chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash erythematous, Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 11th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 21st July 2018, 10 days after receiving SHINGRIX, the patient experienced shingles, blistery rash and erythematous rash. On an unknown date, the outcome of the shingles, blistery rash and erythematous rash were unknown. It was unknown if the reporter considered the shingles, blistery rash and erythematous rash to be related to SHINGRIX. Additional details were received as follows: The pharmacy intern reported that, the patient noticed a blistery, red rash on the right side of her waistline. The patient visited a dermatologist, who diagnosed her with shingles. No additional details were available.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Coma scale abnormal, Posturing, Unresponsive to stimuli
Clinical narrative: Information has been received from a physician, referring to a 13 year old female patient. The patient had no pertinent medical history, drug reactions or allergies. The patient had no concomitant medication. On 31-JUL-2018, the patient was vaccinated with a dose of GARDASIL 9 (lot number N025429, expiration date 21-JUL-2020, route unknown) to prevent human papillomavirus. On 31-JUL-2018, immediately afterwards the patient developed syncope and difficulty breathing. That same day, the patient was admitted to the hospital, where she was intubated and also BENADRYL, SOLU-MEDROL, albuterol (manufacturers unknown) to aid with breathing. The patient underwent chest X-ray, complete blood count (CBC), electrocardiogram (EKG) and head computerized tomography (CT) scan, and all results were not reported. The patient also had pregnancy test, which showed not pregnant. The patient recovered from these events on 01-AUG-2018, but she still had not been discharged from the hospital. The causality assessment between the events and GARDASIL 9 was not provided. The physician considered the severity of these events to be life threatening. Upon internal review, syncope and difficulty breathing (required intubation as treatment) were determined to be medically significant.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Muscle twitching, Pallor
Clinical narrative: Information has been received from a physician, referring to a 13 year old female patient. The patient had no pertinent medical history, drug reactions or allergies. The patient had no concomitant medication. On 31-JUL-2018, the patient was vaccinated with a dose of GARDASIL 9 (lot number N025429, expiration date 21-JUL-2020, route unknown) to prevent human papillomavirus. On 31-JUL-2018, immediately afterwards the patient developed syncope and difficulty breathing. That same day, the patient was admitted to the hospital, where she was intubated and also BENADRYL, SOLU-MEDROL, albuterol (manufacturers unknown) to aid with breathing. The patient underwent chest X-ray, complete blood count (CBC), electrocardiogram (EKG) and head computerized tomography (CT) scan, and all results were not reported. The patient also had pregnancy test, which showed not pregnant. The patient recovered from these events on 01-AUG-2018, but she still had not been discharged from the hospital. The causality assessment between the events and GARDASIL 9 was not provided. The physician considered the severity of these events to be life threatening. Upon internal review, syncope and difficulty breathing (required intubation as treatment) were determined to be medically significant.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Chest X-ray, Computerised tomogram head, Dyspnoea, Electrocardiogram, Endotracheal intubation
Clinical narrative: Information has been received from a physician, referring to a 13 year old female patient. The patient had no pertinent medical history, drug reactions or allergies. The patient had no concomitant medication. On 31-JUL-2018, the patient was vaccinated with a dose of GARDASIL 9 (lot number N025429, expiration date 21-JUL-2020, route unknown) to prevent human papillomavirus. On 31-JUL-2018, immediately afterwards the patient developed syncope and difficulty breathing. That same day, the patient was admitted to the hospital, where she was intubated and also BENADRYL, SOLU-MEDROL, albuterol (manufacturers unknown) to aid with breathing. The patient underwent chest X-ray, complete blood count (CBC), electrocardiogram (EKG) and head computerized tomography (CT) scan, and all results were not reported. The patient also had pregnancy test, which showed not pregnant. The patient recovered from these events on 01-AUG-2018, but she still had not been discharged from the hospital. The causality assessment between the events and GARDASIL 9 was not provided. The physician considered the severity of these events to be life threatening. Upon internal review, syncope and difficulty breathing (required intubation as treatment) were determined to be medically significant.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Full blood count, Immediate post-injection reaction, Pregnancy test negative, Syncope
Clinical narrative: Information has been received from a physician, referring to a 13 year old female patient. The patient had no pertinent medical history, drug reactions or allergies. The patient had no concomitant medication. On 31-JUL-2018, the patient was vaccinated with a dose of GARDASIL 9 (lot number N025429, expiration date 21-JUL-2020, route unknown) to prevent human papillomavirus. On 31-JUL-2018, immediately afterwards the patient developed syncope and difficulty breathing. That same day, the patient was admitted to the hospital, where she was intubated and also BENADRYL, SOLU-MEDROL, albuterol (manufacturers unknown) to aid with breathing. The patient underwent chest X-ray, complete blood count (CBC), electrocardiogram (EKG) and head computerized tomography (CT) scan, and all results were not reported. The patient also had pregnancy test, which showed not pregnant. The patient recovered from these events on 01-AUG-2018, but she still had not been discharged from the hospital. The causality assessment between the events and GARDASIL 9 was not provided. The physician considered the severity of these events to be life threatening. Upon internal review, syncope and difficulty breathing (required intubation as treatment) were determined to be medically significant.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Fall, Hyperhidrosis, Injection site swelling, Syncope
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 62-year-old male patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. On 31st July 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 31st July 2018, immediately after receiving SHINGRIX, the patient experienced swelling arm (serious criteria other: as per reporter), fainting (serious criteria other: as per reporter), loss of consciousness (serious criteria GSK medically significant and other: as per reporter) and excess sweating (serious criteria other: as per reporter). The patient was treated with BENADRYL. On an unknown date, the outcome of the swelling arm, loss of consciousness and excess sweating were unknown and the outcome of the fainting was recovered/resolved. It was unknown if the reporter considered the swelling arm, fainting, loss of consciousness and excess sweating to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right deltoid. The healthcare professional (HCP) reported that, while injecting a dose of SHINGRIX the patient's arm was immediately began to swell and the patient began sweating profusely, fainted and had brief loss of consciousness. The patient was given BENADRYL 50 mg injection (in left arm) by the reporter. The reporter stated that the patient came around by the time the emergency personnel arrived. The patient was brought to hospital via ambulance.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Peripheral swelling, Syncope
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 62-year-old male patient who received SHINGRIX (batch number 9YD45, expiry date 2nd February 2021) for prophylaxis. On 31st July 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 31st July 2018, immediately after receiving SHINGRIX, the patient experienced swelling arm (serious criteria other: as per reporter), fainting (serious criteria other: as per reporter), loss of consciousness (serious criteria GSK medically significant and other: as per reporter) and excess sweating (serious criteria other: as per reporter). The patient was treated with BENADRYL. On an unknown date, the outcome of the swelling arm, loss of consciousness and excess sweating were unknown and the outcome of the fainting was recovered/resolved. It was unknown if the reporter considered the swelling arm, fainting, loss of consciousness and excess sweating to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right deltoid. The healthcare professional (HCP) reported that, while injecting a dose of SHINGRIX the patient's arm was immediately began to swell and the patient began sweating profusely, fainted and had brief loss of consciousness. The patient was given BENADRYL 50 mg injection (in left arm) by the reporter. The reporter stated that the patient came around by the time the emergency personnel arrived. The patient was brought to hospital via ambulance.
Age: 5.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a nurse and refers to a 5 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 31-JUL-2018, the patient was vaccinated with a dose of PROQUAD injection, subcutaneously, lot # R006216, expiration date 28-AUG-2019 (exact dose and anatomical localization were not reported), which was reconstituted with sterile diluent. During the vaccination, the patient pulled away and inadvertently did not receive full 0.5 ml dose. No adverse effects were reported.
Age: 0.17
Sex: U
Vaccine: RV5, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 9 week old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided. On 06-JUL-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020,  for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported.; Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293:
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Sleep disorder
Clinical narrative: Strong shivering from 1 a.m. until 6 a.m., preventing sound sleep.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse manager and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 25-JUN-2018, the patient was vaccinated with improperly stored GARDASIL 9 (lot #: N007931, expiration date: 17-NOV-2019, dose, strength, frequency and route of administration were not provided) for prophylaxis. Administered vaccine experienced multiple temperature excursions of 32-35 degrees Fahrenheit (33 degrees Fahrenheit) for 7 days. Data logger was involved. There was no previous excursion reported. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse, and refers to a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions, concomitant medication and allergies was not provided. On 19-JUL-2018, the patient was vaccinated with GARDASIL 9 lot # N003703 and expiration date of 29-OCT-2019, intramuscular for prophylaxis (dose was not reported). At the time of vaccination, the patient was 32 weeks and 5 days pregnant (maternal exposure during pregnancy). There were no adverse effects reported. No additional information was provided. The patient's estimated last menstrual period (LMP) was calculated to 03-DEC-2017, and her estimated date of delivery (EDD) was calculated to be on 09-SEP-2018. No prenatal tests or results were reported. Neither the pregnancy outcome nor the fetal outcomes were known at the time of the report. The initial exposure to GARDASIL 9 was at 32 weeks, during the third trimester of pregnancy (maternal exposure during pregnancy).
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 4 month old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 27-JUN-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 9 week old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 25-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.  Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 9 week old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 26-JUN-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 9 week old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 29-JUN-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 15 month old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 27-JUN-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 9 weeks old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 29-JUN-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 15 month old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 09-JUL-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 15 month old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 09-JUL-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 13 week old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided. On 28-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020,  for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293:
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 8 week old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 28-JUN-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 8 week old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided. On 27-JUN-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 15 month old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided. On 09-JUL-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020,  for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
Age: 1.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 16 month old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided. On 05-JUL-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020, for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012304: US-009507513-1807USA012294: US-009507513-1807USA012294: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 15 month old patient of unknown gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided. On 26-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot # R001085, expiration date on 30-SEP-2020,  for prophylaxis (dosage schedule, route and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 0 to 1 (1.4) degrees Celsius for 3 hours. Digital Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA004691: US-009507513-1807USA012290: US-009507513-1807USA012291: US-009507513-1807USA012292: US-009507513-1807USA012294: US-009507513-1807USA012295: US-009507513-1807USA012296: US-009507513-1807USA012297: US-009507513-1807USA012298: US-009507513-1807USA012299: US-009507513-1807USA012300: US-009507513-1807USA012301: US-009507513-1807USA012302: US-009507513-1807USA012303: US-009507513-1807USA012289: US-009507513-1807USA012288: US-009507513-1807USA012287: US-009507513-1807USA012286: US-009507513-1807USA012293:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 25-MAR-2014, the patient was inoculated at a pharmacy with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Blood pressure increased, Echocardiogram normal, Hypertension, Loss of consciousness
Clinical narrative: This spontaneous report was received from a 68-year-old male patient referring himself. The patient had no pertinent medical history and drug reactions/allergies. The patient's concomitant therapy included nitrates for circulation to his legs. On an unknown date in 2015 (reported as I believe it was in 2015), the patient was vaccinated with first dose of PNEUMOVAX 23, 0.5 ml, intramuscular for prevention of pneumococcal disease. On 06-JUL-2018, the patient was vaccinated with second dose of PNEUMOVAX 23 0.5 ml, intramuscular (lot # and expiry date was unknown) for prevention of pneumococcal disease. Other suspect therapy included NOVOCAIN (indication, strength, dose, frequency, lot # and expiry date was not reported). On 06-JUL-2018 (later that same day), the patient's blood pressure was elevated. Ever since then, the patient has had hypertension and the patient's blood pressure was elevated in the morning and came back down "to within reason" in the afternoon. The patient also stated that he had "passed out" when he was given NOVOCAIN. The patient had an echocardiogram and the results "were normal". The patient verified that he had not sought medical attention. No treatment was given for the adverse events. Action taken with NOVOCAIN was unknown. The outcome of loss of consciousness and hypertension was reported as not recovered. Causality assessment was not reported. No product quality compliant (PQC) was reported. Upon internal review, the event "loss of consciousness" was determined to be medically significant.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from medical assistant, concerning a 5 year old patient of an unknown gender. The patient's medical history, previously drug reactions, allergies, concurrent conditions and concomitant medications were not reported. On 26-OCT-2017, the patient was vaccinated with the first dose of PROQUAD subcutaneously, lot number N028445 with expiration date on 09-APR-2019 (strength, anatomical location and albumin status were not provided), reconstituted with DILUENT MRK 1 DF once, lot number: M035268 with expiration date on 19-APR-2019 (strength and anatomical location were not provided), as a first dose of measles, mumps, rubella, and varicella vaccination series (prophylaxis). On 31-JUL-2018, the patient received the second dose of their measles, mumps, rubella, and varicella vaccination series with PROQUAD, reconstituted with DILUENT MRK (inappropriate schedule of vaccine administered). No adverse effect were reported.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to a 4 year old male patient. The patient previously received one dose of M-M-R, one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 01-AUG-2018, the patient was vaccinated with PROQUAD from lot R002935 dose 1, subcutaneous in the right thigh for prophylaxis. On the same day, the patient was also vaccinated with KINRIX from lot 95FR9 dose 1, intramuscular in the left thigh for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019, lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The medical assistant was not sure which sterile diluent (manufacturer unknown) lot numbers were used. The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the two reports linked via same reporter link. Sender's Comments: US-009507513-1807USA007589.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Intercepted medication error, Pain, Paraesthesia, Product preparation error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Shingles in a 53 year-old adult male patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced intercepted medication error and inappropriate preparation of medication. On an unknown date, the outcome of the intercepted medication error and inappropriate preparation of medication were unknown. Additional details were provided as follows: The vaccine was not administered (intercepted medication error). The age at vaccination was not applicable for this report. The health care professional reported she reconstituted a dose of SHINGRIX with poor technique and had to waste the dose due to having a very low volume, which led to inappropriate preparation of medication and intercepted medication error. The health care professional could not remember how much was in the vial. The health care professional did not administer vaccine to the patient. No patient information was available. Follow up information received from pharmacist on 1st June 2018: The reporter's contact details were updated. The patient's demographic were updated. On 28th March 2018, the patient received 1st dose 0.5 ml of SHINGRIX vaccine intramuscularly. Less than a year after vaccination, the patient came down with Shingles on his back. The VAERS details were updated. Follow up information received from pharmacist on 24th July 2018: The patient had previously experienced Primary Herpes Zoster (Chicken pox). In 2018, less than month after receiving 1st dose of SHINGRIX, the patient experienced dermatomal pain with rash, itching and altered sensitivity to touch. The patient was not hospitalized. The diagnosis of Herpes Zoster was confirmed and it was specified to be classical herpes zoster (unilateral, involving no more than three adjacent dermatomes). This was the first shingles episode. Right shoulder blade area was the specific affected dermatomes. There were no complications of herpes zoster present or specific organ system involvement. On 7th April 2018, all events were resolved.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Shingles in a 53 year-old adult male patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced intercepted medication error and inappropriate preparation of medication. On an unknown date, the outcome of the intercepted medication error and inappropriate preparation of medication were unknown. Additional details were provided as follows: The vaccine was not administered (intercepted medication error). The age at vaccination was not applicable for this report. The health care professional reported she reconstituted a dose of SHINGRIX with poor technique and had to waste the dose due to having a very low volume, which led to inappropriate preparation of medication and intercepted medication error. The health care professional could not remember how much was in the vial. The health care professional did not administer vaccine to the patient. No patient information was available. Follow up information received from pharmacist on 1st June 2018: The reporter's contact details were updated. The patient's demographic were updated. On 28th March 2018, the patient received 1st dose 0.5 ml of SHINGRIX vaccine intramuscularly. Less than a year after vaccination, the patient came down with Shingles on his back. The VAERS details were updated. Follow up information received from pharmacist on 24th July 2018: The patient had previously experienced Primary Herpes Zoster (Chicken pox). In 2018, less than month after receiving 1st dose of SHINGRIX, the patient experienced dermatomal pain with rash, itching and altered sensitivity to touch. The patient was not hospitalized. The diagnosis of Herpes Zoster was confirmed and it was specified to be classical herpes zoster (unilateral, involving no more than three adjacent dermatomes). This was the first shingles episode. Right shoulder blade area was the specific affected dermatomes. There were no complications of herpes zoster present or specific organ system involvement. On 7th April 2018, all events were resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 59-year-old female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, 7 days after receiving SHINGRIX, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was recovering/resolving. It was unknown if the reporter considered the pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient was the cousin of reporter. The patient contacted the reporter via text. The age at vaccination was not reported. But, it could be 58 or 59 years old. The patient received the SHINGRIX vaccine about 3 weeks before the date of reporting, about one week after receiving the SHINGRIX, the patient experienced itching (not at the injection site) which got less. The itching started on the ankles and shins and moved to the wrists and forearms. She also had itching on the upper neck and face (below eyes to the ears). The itching was first quite aggressive after a week it was almost gone. The only place she still had active itching was on her face at the time of reporting. The reporter did not obtain consent to file a report. The reporter did not ask for doctor of medicine (MD) contact information.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. In 2018, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient developed flu like symptoms after her first SHINGRIX dose. This case has been linked with case US2018136199, US201813203 and US20181362015, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling cold, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received and experienced fever, freezing and had teeth chattering shivers refer linked case US2018GSK140957). On 13th July 2018, the patient received the 2nd dose of SHINGRIX. On 13th July 2018, several hours after receiving SHINGRIX, the patient experienced shivers and feeling cold. On 14th July 2018, the patient experienced injection site pain and fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, shivers, fever and feeling cold were recovered/resolved. It was unknown if the reporter considered the injection site pain, shivers, fever and feeling cold to be related to SHINGRIX. Additional details were provided as follows: This case was reported for reporter's sister-in-law. The age at vaccination was not reported. At 13:00 hours, the patient received SHINGRIX and at bedtime she experienced freezing and had teeth chattering shivers while she was trying to get to sleep. On the next day morning, 1 day after receiving SHINGRIX, the patient experienced fever (the patient's body temperature was recorded as 101.6 degrees F). The patient took an Ibuprofen and started to feel better by 7 pm. The patient adds that all symptoms were fully resolved. Master of doctorate (MD) contact information not obtained.