chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses (temperature excursion) of GARDASIL (lot number L040459 and expiration date 06-APR-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. There was no previous temperature excursion and it was not a data logger. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored ROTATEQ lot # L027719, expiry: APR-2017 (dose and route were unknown). No adverse effects were reported. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a patient's wife refers to a currently 65-year-old male patient. The patient's concurrent conditions included indigestion. The patient's medical history was not reported. The patient was allergic to an intravenous pyelogram (IVP) dye (reported as "IBP dye"). On an unknown date in March 2013, the patient was vaccinated with a dose of ZOSTAVAX in an unspecified arm (dose, lot#, expiration date and route of administration were not reported). The patient's concomitant therapy included PRILOSEC and ZOLOFT. On an unknown dates, after receiving ZOSTAVAX, the patient experienced three to four mild shingles outbreaks. The patient did not seek medical attention. The outcome of the event was not reported. The causality assessment between the event and ZOSTAVAX was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 63-year-old female patient reporting on herself. The patient's concurrent conditions included high cholesterol and high blood pressure. The patient's medical history included chronic shingles. The patient was allergic to DILANTIN and CEFTIN. On an unknown date in March 2013, the patient was vaccinated with ZOSTAVAX in an unspecified arm (dose, route of administration, lot# and expiration date were not reported). The patient's concomitant medications included acyclovir and unspecified cholesterol and blood pressure medications. On unknown dates, after receiving ZOSTAVAX, the patient experienced seven to eight moderate shingles outbreaks. She further stated she had no specific dates, of the sporadic outbreaks. As treatment of event the patient took acyclovir, previously prescribed for her. The patient did not seek medical attention. There was no product quality complaint. The outcome of the event was not reported. The causality assessment between the event and ZOSTAVAX was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient complained of severe pain from the shoulder down to elbow. It hurt when patient moved fingers.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site infection
Clinical narrative: Pt. says developed an infxn. in the back of arm in tissue from vaccine.
Age: 37.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications, drug reactions or allergies provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of VARIVAX injection (lot# reported as L036830, expiration date 24-SEP-2017, dose, anatomical location and route of administration were not reported). No adverse events were reported. Temperature reported as 16 Fahrenheit (F), time frame 2 hours and there was no previous temperature excursion. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown dates, approximately in January 2016 (reported as between 14-JAN-2016 and 20-JAN-2016), the patients were vaccinated with an improperly stored doses of VARIVAX lot # L021215, expiration date 10-JUN-2017; lot # L001330, expiration date 13-JAN-2017; lot # L011084, expiration date 01-APR-2017 (dose and route of administration were not specified). Administered doses of the vaccine underwent temperature excursion at 43.7 Fahrenheit degrees for 94 hours and 42 minutes. No adverse effects and no previous temperature excursion were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a clinical supervisor who was a medical assistant, regarding to multiple (unspecified number patients). Patient demographics were not reported. Information on concurrent conditions, medical history and drug allergies of the patients were not reported. Illness of the patients/siblings at the time of/prior to vaccination were not reported. On an unknown date in January 2016 (at unspecified times between 09-JAN-2016 and 15-JAN-2016) the patients were vaccinated with RECOMBIVAX HB (lot # L029631, expiry date 14-AUG-2017), (lot # L018501, expiry date 22-JUN-2017), (lot # L004754, expiry date 10-NOV-2016) (dose number, dosage units, route and anatomical location not specified). Concomitant medication were not reported. On an unknown date in January 2016 (at unspecified times between 09-JAN-2016 and 15-JAN-2016), the reporter stated that unspecified number of patients received unspecified doses in series of RECOMBIVAX HB that were improperly stored. Temperature at which the vaccines were maintained was reported to be 54.1 (units not provided), time frame was 3.5 hours, no previous temperature excursions were performed. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a clinical supervisor who was a medical assistant, regarding to multiple (unspecified number) patients. Patient demographics were not reported. Information on concurrent conditions, medical history and drug allergies of the patients were not reported. Illnesses of the patients/siblings at the time of/prior to vaccination were not reported. On an unknown date in January 2016 (at unspecified times between 09-JAN-2016 and 15-JAN-2016) the patient was vaccinated with ROTATEQ (lot # L020861, expiry date 25-JAN-2017), (lot # L008057, expiry date 01-DEC-2016) (dose number, dosage units, route and anatomical location not specified). Concomitant medication were not reported. On an unknown date in January 2016 (at unspecified times between 09-JAN-2016 and 15-JAN-2016), the reporter stated that unspecified number of patients received unspecified doses of ROTATEQ that were improperly stored. Temperature at which the vaccines were maintained was reported to be 54.1 (units not provided), time frame was 3.5 hours, no previous temperature excursions were performed. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a patient of unknown age. The patient's medical history and concurrent condition was not reported. On 19-JAN-2016 the patient was vaccinated with expired dose of VAQTA lot # K008332 expiry date 15-JAN-2016 intramuscularly. The patient did not experience any adverse event. There was no product quality complaint involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse and refers to a 14 years old female patient. Concurrent conditions, medical history and concomitant medications were not provided. On 09-SEP-2015, the patient was vaccinated with first dose of GARDASIL (dose, administration route, lot #, expiration date and anatomical site were not reported). On 04-NOV-2015 the patient was vaccinated with the second dose of GARDASIL (dose, administration route, lot #, expiration date and anatomical site were not reported). On 05-JAN-2016, the patient was vaccinated with the third dose of GARDASIL lot # L037003, expiry date 25-MAY-2017 (dose, administration route and anatomical site were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. No product quality complaint (PQC) was involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Dyspnoea, Pain
Clinical narrative: This spontaneous report was received from a pharmacy student refers to a 18 year old female patient. The patient did not have any allergies/drug reactions. On an unknown date, the patient was vaccinated with GARDASIL or GARDASIL 9 (route and site of administration, dose, lot number and expiration date were not reported for both). Concomitant therapy included unspecified birth control pills. On an unknown date, approximately 40 days later, the patient developed shortness of breath, body aches and joint pain. The patient sought medical attention via contacted the pharmacy student. The outcome of the events was unknown. The relatedness between the events and the suspect therapy was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a clinical supervisor who was a medical assistant, regarding to multiple (unspecified number) patients. Patient demographics were not reported. Information on concurrent conditions, medical history and drug allergies of the patients were not reported. Illness of the patients/siblings at the time of/prior to vaccination were not reported. On an unknown date in January 2016 (at unspecified times between 09-JAN-2016 and 15-JAN-2016) the patient was vaccinated with GARDASIL 9 (lot # L018351, expiry date 11-AUG-2017), (lot # L013429, expiry date 21-JUL-2017), (lot # K026246, expiry date 28-JAN-2017) (dose number, dosage units, route and anatomical location not specified). Concomitant medication were not reported. On an unknown date in January 2016 (at unspecified times between 09-JAN-2016 and 15-JAN-2016), the reporter stated that the unspecified number of patients received unspecified doses of GARDASIL 9 that were improperly stored. Temperature at which the vaccines were maintained was reported to be 54.1 (units not provided), time frame was 3.5 hours, no previous temperature excursions were performed. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Staring
Clinical narrative: This spontaneous report as received from an office manager of a physician's office via a company representative refers to a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not mentioned by the reporter. On 07-JAN-2016 (also reported as 07-JAN-2017) the patient was vaccinated with VARIVAX (route, dose# and lot# not reported). Other suspect therapy included HAVRIX. Concomitant medication was not specified. On 07-JAN-2016, the patient experienced a staring episode after receiving VARIVAX. The nurses thought that the event was a sign of a seizure coming on and decided not to give the patient the MMR II. No treatment was given to the patient for the adverse event. The outcome of staring was unknown. Causality statement was not provided by the reporter. No further AE information reported. Product quality complaint was not filed. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blister, Herpes zoster
Clinical narrative: This spontaneous report was received from a 67 year old female patient who was reporting on herself. The patient's medical history included "many medical problems" (unspecified). Her concurrent conditions included an unspecified heart disorder, unspecified thyroid disorder and an unspecified allergy. None drug reactions/allergies were reported. In December 2014, the patient was vaccinated with the dose of ZOSTAVAX (subcutaneously; dose, lot # and expiration date were not reported). Concomitant therapies included NOROXIN, unspecified heart, allergy and thyroid pills and many unspecified medications. In April 2015, the patient experienced really bad back pain with a huge (2 inch) spot on her back and little spots around the big spot. The patient provided that the spots were blisters. The patient went to the doctor bit she could not get an immediate appointment, so she went to the hospital emergency room. She provided that she was diagnosed with shingles on an unknown date. She was treated with an unspecified type of