chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 17-JUL-2017 from a nurse who was reporting on multiple unspecified patients (demographic were unknown). No medical history or concomitant medications were reported. The nurse reported that on unspecified dates, an unspecified number of patients were administered doses of improperly stored MMRII (lot N010426, expires 01-MAR-2018). The lot number and expiration of the sterile diluent is unknown. The nurse also reported that on unspecified dates, an unspecified number of unspecified patients were administered separate doses of improperly stored doses for the following vaccines: PEDVAXHIB (Lot L033690, expires 14-JUN-2018), GARDASIL 9 (lot N00326, expires 14-OCT-2019) and PNEUMOVAX 23 (lot N01867, expires 08-NOV-2018) (dose, injection sites and route not reported). No adverse effects were reported. No additional information was provided. The temperature excursion involved temperature range from 9 degrees C. to 25 degrees C. for 72 hours. There was no previous temperature excursion and a data logger was not involved. The nurse called back and reported that a male patient of unknown age received an improperly stored dose of GARDASIL 9 (lot N000326, expires 14-OCT-2019) for prophylaxis. No medical history or concomitant medications were reported. A second male patient also received a dose of GARDASIL 9 (lot N000326, expires 14-OCT-2019) (MARRS# 1708USA004622). A female patient of unknown age received a dose of improperly stored PNEUMOVAX 23 (lot N011867, expires 08-NOV-2018) vaccine on 14-JUL-2017 (MARRS 1707USA004862). No further information was provided. Follow-up information was received on 17-JUL-2017 from the nurse who reported that the actual time frame of the temperature excursion was 96 hours. The nurse also stated that the improperly stored PEDVAXHIB and MMRII were not administered. No further adverse event information was provided. Additional information has been requested. This is one of several reports by the same reporter.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 17-JUL-2017 from a nurse who was reporting on multiple unspecified patients (demographic were unknown). No medical history or concomitant medications were reported. The nurse reported that on unspecified dates, an unspecified number of patients were administered doses of improperly stored MMRII (lot N010426, expires 01-MAR-2018). The lot number and expiration of the sterile diluent is unknown. The nurse also reported that on unspecified dates, an unspecified number of unspecified patients were administered separate doses of improperly stored doses for the following vaccines: PEDVAXHIB (Lot L033690, expires 14-JUN-2018), GARDASIL 9 (lot N00326, expires 14-OCT-2019) and PNEUMOVAX 23 (lot N01867, expires 08-NOV-2018) (dose, injection sites and route not reported). No adverse effects were reported. No additional information was provided. The temperature excursion involved temperature range from 9 degrees C. to 25 degrees C. for 72 hours. There was no previous temperature excursion and a data logger was not involved. The nurse called back and reported that a male patient of unknown age received a dose of improperly stored GARDASIL 9 (lot N000326, expires 14-OCT-2019) for prophylaxis. No medical history or concomitant medications were reported. A second male patient also received a dose of improperly stored GARDASIL 9 (lot N000326, expires 14-OCT-2019) (MARRS# 1708USA004621) on 14-JUL-2017.  A female patient of unknown age received a dose of improperly stored PNEUMOVAX 23 (lot N011867, expires 08-NOV-2018) vaccine on 14-JUL-2017 (MARRS 1707USA004862). No further information was provided. Follow-up information was received on 17-JUL-2017 from the nurse who reported that the actual timeframe of the temperature excursion was 96 hours. The nurse also stated that the improperly stored PEDVAXHIB and MMRII were not administered. No further adverse event information was provided. Additional information has been requested. This is one of several reports by the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # N014366 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX.; Sender's Comments: US-009507513-1708USA004800:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age. On 08-JUL-2017, the patient was vaccinated with GARDASIL 9 lot # M042853 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age. On 20-JUL-2017, the patient was vaccinated with GARDASIL 9 lot # M042853 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA004692: US-009507513-1708USA004693: US-009507513-1708USA004694: US-009507513-1708USA004695: US-009507513-1708USA004690: US-009507513-1708USA002122.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age. On 21-JUL-2017, the patient was vaccinated with GARDASIL 9 lot # M042853 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA004691: US-009507513-1708USA004693: US-009507513-1708USA004694: US-009507513-1708USA004695: US-009507513-1708USA002122.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age. On 26-JUL-2017, the patient was vaccinated with GARDASIL 9 lot # M042853 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA004691: US-009507513-1708USA004692: US-009507513-1708USA004694: US-009507513-1708USA002122.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a patient of unknown age. On 08-JUL-2017, the patient was vaccinated with ROTATEQ lot # M038208, oral for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA002122: US-009507513-1708USA004693: US-009507513-1708USA004692: US-009507513-1708USA004691.