chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with VARIVAX (lot #: M040137 with expiration date: 28-SEP-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at a temperature of 8.8°F for 4 hours and 32 minutes, and at a temperature of 17.6°F for 4 hours and 29 minutes; this information was registered in a digital data logger. No previous temperature excursion and no adverse symptoms were reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a registered nurse concerning a male patient of unknown age who was vaccinated with his first dose of GARDASIL (lot number, expiration date, and dosage not provided), intramuscularly, on an unspecified date. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient's second dose of GARDASIL (lot number L040459, expiration date 06-APR-2017), was administered approximately 2 years after his first dose, intramuscularly (dosage not provided). No side effects to report. No further information reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the administrator referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, three improperly stored doses ROTATEQ (lot# M033337 with unknown expiration date; and lot number reported as M040269 (reported twice) with unknown expiration date) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis were administered to unspecified patients. The vaccine doses were exposed to a temperature excursion of 48 Fahrenheit degrees for 30 minutes; no digital data logger was involved or previous temperature excursions. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of three reports received from the same reporter. Lot number M040269 has been verified to be a valid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent. Additional information has been requested. Sender's Comments: US-009507513-1704USA000587: US-009507513-1704USA001660.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a medical assistant concerning a 23 year old female patient. The patient did not have any concomitant medications, pertinent medical history or drug reactions/allergies. On 06-FEB-2017, the patient was vaccinated with VARIVAX (lot # M010483 with expiration date 03-MAR-2018) (dose, strength, frequency, route of administration and anatomical location were not provided), for varicella prevention. At the time of the vaccination, the patient was 25 weeks and 4 days pregnant. No adverse effects were reported. No treatment was given for the adverse events. The reporter stated that no tests for pregnancy were performed at the time of the vaccination. Also no other laboratory diagnostics studies were performed. The patient's last menstrual period was 11-AUG-2016 and estimated date of delivery was 18-MAY-2017. The pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of ROTATEQ (lot # M042821, expiration date 14-JUN-2018; lot # M042822 expiration date 19-JUN-2018; lot # M031805 expiration date 07-MAR-2018 and lot # M040269 expiration date 28-APR-2018) dose was not reported orally for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA010673: US-009507513-1704USA010672.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information was received on 06-APR-2017 from a certified nursing assistant concerning a patient of unknown age and gender. No medical history or concomitant medications were reported. On 25-JAN-2017, the patient received a dose of ROTATEQ (lot M026315, expiry unknown)(dose not reported) orally for prophylaxis. On 05-APR-2017 the patient received a second dose of  ROTARIX (Lot 4Ra2T, expiration not reported)(dose not reported) orally for prophylaxis. No other information was provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and was referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, multiple patients were vaccinated with improperly stored PROQUAD albumin status therapy type rHA, lot number M035690, expiration date 06-FEB-2018, subcutaneously (dose was not reported). The vaccines were reconstituted with properly stored sterile diluent. The vaccines were stored in 42 Fahrenheit degrees for 17 hours, and previously in temperature from 15 Fahrenheit degrees to 46 Fahrenheit degrees for 16 hours. The call was not because of a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA007281.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M035385, expiration date: 08-APR-2018, lot # M040269, expiration date: 28-APR-2018 and lot # M038846, expiration date: 26-APR-2018, orally, as prophylaxis. (Strength and dose were not reported), which experienced a temperature excursion between 47 and 77 Fahrenheit degrees (51.9 Fahrenheit degrees), for 2 hours and 10 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010795: US-009507513-1704USA010796:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored PNEUMOVAX 23 (lot # M043424 expiration date: 06-JUN-2018 and lot # M038359 expiration date: 13-MAY-2018). The vaccines were exposed to 32 to 35 Fahrenheit degree for 2 hours. No previous excursions. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004034: US-009507513-1704USA004040: US-009507513-1704USA004041.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy technician and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M034894, expiration date 11-NOV-2018 and lot # M037248, expiration date 21-FEB-2019 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit, for 33 hours. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 10-APR-2017 from a medical assistant who was reporting on a female patient of unknown age. No medical history or concomitant medications were reported. The medical assistant reported that on an unknown date, the patient received a dose of VARIVAX (lot M028553, expires 06-JUN-2018) (dose and site not reported) that had gone through a temperature excursion. Diluent lot number was either M044953, expires 27-FEB-2019 or lot M017324, expires 25-SEP-2018 (medical assistant was unsure of which lot of diluent was used). The vaccine was stored between 6 degrees F and 14 degrees F for 5 hours and 47 minutes. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse referring to an unspecified number of patients of unknown age. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (strength, dose, lot #, expiration date and anatomical location were not reported) intramuscularly for prophylaxis; which experienced a temperature excursion at 1 Celsius degrees for 15 hours. No previous temperature excursions were reported. Data logger was involved. A product quality complaint was not involved, no adverse events were reported and no additional information was provided. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004670.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received on 19-APR-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine on or about 30-JUN-2016 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-JUL-2016, the patient was treated at a medical center for a painful rash that was diagnosed as 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, and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Ophthalmic herpes zoster, Rash
Clinical narrative: Information was received on 19-APR-2017 from an attorney in the form of an initial legal complaint regarding a male patient (age not provided). Medical history, concurrent conditions and concomitant medications were not provided. On 30-NOV-2011 the patient was vaccinated at a local pharmacy with ZOSTAVAX  for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-MAY-2015 the patient was treated at an eye center for blistering on his face that was diagnosed as shingles. On or about 07-JUL-2016 he was treated for a painful rash that spread to his eyes and he was diagnosed as herpes zoster keratitis, or shingles in the eye. On or about 18-JUL-2016 the patient was treated again at a medical center for continued shingles outbreak. 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, and pain and suffering, and other damages. Upon internal review the event of herpes zoster keratitis was determined to be medically significant. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from medical assistant via physician and refers to a 21 year old female patient. The patient's pertinent medical history, concurrent conditions, past drugs and drug allergies were not reported. On 11-MAY-2016, the patient was vaccinated with improperly stored GARDASIL 9 (dose 1) for prophylaxis. On 11-JUL-2016, the patient was vaccinated with dose 2 of GARDASIL 9 for prophylaxis. This is one of the several reports received from the same reporter (1703USA010036, 1704USA010413 and 1704USA010495). Additional information has been requested. Sender's Comments: US-009507513-1703USA010036: US-009507513-1704USA010413.
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant via physician and refers to 18 year old female patient. The patient's pertinent medical history, concurrent conditions, past drugs and drug allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (lot # M009116) for prophylaxis. This is one of the several reports received from the same reporter (1703USA010036, 1704USA010412 and 1704USA010495). Additional information has been requested. Sender's Comments: US-009507513-1703USA010036: US-009507513-1704USA010412.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as 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, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M012990, expiration date 14-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 0 degrees Celsius to -15 degrees Celsius for an unknown time frame. Data logger was not involved. There were no previous excursions reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant via physician and refers to a 21 year old female patient. The patient's pertinent medical history, concurrent conditions, past drugs and drug allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (lot # M009116) for prophylaxis (number of previous doses was 1). This is one of the several reports received from the same reporter (1703USA010036, 1704USA010412 and 1704USA010413). Additional information has been requested. Sender's Comments: US-009507513-1704USA010413: US-009507513-1703USA010036: US-009507513-1704USA010412.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of VAQTA (lot # reported as M047648, expiration date 28-OCT-2017 and lot # M022924 expiration date 24-JAN-2018) dose and route of administration were not reported for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA010673: US-009507513-1704USA002375.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of RECOMBIVAX HB (lot # M039642, expiration date 03-JUL-2019; lot # N002913 expiration date 23-FEB-2019 and lot # M037248 expiration date 21-FEB-2019) dose and route of administration were not reported for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA002375: US-009507513-1704USA010672:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M035487, expiration date: 23-FEB-2019 and lot # M037248, expiration date: 21-FEB-2019, as prophylaxis. (Strength, dose and route were not reported), which experienced a temperature excursion between 47 and 77 Fahrenheit degrees (51.9 Fahrenheit degrees), for 2 hours and 10 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010796: US-009507513-1704USA003974:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M031557, expiration date: 07-APR-2019 and lot # M037770, expiration date: 01-JUN-2019, as prophylaxis (Strength, route and dose were not reported), which experienced a temperature excursion between 47 and 77 Fahrenheit degrees (51.9 Fahrenheit degrees), for 2 hours and 10 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA010795: US-009507513-1704USA003974.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Borrelia test, Electroencephalogram, Electromyogram, Erythema, Gait disturbance
Clinical narrative: Acute onset of swollen, red hands and feet; followed by severe neurological symptoms. Neurological symptoms included paresthesia bilaterally, gait disturbance, tremor of hand and head, and severe pain. I was seen by 13 different physicians and had 3 hospital admissions, with no explanation for my symptoms. The course of symptoms persisted through April of 2017 and a follow-up appointment is scheduled with my neurologist for May 11th @ 9:15 AM. The reaction led to the loss of my job where I worked as a PhD level educator. I lost my insurance coverage and could not find anyone to explain my issues. I have been under the care of rheumatology x2 physicians, neurology x2 physicians, internal medicine, immunology, and family practice. The illness has not been identified and can only be related to the influenza vaccine.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Head titubation, LE cells, Laboratory test, Loss of employment, Lumbar puncture
Clinical narrative: Acute onset of swollen, red hands and feet; followed by severe neurological symptoms. Neurological symptoms included paresthesia bilaterally, gait disturbance, tremor of hand and head, and severe pain. I was seen by 13 different physicians and had 3 hospital admissions, with no explanation for my symptoms. The course of symptoms persisted through April of 2017 and a follow-up appointment is scheduled with my neurologist for May 11th @ 9:15 AM. The reaction led to the loss of my job where I worked as a PhD level educator. I lost my insurance coverage and could not find anyone to explain my issues. I have been under the care of rheumatology x2 physicians, neurology x2 physicians, internal medicine, immunology, and family practice. The illness has not been identified and can only be related to the influenza vaccine.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Nerve conduction studies, Neurological symptom, Nuclear magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: Acute onset of swollen, red hands and feet; followed by severe neurological symptoms. Neurological symptoms included paresthesia bilaterally, gait disturbance, tremor of hand and head, and severe pain. I was seen by 13 different physicians and had 3 hospital admissions, with no explanation for my symptoms. The course of symptoms persisted through April of 2017 and a follow-up appointment is scheduled with my neurologist for May 11th @ 9:15 AM. The reaction led to the loss of my job where I worked as a PhD level educator. I lost my insurance coverage and could not find anyone to explain my issues. I have been under the care of rheumatology x2 physicians, neurology x2 physicians, internal medicine, immunology, and family practice. The illness has not been identified and can only be related to the influenza vaccine.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Rheumatoid factor, Tremor, West Nile virus test
Clinical narrative: Acute onset of swollen, red hands and feet; followed by severe neurological symptoms. Neurological symptoms included paresthesia bilaterally, gait disturbance, tremor of hand and head, and severe pain. I was seen by 13 different physicians and had 3 hospital admissions, with no explanation for my symptoms. The course of symptoms persisted through April of 2017 and a follow-up appointment is scheduled with my neurologist for May 11th @ 9:15 AM. The reaction led to the loss of my job where I worked as a PhD level educator. I lost my insurance coverage and could not find anyone to explain my issues. I have been under the care of rheumatology x2 physicians, neurology x2 physicians, internal medicine, immunology, and family practice. The illness has not been identified and can only be related to the influenza vaccine.
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There was no adverse reaction. Patient was given PROQUAD, PENTACEL and varicella. CDC was contact for guidance. We were informed that we need to complete a VAERS report. Mother was contacted she states patient did not have any adverse reaction.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Hyperhidrosis, Nausea, Tongue discomfort, Vomiting
Clinical narrative: Employee described symptoms of nausea, vomiting, diaphoretic, and sensation of burning of tongue.
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: Red, raised bump, tender to the touch, still present more than 24 hours after immunization.
Age: 17.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Erythema, Skin discolouration
Clinical narrative: Right earlobe turned purple and left earlobe was red; Not warm to the touch, no pain associated with discoloration.
Age: 17.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Purpura
Clinical narrative: Right earlobe turned purple and left earlobe was red; Not warm to the touch, no pain associated with discoloration.
Age: 17.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Skin discolouration, Vaccination site inflammation
Clinical narrative: Right earlobe turned purple and left earlobe was red; Not warm to the touch, no pain associated with discoloration.
Age: 66.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 66 years old patient (gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on 31-MAR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # M041669, expiration date 09-JAN-2018) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine dose was exposed to a temperature excursion between 15 and 46 Fahrenheit degrees for "at least 15 days"; digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported. This is one of two cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA005276.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 61 years old patient (gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on 20-MAR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # M041669, expiration date 09-JAN-2018) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine dose was exposed to a temperature excursion between 15 and 46 Fahrenheit degrees for "at least 15 days"; digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA002349:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates since 02-MAR-2017, the patients were vaccinated with improperly-stored doses of ROTATEQ lot # M032636, the expiration date: 06-APR-2018 and lot#  M038728, the expiration date: 25-APR-2018 (dose a route were not reported) for prophylaxis. There was no concomitant medication provided.  No adverse effects have been reported. The call was made due the data logger.The temperature of excursion was between 32°F to 35°F during 1 hour and 15 minutes. There was no previous temperature excursion provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information had been received on 19-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 28-JUL-2014 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 23-JUL-2015, the patient was hospitalized for a period of seven days at a medical facility for a painful rash that was diagnosed as a severe case of shingles. Although the shingles virus is an incurable condition, the patient was prescribed Gabapentin for the management of his symptoms. As a direct and proximate result of these malfunctions, 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 and pain and suffering and other damages. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA009630: US-009507513-1704USA009568: US-009507513-1704USA009805: US-009507513-1704USA009830: US-009507513-1704USA009869: US-009507513-1704USA009894:
Age: 49.0
Sex: F
Vaccine: PNC13
Symptoms: Depressed mood, Gait disturbance, Muscle injury, Muscular weakness, Pulmonary fibrosis
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable 50-year-old female consumer (patient) of an unspecified race and ethnicity received, on 02Jan2017, at the age of 49 years, PREVNAR 13 single dose, for immunization. Relevant medical history and concomitant medications were unknown. The patient reported that her muscles were damaged in both arms and legs, on an unspecified date. Stairs were a challenge at time of this report and she barely lifted a bottle of water (her arms and legs were weak). The patient reported that she goes to the gym almost every day. She did 7,000 steps recently and was in bed a couple days after that. The patient was feeling a little depressed because she was such an active person. The patient had sepsis. Hospitalization was required and antibiotic therapy was received. The patient had residual lung scaring in one lung and experienced walking difficulty for about a week after getting out of hospital. Clinical outcome of the events was unknown at time of this report. No follow-up attempts possible. No further information expected.
Age: 49.0
Sex: F
Vaccine: PNC13
Symptoms: Sepsis
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable 50-year-old female consumer (patient) of an unspecified race and ethnicity received, on 02Jan2017, at the age of 49 years, PREVNAR 13 single dose, for immunization. Relevant medical history and concomitant medications were unknown. The patient reported that her muscles were damaged in both arms and legs, on an unspecified date. Stairs were a challenge at time of this report and she barely lifted a bottle of water (her arms and legs were weak). The patient reported that she goes to the gym almost every day. She did 7,000 steps recently and was in bed a couple days after that. The patient was feeling a little depressed because she was such an active person. The patient had sepsis. Hospitalization was required and antibiotic therapy was received. The patient had residual lung scaring in one lung and experienced walking difficulty for about a week after getting out of hospital. Clinical outcome of the events was unknown at time of this report. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Feeling abnormal
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer Sales representative. A female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced felt weird on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Dizziness
Clinical narrative: Patient reported dizziness, chest pains.
Age: 21.0
Sex: F
Vaccine: MNQ, YF
Symptoms: Dyspnoea, Rash, Swelling face
Clinical narrative: Client rec'd vaccine on 03/15/2017. States she left the country on 04/07/2017.  After she returned she complains of onset of rash and facial swelling on 4/17/2017. Reports the second and third day she had difficulty breathing.  States she has seen her doctor and been to urgent care.  States she was notified by MD to notify the health district of possible reaction from vaccine.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Productive cough, Pyrexia, Throat irritation
Clinical narrative: Itchy, scratchy throat progressed into clear productive cough with fevers ranging from 102 to 99.7.
Age: 36.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pharyngeal hypoaesthesia
Clinical narrative: PATIENT CALLED STATING HER THROAT WAS NUMB AND SHE COULD NOT FEEL HER FOOD GOING DOWN. I ADVISED THE PATIENT TO GO THE ER.  THE STATED "I THINK I WILL BE OK"  I ADVISED AGAIN, IF THIS FEELING DOES NOT SUBSIDE WITHIN AN HOUR YOU NEED TO GO TO THE ER NO LONGER.  PATIENT UNDERSTOOD. BUT STILL SAID "I THINK I WILL BE OK".
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Hypoaesthesia, Nuclear magnetic resonance imaging normal, Ultrasound Doppler normal
Clinical narrative: This spontaneous report was received from a 66 year old female patient reporting on herself. The patient's pertinent medical history were not provided. Concurrently, the patient was in an unspecified hormone replacement therapy, did not has any drug reactions/allergies and reported a sluggish thyroid (hypothyroidism). Her concomitant medications included: levothyroxine sodium (manufacturer unknown), estradiol (manufacturer unknown) and progesterone (manufacturer unknown). In July 2015, reported as two years ago in July, the patient was vaccinated with ZOSTAVAX subcutaneously (strength, dose, Lot # and expiration date were not reported) for prevention of shingles. On 26-JAN-2017, the patient began experiencing face numbness. Then, on an unspecified date, in 2017, her physician referred to her to neurologist who performed a Computerized Axial Tomography (CAT) scan of the brain, unspecified Magnetic Resonance Imaging (MRI) and a ultrasound of the patient's carotid artery. The neurologist advised the patient that the tests were negative. The patient was no hospitalized and did not receive any treatment for the adverse event. There was no product quality complaint involved. At the reporting time, the patient was not recovered of hypoaesthesia. The causality assessment between this event and vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 06-SEP-2013, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-JUL-2015, the patient was treated for a painful rash that was diagnosed as shingles. While shingles is a chronic and incurable condition, the patient has been prescribed valcyclovir to manage his 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, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 14-MAY-2014, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-JUL-2015, the patient was treated for a painful rash that was diagnosed as shingles and post herpetic neuralgia, an incurable condition. 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, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, after 24-DEC-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (expiration date of 24-DEC-2016; strength, dose, route, anatomical location and lot number were not provided), for prophylaxis. It was not specified if the diluent used to reconstitute the expired ZOSTAVAX was expired as well. No adverse effects were reported. Additional information is not expected because there was no consent to contact the registered pharmacist.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-NOV-2012, the patient was vaccinated with the second dose of GARDASIL (lot # 0555AE with expiration date of 14-DEC-2014; strength, dose, route and anatomical location were not provided), for prophylaxis. Subsequently, on 17-JAN-2013, the patient was vaccinated with the third dose of GARDASIL (lot # H010428 with expiration date of 20-JAN-2015; strength, dose, route and anatomical location were not provided), also for prophylaxis. It was reported that the interval between the second and third dose of GARDASIL was administered too early. Additionally, the registered nurse stated that there was only a ten week interval between the second and third dose of GARDASIL. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information had been received on 19-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 30-SEP-2013 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster (onset not reported). On or about 12-AUG-2014, patient was treated by a physician for an ongoing painful rash which was diagnosed as shingles. Although shingles is an incurable viral condition, patient was prescribed acyclovir for management of her symptoms. As a direct and proximate result of these malfunctions, 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 and pain and suffering and other damages.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 18-AUG-2014, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-MAY-2016, the patient was treated in the emergency room for an ongoing painful rash which was diagnosed as 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, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 20-APR-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB, lot number K026531 with expiration date 15-APR-2017, (dose, route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration) on or about 18-APR-2014, by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-APR-2016, the patient was treated by a physician for a painful rash that was diagnosed as shingles. Again, on or about 12-OCT-2016, the patient was treated at the same facility for a severe outbreak of herpes zoster, a chronic and incurable condition, for which the patient was prescribed VALTREX to manage her 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, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster, Nerve injury, Ophthalmic herpes zoster, Post herpetic neuralgia
Clinical narrative: Information had been received on 20-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 10-MAY-2012 at a health care facility, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of Herpes Zoster. On or about 15-OCT-2013, the patient was treated at a health care facility for a painful rash that was diagnosed as Herpes Zoster with ophthalmic complication (a strain of shingles that has spread into the eye and caused vision loss). On or about 05-DEC-2013, the patient was treated at the same facility for ongoing and worsening symptoms, which were then diagnosed as post-herpetic neuralgia, a chronic and permanent condition involving nerve damage and pain that occurs as a residual effect of shingles. While shingles and post-herpetic neuralgia are an incurable conditions, the patient has been prescribed VALTREX to manage his 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. Upon internal review, the events of Painful rash diagnosed as Herpes Zoster with ophthalmic complications (a strain of shingles that has spread into the eye and caused vision loss) were determined to be medically significant. The event of treated for ongoing and worsening symptoms, which were then diagnosed as post-herpetic neuralgia was considered to be disabling. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA009733.