ointment and pills. The blisters started to heal, but she was still in pain so her doctor sent her to the dermatologist. The dermatologist prescribed her an unspecified type of ointment to be used with an unspecified medication reported as Neosporin and with pain relief. The patient reported that after six months her back had healed but at the time of this report, she was still experiencing back pain. None lab diagnostics studies were performed. The outcome of the adverse event was recovering. The relatedness between the adverse event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to an unspecified patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with the dose of ZOSTAVAX injection (dose, route, lot# and expiration date were not reported), and a dose of unspecified Flu vaccine. On an unknown date, the patient experienced unspecified adverse event. The patient's present status was unspecified. The causality between the unspecified adverse event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Inappropriate schedule of drug administration, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 22 year old female non-pregnant patient. It was reported that the patient had no pertinent medical history and drug reactions or allergies. Concomitant therapies included unspecified birth control pills. On 22-FEB-2007, the patient was vaccinated with the first dose of GARDASIL (lot # reported as 0263U, expiration date August 2007) 0.5 ml, intramuscularly. On 13-MAR-2008, the patient was vaccinated with the second dose of GARDASIL (lot # reported as 1757U, expiration date 13-MAR-2008) 0.5 ml, intramuscularly. On 27-JUN-2008, the patient was vaccinated with the third dose of GARDASIL (lot # reported as 0070X, expiration date October 2010) 0.5 ml, intramuscularly. The reporter stated that the vaccines were given to the patient outside of the recommended schedule. In September 2014 and approximately July 2015 (reported as about 6 months ago), the patient's Papanicolaou (PAP) tests came back abnormal. On 22-JAN-2016, the patient received test results saying that the patient had tested positive showing for an unspecified high risk strain of human papilloma virus (HPV). It was unspecified if the patient's last two PAP test results were related with the patient's current HPV infection. It was reported that the patient did not seek any medical attention and no treatment was given for the events. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. 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 clinical supervisor who was a medical assistant, regarding to multiple (unspecified number) patients. Patient demographics were not reported. Information on concurrent conditions, medical history and drug allergies of the patients were not reported. Illness of the patients/siblings at the time of/prior to vaccination were not reported. On an unknown date in January 2016 (at unspecified times between 09-JAN-2016 and 15-JAN-2016) the patient was vaccinated with M-M-R II (lot # L011528, expiry date 03-APR-2017), (lot/batch # L015280, expiry date 30-APR-2017) (dose number dosage units, route and anatomical location not specified). Concomitant medication were not reported. On an unknown date in January 2016 (at unspecified times between 09-JAN-2016 and 15-JAN-2016), the reporter stated that unspecified number of patients received unspecified doses in series of M-M-R II that were improperly stored. Temperature at which the vaccines were maintained was reported to be 54.1 (units not provided), time frame was 3.5 hours, no previous temperature excursions were performed. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via company representative regarding a 60 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with VARIVAX (Merck) followed 1 month later by administration of ZOSTAVAX (inappropriate schedule of drug administration). No adverse event was reported. The outcome of the event was unknown. Additional information is not expected because the reporter does not wants to get contacted.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified patients of unknown age and gender. On unspecified dates, the patients were administered with M-M-R II injection (dose and route not provided, lot # L009544 with expire date of 19-MAR-2017), which was exposed to temperatures outside of the recommended range (Incorrect product storage). The conditions storage was 11 Celsius degree for 1333 hours, 41 minutes. There was no previous temperature excursion. No adverse effects have been reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified patients of unknown age and gender. On unspecified dates, the patients were administered with ROTATEQ (dose and route not provided, lot # L029934 with expire date of 01-MAY-2017), which was exposed to temperatures outside of the recommended range (incorrect product storage). The conditions storage was 11 Celsius degree for 1333 hours, 41 minutes. There was no previous temperature excursion. No adverse effects have been reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified patients of unknown age and gender. On unspecified dates, the patients were administered with GARDASIL 9 (dose and route not provided, lot# L023230 with expire date of 28-JUL-2017), which was exposed to temperatures outside of the recommended range (Incorrect product storage). The conditions storage was 11 Celsius degree for 1333 hours, 41 minutes. There was no previous temperature excursions. No adverse effects have been reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified patients of unknown age and gender. On unspecified dates, the patients were administered with GARDASIL (dose and route not provided, lot# K011325 with expire date of 08-APR-2017, K010215 with expire date of 05-MAY-2017, L040459 with expire date of 06-APR-2017), which was exposed to temperatures outside of the recommended range (incorrect product storage). The conditions storage was 11 Celsius degree for 1333 hours, 41 minutes. There was no previous temperature excursion. No adverse effects have been reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse and refers to a 18 year old male patient. Patient's concurrent condition, medical history and concomitant medications were not provided. On 09-SEP-2015, the patient was vaccinated the first dose of GARDASIL (dose, administration route, lot #, expiration date and anatomical site were not reported). On 04-NOV-2015 the patient was vaccinated with the second dose of GARDASIL (dose, administration route, lot #, expiration date and anatomical site were not reported). On 05-JAN-2016 the patient was vaccinated with the third dose of GARDASIL lot # L037003, expiry date 25-MAY-2017 (dose, administration route and anatomical site were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. No product quality complaint (PQC) was involved. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 21-JAN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L031066, expiration date 20-JAN-2016, exact dose and route of administration were not reported). The dose of vaccine was expired. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Fatigue, Nasal congestion, Pain, Productive cough
Clinical narrative: Started with fatigue; by 01/22 I was getting nasal congestion; 01/24 I started coughing and the congestion entered my chest.  Since then I have upper respiratory pain and congestion and am coughing up yellow phlegm.  Still have head congestion.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Respiratory tract congestion, Sputum discoloured, Upper respiratory tract congestion
Clinical narrative: Started with fatigue; by 01/22 I was getting nasal congestion; 01/24 I started coughing and the congestion entered my chest.  Since then I have upper respiratory pain and congestion and am coughing up yellow phlegm.  Still have head congestion.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Day after immunization given, school called mom and pt had a hive looking rash from head to toe. No respiratory distress noted, pt given BENADRYL and rash subsided. Previous flu shots did not give these results.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional regarding multiple unspecified patients of unknown age and gender. No historical or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL (HPV 4) (lot # K011325, expiry: 08-APR-2017), (incorrect product storage). No concomitant medications were reported. The improper storage temperature was 31.9 degrees Fahrenheit for a time frame of 23 hours and 30 minutes. The temperature was back in range. There was no previous temperature excursion. No adverse effects were reported. No Product Quality Complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional regarding multiple unspecified patients of unknown age. No historical or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L030868, expiry: 09-JUN-2018), (incorrect product storage). No concomitant medications were reported. The improper storage temperature was 31.9 degrees Fahrenheit for a time frame of 23 hours and 30 minutes. The temperature was back in range. There was no previous temperature excursion. No adverse effects were reported. No Product Quality Complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional regarding multiple unspecified patients of unknown age. No historical or concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot # K023537, expiry: 22-JUN-2016), (lot# L006184, expiry: 13-DEC-2016), (lot# L004466, expiry: 02-AUG-2016) (incorrect product storage). No concomitant medications were reported. The improper storage temperature was 31.9 degrees Fahrenheit for a time frame of 23 hours and 30 minutes. The temperature was back in range. There was no previous temperature excursion. No adverse effects were reported. No Product Quality Complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse refers to unspecified number of patients with unknown demographics. No medical history was reported. It was reported that since 09-DEC-2015, unspecified number of patients had been vaccinated with improperly stored ROTATEQ (dose, route, frequency: unknown). No adverse effects was reported. The excursion temperature was reported as 29.8 degrees Fahrenheit (F) for 24 hours. Outcome of excursion was reported as "not supported" and it was also reported that there was no previous temperature excursion. No product quality complaint (PQC) was involved. 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 received from a registered nurse refers to unspecified number of patients with unknown demographics. No medical history was reported. It was reported that since 09-DEC-2015, unspecified number of patients had been vaccinated with improperly stored VAQTA (dose, route, frequency: unknown, lot number: L015460, expiry date: JULY 2017). No adverse effects was reported. The excursion temperature was reported as 29.8 degrees Fahrenheit (F) for 24 hours. Outcome of excursion was reported as "not supported" and it was also reported that there was no previous temperature excursion. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (LPN) referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On multiple unspecified dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot# L001333, expiration date 13-JAN-2017) (dosage, strength and route unknown). (Temperature: -13 degree Centigrade, time frame: 402 hours 55 minutes. Two previous temperature excursions: -13 degree Centigrade for 24 hours as well as -14 degree Centigrade for 14.5 hours). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as there is no consent for contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to multiple patients of unknown age and gender. On unspecified dates the patients were vaccinated with improperly stored doses of M-M-R II (lot #K004948, expiration date 04-APR-2016, Albumin Status: rHA, dose and route unknown), which were under the temperature of 24 C with time frame reported as 838 hours. The temperature was back in range. No previous temperature excursion was reported. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. Patients' medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses (temperature excursion) of oral, ROTATEQ (lot number reported as L027726 and expiration date 10-MAY-2017, dose was not reported). Concomitant therapy was not reported. No adverse effects were reported. There was no previous temperature excursion and it was not a data logger. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 25-JAN-2016 the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (lot # J001698, expiry date 08-MAY-2014, dose, route and dose number were unspecified). Product quality complaint (PQC) was filed for mismatched lot number and expiration date on the ZOSTAVAX vial and carton. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse refers to unspecified number of patients with unknown demographics. No medical history was reported. It was reported that since 09-DEC-2015, unspecified number of patients had been vaccinated with improperly stored GARDASIL (dose, route, frequency: unknown, lot number: K011325, expiry date: 08-APR-2017). No adverse effects was reported. The excursion temperature was reported as 29.8 degrees Fahrenheit (F) for 24 hours. Outcome of excursion was reported as "not supported" and it was also reported that there was no previous temperature excursion. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning multiple unspecified patients (demographics unknown). There was no medical history or drug reaction/allergies reported. Since 30-NOV-2015, the patient were vaccinated with ZOSTAVAX lot # L011533, expiration date- 03-JUL-2016 which were exposed to temperatures outside of the recommended range, (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. This is one of the two cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a registered nurse refers to unspecified number of patients with unknown demographics. No medical history was reported. It was reported that since 09-DEC-2015, unspecified number of patients had been vaccinated with improperly stored RECOMBIVAX HB; (dose, route, frequency: unknown, lot number: L025738, expiry date: 14-AUG-2017). No adverse effects was reported. The excursion temperature was reported as 29.8 degrees Fahrenheit (degrees F) for 24 hours. Outcome of excursion was reported as "not supported" and it was also reported that there was no previous temperature excursion. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue
Clinical narrative: Extreme fatigue for 5 days could not stay awake fatigue for a further 3 weeks.
Age: 48.0
Sex: F
Vaccine: ANTH
Symptoms: Amnesia, Computerised tomogram head normal, Contusion, Drug screen negative, Electroencephalogram abnormal
Clinical narrative: 49 yo female who developed a new onset seizure disorder while out of the country with temporal association to vaccine receipt of anthrax and influenza vaccine (neither vaccine is documented). The first documented seizure episode occurred on 19 OCT 2012 and a prior undocumented suspected seizure may have occurred 6-8 weeks earlier in late August or early September 2012. She reports she received anthrax vaccine prior to the August/September event and influenza vaccine within 1 day of the October event. Her October seizure event occurred while in a class, was witnessed and history and evaluation is well documented. The patient experienced tonic clonic activity of arms, legs and trunk for 3 minutes (estimated) causing fall from chair to ground and the incident description states "her head struck the surface of the desk and she sustained a large forehead contusion and developed a large facial bruise leaving the patient with bilateral raccoon eyes and the facial hematoma." She demonstrated a postictal state and only responded to painful stimuli for 5-10 minutes. She had no documented incontinence but tongue biting occurred. There were no identified provoking circumstances. She had no self or family history of seizures. She had a normal non-contrast brain CT (no MRI due to stent history), urine drug screen, CBC and chemistry panel. She initially complained of headache which was subsequently consistently documented, and of memory loss. She was medically evacuated to another location where she was evaluated by neurology, noted to have a normal neurological exam and a normal EEG. She was returned to a third location and a repeat awake and sleep EEG demonstrated on 30 Oct 2015 was abnormal and consistent with focal epileptiform discharges. This is less likely to be vaccine related.
