chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 04-AUG-2014, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On 01-MAR-2015, the patient was treated by a healthcare provider at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Muscular weakness, Pain in extremity, Sleep disorder, Weight bearing difficulty
Clinical narrative: Pain in (R) injection site progressively increasing in the deltoid and upper arm. It became exceedingly painful to use the arm. After three months, the pain has not relented but varies in intensity. There is a loss of strength in (R) arm.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Asthenia, Injection site pain, Pain
Clinical narrative: Pain in (R) injection site progressively increasing in the deltoid and upper arm. It became exceedingly painful to use the arm. After three months, the pain has not relented but varies in intensity. There is a loss of strength in (R) arm.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Cough, Deafness bilateral, Influenza, Pyrexia
Clinical narrative: See additional page(s) for complete text.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Unevaluable event
Clinical narrative: See additional page(s) for complete text.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Headache, Myalgia, Pyrexia
Clinical narrative: Patient woke up in the middle of the night with chills, fever, aches, nausea. Patient stated it lasted for 12 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Gait disturbance
Clinical narrative: Patient woke up in the middle of the night with chills, fever, aches, nausea. Patient stated it lasted for 12 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Patient woke up in the middle of the night with chills, fever, aches, nausea. Patient stated it lasted for 12 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Patient woke up in the middle of the night with chills, fever, aches, nausea. Patient stated it lasted for 12 hours.
Age: 16.0
Sex: U
Vaccine: HPV9, HPV9, HPV9
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 16 year old patient. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 08-NOV-2018, the patient was vaccinated with GARDASIL 9 (dosing details were not provided) as a fourth dose after 3 previous HPV vaccinations, for prophylaxis (inappropriate schedule of product administration). Reporter stated that the patient received previous vaccination doses on unspecified dates and it was unknown if the previous doses were GARDASIL or GARDASIL 9 (unidentified Merck hpv vaccine). No adverse effects were reported.
Age: 16.0
Sex: U
Vaccine: HPV9, HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 16 year old patient. Information regarding the patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 08-NOV-2018, the patient was vaccinated with GARDASIL 9 (dosing details were not provided) as a fourth dose after 3 previous HPV vaccinations, for prophylaxis (inappropriate schedule of product administration). Reporter stated that the patient received previous vaccination doses on unspecified dates and it was unknown if the previous doses were GARDASIL or GARDASIL 9 (unidentified Merck hpv vaccine). No adverse effects were reported.
Age: 16.0
Sex: U
Vaccine: HPV9, HPV9, HPV9
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from an unspecified reporter, via company representative, regarding a 16 year old patient of unknown gender. The patient received 3 unspecified HPV vaccinations (manufacturer unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. On 08-NOV-2018, the patient was vaccinated with a fourth dose of GARDASIL 9 for prophylaxis (strength, dose, frequency, route, anatomical location, lot # and expiration date were not provided). No adverse events were reported.
Age: 16.0
Sex: U
Vaccine: HPV9, HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter, via company representative, regarding a 16 year old patient of unknown gender. The patient received 3 unspecified HPV vaccinations (manufacturer unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. On 08-NOV-2018, the patient was vaccinated with a fourth dose of GARDASIL 9 for prophylaxis (strength, dose, frequency, route, anatomical location, lot # and expiration date were not provided). No adverse events were reported.
