chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; expired dose of PROQUAD was inadvertently administered; Information has been received from a medical assistant referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent (STERILE DILUENT) (lot number R032352 and expiration date was on 04-JUN-2021). The patient's pertinent medical history, drug reactions/allergies and current condition were not provided.    On 21-MAR-2019 the patient was inadvertently administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type: recombinant human albumin(rHA); lot # N025927 and expiration date was on 18-MAR-2019) subcutaneously for prophylaxis (expired product administered). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received improperly stored VARIVAX; no adverse effect reported; Information has been received from a pharmacist referring to a patient with unknown age and gender. The patient's concomitant drug included sterile diluent. The patient's pertinent medical history, drug reactions or allergies were not reported.  On 22-MAR-2019, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number: R023513; expiration date: 16-AUG-2020; strength, dose and route were not reported) for prophylaxis. No adverse effect reported. The temperature of storage was 6 degrees Fahrenheit to 14 degrees Fahrenheit (6.9F), the time frame was 45 minutes. There was no previous temperature excursion. Data logger was involved. The outcome of the events was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report was received from a female patient of unknown age via a company representative referring to herself. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was unknown. On an unknown date, the patient was vaccinated with GARDASIL 9 (strength, dose, lot # and expiration date were not reported) intramuscularly for prophylaxis. On an unknown date, the patient developed a "swollen right posterial oracle lymph node". The lymph node was "the size of a walnut", and "hard to the touch", but went away after a week "on its own". No treatment was given for the event. It was unknown if the patient sought medical attention and any lab diagnostics/studies was performed. The outcome of the event was reported as recovered. The causality between GARDASIL 9 and the event was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; administered an expired dose of ZOSTAVAX vaccine; Information has been received from a medical assistant referring to a 74 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided.     On 21-MAR-2019 the patient was as administered an expired dose of zoster vaccine live (ZOSTAVAX) (strength and route were unknown, lot # L006392 and expiration date was on 25-MAY-2016) for prophylaxis (experienced expired product administered). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; patient inadvertently received an expired dose of Varivax; This spontaneous report was received from a lab technician and refers to a patient of unspecified age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. The patient's concomitant therapies included Merck sterile diluent.  On 26-MAR-2019, the patient was inadvertently vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1 dosage form, lot#N008828, expiration date 16-MAR-2019 (anatomical location was not provided) for prophylaxis. No adverse effects were reported.
Age: 21.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: No adverse effects reported; Medical Assistant gave an unspecified 21 year old female patient VARIVAX subcutaneously in the radial aspect of the arm instead of the outer upper part of the arm; This spontaneous report was received from a nurse referring to a 21 years old female patient. Information about the concomitant medication, pertinent medical history and drug reactions or allergies was not provided by the reporter.   On 25-MAR-2019 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (strength and dose detail were not reported; lot # R002506 and expiration date 25-JAN-2020) which was reconstituted with properly stored sterile diluent, subcutaneously in the radial aspect of the arm instead of the outer upper part of the arm for prophylaxis (product administered at inappropriate site). There were no temperature excursions for the two suspects. No adverse effects were reported.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of ROTATEQ was given to unspecified patient at "15 weeks old"; Information has been received from a Medical Assistant referring to a 15 weeks old infant. Concomitant medications, concurrent conditions, historical conditions were not reported. On an unspecified date, the patient vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) at 15 weeks old (product administered to patient of inappropriate age).
