chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information on his/her pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL 9 injection (dose and route of administration were not reported) (lot # N035955, expiry date: 09-OCT-2020) for prophylaxis. The vaccine was exposed to temperature of 9 degrees Celsius (C) to 25 C for 65 hours 15 minutes. There was no previous temperature excursion. No adverse effect was reported. The digital data logger was involved in recording the temperature excursion. There was no product quality complaint (PQC) reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-APR-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018)(dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) (60.33 degrees F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On 28-JUN-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX (strength or anatomical location were not provided) from lot # M027344 with expiration date on 01-JUN-2018, which was administered subcutaneously for prophylaxis. The vaccine never underwent a temperature excursion and no adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a patient of unknown age and gender who was also a pharmacy technician. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. In January 2016, the patient was vaccinated with the first dose of GARDASIL 9 (strength, lot #, expiration date, dose, route of administration or anatomical location were not provided), for prophylaxis. Later in May 2016, the patient received the second dose of GARDASIL 9 (strength, lot #, expiration date, dose, route of administration or anatomical location were not provided) for the same indication. No adverse effect was reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner (also reported as "nurse prescriber"), concerning a female patient over 15 years old. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On unspecified dates, the patient was vaccinated with the three doses of GARDASIL 9) (strength, lot #, expiration date or anatomical location were not provided), which were given intramuscularly for prophylaxis; but only two months lapsed between the second and third dose. No adverse effect was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: The vaccine did not prevent shingles as intended; 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.  In 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, but rather caused the patient to contract a persistent strain of herpes zoster. Later in 2012, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. 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. On or about 30-NOV-2015, the patient was inoculated 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 2015, the patient was treated by at a medical center 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, Pain, 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 09-JUN-2009, the patient was inoculated 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. On or about 17-JUL-2016, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as shingles. The patient had been prescribed VALTREX and NORCO 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. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning a 19 year old male patient. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 28-MAY-2018, the patient was vaccinated with a pediatric dose of VAQTA for prophylaxis, lot #N023953 and expiration date 05-NOV-2018 (strength, dose, frequency and route of administration were not reported). No adverse effects were reported.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with an improperly stored dose of VARIVAX for prophylaxis, lot #N031001 and expiration date 03-NOV-2019 (strength, dose, frequency and route of administration were not reported); the vaccine was reconstituted with a properly stored sterile diluent (MERCK). No adverse effect was reported. The temperature of excursion was reported as from 47°F to 77°F during a time frame of 20 hours. There was no previous temperature of excursion reported. There was a digital data logger involved.
Sex: F
Vaccine: MMR
Symptoms: Serology negative, Therapy non-responder
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with M-M-R II subcutaneously lot # M045393 with expiration date 14-NOV-2018, for prevention of measles, mumps, and rubella (dose and dosage schedule were not provided). Other suspect therapies included sterile diluent. The reporting pharmacist stated that, after having performed a post vaccination serologic test on an unspecified date, the patient had a negative immune response. At the time of the report, the outcome of the event was unknown. The causality assessment between the event and M-M-R II was not reported.
Sex: M
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 male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine "did" function as intended [considered to mean the vaccine did not function as intended], and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated by a physician at a family health clinic for a blistering 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.
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 25-APR-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine "did" function as intended [considered to mean the vaccine did not function as intended], and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 21-MAR-2016, the patient was treated by a physician's assistant and a physician for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was treated with gabapentin, ATARAX, and VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history and concurrent conditions were not reported. On 28-JUN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX Lot # N031004, expiration date 03-NOV-2019, for prophylaxis (strength, dose, route and frequency were not reported) reconstituted with a properly stored sterile diluent (concomitant therapy). The temperature excursion was of 6 Fahrenheit degrees (°F) to 14 °F, during 15 minutes. However, a previous temperature excursion of 6 °F to 14°F for 15 minutes was also reported. A digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1807USA003518.
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Inflammation, Injected limb mobility decreased, Injection site swelling, Loss of personal independence in daily activities, Myalgia
Clinical narrative: This spontaneous report was received from an office manager via a company representative and refers to a 18 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 15-MAY-2018, the patient was vaccinated with GARDASIL 9 (dose, route, lot number and expiration date were not reported) for prophylaxis. On the same date, the patient also received hepatitis a vaccine, inactivated (manufacturer unknown) (dose, route, lot number and expiration date were not reported) for prophylaxis, and MENACTRA (dose, route, lot number, indication and expiration date were not reported). On an unspecified date in 2018, the patient's arm where the GARDASIL 9 was applicate was "swelled tremendously, the patient could not lift her arm, the arm had inflammation, she had fever on and off, myalgia and the patient missed school. It was unknown, if the patient received the hepatitis a vaccine, inactivated (manufacturer unknown) and MENACTRA in the same which received the GARDASIL 9. It was unknown if the patient received treatment for the events. The outcome of peripheral swelling, vaccination site movement impairment, myalgia and pyrexia was unknown. The causal relationship between the events and GARDASIL 9 was not reported.
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from an office manager via a company representative and refers to a 18 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 15-MAY-2018, the patient was vaccinated with GARDASIL 9 (dose, route, lot number and expiration date were not reported) for prophylaxis. On the same date, the patient also received hepatitis a vaccine, inactivated (manufacturer unknown) (dose, route, lot number and expiration date were not reported) for prophylaxis, and MENACTRA (dose, route, lot number, indication and expiration date were not reported). On an unspecified date in 2018, the patient's arm where the GARDASIL 9 was applicate was "swelled tremendously, the patient could not lift her arm, the arm had inflammation, she had fever on and off, myalgia and the patient missed school. It was unknown, if the patient received the hepatitis a vaccine, inactivated (manufacturer unknown) and MENACTRA in the same which received the GARDASIL 9. It was unknown if the patient received treatment for the events. The outcome of peripheral swelling, vaccination site movement impairment, myalgia and pyrexia was unknown. The causal relationship between the events and GARDASIL 9 was not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018) (dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) (60.33 °F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018) (dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) (60.33 °F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018) (dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) (60.33 °F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018) (dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) (60.33 °F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018) (dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) (60.33 °F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018) (dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) (60.33 °F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018) (dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) (60.33 °F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018) (dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) (60.33 °F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018)(dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) (60.33 degrees F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018)(dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) (60.33 degree F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018)(dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) (60.33 degrees F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018)(dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) (60.33 degrees F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1807USA003055: US-009507513-1807USA003054: US-009507513-1807USA003053: US-009507513-1806USA012857: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-MAY-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018)(dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) (60.33 degrees F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-JUN-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018)(dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) (60.33 degrees F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-JUN-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018)(dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) (60.33 degrees F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were  not reported. On 04-JUN-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018)(dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (degrees F) to 77 degrees Fahrenheit (degrees F) (60.33 degrees F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1807USA003177; US-009507513-1807USA003069; US-009507513-1807USA003067; US-009507513-1807USA003066; US-009507513-1807USA003065; US-009507513-1807USA003064; US-009507513-1807USA003063; US-009507513-1807USA003062; US-009507513-1807USA003061; US-009507513-1807USA003060; US-009507513-1807USA003059; US-009507513-1807USA003058; US-009507513-1807USA003057; US-009507513-1807USA003056; US-009507513-1807USA003055; US-009507513-1807USA003054; US-009507513-1807USA003053; US-009507513-1806USA012857.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JUN-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018)(dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) (60.33 degrees F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1807USA003177: US-009507513-1807USA003068: US-009507513-1807USA003067: US-009507513-1807USA003066: US-009507513-1807USA003065: US-009507513-1807USA003064: US-009507513-1807USA003063: US-009507513-1807USA003062: US-009507513-1807USA003061: US-009507513-1807USA003060: US-009507513-1807USA003059: US-009507513-1807USA003058: US-009507513-1807USA003057: US-009507513-1807USA003056: US-009507513-1807USA003055: US-009507513-1807USA003054: US-009507513-1807USA003053: US-009507513-1806USA012857.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-JUN-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018) (dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (°F) to 77 degrees Fahrenheit (°F) (60.33 °F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003067: US-009507513-1807USA003068: US-009507513-1807USA003069.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history and concurrent conditions were not reported. On 03-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX Lot # N031004, expiration date 03-NOV-2019, for prophylaxis (strength, dose, route and frequency were not reported) reconstituted with a properly stored sterile diluent (concomitant therapy). The temperature excursion was of 6 Fahrenheit degrees (F) to 14 degrees F, during 15 minutes. However, a previous temperature excursion of 6 degrees F to 14 degrees F for 15 minutes was also reported. A digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1807USA002917.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2014, the patient was treated by the physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, 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 12-FEB-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 05-JUN-2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed FAMVIR for management of his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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. On an unknown date during 2014, the patient was inoculated with the 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 did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date later in 2014, the patient was treated for symptoms of a blistering vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving zoster vaccine live 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.