chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLUC3
Symptoms: Eye pain, Headache, Migraine, Visual impairment
Clinical narrative: Case number PHHY2016US035307, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 617912) on 15 Mar 2016. This report refers to a 58 years old female patient. Historical conditions included transverse myelitis, fibromyalgia and COPD (chronic obstructive pulmonary disease). The concomitant medication included is gabapentin, diltiazem hydrochloride, pramipexole dihydrochloride, clonazepam; metoprolol tartrate, topiramate, duloxetine hydrochloride, dihydrochloride; tizanidine hydrochloride, meloxicamnexiucam, SYMBICORT, VENTOLIN, Low dose baby Aspirin; and alprazolam. The patient was vaccinated with FLUCELVAX (seasonal influenza vaccine, batch number: not reported) on 27 Oct 2015. On 09 Nov 2015, she had sharp pain in her temple, eye and a black spot in vision. She also had terrible migraines along with the sharp pains in the temple. It just continued to progress and the pain and the black spot continued to grow. The outcome of the events was unknown. The seriousness of the events was reported as non serious and causality was not reported.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Case number PHHY2016US037324, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 620467) website on 18 Mar 2016. This report refers to a 01-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported), hepatitis A (manufacturer unknown and batch number: not reported), measles, mumps and rubella vaccine (manufacturer unknown and batch number: not reported) and varicella vaccine (manufacturer unknown and batch number: not reported) all on 12 Jan 2016. On 22 Jan 2016, the patient experienced raised red welts, about the size of nickel near the injection site on right thigh. The outcome of the events was unknown. The seriousness of the events vaccination site erythema and vaccination site urticaria was reported as non serious and not reported for the event inappropriate age at vaccine administration. The causality of the event was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: Case number PHHY2016US115338 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 635499) on 23 Aug 2016. This report refers to a female patient whose age was not reported. Past medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. After vaccination, the patient experienced swelling. The outcome, seriousness and causality of the events were not reported.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia
Clinical narrative: Case number PHHY2016US116197, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 635659) website on 23 Aug 2016. This report refers to a 60 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza (manufacturer unknown and batch number: not reported) on an unknown date. After vaccination, the patient experienced facial numbness. The outcome, seriousness and causality of the event was not reported.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Computerised tomogram, Full blood count, Immune thrombocytopenic purpura, Immunoglobulin therapy, Mouth haemorrhage
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of idiopathic thrombocytopenic purpura in a 61-year-old female patient who received FLULAVAL QUADRIVALENT. On 2nd October 2016, the patient received the 1st dose of FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 6th October 2016, 4 days after receiving FLULAVAL QUADRIVALENT, the patient experienced idiopathic thrombocytopenic purpura (serious criteria hospitalization, GSK medically significant and life threatening) and platelets decreased (serious criteria hospitalization and life threatening). On an unknown date, the outcome of the idiopathic thrombocytopenic purpura and platelets decreased were recovering/resolving. The reporter considered the idiopathic thrombocytopenic purpura and platelets decreased to be possibly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. The patient had not received any concomitant medications. The pharmacist reported that the patient returned to pharmacy to report after receiving the FLULAVAL vaccine she was hospitalized for 5 days due to a platelet count below 10,000. At the time of reporting, the patient was out of the hospital and doing well. The batch number of the vaccine and site of vaccination were unknown. The pharmacist was not able to access the record during the call to provide all specifics.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Petechiae, Platelet count decreased, Platelet transfusion, Tongue blistering