Sex: U
Vaccine: MMR, MMRV, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 unknown patients, all over the age of 13 years old, were inadvertently administered a dose of PROQUAD (unknown lot/expiration date) on unknown dates instead of MMR II.; 4 unknown patients, all over the age of 13 years old, were inadvertently administered a dose of PROQUAD (unknown lot/expiration date) on unknown dates instead of MMR II.; No adverse effects were reported; This spontaneous report was received from a paramedical referring to 4 unknown patients, all over the age of 13 year old and unknown gender. The patients' medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not reported.  On an unknown date, the 4 patients were inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) intramuscularly (dose, frequency, lot number and expiration date were not reported) for prophylaxis  instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and sterile diluent was used. No adverse effects were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored vaccines since 3/29/2019; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies or medical history.  On 29-MAR-2019, the patient was vaccinated with an improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot numbers: R024024 and R024023, expiration date for both lot numbers on: 22-AUG-2020; and with (rHA) Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # R030794 and R017801, expiration dates on: 22-APR-2020 and 19-DEC-2019 respectively, (dosage schedule, route, anatomical location and indication were not reported for the vaccines). The vaccines were reconstituted with properly stored diluent.   The administered doses of vaccines were exposed to a temperature of multiples excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit (minus 14 degrees Celsius to minus 10 degrees Celsius) for 100 minutes cumulative. There was no previous temperature excursion reported. The call was placed because of a Digital Data logger report. No adverse effects were reported  This is one of several reports received from the same reporter.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: the patient subsequently has negative titers; the patient subsequently has negative titers; the patient subsequently has negative titers; Route of Administration: intramuscularly; This spontaneous report was received from a physician and refers to a currently 16 years old male patient. The patient did not have any pertinent medical history and drug allergies. His concomitant medication included growth hormones (somatropin).   On 10-JUL-2003,  the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and the second dose on 31-JUL-2006, intramuscular (incorrect route of product administration) for prophylaxis (strength, dose, lot # and expiry date were not reported) .  Subsequently, the patient were vaccinated on 25-JAN-2019 and 29-MAR-2019 (strength, dose, lot # and expiry date were not reported) due to his parents had international travel planned. Consequently, it was reported that the patient performed a blood test on 18-MAR-2019 and it showed negative titers (measles antibody negative, mumps antibody test negative and rubella antibody negative)  The outcome of had negative titers was not recovered. The causality assessment between negative titers and vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided.  In or around 21-DEC-2015, the patient was inoculated with ZOSTAVAX (lot# and route not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Approximately two days after receiving ZOSTAVAX the patient suffered blisters on his back to right side and was diagnosed with shingles. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX vaccine, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Shingles was reported to be disabling. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, previous drug reactions, allergies, concurrent conditions and concomitant medications was not provided. On 26-SEP-2018, the patient was vaccinated with the first dose of GARDASIL 9 injection. Lot number N020139 and expiration date 14-FEB-2020 (frequency, route and anatomical location of vaccination were unknown). On 04-MAR-2019, the patient was vaccinated with the second dose of GARDASIL 9 injection. Lot number R010596 and expiration date 11-DEC-2020 (frequency, route and anatomical location of vaccination were unknown) and on 02-APR-2019 was vaccinated with the third dose of GARDASIL 9 injection. Lot number R010596 and expiration date 11-DEC-2020 (frequency, route and anatomical location of vaccination were unknown). All for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report as received from an office manager via a company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL series (lot # and route not reported). On an unknown date, "recently", the patient had an abnormal pap smear. At the time of the report, the patient's outcome was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour) PROQUAD was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 02-APR-2019, the patient was administered improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number R020815, expiration date 16-JAN-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (no lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005133: US-009507513-1904USA005132: US-009507513-1904USA005130: US-009507513-1904USA005129: US-009507513-1904USA005131: US-009507513-1904USA005627: US-009507513-1904USA005628: US-009507513-1904USA005629: US-009507513-1904USA005630: US-009507513-1904USA005631:
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Rash, Rash erythematous, Rash papular, Scab
Clinical narrative: This spontaneous report as received from an unspecified consumer, who refers to a female patient of unknown age. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, injection site, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced rash with red bumps and itchiness on her legs (it was up to her thighs). She applied CAMPHO PHENIQUE, which helped a little. On an unknown date, reported as three days later, the same rash appeared on her arms and trunk. During examination the patient had erythematous papules on trunk and extremities, some with scab on top. The outcome of the events was not recovered. The relatedness between the events and the suspect therapy was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; The patient was inadvertently administered a dose of MMR II (Lot#N024696/Exp: 4/7/2019), on 4/9/2019, that was expired.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 09-APR-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA), lot # N024696, expiration date 07-APR-2019 for prophylaxis (dose and route of administration were not reported) (expired product administered). No adverse effects reported. The outcome of expired product administered was not reported.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Rash
Clinical narrative: had a bad reaction/rash; This spontaneous report was received from a physician via Pfizer referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date in 2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dosage schedule, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.         On an unknown date in 2009, the patient experienced a bad reaction characterized by rash after the vaccine was administered (allergy to vaccine).  The outcome of allergy to vaccine was unknown.     The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).
