chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: HIBV, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pruritus, Pyrexia
Clinical narrative: Fever 101.7, chills, muscle pain, skin rashes, itching, fatigue
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, SARS-CoV-2 test negative
Clinical narrative: Fever 101.7, chills, muscle pain, skin rashes, itching, fatigue
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported; Unspecified number of patients have recieved improperly stored ROTATEQ on unspecified dates; This spontaneous report was received from a nurse, referring to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.   On unknown dates, the patients' were vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ); lot number S004251; expiration date: 22-SEP-2020 (strength, dose, schedule and route of administration were not reported) for prophylaxis (product storage error). No symptoms reported (no adverse effect reported). Administered doses of vaccines underwent temperature excursion of 46.9 degrees Fahrenheit (F) for 55 minutes. Data logger was involved. The previous temperature excursion was 34.9 F for 25 minutes and 48.6 F for 25 minutes.   This case is considered non-valid due the lack of patient identifiers.  As of 15-MAY-2020, a phone call was placed to nurse and a request was made for administration dates and patient identifiers for unspecified patients who were administered the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) that had undergone temperature excursion.  Follow up information has been received from a nurse on 21-MAY-2020, referring to a 9 weeks old male patient. On 12-NOV-2018, the patient was vaccinated with the first improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). On 04-JAN-2019 and 02-APR-2019, the patient had received the rest two doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) as per the dosing schedule (strength, dose, route of administration, lot# and expiration date were not reported) for prophylaxis.; Sender's Comments:  US-009507513-2005USA007560: US-009507513-2005USA007561: US-009507513-2005USA007562:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events.; a patient was administered an expired PNEUMOVAX 23; This initial spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 11-MAY-2020, the patient was vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # R021045, expiration date 14-APR-2020; route and dose details were unknown) for prophylaxis (expired product administered). No additional adverse events. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R021045; expirationdate: 14-APR-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies was provided.  On 05-FEB-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R013564, expiration date: 13-MAY-2020 (dose and route of administration were not reported). The vaccine was reconstitued with a sterile diluent (DILUENT MRK) that was properly stored.  On an unknown date pior to administration, the vaccine underwent a temperature excursion and was stored for 3 hours and 6 minutes in the temperature between 15 and 46 degrees Fahrenheit. There was no previous temperature excursion. Digital Data Logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: The nurse reports the patient received an improperly stored dose of PROQUAD; This spontaneous report was received from a nurse, referring to patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies, or concomitant medications were not reported.  On 13-MAY-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (product storage error) (lot number S027462, which has been verified to be valid, expiration date reported and validated as 02-MAR-2021), as prophylaxis (route of administration, dosage regimen and anatomical location were not reported). The vaccine was reconstituted with properly stored sterile diluent, lot number T003594 and expiration date 07-JUL-2022. The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (°F) to 14 °F for 16 hours 17 minutes, 15 °F to 46 °F (16.7 °F) for 1 hour 21 minutes, as recorded by a data logger. There was no previous temperature excursion.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: experienced an injection site reaction, described as red and itchy; experienced an injection site reaction, described as red and itchy; This spontaneous report has been received from a consumer, referring to a 80 years old female patient. The patient's history condition and concomitant medication were not provided. It was reported that the patient was in the hospital and was a patient prior to receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  On 13-MAY-2020, the patient was administered the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis.         On the same day, the patient experienced an injection site reaction, described as red and itchy. The outcome of the events was unknown. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was provided regarding medical history, concurrent condition, or concomitant medication. On or about 01-MAR-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as "subsequent to zoster vaccine live (ZOSTAVAX) inoculation"), the patient was treated by a physician for stroke. 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 reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of stroke was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was provided regarding medical history, concurrent condition, or concomitant medication. In 2013 the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose number and route was not specified) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as "subsequent to zoster vaccine live (ZOSTAVAX) inoculation"), the patient was treated by a healthcare provider for Bell's palsy. 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 reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of Bell's palsy was considered to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was administered the first dose of Gardasil 9 on 12/10/2018/The second dose was administered on 8/12/2019/The third dose administered on 5/18/2020; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reaction or allergies, concurrent conditions and concomitant medications was not provided.     On 10-DEC-2018, 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) by intramuscular route (strength, dose, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis.    On 12-AUG-2018, 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) lot # 1621934 with expiration date of 29-JAN-2022, by intramuscular route (strength, dose, frequency, and anatomical location, were not provided) for prophylaxis. Then, on 18-MAY-2020, the patient received the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R027946 with expiration date of 27-APR-2021 by intramuscular route (strength, dose, frequency, and anatomical location, were not provided) for prophylaxis ( inappropriate schedule of product administration).    combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621934; expirationdate: 29-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pallor, Paraesthesia
Clinical narrative: she has had unspecified " left arm problems"; her ''hands are tingling and white all the time"; her ''hands are tingling and white all the time"; on an unspecified date, she got shingles; This spontaneous report was received from a consumer referring to herself, an adult female patient.   The patient's current condition included: High blood pressure and breast cancer. The patient's medical history included: ankle surgery.  The patient's previous drug allergies or reactions included: acetaminophen allergy, acetaminophen (+) hydrocodone bitartrate (VICODIN) allergy, and hydrocodone allergye. The patient's concomitant therapies included: bromelains (+) capsicum (+) choline (+) chondroitin (+) chymotrypsin (+) ginger (+) ginkgo (+) guar gum (+) hawthorn (+) inositol niacinate (+) lecithin (+) levocarnitine (+) papain (+) phytosterols (+) taurine (+) trypsin (+) ubidecarenone (LABS LIPOTROL), metoprolol, losartan potassium manufacturer unknown, calcium (unspecified), vitamin d (unspecified), choline bitartrate (+) inositol (+) minerals (unspecified) (+) rutin (+) vitamins (unspecified) (ORTHO MOLECULAR ALPHA BASE WITHOUT IRON) vitamin b (unspecified), sertraline hydrochloride (ZOLOFT)  methadone hydrochloride, misoprostol, and gabapentin.   On 13-DEC-2013 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) 19400 plaque-forming units (PFU) vial, administered subcutaneous, for prevention of shingles (prophylaxis) (dosage regimen and anatomical site of vaccination were not reported) ; lot number J007301, which has been verified to be valid, expiration date reported and validated as 20-SEP-2014.  In approximately April 2014 (also reported as "four months later, on an unspecified date"), she got shingles (herpes zoster).  On an unknown date, the patient reported she had unspecified left arm problems (Limb discomfort). At the reporting time, the patient also stated that her hands were tingling and white all the time  (paraesthesia and pallor).   The patient sought medical attention, and called the physician, the treatment provided was aciclovir cream for herpes zoster (also reported as "was treatment given for AE?: No" conflicting information). The patient did not received treatment for the paraestheria, pallor nor the limb discomfort.   The outcome of herpes zoster and limb discomfort was reported as recovering. At the time of the report, the outcome of paraesthesia and pallos was determind to be not recovered (also reported as "present status: recovering"). The causal relationship between the suspect vaccine regarding the herpes zoster and the limb discomfort was not provided, and the patient attributed the paraesthesia and the pallor to be related to the zoster vaccine live (ZOSTAVAX).
Age: 22.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptoms or adverse effects reported.; patient received second dose in GARDASIL 9 immunization series off recommended schedule/First dose administered: 8/7/2018. Second dose administered: 8/12/2019; This spontaneous report was received from a pharmacist referring to a 23 years old patient of unknown gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.      On 07-AUG-2018, 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)(lot # N004799, expiration date 15-NOV-2019; dose, strength and route were not reported) for prophylaxis at a doctor's office. On 12-AUG-2019, 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)(lot # 1581027, expiration date 03-JUN-2021; dose, strength and route were not reported) for prophylaxis at an unspecified women's health center(inappropriate schedule of product administration). The patient had been pursuing third dose with pharmacy. No symptoms or adverse effects were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1581027; expirationdate: 03-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HPV9
Symptoms: Myalgia
Clinical narrative: the patient experienced muscle tenderness in her upper back and left shoulder; This spontaneous report has been received from an around 49 years old female patient via Merck employee, referring to herself. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were unknown by reporter.  On 14-MAY-2020, the patient was administered a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  (route, dose, strength, lot# and expiration date were unknown by reporter) in her left arm for prevention of human papillomavirus (HPV).  In May 2020 (reported as on an unspecified date after 14-MAY-2020), the patient experienced muscle tenderness in her upper back and left shoulder. It was unknown if lab diagnostics/studies were performed. The patient had not sought medical attention. The outcome of the event was recovered. The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported.; the "14 year old" patient inadvertently received a dose of PROQUAD on 5/18/2020.; This spontaneous report was received from a medical assistant referring to a 14 years old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 18-MAY-2020, the patient inadvertently received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (lot # S027463, has been verified to be a valid lot number, expiration date was reported as 22-MAR-2021, but upon internal validation established as 02-MAR-2021, strength, dose and route were not reported) for prophylaxis with Merck sterile diluent (batch/lot# and expiration date were unknown) (inappropriate age at vaccine administration). No adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; one patient received one dose of improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.   On 10-MAR-2020, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R020654, expiration date 18-JUL-2020; strength and vaccine dosage detail were not reported) subcutaneously for prophylaxis (product storage error). The sterile diluent (STERILE DILUENT) used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly. Current temperature excursion was 5.7 Fahrenheit degrees for 18 minutes. Previous temperature excursion was -13.3 Celsius degrees for 18 minutes and -13.2 Celsius degrees for 18 minutes. No additional adverse effects reported. No product quality complaint (PQC) was involved in this case. Data logger was involved.
Age: 46.0
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, Inappropriate schedule of product administration, Muscle disorder
Clinical narrative: left superior oblique muscle dysfunction; diplopia; Patient's age at ZOSTAVAX vaccination: approx 46 years; This initial spontaneous report was received from a lawyer and an approximately 46 year old male patient regarding a case in litigation on 19-MAY-2020. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On or about 05-FEB-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) at the clinic for the long-term prevention of shingles and zoster-related conditions (inappropriate schedule of vaccine administered). As a result of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered the following injuries: diplopia (diagnosed on or about 18-MAY-2015) and left superior oblique muscle dysfunction (diagnosed on or about 04-JUN-2015). Pt claimed damages as a result of injury to themselves, loss of consortium, loss of services and economic losses. The outcome of diplopia and left superior oblique muscle dysfunction was not reported. The reporters considered the event of diplopia and left superior oblique muscle dysfunction to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Herpes zoster, Iritis, Post herpetic neuralgia, Sudden visual loss
Clinical narrative: Plaintiff suffered sudden vision loss and burning of her eyes. Plaintiff was diagnosed with acute iritis and reoccurring uveitic flares; acute iritis; post herpetic neuralgia; Sudden vision loss; shingles; This spontaneous report has been received on 20-MAY-2020 from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or around 22-JUL-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered sudden vision loss and burning of her eyes. She was diagnosed with acute iritis and reoccurring uveitic flares. She also suffered shingles and post herpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using it. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her 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, 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, the patient 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 the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of sudden vision loss and reoccurring uveitic flares were considered to be medically significant. All events were determined to be disabling by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Uveitis
Clinical narrative: Plaintiff suffered sudden vision loss and burning of her eyes. Plaintiff was diagnosed with acute iritis and reoccurring uveitic flares; acute iritis; post herpetic neuralgia; Sudden vision loss; shingles; This spontaneous report has been received on 20-MAY-2020 from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or around 22-JUL-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered sudden vision loss and burning of her eyes. She was diagnosed with acute iritis and reoccurring uveitic flares. She also suffered shingles and post herpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using it. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her 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, 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, the patient 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 the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of sudden vision loss and reoccurring uveitic flares were considered to be medically significant. All events were determined to be disabling by the reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Axonal neuropathy, Chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: chronic inflammatory demyelinating polyneuritis; Guillain-Barre syndrome; multiple axonal neuropathy secondary to Guillain-Barre syndrome; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or around 22-JUN-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered acute muscle weakness, subacute neuropathy and severe difficulty with mobility, difficulty with activities of daily living. The patient had been diagnosed with Guillain-Barre syndrome, multiple axonal neuropathy secondary to Guillain-Barre syndrome, and chronic inflammatory demyelinating polyneuritis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using it. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his 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, 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, the patient 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 the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of Guillain-Barre syndrome and chronic inflammatory demyelinating polyneuritis were considered to be medically significant. All events were determined to be disabling by the reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Neuropathy peripheral
Clinical narrative: chronic inflammatory demyelinating polyneuritis; Guillain-Barre syndrome; multiple axonal neuropathy secondary to Guillain-Barre syndrome; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or around 22-JUN-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered acute muscle weakness, subacute neuropathy and severe difficulty with mobility, difficulty with activities of daily living. The patient had been diagnosed with Guillain-Barre syndrome, multiple axonal neuropathy secondary to Guillain-Barre syndrome, and chronic inflammatory demyelinating polyneuritis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using it. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his 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, 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, the patient 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 the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of Guillain-Barre syndrome and chronic inflammatory demyelinating polyneuritis were considered to be medically significant. All events were determined to be disabling by the reporter.
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: No other adverse effects were reported in the patient; the seal on a dose of VAQTA was broken for an unknown reason on 5/19/2020 and was administered to a patient on 5/20/2020; the seal on a dose of VAQTA was broken for an unknown reason on 5/19/2020/refers to a needle being attached, possibly compromising sterility of the  vaccine.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.       On 19-MAY-2020, the seal on a dose of hepatitis a vaccine, inactivated(VAQTA) was broken for an unknown reason (also reported as the seal on hepatitis a vaccine, inactivated(VAQTA) being ''broken" referred to a needle being attached, possibly compromising sterility of the vaccine) (needle issue). On 20-MAY-2020, the patient was vaccinated with the hepatitis a vaccine, inactivated(VAQTA)(0.5 mL; lot # S026003, expiration date 17-OCT-2020; strength 25/0.5 (unit unknown)) for prophylaxis (poor quality product administered). The vaccine dose was stored at proper temperature conditions. No adverse effects were reported in the patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S026003; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: a patient faint after administration of a dose of GARDASIL 9; This spontaneous report was received from an office manager who was also a nurse via field representative referring to a child patient of unknown age and unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was unknown.  On an unknown date in 2018 (reported as about 2 years ago), the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose detail, route, lot # and expiration date were not reported) for prophylaxis (reported as normal childhood vaccination).  After vaccination, the patient fainted. The patient was monitored after the incident. On the same date, after resting for an unspecified period, the child recovered and did not need any further medical intervention. Therapy was also reported as dose continued. The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the event of faint was determined to be medically significant.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 3-year-old male patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. On 01-NOV-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage).There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
Sex: F
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 2-year-old female patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 28-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage). On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 22-months-old female patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 23-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage). On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 5-year-old female patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. On 11-NOV-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage).There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 19-months-old female patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. On 13-NOV-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage).There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
Sex: M
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 14-months-old male patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. On 03-NOV-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage).There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 5-year-old female patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. On 12-NOV-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage).There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567: