chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Rash vesicular, Vision blurred, Visual impairment
Clinical narrative: Information was received on 06-JUL-2017 from an attorney in the form of an initial spontaneous report regarding a male patient (age not provided). On or about 06-NOV-2014 the patient was vaccinated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster and herpes zoster eye keratitis. On or about 03-APR-2015, the patient was treated by a physician assistant for a blistering vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. On or about each of the date of 15-APR-2015 and 11-MAY-2015, the patient was treated again by the physician for continued and worsening symptoms of shingles outbreaks that had spread onto his face. On or about each of the dates of 21-JUL-2015, and 25-AUG-2015, the patient sought further treatment for the physician for new and worsening symptoms of shingles that had now spread to the eyes and scalp. He was then referred to an Ophthalmologic specialist for blurred and double vision. On or about 28-JUL-2015, the patient was treated by a physician for vision interruptions and painful blistering in the eye, which was diagnosed as herpes zoster eye keratitis. On or about 21-OCT-2015, 24-NOV-2015, and 22-DEC-2015 the patient had a medical encounter, during which he was treated by the physician to address symptoms of pain and interruptions in vision resulting from herpes zoster eye keratitis. On or about each of the dates of 26-JAN-2016, 29-FEB-2016, 25-MAR-2016, 19-APR-2016, 06-JUL-2016 and 15-NOV-2016 the patient received ongoing  treatment for worsening and uncontrolled herpes zoster eye keratitis which triggered an array of visual impediments and vision loss. On or about 21-MAR-2016 and 22-SEP-2016 the patient was evaluated by his primary care physician for new shingles outbreaks on his body in addition to the vesicles in his eyes and face. He was prescribed acyclovir, NEXIUM, LOTEMAX GEL, Refresh eye drops, PERCOCET, valacyclovir, ZOVIRAX CREAM and ZIRGRAN eye drops to attempt to manage and relieve his painful symptoms and damage to his eyes. 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 suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review, the events of persistent and chronic herpes zoster eye keratitis and vision loss were determined to be medically significant. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Fatigue, Laboratory test normal, Myalgia, Nausea
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 03-Jul-2017. This case involves a 56-year-old female patient who was vaccinated with a dose of FLUZONE QIV (Batch number: UI441AB, Expiry date: 30-Jun-2016, dose, dose in series, route and site of administration were not reported) on 09-Oct-2015. Patient's Illness at time of vaccination was reported as none as per reporter. Patient's pre-existing physician diagnosed allergies includes latex and sodium pentothal and other medical history was reported as none. Concomitant medications were not reported. On an unknown date, about 3 to 6 weeks following the vaccination, the patient gradually developed generalized, extreme muscle pain and joint pain. On an unknown date, the patient also experienced tiredness and nausea. The patient stated that she received vaccination as part of Employee Health Program, and it was reported as the patient had seen her own family physician and a Rheumatologist for numerous visits. The patient previously received several doses of FLUZONE QIV on an unknown dates. It was stated that, since Oct-2015 she has received another Flu vaccination in 2016 with no change in the muscle pain and joint pain following the 2016 vaccination. Patient's x-rays, and other tests have been negative for other causes of her muscle and joint pain. Corrective treatment was not reported. The outcome of all the events were reported as not yet recovered. (It was reported that the patient still has generalized, extreme muscle pain and joint pain which continues to today, as of 03-Jul-2017) List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray normal
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 03-Jul-2017. This case involves a 56-year-old female patient who was vaccinated with a dose of FLUZONE QIV (Batch number: UI441AB, Expiry date: 30-Jun-2016, dose, dose in series, route and site of administration were not reported) on 09-Oct-2015. Patient's Illness at time of vaccination was reported as none as per reporter. Patient's pre-existing physician diagnosed allergies includes latex and sodium pentothal and other medical history was reported as none. Concomitant medications were not reported. On an unknown date, about 3 to 6 weeks following the vaccination, the patient gradually developed generalized, extreme muscle pain and joint pain. On an unknown date, the patient also experienced tiredness and nausea. The patient stated that she received vaccination as part of Employee Health Program, and it was reported as the patient had seen her own family physician and a Rheumatologist for numerous visits. The patient previously received several doses of FLUZONE QIV on an unknown dates. It was stated that, since Oct-2015 she has received another Flu vaccination in 2016 with no change in the muscle pain and joint pain following the 2016 vaccination. Patient's x-rays, and other tests have been negative for other causes of her muscle and joint pain. Corrective treatment was not reported. The outcome of all the events were reported as not yet recovered. (It was reported that the patient still has generalized, extreme muscle pain and joint pain which continues to today, as of 03-Jul-2017) List of documents held by sender: none.
Age: 0.58
Sex: M
Vaccine: IPV
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: Rah on thigh, and chest. Fever.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No event.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Hot, red golf ball sized area at the injection site. Painful to touch.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Induration, Localised infection, Skin warm
Clinical narrative: 10 days after injection developed redness, induration, warmth c/w localized infection. He was treated with KEFLEX. He improved.
Age: 0.92
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Facial paralysis
Clinical narrative: Parents noticed that the right side of patient's face did not move on 5/10/17. Patient was otherwise acting well with no fever. Patient was referred to Neurology and see on 5/10/17. Neurology confirmed the Bell's palsy diagnosis. Patient was observed and did not receive any treatment and the Bell's palsy resolved within 2 weeks.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: The patient came into the pharmacy on 7/12/2017 after receiving PNEUMOVAX on 7/11/2017 with an adverse reaction. The arm where the vaccine was administered was very red, warm, and edematous. The patient also reported that the area that was red was also very itchy. It looked like a delayed allergic reaction or some kind of cellulitis. The patient was told to take BENADRYL for the local reaction and follow-up with her provider. The patient did not report any known allergies or signs of anaphylaxis. Then the patient went to the doctor's office, where she was prescribed prednisone and cephalexin.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Type IV hypersensitivity reaction
Clinical narrative: The patient came into the pharmacy on 7/12/2017 after receiving PNEUMOVAX on 7/11/2017 with an adverse reaction. The arm where the vaccine was administered was very red, warm, and edematous. The patient also reported that the area that was red was also very itchy. It looked like a delayed allergic reaction or some kind of cellulitis. The patient was told to take BENADRYL for the local reaction and follow-up with her provider. The patient did not report any known allergies or signs of anaphylaxis. Then the patient went to the doctor's office, where she was prescribed prednisone and cephalexin.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Breast feeding, Cardiac arrest, Cyanosis, Hypotonia, Intensive care
Clinical narrative: Patient had gone into cardiac arrest two days later, mom was breastfeeding and baby went blue and stopped breathing, treated in intensive care unit for over 1 month, outcome with poor tone with neurological impairment.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, Nervous system disorder, Respiratory arrest
Clinical narrative: Patient had gone into cardiac arrest two days later, mom was breastfeeding and baby went blue and stopped breathing, treated in intensive care unit for over 1 month, outcome with poor tone with neurological impairment.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Breast pain, Chills, Erythema, Injection site erythema
Clinical narrative: Starting 7/10/17 after receiving shot patient reported swelling in the arm and pain in the arm, arm pit and down into breast. The injection site was red and hot to the touch. The patient had chills and thinks she probably had a fever. By the morning of 7/11/17 these symptoms started improving. As of 7/12/17 she still has some pain and redness in the arm but is feeling much better.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Starting 7/10/17 after receiving shot patient reported swelling in the arm and pain in the arm, arm pit and down into breast. The injection site was red and hot to the touch. The patient had chills and thinks she probably had a fever. By the morning of 7/11/17 these symptoms started improving. As of 7/12/17 she still has some pain and redness in the arm but is feeling much better.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (single dose, intramuscularly; lot # M044032, expiration date: 03-JUL-2017). The doses of the vaccine experienced temperature excursion of 13 degrees Celsius for 1 hour and 58 minutes. There was no previous temperature excursions. Digital data logger was involved. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent to contact the nurse. Sender's Comments: US-009507513-1707USA001296.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II injection (lot# M025185, expiry date 18-MAY-2018; exact dose, route of administration and albumin status were not reported), and with an improperly stored dose of VARIVAX injection (lot# M037008, expiry date 25-AUG-2018; exact dose and route of administration were not reported). Both doses were reconstituted with properly stored sterile diluent (MRK). The doses of the vaccines were exposed to a temperature excursion between 47 and 77 degrees Fahrenheit, on an unknown date, for a time frame of 24 hours. There were no previous temperature excursions. A Digital Data Logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, the patients were administered improperly stored doses of ROTATEQ (route of administration defaulted to oral, lot# M011832 and expiration date: 24-JAN-2018; dose was not reported) as prophylaxis. The vaccines were stored in the temperature between 47 degrees Fahrenheit (F) to 77F (51.1F) for 2 hours, with a previous temperature excursion of more than 47F and less than 77F (46.6F) for 15 hours. The temperature excursions were detected by a data logger. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA001313: US-009507513-1707USA001314.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M041212, expiration date: 21-JUN-2019). The doses of the vaccine experienced temperature excursion of 13 degrees Celsius for 1 hour and 58 minutes. There was no previous temperature excursions. Digital data logger was involved. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent to contact the nurse. Sender's Comments: US-009507513-1706USA011354.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot# M039317 and expiration date: 20-SEP-2018 and lot# M033904 and expiration date: 20-JUL-2018; dose and route of administration were not reported) as prophylaxis. The vaccines were stored in the temperature between 6 degrees Fahrenheit (F) to 14F (9.1F) for 2 hours, with a previous temperature excursion of more than 6F and less than 14F (9.9F) for 15 hours. Data logger was not involved. It was reported that sterile diluent (manufacturer unknown) used to reconstitute the vaccines was properly stored. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000248: US-009507513-1707USA001314.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot# M040141 and expiration date: 27-MAR-2018 and lot# M034692 and expiration date: 24-JAN-2018; albumin status therapy type, dose and route of administration were not reported) as prophylaxis. The vaccines were stored in the temperature between 6 degrees Fahrenheit (F) to 14F (9.1F) for 2 hours, with a previous temperature excursion of more than 6F and less than 14F (9.9F) for 15 hours. Data logger was not involved. It was reported that sterile diluent (manufacturer unknown) used to reconstitute the vaccine was properly stored. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000248: US-009507513-1707USA001313.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness around site of injection greater than a quarter size - patient went to urgent care and received a prescription for antibiotic.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Crying, Dizziness, Dizziness postural, Electroencephalogram normal, Eye movement disorder
Clinical narrative: In the days following her shot she began to have mini seizures her Doctor referred to as "drop episodes". Patient ran a fever for days and whenever she'd gently bump her head (standing up under a table or walking into a door) her eyes would roll back in her head and she would fall over. Then act very dizzy as she tried to stand up, crying. 6 days after vaccine she was seen for fever and headaches. 14 days after vaccine I called about the seizures.  2 days later we met with her Doctor and she prescribed an EEG. EEG scheduled for 5/13/13. The results came back normal, but with Interpretation that "Normal EEGs do not rule out seizures".
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Fall, Headache, Pyrexia, Seizure
Clinical narrative: In the days following her shot she began to have mini seizures her Doctor referred to as "drop episodes". Patient ran a fever for days and whenever she'd gently bump her head (standing up under a table or walking into a door) her eyes would roll back in her head and she would fall over. Then act very dizzy as she tried to stand up, crying. 6 days after vaccine she was seen for fever and headaches. 14 days after vaccine I called about the seizures.  2 days later we met with her Doctor and she prescribed an EEG. EEG scheduled for 5/13/13. The results came back normal, but with Interpretation that "Normal EEGs do not rule out seizures".
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling, Pain, Swelling
Clinical narrative: The DTap was given at 12:00 pm on 7/6/17. By 4:00pm on the same day, he was complaining of extreme pain and difficulty walking. He was walking with a limp. Motrin was administered. On 7/7/17, he continued to complain of pain, and there was some localized swelling. By the morning of 7/8/17, he was complaining of extreme pain, and his entire left thigh was red, swollen and hot to the touch. I took a picture, and you can see in the picture that his left thigh is more than twice the size of his right. By Saturday afternoon, the swelling and redness had extended about an inch below his knee and about an inch up into his groin in addition to encompassing his entire left thigh. After being treated with Motrin, multiple epsom salt baths, and  bentonite clay packs throughout the day on 7/8/17, the redness and swelling eventually began to subside by the morning of 7/9/17.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain, Paraesthesia, Peripheral swelling
Clinical narrative: Pt reported pain the day of the injection (7/10/17).  The following morning the arm was tingling, difficult to move (7/11/17).  This resolved after about 4 hours.  Stated arm was white.  Today, 7/12/17, she came to the office because her arm was red, swollen, warm to touch from 4 cm below injection site to the elbow.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Pt reported pain the day of the injection (7/10/17).  The following morning the arm was tingling, difficult to move (7/11/17).  This resolved after about 4 hours.  Stated arm was white.  Today, 7/12/17, she came to the office because her arm was red, swollen, warm to touch from 4 cm below injection site to the elbow.
Age: 58.0
Sex: M
Vaccine: MENB
Symptoms: Wrong drug administered
Clinical narrative: Instead of pt receiving Pneumococcal he received BEXSERO by accident. Dr. was informed. I called the pt and he was informed of the situation. Pt shouldn't have any adverse reactions. Nurse Manager was informed as well.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Irritability, Rash
Clinical narrative: "rash" History of Present Illness (HPI) Patient comes in with her dad with a history of one week rash, which started about one week after her vaccines. Started the size of a dime, seemed to be less angry at that time. Over the last week it has gotten bigger (larger) taller, and more red.  Now over the last 3-4 days patient seems more irritable, fussy, but she is also teething. Sleeping ok, maybe waking up a little more, but nothing drammatic.
Age: 58.0
Sex: M
Vaccine: MNQ, PPV, TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth, Poor quality sleep
Clinical narrative: Patient returned to pharmacy 2 days after vaccination with a red area on her left arm. The spot is at the site of the second injection on that arm, the lower of the 2. The red area is swollen and hot.  Patient says it's uncomfortable and does not let her get restful sleep. We advised the patient to take Benadryl and ibuprofen over the counter to treat the reaction. Patient stated she has both of those at home. She also wanted to take Tylenol in between the ibuprofen doses. We advised the patient to back in to the pharmacy tomorrow for the pharmacist to check up on the reaction. Also, we let her know that we would contact her primary care provider about the reaction, document it on her pharmacy file, and fill out this form.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Measles post vaccine, Pyrexia
Clinical narrative: Measles fever for 7 days.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site nodule
Clinical narrative: Injection site reaction, pt says feels like a knot in arm.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Arthritis, Condition aggravated, Injection site erythema, Injection site pain
Clinical narrative: Patient recieved vaccine about 9:55am on 7/11/2017. on 7/12/2017 patient noticed there was uniform redness, slightley larger than a quarter at the injection site. No pain except when pushed upon. Patient mention some on and off again lower arm/joint paint but said most likely her arthritis. no itching or any other symptoms.
Age: 0.83
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Mom describes her son woke with fever she gave ibuprofen and took to ED. Diagnosis with post vaccine fever.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Erythema, Fatigue, Local reaction
Clinical narrative: Child was lightheaded, body aches, chills, tired easily and local reaction of swelling and redness, tingling down leg, onset day after TRUMENBA.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Paraesthesia, Swelling
Clinical narrative: Child was lightheaded, body aches, chills, tired easily and local reaction of swelling and redness, tingling down leg, onset day after TRUMENBA.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 4-year-old male patient who received INFANRIX (batch number 5N447, expiry date 23rd May 2019). On 27th June 2017, the patient received INFANRIX (intramuscular) .5 ml. In June 2017, less than a month after receiving INFANRIX, the patient experienced fever. On 29th June 2017, the patient experienced injection site swelling and injection site erythema. The patient was treated with BENADRYL and KEFLEX. On an unknown date, the outcome of the injection site swelling, injection site erythema and fever were unknown. The reporter considered the injection site swelling and injection site erythema to be almost certainly related to INFANRIX. It was unknown if the reporter considered the fever to be related to INFANRIX. Additional details were provided as follows: The patient received INFANRIX in left thigh. On 29th June 2017, the patient's mother called the office and noted that 2 days after vaccination with INFANRIX, the patient had an injection site reaction. The patient was seen in office and BENADRYL was prescribed. On 30th 2017, the patient's mother again called, and noted that 2 days after vaccination with INFANRIX, the patient had the injection site reaction was red, and doubled in size. In 2017, less than a month after receiving INFANRIX, the patient experienced fever. The patient required emergency room visit. The order for KEFLEX was prescribed.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Limb discomfort, Myalgia
Clinical narrative: Patient received PREVNAR shot per Dr's order on 5/24/17 and has complained of arm/muscle soreness. Patient has addressed with physician and physician is aware. Patient is still able to perform daily activities, but complains of muscle soreness.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: CSF protein increased, CSF white blood cell count negative, Guillain-Barre syndrome, Immunoglobulin therapy, Neurological examination abnormal
Clinical narrative: PATIENT DEVELOPED GUILLAIN-BARRE SYNDROME. STARTED AS TINGLING AND PAIN IN HANDS ON 5/21/17, PROGRESSED OVER THE NEXT FEW DAYS TO INVOLVE FEET. HAD A FEW VISITS TO OUTPATIENT PEDIATRICS AND THE ER WITH NORMAL NEUROLOGICAL EXAMS, BUT BY 5/28/17 HAD DEVELOPED WEAKNESS AND LOSS OF DEEP-TENDON REFLEXES, AS WELL AS DIPLOPIA, SO WAS ADMITTED WITH THE DIAGNOSIS OF GUILLAIN BARRE SYNDROME (MILLER FISHER VARIANT), CONFIRMED BY LUMBAR PUNCTURE AND MRI. SHE WAS TREATED WITH 5 DAY COURSE OF IVIG AND AGGRESSIVE PULMONARY TOILET, NEVER REQUIRED INTUBATION. WAS SENT TO INPATIENT REHABILITATION FOR ONGOING UPPER AND LOWER EXTREMITY WEAKNESS. To date, she remains hospitalized, so duration of hospitalization is at least 46 days.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Paraesthesia, Respiratory disorder
Clinical narrative: PATIENT DEVELOPED GUILLAIN-BARRE SYNDROME. STARTED AS TINGLING AND PAIN IN HANDS ON 5/21/17, PROGRESSED OVER THE NEXT FEW DAYS TO INVOLVE FEET. HAD A FEW VISITS TO OUTPATIENT PEDIATRICS AND THE ER WITH NORMAL NEUROLOGICAL EXAMS, BUT BY 5/28/17 HAD DEVELOPED WEAKNESS AND LOSS OF DEEP-TENDON REFLEXES, AS WELL AS DIPLOPIA, SO WAS ADMITTED WITH THE DIAGNOSIS OF GUILLAIN BARRE SYNDROME (MILLER FISHER VARIANT), CONFIRMED BY LUMBAR PUNCTURE AND MRI. SHE WAS TREATED WITH 5 DAY COURSE OF IVIG AND AGGRESSIVE PULMONARY TOILET, NEVER REQUIRED INTUBATION. WAS SENT TO INPATIENT REHABILITATION FOR ONGOING UPPER AND LOWER EXTREMITY WEAKNESS. To date, she remains hospitalized, so duration of hospitalization is at least 46 days.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Anti-ganglioside antibody negative, Areflexia, Asthenia, CSF culture negative, CSF glucose normal
Clinical narrative: PATIENT DEVELOPED GUILLAIN-BARRE SYNDROME. STARTED AS TINGLING AND PAIN IN HANDS ON 5/21/17, PROGRESSED OVER THE NEXT FEW DAYS TO INVOLVE FEET. HAD A FEW VISITS TO OUTPATIENT PEDIATRICS AND THE ER WITH NORMAL NEUROLOGICAL EXAMS, BUT BY 5/28/17 HAD DEVELOPED WEAKNESS AND LOSS OF DEEP-TENDON REFLEXES, AS WELL AS DIPLOPIA, SO WAS ADMITTED WITH THE DIAGNOSIS OF GUILLAIN BARRE SYNDROME (MILLER FISHER VARIANT), CONFIRMED BY LUMBAR PUNCTURE AND MRI. SHE WAS TREATED WITH 5 DAY COURSE OF IVIG AND AGGRESSIVE PULMONARY TOILET, NEVER REQUIRED INTUBATION. WAS SENT TO INPATIENT REHABILITATION FOR ONGOING UPPER AND LOWER EXTREMITY WEAKNESS. To date, she remains hospitalized, so duration of hospitalization is at least 46 days.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: CSF protein increased, CSF red blood cell count positive, CSF virus no organisms observed, CSF white blood cell count negative, Campylobacter test positive
Clinical narrative: PATIENT DEVELOPED GUILLAIN-BARRE SYNDROME. STARTED AS TINGLING AND PAIN IN HANDS ON 5/21/17, PROGRESSED OVER THE NEXT FEW DAYS TO INVOLVE FEET. HAD A FEW VISITS TO OUTPATIENT PEDIATRICS AND THE ER WITH NORMAL NEUROLOGICAL EXAMS, BUT BY 5/28/17 HAD DEVELOPED WEAKNESS AND LOSS OF DEEP-TENDON REFLEXES, AS WELL AS DIPLOPIA, SO WAS ADMITTED WITH THE DIAGNOSIS OF GUILLAIN BARRE SYNDROME (MILLER FISHER VARIANT), CONFIRMED BY LUMBAR PUNCTURE AND MRI. SHE WAS TREATED WITH 5 DAY COURSE OF IVIG AND AGGRESSIVE PULMONARY TOILET, NEVER REQUIRED INTUBATION. WAS SENT TO INPATIENT REHABILITATION FOR ONGOING UPPER AND LOWER EXTREMITY WEAKNESS. To date, she remains hospitalized, so duration of hospitalization is at least 46 days.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Cytomegalovirus test positive, Diplopia, Enterovirus test negative, Gram stain negative, Guillain-Barre syndrome
Clinical narrative: PATIENT DEVELOPED GUILLAIN-BARRE SYNDROME. STARTED AS TINGLING AND PAIN IN HANDS ON 5/21/17, PROGRESSED OVER THE NEXT FEW DAYS TO INVOLVE FEET. HAD A FEW VISITS TO OUTPATIENT PEDIATRICS AND THE ER WITH NORMAL NEUROLOGICAL EXAMS, BUT BY 5/28/17 HAD DEVELOPED WEAKNESS AND LOSS OF DEEP-TENDON REFLEXES, AS WELL AS DIPLOPIA, SO WAS ADMITTED WITH THE DIAGNOSIS OF GUILLAIN BARRE SYNDROME (MILLER FISHER VARIANT), CONFIRMED BY LUMBAR PUNCTURE AND MRI. SHE WAS TREATED WITH 5 DAY COURSE OF IVIG AND AGGRESSIVE PULMONARY TOILET, NEVER REQUIRED INTUBATION. WAS SENT TO INPATIENT REHABILITATION FOR ONGOING UPPER AND LOWER EXTREMITY WEAKNESS. To date, she remains hospitalized, so duration of hospitalization is at least 46 days.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Immunoglobulin therapy, Muscular weakness, Neurological examination normal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: PATIENT DEVELOPED GUILLAIN-BARRE SYNDROME. STARTED AS TINGLING AND PAIN IN HANDS ON 5/21/17, PROGRESSED OVER THE NEXT FEW DAYS TO INVOLVE FEET. HAD A FEW VISITS TO OUTPATIENT PEDIATRICS AND THE ER WITH NORMAL NEUROLOGICAL EXAMS, BUT BY 5/28/17 HAD DEVELOPED WEAKNESS AND LOSS OF DEEP-TENDON REFLEXES, AS WELL AS DIPLOPIA, SO WAS ADMITTED WITH THE DIAGNOSIS OF GUILLAIN BARRE SYNDROME (MILLER FISHER VARIANT), CONFIRMED BY LUMBAR PUNCTURE AND MRI. SHE WAS TREATED WITH 5 DAY COURSE OF IVIG AND AGGRESSIVE PULMONARY TOILET, NEVER REQUIRED INTUBATION. WAS SENT TO INPATIENT REHABILITATION FOR ONGOING UPPER AND LOWER EXTREMITY WEAKNESS. To date, she remains hospitalized, so duration of hospitalization is at least 46 days.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Pain in extremity, Paraesthesia, Polymerase chain reaction positive, Therapeutic procedure
Clinical narrative: PATIENT DEVELOPED GUILLAIN-BARRE SYNDROME. STARTED AS TINGLING AND PAIN IN HANDS ON 5/21/17, PROGRESSED OVER THE NEXT FEW DAYS TO INVOLVE FEET. HAD A FEW VISITS TO OUTPATIENT PEDIATRICS AND THE ER WITH NORMAL NEUROLOGICAL EXAMS, BUT BY 5/28/17 HAD DEVELOPED WEAKNESS AND LOSS OF DEEP-TENDON REFLEXES, AS WELL AS DIPLOPIA, SO WAS ADMITTED WITH THE DIAGNOSIS OF GUILLAIN BARRE SYNDROME (MILLER FISHER VARIANT), CONFIRMED BY LUMBAR PUNCTURE AND MRI. SHE WAS TREATED WITH 5 DAY COURSE OF IVIG AND AGGRESSIVE PULMONARY TOILET, NEVER REQUIRED INTUBATION. WAS SENT TO INPATIENT REHABILITATION FOR ONGOING UPPER AND LOWER EXTREMITY WEAKNESS. To date, she remains hospitalized, so duration of hospitalization is at least 46 days.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Rash, Tongue eruption
Clinical narrative: Pt did well with getting vaccines. No adverse reactions happened. Woke up the next morning with a rash all over the torso and arms. Very itchy.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: No adverse event, Pruritus, Rash generalised
Clinical narrative: Pt did well with getting vaccines. No adverse reactions happened. Woke up the next morning with a rash all over the torso and arms. Very itchy.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an allied health care professional referring to two unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On 30-MAR-2016, the patients were vaccinated with improperly stored injections of ROTATEQ, lot # K017573 and expiration date 11-JUN-2016, orally (strength and dose number were not provided) for prophylaxis. The patients' concomitant therapies were not reported. The vaccines were exposed to multiple temperature excursion, first on 18-MAR-2016, exposed to 33.1° Fahrenheit (F) during a time frame of 21 hours. On 23-MAR-2016, exposed to 27.5°F during a time frame of 5 hours and to 31.5°F during a time frame of 8 hours 30 minutes. On 24-MAR-2016, exposed to 30°F during a time frame of 10 hours 30 minutes and to 31.5°F during a time frame of 43 hours 30 minutes. On 28-MAR-2016 (reported as "28-MAR-2015"), exposed to 29.7°F during a time frame of 2 hours 30 minutes and to 31.5°F during a time frame of 24 hours. On 30-MAR-2016, exposed to 31.5°F during a time frame of 8 hours. Finally, on an unknown date the vaccines were exposed to 32°F to 35°F for 105 hours. The temperature excursions were called by a data logger. Adverse effects were not reported. This is one of two reports received from the same source.; Sender's Comments:  US-009507513-1706USA009316:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This information has been received from a registered nurse concerning a 14 year old patient of unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The reporter stated that on 19-SEP-2016, the patient received a dose of GARDASIL with lot number M014929 and expiration date on 27-MAY-2017, and on 15-JUN-2017, the patient received a dose of GARDASIL 9 with lot number N004798 and expiration date on 31-OCT-2019 (doses, dose numbers, routes of administration and anatomical locations were not provided), administered for prophylaxis. The nurse also stated that the patient had not experienced an adverse effect. Lot number N004798 has been verified to be a valid lot number for hpv rl1 6  11 16 181 31 33 45 52 58 vlp vaccine (yeast).
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, concomitant medications or drug allergies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (Lot # K011562, expiry date 08-APR-2017, NDC# 0006-4119-03) for prophylaxis (Strength, dose and route of administration were not reported) (incorrect product storage). Other suspect therapies included sterile diluent(MERCK STERILE DILUENT) as prophylaxis.  There was previous temperature excursions on 23-FEB-2016 to 24-FEB-2016, 27-FEB-2016 to 29-FEB-2016, 01-MAR-2016 to 04-MAR-2016, 08-MAR-2016 to 09-MAR-2016, 15-MAR-2016 to 20-MAR-2016, 23-MAR-2016 to 26-MAR-2016, 30-MAR-2016, 02-APR-201 to 04-APR-2016, 19-APR-2016 to 21-APR-2016 and 23-APR-2016 to 24-APR-2016 for 24 hours each. Data logger was involved. On 27-APR-2016,12-MAY-2016, 24-OCT-2016, 13-NOV-2016, 06-DEC-2016 and 04-APR-2017 there was a temperature excursion of -0.12, -0.46, -0.14, -0.24, +9 and -20.18 to +14 degree Celsius for 1 hour 15 minutes, 1 hour, 30 minutes, 45 minutes, 1 hour and 3 hours 30 minutes respectively. There was no product quality complaint involved. No adverse effects were reported. This is 1 of 6 reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA001491: US-009507513-1707USA001492: US-009507513-1707USA001489: US-009507513-1707USA001488: US-009507513-1707USA001490:
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective literature marketed report has been received from the author of a literature article. Objective of this report was to assess availability and use of measles-mumps-rubella (MMR) vaccination documentation for people vaccinated elsewhere. 1500 records were selected from 14 places from March 2013 through July 2015 to determine whether vaccination records were available at post health assessment and integrated into the Advisory Committee on Immunization Practices schedule. Number of doses, dosing interval, and contraindications were assessed. Twelve of 14 (85.7%) places provided data on 1118 (7 4.5%) people. Records for 972 (86.9%) people were available, most from the Centers for Disease Control and Prevention's Electronic Disease Notification system (66.9%). Most people (829; 85.3%) were assessed appropriately for M-M-R II vaccination; 37 (3.8%) should have received the vaccine but did not; 106 (10.9%) did not need the vaccine but were vaccinated. Author reported that out of 106 patients who did not require vaccination, 1 patient was pregnant and on an unknown date was vaccinated with M-M-R II (inappropriate schedule of drug administration and exposure during pregnancy). Her LMP and EDD were unknown. Patients pregnancy outcome was not reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dermatitis contact, Joint swelling, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a 50 year old female patient, who was also a company representative. The patient referred to herself. The patient concurrent condition included: a heartburn. The patient had a drug reaction or allergies for: BENADRYL, NEOSPORIN, POLYSPORIN, CALADRYL. On 04-JUN-2017, the patient was exposed to poison ivy and got an itchy poison ivy rash. On 06-JUN-2017, the patient was vaccinated with ZOSTAVAX subcutaneously for Shingles prevention (lot # M038864 with expiration date: 12-DEC-2017) that was reconstituted with sterile water diluent (manufacturer unknown). Concomitant therapies included PRILOSEC. Approximately on 11-JUN-2017 (reported as 5 days later), the patient stated that the poison ivy progressed severely and was affecting multiple limbs, torso, and neck. On an unknown date in June 2017, patient ankle was swelling. On 12-JUN-2017, the company representative visited a physician for the poison ivy, and was given an unspecified topical antibiotic and an oral prednisone (manufacturer unknown) (strength, dose, frequency, lot # and expiration date were not reported) titration pack to help relieve the itching. The poison ivy resolved within a few days (in June 2017). However, after the poison ivy resolved, she broke out with angry red raised bumps on both hands, one foot, and the top of the rib cage near the clavicle (unspecified date in June 2017). The patient reported that the bumps kept spreading and were not getting any better. She stated that she visited a nurse on 21-JUN-2017. The nurse stated that it did not appear that patient had a shingles. At the time of the report, as a treatment for the bumps the patient was taking ZYRTEC. The patient declined receiving Varicella Zoster Virus (VZV) packet. There were no lab diagnostic studies performed. The outcome of the event of poison ivy progressed severely and was affecting multiple limbs, torso, and neck was reported as resolved. The outcome of the event of ankle was swelling was not reported. The outcome of the events of she broke out with angry red raised bumps on both hands, one foot, and the top of the rib cage near the clavicle was reported as unresolved. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report was received from a 50 year old female patient, who was also a company representative. The patient referred to herself. The patient concurrent condition included: a heartburn. The patient had a drug reaction or allergies for: BENADRYL, NEOSPORIN, POLYSPORIN, CALADRYL. On 04-JUN-2017, the patient was exposed to poison ivy and got an itchy poison ivy rash. On 06-JUN-2017, the patient was vaccinated with ZOSTAVAX subcutaneously for Shingles prevention (lot # M038864 with expiration date: 12-DEC-2017) that was reconstituted with sterile water diluent (manufacturer unknown). Concomitant therapies included PRILOSEC. Approximately on 11-JUN-2017 (reported as 5 days later), the patient stated that the poison ivy progressed severely and was affecting multiple limbs, torso, and neck. On an unknown date in June 2017, patient ankle was swelling. On 12-JUN-2017, the company representative visited a physician for the poison ivy, and was given an unspecified topical antibiotic and an oral prednisone (manufacturer unknown) (strength, dose, frequency, lot # and expiration date were not reported) titration pack to help relieve the itching. The poison ivy resolved within a few days (in June 2017). However, after the poison ivy resolved, she broke out with angry red raised bumps on both hands, one foot, and the top of the rib cage near the clavicle (unspecified date in June 2017). The patient reported that the bumps kept spreading and were not getting any better. She stated that she visited a nurse on 21-JUN-2017. The nurse stated that it did not appear that patient had a shingles. At the time of the report, as a treatment for the bumps the patient was taking ZYRTEC. The patient declined receiving Varicella Zoster Virus (VZV) packet. There were no lab diagnostic studies performed. The outcome of the event of poison ivy progressed severely and was affecting multiple limbs, torso, and neck was reported as resolved. The outcome of the event of ankle was swelling was not reported. The outcome of the events of she broke out with angry red raised bumps on both hands, one foot, and the top of the rib cage near the clavicle was reported as unresolved. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacy intern referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug and allergy history were not reported. On 21-APR-2017, the patient was vaccinated with the second dose of GARDASIL 9, injection (strength, route, lot and expiration date were not provided) for prophylaxis. Two months 1 day after, on 21-JUN-2017, the patient received the third dose of GARDASIL 9, intramuscular injection, lot # M020103, expiration date 15-FEB-2018, (strength was not provided) for prophylaxis. The patient's concomitant medication was not reported. Adverse effects were not reported.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Paraesthesia oral, Skin warm, Tenderness
Clinical narrative: This spontaneous report was received from a physician and refers to a 69-year-old female patient with no drug reactions or allergies. The patient had no pertinent medical history. On 19-JUN-2017, the patient was subcutaneously vaccinated with a dose of ZOSTAVAX injection (exact dose, lot # and expiration date were not reported) for prophylaxis (reported as vaccination). Concomitant therapies included unspecified hypertension medication and unspecified high cholesterol medication. On 22-JUN-2017, the patient experienced golf ball sized (4 by 2.5 inches) lump in her axilla that was tender and hot and tingling on her lips, described by the reporter like the one you get if you have a cold sore. No lab diagnostic studies were performed. The patient sought medical attention by calling the physician. There was no treatment given for the adverse events. The outcome of the adverse events was not recovered/not resolved. No product quality complaint was involved. The relatedness between the adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 2-year-old patient of unknown gender. No information regarding the patient's medical history or concurrent conditions was provided. On 23-JUN-2017, the patient was inadvertently vaccinated with a dose of PROQUAD injection (lot# M033209, expiry date 09-JAN-2018; exact dose and route of administration were not reported) instead of a dose of M-M-R II injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-JUN-2017, the patient was vaccinated with expired dose of VAQTA lot # M031695, expiration date 26-MAY-2017 (dose and route of administration were not reported) for prophylaxis. The nurse stated that a medical assistant administered VAQTA without checking the expiration date. No adverse effects noted and no additional information given. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were subcutaneously vaccinated with improperly stored doses of VARIVAX injection (lot# M023380, expiry date 11-MAY-2018; exact dose was not reported), reconstituted with properly stored doses of sterile diluent (DILUENT MRK). The doses of the vaccine were exposed to a temperature excursion of -9 to 8 degrees Celsius (also reported as 6 degrees Celsius) on an unknown date, for a time frame of 1252 hours. There were no previous temperature excursions. A Digital Data Logger was involved. No side effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Hypersensitivity, Inflammation, Pruritus
Clinical narrative: Information has been received from a consumer refers to his wife of unknown age. On 22-JUN-2017 the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis at a pharmacy. On an unknown date in June 2017 the patient experienced localized allergic reaction with reddening and inflammation and lots of itching and burning. She went back to the pharmacy today and the pharmacist advised her to take diphenhydramine hydrochloride (BENADRYL) to relieve her symptoms. The outcome of the adverse events was unknown.