chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from two Licensed Vocational Nurses (L.V.N.) referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Since 27-JAN-2016 the patients were vaccinated with improperly stored ROTATEQ (lot # L020865, expiration date: 09-FEB-2017, dose were not reported) orally. The vaccines were exposed to 47.8 F for 1 hour and 5 minutes with previous temperature excursion of 27.5 for 1 hour and 20 minutes. No adverse event had been reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 14 year old male patient. Information regarding the patient's concurrent conditions were not provided. On 30-JUL-2015 and 15-OCT-2015 the patient was vaccinated with GARDASIL (reported as GARDASIL 4), dose 1 and dose 2 respectively. On 30-JAN-2016 the patient was then vaccinated with GARDASIL 9, final dose (interchange of vaccine products). No adverse events were reported. No product quality complaint was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, patients were vaccinated with improperly stored VARIVAX (Merck) lot # L033138, expiry date 31-AUG-2017 (dose, route and site of administration were not reported) immunization series. 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 as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, patients were vaccinated with improperly stored ROTATEQ, orally, lot # K005397, expiry date 29-FEB-2016 (dose was not reported) in immunization series. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On 20-JUL-2011, the patient was vaccinated with first dose of GARDASIL (lot number, expiration date and dose were unknown). On 25-JUL-2012 the patient was vaccinated with second dose of GARDASIL (lot number, expiration date and dose were unknown). Then on 10-JUL-2013, the patient was vaccinated with third dose of GARDASIL (lot number, expiration date and dose were unknown) (inappropriate schedule of vaccine administered). Due to the lapse between doses, the patient was administered an additional dose of either GARDASIL or GARDASIL 9 (lot number, expiration date and dose were unknown) on 25-NOV-2015 (extra dose administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and concerns a multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with unspecified doses of improperly stored VAQTA lot # K012457, expiry date 04-JUN-2017 or lot # L023232 expiry date 25-FEB-2017 or lot # L023936, expiry date 15-MAR-2017 (dose, strength, route and site of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and concerns a multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On unknown dates, the patients were vaccinated with unspecified doses of improperly stored (temperature: 48 F, time frame: less than 30 minutes) GARDASIL 9 lot # L016429, expiry date 09-AUG-2017 (dose, strength, route and site of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 01-FEB-2016, the patient was inadvertently administered with both VARIVAX (Merck) (lot # L013827 with expiration date 21-APR-2017, dose and route unspecified) and PROQUAD (Merck) (Lot # L030587 with expiration date 10-FEB-2017, dose and route unspecified) (overdose). No adverse effect was reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, frequency reported as once, subcutaneously, lot # L000447, expiration date 08-MAR-2016. On an unknown date (reported as "an unspecified time after receiving the ZOSTAVAX"), the patient developed warmth and swelling at the injection site. The patient sought medical attention, on an unknown date she spoke with the pharmacist who instructed to use an ice pack as treatment. At the time of the report the patient was recovering from the events. The relatedness between the events and ZOSTAVAX was not provided. Additional information is not expected as no consent for further contact was given.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and concerns a multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with unspecified doses of improperly stored (temperature: 48 F, time frame: less than 30 minutes) oral, ROTATEQ lot # L013193, expiry date 20-JAN-2017 or lot# L013202, expiry date 27-JAN-2017, orally (dose and strength were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 29 year old female patient. No concurrent conditions, medical history or allergy/drug reactions were reported. The patient had come for pre-natal care and reported that on 07-JAN-2016, she had been vaccinated with VARIVAX (Merck) (dosing details, route, expiration and lot# were not reported). No concomitant medication was reported. She was 9 weeks and one day pregnant as of 08-FEB-2016. The LMP and EDD was not known. The pregnancy outcome was pending. No adverse effect was reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, patients were vaccinated with improperly stored MMR II (therapy type rHA) lot # L015282, expiry date: 30-APR-2017 (dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports 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 as received from a certified medical assistant 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. On 25-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, lot # K018180, expiration date 17-SEP-2016 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33 degrees Fahrenheit for 13 hours and 47 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On multiple dates (08-JAN-2016, 11-JAN-2016, 