chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (thimerosal status, dose number, exact dose, route of administration, lot # and expiration date were not reported), for prophylaxis. No known adverse effects were reported. The administered doses of RECOMBIVAX HB experienced multiple temperature excursions over unspecified time periods. The reporter did not know if digital data logger was involved to capture the temperature excursions. Previous temperature excursions were also reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000808.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally (dose number, exact dose, lot # and expiration date were not reported), for prophylaxis. No known adverse effects were reported. The administered doses ROTATEQ experienced multiple temperature excursions over unspecified time periods. The reporter did not know if digital data logger was involved to capture the temperature excursions. Previous temperature excursions were also reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000808.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose number, exact dose, route of administration, lot # and expiration date were not reported), for prophylaxis. No known adverse effects were reported. The administered doses of VAQTA experienced multiple temperature excursions over unspecified time periods. The reporter did not know if digital data logger was involved to capture the temperature excursions. Previous temperature excursions were also reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000808.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On 30-AUG-2017, the patients were vaccinated with improperly stored VARIVAX (lot # and expiration date were not reported), that was mixed with a properly stored sterile diluent. Administered doses of vaccines underwent a temperature excursion of 3.6 degrees Celsius, which lasted for 23 hours. There was no previous temperature excursion. A digital data logger was involved in recording the excursion. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA000849.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 31-AUG-2017 the patient was vaccinated with GARDASIL 9 lot # M042853 for prophylaxis.       On 31-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage.  On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9.
Age: 54.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Dizziness
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales male patient received PREVNAR 13 intramuscular, on an unspecified date in Aug2017, at 0.5 ml single, for immunization. Medical history and concomitant medications were not reported. Since an unspecified date in Aug2017 the patient experienced lightheadedness, weakness and dizziness lasting 2 to 3 minutes after the injection. The physician resolved it by having the patient laid down and giving fluids and a glucose tablet. The patient completely recovered from the events on an unspecified date in Aug2017. Sender's Comments: Linked Report(s): US-PFIZER INC-2017380860 same reporter/product/events, different patient.
Age: 62.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Dizziness
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative reporting similar events for two patients. This is the 2nd of 2 reports. A 62 years old male patient received PREVNAR 13 intramuscular, on an unspecified date in Aug2017, at 0.5 ml single, for immunization. Medical history and concomitant medications were not reported. Since an unspecified date in Aug2017 the patient experienced lightheadedness, weakness and dizziness lasting 2 to 3 minutes after the injection. The physician resolved it by having the patient laid down and giving fluids and a glucose tablet. The patient completely recovered from the events on an unspecified date in Aug2017. Sender's Comments: Linked Report(s): US-PFIZER INC-2017380818 same reporter/product/events, different patient.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: SEVERE left shoulder pain. Unable to move arm completely.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 month old patient. On 03-AUG-2017 the patient was vaccinated with PROQUAD lot # M033209 for prophylaxis. Other suspect therapies included sterile diluent and VARIVAX. On 03-AUG-2017, 1 day after onset of therapy the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. The outcome of inappropriate schedule of drug administration and no adverse event is unknown. The reporter considered inappropriate schedule of drug administration to be not related to PROQUAD, VARIVAX and sterile diluent. The reporter considered no adverse event to be not related to sterile diluent, PROQUAD and VARIVAX.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from an office manager referring to a 12 month old patient of unknown gender. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # N011867, expiration date (autogenerated with 08-NOV-2018), route and dose not reported) for prophylaxis, when PROQUAD (lot #, expiration date and route not reported) was intended to be given. Product confusion was not the issue. No adverse effect was reported.