Sex: F
Vaccine: HPVX
Symptoms: Cervix carcinoma, Product name confusion
Clinical narrative: Information has been received from a physician via a field employee referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies were not provided. On unknown dates, the patient was vaccinated with all three doses of either GARDASIL (lot #, expiration date, dose, frequency, route of administration and anatomical location were not reported) or GARDASIL 9 (lot #, expiration date, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. On an unknown date the patient was diagnosed with cervical cancer. The patient was receiving an unspecified treatment for cervical cancer. The outcome of cervix carcinoma was unknown. The causality between the cervical cancer and GARDASIL or GARDASIL 9 was not reported. Upon internal review, cervix carcinoma was determined to be medically significant.
Sex: M
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Positive for full blown rotavirus; This spontaneous report was received from a nurse prescriber via company representative regarding a 9-month-old male patient. The patient's concurrent condition, medical history, concomitant medication and drug allergies was not reported. On an unknown date the patient was vaccinated with 3 doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (prevention of rotavirus gastroenteritis) via oral route (strength, frequency and lot/batch number were not reported). On an unknown date the patient developed positive for full blown rotavirus. The patient sought medical attention. The outcome of the event was recovered. The causality of the event with respect to rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Seizure
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) regarding a 12 year old male patient. Information on patient's concurrent condition, medical history, concomitant therapies and drug reactions/allergies were not reported.On an unknown date in 2007 (reported as 12 years ago), the patient was vaccinated with M-M-R II for disease prevention and sterile diluent (dose number 1, dose, frequency, anatomical location, lot# and expiration date unknown) for prophylaxis. On the same day (reported as3 hours after onset of therapy), the patient experienced a high fever and a seizure episode. It was reported that the patient went back to the clinic where he received the vaccine to seek medical attention.The outcome of the events seizure and high fever was reported as recovered.The causal relationship of the events with M-M-R II and sterile diluent was unknown. Upon internal review, the event seizure was determined to be medically significant.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: This spontaneous report was received from the mother of an approximately 12-year-old female patient. The patient's concurrent condition was not reported. The patient did not have any pertinent medical history, concomitant medication and drug reactions or allergies. On 14-MAR-2019, the patient was vaccinated with her first dose of GARDASIL 9 injection in arm (strength, dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis (reported as to prevent cancer). On 25-MAR-2019 (reported as one week later), the patient started experiencing multiple seizures a day. The patient went to see the doctor and a neurologist. Treatment was given for the event. Blood work and magnetic resonance imaging (MRI) was performed and the results were not reported. There was no product quality complaint associated with this report. The outcome of the event, seizure was reported as not recovered. The causality assessment was not reported. Upon internal review, the event seizure was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour) PROQUAD was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 04-APR-2019, the patient was administered improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number R020815, expiration date 16-JAN-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (no lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005132: US-009507513-1904USA005131: US-009507513-1904USA005130: US-009507513-1904USA005133: US-009507513-1904USA004258: US-009507513-1904USA005627: US-009507513-1904USA005628: US-009507513-1904USA005629: US-009507513-1904USA005630: US-009507513-1904USA005631:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour) PROQUAD was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 06-APR-2019, the patient was administered improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number R020815, expiration date 16-JAN-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (no lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA004258: US-009507513-1904USA005131: US-009507513-1904USA005130: US-009507513-1904USA005133: US-009507513-1904USA005129: US-009507513-1904USA005627: US-009507513-1904USA005628: US-009507513-1904USA005629: US-009507513-1904USA005630: US-009507513-1904USA005631:
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Menstruation normal
Clinical narrative: This spontaneous report as received from a medical assistant via a company representative and refers to a 11 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 21-NOV-2018, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, lot number and expiration date were not reported) for prophylaxis. On 28-NOV-2018, the patient started her menstrual cycle (menstruation normal). It was unknown, if the patient received treatment for the event. The outcome of menstruation normal was reported as recovered. The causal relationship between the event and GARDASIL 9 was not reported.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, and refers to a 13 year old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with her second dose of GARDASIL 9, intramuscular, lot # R027577, for prophylaxis. The reporter stated that the patient received the second dose fifteen months after the first dose (inappropriate schedule). No adverse effects were reported.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Body temperature increased, Diarrhoea, Dizziness, Headache, Neck pain
