chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No other AE reported; A temperature excursion on ROTATEQ that was administered 2 times; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 22-SEP-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1684163 was verified to be valid, expiration date was reported as 20-JUN-2021 but upon internal validation was established as: 26-JUN-2021) (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. The reported stated that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered two times. The temperature to which the vaccine was exposed was not reported. It was unknown if previous temperature excursion occurred. It was not reported if a digital data logger was involved. No adverse symptoms were reported.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; Longer than recommended interval between dosing; This spontaneous report was received from a pharmacist referring to a 15 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.     In 2017 (reported as three years ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. On 09-NOV-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. This was longer than recommended interval (inappropriate schedule of product administration). No adverse effects reported.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia
Clinical narrative: cin 1 with hpv effect/ abnormal PAP smear; cin 1 with hpv effect/ abnormal PAP smear/positive for HPV; This spontaneous report was received from a medical assistant and refers to a currently 21-year-old non-pregnant female patient. The patient had no allergies. No information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. In approximately 2013, when the patient was 14 years old, she was vaccinated with all scheduled doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscularly (doses, lot numbers and expiration dates were unknown) to prevent disease or cancer caused by human papilloma virus (HPV). On 01-JUN-2020, the patient had papanicolaou (PAP) smear. On 25-JUN-2020, she had colposcopy performed. On 30-JUN-2020, the patient's pathology tests returned with result of cervical intraepithelial neoplasia 1 (CIN 1) with human papilloma virus (HPV) antibody positive effect. It was reported that the patient did not sought medical attention and no treatment was given for the events. The outcomes of cervical intraepithelial neoplasia 1 and HPV positive were reported as not recovered. The casual relationship between the events and the patient's vaccinations was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Eyelid rash, Nodule, Rash, Skin lesion
Clinical narrative: painful rash outbreak on her head and eyes, consisting of scalp lesions, clusters of tender knots across her head; stabbing pain behind her eyes; painful rash outbreak on her head and eyes, consisting of scalp lesions, clusters of tender knots across her head; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. On or around 30-SEP-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after vaccination, she suffered a painful rash outbreak on her head and eyes, consisting of scalp lesions, clusters of tender knots across her head (rash/skin mass), and stabbing pain behind her eyes (eye pain). Those injuries were caused by zoster vaccine live (ZOSTAVAX). As a result, her husband had suffered loss of services and society and asserts a loss of consortium claim. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the pt's symptoms had resulted in physical limitations no present prior to vaccination. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered.   The reporter considered all of the events to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Skin mass
Clinical narrative: painful rash outbreak on her head and eyes, consisting of scalp lesions, clusters of tender knots across her head; stabbing pain behind her eyes; painful rash outbreak on her head and eyes, consisting of scalp lesions, clusters of tender knots across her head; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. On or around 30-SEP-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after vaccination, she suffered a painful rash outbreak on her head and eyes, consisting of scalp lesions, clusters of tender knots across her head (rash/skin mass), and stabbing pain behind her eyes (eye pain). Those injuries were caused by zoster vaccine live (ZOSTAVAX). As a result, her husband had suffered loss of services and society and asserts a loss of consortium claim. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the pt's symptoms had resulted in physical limitations no present prior to vaccination. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, she had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered.   The reporter considered all of the events to be disabling.
Age: 0.58
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 7 month old patient inadvertently received MMR and VARIVAX due to human error; This spontaneous report was received from a nurse and refers to a 7-month-old patient of unknown gender.      The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant therapies were not reported.   On 12-NOV-2020, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX)  (dose, frequency, route of administration, indication not reported; lot # T017682 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 21-MAY-2022)  and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, frequency, route of administration, indication not reported; lot # S029455 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 19-SEP-2021) due to human error (Inappropriate age at vaccine administration). No further information was available.
