chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M038856, expiration date 14-SEP-2018; lot # M043305, expiration date 26-OCT-2018, lot # M042496, expiration date 19-OCT-2018 and lot # M045204, expiration date 11-NOV-2018 (doses and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 3 hours and 49 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information is not expected because there was no consent to contact the reporter. Sender's Comments: US-009507513-1706USA000988:
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse and refers to a 16 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In November 2016, in March 2017 and in May 2017 the patient was vaccinated with the first, second and third (respectively) doses of GARDASIL 9 lot # M041212, expiration date 21-JUN-2019 (doses and route of administration were not reported). The reporter stated that the second and third doses were separated by 10 weeks. No adverse effects were reported. No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the physician and refers to a patient of unknown age (reported as 0) and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 27-APR-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# M000442; expiration date, dose, route of administration and anatomical location were not reported) and with an improperly stored dose of ROTATEQ orally (lot# M041181; expiration date, dose and anatomical location were not reported). The vaccine doses were exposed to a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There were no digital data logger or previous temperature excursions involved. No adverse effects were reported.  This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1705USA012992: US-009507513-1705USA012997: US-009507513-1705USA012998: US-009507513-1705USA012999: US-009507513-1705USA013000: US-009507513-1705USA013001: US-009507513-1705USA012986: US-009507513-1705USA012985:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes virus test abnormal, Herpes zoster, Polymerase chain reaction positive, Scab, Skin lesion
Clinical narrative: Information was received in a pusblished poster abstract titled as stated above. This case concerns to a 91 year-old male patient. On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) (lot number, expiration date, dose, route and frequency were not provided) for prophylaxis. There was no concomitant medication reported. On an unknown date, 10 years after vaccination, the patient presented with crusted lesions on his face corresponding to the dermatome of the ophthalmic division of the left trigeminal nerve. The patient was diagnosed with herpes zoster; the clinical diagnosis was confirmed with polymerase chain reaction. The herpes zoster vaccine was not as effective with increasing age and with increasing years post-vaccination. This was concerning because the incidence of herpes zoster increases with age. If patients receive their first vaccine at 60 years old, with the advances in medicine they may live for 10 or 20 more years. However, the vaccine would not protect them from contracting herpes zoster at this age. Therefore, studies need to be conducted to evaluate the possible benefit of booster shots in the older population. The clinical characteristics of a patient presenting with a herpes zoster infection after vaccination were presented. Vaccine efficacy and guidelines were reviewed. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 26-MAY-2017 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 were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 28-JUL-2011 at a county healthcare department, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-SEP-2015, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed valacyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age.  Medical history and concomitant medications were not provided.  On or about 08-MAR-2011, the patient was vaccinated with ZOSTAVAX at by a licensed practical nurse (LPN)  as recommended for routine adult health maintenance for the prevention of shingles (route and lot # not provided).  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 04-NOV-2011, the patient was treated by physician  for a vesicular outbreak that was diagnosed as severe shingles. On or about 12-AUG-2012, she was treated by physician for dermatologic conditions, secondary to shingles.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.  The outcome of shingles was not recovered. The outcome of dermatologic disorder was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 26-MAY-2017 regarding a case in litigation concerning a female (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 20-DEC-2007 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 27-MAY-2016 the patient was treated for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed famciclovir (FAMIR) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received on 26-MAY-2017 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 were not reported.  The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 06-MAY-2013 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-FEB-2015, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed IV opioids, valacyclovir and acetaminophen, oxycodone hydrochloride (PERCOCET) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: 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 regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about 23-AUG-2012, as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage, and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-SEP-2013, the patient was treated for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed famciclovir (FAMVIR) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, 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 on 26-MAY-2017 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 were not reported.  