Clinical narrative: This spontaneous report was received from a physician assistant referring to a 11 years old female patient with rhinitis allergic and sinusitis. The patient's medical history included adenoidectomy and tonsillectomy. Concomitant therapies included AUGMENTIN. The patient had no drug reactions/allergies. On an unknown date in September 2018 (reported as 7 months ago), the patient was vaccinated with the first dose of GARDASIL 9 (dose, lot# and expiration date were not reported) route was unknown (given in another clinic), for normal childhood immunization schedule. On 10-APR-2019, the patient was seen for a sinus infection with a temperature of 101-102 Fahrenheit and she was vaccinated with the second dose of GARDASIL 9 (dose was not reported) (lot# was R029117, expiration date was 10-JUL-2021), route was unknown in the left arm for prophylaxis. Approximately 3 hours after receiving the GARDASIL 9, she started AUGMENTIN for her sinus infection. On that day, she experienced diarrhea, headache, neck pain and dizziness. The patient did not have any reaction with the first GARDASIL 9. No treatment was given for the events. The patient sought medical attention and at the reporting time she was recovering from the events. Action taken with the suspect vaccine was not applicable. The reporter did not provide the causality between the events and the suspect vaccine.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Sinusitis
Clinical narrative: This spontaneous report was received from a physician assistant referring to a 11 years old female patient with rhinitis allergic and sinusitis. The patient's medical history included adenoidectomy and tonsillectomy. Concomitant therapies included AUGMENTIN. The patient had no drug reactions/allergies. On an unknown date in September 2018 (reported as 7 months ago), the patient was vaccinated with the first dose of GARDASIL 9 (dose, lot# and expiration date were not reported) route was unknown (given in another clinic), for normal childhood immunization schedule. On 10-APR-2019, the patient was seen for a sinus infection with a temperature of 101-102 Fahrenheit and she was vaccinated with the second dose of GARDASIL 9 (dose was not reported) (lot# was R029117, expiration date was 10-JUL-2021), route was unknown in the left arm for prophylaxis. Approximately 3 hours after receiving the GARDASIL 9, she started AUGMENTIN for her sinus infection. On that day, she experienced diarrhea, headache, neck pain and dizziness. The patient did not have any reaction with the first GARDASIL 9. No treatment was given for the events. The patient sought medical attention and at the reporting time she was recovering from the events. Action taken with the suspect vaccine was not applicable. The reporter did not provide the causality between the events and the suspect vaccine.
Sex: F
Vaccine: HPV9
Symptoms: Fall, Syncope
Clinical narrative: This spontaneous report was received from a medical assistant via company representative regarding a 21-year-old female patient. The patient's relevant medical history, current conditions, drug allergies and concomitant medications were not reported. On an unknown date in April 2019, the patient was vaccinated with the second dose of GARDASIL 9 (strength, dose, frequency, route, lot# and expiry date were unknown) for prophylaxis. On an unknown date in April 2019 (reported as "a day or two ago"), the patient experienced syncope following second dose of GARDASIL 9 and fell. The outcome of the events was unknown. Causality assessment was not reported. There was no product quality complaint (PQC) involved. Upon internal review, syncope was determined to be medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour) VARIVAX was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 02-APR-2019, the patient was administered improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number R026547, expiration date 17-SEP-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (no lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005132: US-009507513-1904USA005131: US-009507513-1904USA005130: US-009507513-1904USA004258: US-009507513-1904USA005129: US-009507513-1904USA005630: US-009507513-1904USA005629: US-009507513-1904USA005628: US-009507513-1904USA005631: US-009507513-1904USA005133:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour) VARIVAX was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 03-APR-2019, the patient was administered improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number R026547, expiration date 17-SEP-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (no lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005132: US-009507513-1904USA005131: US-009507513-1904USA005130: US-009507513-1904USA004258: US-009507513-1904USA005129: US-009507513-1904USA005630: US-009507513-1904USA005629: US-009507513-1904USA005133: US-009507513-1904USA005631: US-009507513-1904USA005627:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour)  VARIVAX was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 04-APR-2019, the patient was administered improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number R026547, expiration date 17-SEP-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (No lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005132: US-009507513-1904USA005131: US-009507513-1904USA005130: US-009507513-1904USA004258: US-009507513-1904USA005129: US-009507513-1904USA005630: US-009507513-1904USA005133: US-009507513-1904USA005628: US-009507513-1904USA005631: US-009507513-1904USA005627:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored doses of VAQTA; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient' s concurrent conditions, medical history and concomitant medications were not reported. On 10-APR-2019, the patient received improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # R025518, expiration date: 15-NOV-2019, for prophylaxis (exact dose, frequency and route of administration were not provided). The vaccine underwent temperature excursion of the lowest temperature of 36 degrees Fahrenheit/ 2 degrees Celsius (34F) for 1 hour and 17 minutes and the highest temperature of 47 degrees Fahrenheit/ 9 degrees Celsius (50F) for 30 minutes. There was no previous temperature excursion. The digital data logger was not involved in recording excursion details. No adverse effects were reported.; Sender's Comments:  US-009507513-1904USA005752:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored doses of VAQTA; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient' s concurrent conditions, medical history and concomitant medications were not reported. On 10-APR-2019, the patient received improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # R025518, expiration date: 15-NOV-2019, for prophylaxis (exact dose, frequency and route of administration were not provided). The vaccine underwent temperature excursion of the lowest temperature of 36 degrees Fahrenheit/ 2 degrees Celsius (34F) for 1 hour and 17 minutes and the highest temperature of 47 degrees Fahrenheit/ 9 degrees Celsius (50F) for 30 minutes. There was no previous temperature excursion. The digital data logger was not involved in recording excursion details. No adverse effects were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005734:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired dose of VAQTA; This spontaneous report was received from an office manager refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On 04-APR-2019 the patient was inadvertently vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # R010368 and expiration date 25-MAR-2019) (dose, units and frequency unknown), intramuscularly (expired product administered). The patient experienced no adverse events. No PQC (product quality complaint) was reported.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; the patient was inadvertently administered a dose of expired VAQTA; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported.  On 10-APR-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscularly, lot number R007211, expiration date 02-APR-2019 (exact dose, frequency and site of administration were not reported) for prophylaxis. No adverse effects were reported.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a eleven year old female patient inadvertently received her booster dose of VAQTA nine days before the six month spacing interval; No adverse effect; This spontaneous report as received from a pharmacist regarding to a 11-year-old female patient.   No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications. On approximately unknown date in 18-OCT-2018, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) first dose for prophylaxis. On 09-APR-2019, the patient inadvertently received her booster dose of with hepatitis a vaccine, inactivated(VAQTA) 25/0.5 (lot # R010369, expiry date:  25-MAR-2019) second dose of 0.5 milligram nine days before the six month spacing interval noted in information for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported. No product quality complaint (PQC) was reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects at this time; VARIVAX and MMR II were administered at the same time to the patient (first and second doses); This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.  On 25-FEB-2019, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported).      On 11-APR-2019, the patient received the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number R030609, expiration date: 23-OCT-2020; and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHa) lot number R015165, expiration date: 29-MAY-2020.      The reporter informed that the second doses were administered in close proximity to the previous first one, but no adverse effects were reported at the time of the report.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; The patient was administered an expired dose of VARIVAX.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 11-APR-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneously, lot # N009768, expiration date 24-MAR-2019 for prophylaxis (dose and route of administration were not reported) (expired product administered).The vaccine was reconstituted with sterile diluent MRK lot # R025519, expiration date 28-NOV-2019. No adverse effects reported. The outcome of expired product administered was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; one dose of expired PROQUAD was administered to a patient; Information has been received from a medical assistant regarding to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, drug reactions or allergies.  On 11-APR-2019 the patient was vaccinated with one dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) with lot number N025924 and expiration date 18-MAR-2019 for prophylaxis (dose, frequency, route of administration and anatomical injection site were not reported) (Expired product administered). The reporter confirmed that the sterile diluent used was not expired. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported; the patient was vaccinated with an expired dose of VAQTA; Information has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, drug reactions or allergies.  