chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR
Symptoms: Injection site reaction, Purulent discharge, Skin lesion
Clinical narrative: This literature marketed report has been received from authors of the published article, referring to a 21 month old male patient with aluminum allergy. He received standard 2 - and 4-month immunizations without any reactions. At 6 months of age, he received a PENTACEL and ENGERIX injection in the left leg. Several days later, a golf ball-sized, firm lesion appeared in the left thigh. The lesion became fluctuant and was subsequently incised, producing a culture which was sterile with a negative Gram stain. Seven days later, a small lesion reappeared in the same area that eventually self-drained purulent fluid. His next series of immunizations were administered at 1 year of age, on 19-OCT-2015, including the first dose of VAQTA (dose, lot# and expiration date unknown) in the right thigh for prophylaxis. Concomitant therapies included FLUZONE and M-M-R II. Following the immunizations he developed a similar lesion on his right thigh at the site of a VAQTA immunization. An incision and drainage procedure was performed, from which purulence was obtained but a culture was sterile and a Gram stain was negative. A third golf ball-sized lesion developed on the right thigh after receiving his next PENTACEL immunization 5 months later (on 01-APR-2016), and a fourth abscess appeared on 16-MAY-2017 in the left leg after another dose of VAQTA (also reported as "13 months later following a ENGERIX immunization"). He remained afebrile during all episodes, with no erythema or significant discomfort. He did not receive any antimicrobial therapy for the lesions. The outcome of the events was reported as recovered. The reporter considered the events to be related to aluminum-adjuvant based vaccine VAQTA.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and past drug reactions/allergies were not reported. The patient's concomitant therapies included sterile diluent (MERCK). On 02-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N021318 with expiration date: 07-AUG-2018 (strength, dose, route and anatomical location were not provided) for prophylaxis. No adverse effects reported. The reporter stated that the temperature excursion occurred between 6° F and 14° F (13.7° F), with a time frame of 964 minutes. The call was given by data logger. There were not previous temperature excursions reported.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-SEP-2012 (also reported as at the age of 11 years old), the  patient was vaccinated with the first dose of GARDASIL 9, intramuscularly for prophylaxis (lot # and expiration date were unknown). On 12-JUL-2016, the patient was vaccinated with  the second dose of GARDASIL 9, lot # M005714, expiration date 03-OCT-2017, intramuscularly for prophylaxis (inappropriate schedule of drug administration). On 05-JUN-2018, the patient was vaccinated with the third dose of GARDASIL 9, lot # N025428, expiration date 19-JUN-2020, intramuscularly for prophylaxis (inappropriate schedule of drug administration). No adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of an unknown age and gender. The patient's medical history, concurrent condition and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD lot# N034561, expiration date: 03-JUN-2019 or lot# N025926, expiration date: 18-MAR-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent (MERCK) for prophylaxis. Administered dose of vaccine experienced the temperature excursion between -14 degrees Celsius to -10 degrees Celsius (also reported as -10.4 degrees Celsius) for 1 hour and 3 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse events were reported. This is one of four reports received from the same reporter. Lot numbers N034561 and N025926 have been verified to be valid lot numbers for measles, mumps, rubella and varicella (oka-merck) virus vaccine live with albumin status rHA. Sender's Comments: US-009507513-1806USA004464: US-009507513-1806USA004465: US-009507513-1806USA001112.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of an unknown age and gender. The patient's medical history, concurrent condition and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD lot# N034561, expiration date: 03-JUN-2019 or lot# N025926, expiration date: 18-MAR-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent (MERCK) for prophylaxis. Administered dose of vaccine experienced the temperature excursion between -14 degrees Celsius to -10 degrees Celsius (also reported as -10.4 degrees Celsius) for 1 hour and 3 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse events were reported. This is one of four reports received from the same reporter. Lot numbers N034561 and N025926 have been verified to be valid lot numbers for measles, mumps, rubella and varicella (oka-merck) virus vaccine live with albumin status rHA. Sender's Comments: US-009507513-1806USA004463: US-009507513-1806USA004465: US-009507513-1806USA001112.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of an unknown age and gender. The patient's medical history, concurrent condition and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD lot# N034561, expiration date: 03-JUN-2019 or lot# N025926, expiration date: 18-MAR-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent (MERCK) for prophylaxis. Administered dose of vaccine experienced the temperature excursion between -14 degrees Celsius to -10 degrees Celsius (also reported as -10.4 degrees Celsius) for 1 hour and 3 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse events were reported. This is one of four reports received from the same reporter. Lot numbers N034561 and N025926 have been verified to be valid lot numbers for measles, mumps, rubella and varicella (oka-merck) virus vaccine live with albumin status rHA. Sender's Comments: US-009507513-1806USA004463: US-009507513-1806USA004464: US-009507513-1806USA001112.