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 12 month old patient of unknown gender. The patient's concomitant medication, medical history and drug allergy were not reported. On an unknown date, the patient received a dose of PNEUMOVAX 23 (route not reported, lot# and expiration date unknown) for prophylaxis (inappropriate age at vaccine administration). No adverse effects were reported.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergy were not reported. On 11-AUG-2017, the patient was given an expired dose of PNEUMOVAX23 (lot # L031459, expiration date 30-APR-2017, route not reported) for prophylaxis. No adverse effect was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a male nurse practitioner of unknown age via a field representative, referring to himself. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX vial (lot#, expiration date, concentration, route and frequency were unknown) in an unspecified arm for prophylaxis. On an unknown date, the patient developed "upper arm pain that went from his shoulder to his elbow for 3 weeks". The outcome of event was unknown. The causality between event and ZOSTAVAX was not provided. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA001201:
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse referring to a male patient of unknown age. Medical history and concomitant medication were not reported. On 10-AUG-2017, the patient was vaccinated with GARDASIL 9 (unspecified dose, lot# and expiration date unknown) intramuscularly to prevent from HPV. A county health center administered the vaccines. While waiting after the GARDASIL 9 was administered, the patient fainted and was "out for less than a minute". No treatment was given for the event and the patient did not seek medical attention. It was reported that the patient was fine now. The causality between the events and the therapy was not reported.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a physician and referred to a female patient of age between 24 and 26 years old. On an unknown date, the patient was vaccinated with one unspecified dose of VARIVAX (dose, route of administration, lot# and expiration date were not reported) as "academic program requirement". The VARIVAX was reconstituted with sterile diluent (MERCK). On 07-AUG-2017, the "varicella titer" was performed to the patient, the result showed "negative titer". The patient sought physician office visit. The outcome of varicella "negative titer" was reported as not recovered. The causality assessment was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA012381.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients was vaccinated with improperly stored PNEUMOVAX 23 lot # N010105 with expiry: 15-NOV-2018 and lot# N010106 with expiry: 15-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 47 F to 77 F for a duration of 45 minutes. During previous temperature excursion vaccines were exposed to a temperature range of 47 F to 77 F for a duration of 2 hours and 30 minutes. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the two reports from the same reporter. Sender's Comments: US-009507513-1709USA001357.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse concerning an unknown number of unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On or after 28-MAY-2017, the patients were administered improperly stored doses of GARDASIL 9 (lot# N002720, expiration date 12-MAY-2019; lot# N004798, expiration date: 31-OCT-2019; lot# M032650, expiration date: 31-MAR-2019) (dose and route were not reported) for prophylaxis. The vaccine (lot# N002720, expiration date 12-MAY-2019; lot# N004798, expiration date: 31-OCT-2019; lot# M032650, expiration date: 31-MAR-2019) were exposed to temperature excursion of 32 Fahrenheit (F) to 35 F cumulative for 165 minutes (85 minutes on 28-MAY-2017, 130minutes on 29-MAY-2017, 20 minutes on 30-MAY-2017, 20 minutes on 31-MAY-2017, and 10 minutes on 01-JUN-2017); exposed to temperature excursion of 47 F to 77 F cumulative for 205 minutes (65 minutes on 15-JUN-2017 and 140 minutes on 12-JUL-2017). The data logger was involved. There was no previous temperature excursion. No adverse effect were reported. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000641: US-009507513-1709USA000645:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient with hypertension, depression, drug hypersensitivity and prophylaxis. On 17-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # N009777, subcutaneous for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown). Concomitant therapies included sertraline hydrochloride and hydrochlorothiazide. On 17-AUG-2017, the patient experienced headache. The outcome of headache was reported as not recovered/not resolved.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age with prophylaxis. On 23-AUG-2017 the patient was vaccinated with M-M-R II lot # L029266 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On 23-AUG-2017, the patient experienced expired product administered. No adverse effects reported. The outcome of expired product administered and no adverse event is unknown.  The reporter considered expired product administered and no adverse event to be not related to M-M-R II.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age. On an unknown date, the patient were vaccinated with M-M-R II lot # M042846 with an expiration date 21-OCT-2018 and lot# M044351 with an expiration date 04-NOV-2018 for prophylaxis. On an unknown date, the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to M-M-R II. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA001301:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a health professional refers to mutiple patients of unknown ages. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004798 for prophylaxis. No adverse events were reported.; Sender's Comments: US-009507513-1709USA000508: US-009507513-1709USA000507:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a health professional refers to mutiple patients of unknown ages. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # N003194 or lot #  N005274 for prophylaxis. No adverse events were reoprted.; Sender's Comments:  US-009507513-1709USA000508: US-009507513-1709USA000505:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a health professional refers to mutiple patients of unknown ages. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # N003702 or lot # N011851 for prophylaxis. No adverse events were reported.; Sender's Comments: US-009507513-1709USA000505: US-009507513-1709USA000507:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, 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 was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about 05-NOV-2013 (dosage, lot number, and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-OCT-2014, the patient was treated by a physician assistant for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as chronic herpes zoster, or shingles, and post-herpetic neuralgia. On or about 15-OCT-2014, the patient was further treated for ongoing and worsening symptoms of shingles and post-herpetic neuralgia, a condition of chronic nerve pain and damage secondary to herpes zoster infections. The patient was prescribed valacyclovir hydrochloride (VALTREX), gabapentin, lidocaine, lidocaine (LIDODERM), tramadol, and hydrocodone/acetaminophen for management of her painful symptoms and chronic pain. 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. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-FEB-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-AUG-2016, the patient was treated at a clinic for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. 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. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse concerning an unknown number of unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On or after 28-MAY-2017, the patients were administered improperly stored doses of PNEUMOVAX 23 (lot# reported as N004798, expiration date 31-OCT-2019; lot# N003993, expiration date: 20-AUG-2018; lot# N004564, expiration date: 22-OCT-2018) (dose, and route were not reported) for prophylaxis. The vaccine (lot# reported as N004798, expiration date 31-OCT-2019; lot# N003993, expiration date: 20-AUG-2018) were exposed to temperature excursion of 32 Fahrenheit (F) to 35 F cumulative for 165 minutes (85 minutes on 28-MAY-2017, 130 minutes on 29-MAY-2017, 20 minutes on 30-MAY-2017, 20 minutes on 31-MAY-2017, and 10 minutes on 01-JUN-2017); exposed to temperature excursion of 47 F to 77 F cumulative for 205 minutes (65 minutes on 15-JUN-2017 and 140 minutes on 12-JUL-2017). The vaccine (lot# N004564, expiration date: 22-OCT-2018) was exposed to temperature excursion of 1 Degrees Celsius or colder for undetermined time. The data logger was involved. There was no previous temperature excursion. No adverse effect reported. This is one of three reports received from the same reporter. Reporter reported PNEUMOVAX 23 with Lot # N004798 which was not valid for PNEUMOVAX 23; Sender's Comments:  US-009507513-1708USA010275: US-009507513-1709USA000645:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse concerning an unknown number of unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On or after 28-MAY-2017, the patients were administered improperly stored doses of ROTATEQ (lot# M002254, expiration date 15-NOV-2017; lot# M045545, expiration date: 15-NOV-2017) (dose was not reported) orally for prophylaxis. The vaccine (lot# M002254, expiration date 15-NOV-2017; lot# M045545, expiration date: 15-NOV-2017) were exposed to temperature excursion of 32  Fahrenheit (F) to 35 F cumulative for 165 minutes (85 minutes on 28-MAY-2017, 130minutes on 29-MAY-2017, 20 minutes on 30-MAY-2017, 20 minutes on 31-MAY-2017, and 10 minutes on 01-JUN-2017); exposed to temperature excursion of 47 F to 77 F cumulative for 205 minutes (65 minutes on 15-JUN-2017 and 140 minutes on 12-JUL-2017). The data logger was involved. There was no previous temperature excursion. No adverse effect reported. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010275: US-009507513-1709USA000641:
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: This spontaneous report was received from an office manager concerning an 18 year old female patient with no relevant drug reactions/allergies and with no pertinent medical history. There were no concomitant medications. On 12-JUN-2017 the patient was vaccinated with a dose of GARDASIL 9 lot # N001533, expiration date  for prophylaxis. Other suspect therapies included a tuberculin(TUBERCULIN) test reported as "TB test" and a dose of HAVRIX for prophylaxis (dose, route of administration, lot number and expiration date were not reported), on the same date. And then immediately the patient had an episode of syncope. No laboratory test was performed. The outcome of syncope was reported as recovered, on an unknown date in 2017.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular, Vaccination site erythema, Vaccination site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced vaccination site erythema, rash vesicular and vaccination site swelling. The outcome of vaccination site erythema, rash vesicular and vaccination site swelling was unknown. The causal relationship between the adverse events and the suspect therapies was not assessed.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, Interchange of vaccine products
