chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 27-Jun-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a 11 years old male patient who received 0.5 ml dose of DAPTACEL (Lot number: C5117AA, expiry date: 31-Jan-2019) instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 27-Jun-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 21-Jun-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves four patients (age and gender not reported) who received expired dose of MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 13-Jun-2018, the patients received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5462AA (expiry date: 19-Jan2018) in the left arm. It was a case of actual medication error due to expired vaccine used. It was unknown whether adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: None.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 27-Jun-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a patient (age and gender not reported), who was vaccinated with an expired dose of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used because expiration date is listed as 24Jun2018 and PENTACEL was given today. It was also reported that the reporter would like to know what adverse events to look for and what expiration date should she follow on 24-Jun-2017 or should she assume the expiration date is the last day of the month. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 37.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial information received on 21-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 37-year-old male patient, who was vaccinated with 0.5 ml first dose of DAPTACEL (batch number: C52068A) via intramuscular route instead of ADACEL (expiration date: 19-May-2019 and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 75.0
Sex: U
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, Extra dose administered
Clinical narrative: Initial information received on 21-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 75-year-old patient (gender not reported), who was vaccinated with 0.5 ml two doses of MENACTRA (batch number: U5984AB, expiry date, dose in series and route administration was not reported) in one of each arm on 21-Jun-2018 at 11 AM. Patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to extra dose administered and inappropriate age at vaccine administration because a 75-year-old patient received MENACTRA dose given twice. Patient was visited to the emergency room. It was unknown if any adverse event occurred or not following the vaccination. Patient was initiated on drug SOLIRIS as corrective treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: HIBV, TTOX
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: Initial information received on 28-Jun-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case involves 70 years female old patient who received who received 0.5 ml and ACTHIB (frequency once, batch number UI911AA, expiry date, route and site of administration reported "route and site: UTR") on 08 June 2018 as she was to receive a Tetanus Toxoid shot and is there enough to cover just the tetanus. It was actual medication error due to inappropriate age at vaccine administration and Wrong vaccine administered as 70 year was given ACTHIB in any contraindications or any side effects. She was to receive a tetanus shot and is there enough to cover (Tetanus shot and received ACTHIB Immunization or TB skin test). On 08 June 2018, patient had emergency room visit (ER/Dr). No adverse event symptom occurred to patient. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 2.0
Sex: F
Vaccine: FLU4, HEP, PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's historical condition, concurrent condition, concomitant therapy, historical drugs or allergies were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (lot # M010671 and expiration date 02-JUN-2018) for prophylaxis (strength, frequency, route of administration, were not provided). No adverse events were reported. The temperature was below 32 degree Fahrenheit (F)/0 degrees Celsius (C) (31.1F), time frame was 45 minutes, there were not previous temperature excursion, and the call was not because of a data logger. Follow-up information has been received from the nurse on 26-JUN-2018 referring to a 2 year old female patient. The patient did not have pre-existing physician - diagnosed allergies, birth defects and illness at time of vaccination. On 23-JAN-2018, the patient was vaccinated with PENTACEL, M-M-R II, VARIVAX and VAQTA. On 27-FEB-2018, the patient was vaccinated with the second dose of improperly stored RECOMBIVAX HB lot # M010671, expiration date 02-JUN-2018 for prophylaxis. On 27-FEB-2018, the patient was vaccinated with improperly stored PREVNAR (dose 3, lot# R75851) and FLUZONE (lot# UT589JA) intramuscularly for prophylaxis. The vaccines were purchased with public funds. The patient was vaccinated at private doctor's office/hospital. The vaccines were improperly storage in clinical practice. There were no labs or diagnostic test. It was not sure a temperature excursion occurred as a result of a reading from a data logger.
Sex: U
Vaccine: VARCEL
Symptoms: Contraindication to vaccination
Clinical narrative: This literature marketed report as received from authors of literature article refers to 2 patients of unknown age and gender with multiple sclerosis (MS). On unknown dates, the patients demonstrated insufficient immunity and were vaccinated with VARIVAX (dose, route of administration, lot #, and expiration date were not provided) prior to ocrelizumab dosing.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The information regarding patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2018 the patient was vaccinated with an expired dose of VAQTA, 50U/1.0 ml, lot # N005605 with expiration date: 08-APR-2018 intramuscularly for prophylaxis. No adverse event was reported. There was no temperature excursion prior to date of administration of vaccine. There was no product quality complaint (PQC) involved in the report.
Sex: F
Vaccine: PPV
Symptoms: Cardiac disorder, Diabetes mellitus, Throat tightness, Vomiting
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a currently 50-year-old female patient. The patient's drug reactions and allergies included allergy for FLAGYL, Sulfa and unspecified plant extracts. The patient's pertinent medical history and concomitant therapies was not provided. On an unknown date in 1983 (reported as 35 years ago), the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date in 1983, after receiving vaccination, the patient vomited, had throat tightening and due to that she received an epinephrine (manufacturer unknown) injection, administered after an unspecified amount of time after the previously reported events. On unknown dates, the patient had newly diagnosed diabetes and heart disease. The outcome of diabetes and heart disease was unknown. The outcome of vomiting and throat tightening was reported as recovered. The relatedness between the events and vaccination with PNEUMOVAX 23 was not reported. Upon internal review, the events of diabetes, throat tightening and vomiting were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, 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. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 07-JUL-2009, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 13-AUG-2010, he was treated at a physician office for onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 18-NOV-2015, the patient was treated at a pain center for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed NORCO and tramadol for management of her painful symptoms. On or about 06-JAN-2016, the patient sought subsequent treatment for a persistent vesicular rash, which was diagnosed as post-herpetic neuralgia. The patient was prescribed LYRICA, NORCO, tramadol, and prednisone for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 04-SEP-2012, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-JUL-2016, she was treated by a physician for onset of a severe vesicular rash, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 23-JAN-2014, she was treated for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies, concurrent conditions were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # N034558, expiration date: 05-DEC-2019 and lot#: R002509, expiration date: 25-JAN-2020 (dose, anatomical location and route of administration were not reported) indicated for prophylaxis, which were reconstituted with properly stored sterile diluent (MERCK) (lot# and expiration date were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius to 25 degrees Celsius (15C) for 1 hour and 25 minutes on unspecified dates called by a data logger. There were no previous excursions reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2008, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) by a physician as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-AUG-2012, the patient was treated by a certified physician assistant (PA-C) for a blistering vesicular outbreak, which was then diagnosed as shingles. The patient was prescribed lidocaine, ketoprofen, dexamethasone and gabapentin for management of his painful symptoms and excruciating pain. On or about 05-SEP-2012, the patient sought subsequent treatment from the same certified physician assistant (PA-C) for a persistent vesicular rash, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient was prescribed tramadol to manage his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JUN-2013, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) at a healthcare facility/medical clinic (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 27-OCT-2014, the patient was treated by a healthcare facility/medical clinic (unspecified healthcare professional) for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-MAY-2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a healthcare facility/office as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 28-DEC-2012, the patient was treated by the healthcare facility/office (by an unspecified healthcare professional) for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 30-NOV-2010, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) at a healthcare facility/clinic (by an unspecified healthcare professional) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-AUG-2011, the patient was treated by a physician at the healthcare facility/clinic for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 26-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N027000, expiration date: 28-SEP-2019 (dose, anatomical location and route of administration were not reported) indicated for prophylaxis which were reconstituted with a properly stored sterile diluent (MERCK) (lot# and expiration date were not reported). No adverse effects. Administered dose of vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 12 hours and 40 minutes on unspecified dates called by a data logger. There were no previous excursions reported.
Sex: U
Vaccine: VARZOS
Symptoms: Skin irritation
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of skin irritation in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced skin irritation. On an unknown date, the outcome of the skin irritation was unknown. The reporter considered the skin irritation to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported.  It was reported that the dose of SHINGRIX caused skin irritation to the patient. The nurse called for assistance on the patient receiving the second dose of SHINGRIX vaccine after reacting to the first dose.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Injection site erythema, Myalgia, Vaccination site pain
Clinical narrative: Soreness at vaccination site, redness at site, stomach upset, muscle soreness, weakness - still having on 2nd day after vaccine.
Age: 51.0
Sex: F
Vaccine: HEP, HEPA, MMR, MNQ, TDAP, VARCEL, VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: SHINGRIX and Varicella given at the same visit.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling of body temperature change, Myalgia, Nausea
Clinical narrative: Like the form states no reaction with my first Shingle vaccine on my second one I did experience Shivering muscle ache neck and shoulders, felt cold and then hot a little nauseousness.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood electrolytes normal, Blood glucose normal, Blood urea normal, Electrocardiogram normal, Facial pain
Clinical narrative: 3 days post vaccination, had skin rash on left side of face, shooting pain that went into teeth. Had to keep water in mouth to help pain. Went to urgent care on 7/3/18. Dx'd as herpes zoster without complications on left side of face. Prescribed VALTREX. Has not yet resolved. Went to ER on 7/4/18 because pain did not subside. ER Dx'd as Zoster with facial pain, was told to continue VALTREX and was given pain medication as well. Still not resolved today 7/5/18.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count normal, Herpes zoster, Pain, Rash, Toothache
Clinical narrative: 3 days post vaccination, had skin rash on left side of face, shooting pain that went into teeth. Had to keep water in mouth to help pain. Went to urgent care on 7/3/18. Dx'd as herpes zoster without complications on left side of face. Prescribed VALTREX. Has not yet resolved. Went to ER on 7/4/18 because pain did not subside. ER Dx'd as Zoster with facial pain, was told to continue VALTREX and was given pain medication as well. Still not resolved today 7/5/18.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Troponin normal
Clinical narrative: 3 days post vaccination, had skin rash on left side of face, shooting pain that went into teeth. Had to keep water in mouth to help pain. Went to urgent care on 7/3/18. Dx'd as herpes zoster without complications on left side of face. Prescribed VALTREX. Has not yet resolved. Went to ER on 7/4/18 because pain did not subside. ER Dx'd as Zoster with facial pain, was told to continue VALTREX and was given pain medication as well. Still not resolved today 7/5/18.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching on wrist and abdomen. Currently recovering. BENADRYL once a day was prescribed. Treatment started 07/05/2018 and is ongoing. Second SHRINGIX dose was  not advised.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ
Symptoms: Axillary pain, Erythema, Pain in extremity, Pruritus, Rash
Clinical narrative: Hives, Itching, Redness and Aching to bilateral legs, bilateral arm pits, sides of torso. Started on inner thighs late afternoon 6/30, as small areas of redness and rash. More extensive coverage of raised hives, itching and redness by 7/1, given BENADRYL 25 mg at home. Was not getting any better and started to spread up torso to arm puts. Went to Emergency Room on 7/1 received double dose of Prednisolone and presciption for 4 days of Prednisolone and instructed to give BENADRYL 3-4 times a day.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ
Symptoms: Urticaria
Clinical narrative: Hives, Itching, Redness and Aching to bilateral legs, bilateral arm pits, sides of torso. Started on inner thighs late afternoon 6/30, as small areas of redness and rash. More extensive coverage of raised hives, itching and redness by 7/1, given BENADRYL 25 mg at home. Was not getting any better and started to spread up torso to arm puts. Went to Emergency Room on 7/1 received double dose of Prednisolone and presciption for 4 days of Prednisolone and instructed to give BENADRYL 3-4 times a day.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ
Symptoms: Arthralgia, Bone pain, Pruritus, Urticaria
Clinical narrative: Hives, Itching, Redness and Aching to bilateral legs, bilateral arm pits, sides of torso. Started on inner thighs late afternoon 6/30, as small areas of redness and rash. More extensive coverage of raised hives, itching and redness by 7/1, given BENADRYL 25 mg at home. Was not getting any better and started to spread up torso to arm puts. Went to Emergency Room on 7/1 received double dose of Prednisolone and presciption for 4 days of Prednisolone and instructed to give BENADRYL 3-4 times a day.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP, MNQ
Symptoms: Arthralgia, Bone pain, Pruritus, Rash, Urticaria
Clinical narrative: Hives, Itching, Redness and Aching to bilateral legs, bilateral arm pits, sides of torso. Started on inner thighs late afternoon 6/30, as small areas of redness and rash. More extensive coverage of raised hives, itching and redness by 7/1, given BENADRYL 25 mg at home. Was not getting any better and started to spread up torso to arm puts. Went to Emergency Room on 7/1 received double dose of Prednisolone and presciption for 4 days of Prednisolone and instructed to give BENADRYL 3-4 times a day.
Age: 20.0
Sex: F
Vaccine: SMALL, TD
Symptoms: Arteriospasm coronary, Autoimmune disorder, Basedow's disease, Biopsy breast normal, Chronic fatigue syndrome
Clinical narrative: Caused an exacerbation and increase in autoimmune disease she has suffered since that time.  Chronic fatigue syndrome; hepatic steatosis; coronary artery spasms; systolic dysfunction; cardiomyopathyviral induced; pulmonary hypertension; fibrocystic breast disease with negative breast biopsy; pre-diabetes; osteoarthritis; GERD; IBS; mitochondrial disorder; Graves' disease; endometriosis; recurrent mild cervical lymphadenopathy with benign workup; depression.  Causality assessment shows temporal relationship only. She was hospitalized 10 days following immunizations for 3 days with an acute respiratory infection. Intermittient fevers followed and developed hepatitis A in June 2076.
Age: 20.0
Sex: F
Vaccine: SMALL, TD
Symptoms: Condition aggravated, Depression, Endometriosis, Fibrocystic breast disease, Gastrooesophageal reflux disease
Clinical narrative: Caused an exacerbation and increase in autoimmune disease she has suffered since that time.  Chronic fatigue syndrome; hepatic steatosis; coronary artery spasms; systolic dysfunction; cardiomyopathyviral induced; pulmonary hypertension; fibrocystic breast disease with negative breast biopsy; pre-diabetes; osteoarthritis; GERD; IBS; mitochondrial disorder; Graves' disease; endometriosis; recurrent mild cervical lymphadenopathy with benign workup; depression.  Causality assessment shows temporal relationship only. She was hospitalized 10 days following immunizations for 3 days with an acute respiratory infection. Intermittient fevers followed and developed hepatitis A in June 2076.
Age: 20.0
Sex: F
Vaccine: SMALL, TD
Symptoms: Glucose tolerance impaired, Hepatic steatosis, Hepatitis A, Irritable bowel syndrome, Lymphadenopathy
Clinical narrative: Caused an exacerbation and increase in autoimmune disease she has suffered since that time.  Chronic fatigue syndrome; hepatic steatosis; coronary artery spasms; systolic dysfunction; cardiomyopathyviral induced; pulmonary hypertension; fibrocystic breast disease with negative breast biopsy; pre-diabetes; osteoarthritis; GERD; IBS; mitochondrial disorder; Graves' disease; endometriosis; recurrent mild cervical lymphadenopathy with benign workup; depression.  Causality assessment shows temporal relationship only. She was hospitalized 10 days following immunizations for 3 days with an acute respiratory infection. Intermittient fevers followed and developed hepatitis A in June 2076.
Age: 20.0
Sex: F
Vaccine: SMALL, TD
Symptoms: Mitochondrial cytopathy, Osteoarthritis, Pulmonary hypertension, Pyrexia, Respiratory tract infection
Clinical narrative: Caused an exacerbation and increase in autoimmune disease she has suffered since that time.  Chronic fatigue syndrome; hepatic steatosis; coronary artery spasms; systolic dysfunction; cardiomyopathyviral induced; pulmonary hypertension; fibrocystic breast disease with negative breast biopsy; pre-diabetes; osteoarthritis; GERD; IBS; mitochondrial disorder; Graves' disease; endometriosis; recurrent mild cervical lymphadenopathy with benign workup; depression.  Causality assessment shows temporal relationship only. She was hospitalized 10 days following immunizations for 3 days with an acute respiratory infection. Intermittient fevers followed and developed hepatitis A in June 2076.
Age: 20.0
Sex: F
Vaccine: SMALL, TD
Symptoms: Systolic dysfunction, Viral cardiomyopathy
Clinical narrative: Caused an exacerbation and increase in autoimmune disease she has suffered since that time.  Chronic fatigue syndrome; hepatic steatosis; coronary artery spasms; systolic dysfunction; cardiomyopathyviral induced; pulmonary hypertension; fibrocystic breast disease with negative breast biopsy; pre-diabetes; osteoarthritis; GERD; IBS; mitochondrial disorder; Graves' disease; endometriosis; recurrent mild cervical lymphadenopathy with benign workup; depression.  Causality assessment shows temporal relationship only. She was hospitalized 10 days following immunizations for 3 days with an acute respiratory infection. Intermittient fevers followed and developed hepatitis A in June 2076.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Blood test, Chills, Dyskinesia, Headache
Clinical narrative: Flu-like symptoms - fever @100.3, shivering, aches, mild headache beginning approx 12 hours after shot, lasting about 5-6 hours. The next 15 hours were relatively calm, and then fever spiked followed very quickly by shivers and shakes so strong that it seemed like a seizure - uncontrollable, frightening, including neck pain and leg thrashing, lasting approximately 5 minutes. We went to the ER, where I was admitted with a fever of 101 (I think) low BP, which dropped into the 70's over 40's and remained there for hours, despite massive amounts of fluids and antibiotics. Fever eventually came back to normal, but BP took 6 hours to get to the high 80s over 50s with consistency.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension, Influenza like illness, Neck pain, Pain, Pyrexia
Clinical narrative: Flu-like symptoms - fever @100.3, shivering, aches, mild headache beginning approx 12 hours after shot, lasting about 5-6 hours. The next 15 hours were relatively calm, and then fever spiked followed very quickly by shivers and shakes so strong that it seemed like a seizure - uncontrollable, frightening, including neck pain and leg thrashing, lasting approximately 5 minutes. We went to the ER, where I was admitted with a fever of 101 (I think) low BP, which dropped into the 70's over 40's and remained there for hours, despite massive amounts of fluids and antibiotics. Fever eventually came back to normal, but BP took 6 hours to get to the high 80s over 50s with consistency.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Seizure like phenomena, Tremor
Clinical narrative: Flu-like symptoms - fever @100.3, shivering, aches, mild headache beginning approx 12 hours after shot, lasting about 5-6 hours. The next 15 hours were relatively calm, and then fever spiked followed very quickly by shivers and shakes so strong that it seemed like a seizure - uncontrollable, frightening, including neck pain and leg thrashing, lasting approximately 5 minutes. We went to the ER, where I was admitted with a fever of 101 (I think) low BP, which dropped into the 70's over 40's and remained there for hours, despite massive amounts of fluids and antibiotics. Fever eventually came back to normal, but BP took 6 hours to get to the high 80s over 50s with consistency.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On an unknown date, the patient was inadvertently vaccinated with improperly stored GARDASIL 9 lot# N019103, expiration date on 03-FEB-2020 (exact dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 47 Fahrenheit degrees to 77 Fahrenheit degrees for 30 minutes. There were no previous excursions reported. The digital data logger was involved. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1806USA011514:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-NOV-2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-APR-2015, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with the ZOSTAVAX vaccine at a clinic as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 27-FEB-2014, she was treated at a dermatology clinic for a persistent vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for the management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-JAN-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2014, the patient was treated by a hospital for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated at a hospital for vesicular outbreaks, which were diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 1 year old patient of unknown gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On 17-MAY-2018, the patient was vaccinated with improperly stored dose of PROQUAD, lot# N035173, expiration date 09-JUN-2019 (strength, dose, frequency and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent. The vaccine underwent temperature excursion on a freezer. The dose of PROQUAD was exposed to a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit during a time frame of 15 minutes, which was detected by the data logger. There was a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes. No adverse effects were reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1805USA010447: US-009507513-1807USA001194: US-009507513-1807USA001195: US-009507513-1807USA001196: US-009507513-1807USA001197: US-009507513-1807USA001198: US-009507513-1807USA001200: US-009507513-1807USA001201.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On 16-MAY-2018, the patient was vaccinated with improperly stored dose of VARIVAX lot # N024566 with expiration date 07-SEP-2019 (strength, dose, frequency and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent. The vaccine underwent temperature excursion on a freezer. The dose of VARIVAX was exposed to a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit during a time frame of 15 minutes, which was detected by the data logger. There was a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes. No adverse effects were reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1807USA001194: US-009507513-1807USA001195: US-009507513-1807USA001196: US-009507513-1807USA001197: US-009507513-1807USA001198: US-009507513-1807USA001199: US-009507513-1807USA001201: US-009507513-1805USA010447.