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a nurse, concerning a 71 year old female patient. The patient did not have any medical history or concurrent conditions to report. The patient's concomitant medications included supplements. On 11-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis, lot #N034525 and expiration date 13-SEP-2019 (strength, dose, frequency and route of administration were not reported). On the same date, after the patient was vaccinated, she had fever, chills, body aches, and injection site redness and tenderness. The patient was treated with cool compresses, ibuprofen and bedtime BENADRYL. At the time of reporting, the patient was better with no fever. The causal relationship between the vaccination with PNEUMOVAX 23 and the events was not provided by the reporting nurse.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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 medication use were not provided. In 2017, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Later in 2017, the patient was treated for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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 medication use were not provided. In 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. In 2015, the patient was treated at a clinic for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
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 medication use were not provided. On or about 11-DEC-2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster with complications. On or about 05-JUL-2016, the patient was treated at a clinic for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015 the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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 medication use were not provided. On or about 24-JUL-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-JUL-2016, the patient was treated at a health center for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a consumer referring herself as a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (MRK). On an unknown date, the patient was vaccinated with an unspecified shingles vaccine (manufacturer unknown) (dose, units, route and frequency not reported) (lot# and expiration date not reported). On an unknown date, patient's pharmacist advised her to receive another dose of the shingles vaccine (manufacturer unknown) (Circumstance or information capable of leading to medication error and extra dose administered) because studies showed that one dose of shingles vaccine (manufacturer unknown) is not effective. No product quality complaint was involved. This is one of the report received from the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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 medication use were not provided. On or about 16-OCT-2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-JUL-2014, the patient was treated at a health center for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In September 2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 05-MAR-2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-NOV-2015, the patient was treated at a clinic for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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 medication use were not provided. In January 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 07-JUL-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2010, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) (by physician) at a healthcare facility/office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2014, the patient was treated by a physician at a healthcare facility/office for a blistering vesicular outbreak, which was diagnosed as a herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Age: 0.58
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, Expired product administered, No adverse event, Product storage error, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse practitioner and a registered nurse concerning a 7 month old patient. Pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 14-JUN-2018, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 injection lot # M042324, expiry date: 10-JUN-2018, 0.5 ml once, intramuscular for prophylaxis (strength and anatomical location were not provided) instead of PREVNAR 13 injection for prophylaxis (strength, dose, dosage schedule, anatomical location, lot # and expiry date were not provided). It also was reported that this PNEUMOVAX 23 was believed to also have had prior temperature excursions. No adverse effects reported.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dyspnoea, Oropharyngeal pain, Syncope
Clinical narrative: Information was received from a physician referring to a 4 year old male patient. The patient did not perform any laboratory data and had no pertinent medical history or concomitant medications; however, he was allergic to gelatin (mother stated he had a similar reaction when he ate gummy bears). On 13-JUN-2018, the patient was vaccinated with M-M-R II lot # N023150 with an expiration date of 24-AUG-2019 for chickenpox, mumps measles rubella prophylaxis (dosage, route and anatomical location were not reported) and VARIVAX lot # N034555 with an expiration date of 05-DEC-2019 for prophylaxis (dosage, route and anatomical location were not reported). The vaccine were reconstituted with sterile diluentv(STERILE DILUENT) lot # N030179 with an expiration date of 03-JUL-2020 (frequency and route were not reported). Shortly after on the same day, the patient complained of a sore throat and difficulty breathing, then shortly after, he experienced syncope for which he was treated with epinephrine and oxygen. Later, the patient was taken to an unspecified emergency room where he was observed for 4 hours and was treated with diphenhydramine hydrochloride(BENADRYL). On 15-JUN-2018, the patient presented to the office and he had recovered from the events. The relatedness between the events and the suspect therapies was not reported. Upon internal review, as the events sore throat, difficulty breathing and syncope required treatment with epinephrine and oxygen were determined to be medically significant.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an 18 year old male patient. Information on his pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date in July 2017 (at the age of 17), the patient was vaccinated with first dose of GARDASIL 9 injection (strength, dose, route of administration, lot # and expiry date were not reported) in the HPV vaccination series for prophylaxis. On 15-JUN-2018 (reported as now, at the age of 18), the patient was at the pharmacy and was late for his second dose of GARDASIL 9 in the human papilloma virus (HPV) vaccination series. No adverse effects were reported. There was no product quality complaint (PQC) reported.