Age: 48.0
Sex: F
Vaccine: ANTH
Symptoms: Eye disorder, Fall, Full blood count normal, Haematoma, Head injury
Clinical narrative: 49 yo female who developed a new onset seizure disorder while out of the country with temporal association to vaccine receipt of anthrax and influenza vaccine (neither vaccine is documented). The first documented seizure episode occurred on 19 OCT 2012 and a prior undocumented suspected seizure may have occurred 6-8 weeks earlier in late August or early September 2012. She reports she received anthrax vaccine prior to the August/September event and influenza vaccine within 1 day of the October event. Her October seizure event occurred while in a class, was witnessed and history and evaluation is well documented. The patient experienced tonic clonic activity of arms, legs and trunk for 3 minutes (estimated) causing fall from chair to ground and the incident description states "her head struck the surface of the desk and she sustained a large forehead contusion and developed a large facial bruise leaving the patient with bilateral raccoon eyes and the facial hematoma." She demonstrated a postictal state and only responded to painful stimuli for 5-10 minutes. She had no documented incontinence but tongue biting occurred. There were no identified provoking circumstances. She had no self or family history of seizures. She had a normal non-contrast brain CT (no MRI due to stent history), urine drug screen, CBC and chemistry panel. She initially complained of headache which was subsequently consistently documented, and of memory loss. She was medically evacuated to another location where she was evaluated by neurology, noted to have a normal neurological exam and a normal EEG. She was returned to a third location and a repeat awake and sleep EEG demonstrated on 30 Oct 2015 was abnormal and consistent with focal epileptiform discharges. This is less likely to be vaccine related.
Age: 48.0
Sex: F
Vaccine: ANTH
Symptoms: Headache, Laboratory test normal, Neurological examination normal, Nuclear magnetic resonance imaging brain normal, Partial seizures
Clinical narrative: 49 yo female who developed a new onset seizure disorder while out of the country with temporal association to vaccine receipt of anthrax and influenza vaccine (neither vaccine is documented). The first documented seizure episode occurred on 19 OCT 2012 and a prior undocumented suspected seizure may have occurred 6-8 weeks earlier in late August or early September 2012. She reports she received anthrax vaccine prior to the August/September event and influenza vaccine within 1 day of the October event. Her October seizure event occurred while in a class, was witnessed and history and evaluation is well documented. The patient experienced tonic clonic activity of arms, legs and trunk for 3 minutes (estimated) causing fall from chair to ground and the incident description states "her head struck the surface of the desk and she sustained a large forehead contusion and developed a large facial bruise leaving the patient with bilateral raccoon eyes and the facial hematoma." She demonstrated a postictal state and only responded to painful stimuli for 5-10 minutes. She had no documented incontinence but tongue biting occurred. There were no identified provoking circumstances. She had no self or family history of seizures. She had a normal non-contrast brain CT (no MRI due to stent history), urine drug screen, CBC and chemistry panel. She initially complained of headache which was subsequently consistently documented, and of memory loss. She was medically evacuated to another location where she was evaluated by neurology, noted to have a normal neurological exam and a normal EEG. She was returned to a third location and a repeat awake and sleep EEG demonstrated on 30 Oct 2015 was abnormal and consistent with focal epileptiform discharges. This is less likely to be vaccine related.
