chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patients identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 2 month old patient (gender not provided) who on 03-JAN-2018, was vaccinated with improperly stored dose of ROTATEQ, orally, lot number: N011648 and expiration date: 01-DEC-2018, (strength, dose and frequency were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Sender's Comments: US-009507513-1808USA010633: US-009507513- 1808USA010635: US-009507513-1808USA010642: US-009507513-1808USA010637: US-009507513-1808USA010638: US-009507513-1808USA010639: US-009507513-1808USA010640: US-009507513-1808USA010641: US-009507513-1808USA010634: US-009507513-1808USA010636.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. Prior medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. This is a non-valid case due to lack of patient identifiers. On 05-APR-2018, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # N022727, expiry date: 12-JUN-2020, for prophylaxis) (strength, dose, dosage schedule and anatomical location were not provided) (product storage error). No adverse effects were reported. The temperature excursion and time frame for GARDASIL 9 was between 32 degrees Fahrenheit to 35 degrees Fahrenheit for a time frame of 0.167 hours (approximately 10 minutes). No previous temperature excursion was reported. Data logger was reported. Lot number K084421 is an invalid lot number for rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Follow-up information was received from a medical assistant on 27-JUN-2018. On unknown dates, an unspecified number of unspecified patients were vaccinated with improperly stored doses of VAQTA (lot # N005274, expiration date: 03-APR-2018, lot # N026997, expiration date: 10-NOV-2018, strength, dose, dosage schedule and anatomical location were not provided) and ROTATEQ orally (lot M045546, expiration date: 12-JUN-2018, strength, dose, dosage schedule and anatomical location were not provided) for prophylaxis. The temperature excursion and time frame for VAQTA and ROTATEQ was between 47 degrees Fahrenheit to 77 degrees Fahrenheit, 32 degrees Fahrenheit up to 35 degrees Fahrenheit and below 32 degrees Fahrenheit for unknown time frame. No previous temperature excursion was reported. Data logger was reported. This is a non-valid case due to the lack of a patient identifier. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. Follow up information has been received from the medical assistant on 23-AUG-2018. This report refers to a 11 year old patient of unknown gender. The medical assistant stated that only one patient was vaccinated on 05-APR-2018 with GARDASIL 9, lot #N022727, expiry date: 12-JUN-2020, for prophylaxis. Also, there were no invalid lot numbers.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 5-year-old patient of unknown gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD intramuscularly (lot # N023969, expiration date: 28-FEB-2019) with a 1 inch needle for prophylaxis. The vaccine was reconstituted with sterile diluent (lot # M041992, expiration date: 16-MAR-2019). No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a physician of unknown age regarding himself/herself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient received a dose of PREVNAR 13 followed by PNEUMOVAX 23 (lot#, expiration date, strength, dosing details and route of administration were not reported) before the patient was 65 years old for prophylaxis. No adverse effects reported.
Age: 5.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 5 year old (also reported as 6 year old) male patient. Concomitant therapies included sterile diluent. Information about concurrent condition and medical history was not provided. On 09-AUG-2018 the patient was vaccinated with PROQUAD via subcutaneous, (lot # N023966, expiration date 28-FEB-2019), for prophylaxis (strength, dose and frequency were not reported) and VARIVAX, (lot # N002203, expiration date 19-JAN-2019), subcutaneously for prophylaxis (strength, dose, frequency were not reported) (overdose). No adverse effect reported.
Age: 19.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Viral titre decreased
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 19 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 10-AUG-2018, the patient was inadvertently vaccinated with PROQUAD (therapy type rHA) (lot # N025924 with expiry date of 18-MAR-2019) for prophylaxis (drug administered to patient of inappropriate age), after an unspecified "blood test" was performed and the results showed "low titre levels".  The patient sought medical attention. The outcome of viral titre decreased was reported as recovered. The causality assessment was not provided by the reporter. No product quality complaint was filed.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a pediatric patient of unknown age and gender. Information on patient's pertinent medical history and drug reactions/allergies were not reported. On 13-AUG-2018, the patient was vaccinated with an adult dose of VAQTA 50/1.0 U/ml injection (dose and route of administration were not reported) (lot # N032753 and expiry date: 23-MAR-2019) instead of a pediatric dose for prophylaxis. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1808USA007658.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 2-year old male patient. The patient's pre-existing conditions included sickle cell anemia and reactive airway disease. At the time of vaccination, patient had follow up for pertussis. On 06-AUG-2018, the patient was vaccinated with M-M-R II (lot: N031294; expiry date: 21-AUG-2019) subcutaneously in the right arm, VARIVAX (lot: N027000; expiry date: 28-SEP-2019) subcutaneously in the left arm, PENTACEL (lot: C546119A) in the right thigh, HAVRIX (lot: 24343) in the right thigh and third dose of PREVNAR 13 (lot: T94424) in the right thigh. Patient did not experience any adverse events with the vaccines. The temperature excursion occurred as a result of reading from a Digital Data Logger. This is one of the several cases received from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 27-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In March 2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (dose, lot # and expiration date were not provided) for prophylaxis. In May 2017, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly (dose, lot # and expiration date were not provided) for prophylaxis. No adverse effects were reported.