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Discomfort, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. On or about 25-MAY-2015, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, lot number, and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-APR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 04-APR-2016, the patient was again treated by this same physician for ongoing and worsening symptoms of shingles. On or about 12-APR-2016, he was treated in the Emergency Room for severe symptoms and pain resulting from the shingles infection. The patient continued to seek medical counseling from the medical facility's phone appointment line, at which time his extreme discomfort was noted and prescriptions were refilled to maintain his ability to function. He had been prescribed nystatin cream, triamcinolone cream and valacyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further and proximate result, he suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The lawyer felt the events were related to ZOSTAVAX. The outcome of the events was not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 08-AUG-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 12-SEP-2015 at a hospital clinic 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. During November of 2015, the patient sought treatment from a nurse practitioner at the hospital clinic for treatment of an ongoing vesicular rash accompanied by weakened immune systems, which was diagnosed as herpes zoster or singles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 08-AUG-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX on or about 15-DEC-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevents shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-JUL-2016, the patient was treated at a clinic for the onset of a severe vesicular rash accompanied by a weakened immune systems, which was diagnosed as  herpes zoster, or shingles. On or about 26-JUL-2016, the patient received subsequent treatment at a physician's office for ongoing and worsening shingles symptoms. The patient has been prescribed gabapentin (manufacturer unknown) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 08-AUG-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age.  Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 06-SEP-2013 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 24-FEB-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed FAMVIR for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 08-AUG-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine in September 2015 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 09-MAR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by a weakened immune systems, which was diagnosed as herpes zoster, or shingles. On or about 11-MAR-2017, the patient was treated by another physician at a hospital emergency room for severe shingles complications including interference with her 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 has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, severe shingles complications, including interference with her eyes was considered medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # N008824 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD. Sender's Comments: US-009507513-1708USA004667.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Influenza like illness, Influenza virus test positive, Vaccination failure
Clinical narrative: SERIOUSNESS CRITERIA: IMPORTANT MEDICAL EVENT. Initial unsolicited case received from a health care professional on 31 Jul 2017. This case involves six-patients (age and gender not reported) who were vaccinated with a dose of FLUZONE HD, and a dose of FLUZONE QIV (Batch numbers, expiry date, dose, dose in series, route, and site of administration were not reported for both vaccines) on an unspecified day in late Aug 2016. The medical history and concomitant medications of patients were not reported. On an unspecified day in May 2017, few months after the vaccination, the patients were diagnosed with influenza via nasal swab (which was positive) when presented with flu like symptoms. It was also reported as does not know if A or B strain or vaccine substrain. Patients were required to visit doctor or ER (emergency room). It was also a case of suspected vaccination failure. The patients' other relevant lab tests were not reported. Patients were treated with TAMIFLU. On an unknown date, all the patients were recovered from the events. Upon internal review the company decided to consider the case as serious due to important medical events influenza and vaccination failure. List of documents held by sender: none. Sender's Comments: 6 patients experienced influenza infection after vaccination with FLUZONE HD and FLUZONE QIV. Time to onset is too long and the dosage regimen followed by the patients is also not reported. Even though the event is listed post vaccination with the suspects it could not be confirmed if the strain responsible for infection was the same used in the vaccines. Therefore based upon the diagnosis made by nasal swab this was a case of suspected vaccination failure. More information regarding possibility of the patients getting infected via alternate sources should be requested. Also, information regarding patients dosage regimen and medical history should also be requested to help in assessment of this case. Based upon the reported information the role of the vaccine cannot be assessed.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Syncope immediately after vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Symptoms: Swelling to L Arm and itchy. Treatment: Ice to affected area and was prescribed Ibuprofen 100/5 to take 2 1/2 tsp by mouth every 6 hours or pain.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt received vaccines 8/8/2017. Parent noticed a red itchy spot on the (R) thigh the day after. Area warm to touch, red, measuring 2 inches x 2 inches. Pt seen in office 8/10/2017 by Dr. and recommended pt take BENADRYL, ibuprofen and apply hydrocortisone cream.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Rash, Vaccination complication
Clinical narrative: Burning rash on chest, neck and left arm, client reports she went to a walk in clinic and doctor told her that the rash was a reaction from the TDaP vaccine.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: PENTACEL given on right thigh 8/8/17. Redness developed shortly after. Next morning mother noted increased redness, warmth, and induration. On PE: 3-4cm round, indurated, slightly warm lesion on right upper thigh.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient received vaccine on 8/7/17 and said her arm from elbow to should was very swollen and red by that evening. She came to pharmacy on 8/9/17 and reported red, swollen, warm upper arm. She was advised to call/see her doctor.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Parent brought the patient into the clinic the day after vaccination 8/4/2017 noting that the patient had a 5" x 7" area of redness, swelling and warmth. Patient was seen by Dr. and recommendation was to use Tylenol and ibuprofen for pain or discomfort, Benadryl for swelling and ice to area if needed. Antibiotic was prescribed because they were going out of town and concerned that the reaction could get worse. I spoke with the patients mom 8/10/2017 and antibiotic did not need to be used.
Age: 38.0
Sex: M
Vaccine: ANTH, JEV1, TYP
Symptoms: Erythema, Tenderness
Clinical narrative: Patient presents with right arm erythema approx 4"x 4". Origination appears to be at the lateral mid-deltoid region and extends distally to approx 3" proximal to the elbow/antecubital fossa. Localized erythema does not extend past elbow joint nor shoulder joint. Area is tender on palpation with normal skin temperature. No warmth, exudate or excoriations appreciated on examination. Neg axillary LAD.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Lip discolouration, Nausea, Pallor, Vomiting
Clinical narrative: Approximately 3 minutes after vaccines were given, patient said she needed to throw up. Patient's skin was pale. I got the patient a cloth for her head, a garbage can and asked her mom to hold her. Patient was alert, responsive and oriented with no wheezing. Paged nurses to immunization room to assist in evaluation patient. After calling for assistance, patient's lips were gray. Patient vomited mostly water. RN reported no edema in throat. BP 82/48, Pulse 96, Respirations 24, Pulse Ox 99 @ approximately 11:00 a.m. Mom reported that patient had a reaction (reports she got chickenpox from vaccine) when she was young, no other reaction reported. Patient's mom stated the doctor told her just to wait and get immunizations in a couple of years. Protocol reviewed by RN, Nurse Manager and 911 was called and arrived approximately 11:10 a.m. and patient was taken to hospital.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Started with redness and swelling that night around 9:00PM. Continues with redness and swelling today (2 days after injection),  now warm to the touch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Dizziness, Glossodynia, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately after receiving the 2nd injection child stated that "her tongue hurt and she felt dizzy". No tongue swelling or uvula swelling noted upon exam but patient was laid down and she passed out for less than one minute. Patient also became pale and diaphoretic. EMS was called and we continued to monitor child and she did have some slight wheezing but no difficulty breathing and wheezing cleared in 2-3 minutes. BP was 82/40. EMS arrived and assessed patient - she was then ambulatory and was alert and talking. Patient departed to Hospital per EMS at approximately 10:45am with mother at her side.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pallor, Wheezing
Clinical narrative: Immediately after receiving the 2nd injection child stated that "her tongue hurt and she felt dizzy". No tongue swelling or uvula swelling noted upon exam but patient was laid down and she passed out for less than one minute. Patient also became pale and diaphoretic. EMS was called and we continued to monitor child and she did have some slight wheezing but no difficulty breathing and wheezing cleared in 2-3 minutes. BP was 82/40. EMS arrived and assessed patient - she was then ambulatory and was alert and talking. Patient departed to Hospital per EMS at approximately 10:45am with mother at her side.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Emotional distress, Herpes zoster, Ophthalmic herpes zoster, Pain
