chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Bacterial test negative, Fungal test, Granulomatous dermatitis, Immunohistochemistry, Rubivirus test positive
Clinical narrative: Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; Infectious vaccine-derived rubella viruses emerge, persist, and evolve in cutaneous granulomas of children with primary immunodeficiencies; This literature marketed report has been received from authors of a published article, referring to an unknown age patient with ataxia telangiectasia (primary immunodeficiency diseases (PID)). Information about concomitant medication and medical history was not provided.  On an unknown date, at about one year old, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient developed cutaneous granulomatous lesions in different body sites, e.g. face, chest, arms or legs, at various times after vaccination. No pathogenic organisms were identified by the histochemical staining or bacterial, fungal and mycobacterial cultures. Rubella viruses (RV) antigen was detected in the available tissue sections of cutaneous granulomas by fluorescent immunohistochemical staining for measles and rubella antigens. Live vaccines, including rubella vaccine, were contraindicated for individuals with severe antibody deficiency, T-cell deficiencies or innate immune defects because they may cause severe or chronic disease.   The outcome of the events was unknown. The reporter considered the events to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown).    A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-1911USA008596:
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: The patient received a dose of M-M-R II and a dose of VARIVAX; This spontaneous prospective pregnancy report was received from a nurse a nurse practitioner concerning a 33-year-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies.  On 04-NOV-2019, (reported as 4 weeks ago), the patient became pregnant. The estimated date of the last menstrual period was on 21-OCT-2019 and the estimated date of delivery would be on 27-JUL-2020. On 07-NOV-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneously, lot # R030614, expiration date 09-DEC-2020 for routine vaccination (dosage schedule was not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA)subcutaneously, lot # R030614, expiration date 02-AUG-2021 for routine vaccination (dosage schedule was not reported) (exposure during pregnancy). On the same date, her urine pregnancy test was negative for pregnancy.    On 16- NOV-2019, her urine pregnancy test was positive for pregnancy. In addition, it was reported that, the patient went to see the nurse practitioner and received prenatal vitamins for her pregnancy. The outcome of the pregnancy was outcome pending and the fetal outcome was unknown.
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Influenza like illness, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: the patient had a temperature of 101 / she no longer has a fever; flu-like symptoms; stiff neck; whole body itching and pain; whole body itching and pain/whole body aches; inflammation and redness of the whole deltoid starting right away after the patient received the vaccination and lasting for two weeks; inflammation and redness of the whole deltoid starting right away after the patient received the vaccination and lasting for two weeks; the area where she received the vaccination is very itchy/itching continued at the site of injection; This spontaneous report has been received from a pharmacist referring to a 57 year old female patient. No information was provided regarding the patient´s medical history, concurrent conditions, drug and allergy history or concomitant medications.   On 11-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscularly (strength, dose and frequency were not provided) lot # R018731, expiration date 27-FEB-2020 for prophylaxis.    The reporter stated that, on 11-NOV-2019, right away after the patient received the vaccination, she experienced whole body itching (pruritus) and pain, inflammation (vaccination site inflammation) and redness (vaccination site erythema) of the whole deltoid. On 12-NOV-2019, the patient had a temperature of 101 (units not provided)(pirexia), flu-like symptoms (influenza like illness), stiff neck (musculoskeletal stiffness) and whole body aches (pain). On an unspecified date in November 2019, the whole body itching went away but continued at the site of the injection (vaccination site pruritus). On 30-NOV-2019, the patient reported to the pharmacist that she went to the doctor because the area where she received the vaccination was very itchy. The doctor prescribed topical diphenhydramine (BENADRYL) which helped a little bit. As of 30-NOV-2019, the patient's deltoid was no longer inflamed, red and sore. She no longer had a fever, flu-like symptoms, stiff neck and whole body aches. The whole body itching had resolved but continued at the site of the injection. At the reporting time, the causal relationship between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported. The reporter considered the events to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Musculoskeletal stiffness, Pain, Pruritus, Pyrexia
Clinical narrative: the patient had a temperature of 101 / she no longer has a fever; flu-like symptoms; stiff neck; whole body itching and pain; whole body itching and pain/whole body aches; inflammation and redness of the whole deltoid starting right away after the patient received the vaccination and lasting for two weeks; inflammation and redness of the whole deltoid starting right away after the patient received the vaccination and lasting for two weeks; the area where she received the vaccination is very itchy/itching continued at the site of injection; This spontaneous report has been received from a pharmacist referring to a 57 year old female patient. No information was provided regarding the patient´s medical history, concurrent conditions, drug and allergy history or concomitant medications.   On 11-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscularly (strength, dose and frequency were not provided) lot # R018731, expiration date 27-FEB-2020 for prophylaxis.    