Age: 1.58
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 19 month old female patient. The patient's concomitant medication, historical and concurrent conditions were not reported. On 09-AUG-2018, the patient was vaccinated at a private doctor's office/hospital using public funds with an improperly stored dose of VARIVAX (lot # R002051, expiry date unknown) subcutaneously and VAQTA (lot #R003739, expiry date unknown) intramuscularly both for prophylaxis in the left thigh. No prescription drug treatment for the experience was required. Details of the temperature excursions were not reported. Data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1808USA007644.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Product storage error
Clinical narrative: Information was received from a licensed practical nurse referring to a 4 year old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions were not reported. On 06-AUG-2018, the patient was vaccinated public funds at a private doctor's office/hospital with improperly stored doses of PROQUAD (lot # R002935, expiry date unknown) subcutaneously in the left arm and KINRIX (lot # 53NBZ, expiry date unknown) intramuscularly in the right deltoid. The patient previously received one dose of PROQUAD and "4 doses of DTaP and 3 doses of IPV". No prescription treatment was required for the experience. The temperature and time frame the vaccines exposed were unknown. Data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1808USA007644.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a pediatric patient of unknown age and gender. Information on patient's pertinent medical history and drug reactions/allergies were not reported. On 13-AUG-2018, the patient was vaccinated with an adult dose of VAQTA 50/1.0 U/ml injection (dose and route of administration were not reported) (lot # N032753 and expiry date: 23-MAR-2019) instead of a pediatric dose (Drug administered to patient of inappropriate age) for prophylaxis. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1808USA006495:
Sex: F
Vaccine: HEPA
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report was received from a physician via daughter of a nurse and field employee referring to a female patient of unknown age. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with VAQTA (strength, dose, route of administration, lot # and expiry date were not reported) for prophylaxis. On an unknown date, the patient experienced arm sore after Hepatitis A vaccine was administered. The adverse event was filed since VAQTA could not be ruled out. It was unknown if treatment was given for the event or if lab diagnostics or studies were performed. It was unknown whether the patient sought medical attention for the event. On an unknown date, the outcome of pain in extremity was recovered/resolved. Causality assessment was not provided. There was no product quality complaint (PQC) reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2018 the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # M039060 with expiration date: 22-MAY-2018 (dose was not reported), intramuscularly for prophylaxis (expired product administered). No adverse effects reported. This is one of the two cases received from the same reporter.; Sender's Comments: US-009507513-1808USA008371:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2018 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # N011491 with expiration date: 11-APR-2018) (dose was not reported), intramuscularly for prophylaxis (expired product administered). No adverse effects reported. This is one of the two cases received from the same reporter. Sender's Comments: US-009507513-1808USA008168.
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a 20-year old female patient. The patient's concurrent conditions, medical history, concomitant medications and drug allergies were not reported. On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) reconstituted with sterile diluent (MERCK) for prophylaxis (dosing details, anatomical location, lot# and expiry date were not reported). On 10-AUG-2018 (reported as "a week ago"), the patient experienced white rash. On an unknown date, the patient came in to the physician office with a white rash and subsequently was hospitalized (in an unknown hospital) for 4 days. The physician had determined the rash as chickenpox. An AE was filed because the physician mentioned that he believed the patient had probably received varicella virus vaccine live (Oka/Merck) at some point. Outcome of the event varicella was reported as recovered. Causality assessment was considered as related to varicella virus vaccine live (Oka/Merck). No Product Quality Complaint (PQC) was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 23-DEC-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 11-MAY-2016, the patient was treated at a hospital by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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: 10.0
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patient's identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 10 year old patient (gender not provided) who on 03-JAN-2018, was vaccinated with improperly stored dose of ROTATEQ, orally, lot number: N011648 and expiration date: 01-DEC-2018, (strength, dose and frequency were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Sender's Comments: US-009507513-1801USA008060.
Age: 16.0
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 patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) (product storage error) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patients identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 16 year old patient (gender not provided) who on 23-DEC-2017, was vaccinated with improperly stored dose of GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020), (strength, dose, frequency and route of administration were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Sender's Comments: US-009507513-1801USA008060.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patient's identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 6 month old patient (gender not provided) who on 03-JAN-2018, was vaccinated with improperly stored dose of ROTATEQ, orally, lot number: N011648 and expiration date: 01-DEC-2018, (strength, dose and frequency were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Sender's Comments: US-009507513-1801USA008060.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) (product storage error) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patients identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 11 year old patient (gender not provided) who on 23-DEC-2017, was vaccinated with improperly stored dose of of GARDASIL 9 lot number: N021475 and expiration date: 31-JAN-2020, (strength, dose, frequency and route of administration were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Sender's Comments: US-009507513-1801USA008060.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) (product storage error) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patients identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 13 year old patient (gender not provided) who on 03-JAN-2018, was vaccinated with improperly stored dose of of GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020), (strength, dose, frequency and route of administration were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Sender's Comments: US-009507513-1801USA008060.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) (product storage error) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patients identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 16 year old patient (gender not provided) who on 02-JAN-2018, was vaccinated with improperly stored dose of GARDASIL 9, lot number: N021475 and expiration date: 31-JAN-2020, (strength, dose, frequency and route of administration were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Sender's Comments: US-009507513-1801USA008060.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) (product storage error) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patients identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 17 year old patient (gender not provided) who on 29-DEC-2017, was vaccinated with improperly stored dose of GARDASIL 9 lot number: N021475 and expiration date: 31-JAN-2020, (strength, dose, frequency and route of administration were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported.; Sender's Comments: US-009507513-1801USA008060:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) (product storage error) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patients identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 11 year old patient (gender not provided) who on 26-DEC-2017, was vaccinated with improperly stored dose of GARDASIL 9 lot number: N021475 and expiration date: 31-JAN-2020, (strength, dose, frequency and route of administration were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported.; Sender's Comments: US-009507513-1801USA008060:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) (product storage error) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patients identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 14 year old patient (gender not provided) who on 26-DEC-2017, was vaccinated with improperly stored dose of GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020), (strength, dose, frequency and route of administration were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Sender's Comments: US-009507513-1801USA008060.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patient's identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 1 month old patient (gender not provided) who on 03-JAN-2018, was vaccinated with improperly stored dose of ROTATEQ, orally, lot number: N011648 and expiration date: 01-DEC-2018, (strength, dose and frequency were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Sender's Comments: US-009507513-1801USA008060.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Prolonged Pain at site of injection.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Muscle spasms, Pyrexia
Clinical narrative: Severe shaking/shivering in the core body, some muscle cramping in arms and legs, red swelling at injection site. Patient reported feeling feverish, but when temperature was taken, there was no fever. Severe shivering lasted approximately 1 hour, then symptoms subsided except for the red swollen injection site, which lasted 3 days.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Tremor
Clinical narrative: Severe shaking/shivering in the core body, some muscle cramping in arms and legs, red swelling at injection site. Patient reported feeling feverish, but when temperature was taken, there was no fever. Severe shivering lasted approximately 1 hour, then symptoms subsided except for the red swollen injection site, which lasted 3 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Patient received 4 year old vaccines. Over the next 3 days, developed worsening redness and swelling at vaccine injection site. Patient seen in clinic on 7/19/2018 and was diagnosed with R thigh cellulitis. He was prescribed cephalexin. He showed improvement in symptoms by follow-up the next day 7/20/2018.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Emotional disorder, Regressive behaviour, Speech disorder
Clinical narrative: Child stopped being verbal. Stopped showing emotion besides crying contantly. Stopped smiling, cooing, babbling.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased, Stomatitis
Clinical narrative: Running a temp of 99.5-100.5 and on Aug 24th had sores in her mouth.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red raised bumps at site of MMRV vaccine. Developed approx. 16  days post vaccine. No other problems. Referred to Dr.'s for evaluation.
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 2016, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for prevention of shingles (dose, route, and lot # not provided).The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2016, the patient was treated at for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9, PPV
Symptoms: Syncope
Clinical narrative: Syncope 24hrs. after vaccines given.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Seizure, Unresponsive to stimuli, Vomiting
Clinical narrative: Pt became unresponsive and appeared to be having a seizure and then she became conscious again and vomited. Pt was sent via ambulance to the ER for further evaluation.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Nausea, Pyrexia
Clinical narrative: This was second shingles shot, 10 wks after first shot. No reactions to first shot. Second shot, woke up at 5am with headache, by 9am nauseated stomach, and arms and legs aching, fever of 100.5.  Took 2 TYLENOL and fever broke about 2pm. Aching and nausea stopped about 6pm. Headache lasted till next morning. Nothing after that.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea vomiting fever.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Rash, Rash erythematous, Rash pruritic, Skin discolouration
Clinical narrative: Large area of red rash--itchy, painful--on both upper arms, upper thighs, abdomen (below the navel) front and sides; lesser irritation on back of neck.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Contusion, Urticaria
Clinical narrative: Hives started the next day along with bruising along his waistband and tops of his socks.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Burning on administration, afterwards severe pain in upper arm and myalgia in arms, back and legs. Continues over 48 hours after administration.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test normal, Chest X-ray normal, Chills, Computerised tomogram thorax normal, Dyspnoea
Clinical narrative: Vaccine received at 27 weeks 2 days pregnant. Baby's due date is 10/27/2018. This is my second pregnancy. I had this same vaccine during my first pregnancy with no reactions. I did receive the vaccine a few weeks later with pregnancy #1 around 32 weeks I believe. I have also had this vaccine when I was not pregnant previously with no reactions. I woke up 7/31/18 with body aches, chills, low grade fever 99.1 orally, fatigue, and overall just feeling miserable and flu like. I took Tylenol about every 4 hours and the symptoms subsided. These flu symptoms were gone the next day. However, I developed different symptoms later in the day. Later that same day 7/31/18 around 5pm I noticed I was increasing fatigued (more than the morning) and winded with very minimal activity. My heart rate would increase to about 130 and I was short of breath/winded with very light activity such as walking 15 feet at a very slow pace. I would have to stop and sit down and rest for a few mins and my heart rate would come down and I could start again. Activity such as doing a load of laundry or washing the dishes caused in increase in HR/SOB as well which was not the case prior even being pregnant. 8/1/18 the elevated heart rate and shortness of breath continued and prompted a trip to the ED. After multiple tests it was determined I had a likely inflammatory reaction to the Tdap vaccine. These symptoms finally subsided 8/12/2018. I was told to increase hydration and take it easy. If it would have persisted a beta blocker was the next step but I did not need that.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Exposure during pregnancy, Fatigue
Clinical narrative: Vaccine received at 27 weeks 2 days pregnant. Baby's due date is 10/27/2018. This is my second pregnancy. I had this same vaccine during my first pregnancy with no reactions. I did receive the vaccine a few weeks later with pregnancy #1 around 32 weeks I believe. I have also had this vaccine when I was not pregnant previously with no reactions. I woke up 7/31/18 with body aches, chills, low grade fever 99.1 orally, fatigue, and overall just feeling miserable and flu like. I took Tylenol about every 4 hours and the symptoms subsided. These flu symptoms were gone the next day. However, I developed different symptoms later in the day. Later that same day 7/31/18 around 5pm I noticed I was increasing fatigued (more than the morning) and winded with very minimal activity. My heart rate would increase to about 130 and I was short of breath/winded with very light activity such as walking 15 feet at a very slow pace. I would have to stop and sit down and rest for a few mins and my heart rate would come down and I could start again. Activity such as doing a load of laundry or washing the dishes caused in increase in HR/SOB as well which was not the case prior even being pregnant. 8/1/18 the elevated heart rate and shortness of breath continued and prompted a trip to the ED. After multiple tests it was determined I had a likely inflammatory reaction to the Tdap vaccine. These symptoms finally subsided 8/12/2018. I was told to increase hydration and take it easy. If it would have persisted a beta blocker was the next step but I did not need that.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Heart rate increased, Inflammation, Influenza like illness, Pain
Clinical narrative: Vaccine received at 27 weeks 2 days pregnant. Baby's due date is 10/27/2018. This is my second pregnancy. I had this same vaccine during my first pregnancy with no reactions. I did receive the vaccine a few weeks later with pregnancy #1 around 32 weeks I believe. I have also had this vaccine when I was not pregnant previously with no reactions. I woke up 7/31/18 with body aches, chills, low grade fever 99.1 orally, fatigue, and overall just feeling miserable and flu like. I took Tylenol about every 4 hours and the symptoms subsided. These flu symptoms were gone the next day. However, I developed different symptoms later in the day. Later that same day 7/31/18 around 5pm I noticed I was increasing fatigued (more than the morning) and winded with very minimal activity. My heart rate would increase to about 130 and I was short of breath/winded with very light activity such as walking 15 feet at a very slow pace. I would have to stop and sit down and rest for a few mins and my heart rate would come down and I could start again. Activity such as doing a load of laundry or washing the dishes caused in increase in HR/SOB as well which was not the case prior even being pregnant. 8/1/18 the elevated heart rate and shortness of breath continued and prompted a trip to the ED. After multiple tests it was determined I had a likely inflammatory reaction to the Tdap vaccine. These symptoms finally subsided 8/12/2018. I was told to increase hydration and take it easy. If it would have persisted a beta blocker was the next step but I did not need that.