The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about December of 2006 by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-JAN-2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX) for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further 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: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a  patient of unknown age and gender .  Medical history and concomitant medications were not provided. On or about 09-JUL-2014, the patient was vaccinated with ZOSTAVAX at a  pharmacy as recommended for routine adult health maintenance for the prevention of shingles (route and lot # not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-JUN-2016, the patient was treated by a nurse practitioner for a vesicular outbreak that was diagnosed as severe shingles. The patient was treated on unspecified date by a physician for worsening symptoms and was prescribed  acyclovir, gabapentin, and hydrocodone-acetaminophen for management of  painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.  The outcome was singles was not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Medical history and concomitant medications were not provided. On or about 29-MAY-2014, the patient was vaccinated with ZOSTAVAX at a pharmacy  as recommended for routine adult health maintenance for the prevention of shingles (route and lot # not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-SEP-2015, the patient was treated by physicians assistant at urgent care clinic for a vesicular outbreak that was diagnosed as severe shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.  The outcome of shingles was not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was 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. The patient was inoculated with ZOSTAVAX in June 2014 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage, and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-JUL-2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as herpes zoster (shingles). As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 26-MAY-2017 regarding a case in litigation concerning a male (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On or about 01-JUN-2012 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 25-AUG-2016 the patient was treated for a vesicular outbreak that was diagnosed as severe shingles. The patient was treated by a physician and was prescribed hydrocodone-acetaminophen for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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 regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about 17-NOV-2009, as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage, and route of administration not provided). The zoster vaccine live (ZOSTAVAX) did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-DEC-2013, the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed valacyclovir and acetaminophen (+) codeine phosphate (TYLENOL WITH CODEINE) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Medical history and concomitant medications were not provided. On or about 13-AUG-2012, the patient was vaccinated with ZOSTAVAX at a pharmacy  as recommended for routine adult health maintenance for the prevention of shingles (route and lot # not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-SEP-2016, the patient was treated in emergency department for a vesicular outbreak that was diagnosed as severe shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of shingles was not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 26-MAY-2017 regarding a case in litigation concerning a patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2015 the patient received a dose of ZOSTAVAX (lot # and dose not specified) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-JUN-2016 the patient was treated by a physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed valacyclovir (VALTREX) and aluminum sulfate tetradecahydrate, calcium acetate monohydrate (PEDIBORO) compresses for management of the painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and referred to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally (strength, dose, and frequency were not reported; lot number M007125 with an expiration date 06-OCT-2017) for prophylaxis. The vaccine data logger measured a temperature of 25°C for a total time frame of 23 hours. Previous temperature excursion measured 25°C for a total time frame 57 minutes. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA011313: US-009507513-1705USA015159: US-009507513-1705USA015157:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and referred to 22 patients of unknown ages and genders. The patients' relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally (strength, dose, and frequency were not reported; lot number M042822 with an expiration date 19-JUN-2018) for prophylaxis. The vaccine data logger measured a temperature of 25°C for a total time frame of 23 hours. Previous temperature excursion measured 25°C for a total time frame 57 minutes. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015158: US-009507513-1705USA011313: US-009507513-1705USA015157:
Age: 61.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no information provided about the patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies. On 30-MAY-2017, the patient was vaccinated with an expired dose of injectable VAQTA (Lot number reported as N005885 with expiration date 26-MAY-2017) for prophylaxis (dose, frequency, route of administration and anatomical location were not reported). There were no adverse effects reported. Lot number N005885 is an invalid lot number for Hepatitis A Vaccine, Inactivated. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided.  On unknown dates, the patients were vaccinated with PROQUAD recombinant human albumin (rHA) (lot #: M007964 with expiration date: 15-AUG-2017 and lot# M043307 with expiration date 24-APR-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT), which were properly stored. The administered vaccines were improperly stored at temperature greater than -10°C but less than -14°F (-11.5°C) for 18 days with previous temperature excursion at temperature greater than -9°C but less than 8°C (-9°C) for 1 hour and 14 minutes; this information was registered in a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015810: US-009507513-1706USA000283:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring a patient of unknown age and gender. Information on medical history, concomitant medications and drug allergies was not provided.   On an unknown date, the patient was vaccinated with a dose of improperly stored PROQUAD (lot# M039448, expiration date 20-MAR-2018) for prophylaxis (dose and route of administration were not reported). The temperature of storage for PROQUAD was above -10 Celsius and below 8 Celsius for 1 hour and 2 minutes (2 excursions). A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA011638: US-009507513-1706USA000480: US-009507513-1706USA000482: US-009507513-1703USA002284: US-009507513-1706USA000487: US-009507513-1706USA000488: US-009507513-1706USA000489: US-009507513-1706USA000490: US-009507513-1706USA000491: US-009507513-1706USA000492:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring a patient of unknown age and gender. Information on medical history, concomitant medications and drug allergies was not provided.   On an unknown date, the patient was vaccinated with a dose of improperly stored PROQUAD (lot# M039448, expiration date 20-MAR-2018) for prophylaxis (dose and route of administration were not reported). The temperature of storage for PROQUAD was above -10 Celsius and below 8 Celsius for 1 hour and 2 minutes (2 excursions). A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA011638: US-009507513-1706USA000480: US-009507513-1706USA000481: US-009507513-1703USA002284: US-009507513-1706USA000487: US-009507513-1706USA000488: US-009507513-1706USA000489: US-009507513-1706USA000490: US-009507513-1706USA000491: US-009507513-1706USA000492:
Age: 37.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Laceration
Clinical narrative: Itching and redness on bilateral deltoid area. More on Left arm. Employee came to me around 9:00AM and she had lacerations on left deltoid where she had scratched. Advised to take Zyrtec, apply ice, and 1% Hydrocortisone cream on both arms. Employee continued w/daily work. Checked with employee about 4 hours later and she stated itching resolved.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left Shoulder with swelling, redness and painful to touch.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Dysgeusia, Gastrointestinal pain, Injection site pruritus, Nausea
Clinical narrative: Pt had GI cramping, metallic taste in mouth, palpitations, Nausea, lightheaded, increased respiration, itching of the site.
Age: 20.0
Sex: M
Vaccine: HPV9
Symptoms: Palpitations, Respiratory rate increased
Clinical narrative: Pt had GI cramping, metallic taste in mouth, palpitations, Nausea, lightheaded, increased respiration, itching of the site.
Age: 21.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Chest pain, Dyspnoea, Migraine
Clinical narrative: Migraines started and lasted for 2 days. Chest pain and shortness of breath started on 26 May 2017 approximately 1700 and lasted until the next day. Took Ibuprofen that evening.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, Interchange of vaccine products
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 31-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. The patient was vaccinated with the mixed regimen of Human Papillomavirus vaccines: on 30-JUN-2016, the patient received dose GARDASIL injection (dose, route of administration, lot# and expiration date were not provided), on 30-JUN-2016 GARDASIL 9 injection (dose, route of administration, lot# and expiration date were not provided), and on 23-FEB-2017 again the dose of GARDASIL 9 injection (dose, and route of administration were not provided; lot# M023169, expiration date:13-JUN-2018). there was no adverse reactions. The outcome of the event was unknown. The relatedness between the event and the vaccines was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the administrator referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. 21-APR-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# M000442; expiration date, dose, route of administration and anatomical location were not reported) and with an improperly stored dose of ROTATEQ orally (lot# M041181; expiration date, dose and anatomical location were not reported). The vaccine doses were exposed to a temperature excursion of 48 Fahrenheit degrees for 30 minutes. There were no digital data logger or previous temperature excursions involved. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660: US-009507513-1705USA012988: US-009507513-1705USA012990: US-009507513-1705USA012992: US-009507513-1705USA012995: US-009507513-1705USA012999: US-009507513-1705USA013000: US-009507513-1705USA013001:
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Initial unsolicited report received from healthcare professional on 22-May-2017. This case involves 20 years old female patient who was vaccinated with a second dose of IMOVAX (batch number: M13142M, expiry date: 19 June 2018 and route of administration was not reported) in the gluteal muscle on 18 May 2017 in morning. Patient did not have illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medication. On 18 May 2017 at night few hours following vaccination patient developed nausea, vomiting and diarrhea with low grade fever. Patient did not perform Laboratory investigation. Corrective treatment was not reported. On an unspecified date patient was recovered from events. It was reported that events lasted about a day or so and resolved. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: The patient stated that her upper arm from elbow to shoulder became swollen and red almost immediately after leaving.  She was seen at an urgent care and given a course of antibiotics for treatment.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Fatigue, Pain in extremity, Swelling
Clinical narrative: RM is really sore still after Men B injection. Swelling is size of quarter and slightly raised; sore arm continuously; slightly red; no fever; slightly more tired; no N/V, diarrhea.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age or gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, and anatomical location were not reported), lot # M032493 and expiration date on 06-JUL-2018, for prophylaxis; which experienced a temperature excursion between 6 and 14 Fahrenheit degrees for 3 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported and no further information was provided. A product quality complaint was not involved. The vaccine was reconstituted with properly stored steril diluent. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose from 24-APR-2017 to 09-MAY-2017 of M-M-R II with Lot # M022407 with an expiration date of 02-MAY-2018 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 47 Fahrenheit degrees (°F) to 77 °F range for a time frame of 28 minutes. The temperature excursion was recorded by a data logger and it had previous temperature excursions on 19-APR-2017 of 32 °F to 35 °F by 29 minutes. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. This is an amended report, as corrected.  The preferred term (PT) for the event improperly stored dose of vaccine was corrected to Incorrect product storage.; Sender's Comments: US-009507513-1705USA005357: US-009507513-1705USA009721.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a office manager/nurse refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-MAY-2017 the patient was vaccinated with GARDASIL 9 dose 2, (lot number, expiration date not reported) for prophylaxis. The patient was vaccinated with first dose of GARDASIL 9 on 12-MAY-2017. No adverse effects reported. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed practical nurse who reported that an unspecified patient was administered improperly stored M-M-R II lot #M039904, expiration date 26-SEP-2018, (dose and route of administration not provided) reconstituted with properly stored sterile diluent (MSD) on 04-MAY-2017. No adverse effects reported.  Temperature: 9°C to 25°C Time frame: 3 hours Previous temperature excursion: Yes, 11.4°C for 17 hours on 17-APR-2017; 16°C for 3 hours on 01-MAY-2017. Data logger involved: Yes This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA000340: US-009507513-1705USA006221: US-009507513-1706USA000339: US-009507513-1706USA001007: US-009507513-1706USA000343: US-009507513-1706USA000342:
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a pharmacist concerning an adult female patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly, lot number reported as M002583, and expiration date 27-NOV-2017 (dose was not reported) for prophylaxis, after her 26th birthday. Lot number M002583 is an invalid lot number for GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history and historical drugs were not reported. The patient's concomitant medication included sterile diluent. On 17-APR-2017, the patient was administered the first dose of M-M-R-II lot number M037096, expiration date 23-AUG-2018, and on 08-MAY-2017, the patient received the second dose of M-M-R-II lot number M044350, expiration date 04-NOV-2018 (dose and route were not reported) both for prophylaxis. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 30-MAY-2017, the patient was inadvertently vaccinated with an expired dose of VAQTA, intramuscular, with lot # M003025 and an expiration date on 26-MAY-2017 (strength and dose were not reported) for prophylaxis. No adverse effects were reported in the patient. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed practical nurse who reported that an unknown number of unspecified patient or patients were administered improperly stored GARDASIL 9 lot #M034780, expiration date 15-APR-2019, (dose and route of administration not provided) on 11-MAY-2017. No adverse effects reported. Temperature: 12°C Time frame: 17 hours Previous temperature excursion: Yes, 11.4°C for 17 hours on 17-APR-2017; 16°C for 3 hours on 01-MAY-2017. Data logger involved: Yes. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA006221: US-009507513-1706USA000340: US-009507513-1706USA000343: US-009507513-1706USA000341: US-009507513-1706USA000342: US-009507513-1706USA000339.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to multiple patients of unknown age or gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of ROTATEQ (strength and dose were not reported), lot # M019690 with expiration date on 02-NOV-2017 and lot # M038724 with expiration date on 24-APR-2018, orally for prophylaxis; which experienced a temperature excursion between 47 and 77 Fahrenheit degrees for 50 minutes. Previous temperature excursion was between 47 and 77 Fahrenheit degrees for 3 hours. Data logger was involved. No adverse effects were reported and no additional information was provided. A product quality complaint was not involved. This is one of multiple reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001034: US-009507513-1706USA001035: US-009507513-1705USA008599.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to multiple patients of unknown age or gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (strength, dose, route and anatomical location were not reported), lot # M034780 with expiration date on 15-APR-2019, for prophylaxis; which experienced a temperature excursion between 47 and 77 Fahrenheit degrees for 50 minutes. Previous temperature excursion was between 47 and 77 Fahrenheit degrees for 3 hours. Data logger was involved. No adverse effects were reported and no additional information was provided. A product quality complaint was not involved. This is one of the multiple reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA008599: US-009507513-1706USA001035: US-009507513-1706USA001033.
Sex: F
Vaccine: FLUN3
Symptoms: Aggression, Headache, Irritability
Clinical narrative: A spontaneous report has been received from a physician via medical representative concerning female patient. The health professional reported when her daughter got the nasal FLUMIST (intranasal) vaccine 6 or 7 years ago, she noticed the daughter had irritability, like a temper tantrum. The infectious disease physician said the daughter probably was experiencing headaches from the medication, but she just could not tell, as the daughter was 3 or 4 years of age at the time of this event. The patient recovered from irritability, like a temper tantrum and probably was experiencing headaches on an unspecified date. Company physician considered irritability, like a temper tantrum and probably was experiencing headaches to be non-serious.
Age: 1.0
Sex: F
Vaccine: HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Hepatitis B vaccine given in error. HIB was intended. Contacted Health Dept she stated no adverse effects. Spoke with patients and she is doing good.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Abdominal pain and vomiting started 1.5 hours after vaccines administered.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On 06/02/17, 31 yo F presented to clinic for Nurse Only visit for immunization. During visit, pt was ordered to receive MMR vaccine and Varicella vaccine. Per immunization record, MMR was administered in the right arm and varicella was administered in the left arm. 5 minutes after injections, pt developed redness and a quarter-sized area of swelling at the injection sites. MD notified, vitals assessed (BP: 130/87) and pt was ordered and administered diphenhydramine 25 mg PO. Pt was provided with after care instructions and instructed to take fexofenadine (Allegra) for 1 week. Pt was also advised to have a titer completed in 1 month. Pt was discharged in stable condition.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: LEFT THIGH WAS SWOLLEN, RED AND HOT. PT FELT DISCOMFORT AND PRURITUS, LATER ON DEVELOPED A FEVER OF 103.5 F, AND WAS BROUGHT TO CLINIC.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: LEFT THIGH WAS SWOLLEN, RED AND HOT. PT FELT DISCOMFORT AND PRURITUS, LATER ON DEVELOPED A FEVER OF 103.5 F, AND WAS BROUGHT TO CLINIC.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Abnormal behaviour, Anxiety, Condition aggravated, Crying, Decreased appetite
Clinical narrative: Fatigue, loss of appetite, general feeling of unwellness, tired but not able to sleep easily or well, increase in sensory integration issues, increase in anxiety, crying, being upset, and other signs of sadness or frustration (inevitably from not feeling well), wanting to sit and not be up and active and playing like normal, increase in attachment to mother, also from not feeling well. Patient is unable to express specifically how he feels due to age, just that he doesn't feel well.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Depressed mood, Emotional distress, Fatigue, Frustration tolerance decreased, Insomnia
Clinical narrative: Fatigue, loss of appetite, general feeling of unwellness, tired but not able to sleep easily or well, increase in sensory integration issues, increase in anxiety, crying, being upset, and other signs of sadness or frustration (inevitably from not feeling well), wanting to sit and not be up and active and playing like normal, increase in attachment to mother, also from not feeling well. Patient is unable to express specifically how he feels due to age, just that he doesn't feel well.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Malaise, Poor quality sleep, Sensory integrative dysfunction
Clinical narrative: Fatigue, loss of appetite, general feeling of unwellness, tired but not able to sleep easily or well, increase in sensory integration issues, increase in anxiety, crying, being upset, and other signs of sadness or frustration (inevitably from not feeling well), wanting to sit and not be up and active and playing like normal, increase in attachment to mother, also from not feeling well. Patient is unable to express specifically how he feels due to age, just that he doesn't feel well.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Musculoskeletal stiffness, Rash
Clinical narrative: Patient first described a rash developing on arm of injection site. The next day, on 5/31/17, patient noticed arm began to feel stiff and more redness occurred. Patient came to pharmacy on 6/1/17 to report symptoms. Pharmacist encouraged patient to report symptoms to primary care physician to make them aware. In addition, pharmacist explained that rash was common, however patient believed redness and stiffness on arm to be a hematoma, which is a more rare side effect. Pharmacist counseled to use Hydrocortisone cream to assist with itching and to keep an eye out to see if any improvement. If no improvement occurs, stated to contact pharmacy and physician once more.