chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: ANTH, HEPA, SMALL, TYP
Symptoms: Scan with contrast normal, Troponin I increased, White blood cell count normal
Clinical narrative: Pt evaluated in ED on 20JAN2018 due to male presents to chest pain. States he woke up that morning and felt fine and then while standing felt a little lightheaded and had acute onset of severe 10 out of 10 chest pain. No similar symptoms in past. No stimulant or supplement use. No recent travel, trauma, or illness. Hx significant for smallpox vaccination along with a series of others on 10JAN2018. ED evaluation significant for rising troponin and elevate CPK-MB. He was transferred to another hospital for further eval. Records currently not available. Pt report that they completed multiple chest ultrasounds, EKG, and CT w/ contrast without any pathological findings. No recommendations for medication or f/u. He was discharged this morning. Reports hasn't had chest pain or dizziness since Sat/Sun. This is a 19yoM otherwise healthy presenting to office for f/u chest pain. Patient presented to the ER 20JAN with non-exertional midsternal chest pain associated with LUE weakness in the setting of recent smallpox vaccination 14d prior. Cardiac w/u was initiated at this time, notable for elevated troponins (1.870, and 90min later, 5.750) and CK-MB (28). The patient was then transferred to another hospital, where he was evaluated with CT Chest with contrast and Echocardiogram, both of which were unremarkable. With resolution of his chest pain (no documented troponins), the patient was discharged 2d later with instructions to follow-up in clinic. Records were not available at this clinic visit and the patient was unfortunately lost to f/u. Since the episode 20JAN, patient reports no further episodes of chest pain or difficulty breathing. He has been PT'ing at his own pace, which includes runs and light weightlifting. He reports no SOB, DOE, edema, or palpitations. Acute myocarditis, unspecified: This is a 19yoM otherwise healthy presenting with episode of chest pain and elevated troponins in the setting of recent smallpox vaccination. Submitted consult prior to appointment, deemed probable Post-smallpox-vaccine-associated myopericarditis. Initiated LIMDU (Patient to PT at own pace and to be non-travel x6mo); forms submitted and patient instructed to report to office at hospital. Will repeat cardiac enzymes (troponin/CK-MB). Obtain baseline ESR/CRP. Include patient in Smallpox Vaccine Myopericarditis Registry for long-term follow up. Submitted VAERS form for Smallpox allergy. Patient to receive temporary deferment for Anthrax, JEV, etc - Referring to Internal Medicine (as no Cardiology on island) for follow-up. Patient to be seen 03-17MAR, then again JUL2018 prior to RTFD. Will leave to Internal Medicine discretion whether patient needs local outpatient Cardiology referral or further risk stratification, like exercise stress testing. Will f/u consult; patient may need medevac to MC for Cardiology evaluation. Case management actively involved and will help coordination of care. RTC for f/u 6wks; patient will need close monitoring to ensure appropriate follow-up care and coordination.
Age: 1.25
Sex: M
Vaccine: HEPA, HIBV, PNC13, UNK
Symptoms: Blood test normal, Erythema, Fatigue, Furuncle, Gait inability
Clinical narrative: Before he had his shots done, he was perfectly fine and NO signs of sickness- i intact have a video of him playing in the dr room. By the time we were home around 12, he started acting tired (normal nap time), so he instantly fell asleep but only for 20 minutes- he than started acting super fussy and very tired still, I left at 12:30 for my dentist appt, by the time I got home an hour and half later- he was very lethargic, I took him to lay down for a nap but he started having bad 'shaking' and wouldn't move or respond too much with emotions, so I called the doctors office and spoke with the nurse who insisted he was okay and just take some children's fever reducer and such, a couple hours later his fever was at 102.9 so I called the nurse again and insisted the medicine wasn't helping so she suggested another 2.5 liters to help with the fever and then waited another 30 minutes and he was still at this point not moving or talking so by the time I got to the ER and they took his temp he was as 101.+ but responding much more and the dr tried saying he just have been sick so we insisted on blood and urine testing which came back PERFECT, she than concluded it was related to vaccinations. He was not able to move his legs or walk that entire night and following into the next day, he woke up with red boils on his face and hands.
Age: 1.25
Sex: M
Vaccine: HEPA, HIBV, PNC13, UNK
Symptoms: Hyporesponsive to stimuli, Irritability, Lethargy, Mobility decreased, Pyrexia
Clinical narrative: Before he had his shots done, he was perfectly fine and NO signs of sickness- i intact have a video of him playing in the dr room. By the time we were home around 12, he started acting tired (normal nap time), so he instantly fell asleep but only for 20 minutes- he than started acting super fussy and very tired still, I left at 12:30 for my dentist appt, by the time I got home an hour and half later- he was very lethargic, I took him to lay down for a nap but he started having bad 'shaking' and wouldn't move or respond too much with emotions, so I called the doctors office and spoke with the nurse who insisted he was okay and just take some children's fever reducer and such, a couple hours later his fever was at 102.9 so I called the nurse again and insisted the medicine wasn't helping so she suggested another 2.5 liters to help with the fever and then waited another 30 minutes and he was still at this point not moving or talking so by the time I got to the ER and they took his temp he was as 101.+ but responding much more and the dr tried saying he just have been sick so we insisted on blood and urine testing which came back PERFECT, she than concluded it was related to vaccinations. He was not able to move his legs or walk that entire night and following into the next day, he woke up with red boils on his face and hands.
Age: 1.25
Sex: M
Vaccine: HEPA, HIBV, PNC13, UNK
Symptoms: Tremor, Urine analysis normal
Clinical narrative: Before he had his shots done, he was perfectly fine and NO signs of sickness- i intact have a video of him playing in the dr room. By the time we were home around 12, he started acting tired (normal nap time), so he instantly fell asleep but only for 20 minutes- he than started acting super fussy and very tired still, I left at 12:30 for my dentist appt, by the time I got home an hour and half later- he was very lethargic, I took him to lay down for a nap but he started having bad 'shaking' and wouldn't move or respond too much with emotions, so I called the doctors office and spoke with the nurse who insisted he was okay and just take some children's fever reducer and such, a couple hours later his fever was at 102.9 so I called the nurse again and insisted the medicine wasn't helping so she suggested another 2.5 liters to help with the fever and then waited another 30 minutes and he was still at this point not moving or talking so by the time I got to the ER and they took his temp he was as 101.+ but responding much more and the dr tried saying he just have been sick so we insisted on blood and urine testing which came back PERFECT, she than concluded it was related to vaccinations. He was not able to move his legs or walk that entire night and following into the next day, he woke up with red boils on his face and hands.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Product storage error, Pyrexia, Rhinorrhoea
Clinical narrative: This spontaneous report was received from a physician, and refers to a 4 month old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-JAN-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # M043836, expiration date 17-JUN-2018 (dose and anatomical location of administration were not reported). On 22-JAN-2018, the patient received other dose. Subsequently, the patient experienced runny nose and fever and went to the emergency room but he was not admitted to hospital; the physician believed that these events were not related to ROTATEQ. The administered dose of vaccine experienced the temperature excursion of below 32 F for 9 hours 6 minutes, 32 degrees Fahrenheit up to 35 degrees Fahrenheit in 19 hours 11 minutes. The outcome of the events and the relatedness between the events and ROTATEQ were not reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1802USA004843.
Sex: F
Vaccine: PPV
Symptoms: Contusion, Peripheral swelling
Clinical narrative: This spontaneous report was received from a female patient of unknown age. The patient's current condition, historical condition, historical drug, drug allergies and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, unit, frequency not reported) (expiration date and lot number not specified) subcutaneously as active immunization for the prevention of pneumococcal disease. The patient reported after having the first shot of PNEUMOVAX 23, she experienced bruising and swelling. The swelling has gone completely down the arm. The patient was treated with an unspecified antibiotic. The outcome of the events contusion and peripheral swelling was unknown. The reporter did not assess the causality of the events. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 89-year-old female patient with high cholesterol. Information about the patient's dug reaction or allergies were not reported. On 21-JAN-2018, the patient was vaccinated with ZOSTAVAX, vaccine dose, to prevent shingles (lot#, route of administration, anatomical location and expiration date were not reported). Concomitant therapies included gabapentin, omega-3 marine triglycerides, TYLENOL WITH CODEINE and aspirin. On 02-FEB-2018, the patient was diagnosed with shingles. She sought medical attention and saw her physician (date was not reported). However, it was unknown if the patient received any treatment for the event. The outcome of herpes zoster was reported as not recovered. Causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, General symptom, Herpes zoster, Pain, Suspected counterfeit product
Clinical narrative: This spontaneous report was received from a consumer regarding a currently 97 year old female patient. The patient's concurrent condition included diabetes mellitus. The patient had no medical history, drug reactions and allergies. The patient's concomitant medications included unspecified diabetes medications (manufacturer unknown). On an unknown date (reported as about 4 years ago), the patient was vaccinated with injection ZOSTAVAX 19400 PFU vial with sterile diluent (manufacturer unknown) (dose, units, frequency and route was not reported) (lot # and expiration date not reported) to prevent shingles. On an unknown date, one to two months later patient experienced shingles and patient was in lot of pain (pain). On an unknown date in 2013, patient was hospitalized for shingles for 2 weeks. The patient sought medical attention. On an unspecified date, patient had many unspecified illnesses precipitated by the shingles (general symptom). On an unknown date, the patient developed two strokes (Cerebrovascular accident) after receiving the ZOSTAVAX. On an unknown date, it was reported that, patient still had pain from the shingles. The reporter considered the event of shingles as life-threatening as the patient nearly died. The patient received unspecified treatment for the events. Lab/diagnostic studies were not performed. On an unknown date, the patient suspected that injection ZOSTAVAX was fake vaccine because of how cheap it was and how ineffective it was (vaccination failure and suspected counterfeit product). The outcome of herpes zoster, cerebrovascular accident, general symptom, and vaccination failure was reported as not recovered/not resolved. The reporter did not provide causal assessment for the events. Upon internal review, the events cerebrovascular accident and herpes zoster were determined as medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: This spontaneous report was received from a consumer regarding a currently 97 year old female patient. The patient's concurrent condition included diabetes mellitus. The patient had no medical history, drug reactions and allergies. The patient's concomitant medications included unspecified diabetes medications (manufacturer unknown). On an unknown date (reported as about 4 years ago), the patient was vaccinated with injection ZOSTAVAX 19400 PFU vial with sterile diluent (manufacturer unknown) (dose, units, frequency and route was not reported) (lot # and expiration date not reported) to prevent shingles. On an unknown date, one to two months later patient experienced shingles and patient was in lot of pain (pain). On an unknown date in 2013, patient was hospitalized for shingles for 2 weeks. The patient sought medical attention. On an unspecified date, patient had many unspecified illnesses precipitated by the shingles (general symptom). On an unknown date, the patient developed two strokes (Cerebrovascular accident) after receiving the ZOSTAVAX. On an unknown date, it was reported that, patient still had pain from the shingles. The reporter considered the event of shingles as life-threatening as the patient nearly died. The patient received unspecified treatment for the events. Lab/diagnostic studies were not performed. On an unknown date, the patient suspected that injection ZOSTAVAX was fake vaccine because of how cheap it was and how ineffective it was (vaccination failure and suspected counterfeit product). The outcome of herpes zoster, cerebrovascular accident, general symptom, and vaccination failure was reported as not recovered/not resolved. The reporter did not provide causal assessment for the events. Upon internal review, the events cerebrovascular accident and herpes zoster were determined as medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, 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 30-JAN-2016 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, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-FEB-2016, the patient was treated at a medical center for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash 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. On an unspecified date 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, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-MAR-2016, the patient was treated by a physician for the onset of severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The patient had been prescribed valacyclovir (VALTREX) for management of his symptoms and pain. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 09-FEB-2018 from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender.  Medical history, concurrent conditions, and concomitant medications were not provided. On or about 08-OCT-2011, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-FEB-2016, the patient was treated (by an unspecified healthcare professional) at a facility for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 09-FEB-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 20-FEB-2012 the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) (by an unspecified healthcare professional) at an urgent care facility as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-APR-2016, the patient was treated (by an unspecified healthcare professional) at a healthcare facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acyclovir for management of her symptoms and pain. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, 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. On an unspecified date 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, but rather caused the patient to contract a persistent strain of herpes zoster. The patient was treated at a health facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has  suffered  and will  continue  to  suffer  significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 02-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA007574: US-009507513-1802USA007580: US-009507513-1802USA007576: US-009507513-1802USA007577: US-009507513-1802USA007578: US-009507513-1802USA007579: US-009507513-1802USA007573: US-009507513-1802USA007572: US-009507513-1802USA007575:
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional via field employee refers to a 9 months old male patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On Thursday, 08-FEB-2018 the patient was inadvertently vaccinated with VAQTA (dose, units and frequency were unknown) (lot # N023953 and expiration date 05-NOV-2018) for prophylaxis. No adverse effects reported. The outcome of events accidental exposure to product and no adverse effects was unknown. The causal relationship between the events accidental exposure to product, no adverse effects and VAQTA was not provided by the reporter. There was no product quality compliant reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 02-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA007574: US-009507513-1802USA007580: US-009507513-1802USA007576: US-009507513-1802USA007577: US-009507513-1802USA007578: US-009507513-1802USA007579: US-009507513-1802USA007573: US-009507513-1802USA006448: US-009507513-1802USA007575:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 06-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA007574: US-009507513-1802USA007580: US-009507513-1802USA007576: US-009507513-1802USA007577: US-009507513-1802USA007578: US-009507513-1802USA007579: US-009507513-1802USA006448: US-009507513-1802USA007572: US-009507513-1802USA007575:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 06-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA006448: US-009507513-1802USA007580: US-009507513-1802USA007576: US-009507513-1802USA007577: US-009507513-1802USA007578: US-009507513-1802USA007579: US-009507513-1802USA007573: US-009507513-1802USA007572: US-009507513-1802USA007575:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 07-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA007574: US-009507513-1802USA007580: US-009507513-1802USA007576: US-009507513-1802USA007577: US-009507513-1802USA007578: US-009507513-1802USA007579: US-009507513-1802USA007573: US-009507513-1802USA007572: US-009507513-1802USA006448:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 08-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA007574: US-009507513-1802USA007580: US-009507513-1802USA006448: US-009507513-1802USA007577: US-009507513-1802USA007578: US-009507513-1802USA007579: US-009507513-1802USA007573: US-009507513-1802USA007572: US-009507513-1802USA007575:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 12-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA007574: US-009507513-1802USA007580: US-009507513-1802USA007576: US-009507513-1802USA006448: US-009507513-1802USA007578: US-009507513-1802USA007579: US-009507513-1802USA007573: US-009507513-1802USA007572: US-009507513-1802USA007575:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 12-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 12-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA007574: US-009507513-1802USA007580: US-009507513-1802USA007576: US-009507513-1802USA007577: US-009507513-1802USA007578: US-009507513-1802USA006448: US-009507513-1802USA007573: US-009507513-1802USA007572: US-009507513-1802USA007575.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 08-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA007574: US-009507513-1802USA006448: US-009507513-1802USA007576: US-009507513-1802USA007577: US-009507513-1802USA007578: US-009507513-1802USA007579: US-009507513-1802USA007573: US-009507513-1802USA007572: US-009507513-1802USA007575.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Immediate post-injection reaction, Mental disorder, Muscle spasms, Tic
Clinical narrative: Initial unsolicited report received from consumer (Patients mother) on 06 Feb 2018. This case involves nine years old male patient who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (frequency: once, batch number: unknown and expiry date not reported) intramuscularly in left deltoid on 31 Jan 2018. She state it was a multi dose vial. The patient's medical history and concomitant medication were not reported. On 31 Jan 2018, immediately after the vaccination patient had an exacerbation of Tourettes syndrome. On an unspecified date, post vaccination patient had hyper mind, increased cramps and ticks. Laboratory investigation and corrective treatment were not reported. Outcome of event was unknown. Upon internal review the case was considered as serious because of important medical event: exacerbation of Tourettes syndrome. List of documents held by sender: none; Sender's Comments: Patient experienced an exacerbation in Tourette's syndrome after vaccination. Time to onset is compatible with the role of vaccine. More details regarding patient's medical history, previous vaccination history, condition at the time of vaccination, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine seems unlikely.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Tourette's disorder
Clinical narrative: Initial unsolicited report received from consumer (Patients mother) on 06 Feb 2018. This case involves nine years old male patient who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT (frequency: once, batch number: unknown and expiry date not reported) intramuscularly in left deltoid on 31 Jan 2018. She state it was a multi dose vial. The patient's medical history and concomitant medication were not reported. On 31 Jan 2018, immediately after the vaccination patient had an exacerbation of Tourettes syndrome. On an unspecified date, post vaccination patient had hyper mind, increased cramps and ticks. Laboratory investigation and corrective treatment were not reported. Outcome of event was unknown. Upon internal review the case was considered as serious because of important medical event: exacerbation of Tourettes syndrome. List of documents held by sender: none; Sender's Comments: Patient experienced an exacerbation in Tourette's syndrome after vaccination. Time to onset is compatible with the role of vaccine. More details regarding patient's medical history, previous vaccination history, condition at the time of vaccination, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine seems unlikely.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient complaint of left upper arm pain and itching since receiving vaccination. No fever, body aches or chills reported. 3 x 3 cm circular, tender, swollen, red area over injection site. Client treated for cellulitis with Keflex 500 mg x 1 every 6 hours for 7 days and ibuprofen 800 mg every 8 hours for pain and swelling.  Patient contacted on 02/15/2018 and reports symptoms are improving.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Condition aggravated, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Signs and symptoms: extreme fatigue (sleeping 15-20 hours/day), migraine headaches, nausea, vomiting, diarrhea, shortness of breath, chest pain, dizziness, increased frequency and intensity of heart palpitations and near syncopal episodes. Time Course: Began 2 days after vaccine was administered and has not ceased yet as of this submission. Some symptoms have decreased in intensity/frequency but are still present daily.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Hypersomnia, Migraine, Nausea, Palpitations
Clinical narrative: Signs and symptoms: extreme fatigue (sleeping 15-20 hours/day), migraine headaches, nausea, vomiting, diarrhea, shortness of breath, chest pain, dizziness, increased frequency and intensity of heart palpitations and near syncopal episodes. Time Course: Began 2 days after vaccine was administered and has not ceased yet as of this submission. Some symptoms have decreased in intensity/frequency but are still present daily.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Presyncope, Vomiting
Clinical narrative: Signs and symptoms: extreme fatigue (sleeping 15-20 hours/day), migraine headaches, nausea, vomiting, diarrhea, shortness of breath, chest pain, dizziness, increased frequency and intensity of heart palpitations and near syncopal episodes. Time Course: Began 2 days after vaccine was administered and has not ceased yet as of this submission. Some symptoms have decreased in intensity/frequency but are still present daily.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Blood test normal, Chest X-ray normal, Unresponsive to stimuli
Clinical narrative: With in 2 days my son was non responsive.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Condition aggravated, Cough, Disorientation, Dyspnoea
Clinical narrative: Sudden onset of shortness of breath, the use of asthma inhaler, severe cough, disorientation.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent. On 08-FEB-2018 the patient was vaccinated with VARIVAX (dose, frequency and route were not reported) (lot # N012619 and expiry date: 21-APR-2019) for prophylaxis. The nurse reported that, first patient was administered a dose of improperly stored VARIVAX on 08-FEB-2018. The vaccines were stored in temperature 6 degree Fahrenheit (F) to 14 F (7.3F) for 25 Minutes. There was a previous temperature excursion of 6 F to 14 F for 206 minutes. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. The outcome of events was unknown. The relationship between events and VARIVAX was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concurrent conditions were not reported. Concomitant therapy included sterile diluent. On 09-FEB-2018 the patient was vaccinated with VARIVAX (dose, frequency and route were not reported) (lot # N012619 and expiry date: 21-APR-2019) for prophylaxis. The nurse reported that, second patient was administered a dose of improperly stored VARIVAX on 09-FEB-2018. The vaccines were stored in temperature 6 degree Fahrenheit (F) to 14 F (7.3F) for 25 Minutes. There was a previous temperature excursion of 6 F to 14 F for 206 minutes. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. The outcome of events was unknown. The relationship between events and VARIVAX was not provided.
Age: 1.0
Sex: F
Vaccine: MENB
Symptoms: Drug administered to patient of inappropriate age, Insomnia, Pyrexia, Wrong drug administered
Clinical narrative: This is a spontaneous report from a contactable nurse. A 12-month-old female patient received TRUMENBA (lot number: R47584, expiration date Jul2018), intramuscular in the right thigh on 07Feb2018 14:30 at 0.5 ml (also reported at 0.5 cc), single for routine vaccination at the physician office. Medical history included supplementation therapy. Concomitant medication included second dose of PEDVAXHIB (lot number: N013294, expiration date 28Feb2020), intramuscularly in the left thigh; first dose of HAVRIX (lot number: ZK374), intramuscularly in the right thigh; first dose of PROQUAD (lot number: N020007), subcutaneously in left thigh; all at unknown dose, single for immunization and ongoing multivitamins from 2017 as supplement.  It was reported that on 07Feb2018, the patient was inadvertently administered the wrong vaccine. It was also reported that the patient experienced drug administered to patient of inappropriate age as the patient was only 12 months old. The patient also has high fever and didn't sleep much on 07Feb2018. The adverse reactions started about 5 hours after being given meningococcal group b rlp2086. The outcome of the events was unknown.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Area on left arm was raised, red, swollen, warm to touch areas, itchy and painful. +cellulitis. Treatment:  Benadryl, Hydrocortisone Cream, 1 %, Keflex  500 MG, 1 capsule, Orally, Twice a day, 10 days. Naproxen Tablet, 500 MG, 1 tablet as needed, Orally, every 12 hrs, 14 days.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm
Clinical narrative: Area on left arm was raised, red, swollen, warm to touch areas, itchy and painful. +cellulitis. Treatment:  Benadryl, Hydrocortisone Cream, 1 %, Keflex  500 MG, 1 capsule, Orally, Twice a day, 10 days. Naproxen Tablet, 500 MG, 1 tablet as needed, Orally, every 12 hrs, 14 days.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Rash, Tenderness, Urticaria
Clinical narrative: Severe L arm pain and tenderness, with inability to move arm or shoulder, following PNEUMOVAX 23 vaccine not abating when assessed at 5 days following vaccination. She reports some initial hives, but rash has resolved in the first 24 hours.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: ACT HIB was given with Sterile diluent instead of the Saline diluent the HIB comes with. Contacted Sanofi Pasteur and spoke to a nurses in the medical management team. She informed me the vaccine is not valid since it was not given with the correct diluent. Child will have to get another HIB vaccine and there is no wait time. Can be given at any time.
Age: 36.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Chills, Feeling abnormal, Pain, Pyrexia, Vaccination complication
Clinical narrative: Intense fever and chills and body pain. Woke me up at 11:30. Blasted all the heaters, took TYLENOL at about midnight, finally went back to sleep around 2:00. By 6:00 the TYLENOL wore off and I was in agonizing pain and chills again. More TYLENOL solved the problem although I feel completely wiped out. I wasn't sick before getting the flu shot. This is truly an adverse reaction. I usually have a little bit of a reaction after the flu shot (some pain and chills) but nothing this bad.
Age: 36.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Intense fever and chills and body pain. Woke me up at 11:30. Blasted all the heaters, took TYLENOL at about midnight, finally went back to sleep around 2:00. By 6:00 the TYLENOL wore off and I was in agonizing pain and chills again. More TYLENOL solved the problem although I feel completely wiped out. I wasn't sick before getting the flu shot. This is truly an adverse reaction. I usually have a little bit of a reaction after the flu shot (some pain and chills) but nothing this bad.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: L arm red, hot and swollen.
Age: 85.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Arm swelling, went to ER and given antibiotics.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 48 hours after injection reported with red, warm injection site. Redness induration at 10cmx10cm.  There is a central area of darker redness that is 4cmx3cm. Treating with ice, OTC BENADRYL, OTC Ibuprofen and Rx antibiotics.
Age: 10.0
Sex: M
Vaccine: DTAPHEPBIP, TDAP
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Patient received PEDIARIX vaccine and Tdap. Patient was to receive Tdap and Flu Vaccine. At the time of d/c, no adverse reaction was noted.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unspecified date 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, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-NOV-2015 the patient was treated by a physician for the onset of a rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, drug reactions, allergies and concomitant therapies were not provided. The reporter stated that on 13-FEB-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX subcutaneous, lot # M004663, expiration date: 27-JAN-2018, for prophylaxis, (strength and dosage were not reported). No adverse effects were reported.
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Palpitations
Clinical narrative: Headache, diarrhea, joint pain, fever, fatigue, palpitations.
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Pyrexia
Clinical narrative: Headache, diarrhea, joint pain, fever, fatigue, palpitations.
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Arrhythmia, Arthralgia, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Headache, diarrhea, joint pain, fever, fatigue, palpitations.
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Dyspnoea exertional, Headache, Hyperacusis, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Headache, diarrhea, joint pain, fever, fatigue, palpitations.
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Neck pain, Photosensitivity reaction
Clinical narrative: Headache, diarrhea, joint pain, fever, fatigue, palpitations.
Age: 65.0
Sex: F
Vaccine: TD, TD
Symptoms: Pyrexia, Vertigo
Clinical narrative: Headache, diarrhea, joint pain, fever, fatigue, palpitations.