Sex: F
Vaccine: MMR
Symptoms: Intensive care, Mumps, Obstructive airways disorder, Parotitis, Polymerase chain reaction positive
Clinical narrative: mumps parotitis; vaccination failure; This literature marketed report has been received from authors of published article. The incidence of parotitis and mumps in children was increasing nationwide. Retrospective chart reviews were conducted using ICD9/10-codes for parotitis and mumps from January 2007 to December 2017. Data on demographics, vaccination status, labs, management and disposition were collected. The patients had mumps immunoglobulin (IgM) and/or buccal swab for mumps reverse transcription polymerase chain reaction (RT-PCR) or viral culture to test mumps. 1017 parotitis cases were diagnosed, an upward trend in incidence occurred over time. Of the 1017 children with parotitis evaluated over the decade the emergency departments, 47 (4.6%) were tested for mumps and 9 (19%) of those tested were positive for mumps either by serology and/or PCR. Five of those cases were considered probable mumps and 4 were confirmed mumps. Of the 9 patients identified with probable or confirmed mumps, 7 (78%) were fully immunized, one was incompletely immunized (one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)) and 1 child was unvaccinated. The most likely explanation for mumps cases in previously immunized persons may be secondary vaccine failure, or waning immunity.  This report referring to a 17 years old female patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On unknown dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose detial, route, lot #, expiration date and anatomical location were not provided).   In 2017, the patient was tested mumps IgM, RT-PCR and viral culture at buccal. All results were postive for mumps at bilateral buccal. It was confirmed that the patient experienced mumps parotitis and developed airway involvement and retropharyngeal spread related to parotitis. The patient required pediatric intensive care unit (PICU) admission. On an unknown date, the patient experienced vaccination failure. 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. Literature report: This is one of several reports received from the same literature. Sender's Comments:  US-009507513-2011USA012662: US-009507513-2011USA012663: US-009507513-2011USA012664: US-009507513-2011USA012665: US-009507513-2011USA012666: US-009507513-2011USA012667: US-009507513-2011USA012668:
Sex: F
Vaccine: MMR
Symptoms: Rubulavirus test positive, Smear buccal abnormal, Vaccination failure
Clinical narrative: mumps parotitis; vaccination failure; This literature marketed report has been received from authors of published article. The incidence of parotitis and mumps in children was increasing nationwide. Retrospective chart reviews were conducted using ICD9/10-codes for parotitis and mumps from January 2007 to December 2017. Data on demographics, vaccination status, labs, management and disposition were collected. The patients had mumps immunoglobulin (IgM) and/or buccal swab for mumps reverse transcription polymerase chain reaction (RT-PCR) or viral culture to test mumps. 1017 parotitis cases were diagnosed, an upward trend in incidence occurred over time. Of the 1017 children with parotitis evaluated over the decade the emergency departments, 47 (4.6%) were tested for mumps and 9 (19%) of those tested were positive for mumps either by serology and/or PCR. Five of those cases were considered probable mumps and 4 were confirmed mumps. Of the 9 patients identified with probable or confirmed mumps, 7 (78%) were fully immunized, one was incompletely immunized (one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)) and 1 child was unvaccinated. The most likely explanation for mumps cases in previously immunized persons may be secondary vaccine failure, or waning immunity.  This report referring to a 17 years old female patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On unknown dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose detial, route, lot #, expiration date and anatomical location were not provided).   In 2017, the patient was tested mumps IgM, RT-PCR and viral culture at buccal. All results were postive for mumps at bilateral buccal. It was confirmed that the patient experienced mumps parotitis and developed airway involvement and retropharyngeal spread related to parotitis. The patient required pediatric intensive care unit (PICU) admission. On an unknown date, the patient experienced vaccination failure. 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. Literature report: This is one of several reports received from the same literature. Sender's Comments:  US-009507513-2011USA012662: US-009507513-2011USA012663: US-009507513-2011USA012664: US-009507513-2011USA012665: US-009507513-2011USA012666: US-009507513-2011USA012667: US-009507513-2011USA012668:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: herpes zoster; postherpetic neuralgia; Information has been received from a lawyer referring to a patient of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 06-SEP-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and is still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster and postherpetic neuralgia was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events herpes zoster and postherpetic neuralgia to be disability.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event
Clinical narrative: No other AE/PQC reported; received the Proquad and Varivax injection on the same day; This spontaneous report was received from a nurse and refers to a 12-month-old female patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 12-NOV-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (lot number T016991 was verified to be valid, expiration date reported and established as 11-NOV-2021) (strength, dose, frequency and route of administration were not provided. On the same day, the patient was also vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot number T003707 was verified to be valid, expiration date reported and established as 30-JAN-2022) (strength, dose, frequency and route of administration were not provided.   The patient did not experience any additional adverse reactions.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2011USA009469:
Sex: F
Vaccine: PPV
