chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Injected limb mobility decreased, Peripheral swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 73-year-old female patient. The patient was allergic to moxifloxacin hydrochloride (AVELOX), erythromycin, lisinopril (manufacturer unknown) (captured in MAARS # 1807USA001520) and miconazole nitrate (MONISTAT). She had no concomitant therapies or medical history. On 19-JUN-2018, the patient was vaccinated with a first dose of PNEUMOVAX 23 injection, lot # R002084, expiration date 26-OCT-2019, for prophylaxis (exact dose and insertion site were unknown). On 21-JUN-2018, the patient was vaccinated with a first dose of PNEUMOVAX 23 injection, lot # R002084, expiration date 26-OCT-2019, in the right arm, for prophylaxis (exact dose was unknown). On an unknown date in June 2018, the patient experienced swelling in the right arm, bilateral arm pain from shoulder to elbow making it hard to move their arms and was experiencing nausea. The patient called the office on 22-JUN-2018 and was seen by a nurse practitioner. The nurse practitioner prescribed an unspecified treatment for the patient to control their symptoms. The outcome of the events was unknown. The causality assessment was not provided. This is one of two cases concerning the same patient.; Sender's Comments: US-009507513-1807USA001520:
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Extra dose administered, Injected limb mobility decreased, Injection site pain, Mobility decreased, Nausea
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 73-year-old female patient. The patient was allergic to moxifloxacin hydrochloride (AVELOX), erythromycin, lisinopril (manufacturer unknown) (captured in MAARS # 1807USA001520) and miconazole nitrate (MONISTAT). She had no concomitant therapies or medical history. On 19-JUN-2018, the patient was vaccinated with a first dose of PNEUMOVAX 23 injection, lot # R002084, expiration date 26-OCT-2019, for prophylaxis (exact dose and insertion site were unknown). On 21-JUN-2018, the patient was vaccinated with a first dose of PNEUMOVAX 23 injection, lot # R002084, expiration date 26-OCT-2019, in the right arm, for prophylaxis (exact dose was unknown). On an unknown date in June 2018, the patient experienced swelling in the right arm, bilateral arm pain from shoulder to elbow making it hard to move their arms and was experiencing nausea. The patient called the office on 22-JUN-2018 and was seen by a nurse practitioner. The nurse practitioner prescribed an unspecified treatment for the patient to control their symptoms. The outcome of the events was unknown. The causality assessment was not provided. This is one of two cases concerning the same patient.; Sender's Comments: US-009507513-1807USA001520:
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 73-year-old female patient. The patient was allergic to moxifloxacin hydrochloride (AVELOX), erythromycin, lisinopril (manufacturer unknown) (captured in MAARS # 1807USA001520) and miconazole nitrate (MONISTAT). She had no concomitant therapies or medical history. On 19-JUN-2018, the patient was vaccinated with a first dose of PNEUMOVAX 23 injection, lot # R002084, expiration date 26-OCT-2019, for prophylaxis (exact dose and insertion site were unknown). On 21-JUN-2018, the patient was vaccinated with a first dose of PNEUMOVAX 23 injection, lot # R002084, expiration date 26-OCT-2019, in the right arm, for prophylaxis (exact dose was unknown). On an unknown date in June 2018, the patient experienced swelling in the right arm, bilateral arm pain from shoulder to elbow making it hard to move their arms and was experiencing nausea. The patient called the office on 22-JUN-2018 and was seen by a nurse practitioner. The nurse practitioner prescribed an unspecified treatment for the patient to control their symptoms. The outcome of the events was unknown. The causality assessment was not provided. This is one of two cases concerning the same patient.; Sender's Comments: US-009507513-1807USA001520:
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Mycoplasma test negative, Pyrexia, Rash generalised, Urticaria
Clinical narrative: Hives, rash, fever daily. Been put on hydrocortisone cream and cetirizine. Was tested for mycoplasma which came back negative. The hives and rash spread all over his body and last 3-4 hours and then go away for about 8 - 10 hours and then repeat.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Malaise, Myalgia
Clinical narrative: Nausea, chills, severe muscle aches, malaise, fatigue lasting 24 hours. Took extra strength aceteminophen which provided some relief. Soreness at injection site remains.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Nausea, chills, severe muscle aches, malaise, fatigue lasting 24 hours. Took extra strength aceteminophen which provided some relief. Soreness at injection site remains.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Lethargy, Pain
Clinical narrative: Extreme fatigue and lethargy, body aches, chills, fever, minor shoulder pain at injection site.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Extreme fatigue and lethargy, body aches, chills, fever, minor shoulder pain at injection site.
Age: 45.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous non-valid report has been received from a physician assistant referring to an unspecified patients of unknown age and gender. No information was provided regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # M036292, expiration date 17-AUG-2018, and lot# N024566 with expiration date 07-SEP-2019, (strength, dose, frequency and route of administration were not provided) for prophylaxis and 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 doses of VARIVAX and PROQUAD, were 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. Follow up information was received on 29-MAY-2018. A telephone call was taken from the corresponding reporter. The reporter provided that there had been no reported adverse events following the administration of the vaccinations PROQUAD and VARIVAX. The patient identification information was not readily available at the time of the call. Additional information should become available in the future, the follow up correspondence process was reviewed. Additional information has been requested. Follow up information has been received from the medical assistant on 05-JUN-2018. The case became valid due to provided patient's information. The report was referring to 44 year old male patient. On 10-MAY-2018, the patient was vaccinated with a second dose of improperly stored VARIVAX subcutaneously in the left triceps (LT), lot# N024566 with expiration date 07-SEP-2019. The vaccine underwent temperature excursion on a freezer. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1807USA001195: US-009507513-1807USA001196: US-009507513-1807USA001197: US-009507513-1807USA001198: US-009507513-1807USA001199: US-009507513-1807USA001200: US-009507513-1807USA001194: US-009507513-1807USA001201.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose (1DF) of (wistar ra 27-3) M-M-R II, subcutaneously, lot # N013296 (Albumin status rHA), expiration date 28-APR-2019 (dose, strength, batch number not specified) for prophylaxis. The (wistar ra 27-3) M-M-R II was stored improperly. Digital Data Logger reported the storage of the suspect vaccine in temperature 48F (degrees Fahrenheit) for 4 hours. There was no previous temperature excursion. No adverse events were reported and no further information was provided by the reporter.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Anxiety, Condition aggravated, Extra dose administered
Clinical narrative: This spontaneous report was received from a physician and an office manager via a company representative and refers to a 16-yer-old female patient with no pre-existing physician-diagnosed allergies, birth defects, medical conditions. The patient had no illness at the vaccination time. Her current condition included anxiety. On 01-JUN-2018, the patient was inadvertently vaccinated with the fourth dose of GARDASIL 9 intramuscularly in the left arm (exact dose was not reported; lot # N028092, expiration date: 28-MAY-2020) for prophylaxis. On the same date, the patient was also vaccinated with the second dose of MENACTRA, intramuscularly in the right deltoid. The administered doses of vaccines were stored properly. On an unknown date in June 2018, the patient experienced increased anxiety due to receiving two vaccines instead of one. The outcome of increased anxiety was unknown. The relatedness between anxiety and suspect vaccines was not reported.
Sex: U
Vaccine: MMR
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, and it refers to a patient of unknown age and gender. The patient's current condition included unspecified autoimmune disorder and being immunocompromised. The patient's concomitant medications included unspecified immunosuppressant therapy. No information was provided regarding the patient's medical history. On 05-JUN-2018, the patient was vaccinated with M-M-R II lot # N023150 with expiration date of 24-AUG-2019, for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Despite the fact, the vaccine was contraindicated for people that had a weakened immune system, such as an immune deficiency, an inherited immune disorder. There were no adverse effects reported and no further information was provided.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Chlamydia test, Exposure during pregnancy, Human chorionic gonadotropin, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant refers to a 25-year-old female patient. The patient's medical history included thyroid cancer, endometriosis, irregular menstrual periods, "psych issues", motor vehicle accident and facial nerve damage. She had no concomitant medications or drug reactions and allergies. On 06-JUN-2018, the patient was vaccinated with a second dose of GARDASIL 9 injection, lot # N019104, expiration date 02-MAR-2020, intramuscularly, for prophylaxis. After the vaccine was administered, the patient had a urine pregnancy test done which was positive. The patient reported her last menstrual period (LMP) was in February of 2018. The pregnancy outcome was outcome pending. On the same day, the patient also had a Papanicolaou test (reported as "pap smear") done, a urine test for chlamydia and a blood test for human chorionic gonadotropin (HCG) but results were not available. The patient sought medical attention. No adverse effects were reported. The outcome of exposure during pregnancy was unknown.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Smear cervix
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant refers to a 25-year-old female patient. The patient's medical history included thyroid cancer, endometriosis, irregular menstrual periods, "psych issues", motor vehicle accident and facial nerve damage. She had no concomitant medications or drug reactions and allergies. On 06-JUN-2018, the patient was vaccinated with a second dose of GARDASIL 9 injection, lot # N019104, expiration date 02-MAR-2020, intramuscularly, for prophylaxis. After the vaccine was administered, the patient had a urine pregnancy test done which was positive. The patient reported her last menstrual period (LMP) was in February of 2018. The pregnancy outcome was outcome pending. On the same day, the patient also had a Papanicolaou test (reported as "pap smear") done, a urine test for chlamydia and a blood test for human chorionic gonadotropin (HCG) but results were not available. The patient sought medical attention. No adverse effects were reported. The outcome of exposure during pregnancy was unknown.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17-year-old patient of an unknown gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 30-APR-2018, the patient was inadvertently vaccinated with a dose of Oka-Merck PROQUAD injection, lot # N029672, expiration date 21-APR-2019, for prophylaxis (exact dose and route of administration were not provided). The vaccine was reconstituted with MERCK STERILE DILUENT. No adverse effects reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot number M038359, expiration date 13-MAY-2018; dose and route of administration were not reported) for prophylaxis. It was reported that the vaccine was properly stored. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, Injection site rash
Clinical narrative: This spontaneous report was received from a 14 or 15-year-old female patient, who was reporting on herself, via a company representative. The patient's concurrent conditions, medical history and concomitant therapies and were not reported. On an unknown day, the patient was vaccinated with the first 0.5 ml dose of GARDASIL 9 injection (route of administration, lot number, expiration date were not provided) for prophylaxis. On an unknown day, the patient developed a rash around the injection site that got worse the next day. The patient chose not to complete the series. The outcome of the event was unknown. The causality assessment between the event and GARDASIL 9 was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unspecified day in 2009, the patient was vaccinated with the first dose in the vaccination series of GARDASIL (dose, frequency, route of administration, LOT number, expiration date were not provided). On 16-MAY-2018, the patient received GARDASIL 9 intramuscularly, as the second dose in the vaccination series (dose, frequency, LOT number, expiration date were not provided), and on 11-JUN-2018, received GARDASIL 9 intramuscularly, lot # N023828/ exp. 25-JUN-2020 (dose, frequency and indication were not provided), for the third dose in the vaccination series. No adverse effects were reported. No further information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Rash vesicular
Clinical narrative: This spontaneous report was received from a 76 year old male patient, who was reporting on himself. The patient did not have medical history, concurrent conditions drug reactions or allergies; and his concomitant medications included unspecified blood pressure and cholesterol medications. In approximately 2006 (reported as "12 years ago"), the patient was vaccinated with ZOSTAVAX (lot #, expiration date, strength, dose or anatomical location were not provided), administered for herpes (prophylaxis) by injection and had no adverse effects. In January 2018, the patient received SHINGRIX (lot #, expiration date, strength, dose, indication, route of administration or anatomical location were not provided) and he developed herpes blisters in approximately June 2018 (reported as "two weeks ago") which lasted for 10 days (rash vesicular). The patient did not seek medical attention but an unknown treatment was given for the event. Therefore, he stated that he would not get the second dose of SHINGRIX. No laboratory diagnostics studies were performed. The outcome of the patient's rash vesicular event was not provided. As of 19-JUN-2018, it was confirmed by a licensed practical nurse that the adverse event rash vesicular only occurred with SHINGRIX and that ZOSTAVAX was not involved.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown gender and age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date in October 2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, exact dose, route of administration, indication, lot number and expiration date were not reported). On 19-JUN-2018, the patient was vaccinated with the second dose of GARDASIL 9 lot number N017832, expiration date 19-JUN-2018 (also reported as 16-NOV-2019) (strength, exact dose, route of administration and indication were not reported). No adverse effects were reported. No additional information.
Age: 1.0
Sex: F
Vaccine: MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from an office manager concerning a 12 month old female patient. The patient had no any pre-existing allergies, birth defects, medical conditions or illness at time of vaccination. On 18-JUN-2018, the patient was vaccinated with her first dose of Oka-Merck PROQUAD, subcutaneously in the left thigh, lot # N035174, expiration date: 09-JUN-2019; and with her first dose of Oka/Merck VARIVAX subcutaneously in the left thigh, lot # N031003, expiration date: 03-NOV-2019, both for prophylaxis. Concomitant therapies included PREVNAR and sterile diluent. The reporter stated that "wrong medication was pulled" because the doctor ordered MMR virus vaccine (manufacturer unknown) and varicella vaccine, but the patient received Oka-Merck PROQUAD. During verification, the verifier seen MMR on label, but did not realize it said Oka-Merck PROQUAD "further down the label". No adverse effects reported. On 19-JUN-2018, the patient was asymptomatic, and in a follow up visit 10 days later the patient was still asymptomatic. No prescription drug treatment was required.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a physician and refers to an adult patient of unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with his second dose of a pediatric VAQTA 25/0.5 DF injection, 0.5 ml once, intramuscularly, lot # R00620, expiration date of 16-MAR-2019, for prophylaxis. The first dose was an adult dose and it was administered at an unspecified date. No adverse effects reported.
Sex: U
Vaccine: HIBV, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse concerning an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On unknown dates, the unspecified patients might had been vaccinated with improperly stored doses of PEDVAXHIB injection for prophylaxis (strength, dose, dosage schedule, anatomical location, lot # and expiry date were not provided) and M-M-R II injection for prophylaxis (strength, dose, dosage schedule, anatomical location, lot # and expiry date were not provided). It was reported that sterile diluent (MERCK) was properly stored. No adverse effects were reported. Both vaccines underwent a temperature excursion 47.6° C for a time frame of 27 minutes. None previous temperature excursion and data logger yes was reported.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a non-healthcare professional (office administrator) regarding a 4 month old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-JUN-2018 the patient was vaccinated with expired dose of oral, ROTATEQ lot # M045375 with expiration date: 24-JUN-2018 orally for prophylaxis (expired product administered). No adverse effects were reported.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL, VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 4 year old male patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 26-JUN-2018, the patient was vaccinated with VARIVAX (lot #, expiration date, dose, frequency and route of administration were not provided) for prophylaxis. Other suspect therapies included M-M-R II (lot #, expiration date, dose, frequency and route of administration were not provided) and SHINGRIX intramuscularly (lot #, expiration date and dose were not provided). Concomitant therapies included sterile diluent (STERILE DILUENT MRK INJ). The reporter stated that the patient was vaccinated in February 2018 and could not clarify which vaccines were administered, VARIVAX and M-M-R II could not be ruled out. The patient did not experienced any adverse events.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 30-MAY-2018, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 injection (strength and dose were not reported) (lot # M040804, expiry date: 20-MAY-2018) intramuscularly for prophylaxis. No adverse effects were reported. There was no product quality complaint (PQC) reported.
Sex: F
Vaccine: HPV9
Symptoms: Tinnitus
Clinical narrative: This spontaneous report was received from a nurse and refers to a 23 year old female patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 27-DEC-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M043731, expiration date: 22-JUN-2019, dose and route of administration were not provided) for Human papilloma virus (HPV) prevention. On 28-FEB-2018, the patient was vaccinated with the second dose of GARDASIL 9 (lot # reported as M026812, expiration date reported as: 20-JUN-2020, dose and route of administration were not provided). On an unknown date in 2017 or 2018, the patient experienced tinnitus. There was no information if tinnitus developed after the patient received the first dose of GARDASIL 9 or after the second dose. The outcome of tinnitus was unknown. The causal relationship between the event and therapy with GARDASIL 9 was not provided by the reporter.
Sex: U
Vaccine: DTP, HEP, HEPA, PPV, TYP
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Swollen tongue, Tongue disorder
Clinical narrative: This literature marketed report was received from the authors of a published article, and refers to an elderly patient of unknown gender. The objective of this retrospective study was to examine a large cohort of adults age 65 years and older for evidence of increased risk of adverse events (AEs) requiring medical attention following vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) as compared with vaccination with of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown; PPSV23). On an unknown date, the patient was vaccinated with hepatitis A vaccine, inactivated (manufacturer unknown), hepatitis B vaccine (recombinant) (manufacturer unknown), diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, typhoid vaccine (unspecified) and pneumococcal 13v conj vaccine (CRM197) (exact dose, route of administration, lot# and expiration date were not provided for all). Within 15 minutes of immunization, the patient felt the tongue swollen/thick and experienced mild difficulty in breathing and swallowing, which was confirmed as anaphylaxis. The patient had no rash hives or facial swelling, no nausea or abdominal pain, and no confusion. The patient had a history of anaphylaxis to other agents such as eggs and intravenous contrast and experienced the same symptoms. The outcome of anaphylaxis was not reported. The author considered the event to be related to the vaccines. Upon internal review, the event of anaphylaxis after vaccination was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain, 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. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy, 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 24-FEB-2016, the patient was treated by a physician at a medical center for a severe vesicular outbreak, which was diagnosed as herpes zoster along with neurological pain from shingles. The patient was prescribed ZOVIRAX and prednisone for management of his painful symptoms and chronic pain. 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.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 30-JAN-2009, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and 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 12-JAN-2015, the patient was treated by a physician for a persistent vesicular outbreak accompanied by weakened immune symptoms, 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 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 2006, the patient was inoculated with the ZOSTAVAX vaccine at a health department 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. In 2013, she was treated by a physician for a vesicular outbreak, 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.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Pyrexia, Rash, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 years and 10 months old male patient. There were no historical conditions, concurrent conditions and concomitant therapies. On 11-FEB-2015, the patient was vaccinated with the first dose of varicella Oka/Merck VARIVAX, subcutaneously, lot # K006136, expiration date on 29-APR-2016, for prophylaxis. It was stated that on an unspecified date in June 2018 (reported as "last week"), the patient was exposed to an unspecified child with chicken pox. Subsequently, on an unspecified date in 2018 (reported as over the weekend), the patient developed chicken pox (varicella). Therefore, the patient's mother called to the physician's office and was recommended unspecified doses of TYLENOL for fever, BENADRYL and Calamine lotion for rash. Also it was recommended oatmeal bath for rash and the patient's mother was advised to return to physician office if the patient developed high fever. There were no laboratories performed. The registered nurse stated that the patient was due for second dose of Oka/Merck VARIVAX on an unspecified date "before kindergarten". The outcome of varicella was reported as not recovered. The reporter did not provide causality assessment between Oka/Merck VARIVAX.
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a medical assistant referring to an adult male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 15-JUN-2018, the patient was vaccinated with RECOMBIVAX HB lot number M023718 and expiration date of 09-AUG-2018 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator regarding a unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 28-JUN-2017, the patient received a dose of improperly stored dose of LIQUID PEDVAXHIB lot# M025194 and 22-MAR-2019 expiration date for prophylaxis (strength, frequency and route of administration were not reported). Data logger was reported. The temperature excursion was reported as 28°F for a time frame of 48 hours. No previous temperature excursion was reported. No adverse effects was reported. No product quality complain was present. This is one of several reported received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an administrator concerning a patient of unknown age and gender. Pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 17-AUG-2017, the patient was vaccinated with an improperly stored dose of PEDVAXHIB injection, lot # M025194 for prophylaxis (strength, dose, dosage schedule, anatomical location and expiry date were not provided). No adverse effects reported. It was reported that the vaccine underwent a temperature excursion of 28° F during a time frame of 48 hours. No previous temperature excursion and data logger "yes" were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA012918: US-009507513-1807USA001050.
Age: 3.0
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 3 year old patient of unknown gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On 10-MAY-2018, the patient was vaccinated with improperly stored dose of Oka/Merck 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 Oka/Merck 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-009507513-1807USA001197: US-009507513-1807USA001195: US-009507513-1807USA001196: US-009507513-1807USA001198: US-009507513-1807USA001199: US-009507513-1807USA001200: US-009507513-1807USA001201: US-009507513-1805USA010447.
Age: 4.0
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 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 22-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-009507513-1807USA001194: US-009507513-1807USA001196: US-009507513-1807USA001197: US-009507513-1807USA001198: US-009507513-1807USA001199: US-009507513-1807USA001200: US-009507513-1807USA001201: US-009507513-1805USA010447.
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 29-MAY-2018, the patient was vaccinated with improperly stored dose of Oka-Merck 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 Oka-Merck 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-009507513-1807USA001194: US-009507513-1807USA001195: US-009507513-1807USA001197: US-009507513-1807USA001198: US-009507513-1807USA001199: US-009507513-1807USA001200: US-009507513-1807USA001201: US-009507513-1805USA010447:
Age: 4.0
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 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 21-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-009507513-1807USA001198: US-009507513-1807USA001199: US-009507513-1807USA001200: US-009507513-1807USA001201.
Age: 4.0
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 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 18-MAY-2018, the patient was vaccinated with improperly stored dose of Oka-Merck) 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 Oka-Merck 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-009507513-1807USA001194: US-009507513-1807USA001195: US-009507513-1807USA001196: US-009507513-1807USA001197: US-009507513-1807USA001199: US-009507513-1807USA001200: US-009507513-1807USA001201: US-009507513-1805USA010447.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of herpes on lip in a 70-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 20th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced herpes on lip. The patient was treated with VALTREX. On an unknown date, the outcome of the herpes on lip was not recovered/not resolved. It was unknown if the reporter considered the herpes on lip to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the doctor. The patient received her dose of SHINGRIX in the left deltoid. The patient was experiencing an outbreak of herpes simplex on her lips and her physician had prescribed VALTREX for her. The reporting pharmacist was not sure when the patient started having symptoms of the outbreak or when the outbreak began.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX for prophylaxis. On 23rd April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that the husband of the patient told that his wife (the patient) received SHINGRIX and she developed shingles. The pharmacist had little information and could not read the lot number and expiration date on the paperwork. The reporter wanted to speak to medical information and transferred her there.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Drug ineffective, Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. Co-suspect products included VALTREX unknown for shingles. The patient's past medical history included shingles (on the lower back). On 21st June 2018, the patient received SHINGRIX. On 24th June 2018, the patient started VALTREX at an unknown dose and frequency. On 24th June 2018, 3 days after receiving SHINGRIX and not applicable after starting VALTREX, the patient experienced shingles and lack of drug effect. On an unknown date, the outcome of the shingles was unchanged and the outcome of the lack of drug effect was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: In the morning the patient experienced shingles outbreak which occurred on the lower back, which was where the patient historically notices when a shingles attack was present. The patient did not had the VALTREX filled at the pharmacy reporting. The patient reported an unknown formulation or manufacturer of VALTREX was not helping her shingles symptoms.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 61-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. Concomitant products included Celebrex. On 21st June 2018 13:45, the patient received SHINGRIX. On 21st June 2018, several hours after receiving SHINGRIX, the patient experienced fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by an Office Manager. The patient received the SHINGRIX vaccine on the left arm. The healthcare professional reported that, after receipt of SHINGRIX vaccine, the patient developed a fever later that night. The caller thought that, the patient might have taken TYLENOL and the fever was resolved within one day. This case has been linked with US2018114226, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of heaviness in limbs in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced heaviness in limbs. On an unknown date, the outcome of the heaviness in limbs was unknown. It was unknown if the reporter considered the heaviness in limbs to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who is an Office Manager. The healthcare professional reported that, her arm felt heavy after receiving the SHINGRIX. No further information was collected at the time of the call. This case has been linked with US2018114223, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. The patient was treated with antivirals for systemic use. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient diagnosed with shingles by her physician and that the patient's physician had prescribed an antiviral therapy. The reporter had no further specific details. The reporter called to inquire if GlaxoSmithKline (GSK) had reports of patient's getting shingles following vaccination with SHINGRIX and hypothetically if a patient gets a rash that was not truly shingles and begins taking antiviral therapy how that would affect things. This caller was transferred to the GSK medical information team regarding her inquiries upon request. The reporter gave consent for contact for further related questions. The reporter declined to answer camel form questions during the call, commenting that her pharmacist partner had actually spoken with the patient and already completed a VAERS form.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of painful rash in a female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a month after receiving SHINGRIX, the patient experienced painful rash and shingles. On an unknown date, the outcome of the painful rash and shingles were recovering/resolving. It was unknown if the reporter considered the painful rash and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, during the first week of June, a patient received the 1st dose of SHINGRIX. Pharmacist reported that early last week from the reporting date, the patient experienced a small painful rash on the back of her arm that looked like a small case of shingles. On the reporting date, the patient came back into the pharmacy and the rash looked better and it was not as painful. The pharmacist reported that the patient had not been to the doctor. The sales representative had limited information regarding this event.