20-JAN-2016, 26-JAN-2016, 27-JAN-2016, 01-FEB-2016, 02-FEB-2016 and 03-FEB-2016), the patients were vaccinated with improperly stored doses of M-M-R II albumin status recombinant human albumin (rHA), lot # L020188, expiration date 03-JUN-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 13 hours and 47 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certifies medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L020015, expiration date 16-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 13 hours and 47 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant 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. On 19-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, lot # K018180, expiration date 17-SEP-2016 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33 degrees Fahrenheit for 13 hours and 47 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant 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. On 08-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, lot # K018180, expiration date 17-SEP-2016 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33 degrees Fahrenheit for 13 hours and 47 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant 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. On 12-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, lot E K018180, expiration date 17-SEP-2016 (dose and route of administration were not reported). There were no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33 degrees Fahrenheit for 13 hours and 47 degrees Fahrenheit for 13 hours. 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 as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ, lot # L013203, expiration date 28-JAN-2017 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 13 hours and 47 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant 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. On 05-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, lot # K018180, expiration date 17-SEP-2016 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33 degrees Fahrenheit for 13 hours and 47 degrees Fahrenheit for 13 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: Information has been received from a nurse via a company representative referring to 6 female patients of unknown age. The nurse saw the information from an online article about GARDASIL on a website. On unknown dates the patients were vaccinated with GARDASIL (dose and route were not reported). On unknown dates the patients developed premature ovarian failure (POF), also known as premature menopause. At the time of this report, the event outcome was unknown. The causality between the event and the vaccination was not reported. Additional information is not expected since contact information is not provided.
Age: 15.0
Sex: M
Vaccine: RAB
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of allergic reaction in a 15-year-old male patient who received RABAVAERT. On 23rd August 205, the patient received RABAVERT 1 ml. On an unknown date, an unknown time after receiving RABAVERT, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to RABAVERT. Additional details were received as follows: The reporter stated that, the patient had an allergic reaction to RABAVERT. The patient was tested for allergy and found to be positive for gelatin allergy. The patient continued the series of vaccination with IMIVEX because it was latex free. The reporter did not have the batch number and expiry date of the vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple, different unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medication were not reported. On an unknown dates, the patients were vaccinated with improperly stored (-14 degrees Celsius (C), for 2 hours and 48 minutes) VARIVAX (Merck) injection, lot # L029466, expiry date 06-AUG-2017, (dose and frequency not reported). Vaccine had previous temperature excursion (-14 C) for 32.5 hours, because of data logger. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Musculoskeletal pain, Paraesthesia
Clinical narrative: This spontaneous report was received from a physician referring to a 66 year old male patient who was also a physician. The patient's medical history included chickenpox. The patient had no history of herpes zoster or herpes zoster ophthalmicus. The patient's concurrent conditions were not reported. On 30-JAN-2016, the patient was vaccinated with a dose of ZOSTAVAX in the shoulder (lot#, dose, route of administration and frequency were unspecified). Concomitant medications were not reported. On 02-FEB-2016, the patient experienced pain in the right scapula, tingling without rash and swollen for 2 days. On an unknown date in 2016, the patient experienced shingles after receiving ZOSTAVAX. It was stated that the patient sought for medical attention by visiting the doctor's office and that the adverse events were not significant disability or incapacity or life threatening and that the patient was not hospitalized. No product quality complaint was involved. At the time of the report, the outcome of the musculoskeletal pain, injection site swelling and paresthesia was reported as not recovered. The outcome of the herpes zoster was unknown. The relatedness of ZOSTAVAX with the adverse events was not reported. Additional information is not expected as all follow up information has been received.