Symptoms: Gaze palsy, Injection site bruising, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: injection site pain; bruising at injection site; injection site redness; severe chills; headaches with the vaccine; high fever of 104.3; This spontaneous report was received from a consumer, regarding herself, a female patient of unknown age. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were reported as unknown.  On 10-NOV-2020, the patient was vaccinated with a single dose shot of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# unknown; dose, frequency, route and expiration date were not reported) to prevent pneumonia from her pharmacy.  On the same date, the patient had some adverse experiences such as injection site pain, bruising at injection site, injection site redness, severe chills, high fever of 104.3 (unit not reported), and headaches with the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). She stated as of 16-NOV-2020 (reported as today), she still had these symptoms. No treatment was given for the events. The patient stated that she was going to contact her physician for follow-up. It was unknown if lab diagnostics or studies were performed. The patient did not sought medical attention. The outcomes of the events were reported as not recovered. The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: injection site pain; bruising at injection site; injection site redness; severe chills; headaches with the vaccine; high fever of 104.3; This spontaneous report was received from a consumer, regarding herself, a female patient of unknown age. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were reported as unknown.  On 10-NOV-2020, the patient was vaccinated with a single dose shot of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# unknown; dose, frequency, route and expiration date were not reported) to prevent pneumonia from her pharmacy.  On the same date, the patient had some adverse experiences such as injection site pain, bruising at injection site, injection site redness, severe chills, high fever of 104.3 (unit not reported), and headaches with the vaccine pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). She stated as of 16-NOV-2020 (reported as today), she still had these symptoms. No treatment was given for the events. The patient stated that she was going to contact her physician for follow-up. It was unknown if lab diagnostics or studies were performed. The patient did not sought medical attention. The outcomes of the events were reported as not recovered. The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injury
Clinical narrative: other zoster related injuries; shingles; Information has been received from a lawyer and refers to a female patient of unknown age. On or about 04-FEB-2008, the patient was administered with zoster vaccine live (ZOSTAVAX) (dose, unit, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions by a healthcare provider at a pharmacy. Subsequently, the patient was treated by a physician for the following injuries resulting from patients's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of the events was not reported. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Age: 4.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Adenovirus test positive, Arthralgia, C-reactive protein increased, Complement factor C3, Complement factor C4
Clinical narrative: She was diagnosed with SSLR due to routine vaccinations; This literature marketed report was received from the authors of a published literature, referring to a 4-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.   On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and varicella virus vaccine live (Oka/Merck) (manufacturer unknown) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). Additional suspect vaccines administered the same day, included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine inactivated (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported).  On an unspecified date, six days after vaccination, the patient developed a generalized urticarial rash with swelling of her joints. She was started on prednisolone by her pediatrician for presumed Serum sickness-like reaction (SSLR) however was subsequently admitted with high fevers and worsening arthralgia. Her C-reactive protein (CRP), procalcitonin and erythrocyte sedimentation rate (ESR) were all elevated and her respiratory viral panel was positive for adenovirus. Her complement levels (C3, C4) were normal. Intravenous methylprednisolone was started with dramatic improvement. She was diagnosed with SSLR and was discharged on a prednisone taper with instructions to space out vaccinations in the future to elicit the causal vaccine.  On an unspecified date, resolution in symptomatology over the course of 48 hours occurred. The author assessed the causal relationship between suspect vaccines and the events as related as they stated that the patient was diagnosed with SSLR due to routine vaccinations.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Complement factor normal, Joint swelling, Procalcitonin increased, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: She was diagnosed with SSLR due to routine vaccinations; This literature marketed report was received from the authors of a published literature, referring to a 4-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.   On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and varicella virus vaccine live (Oka/Merck) (manufacturer unknown) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). Additional suspect vaccines administered the same day, included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine inactivated (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported).  On an unspecified date, six days after vaccination, the patient developed a generalized urticarial rash with swelling of her joints. She was started on prednisolone by her pediatrician for presumed Serum sickness-like reaction (SSLR) however was subsequently admitted with high fevers and worsening arthralgia. Her C-reactive protein (CRP), procalcitonin and erythrocyte sedimentation rate (ESR) were all elevated and her respiratory viral panel was positive for adenovirus. Her complement levels (C3, C4) were normal. Intravenous methylprednisolone was started with dramatic improvement. She was diagnosed with SSLR and was discharged on a prednisone taper with instructions to space out vaccinations in the future to elicit the causal vaccine.  On an unspecified date, resolution in symptomatology over the course of 48 hours occurred. The author assessed the causal relationship between suspect vaccines and the events as related as they stated that the patient was diagnosed with SSLR due to routine vaccinations.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Respiratory viral panel, Serum sickness-like reaction, Urticaria
