved over about 8 hours.  After consult with cardiology we concluded that this is acute myocarditis.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Chills, Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Hyperhidrosis
Clinical narrative: Patient complained of 24+ hrs of dull substernal chest tightness/pain with shortness of breath described as difficulty takin in deep breaths with subjective fevers and chills, mild sweating, sore throat, and intermittent cough to clear mucus.  Initially he was found to have an elevated troponin of 7.46 and had an ECHO conducted showing normal function and repeat troponin to 11.  All symptoms resolved over about 8 hours.  After consult with cardiology we concluded that this is acute myocarditis.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Oropharyngeal pain, Productive cough, Pyrexia, Troponin I increased
Clinical narrative: Patient complained of 24+ hrs of dull substernal chest tightness/pain with shortness of breath described as difficulty takin in deep breaths with subjective fevers and chills, mild sweating, sore throat, and intermittent cough to clear mucus.  Initially he was found to have an elevated troponin of 7.46 and had an ECHO conducted showing normal function and repeat troponin to 11.  All symptoms resolved over about 8 hours.  After consult with cardiology we concluded that this is acute myocarditis.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB normal, Chest X-ray normal, Chest discomfort, Chest pain, Chills
Clinical narrative: Patient complained of 24+ hrs of dull substernal chest tightness/pain with shortness of breath described as difficulty takin in deep breaths with subjective fevers and chills, mild sweating, sore throat, and intermittent cough to clear mucus.  Initially he was found to have an elevated troponin of 7.46 and had an ECHO conducted showing normal function and repeat troponin to 11.  All symptoms resolved over about 8 hours.  After consult with cardiology we concluded that this is acute myocarditis.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Differential white blood cell count normal, Dyspnoea, Electrocardiogram normal, Full blood count normal, Hyperhidrosis
Clinical narrative: Patient complained of 24+ hrs of dull substernal chest tightness/pain with shortness of breath described as difficulty takin in deep breaths with subjective fevers and chills, mild sweating, sore throat, and intermittent cough to clear mucus.  Initially he was found to have an elevated troponin of 7.46 and had an ECHO conducted showing normal function and repeat troponin to 11.  All symptoms resolved over about 8 hours.  After consult with cardiology we concluded that this is acute myocarditis.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Metabolic function test normal, Myocarditis, Oropharyngeal pain, Productive cough, Pyrexia
Clinical narrative: Patient complained of 24+ hrs of dull substernal chest tightness/pain with shortness of breath described as difficulty takin in deep breaths with subjective fevers and chills, mild sweating, sore throat, and intermittent cough to clear mucus.  Initially he was found to have an elevated troponin of 7.46 and had an ECHO conducted showing normal function and repeat troponin to 11.  All symptoms resolved over about 8 hours.  After consult with cardiology we concluded that this is acute myocarditis.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin increased
Clinical narrative: Patient complained of 24+ hrs of dull substernal chest tightness/pain with shortness of breath described as difficulty takin in deep breaths with subjective fevers and chills, mild sweating, sore throat, and intermittent cough to clear mucus.  Initially he was found to have an elevated troponin of 7.46 and had an ECHO conducted showing normal function and repeat troponin to 11.  All symptoms resolved over about 8 hours.  After consult with cardiology we concluded that this is acute myocarditis.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB normal, Blood creatine phosphokinase increased, Blood creatine phosphokinase normal, Chest X-ray normal, Chest discomfort
Clinical narrative: Patient complained of 24+ hrs of dull substernal chest tightness/pain with shortness of breath described as difficulty takin in deep breaths with subjective fevers and chills, mild sweating, sore throat, and intermittent cough to clear mucus.  Initially he was found to have an elevated troponin of 7.46 and had an ECHO conducted showing normal function and repeat troponin to 11.  All symptoms resolved over about 8 hours.  After consult with cardiology we concluded that this is acute myocarditis.