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of idiopathic thrombocytopenic purpura in a 61-year-old female patient who received FLULAVAL QUADRIVALENT. On 2nd October 2016, the patient received the 1st dose of FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 6th October 2016, 4 days after receiving FLULAVAL QUADRIVALENT, the patient experienced idiopathic thrombocytopenic purpura (serious criteria hospitalization, GSK medically significant and life threatening) and platelets decreased (serious criteria hospitalization and life threatening). On an unknown date, the outcome of the idiopathic thrombocytopenic purpura and platelets decreased were recovering/resolving. The reporter considered the idiopathic thrombocytopenic purpura and platelets decreased to be possibly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. The patient had not received any concomitant medications. The pharmacist reported that the patient returned to pharmacy to report after receiving the FLULAVAL vaccine she was hospitalized for 5 days due to a platelet count below 10,000. At the time of reporting, the patient was out of the hospital and doing well. The batch number of the vaccine and site of vaccination were unknown. The pharmacist was not able to access the record during the call to provide all specifics.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Immune thrombocytopenic purpura, Platelet count decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of idiopathic thrombocytopenic purpura in a 61-year-old female patient who received FLULAVAL QUADRIVALENT. On 2nd October 2016, the patient received the 1st dose of FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 6th October 2016, 4 days after receiving FLULAVAL QUADRIVALENT, the patient experienced idiopathic thrombocytopenic purpura (serious criteria hospitalization, GSK medically significant and life threatening) and platelets decreased (serious criteria hospitalization and life threatening). On an unknown date, the outcome of the idiopathic thrombocytopenic purpura and platelets decreased were recovering/resolving. The reporter considered the idiopathic thrombocytopenic purpura and platelets decreased to be possibly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. The patient had not received any concomitant medications. The pharmacist reported that the patient returned to pharmacy to report after receiving the FLULAVAL vaccine she was hospitalized for 5 days due to a platelet count below 10,000. At the time of reporting, the patient was out of the hospital and doing well. The batch number of the vaccine and site of vaccination were unknown. The pharmacist was not able to access the record during the call to provide all specifics.
Age: 59.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Induration, Local swelling, Mass, Pain
Clinical narrative: Patient had redness and swelling at the injection site that spread below the elbow.  The patient's physician diagnosed her with cellulitis.
Age: 59.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin warm
Clinical narrative: Patient had redness and swelling at the injection site that spread below the elbow.  The patient's physician diagnosed her with cellulitis.
Age: 59.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Patient had redness and swelling at the injection site that spread below the elbow.  The patient's physician diagnosed her with cellulitis.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV1
Symptoms: Choking, Cough, Diarrhoea, Dyspnoea, Nasal congestion
Clinical narrative: Diarrhea immediately after getting home, nasal congestion beginning 02/01/2017 around 8:00 AM that led to choking/coughing, struggling to breath.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Initial solicited pregnancy report and SAE report received on 18 January 2017 from a health care professional participating in a study. This is a prospective pregnancy registry case. This case involves a 42-year-old female subject who had during pregnancy and had miscarriage during the study participation. The subject's medical history was not reported The date of LMP was not reported. The estimated date of delivery was not reported. The mother and father's health status was not reported. The father's age in years was not reported. The current pregnancy history was not reported. The information on subjects' previous pregnancy and maternal drug exposure were not reported. The information on subject's concomitant therapies was not reported. On 09 January 2017, 40 days after receiving a first intramuscular dose of Influenza Quadrival A-B Vaccine on 30 November 2016 (site of administration and batch number was not reported), the subject had miscarriage. The event appeared after visit was not reported. The subject's treatment for infertility was unknown. The subject had no other relevant non serious adverse event. According to the investigator the, the event of miscarriage was considered as other medically significant. The information on Lab data and prenatal testing were not reported. The subject's corrective treatment was not reported. The pregnancy outcome was reported as; the subject had miscarriage on 09 January 2017. At the time of the report, the subject did not recover from the event miscarriage. List of documents held by sender: none. Sender's Comments: A 42-year-old pregnant female subject received a dose of study vaccine (information regarding LMP, date of conception, EDD or USG findings were unknown). The subject had a miscarriage 5 weeks after receiving the study product. Based on limited available information, the sponsor assess the event as not related to study product or trial procedure.