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On 25-AUG-2016 the patient was vaccinated with adult formulation RECOMBIVAX HB lot # L035881 dose 1, intramuscular for prophylaxis. On 04-NOV-2016 the patient was vaccinated with pediatric formulation RECOMBIVAX HB lot # L023387 dose 2, intramuscular for prophylaxis. On 25-FEB-2017 the patient was vaccinated with ENGERIX-B (incorrect dose administered, interchange of vaccine products, inappropriate schedule of drug administration). No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a nurse practitioner via a field representative, referring to 2 unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with ZOSTAVAX vial (lot#, expiration date, concentration, dose, route and frequency were unknown) for prophylaxis. On unknown dates, the patients developed "upper arm pain that went from their shoulder to his elbow and lasted for 4 weeks". The outcome of event was unknown. The causality between event and ZOSTAVAX was not provided. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA006513:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with ROTATEQ, oral for prophylaxis. On an unknown date, the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA012320:
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Full blood count, Metabolic function test, Nausea, Pyrexia
Clinical narrative: Fever 100.4 deg F, nausea, vomiting, fatigue, drowsiness
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence, Urine analysis, Vomiting
Clinical narrative: Fever 100.4 deg F, nausea, vomiting, fatigue, drowsiness
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Paraesthesia, Rash pruritic
Clinical narrative: Prickly, itchy rash on legs, spreading to feet and toes Yellowing hard tips on rash.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site pain, Nausea
Clinical narrative: Pain in left deltoid, nausea, headache.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pruritus, Injection site reaction, Rash papular
Clinical narrative: Patient developed a rash of small red papular lesions on his left upper thigh (at location of PROQUAD injection) with itching; started on 8/26/17. Was evaluated by Dr. on 8/28/17 and started Rx for Triamcinolone topical. Also using VASELINE and AQUAPHOR to the affected area and to continue routine allergy regimen, including ZYRTEC and SINGULAIR.
Age: 1.83
Sex: F
Vaccine: MMR
Symptoms: Memory impairment, Mental impairment, Speech disorder
Clinical narrative: This spontaneous report was received from a healthcare professional who was also a patient's mother and referred to a female patient of an unknown age. The patient had no relevant medical history or drug history. On an unknown date, the patient was vaccinated with the first dose of M-M-R II (dose, frequency, route of administration, lot# and expiration date were not reported). The patient's mother reported that the patient received many unknown vaccines on an unknown date, at the age of 18 months. These vaccines were the normal vaccines that a child of 18 months would receive, but the reported did not have specific names. On an unknown date, after receiving these vaccines the patient experienced a slight mental decline which was displayed in the patient's speech. This slight mental decline did resolve on an unknown date. On 02-SEP-2016 (reported also as 02-SEP-2017) at the age of 2, the patient was vaccinated with the second dose of M-M-R II (dose, frequency, route of administration, lot# and expiration date were not reported). The patient's concomitant medications administered on the same day included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and varicella virus vaccine live (oka/merck) (manufacturer unknown). The patient's mother stated that these were all given to "catch her up" so she could get in the "STEP" program. On an unknown date in September 2016, reported as on 3rd or 4th week of September 2016, after receiving these vaccines, the patient experienced a pronounced mental decline that included speech and memory. One of the memory disorder symptoms was that the patient began forgetting colors. On an unknown date, mental deterioration was noticed by the patient's teachers, which led to the patient being admitted to special education (unknown date). The patient continued to attend the special education. The patient's laboratory data was unknown. The outcome of pronounced mental decline that included speech and memory was unknown. The causailty assessment was not reported. Upon internal review, both episodes of mental deterioration were condidered to be medically significant.  Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMR
Symptoms: Dysarthria, Dyskinesia, Viral infection
Clinical narrative: This spontaneous report as received from a office manager refers to a 2 year old patient. On an unknown date, the patient was vaccinated with M-M-R II lot # N009171, expiration date 20-MAR-2017 (dose, route and anatomical location were not reported) for prophylaxis. Other suspect therapies included sterile diluent (MRK) (dose, route, anatomical location, lot# and expiration date were not reported). On an unknown date, the patient developed "slurred speech and lost full control of her mouth". The patient was taken to the emergency room and the parents were told that it was "more like a viral infection". The outcome of the events resolved 3 days later. The relatedness between the events and the vaccination with M-M-R II was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 01-SEP-2017 from a lawyer regarding case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 06-SEP-2011 at a pharmacy, as recommended for route 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. On or about 29-DEC-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by a weakened immune system, which was diagnosed as severe herpes zoster or shingles. The patient has been prescribed famciclovir (FAMVIR) for management of her painful symptoms. 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, 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 was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about 12-SEP-2012 (dosage, lot number, and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-JUN-2014, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent and conditions and concomitant medications were not provided. On or about 01-SEP-2015, the patient was inoculated with ZOSTAVAX 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. On or about 01-OCT-2015, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. 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 outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Chalazion, Conjunctivitis, Eye disorder, Eye pain, Injection site erythema
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 30-SEP-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to have extensive eye disorders and complications. The day after being administered ZOSTAVAX vaccine, the patient experienced pain and injection site redness and swelling, as well as pain in both of her eyes. On or about 01-OCT-2015, the patient began to experience further eye issues and sought treatment from physicians and was diagnosed with acute conjunctivitis in both eyes, multiple and a corneal ulcer attributable to the ZOSTAVAX vaccine. Between the dates of 12-FEB-2016 and 27-OCT-2016, the patient underwent twelve additional medical encounters and was treated for multiple chalazions in both eyes, peripheral ulcers, severe eye pain and further complications with her vision resulting from her ZOSTAVAX vaccine. The patient has been prescribed ofloxacin ophthalmic solution, gentamicin sulfate ophthalmic, PENLAC, MAXITROL drops and ointment, and 'besbiance' for management of her painful ocular symptoms. 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. Upon internal review, corneal ulcer was determined a significant medical event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Ulcerative keratitis, Visual impairment
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 30-SEP-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to have extensive eye disorders and complications. The day after being administered ZOSTAVAX vaccine, the patient experienced pain and injection site redness and swelling, as well as pain in both of her eyes. On or about 01-OCT-2015, the patient began to experience further eye issues and sought treatment from physicians and was diagnosed with acute conjunctivitis in both eyes, multiple and a corneal ulcer attributable to the ZOSTAVAX vaccine. Between the dates of 12-FEB-2016 and 27-OCT-2016, the patient underwent twelve additional medical encounters and was treated for multiple chalazions in both eyes, peripheral ulcers, severe eye pain and further complications with her vision resulting from her ZOSTAVAX vaccine. The patient has been prescribed ofloxacin ophthalmic solution, gentamicin sulfate ophthalmic, PENLAC, MAXITROL drops and ointment, and 'besbiance' for management of her painful ocular symptoms. 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. Upon internal review, corneal ulcer was determined a significant medical event. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 31-AUG-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 20-NOV-2015 at a pharmacy 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. On or about 07-DEC-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed valacycloriv, triamcinolone acetonide for management of his painful condition. 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, pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Iritis, Ocular hypertension, Ophthalmic herpes zoster
Clinical narrative: Information was received on 31-AUG-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 07-JAN-2015 at a County Health Services Department 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. On or about 10-AUG-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 17-AUG-2015 the patient received subsequent treatment by a physician for continuing and worsening symptoms of herpes zoster that had spread to the eye, and was diagnosed as herpes zoster ophthalmicus. On or about 19-AUG-2015 the patient was treated again by a physician for continued shingles in the eyes, with the added optical complications of iritis and ocular hypertension secondary to zoster. The patient was prescribed famciclovir, atropine sulfate solution and prednisolone acetate ophthalmic for management of his symptoms and pain. 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, pain and suffering and other damages. Upon internal review, the events of herpes zoster ophthalmicus and ocular hypertension secondary to zoster were determined to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information was received on 31-AUG-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 07-JAN-2015 at a County Health Services Department 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. On or about 10-AUG-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 17-AUG-2015 the patient received subsequent treatment by a physician for continuing and worsening symptoms of herpes zoster that had spread to the eye, and was diagnosed as herpes zoster ophthalmicus. On or about 19-AUG-2015 the patient was treated again by a physician for continued shingles in the eyes, with the added optical complications of iritis and ocular hypertension secondary to zoster. The patient was prescribed famciclovir, atropine sulfate solution and prednisolone acetate ophthalmic for management of his symptoms and pain. 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, pain and suffering and other damages. Upon internal review, the events of herpes zoster ophthalmicus and ocular hypertension secondary to zoster were determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to two unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported.  On 03-AUG-2017 the patients were vaccinated with improperly stored VARIVAX (Incorrect product storage) from lot # M039317 expiry date 20-SEP-2018. Concomitant therapies included sterile diluent(MERCK STERILE DILUENT) (unknown lot number and expiration date) used for reconstitution was properly stored. No adverse effects reported. The vaccine was exposed to temperature -14"C to-10"C (-9.9"C) for a time frame of 15 minutes. No previous temperature excursion was reported. The call because of a "data logger". No further information provided. No PQC involved.
