chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza, Influenza A virus test, Influenza B virus test, Injection site erythema, Injection site swelling
Clinical narrative: Raised, red area around where vaccine was given. Mom noticed it that night. Informed Dr.; she was to be watched. Pt presented on 9-13-2017 with flu symptoms and fever. By 9-13-2017 the redness had diminished. Pt to take NSAIDS if fever >101, continue fluids and rest follow up 2-3 wks if not better.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: Raised, red area around where vaccine was given. Mom noticed it that night. Informed Dr.; she was to be watched. Pt presented on 9-13-2017 with flu symptoms and fever. By 9-13-2017 the redness had diminished. Pt to take NSAIDS if fever >101, continue fluids and rest follow up 2-3 wks if not better.
Age: 1.92
Sex: F
Vaccine: DTAPHEPBIP, MMRV, PNC13, VARCEL, DTAPHEPBIP, MMRV, PNC13, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: While giving Imms PROQUAD grabbed out of freezer instead of MMR. Was later realized after given. PCP and family notified. Family reports no adverse reaction.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Injection site haemorrhage, Nausea
Clinical narrative: Pt bleed at injection site. Under skin. We talked about blood she immediately felt nauseated, was not pale but felt bad. She stayed seated, her son brought a cold item from fridge. She asked to lie down on floor, with ice on head and within 2 min said she felt better. Kept her for 10 min, Gatorade.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Bradycardia, Electrocardiogram, Pallor, Syncope
Clinical narrative: Syncope with bradycardic rate after the vaccine injected, slight pallor.
Age: 9.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Dyskinesia, Fall, Head injury, Hypotonia, Injection site erythema
Clinical narrative: Pt received KINRIX 2 days ago. This AM noticed red arm in deltoid area and was nauseated, no fever detected, then she started shaking, jerking and fell backwards and became limp, hit head when falling backwards. A seizure-like episode lasted less than 5 mins and 911 - called - VS stable, went to ER and referred to neurologist.
Age: 9.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Nausea, Seizure like phenomena, Tremor
Clinical narrative: Pt received KINRIX 2 days ago. This AM noticed red arm in deltoid area and was nauseated, no fever detected, then she started shaking, jerking and fell backwards and became limp, hit head when falling backwards. A seizure-like episode lasted less than 5 mins and 911 - called - VS stable, went to ER and referred to neurologist.
Age: 68.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: Patient received Tdap and PNUPS - had local reaction of red, hot arm to elbow. No swelling at this time.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Lymphadenopathy, Peripheral swelling
Clinical narrative: Left arm redness and raised area. Pain. Lymph node swelling in arm pits.
Age: 0.17
Sex: F
Vaccine: HEPA, DTAPIPVHIB, HEP, HEPA, PNC13, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No.
Age: 0.17
Sex: F
Vaccine: HEPA, DTAPIPVHIB, HEP, HEPA, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: No.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fatigue, Joint range of motion decreased, Peripheral swelling
Clinical narrative: Swelling of arm down to elbow, couldn't bend elbow, no fever, swollen like a red apple, spreading to inner arm, fatigue, pulse 120.
Age: 6.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Induration, Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Pain in her left arm, swollen and hard. Can't move with her arm. Rash on that spot.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, and concurrent condition were not reported. Concomitant therapy included sterile diluent (manufacturer unknown). From May 2017 until 22-AUG-2017, the patients were vaccinated with improperly stored of VARIVAX injection (lot # M036272 with expiration date of 17-AUG-2018 and M048203 with expiration date of 07-DEC-2018) subcutaneously for prophylaxis, which were stored under 15 Fahrenheit degree to 46 Fahrenheit degree (27.7 Fahrenheit degree) for 63 hours. There was no previous temperature excursion. And the call was because of digital data logger. Sterile diluent (manufacturer unknown) was properly stored. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a 12 month old patient of unknown gender. Information about medical history and concurrent condition were not reported. On 10-JUL-2017, the patient was vaccinated with one dose of ZOSTAVAX injection (Batch# M009777 (which is not valid lot number for zoster vaccine live) with expiration date of 04-MAR-2018), 0.65 ml, subcutaneously for prophylaxis reconstituted with sterile diluent (lot# M044950 with expiration date of 30-MAY-2019), instead of VARIVAX. No adverse effects were reported.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot # N008823, expiration date of 26-MAY-2018 or N017094, expiration date of 31-AUG-2018; strength, dosage, frequency and route unspecified) for prophylaxis. No adverse effects were reported. Temperature was from 0 degree C to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature was reported as from 9 to 25 degree C (10.9 degree C) for 3 hours 17 minutes. This is one of 5 cases received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to four patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, those patients were vaccinated with improperly stored doses of VARIVAX lot# reported as M0402496, expiration date: 19-NOV-2017 (dose and route of administration were not reported). The vaccines were stored in the temperature of -4 degrees Celsius for 105 minutes. Digital Data Logger was involved. There was no previous temperature excursion. Vaccines were reconstituted with properly stored sterile diluent lot# N016122, expiration date: 05-OCT-2019. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a consumer regarding a young male patient of unknown age. Patient's pertinent medical history, drug allergies/reactions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis and sterile diluent (manufacturer unknown) for unknown indication (doses, routes, lot #s, and expiration dates unknown). The reporter stated that she knew "personal event" that occurred with the young male patient (adverse event). It was unspecified as to what this "personal event" was entailed. The outcome of adverse event was unknown. The causality assessment of adverse event with both suspect therapies was unknown. No product quality complaint was involved. This is one of two reports from the same reporter (1709USA002309).
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not provided. On unknown dates, the patient was vaccinated with two doses of PNEUMOVAX 23 (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported. No product quality complaint was involved.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from an employee and refers to her father, a 72-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies or pertinent medical history provided. On an unknown date approximately in 2014 (reported as 2 to 3 years ago), the patient was vaccinated with a dose of zoster vaccine live (also reported as a "shingles vaccine") (manufacturer unknown) (dose, frequency, route of administration, lot # and expiration date were not reported). On approximately 27-AUG-2017 (reported as last week), the patient experienced fatigue and headache. On the night of 01-SEP-2017, the patient experienced rash around his stomach. The patient sought medical attention via a physician's office visit and on 02-SEP-2017, the patient was diagnosed with shingles. The patient was treated with valacyclovir (manufacturer unknown) (also reported as "generic VALTREX") 1 g, 3 times a day, for 10 days. The relatedness between the events and ZOSTAVAX was not reported. The outcome of the events was reported as not recovered/not resolved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were administered multiple doses of improperly stored VAQTA (dose, route of administration, lot # and expiration date were not reported). Administered doses of vaccines underwent an unknown temperature excursion, which lasted for an unknown time frame. There was no previous temperature excursion. A digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007015: US-009507513-1709USA007016: US-009507513-1709USA007017: US-009507513-1709USA007018: US-009507513-1709USA007019.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-SEP-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N007931 and expiration date 17-NOV-2019 (dose, frequency and route of administration were not reported). There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion from 32 to 35 degrees Fahrenheit for 8 hours 45 minutes. Previously, there was also temperature excursion from 44 to 77 degrees Fahrenheit for 55 hours. Data loger was involved.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a licensed practical nurse, and refers to a 66 year old male patient. The patient had none pertinent medical history, concurrent conditions, drug reactions or allergies. The patient had none concomitant therapies. On 06-SEP-2017, the patient was vaccinated with PNEUMOVAX 23, lot # N011867, expiration date 08-NOV-2018, for prophylaxis (dose, dose number, route, and anatomical location were unspecified). On 07-SEP-2017, the patient went into the reporter's office with fever of 102 (units not provided), chills, and his left arm was red, swollen and very painful. The patient stated that "he could not pick up anything with his arm." The outcome of the events was reported as not recovered. No treatment was given for the adverse events and none laboratory diagnostic studies were performed. The relatedness between the events and PNEUMOVAX 23 was not reported.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Kidney infection
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a 71 year old female patient. The patient's concurrent conditions, pertinent medical history and  concomitant medications were not provided. The patient did not have any known drug allergies or reactions. On 05-SEP-2017 the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscular in the right arm lot # N012840 with expiration date on 20-JAN-2019) for prophylaxis. On the same date (reported as "that evening"), the patient experienced soreness at the injection site (injection site pain). The next day, on 06-SEP-2017, the patient developed swelling at the injection site (size of a grapefruit), injection site tenderness and injection site warmth. It was also reported that the patient thought she developed a kidney infection on an unspecified date after vaccination. No treatment was given for the adverse events and no laboratory tests were performed. On 07-SEP-2017, the patient sought medical attention by calling and spoking with the pharmacist regarding the events. The outcome of kidney infection, injection site warmth, injection site swelling and injection site pain was reported as not recovered. Upon internal review, kidney infection was considered medically significant.      The causal relationship between vaccination with PNEUMOVAX 23 and the events was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified amount of patients with ages and gender unknown. Patient's medical history, current conditions and concomitant medications were not reported. On unspecified dates the patients were administered improperly stored doses of VARIVAX (strength, route of administration and dose were not provided) Lot # N017399, expiration date 07-JUN-2019; Lot # N010108, expiration date 28-MAR-2019; Lot # N012488, expiration date 20-APR-2019; reconstituted with properly stored sterile diluent (unknown lot and expiration date) indicated for prophylaxis. The time frame was 6 hours with temperature of 6 Fahrenheit degrees to 14 Fahrenheit degrees. Digital Data Logger was involved. No adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 05-SEP-2017, two siblings (captured in 1709USA004215) were vaccinated with an improperly stored dose of GARDASIL 9 lot # N019923 and expiration date of 28-APR-2019 0.5 ml, intramuscularly for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature excursion of  -1°C or colder, with a time frame of 1 day 13 hours 30 minutes. There was previous temperature excursion of 9°C to 25°C for 7 hours 20 minutes. A "data logger" was involved.; Sender's Comments: US-009507513-1709USA004215:u
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse and refers to an 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 VAQTA lot # N008823, expiration date 26-MAY-2018 and lot # N017094, expiration date 31-AUG-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 0.8 degrees Celsius for 52 minutes and 10.9 degrees Celsius for 3 hours and 17 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint has been filled. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007137: US-009507513-1709USA007138: US-009507513-1709USA007139.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (dose, strength and route of administration were not provided) lot # M017982, expiration date 13-SEP-2017, for prophylaxis. No adverse effects were reported. The doses of VAQTA were exposed to a temperature excursion of 32°Fahrenheit (°F) to 35°C (32.4F) during a time frame of 16 hours, which was not detected by the data logger. There was a previous temperature excursion reported.
Sex: F
Vaccine: HPV4
Symptoms: Pancreatitis acute, Pancreatitis chronic
Clinical narrative: This spontaneous report as received from a physician via company representative, refers to a female patient of unknown age. The patient's medical history and concomitant therapies were not reported. The Field Representative read an article from an unknown author, that in 2015 the patient was vaccinated with GARDASIL (dosage, and anatomical location were unknown) for HPV prophylaxis. On an unknown date after receiving the vaccine the patient experienced bouts of acute pancreatitis and was diagnosed with chronic pancreatitis. The patient was seen by multiple unknown physicians and was hospitalized for an unknown period of time. The outcome of pancreatitis chronic was unknown. Upon internal review pancreatitis chronic was considered to be a medically significant event.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician, referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, drug and allergy history were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot number M036292, expiration date 17-AUG-2018 and lot number M041079, expiration date 06-OCT-2018 (dose, frequency and administration route were not reported), for prophylaxis.  Concomitant therapies included a properly stored sterile diluent used for reconstitution (lot number and expiration date were not provided). The data logger registered a temperature of 8.8 Fahrenheit (F) for 8 months. There was not previous temperature excursion. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions or medical histories provided. On unknown dates (reported as on or after February 2016), the patients were vaccinated with improperly stored doses of VARIVAX lot # M027886 with expiration date on 03-JUN-2018 (dose and route of administration were not reported). The sterile diluent (MRK) used for reconstitution did not undergo a temperature excursion. There was no adverse effect reported. Administered doses of vaccines experienced unknown temperature excursion for unknown time. Data logger was involved. There was previous excursion reported. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. The patient' medical history and concurrent conditions were not reported. On 11-SEP-2017, the patient was vaccinated with a dose of improperly stored VARIVAX lot # N017699, expiration date 09-JUN-2017 (route and anatomical location were not reported) for prophylaxis. A sterile diluent (MRK) used for reconstitution was properly stored. Time frame and temperature of excursion were not reported. It was not reported if there were previous temperature excursions. Digital data logger was not involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse and refers to multiple 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 ROTATEQ orally, lot # M041768 expiration date 25-JUN-2018, lot# N005078 expiration date 22-NOV-2018, lot# N004812 expiration date 04-OCT-2018 for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of ROTATEQ experienced the temperature excursion between 32 and 35 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA007044.
Age: 0.5
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored dose of PNEUMOVAX 23 lot # M040004 with expiration date on 20-MAY-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 33 Fahrenheit grades range for a time frame of 336 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Alopecia, Skin warm, Swelling
Clinical narrative: This spontaneous report was received from a 60 year old female patient regarding herself. The patient refused to answer about her concurrent conditions or pertinent medical history. The patient was receiving unspecified concomitant medications and had no drug reactions or allergies. On an unspecified date in August 2017 (reported as mid-august), the patient was vaccinated with a dose of ZOSTAVAX and PNEUMOVAX 23 at the same time (lot#, dose, frequency and route of administration were unspecified for both vaccines) for prophylaxis. The patient reported that since she was vaccinated, she had been experiencing hair loss, and that after she received the vaccines she had a large bump near the vaccine site and it was warm to the touch. She sought for medical attention; however, no treatment was given for the aforementioned adverse events. No product quality complaint was involved. At the time of the report, the outcome of alopecia, vaccination site warmth and vaccination site mass was unknown. The relatedness assessment between ZOSTAVAX and PNEUMOVAX 23 and alopecia, vaccination site warmth and vaccination site mass was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information was received on 12-SEP-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 31-OCT-2014, administered at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 22-APR-2015, the patient was treated at a medical center, for a painful outbreak that was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information was received on 12-SEP-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about October 4, 2013, administered by a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about September 9, 2016, the patient was treated by a physician for a painful outbreak that was diagnosed as herpes zoster, or shingles. The patient has been prescribed ZOVIRAX for management of his painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX vaccine on or about 23-APR-2013 as recommended for routine adult health maintenance and for the prevention of shingles (lot number, dosage, and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 22-MAR-2016, the patient was treated by a physician assistant for a blistering vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX to attempt to manage and relieve her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information about the patient's past medical history, concurrent conditions, or concomitant medication was received. The patient was inoculated with ZOSTAVAX vaccine on or about 11-JAN-2008 as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 25-AUG-2016, the patient was treated by a physician for a painful outbreak that was diagnosed as herpes zoster, or shingles. On or about 05-SEP-2016, the patient was treated again for continued and worsening symptoms of shingles outbreaks, which was diagnosed as post herpetic neuralgia. The patient has been prescribed VALTREX and Lidocaine for management of her painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 12-SEP-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 30-OCT-2014, administered by a licensed practical nurse at a medical facility, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 02-JUN-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as herpes zoster, or shingles. The patient has been prescribed VALTREX for management of his painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In 2017, also reported as "27-JUN-2017-12-SEP-2017", patients were vaccinated with VARIVAX lot # N008077 with an expiration date 09-MAR-2019, lot# N015477 with an expiration date 18-MAY-2017 for prophylaxis (doses and routes of administration were not reported). Administered doses of VARIVAX experienced the temperature excursion between 15 and 46 degrees Fahrenheit for 21.5 hours. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports received form this reporter. Sender's Comments: US-009507513-1709USA006189: US-009507513-1709USA007003.
Age: 7.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # N002202, expiration date of 04-NOV-2019 or N006321, expiration date of 08-NOV-2019 or N009802, expiration date of 19-DEC-2019; strength, dosage, frequency and route unspecified) for prophylaxis. No adverse effects were reported. Temperature was from 0 degree C to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature was reported as from 9 to 25 degree C (10.9 degree C) for 3 hours 17 minutes. This is one of 5 cases received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot # M039914, expiration date of 26-SEP-2018 or M045392, expiration date of 14-NOV-2018 or M045401, expiration date of 14-NOV-2018; strength, dosage, frequency and route unspecified) for prophylaxis. No adverse effects were reported. Temperature was from 0 degree C to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature was reported as from 9 to 25 degree C (10.9 degree C) for 3 hours 17 minutes. This is one of 5 cases received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # N007931, expiration date of 17-NOV-2019 or N019923, expiration date of 28-APR-2019; strength, dosage, frequency and route unspecified) for prophylaxis.  No adverse effects were reported. Temperature was from 0 degree C to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature was reported as from 9 to 25 degree C (10.9 degree C) for 3 hours 17 minutes. This is one of 5 cases received from the same reporter. ; Sender's Comments:  US-009507513-1709USA000054:
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # M042170, expiration date of 22-JUN-2018 or M044396, expiration date of 19-JUN-2018 or M044397, expiration date of 20-JUN-2018 or N009948, expiration date of 21-OCT-2018; strength, dosage, frequency and route unspecified) for prophylaxis. No adverse effects were reported. Temperature was from 0 degree C to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature was reported as from 9 to 25 degree C (10.9 degree C) for 3 hours 17 minutes. This is one of 5 cases received from the same reporter. Sender's Comments: US-009507513-1709USA007014: Original Case: 1709USA000054.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were administered multiple doses of improperly stored RECOMBIVAX HB (strength, dose, route of administration, lot # and expiration date were not reported). Administered doses of vaccines underwent an unknown temperature excursion, which lasted for an unknown time frame. There was no previous temperature excursion. A digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007016: US-009507513-1709USA007017: US-009507513-1709USA007018: US-009507513-1709USA007019: US-009507513-1709USA002966.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were administered multiple doses of improperly stored ROTATEQ (dose, lot # and expiration date were not reported). Administered doses of vaccines underwent an unknown temperature excursion, which lasted for an unknown time frame. There was no previous temperature excursion. A digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA002966: US-009507513-1709USA007015: US-009507513-1709USA007017: US-009507513-1709USA007018: US-009507513-1709USA007019.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were administered multiple doses of improperly stored M-M-R II (dose, route of administration, lot # and expiration date were not reported), reconstituted with properly stored sterile diluent. Administered doses of vaccines underwent an unknown temperature excursion, which lasted for an unknown time frame. There was no previous temperature excursion. A digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA002966: US-009507513-1709USA007015: US-009507513-1709USA007016: US-009507513-1709USA007018: US-009507513-1709USA007019.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were administered multiple doses of improperly stored GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). Administered doses of vaccines underwent an unknown temperature excursion, which lasted for an unknown time frame. There was no previous temperature excursion. A digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007015: US-009507513-1709USA007016: US-009507513-1709USA007017: US-009507513-1709USA007019: US-009507513-1709USA002966:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were administered multiple doses of improperly stored VARIVAX (dose, route of administration, lot # and expiration date were not reported). Administered doses of vaccines underwent an unknown temperature excursion, which lasted for an unknown time frame. There was no previous temperature excursion. A digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA002966: US-009507513-1709USA007015: US-009507513-1709USA007016: US-009507513-1709USA007017: US-009507513-1709USA007018.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse and refers to multiple 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 VAQTA lot # N019924, expiration date 02-SEP-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 32 and 35 degrees Fahrenheit for 12 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA006172.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse and refers to an 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 RECOMBIVAX HB lot # N006321, expiration date 08-NOV-2019 and lot # N009802, expiration date 19-DEC-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 0.8 degrees Celsius for 52 minutes and 10.9 degrees Celsius for 3 hours and 17 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint has been filled. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007138: US-009507513-1709USA007139: US-009507513-1709USA004848:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse and refers to an 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 M-M-R II lot # M045392, expiration date 14-NOV-2018 and lot # M045401, expiration date 14-NOV-2018 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (MERCK). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 10.9 degrees Celsius for 3 hours and 17 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint has been filled. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007137: US-009507513-1709USA007139: US-009507513-1709USA004848.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions or medical histories provided. On unknown dates (reported as on or after February 2016), the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # N016090 with expiration date on 23-AUG-2018 (dose and route of administration were not reported). The sterile diluent (MRK) used for reconstitution did not undergo a temperature excursion. There was no adverse effect reported. Administered doses of vaccines experienced unknown temperature excursion for unknown time. Data logger was involved. There was previous excursion reported. This is one of several reports received from the same reporter.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Headache, Hypertension, Oropharyngeal pain, Pulmonary congestion
Clinical narrative: This is a spontaneous report from a contactable consumer reported similar events for himself and his wife. This is for himself. This 78-years-old male patient received PREVNAR 13 (Lot number S35324), at 0.5 ml, single in the right arm on 31Aug2017 for immunisation. The patient medical history was not reported. Concomitant medication included metoprolol succinate at 100 mg, 1x/day, in the evening from an unpecified date and ongoing for heart rhythm, acetylsalicylic acid (ASPIRIN ) at 81 mg, 1x/day from an unpecified date and ongoing  for thin blood, colecalciferol (VITAMIN D3) at 5000 IU, alternate day from an unpecified date and ongoing for vitamin D deficiency. The patient experienced lung congestion on Sep2017 with outcome of recovering, sore throat on 31Aug2017 with outcome of recovering, nose running on 01Sep2017 with outcome of recovering, pounding headache on 01Sep2017 with outcome of recovering, blood pressure high on 05Sep2017 with outcome of recovering, coughing on an unspecified date with outcome of unknown. No reaction around the injection site. The patient underwent lab tests and procedures which included blood pressure measurement: 190/100 on 05Sep2017, blood pressure measurement: 180/100 on 07Sep2017. Therapeutic measures were taken as a result of sore throat included gargles with salt water.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Rhinorrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer reported similar events for himself and his wife. This is for himself. This 78-years-old male patient received PREVNAR 13 (Lot number S35324), at 0.5 ml, single in the right arm on 31Aug2017 for immunisation. The patient medical history was not reported. Concomitant medication included metoprolol succinate at 100 mg, 1x/day, in the evening from an unpecified date and ongoing for heart rhythm, acetylsalicylic acid (ASPIRIN ) at 81 mg, 1x/day from an unpecified date and ongoing  for thin blood, colecalciferol (VITAMIN D3) at 5000 IU, alternate day from an unpecified date and ongoing for vitamin D deficiency. The patient experienced lung congestion on Sep2017 with outcome of recovering, sore throat on 31Aug2017 with outcome of recovering, nose running on 01Sep2017 with outcome of recovering, pounding headache on 01Sep2017 with outcome of recovering, blood pressure high on 05Sep2017 with outcome of recovering, coughing on an unspecified date with outcome of unknown. No reaction around the injection site. The patient underwent lab tests and procedures which included blood pressure measurement: 190/100 on 05Sep2017, blood pressure measurement: 180/100 on 07Sep2017. Therapeutic measures were taken as a result of sore throat included gargles with salt water.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Decreased activity, Irritability, Pyrexia, Tachycardia
Clinical narrative: Fever to 101.8, decreased activity, fussy, tachycardia. Treated with TYLENOL and PO hydration. Fever persisted for 36 hours. Then patient was back to normal.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Dry throat, Erythema, Paraesthesia, Throat irritation
Clinical narrative: Employee was given vaccine in early morning and shortly after developed erythema and tingling around her left arm. Employee also experienced "itchiness" and a dry throat.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash erythematous, Rash pruritic
Clinical narrative: Red, raised rash appeared that looks like a band and is itchy. The pain is minor.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: NO ADVERSE EVENT, only a medication error being reported. Patient being seen for a routine child health examination without abnormal findings. Influenza vaccine was ordered - was to be split in two doses, over 2 different appointments. MD order states "Influenza Quad 6-35 mo- 2.5ml", and patient was to report in a month for second dose of .25. Medication error occurred when the LPN gave .5 ml all at once.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Axillary pain, Erythema, Induration, Neck pain, Pruritus
Clinical narrative: 4 x 4 cm indurated, erythematous eruption present on posterior side of (R) arm. Pain at site of vaccination and in axilla area. Minimal itching. No edema in axilla. Normal range of motion. Little bit of neck pain on 9/10/17 but none today. VS signs-afebrile. Used ice and Ibuprofen to treat pain axilla area started 9/10/17. Pt denies chest pain, breathing problems, swelling in tongue or throat, seizures and rash in other areas if body. Conservative treatment continued with ice and Ibuprofen 400 mg every 6 hours for pain. Can take a histamine to help with itching. 9/12/2017 Induration still present erythema, per mother, about the same maybe slightly improved used ice x 1 last night with Ibuprofen. Will continue with conservative treatment. Child in school this am. Will call with update PRN.