Clinical narrative: Information was received from a lawyer 08-AUG-2017 regarding a case in litigation concerning a plaintiff of unspecified age and gender. It was claimed the plaintiff was inoculated with ZOSTAVAX on or about 28-SEP-2011 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused the plaintiff to contract a persistent strain of herpes zoster. On or about 24-JAN-2016, the plaintiff was treated by a Family Nurse Practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles interference into the eye. As a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Upon internal review, ophthalmic herpes zoster was considered medically significant. Additional information was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information was received from a lawyer 08-AUG-2017 regarding a case in litigation concerning a plaintiff of unspecified age and gender. It was claimed the plaintiff was inoculated with ZOSTAVAX on or about 28-SEP-2011 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused the plaintiff to contract a persistent strain of herpes zoster. On or about 24-JAN-2016, the plaintiff was treated by a Family Nurse Practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles interference into the eye. As a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Upon internal review, ophthalmic herpes zoster was considered medically significant. Additional information was requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 08-AUG-2017 from a lawyer and a female patient of unknown age regarding a case in litigation. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX, (lot number and expiration not reported) subcutaneous in June of 2016 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 01-SEP-2016, the patient was treated by a family nurse practitioner at a medical center for the onset of a severe 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, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received on 08-AUG-2017 from a lawyer and a female patient of unknown age regarding a case in litigation. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was inoculated with ZOSTAVAX, (lot number and expiration not reported) subcutaneous 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 28-MAY-2016, the patient was treated by a physician in a physician's office for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as abdominal herpes zoster, or shingles with post-herpetic neuralgia. Post-herpetic neuralgia is a chronic condition of nerve pain and damage secondary to shingles infections. The patient has been prescribed gabapentin and NEURONTIN for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 02-MAR-2012, the patient was inoculated with ZOSTAVAX for routine adult health maintenance and for the prevention of shingles (dose, lot #, and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-DEC-2015, he was treated by a physician for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered injuries and damages, and required extensive medical care and treatment. As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Inflammation, Pain in extremity
Clinical narrative: Left arm was painful, very inflamed.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Muscular weakness, Peripheral swelling
Clinical narrative: Stated Burning or stinging at injection site, later in the day weakness in right arm and some swelling in the hand, getting better the next afternoon.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: Mild swelling, redness, tenderness, itching covering about 12cm area on the arm.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Chills, Fatigue, Nausea, Headache, Very Sore Arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Agitation, Dysphonia, Swelling face
Clinical narrative: Facial swelling, hoarseness, agitation. Pt given BENADRYL and oral steroid in office, stayed in office for approximately an hour. The hoarseness went away, continued to have swelling to face. Did not have any resp distress.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Diarrhoea, Fluid intake reduced, Injection site erythema, Irritability, Pyrexia
Clinical narrative: Patient administered PENTACEL vaccine on 8-9-2017. Developed redness at injection site later the same day. Developed fever 101.5 on 8-10-2017, fussy, sleepy,  water chunky diarrhea and local redness at injection site (golf ball size). Comfort measures(tylenol/advil), encouraged fluids. Per patient's mother, temp is 98.8 on 8-10-2017 @ 5:50 pm. Patient still fussy and still has diarrhea.  Patient refuses liquids except her formula.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Somnolence
Clinical narrative: Patient administered PENTACEL vaccine on 8-9-2017. Developed redness at injection site later the same day. Developed fever 101.5 on 8-10-2017, fussy, sleepy,  water chunky diarrhea and local redness at injection site (golf ball size). Comfort measures(tylenol/advil), encouraged fluids. Per patient's mother, temp is 98.8 on 8-10-2017 @ 5:50 pm. Patient still fussy and still has diarrhea.  Patient refuses liquids except her formula.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Autoimmune disorder, Condition aggravated, Diarrhoea, Migraine
Clinical narrative: Pt presented to office today and relayed the last few weeks symptoms to the MD. Migraines, nausea, diarrhea, myalgia, abdominal cramps, sore throat. Pt has autoimmune diseases and the MD thought that the shot could have exacerbated the symptoms. Pt has been given prescriptions for zofran, and codeine.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: Pt presented to office today and relayed the last few weeks symptoms to the MD. Migraines, nausea, diarrhea, myalgia, abdominal cramps, sore throat. Pt has autoimmune diseases and the MD thought that the shot could have exacerbated the symptoms. Pt has been given prescriptions for zofran, and codeine.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Autopsy, Culture tissue specimen, Hypersomnia, Lethargy, Respiratory arrest
Clinical narrative: Patient was unusually lethargic and slept from 9pm on July 28, 2017 to 9am on July 29, 2017.  He remained lethargic throughout the day, and was last known alive at approximately 10pm on July 29, 2017. He went to sleep on his mother's chest while she was reclining partially upright on a sofa. She also went to sleep and awoke approx. half hour later to find him not breathing. 911 call at 10:37pm with CPR in progress.  Patient never revived and was pronounced dead at 11:15pm.  SUIDI at this time; investigation ongoing.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Resuscitation, Sudden death, Toxicologic test
Clinical narrative: Patient was unusually lethargic and slept from 9pm on July 28, 2017 to 9am on July 29, 2017.  He remained lethargic throughout the day, and was last known alive at approximately 10pm on July 29, 2017. He went to sleep on his mother's chest while she was reclining partially upright on a sofa. She also went to sleep and awoke approx. half hour later to find him not breathing. 911 call at 10:37pm with CPR in progress.  Patient never revived and was pronounced dead at 11:15pm.  SUIDI at this time; investigation ongoing.
Age: 80.0
Sex: M
Vaccine: PNC13, PNC13, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient recieved prevnar 13 on August 5th, 2017, then patient received PREVNAR 13 again on August 10th on accident. Pharmacist already called Pfizer company to verify if there was any side effects to getting PREVNAR 13 twice in a short amount of time and company said they do not have enough data yet to say there is a side effect. Patient is aware.
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Chills, Headache, Nausea, Pain
Clinical narrative: PT WAS FINE UNTIL 2 1/2 HOURS AFTER VACCINATION. STARTED HAVING HEADACHE AND NAUSEA. LAY DOWN. 1 HOUR LATER, WHICH WAS 3 1/2 HOURS AFTER VACCINATION, HEADACHE/VOMITING/CHILLS/BODY ACHE. CAME TO OFFICE, HAD VOMITED 4 TIMES, HAD TEMP TO 100.3. VITAL SIGNS STABLE. NORMAL EXAM, NO SOB/TROUBLE BREATHING/RASH/ETC. SIMILAR EVENT AFTER FIRST DOSE WITH MILD FEVER AND BODY ACHES, NO VOMITING.
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: PT WAS FINE UNTIL 2 1/2 HOURS AFTER VACCINATION. STARTED HAVING HEADACHE AND NAUSEA. LAY DOWN. 1 HOUR LATER, WHICH WAS 3 1/2 HOURS AFTER VACCINATION, HEADACHE/VOMITING/CHILLS/BODY ACHE. CAME TO OFFICE, HAD VOMITED 4 TIMES, HAD TEMP TO 100.3. VITAL SIGNS STABLE. NORMAL EXAM, NO SOB/TROUBLE BREATHING/RASH/ETC. SIMILAR EVENT AFTER FIRST DOSE WITH MILD FEVER AND BODY ACHES, NO VOMITING.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Erythematous rash on right deltoid extending to bicep approx 3in x 5in; warm and tender to the touch.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received both vaccines on 8/9/17 at approximately 12:35 pm. Patient experienced arm soreness and stiffness last night. This morning the patient said her arm was red and swollen. She went to her doctor today for treatment of the reaction.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: ADULT PATIENT RECEIVED PEDS DOSE.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site swelling
Clinical narrative: Symptoms: Left thigh swelling. Treatments: Place ice pack on site three times a day for 10-15 minutes.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Nausea, Pain, Pruritus, Swelling
Clinical narrative: Swelling, redness, painful, itching, nausea, vomiting.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Swelling, redness, painful, itching, nausea, vomiting.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Blood test, Chest X-ray, Dyspnoea, Painful respiration
Clinical narrative: Swollen face and throat. Rashes and blisters on hands, face, & feet that were extremely painful and itchy. Difficult and painful breathing. Went to ER 3 times within a week same doctor at 2 visits misdiagnosed me. I was not treated for actual symptoms until 3rd ER visit with a different doctor who gave steroids which started to help the breathing finally. It took a long time, over a month for blisters and rashes to go away. I still continue to this day  get these same rashes  which are itchy and painful.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Rash, Rash pruritic, Swelling face
Clinical narrative: Swollen face and throat. Rashes and blisters on hands, face, & feet that were extremely painful and itchy. Difficult and painful breathing. Went to ER 3 times within a week same doctor at 2 visits misdiagnosed me. I was not treated for actual symptoms until 3rd ER visit with a different doctor who gave steroids which started to help the breathing finally. It took a long time, over a month for blisters and rashes to go away. I still continue to this day  get these same rashes  which are itchy and painful.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site urticaria, Myalgia, Urticaria
Clinical narrative: Starting on the AM of 8/8/17 patient experienced myalgia in the neck radiating into the left scapula region. Started to decrease in severity, however on 8/10/17 developed hives bilaterally in the deltoid region, left deltoid region greater than the right.
Age: 79.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: REDNESS AROUND THE AREA WHERE SHOT WAS GIVEN. PATIENT COMPLAINED OF ITCHINESS.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: PATIENT PASSED AT REGISTER IN THE FRONT OF STORE ABOUT 15 MINUTES AFTER RECEIVING VACCINE. I HEARD SOMEONE YELLING FOR AN AMBULANCE, I HAD TECHNICIAN CALL 911 AND I RAN TO FRONT OF STORE. PATIENT WAS PASSED OUT ON HER BACK ON THE FLOOR. I CHECKED AND COULD SEE THAT SHE WAS BREATHING, AND TAPPED HER SHOULDER AND ASKED HER IF SHE COULD HEAR ME WHILE I CHECK FOR PULSE. SHE CAME TO QUICKLY JUST AS I CONFIRMED SHE HAD PULSE. I WAS TOLD AMBULANCE WAS ON THE WAY AND HAD HER REMAIN LYING DOWN. AMBULANCE ARRIVED WITHIN 2 TO 3 MINUTES. THEY TOOK OVER.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Right arm turns red, tender and warm to the touch from right deltoid down to elbow.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: High fever and red bumps.
Age: 1.25
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Pt developed fever on 08/07/17 and then a generalized rash to face and legs and progressed to body.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Headache, Pain in extremity
Clinical narrative: Patient complained of severe headache and leg pain 30 minutes following the vaccine, she was advised by CPNP, who had ordered the vaccine at her well visit appointment, to go to the ED.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Conversion disorder, Headache, Pain in extremity
Clinical narrative: Patient complained of severe headache and leg pain 30 minutes following the vaccine, she was advised by CPNP, who had ordered the vaccine at her well visit appointment, to go to the ED.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Hyperhidrosis, Limb discomfort, Pain
Clinical narrative: Mild swelling, redness, pain, warmth, "heavy arm", headache and sweaty however lower in arm than site injection. Started couple hours after injection. Redness gone by next morning. Reassured expect continue to improve over next 72 hrs. ZYRTEC given daily and advised to ice 3x/day as needed. Unsure if from vaccine itself or because of previous B12 injection in arm within last week.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Mild swelling, redness, pain, warmth, "heavy arm", headache and sweaty however lower in arm than site injection. Started couple hours after injection. Redness gone by next morning. Reassured expect continue to improve over next 72 hrs. ZYRTEC given daily and advised to ice 3x/day as needed. Unsure if from vaccine itself or because of previous B12 injection in arm within last week.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Contusion, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction of (R) deltoid - lump, swelling, warmth, tenderness, bruising.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Lg local reaction redness 7 1/2 inches / 4 1/2 inches plus induration 2 1/2 inches at site.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Seizure
Clinical narrative: Possible seizure.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Swollen arm, red and hot to the touch. Mild pain.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Redness, swollen, pain, hot - (L) arm.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: None. Patient received wrong vaccination. She received BOOSTRIX instead of FINARIX.
Age: 0.42
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Rash papular
Clinical narrative: Pink papular dermatitis on outer arms shoulder to hand and anterior thigh and lower legs (B). Plan: No treatment advised. Follow up if not resolve in one week. May use BENADRYL 3-5ml if itchy. Call if worse.
Age: 1.5
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: On 8/9/17, patient developed redness and swelling of left upper extremity. On exam, 7 x 11 cm area of redness with 3cm x 3cm area of induration. KEFLEX started.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Peripheral swelling, Soft tissue swelling
Clinical narrative: Patient got vaccine 8/10/17. That night Lt upper arm sore. Worse. L arm. Tried cold pack. Arm swollen left UE internal aspect pink 7 x 3 cm and soft tissue swell 10 x 1.5 cm. Decreased ROM left shoulder with rib duration and forward arc. No axillary lymphadenopathy. Plan: Ice q 2h for 10-15 min. Work note. F/u if worse.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: Area of painful redness started under vaccine, 1 day after administration and still present 4 days later.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Decreased appetite, Dizziness, Fatigue, Malaise
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of malaise in a 63-year-old female patient who received BOOSTRIX (batch number 3K799, expiry date 18th May 2019). On 11th July 2017, the patient received BOOSTRIX. On 18th July 2017, 7 days after receiving BOOSTRIX, the patient experienced malaise, fever, appetite lost, light headedness, skin sensitization, stomach pain, fatigue and nausea. On an unknown date, the outcome of the malaise, fever, appetite lost, light headedness, skin sensitization, stomach pain, fatigue and nausea were unknown. It was unknown if the reporter considered the malaise, fever, appetite lost, lightheadedness, skin sensitization, stomach pain, fatigue and nausea to be related to BOOSTRIX. Additional information was provided as follows: The age at vaccination was not reported, but it could be 62 or 63 years. One week after vaccination the patient experienced fever and skin that was sensitive all over the body. On 18th July 2017, the body temperature was recorded as 99.5 degree C. On 31st July 2017, the patient was seen by the doctor. The patient required emergency room visit. At the time of visit, the events were unchanged.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pyrexia, Skin sensitisation
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of malaise in a 63-year-old female patient who received BOOSTRIX (batch number 3K799, expiry date 18th May 2019). On 11th July 2017, the patient received BOOSTRIX. On 18th July 2017, 7 days after receiving BOOSTRIX, the patient experienced malaise, fever, appetite lost, light headedness, skin sensitization, stomach pain, fatigue and nausea. On an unknown date, the outcome of the malaise, fever, appetite lost, light headedness, skin sensitization, stomach pain, fatigue and nausea were unknown. It was unknown if the reporter considered the malaise, fever, appetite lost, lightheadedness, skin sensitization, stomach pain, fatigue and nausea to be related to BOOSTRIX. Additional information was provided as follows: The age at vaccination was not reported, but it could be 62 or 63 years. One week after vaccination the patient experienced fever and skin that was sensitive all over the body. On 18th July 2017, the body temperature was recorded as 99.5 degree C. On 31st July 2017, the patient was seen by the doctor. The patient required emergency room visit. At the time of visit, the events were unchanged.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in patients who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: This case was reported by an office manager. The age at vaccination was not reported. The reporter stated that an unknown number of patients have experienced injection site soreness after receiving BEXSERO. As per reporter, no other reactions or necessary medical intervention was needed to the patients. It was reported that, some patients had also received 2nd dose of BEXSERO more than one month after their first dose. The reporter did not have access to information regarding specific patients during time of call.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Asthenia, Dyspnoea, Eating disorder, Fatigue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fatigue in a 18-year-old female patient who received BEXSERO (batch number 165601A, expiry date 31st October 2018). On 31st July 2017 09:30, the patient received the 1st dose of BEXSERO .5 ml. On 31st July 2017 14:00, 4 hrs 30 min after receiving BEXSERO, the patient experienced fatigue, loss of energy, difficulty breathing and eating disorder. On an unknown date, the outcome of the fatigue, loss of energy, difficulty breathing and eating disorder were unknown. It was unknown if the reporter considered the fatigue, loss of energy, difficulty breathing and eating disorder to be related to BEXSERO. Additional details were provided as follows: The patient experienced, extreme fatigue, having to force herself to eat, lack of energy, and had to force air out to breathe. No emergency interventions were required. The healthcare professional would continue to monitor the patient.