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 05-FEB-2016, the patient was vaccinated with an improperly stored dose (temperature: 6 degrees F, time frame 8 hours) of ZOSTAVAX (lot# L029483, expiration date 06-NOV-2016) (dose, route of administration and frequency were unspecified). No adverse effects were reported. Concomitant medications were not reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions, drug reactions/allergies or concomitant therapies were reported. The patient was vaccinated with the first dose of VAQTA (dosage, route of administration, lot # or expiration date were not reported), on 20-JUL-2015 and then received the second dose on 05-FEB-2015, which was way earlier than the recommended 6 month interval. No adverse effects were reported. No product quality complaint (PQC) were involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients. The nurse reported the patients were administered improperly stored doses of PNEUMOVAX 23 (lot # L036437, Expiration Date 18-MAY-2017, dose and frequency unspecified) on unspecified dates (incorrect product storage). Excursion details were as follow: temperature 0 degree Celsius, time frame 192 hours. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. Concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot # L015460, expiration date 20-JUL-2017; Lot# L028666, expiration date 04-NOV-2016 (the nurse could not identify the lot numbers which had been administered to the patients) strength, dose, frequency and route were unknown) (incorrect product storage). No adverse effects were 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: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. Concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with improperly stored oral ROTATEQ (lot # L013192 date 19-JAN-2017; lot# was reported as L027070, expiration date 30-APR-2017; Lot# L029615, expiration date 15-MAY-2017 (the nurse could not identify the lot numbers which had been administered to the patients) strength, dose and frequency were unknown) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. Concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L025738, expiration date 14-AUG-2017; Lot# K026666, expiration date 22-OCT-2016 (the nurse could not identify the lot numbers which had been administered to the patients) strength, dose, frequency and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L038018 with expiration date of 13-SEP-2017, lot# reported as L044694 with expiration date of 04-FEB-2018, lot # reported as L023387 with expiration date of 22-JUN-2017, dose, strength and route unknown). The RECOMBIVAX HB was stored at 9.9 Celsius degree for 1 hour and 23 minutes. There was no previous temperature excursion. No adverse effects were 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: Information has been received from a nurse referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L029615 with expiration date 0f 15-MAY-2017, lot# L025508 with expiration date of 12-MAY-2017, dose and strength unknown, oral). The ROTATEQ was stored at 9.9 Celsius for 1 hour and 23 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. Since 27-JAN-2016, the patients were vaccinated with an unknown number of doses of improperly stored M-M-R II (lot # L015279, expiration date 30-APR-2017, strength, dose, frequency, lot# expiration date and route were unknown). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from healthcare worker concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients received unspecified improperly stored doses (Oka/Merck) VARIVAX (strength, frequency and route unknown, Lot# L026406 and Exp. date 15-JUL-2017). The vaccines were expose tot 9F for 3 hours. This was the first excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from healthcare worker concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients received unspecified improperly stored doses of PROQUAD (Merck) (strength, frequency and route unknown, Lot# L033697, therapy type rHA and unknown Exp. date in 2017). The vaccines were exposed to 9F for 3 hours. This was the first excursion. No adverse effects were reported. 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 healthcare worker concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients received unspecified improperly stored doses of VARIVAX (Merck) (strength, frequency and route unknown, Lot# L017998 with Exp. date 19-MAY-2017, Lot# L007224 with Exp. date 30-MAR-2017, Lot# L009205 with Exp. date 17-MAR-2017). The vaccines were expose to 30.9F for 11 hours and 50 minutes at first excursion; and then exposed to 9 F for 3 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Case number PHHY2014US0154106, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 543726) website on 13 NOV 2014. This report refers to a 55-year-old female patient.  Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412601) intramuscularly into right arm on 11 SEP 2014. On 13 SEP 2014, the patient experienced swelling and redness which was hot and sore to touch. It was reported that the patient previously had flu shots with no reaction. Advised the patient to ice, take Benadryl, ibuprofen and to follow-up with physician. Outcome of the events was reported as  unknown. These events were reported as non-serious. Causality of the events was not reported.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Case number PHHY2014US0170991, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS ID: 543889) website on 29 DEC 2014. This report refers to a 78-year-old male patient.   His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411101) intramuscularly in the right arm on 02 SEP 2014. On 03 SEP 2014, in the morning after flu shot, he reported a painful rash on abdomen. He went to the emergency room. The event outcome was reported as unknown. The event was reported as n on-serous. The doctor thought that there might have been a connection between the event and administration of the flu shot.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Pyrexia
