chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a female 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 at a free clinic 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 condition of herpes zoster. During June 2016, the patient was treated for a blistering vesicular outbreak, which was 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.
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 was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. During January 2016, the patient was inoculated at a pharmacy with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 06-JUN-2016, the patient was treated at a clinic for a blistering vesicular outbreak, which was diagnosed as shingles. As a direct and proximate result of the ZOSTAVAX, 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 is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 26-JUN-2007, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a medical office (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 08-JUL-2013, the patient was treated (by an unspecified healthcare professional) at the medical office, for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles.  The patient has been prescribed gabapentin for management of her 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 was unknown.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at a hospital for a blistering vesicular outbreak which was diagnosed as severe 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia, 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 15-OCT-2014, the patient was inoculated with ZOSTAVAX, administered by a physician, as recommended 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 14-JUN-2016, the patient was treated by the same physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. On or about 08-JUL-2016, 26-JUL-2016 and 09-AUG-2016, she sought subsequent treatments from the same physician for new and worsening outbreaks of severe shingles. On or about the dates of 16-FEB-2017 and 29-JUN-2017, the patient was further treated for uncontrolled shingles pain, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections. The patient was prescribed valacyclovir (VALTREX), gabapentin, hydrocodone, and lidocaine patches for management of her persistent and painful symptoms. 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: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a burning 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. Additional information has been requested.
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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  During 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX, is intended to prevent. On or about 01-MAR-2016, the patient was treated by a physician for a 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. 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. Medical history, concurrent conditions, and concomitant medications were not provided. During 2014, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-JUL-2016, the patient was treated by a physician (site not specified), for a vesicular outbreak, which was diagnosed as 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-JUN-2013, the patient was inoculated  with ZOSTAVAX (lot number, dosage, and route of administration not provided) at a pharmacy, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 28-JUN-2016, the patient was treated by a nurse practitioner (at a skin institute), for a vesicular outbreak, which was diagnosed as herpes zoster. The patient has been prescribed valacyclovir hydrochloride (VALTREX) for management of her 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, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The lawyer had also reported that the patient was inoculated with the ZOSTAVAX vaccine for the long-term prevention of shingles. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX vaccine and suffered serious physical, emotional and economic damages as a result of her shingles and associated injuries. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 14-JUN-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX, is intended to prevent.  On or about 05-JUL- 2016, the patient was treated by a physician and diagnosed with severe 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. 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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-MAR-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX, is intended to prevent. During July 2016, the patient was treated by a physician for symptoms of 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. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Papilloma viral infection
Clinical narrative: This spontaneous report was received from nurse prescriber, via a company representative, referring to a 21 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with the complete dosage schedule of GARDASIL 9, for prophylaxis when she was 1112 years old (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, the patient was diagnosed with human papilloma virus (HPV) with low grade lesions. It was unknown by the reporter whether the patient received treatment, sought medical attention or if any laboratory tests were carried out. The outcome of papilloma viral infection was unknown. Causality assessment was not provided.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 12 month old female patient. The patient had not pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications. On 03-MAY-2018, the patient was vaccinated with VARIVAX for prophylaxis (dose, route of administration, lot # and expiration date were not reported).  On 16-MAY-2018, the patient developed chickenpox (varicella). The patient went to the physician's office on the same date. It was unknown if any treatment was given for the event. No laboratory/diagnostic test was performed. At the time of reporting, the outcome of the event was reported as not recovered. The causality assessment between the event and VARIVAX was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Rash generalised, Tinea pedis
Clinical narrative: This spontaneous report was received from a physician via a company representative, and refers to a female patient of unknown age. It was unknown if the patient had concomitant medications, medical history, concurrent conditions and drug reactions/allergies. On an unknown recent date, the patient was vaccinated with the second dose of GARDASIL 9, intramuscularly, for prophylaxis, (dose, frequency, lot number and expiration date were not provided). On an unknown date (reported as "afterwards"), the patient developed athlete's foot and "a rash spread all over her body shortly after receiving the dose" of GARDASIL 9. Furthermore, it was reported that on an unknown date, the patient was seen again by the physician and was prescribed an unknown treatment for the rash. At the time of reporting, the outcome of tinea pedis and rash generalized was unknown. The causal relationship between GARDASIL 9 and the reported events was not provided.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in a 54-year-old male patient who received SHINGRIX. 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 pain. The patient was treated with Steroid Therapy NOS. On an unknown date, the outcome of the pain was recovered/resolved. The reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain beyond eight days. The patient visited physician and was placed on steroid therapy. The reporter might suspected event and product related. This case has been linked to case US2018GSK082128 and US2018GSK082131, reported by the same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: This case was reported by a nurse and described the occurrence of localized erythema in a 72- year-old female patient who received SHINGRIX. On 2nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th May 2018, 3 days after receiving SHINGRIX, the patient experienced localized erythema, tenderness and skin warm. On an unknown date, the outcome of the localized erythema, tenderness and skin warm were unknown. It was unknown if the reporter considered the localized erythema, tenderness and skin warm to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, patient experienced patch of erythema with mild warmth and tenderness in the left mid arm of the 2 by 1.5 cm. Also, at lateral mid arm of the patient, 1 cm patch of erythema with mild warmth and tenderness was observed.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Systemic inflammatory response syndrome
Clinical narrative: Pt was okay at the time of the injection. The following day he experienced swelling at injection site and a systematic inflammatory response. Pt is a medical doctor so did not seek medical attention from his PCP and took care of treatment on his own. He is now following up with his doctor and an immunologist to pursue further treatment and investigation.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Eye discharge, Pruritus, Retinal artery occlusion, Rhinorrhoea
Clinical narrative: Joint pain, severe itching, runny nose, runny eyes. Next day vision affected. After seeing opthamologist diagnosed with a stroke in the optic nerve.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Joint pain, severe itching, runny nose, runny eyes. Next day vision affected. After seeing opthamologist diagnosed with a stroke in the optic nerve.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: About 6 hours after the shot the patient experienced a fever and headache that lasted about 12 hours and then resolved.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Nausea
Clinical narrative: Chill, headache, upset stomach, nausea. (However, the symptoms decreased as days went by).
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Headache, Influenza like illness, Pyrexia
Clinical narrative: Felt like I had the flu. My back (kidney area) ached, I felt feverous, headache, tired - went to bed early woke up feeling better - took an aspirin during the night. My husband also had the shot at the same time - and had difficulty sleeping - restless.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizziness.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced fever, On an unknown date, the outcome of the fever was recovered/resolved. It as unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The reporting physician was the patient. The age at vaccination was not reported. The patient developed fever with body temperature of 102. 4 degree Fahrenheit, 12 hours later. The fever resolved by 36 hours after injection. The reporter agreed to be contacted for follow up.
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site erythema in a 74-year-old patient who received SHINGRIX (batch number LT533, expiry date unknown). On 2nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th May 2018, 3 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site tenderness and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site tenderness and injection site warmth were unknown. It was unknown if the reporter considered the injection  site erythema, injection site tenderness and injection site warmth to be related to SHINGRIX. Additional information was reported as follows: The patient experienced local erythema and tenderness with warm to touch (6 by 2.5 cm). The patient had 6 by 2.5 cm area of erythema from around the injection site deltoid area to the lower mid arm.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of an improperly stored VARIVAX injection, lot # N030571 with expiration date on 31-OCT-2019 (dose and route of administration were not reported). The dose of the vaccine experience temperature excursion of 7.5 degrees Fahrenheit for 30 minutes. Previous temperature excursions of 8.8 degrees Fahrenheit for 1 hour and 14.7 degrees Fahrenheit for 1 hour and 45 minutes were reported. It was not reported if digital data logger was involved in the recording of the excursions. No adverse symptoms were reported.
Sex: F
Vaccine: RV5
Symptoms: Coronary artery bypass
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 5 month old female patient. The patient had not pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications. On 28-MAR-2018, the patient was vaccinated with ROTATEQ lot # N013884 with expiration date 05-DEC-2018, orally, for prophylaxis (dose was not reported). On 09-APR-2018, the patient received a a coronary artery bypass. The patient was hospitalized and an unspecified treatment was given for the event. No laboratory/diagnostic test was performed. At the time of reporting, the outcome of the event was reported as recovered on a unspecified date in 2018. The causality assessment between the event and ROTATEQ was not provided. Upon internal review, coronary artery bypass was determined to be a medically significant event.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-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 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical clinic 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 condition of herpes zoster. During June 2016, the patient was treated at a medical clinic for a blistering vesicular outbreak, which was 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.
Sex: F
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 female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 06-SEP-2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-JUN-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster. On or about 20-JUN-2016, the patient sought subsequent treatment for ongoing and worsening symptoms of shingles pain, which was diagnosed as post-herpetic neuralgia. The patient was prescribed famciclovir and gabapentin to manage her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, 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: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2015, 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 function as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 10-JUN-2016, the patient was treated at hospital medical center for a blistering vesicular outbreak, which was 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.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, 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 was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 08-FEB-2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-JAN-2015, the patient was treated by a physician for a persistent and blistering vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX, 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 is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-JAN-2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 11-JAN-2017, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as shingles. The patient was prescribed acyclovir and gabapentin for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, 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 is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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 12-SEP-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended 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 14-MAY-2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. 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: Blister, 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. On or about 10-APR-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended 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 27-FEB-2017, the patient was treated at an Internal Medicine office for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed valacyclovir (VALTREX) and gabapentin for management of her painful symptoms. 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: 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 21-JUN-2013, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and the intended purpose for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. During January 2014, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. She was diagnosed with shingles after being inoculated with ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX, 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 is unknown. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: RV5
Symptoms: Drug dispensed to wrong patient, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified 18-month-old patient. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On an unknown date, the patient was vaccinated with ROTATEQ, drug of administration was reported as injection (dose, anatomical location, lot# and expiration date were not reported), that was intended for another patient. No adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: Accidental exposure to product, Exposure via eye contact, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner, who was reporting on herself. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 15-MAY-2018, while preparing a dose of M-M-R II (strength, dose, frequency, lot# and expiration date were not reported), the nurse squirted some of the vaccine into her eyes in error. No adverse effects were reported. Product quality complaint (PQC) was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a currently 4 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# N035177, expiration date: 09-JUN-2019; N028447, expiration date 09-APR-2019 or lot#N025929, expiration date: 18-MAR-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15°F to 46°F (-9°C to 8°C) (19F). The previous temperature excursions were 6°F to 14°F (-14°C to -10°C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of PROQUAD was received by the patient. No adverse effects were reported. This is one of several reports from the same source.; Sender's Comments: US-009507513-1805USA007511: US-009507513-1805USA007507: US-009507513-1805USA007508: US-009507513-1805USA007509: US-009507513-1805USA007504: US-009507513-1805USA007510: US-009507513-1805USA007505: US-009507513-1805USA007506:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a currently 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot# N024567, expiration date: 07-SEP-2019; lot# N022995, expiration date: 23-AUG-2019 or lot# N017701, expiration date: 09-JUN-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15°F to 46°F (-9°C to 8°C) (19F). The previous temperature excursions were 6°F to 14°F (-14°C to -10°C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of VARIVAX was received by the patient. No adverse effects were reported. This is one of several reports from the same source.; Sender's Comments:  US-009507513-1805USA007511: US-009507513-1805USA007507: US-009507513-1805USA007508: US-009507513-1805USA007509: US-009507513-1805USA007510: US-009507513-1805USA007505: US-009507513-1805USA006682: US-009507513-1805USA007506:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a currently 2 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot# N024567, expiration date: 07-SEP-2019; lot# N022995, expiration date: 23-AUG-2019 or lot# N017701, expiration date: 09-JUN-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15°F to 46°F (-9°C to 8°C) (19F). The previous temperature excursions were 6°F to 14°F (-14°C to -10°C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of (Oka/Merck) VARIVAX was received by the patient. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1805USA006682: US-009507513-1805USA007511: US-009507513-1805USA007507: US-009507513-1805USA007508: US-009507513-1805USA007509: US-009507513-1805USA007504: US-009507513-1805USA007510: US-009507513 1805USA007506.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a currently 14 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot# N024567, expiration date: 07-SEP-2019; lot# N022995, expiration date: 23-AUG-2019 or lot# N017701, expiration date: 09-JUN-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15°F to 46°F (-9°C to 8°C) (19F). The previous temperature excursions were 6°F to 14°F (-14°C to -10°C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of (Oka/Merck) VARIVAX was received by the patient. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1805USA006682: US-009507513 1805USA007511: US-009507513-1805USA007507: US-009507513-1805USA007508: US-009507513-1805USA007509: US-009507513-1805USA007504: US-009507513-1805USA007510: US-009507513-1805USA007505.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a currently 4 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# N035177, expiration date: 09-JUN-2019; N028447, expiration date 09-APR-2019 or lot#N025929, expiration date: 18-MAR-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15°F to 46°F (-9°C to 8°C) (19F). The previous temperature excursions were 6°F to 14°F (-14°C to -10°C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of PROQUAD was received by the patient. No adverse effects were reported. This is one of several reports from the same source.; Sender's Comments:  US-009507513-1805USA006682: US-009507513-1805USA007511: US-009507513-1805USA007508: US-009507513-1805USA007509: US-009507513-1805USA007504: US-009507513-1805USA007510: US-009507513-1805USA007505: US-009507513-1805USA007506:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a currently 4 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# N035177, expiration date: 09-JUN-2019; N028447, expiration date 09-APR-2019 or lot# N025929, expiration date: 18-MAR-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15 degrees F to 46 degrees F (-9 degrees C to 8 degrees C) (19F). The previous temperature excursions were 6 degrees F to 14 degrees F (-14 degrees C to -10 degrees C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of PROQUAD was received by the patient. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1805USA006682; US-009507513-1805USA007511; US-009507513-1805USA007507; US-009507513-1805USA007509; US-009507513-1805USA007504; US-009507513-1805USA007510; US-009507513-1805USA007505; US-009507513-1805USA007506.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a currently 12 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# N035177, expiration date: 09-JUN-2019; N028447, expiration date 09-APR-2019 or lot#N025929, expiration date: 18-MAR-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15°F to 46°F (-9°C to 8°C) (19F). The previous temperature excursions were 6°F to 14°F (-14°C to -10°C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of PROQUAD was received by the patient. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1805USA006682: US-009507513-1805USA007511: US-009507513-1805USA007507: US-009507513-1805USA007508: US-009507513-1805USA007504: US-009507513-1805USA007510: US-009507513-1805USA007505: US-009507513-1805USA007506.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning a currently 19 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot# N024567, expiration date: 07-SEP-2019; lot# N022995, expiration date: 23-AUG-2019 or lot# N017701, expiration date: 09-JUN-2019) (dose and route of administration were not provided) as prophylaxis following temperature excursions of 15°F to 46°F (-9°C to 8°C) (19F). The previous temperature excursions were 6°F to 14°F (-14°C to -10°C) (12.7F) for 55 minutes. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No product quality complaint was involved. The nurse did not indicate which lot#/expiration date of VARIVAX was received by the patient. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1805USA006682: US-009507513-1805USA007511: US-009507513-1805USA007507: US-009507513-1805USA007508: US-009507513-1805USA007509: US-009507513-1805USA007504: US-009507513-1805USA007505: US-009507513-1805USA007506.