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Dizziness, Dysgeusia, Dyspnoea, Hypertension
Clinical narrative: vision loss; difficulty breathing; numbing of the mouth; dizziness; a weird taste in her mouth; high blood pressure; Information has been received from a pharmacist referring to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot # M034766 with expiration date of 26-OCT-2017, dose and route unspecified) for prophylaxis. On an unknown date, after receiving the vaccination, the patient experienced difficulty breathing, numbing of the mouth, vision loss, dizziness, a weird taste in her mouth, and high blood pressure. The patient had to go to an unspecified emergency room. At the reporting time, the outcome of the events was unknown. The causality between the events and ZOSTAVAX was not reported. The pharmacist requested a lot check for this lot number of ZOSTAVAX. Upon internal review, vision loss was considered to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested. An investigation into the manufacture of lot(s) (M034766) was completed and confirmed that all in-process quality checks were satisfactory. The results indicated that the lot was manufactured in accordance with manufacturing site standard operating procedures. The lot was confirmed to have met the requirements for market release. Following medical review of the AE report and the Quality investigation, there were no identified concerns related to quality within the results of the investigation. Sender's Comments: US-009507513-1611USA010078: MERCK 1611USA014390: Mfr number.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral
Clinical narrative: vision loss; difficulty breathing; numbing of the mouth; dizziness; a weird taste in her mouth; high blood pressure; Information has been received from a pharmacist referring to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot # M034766 with expiration date of 26-OCT-2017, dose and route unspecified) for prophylaxis. On an unknown date, after receiving the vaccination, the patient experienced difficulty breathing, numbing of the mouth, vision loss, dizziness, a weird taste in her mouth, and high blood pressure. The patient had to go to an unspecified emergency room. At the reporting time, the outcome of the events was unknown. The causality between the events and ZOSTAVAX was not reported. The pharmacist requested a lot check for this lot number of ZOSTAVAX. Upon internal review, vision loss was considered to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested. An investigation into the manufacture of lot(s) (M034766) was completed and confirmed that all in-process quality checks were satisfactory. The results indicated that the lot was manufactured in accordance with manufacturing site standard operating procedures. The lot was confirmed to have met the requirements for market release. Following medical review of the AE report and the Quality investigation, there were no identified concerns related to quality within the results of the investigation. Sender's Comments: US-009507513-1611USA010078: MERCK 1611USA014390: Mfr number.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 year old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported.  On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (dose and route not reported) from lot # M016193 and expiry date 24-APR-2018 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments:  US-009507513-1610USA008140: US-009507513-1610USA014706: US-009507513-1610USA014705:
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 29-NOV-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (dose and route not reported) from lot # M016193 and expiry date 24-APR-2018 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014706: US-009507513-1610USA014705:
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 year old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 02-DEC-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (dose and route not reported) from lot # M016193 and expiry date 24-APR-2018 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments:  US-009507513-1610USA008140: US-009507513-1610USA014706: US-009507513-1610USA014705:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via Pfizer's field representative and refers to a 57 year old female patient. There was no information about the patient's concurrent conditions, medical history and concomitant therapy. Past drugs included HUMIRA discontinued 4 weeks before vaccination. On an unknown date, the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (reported as shingles vaccine) (dose, route, site of administration, lot # and expiration date were not reported). On an unknown date, reported as 6 weeks after vaccination, therapy with XELJANZ extended release (XR) was initiated (dose, frequency, route of administration and indication were not provided). On an unknown date (reported as 9 weeks later), the patient developed shingles. The outcome of the event was not reported. The relatedness between the event and zoster vaccine live (manufacturer unknown) was not reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 12 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, during a well check, the patient was vaccinated with PROQUAD, subcutaneously, Batch #M027637 and expiration date: 02-JUN-2018 (dose not reported); VARIVAX subcutaneously, Batch #M035140 and expiration date: 03-AUG-2018 (dose not reported) and hepatitis a vaccine, inactivated(VAQTA) intramuscularly (dose, Lot # and expiration date were not reported); all three vaccines for prophylaxis. The nurse reported that the patient received PROQUAD instead of M-M-R II. The Nurse no reported adverse effects after administration. There was no product quality complaint involved. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Information has been received from a nurse via Pfizer (Mrf. control# 2016575911) for pneumococcal 13v conj vaccine (CRM197)(PREVNAR 13), referring to a 69 year old patient of unknown gender. The patient's concurrent conditions, concomitant therapy and medical history were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced a large red area, more that the local usual reaction. The reporter asked if the patient could be vaccinated with pneumococcal PREVNAR 13. The patient had not received PREVNAR 13 at the reporting time. The outcome of the event was unknown. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP, HIBV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The patient had a "history of allergic reaction to Thimerosal". On an unknown date, reported as prior to 01-JAN-2007, the patient was vaccinated with PEDVAXHIB (dose, route of administartion, lot# and expiration were not reported) or RECOMBIVAX HB (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced allergic reaction. The pharmacist could not provide specific details about the reaction. The outcome of allergic reation was unknown. The reporter considered allergic reaction to be related to PEDVAXHIB or RECOMBIVAX HB. Additional information is not expected because there was no consent to contact the reporter.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date of the administration of GARDASIL 9 for this male (age unknown) was reported to be 1) 30-SEP-2015. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1702USA000324: US-009507513-1702USA000325: US-009507513-1702USA000326: US-009507513-1702USA000327: US-009507513-1702USA000328: US-009507513-1702USA000329: US-009507513-1702USA000330: US-009507513-1702USA000331: US-009507513-1702USA000311: US-009507513-1702USA000312: US-009507513-1702USA000313: US-009507513-1702USA000314: US-009507513-1702USA000315: US-009507513-1702USA000316: US-009507513-1702USA000317: US-009507513-1702USA000318: US-009507513-1702USA000319: US-009507513-1702USA000320: US-009507513-1702USA000321: US-009507513-1702USA000322: US-009507513-1702USA000323: US-009507513-1702USA000309: US-009507513-1702USA000310.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a 54 year old female patient reporting on herself. The patient had no pertinent medical history and drug reactions or allergies. On 17-JAN-2017, the patient was vaccinated with one dose of ZOSTAVAX injection (lot#, expiration date, dose and route of administration were not reported) for prevention of shingles. Concomitant therapies included SYNTHROID. On 18-JAN-2017, the patient noticed little bump on her arm after receiving ZOSTAVAX, at the same location. On 19-JAN-2017 (reported as "the next day"), her arm was stiff, there was redness and the bump became hard. No treatment was given for the events. The outcome of the events was reported as not recovered. The causality between the events and ZOSTAVAX was not reported. No laboratory diagnostics tests were performed. The patient did not seek medical attention. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with improperly stored doses of M-M-R II Lot#: M016234, expiration date on 31-MAR-2018 (strength, dose number, route and anatomical location were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. No product quality complaint was involved. The vaccines experienced the following temperature excursions during 20 minutes: 32°F (Fahrenheit), 36°F and 46°F; during 41 minutes: 77°F; during 1 hour and 20 minutes: freezer 5°F and 14°F. The aforementioned ones were identified due to a data logger. There was no previous temperature excursion. It was reported that the vaccines were supported. This is one of several reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided. Sender's Comments: US-009507513-1701USA012289: US-009507513-1701USA012392.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 2 unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX Lot#: M009769, expiration date on 25-FEB-2018 (strength, dose number, route and anatomical location were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. No product quality complaint was involved. The vaccines experienced the following temperature excursions during 20 minutes: 32°F (Fahrenheit), 36°F and 46°F; during 41 minutes: 77°F; during 1 hour and 20 minutes: freezer 5°F and 14°F. The aforementioned ones were identified due to a data logger. There was no previous temperature excursion. It was reported that the vaccines were supported. This is one of several reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided.; Sender's Comments: US-009507513-1701USA012391: US-009507513-1701USA012289:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring to unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the unspecified patients were vaccinated with an improperly stored doses of VARIVAX lot # M006731 expiration date 09-FEB-2018; lot # M012990 expiration date 14-MAR-2018 and lot # M034586 expiration date 27-JUL-2018 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. It was reported, that the vaccines had a temperature excursion of 9.0 Fahrenheit (F) with a time frame of 70 minutes, also, it was reported that no previously excursions occurred and a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected because the reporter did not want to be contacted. Sender's Comments: US-009507513-1701USA013127: US-009507513-1701USA008029.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring to unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the unspecified patients were vaccinated with an improperly stored doses of ZOSTAVAX lot # M018453 expiration date 28-JUN-2017 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. It was reported, that the vaccines had a temperature excursion of 9.0 Fahrenheit (F) with a time frame of 70 minutes, also, it was reported that no previously excursions occurred and a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected because the reporter did not want to be contacted.; Sender's Comments:  US-009507513-1701USA013126: US-009507513-1701USA008029:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 66 year old female patient. The patient had no relevant medical history or concomitant medications. On 28-JAN-2007, the patient was vaccinated an expired dose of ZOSTAVAX (lot # L037790, expiry date: 30-DEC-2016) for prophylaxis, because of a prescription received from the doctor. It is unknown if there was relevant lab work. Additional information has been requested.
