chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to an unspecified number of unspecified patients of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not reported. On an unknown dates, patients were vaccinated with improperly stored (temperature 47.1 F for 10 minutes, because of data logger) MMR II injection, lot # K024824, expiry date, 02-DEC-2016 (dose, frequency and route of administration not reported). No previous temperature excursion was reported. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. GARDASIL 9 and GARDASIL appeared on the product list as temperature stability questions were asked, however, no doses of improperly stored GARDASIL 9 or GARDASIL were administered to patients. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with ZOSTAVAX refrigerated vial (lot#, expiration date, strength, dose, anatomical location and route of administration were not reported). On an unknown date, about a week after getting the vaccine, the patient experienced injection site reaction. The patient was treated with hydrocortisone and the event was considered as not serious. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unknown number of patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. The healthcare worker reported that on unspecified dates since 15-OCT-2015 the patients were vaccinated with doses of VAQTA (dose and route not reported, lot # L023232 with expiration date 25-FEB-2017), which were exposed to the temperatures outside of the recommended range (temperature: 31F and time frame: 838 hours 59 minutes). The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unknown number of patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. The healthcare worker reported that on unspecified dates since 15-OCT-2015 the patients were vaccinated with doses of RECOMBIVAX HB (dose and route not reported, lot # L027733 with expiration date 13-SEP-2017), which were exposed to the temperatures outside of the recommended range (temperature: 31F and time frame: 838 hours 59 minutes). The reporter was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. This is one of the several reports from the same source. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to be rHA. Follow up information was received on 12-FEB-2016, from health professional regarding a 4 year old female patient. On 17-DEC-2015, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site inflammation, Injection site swelling, Injection site vesicles
Clinical narrative: This spontaneous report as received from a 55 year old male patient regarding himself. Patient's current conditions, pertinent medical history and drug reactions/allergies were not specified. On 12-FEB-2016, the patient was vaccinated with ZOSTAVAX route subcutaneous (strength, dose, lot# and expiration date was not provided). Concomitant therapies included an unspecified cholesterol medicine. On 13-FEB-2016, after vaccination the patient developed a "red inflamed area that looked like blisters" at the vaccine injection site that had "spread up the underside of the left arm toward the elbow and up toward the left shoulder". On 13-FEB-2016, the patient developed swelling and "warmth to touch" at the injection site. On 13-FEB-2016, the patient had experienced "chills" and had an unspecified fever. The patient sought medical attention for the events and had an office visit for the treatment. The outcome of the adverse events was reported as not recovered. Causality assessment was not provided. No product quality complaint (PQC) was involved. No other information was provided. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report as received from a 55 year old male patient regarding himself. Patient's current conditions, pertinent medical history and drug reactions/allergies were not specified. On 12-FEB-2016, the patient was vaccinated with ZOSTAVAX route subcutaneous (strength, dose, lot# and expiration date was not provided). Concomitant therapies included an unspecified cholesterol medicine. On 13-FEB-2016, after vaccination the patient developed a "red inflamed area that looked like blisters" at the vaccine injection site that had "spread up the underside of the left arm toward the elbow and up toward the left shoulder". On 13-FEB-2016, the patient developed swelling and "warmth to touch" at the injection site. On 13-FEB-2016, the patient had experienced "chills" and had an unspecified fever. The patient sought medical attention for the events and had an office visit for the treatment. The outcome of the adverse events was reported as not recovered. Causality assessment was not provided. No product quality complaint (PQC) was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 13-NOV-2015, the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly, lot # J007354 and expiration date: 20-FEB-2016. On 01-MAR-2016, the patient received an expired dose of GARDASIL 0.5 ml, intramuscularly, lot # J007354 and expiration date: 20-FEB-2016 as the second dose of the vaccination series. There were no adverse effects reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 17-DEC-2015 the patient was vaccinated with the first dose of GARDASIL (dose, lot# and route unknown). On 01-MAR-2016 the patient was vaccinated with the second dose of GARDASIL (lot # L006549, dose and route unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 12-FEB-2016, the patient was vaccinated with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash
Clinical narrative: This spontaneous report was received from a physician via an other company representative and refers to a female non-pregnant patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously (anatomical location, dose number, lot number and expiration date were not reported). On an unknown date, right after ZOSTAVAX injection (also reported as immediately), the patient broke out in a rash from her chest to her neck and experienced extreme swelling at the injection site. The patient did not seek medical attention as the event occurred at the physician's office. It was not reported if any treatment was given for the event and if any lab diagnostic studies were performed. Product quality complaint was not involved. Company representative reported that the physician declined Varicella zoster virus (VZV) analysis. The outcome of the events was reported as recovering. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from two healthcare workers refers to a 3 month old patient of unknown gender. Pertinent medical history and drug reactions/allergies were not reported. On 18-FEB-2016 the patient was inadvertently vaccinated with VAQTA (dose was not reported, lot # was reported as L038018 and expiration date was reported as 13-SEP-2017) intramuscularly (inappropriate schedule of drug administration). Concomitant drug was not reported. No adverse event was reported. Lot # L038018 was invalid for VAQTA. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Exposure via direct contact, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a pharmacist referring to another male pharmacist of unknown age. The pharmacist had ZOSTAVAX powder (lot # L036454, expiration date: 22-DEC-2016) spill on his hands due to the vial being broken. No adverse effects were being reported. Product quality complaint (PQC) was filed. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to be rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 4 year old male patient. On 27-JAN-2016, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient tab, product tab, event tab and narrative were updated.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and a healthcare worker refers to a 5 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to be rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 5 year old male patient. On 30-NOV-2015, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient tab, product tab, event tab and narrative were updated.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and a healthcare worker and refers to a 4 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Exposure during pregnancy, Hallucination, Pyrexia, Vomiting
Clinical narrative: Hallucinations, joint pain, fever, vomiting. Pt is 28 weeks pregnant. EDC 5/22/16.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and health professional and refers to a 4 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (rHA), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and healthcare worier and refers to a 5 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and a healthcare worker refers to a currently 4 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (rHA), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and a healthcare worker refers to a 5 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to be rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 5 year old female patient. On 10-DEC-2015, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient tab, product tab, event tab and narrative were updated.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and a healthcare worker and refers to a 4 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse regarding multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD (Merck) lot # L030586, expiry date: 10-FEB-2017 (dose, route and frequency: unknown). No adverse effects were reported. There was no product quality complaints (PQC). This is one of the several reports from the same reporter. Follow up information was received on 30-DEC-2015. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 5 year old male patient. On 23-NOV-2015, the patient was vaccinated with PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient, product, event and narrative were updated.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and health professional and refers to a 4 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-DEC-2015, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and health professional and refers to a 5 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medial history provided. On 20-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. This is one of the several reports from the same source. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to be rHA. Follow up information was received on 12-FEB-2016, from health professional regarding a 4 year old female patient. On 09-NOV-2015, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse and a healthcare worker refers to a 4 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-NOV-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) recombinant human albumin (rHA), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 12-FEB-2016, the patient was vaccinated with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route), which was exposed to temperature outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse regarding multiple patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD lot # L030586, expiry date: 10-FEB-2017 (dose, route and frequency: unknown). No adverse effects were reported. There was no product quality complaints (PQC). This is one of the several reports from the same reporter. Follow up information was received on 30-DEC-2015. Lot number L030586 has been verified to be a valid lot number for PROQUAD. Albumin status was verified to rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 11 year old (also reported as 13 year old) female patient. On 10-JUN-2013, the patient was vaccinated with PROQUAD. This is one of the several reports from the same source. Additional information has been requested. Patient, product, event and narrative were updated.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications and drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (lot# L018351, expiration date 11-AUG-2017, dose, anatomical location and route of administration were not reported). The vaccine was exposed to the temperature 9 Celsius degree for 10 minutes. No previous temperature excursion was reported. No adverse symptoms reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse regarding multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD (Merck) lot # L030586, expiry date: 10-FEB-2017 (dose, route and frequency: unknown). No adverse effects were reported. There was no product quality complaints (PQC). This is one of the several reports from the same reporter. Follow up information was received on 30-DEC-2015. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 5 year old female patient. On 17-NOV-2015, the patient was vaccinated with PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient, product, event and narrative were updated.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse regarding multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD (Merck) lot # L030586, expiry date: 10-FEB-2017 (dose, route and frequency: unknown). No adverse effects were reported. There was no product quality complaints (PQC). This is one of the several reports from the same reporter. Follow up in formation was received on 30-DEC-2015. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 4 year old female patient. On 16-NOV-2015, the patient was vaccinated with PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient, product, event and narrative were updated.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. The patient did not have any concurrent conditions, concomitant therapies, medical history, known drug reactions or allergies. On 21-FEB-2016, the patient was vaccinated with a dose of ZOSTAVAX lot # reported as L039096, expiration date 08-JAN-2017 (dose and route of administration were not reported). On 22-FEB02916, the patient developed a 3 inch by 2 inch rash at the injection site. The patient sought medical attention by called the pharmacist. The outcome of the rash at the injection site and the relatedness between the event and ZOSTAVAX were not reported. Additional information is not expected as there was no consent for follow up.