Age: 48.0
Sex: F
Vaccine: ANTH
Symptoms: Postictal state, Seizure, Tongue biting, Tonic clonic movements
Clinical narrative: 49 yo female who developed a new onset seizure disorder while out of the country with temporal association to vaccine receipt of anthrax and influenza vaccine (neither vaccine is documented). The first documented seizure episode occurred on 19 OCT 2012 and a prior undocumented suspected seizure may have occurred 6-8 weeks earlier in late August or early September 2012. She reports she received anthrax vaccine prior to the August/September event and influenza vaccine within 1 day of the October event. Her October seizure event occurred while in a class, was witnessed and history and evaluation is well documented. The patient experienced tonic clonic activity of arms, legs and trunk for 3 minutes (estimated) causing fall from chair to ground and the incident description states "her head struck the surface of the desk and she sustained a large forehead contusion and developed a large facial bruise leaving the patient with bilateral raccoon eyes and the facial hematoma." She demonstrated a postictal state and only responded to painful stimuli for 5-10 minutes. She had no documented incontinence but tongue biting occurred. There were no identified provoking circumstances. She had no self or family history of seizures. She had a normal non-contrast brain CT (no MRI due to stent history), urine drug screen, CBC and chemistry panel. She initially complained of headache which was subsequently consistently documented, and of memory loss. She was medically evacuated to another location where she was evaluated by neurology, noted to have a normal neurological exam and a normal EEG. She was returned to a third location and a repeat awake and sleep EEG demonstrated on 30 Oct 2015 was abnormal and consistent with focal epileptiform discharges. This is less likely to be vaccine related.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medications were not reported. On unknown dates, the multiple unspecified patients received doses of improperly stored GARDASIL 9 lot# L016429, expiry date 31-MAR-2017 (dose, route and site of administration were not reported). No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Blood test, Rash generalised
Clinical narrative: This spontaneous report was received from a 63 year old male patient reporting on himself. The patient's concurrent condition included iodine allergy. Information on medical history was not provided. On an unknown date in August 2015, the patient was vaccinated with ZOSTAVAX (lot, expiry date, route, dose number and anatomical location were not specified). Concomitant medication was not reported. Approximately in 2015 ("may be two or three weeks after"), after being vaccination with ZOSTAVAX he had been experiencing "small rashes that look more like scratches, about an inch long" (rash). The scratches resemble "zippers and bubble up [blister]". The outbreaks had been reappearing sporadically over the past four months since getting the ZOSTAVAX. He was experiencing these outbreaks on his hands, forearms, shoulders, thighs, calves and ankles (rash generalized) and he was also experiencing an outbreak today (07-JAN-2016). The patient did not recall having Chickenpox in his lifetime. The patient had sought medical attention by visiting a physician for an unspecified reason and was prescribed Mometasone Furoate cream as treatment for his symptoms. Lab diagnostics studies of routine bloodwork was performed, although their results were not provided. The patient did not currently have a physician whom he could visit regularly. The outcome of the events rash generalized and blister were reported as not recovered/not resolved at the time of reporting. There was no Product Quality Complaint (PQC) filed. The reporter did not provide the causal relationship of the events with ZOSTAVAX. Additional information is not expected as there was not consent to follow up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant medications were not reported. On unknown dates, the multiple unspecified patients received doses of improperly stored oral, ROTATEQ (dose, route and site of administration were not reported) lot# K013868, expiry date 27-MAY-2016. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass
Clinical narrative: Hard lump at injection site.  About 2-3 cm in diameter.
Age: 0.34
Sex: F
Vaccine: HIBV, IPV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Mom reports hives at injection site, diaper area, foot.  Still with hives 5 days later.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Arm became very painful and swollen. Swelling goes from around the bicep up to the shoulder. Fingers felt weak, but that went away today. Swollen and sore to the touch but not red.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Crying, Erythema, Injection site bruising, Irritability, Pyrexia
Clinical narrative: Imms given 11/30 symptoms began on 12/1. They lasted until approximately 12/2. Patient was noted to be fussy, crying with red face and febrile up to 105.2. Mom reported use of antipyretic meds (ibuprofen and acetaminophen). There was no injection site reaction noted except bruising (no nodules, rash). Patient's mom instructed to bring baby in to ED/UC for evaluation but did not. Symptoms self resolved.
Age: 69.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt has localized allergic reaction in the arm. Swollen, pain, redness in the area following PNEUMOVAX 23 vaccination in the left arm. Pt was put on antibiotic and a MEDROL dose pack.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Mucous stools
Clinical narrative: Pt received her 2nd ROTATEQ vaccine on 1/21/16. Approx 8 hrs after vaccine, the pt had 1 episode of diarrhea with mucus and streaks of blood. Pt was not fussy and had a normal BM later.
Age: 10.0
Sex: M
Vaccine: FLU3, HEPA, TDAP
Symptoms: Rash generalised
Clinical narrative: Patient reports rash on chest and back starting 1 day ago. Generalized rash on chest, arms, and thighs. 98.1 temp in clinic.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Tachyphrenia
Clinical narrative: Shot administered 10-11-15. Pt came into store on 1/21/16 stating arm turned red and the shot caused his mind to race. Could not remember how long symptoms persisted - sought no medical attention.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Vaccination complication
Clinical narrative: Oth complications following immunization, NEC, init on 2015-08-07.
Age: 1.12
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Oth complications following immunization NEC, init on 2015-06-29.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Allergy status to serum and vaccine status on 2015-09-17.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination complication
Clinical narrative: Oth complications following immunization, NEC, init on 2015-09-24.