Clinical narrative: Case number PHHY2014US170993, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS ID: 543898) website on 29 DEC 2014. This report refers to a 68-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 14511P) intramuscularly on 07 SEP 2014. On the same day she also received PNEUMOVAX (other manufacturer, batch number: K007773) intramuscularly in the right arm on 07 SEP 2014. On 09 SEP 2014, she presented with soreness, redness and inflammation in the right arm where the shot was given. She also had fever for a day. She went to the emergency room and doctor prescribed her Cipro 500 mg. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Nausea, Pruritus
Clinical narrative: Case number PHHY2014US171007, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544122) website on 29 DEC 2014. This report refers to a 57-year-old female patient.  Historical conditions included lupus. No concomitant medication was reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412901) along with PNEUMOVAX (batch number: K00989) intramuscularly into the right arm on 16 SEP 2014. On 17 SEP 2014, the patient experienced swelling, tenderness and warmness at the site of injection in the arm. The patient felt nauseated and had little itching. The patient was advised to go to emergency room. The final outcome of the events was recovered. The events were reported as non-serious. It was reported that the reactions are due to PNEUMOVAX.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Case number PHHY2014US170944, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544360) website on 29 DEC 2014. This report refers to a 49-year-old female patient. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1410801) in the left arm on 11 SEP 2014. On an unknown date, she experienced large rash as big as a baseball with fever and itching. The outcome of the events reported as recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US170958, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544377) website on 29 DEC 2014. This report refers to a 20-year-old female patient.   Her medical history included penicillin allergy. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145405) intramuscularly in the right arm on 17 SEP 2014. On the same date, after vaccination her injection site was swollen, felt warm and was firm. It was reported that the symptoms started in the evening and had progressed. The events reported as non-serious. The causality of the events was not reported.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHHY2014US171013, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544426) website on 29 DEC 2014. This report refers to a 49-year-old female patient.  Medical history included hay fever. Vaccination history included Anthrax vaccine (other manufacturer and batch number: not reported) and experienced more severe swelling, heat, redness, pain and itching at injection site and fatigue. She was vaccine with FLUVIRIN 2014/2015 (batch number: 1410801) in the left arm  on 09 SEP 2014. On the same date, after vaccination she experienced swelling, heat, redness, pain and itching at the injection site and felt fatigue. The outcome of the events reported as recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Case number PHHY2014US171013, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544426) website on 29 DEC 2014. This report refers to a 49-year-old female patient.  Medical history included hay fever. Vaccination history included Anthrax vaccine (other manufacturer and batch number: not reported) and experienced more severe swelling, heat, redness, pain and itching at injection site and fatigue. She was vaccine with FLUVIRIN 2014/2015 (batch number: 1410801) in the left arm  on 09 SEP 2014. On the same date, after vaccination she experienced swelling, heat, redness, pain and itching at the injection site and felt fatigue. The outcome of the events reported as recovered. The events reported as non-serious. The causality of the events was not reported.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Peripheral swelling