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On approximately 15-FEB-2016 (reported as about 2 weeks ago), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiry date, dose, route of administration and anatomical location not reported). On the same date, the patient was vaccinated with an unspecified influenza virus vaccine. On an unknown date in February 2016, the patient experienced what appeared to look like shingles; not at the injection site. The rash was spread over the arm, torso, and on the lower chest. The rash looked like vesicular lesions, no particular dermatome. There was no rash on the lower extremities. On 29-FEB-2016, the patient presented with these symptoms in the office. The patient did not recover from the adverse event at the time of reporting. The relatedness between the adverse event and ZOSTAVAX was not provided. Additional information is not expected as there was no consent for follow-up.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to be rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 4 year old male patient. On 11-FEB-2016, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient tab, product tab, event tab and narrative were updated.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse regarding multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD (Merck) lot # L030586, expiry date: 10-FEB-2017 (dose, route and frequency: unknown). No adverse effects were reported. There was no product quality complaints (PQC). This is one of the several reports from the same reporter. Follow up information was received on 30-DEC-2015. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 4 year old female patient. On 10-NOV-2015, the patient was vaccinated with PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient, product, event and narrative were updated.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with a total of 5 doses (unspecified in series) of improperly stored VAQTA, lot no. L048460, expiration date-14-JAN-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature was 58 F, time frame was 72 hours, there was no previous temperature excursion and call was because of data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of PROQUAD (Merck) (dose and route were not reported, lot # L030586, expiry date: 10-FEB-2017). There was no adverse effects reported. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was rHA. Follow up information was received on 12-FEB-2016, regarding a 4 year old male patient. On 11-NOV-2015, the patient was vaccinated with a dose of PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse regarding multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD (Merck) lot # L030586, expiry date: 10-FEB-2017 (dose, route and frequency: unknown). No adverse effects were reported. There was no product quality complaints (PQC). This is one of the several reports from the same reporter. Follow up information was received on 30-DEC-2015. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 4 year old male patient. On 23-DEC-2015, the patient was vaccinated with PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient, product, event and narrative were updated.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 16-FEB-2016, the patient was vaccinated with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route), which was exposed to temperature outside of the recommended range. There were not concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse regarding multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD (Merck) lot # L030586, expiry date: 10-FEB-2017 (dose, route and frequency: unknown). No adverse effects were reported. There was no product quality complaints (PQC). This is one of the several reports from the same reporter. Follow up information was received on 30-DEC-2015. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 4 year old male patient. On 10-NOV-2015, the patient was vaccinated with PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient, product, event and narrative were updated.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with a total of 5 dose (unspecified in series) of improperly stored RECOMBIVAX HB, lot # L0428646, expiration date 15-SEP-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature was 58 F, time frame was 72 hours, there was no previous temperature excursion and call was because of data logger. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse regarding multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PROQUAD (Merck) lot # L030586, expiry date: 10-FEB-2017 (dose, route and frequency: unknown). No adverse effects were reported. There was no product quality complaints (PQC). This is one of the several reports from the same reporter. Follow up information was received on 30-DEC-2015. Lot number L030586 has been verified to be a valid lot number for PROQUAD (Merck). Albumin status was verified to rHA. Follow up information was received on 12-FEB-2016 from a healthcare worker regarding a 4 year old male patient. On 11-JAN-2016, the patient was vaccinated with PROQUAD (Merck). This is one of the several reports from the same source. Additional information has been requested. Patient, product, event and narrative were updated.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: 5.5 cm x 5.5 cm erythematous annular area on back of left arm, warm to touch, minimally tender. Outline drawn around area. Pt to take BENADRYL and use cold compress if needed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Mom called 2/18/16 to say that patient had redness, hard swollen left arm where injection was given. PROQUAD was given (L) arm. Mom states she called dr office and they told her to give him BENADRYL and apply cold compress to area and if not any better by Friday 2/19/16 to bring the min to MD office, mom to notify DOH of any action taken.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Mom called 2/18/16 to say that patient had redness, hard swollen right and left arm where injections were given KINRIX given (L) deltoid PROQUAD (R) arm. She stated she called dr and they told her to give BENADRYL and apply cool compresses and if not any better by Friday 2/19/16 - MD office to see pt. Mom states patient gets "cellulitis with mosquito bites was not told of this during visit. Mom to call DOH of any action taken.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Localized redness, swelling, and warmth to left deltoid - area where vaccine was administered. Placed on antibiotic tx.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right thigh swelling and redness shortly after vaccine was administered.