Age: 1.75
Sex: F
Vaccine: HPV9
Symptoms: Injection site haemorrhage, Injection site swelling, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a 21 month old female patient. The patient was generally healthy and had no medical history, concurrent conditions, drug reactions/allergies and concomitant therapy reported. On 28-JAN-2017, the patient was accidentally vaccinated with a full dose of GARDASIL 9 (dose: 0.5 ml) via intramuscular route, for prophylaxis. Physician reported that on 28-JAN-2017, the patient who was supposed to be vaccinated with hepatitis a vaccine, inactivated (Manufacturer unknown), but was accidentally injected with GARDASIL 9 by a medical assistant because of logistics. He stated that GARDASIL 9 was supposed to be given to a teenager. He was present at the time of vaccination and was asked to see the child. He reported that on the same day after vaccination, the patient developed swelling and ecchymosis at injection site. No treatment was given for the adverse events. Physician mentioned that he contacted the patient's mother on 30-JAN-2017, and she informed that the patient was running around and was doing fine. Outcome of the events, swelling and ecchymosis at injection site was unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients received improperly stored doses of ROTATEQ oral liquid, orally, lot # L013206 with an expiration date of 29-JAN-2017 and lot # L033694 with an expiration date of 06-JUN-2017 (doses were not reported). No adverse effects were reported. Administered doses of vaccine underwent the temperature excursion of 9 degrees Celsius for 30 minutes which was detected by a data logger. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA014075: US-009507513-1701USA014062: US-009507513-1701USA003654.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients received improperly stored doses of VAQTA lot # M017982 with an expiration date of 13-SEP-2017 (doses and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine underwent the temperature excursion of 9 degrees Celsius for 30 minutes which was detected by a data logger. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1701USA014067: US-009507513-1701USA014062: US-009507513-1701USA003654.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: hTis initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this male (age unknown) were reported to be  1) 30-OCT-2015  and 2)  15-MAY-2016 (The date for this vaccination was also reported as 16-MAY-2015.)  Further clarification needed. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) were reported to be  1) 18-JUN-2014 and 2) 27-JUL-2016. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) were reported to be  1) 16-AUG-2016 and 2) 23-DEC-2016. [These dates were as reported. Further clarification of dates is needed.]  No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) was reported to be  1) 22-DEC-2016. [It was written next to this date "due" 22-FEB-2017.) No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this male (age unknown) were reported to be  1) 31-JUN-2012 and 2) 13-DEC-2016 (Next to this date it is written "(due)". No details provided,) No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments:  US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was  reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) were reported to be 1) 09-JUL-2016 and 2) 11-NOV-2016. [These dates were as reported. No details reported.] No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this male (age unknown) were reported to be 1) 11-AUG-2016 and 2) 24-OCT-2016. [These dates were as reported. It was also written next to the 24-OCT-2016 date (due 24-FEB-2017.) No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this patient (gender not specified) was reported as 1) 24-OCT-2016 [Date as reported. Further clarification needed.] No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this patient (gender not specified) was reported to be 17-AUG-2016. [Date as reported. No details reported.] No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this patient (gender not specified) were reported to be 1) 22-JUL-2013 and 2) 28-JUL-2014. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) was reported to be 1) 21-JUL-2015. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date of the administration of GARDASIL 9 for this male (age unknown) was reported to be 1) 31-AUG-2015. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) was reported to be 1) 15-JUL-2015. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.