The reporter stated that, on 11-NOV-2019, right away after the patient received the vaccination, she experienced whole body itching (pruritus) and pain, inflammation (vaccination site inflammation) and redness (vaccination site erythema) of the whole deltoid. On 12-NOV-2019, the patient had a temperature of 101 (units not provided)(pirexia), flu-like symptoms (influenza like illness), stiff neck (musculoskeletal stiffness) and whole body aches (pain). On an unspecified date in November 2019, the whole body itching went away but continued at the site of the injection (vaccination site pruritus). On 30-NOV-2019, the patient reported to the pharmacist that she went to the doctor because the area where she received the vaccination was very itchy. The doctor prescribed topical diphenhydramine (BENADRYL) which helped a little bit. As of 30-NOV-2019, the patient's deltoid was no longer inflamed, red and sore. She no longer had a fever, flu-like symptoms, stiff neck and whole body aches. The whole body itching had resolved but continued at the site of the injection. At the reporting time, the causal relationship between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported. The reporter considered the events to be medically significant.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse event terms were provided.; Expired vaccine used; This spontaneous report was received from a registered nurse, concerning a 22 year old female patient. Information on concurrent conditions, medical history and concomitant medications was not reported.   On 29-NOV-2019, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose, dose number, route of administration and anatomical location were not reported) (lot # R030120, expiration date: 15-NOV-2019) for prophylaxis. It was not noted that the product was expired until after it was administered. No other adverse event terms were provided.
Age: 70.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; a patient was administered an improperly stored dose of PNEUMOVAX 23.; This spontaneous report was received from a nurse referring to a 70 years old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 02-DEC-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # R030140, expiration date 07-AUG-2020; strength, dose, route, lot # and were not reported) for prophylaxis (product storage error). Temperature excursions were below 32 degrees Fahrenheit (27 degrees Fahrenheit) for 4 hours 3 minutes (1 cycle) and below 36 degrees Fahrenheit (32 degrees Fahrenheit) for 6 hours 13 minutes. There was no previous temperature excursion. Data logger was involved. No additional adverse events were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported), as prescribed and/or administered by a healthcare provider in nursing home for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) vaccination, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was reported as not recovered. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was reported as related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, anatomical location and route of administration were not specified), as prescribed and/or administered by a healthcare provider at pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a physician for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was reported as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. Patient was inoculated with zoster vaccine live (ZOSTAVAX) in 2008, as prescribed and/or administered by a healthcare provider at a Public Health District for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by the physician for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, anatomical location and route of administration were not specified), as prescribed and/or administered by a pharmacist at pharmacy for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a physician for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was reported as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On or about 04-SEP-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 06-APR-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles and was treated by a physician. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 18-NOV-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions, in a pharmacy. Subsequent to the patient's inoculation with zoster vaccine live (ZOSTAVAX), she was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was reported as not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer concerning a case in litigation and refers to a male patient of an unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On or about 14-FEB-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) as prescribed and/or administered by a healthcare provider at the physician's office for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. Patient was inoculated with zoster vaccine live (ZOSTAVAX) on or about 15-OCT-2012, as prescribed and/or administered by healthcare provider at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by the healthcare provider at a hospital, for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) vaccination, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of use of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was reported as not recovered. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles and was treated by a healthcare provider. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 31-MAR-2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions, in a pharmacy by a pharmacist. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, she was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was not recovered. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was related.