Age: 0.59
Sex: M
Vaccine: DTAP, RV5
Symptoms: Muscle spasms
Clinical narrative: Very brief spasms possibly partial seizure noticed by mother hours after vaccine administration and next day (s).
Age: 60.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cellulitis, Local reaction
Clinical narrative: Case number PHHY2016US007806, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 605603) website on 18 Jan 2016. This case also contains QA reference number: 1011649. This report refers to a 60 years old female patient. Past medical history included as asthma, diabetes type II, hyperlipidemia, hypothyroidism and no known drug allergies (NKDA). Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515601) into left arm, intramuscularly and also vaccinated with ADACEL vaccine (other manufacturer, batch number: U52478A) into right arm, intramuscularly, both on 23 Oct 2015. On 26 Oct 2015, the patient experienced local reaction (cellulitis symptoms) developed 01 to 02 days after injection of KEFLEX (other manufacture, batch number: not reported). The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported. The seriousness assessment of cellulitis was upgraded to medically significant based on the source document. The quality assurance department reported that, batch review report (reference number: 1011649) received from quality assurance department on 29 Feb 2016: Based on the document review, it was stated that the concerned FLUVIRIN, batch number: 1515601, was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No anomalies were noted during this review. Non significant follow up report from the QA department (QA reference number: 1011649) received on 29 Jan 2016: Updated QA reference number only. Follow up report received from a Quality Assurance Department (QA reference number: 1011649) on 29 Feb 2016: Updated batch review report (Conclusion added).
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anxiety, Dizziness, Dizziness postural, Dysaesthesia, Dyspnoea
Clinical narrative: Initial unsolicited report received from a Physician via partner company (Novartis) (under reference number- PHHY2015US173497) on 14 January 2016. This case involves 54-year-old male patient who was vaccinated with a dose of Fluzone (batch number, route and site of administration not reported) on 21 September 2015. The patient's medical history includes pump implanted on 09 March 2005 and 05 December 2011, dialysis, inguinal lobectomy in 2009 and neck surgery in 2014, quitted tobacco in 2009, spinal cord injury, anemia necrotizing enterocolitis, benign hypertension, chronic kidney disease stage three, diabetes type II NIDDM (non-insulin dependent diabetes mellitus), diabetes type II uncontrolled, quality insulin dependent, esophageal reflux, hypertension, kidney disease ben without chronic kidney disease, bronchogenic, obstructive sleep apnea, other constipation neurogenic bowel, panic disorder (episodic paroxysmal anxiety) without agoraphobia, paraplegia, complete with spasticity of muscles, paraplegia complete with spasm, pressure ulcer, pressure ulcer of unspecified site stage 1 on scrotum, pressure ulcer stage intravenous left ischial tuberosity, renal failure on dialysis, renal osteodystrophy, type 2 diabetes mellitus with other specified complication unspecified kidney failure on dialysis, panic disorder episodic paroxysmal anxiety without agoraphobia, paraplegia, complete thoracic 4, rarely drank alcohol, never used illegal drugs and had drug allergy to Septra and Metformin, hernia, lymph node excision, cervical spinal stenosis, femur fracture, spinal cord injury and vaccination with Fluvirin injection on 12 December 2013 and lung cancer in 2009. The patient's concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced anxiety (2 weeks prior) daily, the length of episode was 05 minutes, deep breathing, and avoidance behavior, dizziness with position change, dyspnea, lightheadedness and sweating, granulation tissue at his catheter insertion site, skin lesion, hypoalbuminemia. The patient denied diaphoresis, feeling of dread and palpitations. The patient was hospitalized for 11 months. Laboratory data and corrective treatment were not reported. The patient was not recovered from event anxiety and event of deep breathing, and avoidance behavior, dizziness with position change, dyspnea, and lightheadedness and sweating, granulation tissue at his catheter insertion site, skin lesion, hypoalbuminemia were not reported. List of documents held by sender: none. Sender's Comments: Anxiety, excessive granulation tissue, skin lesion, Social avoidant behavior, hypoalbuminemia, Are unlisted with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE but dizziness postural is listed. However Concomitant medication, Concurrent condition and family history are needed to complete this case.