Clinical narrative: She was diagnosed with SSLR due to routine vaccinations; This literature marketed report was received from the authors of a published literature, referring to a 4-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.   On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and varicella virus vaccine live (Oka/Merck) (manufacturer unknown) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). Additional suspect vaccines administered the same day, included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine inactivated (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported).  On an unspecified date, six days after vaccination, the patient developed a generalized urticarial rash with swelling of her joints. She was started on prednisolone by her pediatrician for presumed Serum sickness-like reaction (SSLR) however was subsequently admitted with high fevers and worsening arthralgia. Her C-reactive protein (CRP), procalcitonin and erythrocyte sedimentation rate (ESR) were all elevated and her respiratory viral panel was positive for adenovirus. Her complement levels (C3, C4) were normal. Intravenous methylprednisolone was started with dramatic improvement. She was diagnosed with SSLR and was discharged on a prednisone taper with instructions to space out vaccinations in the future to elicit the causal vaccine.  On an unspecified date, resolution in symptomatology over the course of 48 hours occurred. The author assessed the causal relationship between suspect vaccines and the events as related as they stated that the patient was diagnosed with SSLR due to routine vaccinations.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored then administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, current condition, previous drugs reactions or allergies, and concomitant medications were not reported.  On 16-NOV-2020, the vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ) had a temperature excursion. The vaccine was exposed to the following temperature excursion: 46.9 degrees Fahrenheit for 15 minutes as recorded by a data logger. There were no previous temperature excursions. On 17-NOV-2020, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml (strength, vaccination scheme and anatomical site of vaccination were not reported, lot # 1684152, expiration date reported and validated as 19-JUN-2021) orally for prophylaxis.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: vision loss; Information has been received regarding a case in litigation, referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. In 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot# and expiration date were not reported). On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for vision loss. As a direct and proximate result of the patient's 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 would continue to suffer such losses, and damages in the future. The outcome of vision loss was not reported. The reporter considered vision loss to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of vision loss was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation, referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot# and expiration date were not reported). On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's 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 would continue to suffer such losses, and damages in the future. The outcome of shingles was not reported. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
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 patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or about 01-OCT-2013, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) by a healthcare provider at the medical office, for the long-term prevention of shingles and/or zoster-related conditions.        Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, patient was treated on an unknown date at the medical office 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.   The outcome of shingles was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and refers to a patient of unknown age and gender. In 2010, patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, unit, route of administration, lot # and expiration date were not reported), as prescribed and/or administered by a healthcare provider at the medical office of a physician 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 physician for shingles. As a direct and proximate result of patient's use 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. The outcome of the event was not reported. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and refers to a patient of unknown age and gender. In 2016, patient was inoculated with zoster vaccine live (ZOSTAVAX), as prescribed and/or administered by a healthcare provider  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 healthcare provider  for shingles. As a direct and proximate result of patient's use 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. The outcome of the event was not reported. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
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 patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or about 20-JUN-2013, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dose, route of administration and anatomical location were not reported) by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions.        Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, patient was treated on an unknown date at the medical office 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.   The outcome of shingles was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster
Clinical narrative: hearing loss; shingles; Information has been received regarding a case in litigation, referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot# and expiration date were not reported). On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles and the patient sought for additional treatment from a pharmacist for hearing loss. As a direct and proximate result of the patient's 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 would continue to suffer such losses, and damages in the future. The outcome of shingles and hearing loss was not reported. The reporter considered shingles and hearing loss to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of hearing loss was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Macular degeneration
Clinical narrative: Macular degeneration; Information has been received regarding a case in litigation, referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot# and expiration date were not reported). On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for macular degeneration. As a direct and proximate result of the patient's 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 would continue to suffer such losses, and damages in the future. The outcome of macular degeneration was not reported. The reporter considered macular degeneration to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of macular degeneration was considered to be medically significant.