Age: 16.0
Sex: U
Vaccine: HEP, HPV9, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 16 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB, VARIVAX and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 17 year old male patient. The patient passed out at this doctor's office in the past when he had blood drawn. Information about concomitant medication and pertinent medical history was unknown by the reporter. On 22-OCT-2018, the patient was vaccinated with GARDASIL 9 (strength, dose,  lot # and expiration date were not reported) intramuscularly(IM) for prophylaxis. On the same day after the vaccination, the patient experienced a syncopal episode. The patient was kept at the doctor's office until he recovered. There was no treatment given for the event and not seek medical attention. Information about lab diagnostics/studies was unknown by the reporter. The causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 17-OCT-2018 or 22-OCT-2018 the patient was vaccinated with improperly stored VARIVAX (lot # N029628 and expiration date 23-NOV-2019, route, strength, dose and frequency were not reported) for prophylaxis. Medical assistant also reported the sterile diluent (lot # M041989 and expiration date 03-JUL-2019) used to reconstitute VARIVAX did not undergo a temperature excursion. No adverse effects were reported. The temperature excursion was 6 Fahrenheit to 14 Fahrenheit (also reported as 12 Fahrenheit) for 1 hour and 59 minutes. The previous excursion was 6 Fahrenheit to 14 Fahrenheit for 47 hours and 57 minutes and 15 Fahrenheit to 46 Fahrenheit for 39 hours and 57 minutes. The call was because of a data logger. This is one of three reports from the same reporter.; Sender's Comments: US-009507513-1810USA012248: US-009507513-1810USA010189:
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. The patient had two doses of GARDASIL (dose detail, route of administration, lot # and expiration date were not reported) administered in 2016 or earlier, and the patient was vaccinated the third dose in the series on 25-OCT-2018 (lot #: J009243, expire date: 23-APR-2016, intramuscularly; dose detail and strength were unknown) (inappropriate schedule of product administration, expired product administered). No adverse effects were reported for the patient. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided.
Sex: F
Vaccine: HPVX
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a physician via field representative, referring to a female patient of unknown age. Information about medical history, concurrent condition and concomitant therapy was unknown. On unknown dates, the patient was vaccinated with all three doses of GARDASIL or GARDASIL 9 (dose, strength, route, frequency, lot# and expiration date were unknown) for prophylaxis(product name confusion). On an unknown date, the patient was diagnosed with papilloma viral (HPV) type 16. The outcome of the event was unknown. The causality assessment was not provided by the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. The reporter reported the patient received the third dose in the GARDASIL 9 (intramuscularly for prophylaxis; strength, dose, lot number and expiration date were not provided) series more than a year after the second dose (inappropriate schedule of vaccine administration). No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a medical assistant concerning a 30 years old female patient. The patient had none concomitant medication or medical history. The patient was Reactions/Allergies to lobster and asparagus. On 21-JUL-2014, the patient received the first dose of dose of the GARDASIL (lot # J002641 with expiration date 10-DEC-2015; strength and dose were not reported) intramuscularly in the left deltoid for prophylaxis. On 23-SEP-2014, the patient received a second dose of GARDASIL (lot # K009482 with expiration date in March 2017; strength and dose were not reported) intramuscularly in the left deltoid for prophylaxis. On 19-SEP-2015, the patient received the third dose of GARDASIL (lot # J002641 with expiration date 10-DEC-2015; strength and dose were not reported) intramuscularly in the left deltoid for prophylaxis. On 12-OCT-2018, the patient was seen in the office for a wellness exam and a human papilloma virus test was conducted. On 01-NOV-2018, the results from the a Papanicolaou (PAP) test came back with positive for human papilloma virus (HPV) 16, Messenger Ribonucleic Acid (MRNA) E 6 and 7. No treatment was given for the events and the outcome of the event was not recovered. Causality assessment was not provided.
Sex: M
Vaccine: HPV9
Symptoms: Headache, Herpes zoster, Rash
Clinical narrative: Information has been received from a physician via a field representative, referring to a 16 years and 5 months old male patient. The patient had no medical history. Information about concurrent condition and concomitant therapy was unknown. On 22-OCT-2018, the patient was vaccinated with the first dose of GARDASIL 9 (1 dosage form, lot # R008165, expiration date: 11-NOV-2020; strength, route and frequency were unknown) for prophylaxis (reported as human papillomavirus (HPV) prevention). On 23-OCT-2018 (reported as the following day), the patient experienced headache that he described as a pain in the back of his head that lasted for days. Then on 31-OCT-2018, the patient developed a rash that appeared on the back of his neck, a little bit on his back, and an unspecified arm. Then on 02-NOV-2018, at an office visit with the physician, the physician stated that patient had shingles. There was no lab diagnostics or studies performed. The patient received the treatment for the events. The outcome of the events was reported as not recovered. The causality assessment was not provided by the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improper stored VARIVAX (lot# N034559, expiration date: 05-DEC-2019, strength, dose, frequency and route were unknown) for prophylaxis reconstituted with well stored sterile diluent (Product storage error). The vaccines had temperature excursion of 15 degree F to 46 degree F (18.9F) for 7 hours 18 minutes. Previous temperature excursion was 15 degree F to 46 degree F (14.5 F) for 48 minutes. The call was due to the digital data logger. No adverse event was reported. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a pharmacist, referring to an adult patient of unknown age and gender. Information about medical history, concurrent condition and concomitant therapy was unknown. On an unknown date, the patient was vaccinated with two pediatric doses of VAQTA injection 25/0.5(unit unknown) (dose, route, frequency, lot# and expiration date were unknown) for prophylaxis which was equal one adult dose(adult use of a child product). No adverse effects had been reported.
Sex: F
Vaccine: HPV9
Symptoms: Ovarian cyst, Ovarian cystectomy
Clinical narrative: This spontaneous report was received from physician, via field representative, referring a 21 year old female patient. The patient's medical history, concomitant medication, allergies and drug reactions were not reported. In April 2017, the patient was vaccinated GARDASIL 9 injection, a single dose of 0.5 ml, intramuscular for prevention of HPV (anatomical injection site, lot # and expiration date were not provided). In May 2017, the patient developed a cyst on her right ovary. The patient sought medical attention from a physician, and subsequently she was hospitalized, on an unspecified date in 2017, for the surgical removal of the ovarian cyst in July 2017. It was unknown if laboratory test were performed to the patient. At the time of this report, the patient recovered from the adverse event. The causality assessment between the GARDASIL 9 and the adverse event was not provided. Upon internal review, the event ovarian cyst was determined to be medically significant as an ovarian cystectomy was performed.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Injection site erythema, Pyrexia, Viral infection, Vomiting
Clinical narrative: This spontaneous report as received from a medical assistant regarding a 4-year old male patient.  The patient's concurrent conditions, past drugs, historical drugs and concomitant medications were not reported. On an unknown date in November 2018 (reported as last week) the patient was vaccinated with second dose of VARIVAX (dose, lot# and expiration date were unknown) via subcutaneous route and second dose of M-M-R II (dose, lot# and expiration date were unknown). It was reported that both the vaccines were administered on same day on different arms. On unknown date in November 2018, next morning (following morning), the patient came to the office due to vomiting, fever and diarrhea, and was diagnosed with a viral infection (patients father was sick with same symptoms) and patient left office. Within one hour after the patient left, the patient's mother called the office and stated that the injection site of both the VARIVAX and M-M-R II were red about 2 inches in diameter (vaccination site erythema). It was reported that no treatment was provided for the events. The outcome of viral infection was unknown and that of vaccination site erythema was reported as recovered/resolved. Causality of events was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Therapy non-responder
Clinical narrative: This retrospective study aimed to assess the prevalence of non-immunity to varicella zoster virus (VZV) and measles in previously immunized pediatric liver transplant (LT) recipients and identify correlative factors. Children who received LT were evaluated for pre-LT immunization and post-LT VZV and measles titers during clinic visits from January 2016 to November 2017. Those who did not receive VZV or measles vaccine prior to LT were excluded from the respective cohort. 72 patients were included in the analysis of measles immunity, and 67 in the analysis of VZV immunity. Median time from LT to titers for measles and VZV were 4.0  and 3.2 (0.8-14.0) years, respectively. In the measles cohort, the median age at LT was 3.2 (0.7-16.2) years. Age at LT, age at last pre-LT vaccine dose, number of pre-LT vaccine doses, height and use of whole-liver grafts were each significantly lower for non-immune versus immune patients, and the proportion of patients of ethnicity was greater in the non-immune group. It was concluded that non-immunity to measles and VZV among pediatric LT recipients was common within 3 years after liver transplantation, despite immunization prior to transplant. This literature marketed report as received from the authors of the published literature article, refers to 42 children of unknown ages and genders. The patients' concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients vaccinated with varicella virus vaccine live (manufacture unknown) (dose, route, lot# and expiration were not reported) for prophylaxis. On unknown dates, at the post-transplant follow up point, the patients were VZV non-immune (therapy non-responder). The outcome of the event was not reported. The reporter considered the event to be related to varicella virus vaccine live (manufacture unknown). This is one of several reports received from the same literature.; Sender's Comments: US-009507513-1811USA006964:
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 33 year old female patient. The patient's pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On an unknown date the patient was vaccinated with M-M-R II (lot, expiry date, dose, frequency and route of administration were not reported) for immunization (also reported as it was unsure if she received in the past or not). The patient had an "unspecified Serologic screening for measles, rubella, or mumps immunity, for pre- pregnancy planning. " The "unspecified serologic test was negative(measles antibody negative, rubella antibody negative and mumps antibody test negative). " On 16-OCT-2018, The patient received a dose of M-M-R II. Outcome and causality assessment were not provided by the reporter. No product quality complaint was filed.
Age: 16.0
Sex: U
Vaccine: HEP, HPV9, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 17 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB, VARIVAX and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 13.0
Sex: U
Vaccine: HEP, HPV9, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 13 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB, VARIVAX and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 17.0
Sex: U
Vaccine: HEP, HPV9, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 17 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB, VARIVAX and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 15.0
Sex: U
Vaccine: HEP, HPV9, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 15 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB, VARIVAX and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a medical assistant, referring to a 68 year old female patient, whose drug reactions/allergies included penicillin allergy. The patient's concomitant therapy included receiving influenza virus vaccine inactivated (unspecified)(reported as "flu shot") in left arm on an unknown date. The patient had no pertinent medical history. On 12-NOV-2018 the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency and route were unknown. lot # R016638, expiration date: 28-JAN-2020) in the right arm for prophylaxis. "A few hours" following administration the patient began experiencing swelling, warmth, and pain at the injection site. As the day progressed the patient began having difficulty moving her right arm. The patient treated herself with heat, ice and ibuprofen. On 13-NOV-2018, the patient was seen in the office by the nurse practitioner. The patient presented with swelling, warmth and pain at the injection site, total loss of range of motion of the right arm (upper limb motor deficit) and a fever of "101"(unit not provided). The nurse practitioner told the patient to continue treating with heat, ice and ibuprofen. No lab diagnostics or studies were performed for the events. The outcome of the events was not recovered. The causality assessment was not provided by the reporter. Upon internal review, upper limb motor deficit was determined to be significant disability or incapacity.
Age: 14.0
Sex: U
Vaccine: HEP, HPV9, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 14 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB, VARIVAX and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a nurse concerning a 4 year old female patient. Information on the patient's concomitant medications, pertinent medical history and drug reactions or allergies was unknown. On 13-NOV-2018, the patient received an additional dose of PROQUAD lot # R015746, expiry date: 02-DEC-2019 for prophylaxis instead of VARIVAX with sterile diluent (extra dose administered and wrong product administered). No adverse event was reported. No product quality complaint was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 14-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 31-JUL-2014, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 09-JAN-2016, the patient was treated by a physician at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2013, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's physician recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 28-APR-2009, the physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 06-MAR-2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received on 14-NOV-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 14-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received on 14-NOV-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 14-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received on 14-NOV-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 14-NOV-2018 regarding a case in litigation from a lawyer concerning a patient of unknown age and gender. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2010, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2015, the patient was treated by the patient's healthcare providers at a medical group for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 14-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 2016, the patient was treated by the patient's healthcare providers at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2011, the healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2016, the patient was treated by the healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 14-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 03-APR-2009, the patient's healthcare provider administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 29-APR-2013, the patient was treated by the patient's healthcare providers at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.