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. In 2012, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, frequency, route, anatomical location, lot # and expiration date were not provided) at the physician's office, for long term prevention of shingles and/or zoster-related conditions. Subsequently, the patient was treated by the same physician at his office for shingles. As a direct and proximate result of patient's vaccination with zoster vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The patient's outcome was not recovered and the event was considered related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional symptoms were reported; Inappropriate schedule of vaccine administered; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/ allergies was not provided.  On 03-MAY-2017, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 milliliter/ once, lot number M041990, expiration date 28-JUN-2019; anatomical location and route of administration were unknown) for prophylaxis and the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 milliliter/once, lot number M040412, expiration date 30-JUN-2019; anatomical location and route of administration were unknown) for prophylaxis on 16-MAY-2017(inappropriate schedule of product administration). No additional symptoms were reported.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Patient received improperly stored VAQTA; Information has been received from a Certified Medical Assistant concerning to a 6 year old male patient. No medical history, concurrent conditions nor concomitant medications were reported. On 01-NOV-2019, the patient was vaccinated with an improper stored dose of hepatitis a vaccine, inactivated (VAQTA), 25/0.5 (units not reported) (lot No. S009562, expiration date reported as 26-JUL-2020, conflicting information as per internal verification was 05-MAY-2019) (route not reported) for prophylaxis. No adverse event was reported.   Temperature timeframe: Above 47°F (52.09 F) for 1.39 hours Previous temperature excursion: Above 47°F (64.83 F) for 13.35 hours Call made because of data logger: Yes
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; a male Patient received improperly stored M-M-R II (lot R031680 & expiration date 11/1/2020).; This spontaneous report was received from a medical assistant referring to a 5 years old male patient. Concomitant therapy included sterile diluent. Information about medical history and concurrent conditions was not provided.        On 05-NOV-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R031680, expiration date 01-NOV-2020; strength, dose and route were not reported) for prophylaxis (product storage error). Temperature excursion was -58 degrees Fahrenheit and +46 degrees Fahrenheit (19.13 degrees Fahrenheit) for 1.5 hours. There was previous temperature excursion above 47 degrees Fahrenheit (54.93 degrees Fahrenheit) for 15 minutes and -58 degrees Fahrenheit and +46 degrees Fahrenheit for 12 hours and 15 minutes.  Data logger was involved. No additional adverse effect was reported.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; a male Patient received improperly stored VAQTA (lot S009562 & expiration date 7/26/2020).; This spontaneous report was received from a medical assistant referring to a 3 years old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 05-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) vial 25/0.5(unit not provided) (lot # S009562, expiration date 26-JUL-2020; dose and route were not reported) for prophylaxis (product storage error). Temperature excursion was above 47 degrees Fahrenheit (52.09 degrees Fahrenheit) for 1.39 hours. There was previous temperature excursion above 47 degrees Fahrenheit (64.83 degrees Fahrenheit) for 13.35 hours. Data logger was involved. No additional adverse effect was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation concerning a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On or about 18-SEP-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported), as prescribed and/or administered by a healthcare provider at a hospital for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by a healthcare provider at the hospital for shingles (onset date not provided). As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not reported. The event of shingles was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; the patient received a dose of VARIVAX following temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history and concomitant medications was provided.  On 03-DEC-2019 the patient was vaccinated improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S006018, expiration date 27-FEB-2021 (dose, frequency and route of administration were not provided) for prophylaxis. No adverse effect was reported.  The temperature was 15 to 46 Fahrenheit degrees (-9 to 8 Celsius degrees) for 1 hour and 3 minutes. There was no previous temperature excursion. The data logger was involved. The outcome of the event was unknown.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms; "patient who had been administered PNEUMOVAX 23 in November 2017  was accidentally  administered PNEUMOVAX 23 again on 12/2/2019."; "patient who had been administered PNEUMOVAX 23 in November 2017  was accidentally  administered PNEUMOVAX 23 again on 12/2/2019."; This spontaneous report was received from a physician referring to a patient of unknown age.      The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On an unspecified date in November 2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, frequency, route of administration, lot # and expiration date were not reported) as prophylaxis. On 02-DEC-2019, the patient was was accidentally administered pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) again, lot # R012550, expiration date 25-JAN-2020, intramuscularly. It was verified that the administratiobn was not a result of product confusion, and it was reported that the patient did not experience symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. In 2014 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. The patient reported that she relied on the warning label affixed to zoster vaccine live(ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live(ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced her to be vaccinated. On an unspecified date (reported as subsequent to zoster vaccine live(ZOSTAVAX) inoculation), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered the event to be related to zoster vaccine live(ZOSTAVAX).
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given 2 PNEUMOVAX 23 vaccines within a year; This spontaneous report was received from a pharmacist regarding an adult patient of unknown gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions/allergies were not reported. It was reported that a patient was given 2 Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) with in an year (inappropriate schedule of product administration). The outcome of the event was unknown. There was no Product Quality Complaint (PQC) identified.
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 15 year old patient was inadvertently administered a dose of PROQUAD; 15 year old patient was inadvertently administered a dose of PROQUAD; This spontaneous report was received from a physician referring to a 15-year-old male patient. The patient's pertinent medical history and drug allergies were not reported. Concomitant therapy included sterile diluent.     On 19-NOV-2019 the patient was inadvertently administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot # S002926, expiration date 28-JUL-2020; dose was not reported) via subcutaneous for prophylaxis (product administered to patient of inappropriate age, product use issue).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; the patient was inadvertently administered a dose of MMR II , that was expired; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies were not reported.  On 04-DEC-2019 the patient was inadvertently administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # N032757, expiration date 20-NOV-2019; dose was not reported) via subcutaneous for prophylaxis, which was expired (expired product administered). No additional adverse events.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no additional adverse events; patient received VAQTA pediatric dose instead of adult dose; This spontaneous report was received from a licensed practical nurse referring to an adult patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 21-OCT-2019, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) lot # S021092 with expiration date on 18-MAY-2020 (dosage schedule, route and anatomical location were not reported), for prophylaxis (incorrect dose administered). No adverse event was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Herpes zoster, Myocardial infarction, Pain, Rash
Clinical narrative: heart attack; pain; balances issues; shingles/painful rash; Information has been received from a lawyer regarding a case in litigation concerning a male patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. Pt was prescribed the zoster vaccine live(ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 16-MAY-2017, pt was administered the zoster vaccine live(ZOSTAVAX) at a pharmacy. Pt suffered the following injuries and was diagnosed on unknown dates as a result of the zoster vaccine live(ZOSTAVAX): pain, painful rash, shingles, balances issues and a heart attack.  Upon internal review, heart attack was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Cerebrovascular accident, Herpes zoster, Hypoacusis, Rash
Clinical narrative: painful blistering rash/ shingles; multiple strokes; vision issues; hearing issues; balance issue; kidney injury; Information has been received from a lawyer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 21-OCT-2015, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced painful blistering rash, shingles, multiple strokes, vision issues, hearing issues, balance issue and kidney injury. The outcome of the events was unknown.   The reporter considered the events were related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events of strokes and kidney injury were considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Renal injury, Visual impairment
Clinical narrative: painful blistering rash/ shingles; multiple strokes; vision issues; hearing issues; balance issue; kidney injury; Information has been received from a lawyer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 21-OCT-2015, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced painful blistering rash, shingles, multiple strokes, vision issues, hearing issues, balance issue and kidney injury. The outcome of the events was unknown.   The reporter considered the events were related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events of strokes and kidney injury were considered to be medically significant.
Age: 19.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse effect; received a fourth dose of GARDASIL 9; This spontaneous report was received from a Medical assistant referring to a 19-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On 03-DEC-2019, the patient was vaccinated with fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (extra dose administered) via intramuscular route in the right arm for prophylaxis (strength, dose, lot # and expiry date not reported), who was previously vaccinated with three dose series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse event was reported. No product quality complaint was involved in this report.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional adverse events; patient received VAQTA pediatric dose instead of adult dose.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender.  Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.    On 23-SEP-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # S021092, expiration date 18-MAY-2020; strength and route were not reported) pediatric dose instead of adult dose for prophylaxis (incorrect dose administered). No adverse events were reported.