On 10-APR-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) injection with lot number R010369 and expiration date on 25-MAR-2019,  for prophylaxis (strength, dose, dose number, route of administration and anatomical injection site were not reported) (Expired product administered). No adverse symptoms reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: The posibility of the administration of one separate dose of an improperly stored vaccine; The posibility of the administration of one separate dose of an improperly stored vaccine; No adverse effect; This spontaneous report was received from a medical assistant and refers to a 4 or 5 years old child of unknown gender. The patients' pertinent concurrent conditions, medical history, concomitant medications and drug reactions or allergies were not provided.   The medical assistant reported, the possibility of the administration an improperly stored dose (product storage error and circumstance or information capable of leading to medication error) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD)subcutaneously,  lot # R001540 with expiration date on 15-JUL-2019 for prophylaxis (strength, anatomical side of injection and dose # were not provided) to one patient who was approximately 4 or 5 years old on unspecified date. No adverse effect reported nor product quality complain.  In addition, the medical assistant stated that measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) was reconstituted with properly stored sterile diluent (lot # N006325 with expiration date on 07-AUG-2019).   The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) was exposed to a temperature excursion of -13 degrees Celsius (°C)  for 5 hours and a temperature of -13 degrees Celsius (°C) with time frame of 8 hours, which was detected by the Digital Data Logger.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from an unspecified reporter, via a company representative referring to 2 female patients of unknown age. No information was provided regarding the patients' historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications. On an unknown dates, the patients were vaccinated with GARDASIL 9 by intramuscular route for prophylaxis (dose, lot number and expiration date were not reported). On an unknown dates, after receiving GARDASIL 9, the patients fainted. It was unknown if the patients received any treatment for the event, or if laboratory diagnostic studies were performed. The outcome of syncope was unknown and the causality assessment between GARDASIL 9 and the event was not reported. Upon internal review the event of syncope was considered to be medically significant.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored vaccines since 3/29/2019; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies or medical history.  On 29-MAR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot numbers: R024024 and R024023, expiration date for both lot numbers on: 22-AUG-2020; and with (rHA) Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # R030794 and R017801, expiration dates on: 22-APR-2020 and 19-DEC-2019 respectively, (dosage schedule, route, anatomical location and indication were not reported for the vaccines). The vaccines were reconstituted with properly stored diluent.   The administered doses of vaccines were exposed to a temperature of multiples excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit (minus 14 degrees Celsius to minus 10 degrees Celsius) for 100 minutes cumulative. There was no previous temperature excursion reported. The call was placed because of a Digital Data logger report. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA002283:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored vaccines since 3/29/2019; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies or medical history.  On 29-MAR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot numbers: R024024 and R024023, expiration date for both lot numbers on: 22-AUG-2020; and with (rHA) Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # R030794 and R017801, expiration dates on: 22-APR-2020 and 19-DEC-2019 respectively, (dosage schedule, route, anatomical location and indication were not reported for the vaccines). The vaccines were reconstituted with properly stored diluent.   The administered doses of vaccines were exposed to a temperature of multiples excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit (minus 14 degrees Celsius to minus 10 degrees Celsius) for 100 minutes cumulative. There was no previous temperature excursion reported. The call was placed because of a Digital Data logger report. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA002283:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired dose of VAQTA; This spontaneous report was received from an office manager refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On 09-APR-2019 the patient was inadvertently vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # R010368 and expiration date 25-MAR-2019) (dose, units and frequency unknown), intramuscularly (expired product administered). The patient experienced no adverse events. No PQC (product quality complaint) was reported.
Age: 48.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patient received improperly stored VARIVAX; Information has been received from a pharmacist referring to a 48 years old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported.  On 01-APR-2019, the patient received improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number R024023 and expiration date 22-AUG-2020; route of administration was not reported) for prophylaxis (incorrect product storage). The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effect was reported.   The temperature excursion was from 15 Fahrenheit scale to 46 Fahrenheit scale for 744 hours. There was no previous temperature excursion. Data logger was not involved.  This is one of two linked cases received from the same reporter.; Sender's Comments:  US-009507513-1904USA006290: