chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Angiogram normal, Aphasia, Blood test normal, Computerised tomogram normal, Discomfort
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. It was unknown if the reporter considered the Bell's palsy to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporter did not know any information in regards to the patient or their health care provider. Very limited information was provided.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Drooling, Emotional distress, Eyelid ptosis, Facial paralysis, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. It was unknown if the reporter considered the Bell's palsy to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporter did not know any information in regards to the patient or their health care provider. Very limited information was provided.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Hemiplegia, Hypoacusis, Hypoaesthesia, Malaise, Nuclear magnetic resonance imaging normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. It was unknown if the reporter considered the Bell's palsy to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporter did not know any information in regards to the patient or their health care provider. Very limited information was provided.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Vision blurred, Visual impairment
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. It was unknown if the reporter considered the Bell's palsy to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporter did not know any information in regards to the patient or their health care provider. Very limited information was provided.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Angiogram normal, Blood test normal, Computerised tomogram normal, Discomfort, Drooling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. It was unknown if the reporter considered the Bell's palsy to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporter did not know any information in regards to the patient or their health care provider. Very limited information was provided.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Dysarthria, Emotional distress, Eyelid ptosis, Facial paralysis, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. It was unknown if the reporter considered the Bell's palsy to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporter did not know any information in regards to the patient or their health care provider. Very limited information was provided.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Hypoacusis, Hypoaesthesia, Malaise, Nuclear magnetic resonance imaging normal, Vision blurred
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. It was unknown if the reporter considered the Bell's palsy to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporter did not know any information in regards to the patient or their health care provider. Very limited information was provided.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Visual impairment
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. It was unknown if the reporter considered the Bell's palsy to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporter did not know any information in regards to the patient or their health care provider. Very limited information was provided.
Sex: U
Vaccine: PNC13, PNC13, PNC13
Symptoms: Antibody test positive, Extra dose administered, Product use issue, Therapy non-responder
Clinical narrative: This is a spontaneous report from a contactable physician (pediatrician) received via a Pfizer sales representative. This physician reported similar events for four patients. This is the third of four reports. A patient of unspecified age, race/ethnicity and gender received the fourth single dose of PREVNAR 13 on an unspecified date, for immunisation. The patient medical history and concomitant medications were not reported. The patient did not seroconvert after the 4th administration of pneumococcal 13-val conj vaccine. Checking titers was necessary after a complete immune work-up due to frequent illnesses. After the 5th dosage, titers increased significantly. Information on batch number has been requested. Sender's Comments: Linked Report(s): PFIZER INC-2018193889 same reporter/product/event, different patient.
Sex: U
Vaccine: PNC13, PNC13, PNC13
Symptoms: Antibody test negative, Autoantibody test
Clinical narrative: This is a spontaneous report from a contactable physician (pediatrician) received via a Pfizer sales representative. This physician reported similar events for four patients. This is the third of four reports. A patient of unspecified age, race/ethnicity and gender received the fourth single dose of PREVNAR 13 on an unspecified date, for immunisation. The patient medical history and concomitant medications were not reported. The patient did not seroconvert after the 4th administration of pneumococcal 13-val conj vaccine. Checking titers was necessary after a complete immune work-up due to frequent illnesses. After the 5th dosage, titers increased significantly. Information on batch number has been requested. Sender's Comments: Linked Report(s): PFIZER INC-2018193889 same reporter/product/event, different patient.
Sex: U
Vaccine: PNC13, PNC13, PNC13
Symptoms: Antibody test positive, Extra dose administered, Immune complex assay, Product use issue, Therapy non-responder
Clinical narrative: This is a spontaneous report from a contactable physician (pediatrician) received via a Pfizer sales representative. This physician reported similar events for four patients. This is the third of four reports. A patient of unspecified age, race/ethnicity and gender received the fourth single dose of PREVNAR 13 on an unspecified date, for immunisation. The patient medical history and concomitant medications were not reported. The patient did not seroconvert after the 4th administration of pneumococcal 13-val conj vaccine. Checking titers was necessary after a complete immune work-up due to frequent illnesses. After the 5th dosage, titers increased significantly. Information on batch number has been requested. Sender's Comments: Linked Report(s): PFIZER INC-2018193889 same reporter/product/event, different patient.
Age: 46.0
Sex: M
Vaccine: YF
Symptoms: Influenza
Clinical narrative: Flu Symptoms.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # N007931 for prophylaxis. On an unknown date, the patient experienced incorrect product storage, circumstance or information capable of leading to medication error and no adverse event. The outcome of incorrect product storage, no adverse event and circumstance or information capable of leading to medication error is unknown. The reporter considered incorrect product storage, circumstance or information capable of leading to medication error and no adverse event to be not related to GARDASIL 9. (Additional information has been requested. / Additional information is not expected.) Upon receipt of follow-up information it was determined that this case is now valid because patient identifiers were identified. It was reported that there were 5 patients who were vaccinated with the lot# N007931 involved in the temperature excursion. Follow up information received on 10-MAY-2018: This spontaneous report was received from a nurse practitioner refers to a 16-year-old female patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On 09-OCT-2017 the patient was vaccinated with doses of improperly stored GARDASIL 9 (dose, units and frequency were unknown) (lot # N007931 and expiration date 17-NOV-2019). The temperature excursion was at 9 C to 25 C (10 C) [C (degree centigrade)] for 1 hour. No adverse effects were reported. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was reported. This is one of several reports received from the same reporter (1805USA004616, 1805USA004664, 1805USA004665 and 1805USA004666).
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an unspecified number of patients of unknown age and gender. The patients' medical history, drug reactions, allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 for prophylaxis (lot # M043987, expiry date: 30-JUN-2018). No adverse events were reported. The temperature/Time frame was as follows: 32°F to 35°F for 8 minutes. 32°F to 35°F for 6 minutes. No previous temperature excursion reported. Call was because of data logger (Yes). As of 11-MAY-2018, all telephone attempts to obtain follow-up information have been unsuccessful.
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Amnesia, Diplegia, Fall, Head injury, Seizure
Clinical narrative: This spontaneous report was received from a pediatrician via a company representative and refers to an unspecified patient of an unknown age and gender. The patient had been fasting prior the office visit, for an unspecified period of time. The patient's medical history, historical drugs and concomitant therapies were not reported. In April 2018 (reported as "last week"), the patient was vaccinated with GARDASIL 9 intramuscularly (strength, dose, lot number and expiration date were not reported) for prevention of human papillomavirus (HPV). On the same date within the 30 seconds of administering the injection (April 2018), the patient experienced a seizure. It was unknown if treatment was given for the aforementioned event or if laboratory diagnostics or studies were performed. The outcome of seizure was unknown. The causal relationship between the event and GARDASIL 9 was not reported. There was no product quality complaint (PQC) reported. No further adverse event information was provided. Upon internal review, the event of seizure was considered to be serious due to medically significant. This is a non-valid case due to lack of patient identifier. Follow up information has been received on 07-MAY-2018. Upon receipt of follow-up information it was determined that this case is now valid because of availability of patient demographics. The reporter stated that the patient was 11 year old male. On 06-APR-2018, the patient was vaccinated with GARDASIL 9 for prophylaxis. At the same time the patient received co-suspect diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TdaP) (dose, frequency, route, lot number and expiry date not reported) for prophylaxis. On the same day, the patient experienced seizure manifested by syncope, temporary paralysis of arms and legs which was followed by amnesia. It was further stated that the patient fell back (fall) and hit his head on an unspecified object (head injury). It was also reported that after the event, the patient was transferred by ambulance to emergency room (ER) for evaluation. No treatment was given in ER. Patient was advised to follow up with a neurologist. The outcome of head injury was not reported. The relationship between the suspects and the events was not reported. No further information was provided. Upon follow up, it has been determined that case # US-009507513-1804USA010705 is a duplicate of case # US-009507513-1804USA010540. Therefore, case # US-009507513-1804USA010705 is being deleted from our files and the cases are consolidated into case # US-009507513-1804USA010540.
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a pediatrician via a company representative and refers to an unspecified patient of an unknown age and gender. The patient had been fasting prior the office visit, for an unspecified period of time. The patient's medical history, historical drugs and concomitant therapies were not reported. In April 2018 (reported as "last week"), the patient was vaccinated with GARDASIL 9 intramuscularly (strength, dose, lot number and expiration date were not reported) for prevention of human papillomavirus (HPV). On the same date within the 30 seconds of administering the injection (April 2018), the patient experienced a seizure. It was unknown if treatment was given for the aforementioned event or if laboratory diagnostics or studies were performed. The outcome of seizure was unknown. The causal relationship between the event and GARDASIL 9 was not reported. There was no product quality complaint (PQC) reported. No further adverse event information was provided. Upon internal review, the event of seizure was considered to be serious due to medically significant. This is a non-valid case due to lack of patient identifier. Follow up information has been received on 07-MAY-2018. Upon receipt of follow-up information it was determined that this case is now valid because of availability of patient demographics. The reporter stated that the patient was 11 year old male. On 06-APR-2018, the patient was vaccinated with GARDASIL 9 for prophylaxis. At the same time the patient received co-suspect diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TdaP) (dose, frequency, route, lot number and expiry date not reported) for prophylaxis. On the same day, the patient experienced seizure manifested by syncope, temporary paralysis of arms and legs which was followed by amnesia. It was further stated that the patient fell back (fall) and hit his head on an unspecified object (head injury). It was also reported that after the event, the patient was transferred by ambulance to emergency room (ER) for evaluation. No treatment was given in ER. Patient was advised to follow up with a neurologist. The outcome of head injury was not reported. The relationship between the suspects and the events was not reported. No further information was provided. Upon follow up, it has been determined that case # US-009507513-1804USA010705 is a duplicate of case # US-009507513-1804USA010540. Therefore, case # US-009507513-1804USA010705 is being deleted from our files and the cases are consolidated into case # US-009507513-1804USA010540.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Herpes zoster, Polymerase chain reaction, Varicella virus test
Clinical narrative: This spontaneous report as received from a physician refers to a 10-year-old male patient with no pertinent medical history and no drug reactions/allergies. The patient had never had chicken pox. There was no concomitant medications. On 20-SEP-2007, the patient was vaccinated with a dose of VARIVAX (dose, route of administration, lot number and expiration date were not reported)for prophylaxis by another unspecified healthcare provider. On 21-SEP-2010, the patient was vaccinated with a dose of PROQUAD (dose, route of administration, albumin status, lot number and expiration date were not reported) for prophylaxis. Other suspect products included sterile diluent (route of administration, lot number and expiration date were not reported) administered on 20-SEP-2007 and 21-SEP-2010. On 27-SEP-2016, the patient developed herpes zoster, which was confirmed by the dermatologist. He sought medical attention. The reporting physician saw the patient for a well visit on 28-SEP-2016, and at that time, the herpes zoster was located on the patient's right shoulder. On 27-APR-2017, the patient was seen by the physician and the herpes zoster was developed for the second time and was located on the dorsum of his right hand. The reporting physician explained that he sent the pictures of the patient's experienced to an other physician and she said that the patient looked like he had a zoster. At the time of the report, the patient was being treated with acyclovir 4 grams a day (no other details was reported). No lab diagnostics/studies were performed. The outcome of herpes zoster was reported as not recovered. The reporter was interested in varicella zoster virus (VZV) analysis by Polymerase Chain Reaction (PCR). The patient's sample was sent to the laboratory on 03-MAY-2018, for PCR analysis. The causality between the herpes zoster and VARIVAX, PROQUAD and sterile diluent was not provided.
Age: 7.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 7 year old female patient. The patient's relevant medical history and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent. On 02-MAY-2018, the patient was vaccinated with VARIVAX lot number: N022978, expiration date: 23-AUG-2019, for prophylaxis (strength, route and dosage schedule were not reported). On the same day, the patient was also vaccinated with PROQUAD (rHa/HSA) lot number: N022954, expiration date: 02-MAY-2019, subcutaneously, for prophylaxis (strength and dosage schedule were not reported). No adverse effects were reported.
Sex: M
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse, concerning a male patient of unknown age. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 20-APR-2018, a dose of ROTATEQ was improperly stored. The temperature of excursion was reported as 9C, during a time frame of 1 hour 50 minutes. There was no previous temperature of excursion. On 26-APR-2018, the patient was vaccinated with the improperly stored ROTATEQ first dose, 1 tube orally, for prophylaxis, lot #N02200 and expiration date reported as 31-OCT-2019 (strength was not reported). There was a Digital Data Logger involved.
Sex: U
Vaccine: MMRV, VARCEL, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies, and concomitant medications were not provided. On an unknown date, the patient may have received an improperly stored dose of PROQUAD for prophylaxis, lot #N025718 and expiration date 17-MAR-2019; lot #N021725 and expiration date 06-FEB-2019; lot #N035171 and expiration date 19-JUN-2019; and lot #N028447 and expiration date 09-APR-2019 (strength, dose, frequency and route of administration were not reported); or may have received an improperly stored dose VARIVAX for prophylaxis, lot #N022986 and expiration date 23-AUG-2019; lot #N025934 and expiration date 19-SEP-2019; lot #N025933 19-SEP-2019; and lot #N030410 and expiration date 30-OCT-2019 (strength, dose, frequency and route of administration were not reported); or may have received an improperly stored dose of ZOSTAVAX for prophylaxis, lot #N025569 and expiration date 13-DEC-2018 and lot #N025704 16-DEC-2018 (strength, dose, frequency and route of administration were not reported). No adverse event was reported. The temperature of excursion was reported as 15°F to 46°F during a time frame of 1 hour. Previous temperature of excursion was reported as a total time in the range of 15°F to 46°F for 24 hours and in the range of 6°F to 14°F for 519 hours and 45 minutes. There was a digital data logger involved.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # N003703 expiry date: 29-OCT-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9) (dose, frequency and route of administration were not reported) (lot # N003703, expiry date: 29-OCT-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # N003703 expiry date: 29-OCT-2019 and lot # N018273 expiry date: 17-JUN-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was 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. During 2014, the patient as inoculated by a physician with ZOSTAVAX (lot number, dosage, and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 13-JUN-2016, the patient was treated at a hospital for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 02-MAR-2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 17-JUN-2016, the patient was treated by a physician, for the onset of a vesicular rash, which was diagnosed as herpes zoster. On or about 02-AUG-2016, the patient sought subsequent treatment from the physician for ongoing and worsening symptoms of shingles and pain, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections.  The patient has been prescribed gabapentin, LYRICA, nortriptyline, and OXYCONTIN for management of her painful symptoms and excruciating pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 16-JUL-2016, the patient was treated at a medical clinic for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acyclovir and gabapentin to manage his painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 23-OCT-2008, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2017, the patient was treated at a medical center for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 17-JUN-2016, the patient was treated by a physician for a persistent vesicular rash, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed naproxen and VALTREX for management of his painful and chronic symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 06-JAN-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was 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. During 2016, the patient was inoculated by a physician at a clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in-2016, the patient was treated by the same physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 09-MAY-2018, the patient was vaccinated with an expired dose of VAQTA (strength and dose were not reported) with lot # N005605 and expiration date of 08-APR-2018, intramuscularly for prophylaxis. No adverse effects were reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1805USA006170.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from two pharmacists via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 09-MAY-2018, the patient was vaccinated with an expired dose of VAQTA (strength and dose were not reported) with lot # N005605 and expiration date of 08-APR-2018, intramuscularly for prophylaxis. No adverse effects were reported. This is one of two reports received  from  the same reporter.; Sender's Comments: US-009507513-1805USA006121:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster, Immunology test, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 46-month-old male with no pertinent medical history who in approximately February 2000, was vaccinated with a 0.5 ml dose of varicella virus vaccine live. There was no concomitant medication. Subsequently, as reported on 23-Dec-2002, the patient "just recently" experienced zoster on his face. It was reported that the patient was hospitalized. He was treated with topical and systemic steroids. The physician has an isolate, and requested analysis by PCR. No further data was provided. Follow up information, received from a physician, indicates that the patient was a 44 month old male, with no allergies, who on 11-Feb-2000 was vaccinated with a dose of varicella virus vaccine live (lot # 631777/1352J) into the right thigh. It was noted that there was no illness at the time of vaccination. Subsequently, on 18-Oct-2002 the patient was diagnosed with right facial herpes zoster of the V1 and V2 dermatome, fever and a pain level of  6 out of 10. Patient was treated with oral prednisone, topical hydrocortisone and acyclovir. It was reported that patient did not have recent exposure to chickenpox. However, he was exposed to varicella at one day of age. Additional information received from a physician indicates that the patient was hospitalized for a total of 6 days. The reporter also indicates that a herpes simplex virus culture collected from the vesicles on 18-Oct-2002 isolated varicella zoster, the culture was confirmed by immunofluorescence testing. A vesicular lesion, adequate specimen, isolated from the face of the patient was amplified and showed wild-type strain. B-globin DNA was not amplified. The reporter indicates that the patient recovered on 24-Oct-2002. This is an amended report. The PT for event of zoster on his face was changed from varicella zoster virus infection to Herpes Zoster. Sender's Comments: MERCK 0212USA02052: Mfr number.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella virus test positive
Clinical narrative: Information has been received from a physician concerning a 46-month-old male with no pertinent medical history who in approximately February 2000, was vaccinated with a 0.5 ml dose of varicella virus vaccine live. There was no concomitant medication. Subsequently, as reported on 23-Dec-2002, the patient "just recently" experienced zoster on his face. It was reported that the patient was hospitalized. He was treated with topical and systemic steroids. The physician has an isolate, and requested analysis by PCR. No further data was provided. Follow up information, received from a physician, indicates that the patient was a 44 month old male, with no allergies, who on 11-Feb-2000 was vaccinated with a dose of varicella virus vaccine live (lot # 631777/1352J) into the right thigh. It was noted that there was no illness at the time of vaccination. Subsequently, on 18-Oct-2002 the patient was diagnosed with right facial herpes zoster of the V1 and V2 dermatome, fever and a pain level of  6 out of 10. Patient was treated with oral prednisone, topical hydrocortisone and acyclovir. It was reported that patient did not have recent exposure to chickenpox. However, he was exposed to varicella at one day of age. Additional information received from a physician indicates that the patient was hospitalized for a total of 6 days. The reporter also indicates that a herpes simplex virus culture collected from the vesicles on 18-Oct-2002 isolated varicella zoster, the culture was confirmed by immunofluorescence testing. A vesicular lesion, adequate specimen, isolated from the face of the patient was amplified and showed wild-type strain. B-globin DNA was not amplified. The reporter indicates that the patient recovered on 24-Oct-2002. This is an amended report. The PT for event of zoster on his face was changed from varicella zoster virus infection to Herpes Zoster. Sender's Comments: MERCK 0212USA02052: Mfr number.
Age: 56.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Headache, Oropharyngeal pain, Vision blurred
Clinical narrative: Headache for two days straight, very bad. Front and back of the head. Blurry vision. Tiredness and throat pain. Headache doesn't go away. No treatment, waiting for the headache to stop but it only gets worse.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Dry skin
Clinical narrative: Uncontrolled drying with apparent Abd pain.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Dermatitis acneiform, Discomfort, Fatigue, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of neuropathy peripheral in a 75-year-old female patient who received SHINGRIX. The patient's past medical history included depression. Concurrent medical conditions included cholesterol. On 20th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 1 day 2 hrs after receiving SHINGRIX, the patient experienced fatigue and activities of daily living impaired. On 20th April 2018, the patient experienced neuropathy peripheral (serious criteria GSK medically significant), pain, discomfort and insomnia. In May 2018, the patient experienced pimples. On an unknown date, the patient experienced rash acneiform. The patient was treated with VALIUM and TYLENOL. On 21st April 2018, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the neuropathy peripheral, fatigue, activities of daily living impaired and pimples were not recovered/not resolved and the outcome of the discomfort, insomnia and rash acneiform were unknown. The reporter considered the neuropathy peripheral, pain, fatigue and pimples to be related to SHINGRIX. It was unknown if the reporter considered the discomfort, insomnia, activities of daily living impaired and rash acneiform to be related to SHINGRIX. Additional information was received as follows: The patient received concomitant products included LEXAPRO generic and Statin. On 20th April 2018, at 01:00, the patient received SHINGRIX on right arm. On 20th April 2018, at 03:00, 2 hrs after receiving SHINGRIX, the patient experienced neuropathy which was down her arm, across her shoulder and down her spine and pain. On 21st April 2018, the patient experienced fatigue at (03:00 hrs) and activities of daily living impaired. The patient took VALIUM but it did not help and she drank some scotch but that only made the pain worse. Three to four days before the reporting date, the patient started to experience a breakout on her face. The patient described it as looking like pimples. They are scattered all over her face. The patient was noticing that there were new spots every day. The patient stated that neuropathy and fatigue were not as severe, but they were still there and still affecting her daily life and kept her from doing some things. The patient had spoken to her physician who told her not to do anything and would check on her weekly.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Neuropathy peripheral, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of neuropathy peripheral in a 75-year-old female patient who received SHINGRIX. The patient's past medical history included depression. Concurrent medical conditions included cholesterol. On 20th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 1 day 2 hrs after receiving SHINGRIX, the patient experienced fatigue and activities of daily living impaired. On 20th April 2018, the patient experienced neuropathy peripheral (serious criteria GSK medically significant), pain, discomfort and insomnia. In May 2018, the patient experienced pimples. On an unknown date, the patient experienced rash acneiform. The patient was treated with VALIUM and TYLENOL. On 21st April 2018, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the neuropathy peripheral, fatigue, activities of daily living impaired and pimples were not recovered/not resolved and the outcome of the discomfort, insomnia and rash acneiform were unknown. The reporter considered the neuropathy peripheral, pain, fatigue and pimples to be related to SHINGRIX. It was unknown if the reporter considered the discomfort, insomnia, activities of daily living impaired and rash acneiform to be related to SHINGRIX. Additional information was received as follows: The patient received concomitant products included LEXAPRO generic and Statin. On 20th April 2018, at 01:00, the patient received SHINGRIX on right arm. On 20th April 2018, at 03:00, 2 hrs after receiving SHINGRIX, the patient experienced neuropathy which was down her arm, across her shoulder and down her spine and pain. On 21st April 2018, the patient experienced fatigue at (03:00 hrs) and activities of daily living impaired. The patient took VALIUM but it did not help and she drank some scotch but that only made the pain worse. Three to four days before the reporting date, the patient started to experience a breakout on her face. The patient described it as looking like pimples. They are scattered all over her face. The patient was noticing that there were new spots every day. The patient stated that neuropathy and fatigue were not as severe, but they were still there and still affecting her daily life and kept her from doing some things. The patient had spoken to her physician who told her not to do anything and would check on her weekly.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Erythema, Headache, Myalgia
Clinical narrative: Fever, redness, swelling in the arm, pain, muscle aches chills, sore joins, headache (symptoms lasted four days). Swelling in the arm and redness spread to a very large area. With very high fever in the arm. Continued for more than a week I just took TYLENOL.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Fever, redness, swelling in the arm, pain, muscle aches chills, sore joins, headache (symptoms lasted four days). Swelling in the arm and redness spread to a very large area. With very high fever in the arm. Continued for more than a week I just took TYLENOL.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: Patient states that they started seeing signs of Bell's palsey including facial drooping and numbness.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 20 cm x 10 cm swelling, erythema, warmth of left upper arm. Recommend cool compress, antihistamine. (Patient currently on an antibiotic for UTI). Temp: 99.2 Tympanic. No tongue swelling, throat swelling, cough, wheezing, or shortness of breath.