Clinical narrative: Case number PHHY2014US170956, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 544439) on 29 DEC 2014. This report refers to a 64 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413301) into left arm on 16 SEP 2014. On the same day, she was vaccinated with PNEUMOVAX (batch number: J013555, other manufacturer) intramuscularly into right arm and ZOSTAVAX (batch number: J008433, other manufacturer) subcutaneously into left arm. On the same day, after vaccinations, she experienced swelling above the injection site around whole right arm. She experienced pain, itchy, red dot (three and half inches diameter and raised approximately half inch) and welt at injection site of left arm. She was treated with Benadryl. She would visit physician on 19 SEP 2014. Final outcome of the events was condition unchanged. The case was assessed as non-serious. Causality of the events was not reported.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2014US170968, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 544443)) on 29 Dec 2014. This report refers to a 49 years old female patient. Medical history and concomitant medications was not reported. She was vaccinated FLUVIRIN (batch number: 145001) into left deltoid on 17 Aug 2014. On an unknown date, after vaccination, she developed sore arm for couple of days and then felt fine. Then after 20 days she developed pain in arm radiating to shoulder. The treating physician and stated that the pain may be due to flu shot. Final outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Injection site pain, Pyrexia
Clinical narrative: Case number PHHY2014US170996, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 544474) on 29 Dec 2014. This report refers to a 56 years old female patient. Medical history and concomitant medications was not reported. She was vaccinated with FLUVIRIN (batch number: 1412601) and PNEUMOVAX (batch number: J004332, other manufacturer); both vaccines administered intramuscularly in the left arm on 18 Sep 2014. On the same day, after vaccinations, the patient experienced pain under injected arm at site, fever and weakness. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Case number PHHY2014US171011, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 544484) on 29 Dec 2014. This report refers to a 60 years old female patient. Medical history and concomitant medications was not reported. She was vaccinated with FLUVIRIN (batch number: 1411101) into left arm on 15 Sep 2014. On the same day, after vaccination, the patient developed an immediate bump at the site of injection. The patient applied cold pack and the event recovered in 3 hours. Final outcome of the event was recovered. The case was assessed as non-serious. Causality of the event was not reported.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Dizziness, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Case number PHHY2014US170984, is an initial spontaneous report received from a vaccines adverse event reporting system (VAERS reference number: 544712) on 29 Dec 2014. This report refers to a 52 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1411101) intramuscularly in right arm on 15 Sep 2014. On 18 Sep 2014, he felt nauseous and woozy. He also presented with low grade fever, sweating and there was no appetite for about 36 hours. The outcome of the events was reported as unknown. The health authority reported that the events were non-serious and causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Case number PHHY2014US170556, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546031) website on 29 Dec 2014. This report refers to a 53-year-old female patient. Concurrent conditions included allergy. Concomitant medications included NASONEX and ADVAIR. She was vaccinated with FLUVIRIN (batch number: 145223) intramuscular on 24 Sep 2014. On 25 Sep 2014, the patient experienced red rash at injection site. The final outcome of the events was complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHHY2014US170673, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546170) website on 29 DEC 2014. This report refers to a 24-year-old female patient. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1412601) in the right arm on 20 SEP 2014. On the same date, after vaccination she fainted. The outcome of the event reported as recovered. The event reported as non-serious. The causality of the event was not reported.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Case number PHHY2014US170918 is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS ID: 546477) website on 29 Dec 2014. This report refers to a 63 year old male patient. His current conditions included diabetes. His concomitant medications included lisinopril, lovastatin and glipizide for diabetes. On 22 Sep 2014, he was vaccinated with FLUVIRIN (batch number: 145222) intramuscularly into his left arm. On 24 Sep 2014, he developed a rash all over his hands and fore arms. He had no itching but the rash was persisting 10 days later. He was advised to take antihistamine until clear. The final outcome of the event was condition unchanged. The event was reported as non serious and causality of the event was not reported. Following internal review on 07 Jan 2015 of the data received on 29 Dec 2014: It was identified that the event Rash all over hands and forearms erroneously coded to rash all over and now event recoded to hand rash.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Case number PHHY2014US171712 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 546641) on 29 Dec 2014. This report refers to a 60 years old female patient. Her current conditions were hypercholesterolemia and penicillin allergy. Her concomitant medications were PAXIL, pravastatin, meloxicam and gabapentin. She was vaccinated with FLUVIRIN (batch number: 145204) intramuscularly and ZOSTAVAX (other manufacturer, batch number: K003596) subcutaneously; both vaccines given on 25 Sep 2014. On 27 Sep 2014, her upper arm was extremely swollen (might be edemic, not confirmed). Her upper arm was intensely erythematic and she was in lot of pain. She went to emergency room and was advised to take BENADRYL. The reporter thought it might be an allergy and had a talk with CDC who confirmed that it was not. The events outcome was unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Case number PHHY2014US171762, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 546756) on 29 Dec 2014. This report refers to a 53 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1413501) intramuscularly in left arm PNEUMOVAX (other manufacturer, batch number: K009809) intramuscularly in right arm both on 29 Sep 2014. On the same day after vaccination, her arm was red (not at injection site) but underneath the arm close to the arm pit. She also developed local swelling. She was taken to an emergency room. Final outcome of these events was reported as complete recovery. Events were reported as non-serious. Causality was not reported.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Mobility decreased, Musculoskeletal pain, Sleep disorder
Clinical narrative: Case number PHHY2014US171763, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS, reference number: 546759) on 29 Dec 2014. This report refers to a 41 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1412301) on 23 Sep 2014. It was reported that the flu shot was given high up on her right shoulder. On 25 Sep 2014 (36 hours after vaccination), she experienced severe shoulder pain and limited limb mobility. Pain increased over the next week. She was unable to do normal tasks and her sleep was also disrupted. Final outcome of these events was reported as complete recovery. Events were reported as non-serious. Causality was not reported.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHHY2014US171728 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 547158) website on 29 Dec 2014. This report refers to a 69 year old male patient. His past medical history and concomitant medications were not reported. On 30 Sep 2014, he was vaccinated with FLUVIRIN (batch number: 1413401) subcutaneously into his left arm instead of FLUZONE (other manufacturer, batch number: not reported) as requested by the patient. No adverse events were reported following this medication error.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain
Clinical narrative: Case number PHHY2014US171738 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 547288) website on 29 Dec 2014. This report refers to a 51 year old female patient. Her past medical history and concomitant medications were not reported. On 01 Oct t2014, she was vaccinated with FLUVIRIN (batch number: 1413301) intramuscularly and with PNEUMOVAX (other manufacturer, batch number: K0041413) intramuscularly. On 01 Oct 2014, immediately after the vaccination, she felt pain which throbbed through out the night. She could barely life her arm the next morning. The pharmacist suggested the patient to take TYLENOL or Ibuprofen, use an ice pack and to watch for the next few hours. The final outcome of the events was unknown. The event were reported as non serious and causality of the events was not reported.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Case number PHHY2014US171012, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 547347) on 29 Dec 2014. This report refers to a 45 year old male patient. Historical condition and concomitant medication were none. The patient was vaccinated with FLUVIRIN (batch number: 1411601) intramuscularly in right arm on 05 Oct 2014. On 06 Oct 2014 (in the morning), he developed rash all over arms and chest. He took two doses of BENADRYL. The patient fully recovered from rash. The event rash was reported as non-serious. Causality was not reported.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine
Clinical narrative: Case number PHHY2015US019085 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 548006) on 03 Feb 2015. This report refers to a 59 years old female patient. She had no medical history. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 411501) intramuscularly in the left arm on 10 Oct 2014. On the same date, she experienced severe migraine type headache lasting for four days. The final event outcome was unknown. The event was reported as non-serious. The causality of the event was not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2015US018741, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548069) website on 03 Feb 2015. This report refers to a 54-year-old female patient. Current condition included urinary tract infection. Concomitant drugs included ACIPHEX, calcium, Vitamin D, glucosamine and Cipro with last dose received on 14 Oct 2014. She was vaccinated with FLUVIRIN (batch number: 1411501) intramuscularly in the left arm on 14 Oct 2014. On the same date, after vaccination her injection site was reddish purple, swollen and warm to touch. On 15 Oct 2014 at 15:00, she had one inch by 4 inch area with bruising in the center and redness with slight swelling and area was warm to touch. The outcome of the events reported as recovered. The events reported as non-serious. The causality of the events was not reported.