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 17 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions and concomitant medications were not reported. On 29-MAR-2017, the patient was vaccinated with first dose of GARDASIL 9 (dose, units and frequency not reported) (lot# and expiration date not reported), intramuscularly, on 26-SEP-2017, the patient was vaccinated with second dose of GARDASIL 9 (lot# N019923 and expiration date: 28-APR-2019), on 04-DEC-2017, the patient was vaccinated with third dose of GARDASIL 9 (lot# N019923 and expiration date: 28-APR-2019) and on 01-MAY-2018, the patient was vaccinated with fourth dose of GARDASIL 9 (lot# N004798 and expiration date: 31-OCT-2018). Reporter stated that the patient received the vaccines outside of the schedule. No adverse effects reported. No product quality complaint was involved.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a physician, concerning a 9 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 17-JUN-2018, the patient was vaccinated with the first dose of PEDVAXHIB and, on 19-JUN-2018, the patient was vaccinated with the second dose of PEDVAXHIB (route, lot number and expiration date were not provided for both doses) for prophylaxis. No adverse effects reported.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Headache, Myalgia, Paralysis, Urticaria
Clinical narrative: This spontaneous report as received from a medical assistant referring to an approximately 16 year old female patient. The patient had no concurrent conditions, pertinent medical history or known allergies. Additionally, she was not taking any concomitant therapies. On 16-MAR-2018, the patient received a dose of GARDASIL 9 intramuscular, Lot# N021732, expiration date on 01-FEB-2020 (strength, frequency were not provided) for prophylaxis. Then on 04-JUN-2018,  the patient was vaccinated with another dose of GARDASIL 9 intramuscular, lot # N028567, expiration date 17-MAY-2020 (strength and frequency were not provided) for prophylaxis. On 13-JUN-2018, the patient experienced headache. On 14-JUN-2018, the patient experienced muscle pain (myalgia) and paralysis of the fingers (paralysis). On 18-JUN-2018, the patient developed hives on her whole body (urticaria).  It was reported that, on an unknown date, the patient sought medical attention and went to see the nurse practitioner. Therefore, treatment was given to the patient due the events and ibuprofen (MOTRIN) (manufacturer unknown) was started. It was reported that unspecified "blood tests" were performed, however the results were not provided. At the reporting time, the outcome of paralysis, urticaria, myalgia and headache was reported as not recovered. The causality between the events and the GARDASIL 9 was not provided. Upon internal review, the even paralysis was considered to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding an unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient initiated the GARDASIL 9 for prophylaxis, intramuscular route (dose, strength, frequency, lot# and expiration date were not reported) series after age 26. No adverse effects were reported. No product quality complain was present.
Sex: F
Vaccine: HPV9
Symptoms: Chills, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: This spontaneous report was received from a nurse via company representative regarding an unknown age female patient. The patient's medical history included seasonal allergies. No other pertinent concurrent conditions, concomitant medications were provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 for prevention of HPV (strength, frequency, lot#, expiration date and route of administration were not reported). On an unknown date, the patient experienced fever (pyrexia), chills, nausea, vomiting and body aches (pain) for 2 days. The patient was told to take ibuprofen at home. The outcome of the events were not reported. The causal relationship between GARDASIL 9 and the event was not reported. No product quality complain was present.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Therapy non-responder
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 38-year-old female patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On 05-JUN-2018 the patient was vaccinated with first dose of M-M-R II at another unspecified site and a titer drawn was negative. The exact date of the titer was unknown but it was known that the titer was after the dose on 05-JUN-2018. No treatment was given for the event. The outcome of the event a titer drawn was negative was unknown. The causality of the event titer drawn was negative M-M-R II was not reported. No product quality complaint was reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant 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 15-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant 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 16-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant 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 18-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant 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 18-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant 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 21-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant 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 21-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 22 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date in December 2017, the patient was vaccinated with first dose of GARDASIL 9 (dose, units, route and frequency not reported) (lot# and expiration date unknown) and on an unknown date in June 2018, also reported as 6 months later (inappropriate schedule of drug administration), the patient vaccinated with second dose of GARDASIL 9) (dose, units, route and frequency not reported) (lot# and expiration date unknown). No adverse effects reported. No product quality complaint was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-OCT-2015, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 22-OCT-2013, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided), at a healthcare facility as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated (by an unspecified healthcare worker) at a health care facility, for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 07-JAN-2013, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided), at a medical center/hospital (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2014, the patient was treated at a medical center/hospital (by an unspecified health care professional) for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.