Age: 0.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to three patients of unknown demographics. On an unknown date in August 2017, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # N007930 with expiration date on 08-MAR-2018, reconstituted with properly stored sterile diluent (manufacturer unknown). Additional information has been requested. Sender's Comments: US-009507513-1709USA001401.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Skin warm, Swelling, Swelling face, Urticaria
Clinical narrative: 8/30 - hives develop on legs, back and arms; 8/31 - hives spread to face and neck; 9/1 - hives continue..worsen low fever 100.5; 9/2 - hives all over body. Hot to touch, raised; 9/3- severe hives with facial swelling baby taken to emergency room. Steroid given at ER and EpiPen prescribed. 9/4- hives continue swelling reduces; 9/5-  still battling hives even after a constant doses of Benadryl and steroid admitted at emergency room.
Age: 40.0
Sex: F
Vaccine: TTOX
Symptoms: Burning sensation, Injection site pain, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: Pain/soreness/stiffness to L deltoid upon waking the morning following injection. Pain/soreness/stiffness continues to this day with no improvement. Had a similar event to flu vaccine approximately 7 years ago to R deltoid, and continue to have a "lactic acid burn" in that arm to this day.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Pruritus, Rash, Swelling face
Clinical narrative: Itching, rash, swelling of face and hands.
Age: 48.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Allergy test positive, Anaphylactic reaction, Pharyngeal oedema, Vaccine positive rechallenge
Clinical narrative: Anaphalaxis (throat swelling), took 2 BENADRYL, took care of reaction.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Injection site papule, Injection site pruritus, Injection site rash, Oropharyngeal pain
Clinical narrative: HPI Generic: 8-year-old girl here with mother and brother for evaluation of rash. She is here accompanying her brother while he is here for his physical. She was seen last week for well-child check. She received a varicella vaccine. 2 days later she developed itching and rash to the injection site. Then she also developed scattered pruritic lesions throughout the trunk. She had moderate sore throat with subjective low-grade fever and chills. No cough, wheeze, chest pain or difficulty breathing. No abdominal pain or vomiting. Sore throat and fever have resolved. The rash is starting to improve.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Papule, Pruritus, Pyrexia, Skin lesion
Clinical narrative: HPI Generic: 8-year-old girl here with mother and brother for evaluation of rash. She is here accompanying her brother while he is here for his physical. She was seen last week for well-child check. She received a varicella vaccine. 2 days later she developed itching and rash to the injection site. Then she also developed scattered pruritic lesions throughout the trunk. She had moderate sore throat with subjective low-grade fever and chills. No cough, wheeze, chest pain or difficulty breathing. No abdominal pain or vomiting. Sore throat and fever have resolved. The rash is starting to improve.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Musculoskeletal stiffness, Nausea, Photophobia, Pyrexia
Clinical narrative: Lot # is accurate. I am not certain re: manufacturer though it was "Meningococcal MVC4" circled on his form. The Health Dept said mnfr started w/ 'geni...' but I did not see that listing. Symptoms were very similar to meningitis. SEVERE headache worsening w/ any position change, photophobia, nausea, stiff neck but no increased pain flexing lower spine. Low grade fever (<100). Lasted 3 days despite symptomatic treatment w/ rest and alternating Ibuprofen / Acetominophen round the clock. (this is a 'never sick kid' and I am an acute care NP and this was worrisome enough to me I called Head of Peds Dept at my facility on Sat to discuss case as my ped office was closed. We discussed again 24h later to insure improvement. I am marking 'office visit below since the exams I did & conversations had were consistent w/ an office visit.)