Sex: M
Vaccine: MMR
Symptoms: Mumps, Mumps antibody test positive, Parotitis, Pyrexia, Vaccination failure
Clinical narrative: mumps parotitis; vaccination failure; This literature marketed report has been received from authors of published article. The incidence of parotitis and mumps in children was increasing nationwide. Retrospective chart reviews were conducted using ICD9/10-codes for parotitis and mumps from January 2007 to December 2017. Data on demographics, vaccination status, labs, management and disposition were collected. The patients had mumps immunoglobulin (IgM) and/or buccal swab for mumps reverse transcription polymerase chain reaction (RT-PCR) or viral culture to test mumps. 1017 parotitis cases were diagnosed, an upward trend in incidence occurred over time. Of the 1017 children with parotitis evaluated over the decade in emergency departments (EDs), 47 (4.6%) were tested for mumps and 9 (19%) of those tested were positive for mumps either by serology and/or PCR. Five of those cases were considered probable mumps and 4 were confirmed mumps. Of the 9 patients identified with probable or confirmed mumps, 7 (78%) were fully immunized, one was incompletely immunized (one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)) and 1 child was unvaccinated. The most likely explanation for mumps cases in previously immunized persons may be secondary vaccine failure, or waning immunity.  This report referring to a 7 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On unknown dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose detial, route, lot #, expiration date and anatomical location were not provided).   In 2017, the patient was tested mumps IgM and RT-PCR at buccal and urine. The results were postive for mumps at left buccal. It was confirmed that the patient experienced mumps parotitis. The patient required admission to the ward. The patient had fever with body temperature more than 38 degree Celsius. On an unknown date, the patient experienced vaccination failure. 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).   Literature report:   This is one of several reports received from the same literature. Sender's Comments:  US-009507513-2011USA009173:
Sex: M
Vaccine: MMR
Symptoms: Mumps, Mumps antibody test positive
Clinical narrative: vaccination failure; Probable mumps parotitis; This literature marketed report has been received from authors of published article. The incidence of parotitis and mumps in children was increasing nationwide. Retrospective chart reviews were conducted using ICD9/10-codes for parotitis and mumps from January 2007 to December 2017. Data on demographics, vaccination status, labs, management and disposition were collected. The patients had mumps immunoglobulin (IgM) and/or buccal swab for mumps reverse transcription polymerase chain reaction (RT-PCR) or viral culture to test mumps. 1017 parotitis cases were diagnosed, an upward trend in incidence occurred over time. Of the 1017 children with parotitis evaluated over the decade in the Healthcare  emergency departments (EDs), 47 (4.6%) were tested for mumps and 9 (19%) of those tested were positive for mumps either by serology and/or PCR. Five of those cases were considered probable mumps and 4 were confirmed mumps. Of the 9 patients identified with probable or confirmed mumps, 7 (78%) were fully immunized, one was incompletely immunized (one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)) and 1 child was unvaccinated. The most likely explanation for mumps cases in previously immunized persons may be secondary vaccine failure, or waning immunity.  This report referring to a 1.5 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On an unknown date, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose detial, route, lot #, expiration date and anatomical location were not provided).   In 2017, the patient was tested mumps IgM, RT-PCR and viral culture at buccal. The result of mumps IgM was postive for mumps at left buccal. Other results were not provided. It was considered probable mumps parotitis. The patient had fever with body temperature more than 38 degree Celsius. On an unknown date, the patient experienced vaccination failure. 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).  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-2011USA009173: