chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 21-JUL-2015 and on 19-NOV-2015, the patient was vaccinated with a dose of GARDASIL 9 (via intramuscular route, dose and lot # were not reported). There was no known adverse events. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-NOV-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. No medical history and concurrent conditions were reported. On unspecified dates the patient was vaccinated with first and second dose (each dose on a separate unspecified date) of RECOMBIVAX HB (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On 05-FEB-2016 the patient was in the pharmacy to receive the third dose of RECOMBIVAX HB which was greater than six months from the first dose which was outside the recommendation per the prescribing information (inappropriate schedule of drug administration). No adverse effect was reported. No product quality complaint was reported. The action taken with the therapy with RECOMBIVAX HB and outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JAN-2016, the patient was vaccinated with an improperly stored Oral, ROTATEQ lot # L027719, 28-APR-2017. This is one of the 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date: 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-JAN-2016, the patient was vaccinated with an improperly stored VAQTA lot # L023232, 25-FEB-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a 71 year old male consumer, via Pfizer (2015422117), referring to himself. Information about the patient's medical history and concurrent conditions was not reported. The patient reported that, on unspecified date in 2001, 2006, 2014, and in 2015 he received PNEUMOVAX 23, (dose, route of administration, lot #'s and expiration dates were not provided). On an unspecified date in 2015, the patient was given PNEUMOVAX 23 when he was supposed to be given the PNEUMOVAX 23. The patient wanted to know if he should get the pneumococcal 13 (manufacturer unknown) after he has already been given PNEUMOVAX 23. Also the patient wanted to know if the PNEUMOVAX 23 pretty much covered him for pneumonia. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 17-DEC-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # L013429, expiration date 21-JUL-2017). There was no adverse effect reported. This is one of several reports received from the same source. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration ate 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. 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 care worker regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 29-DEC-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, dose was not reported, lot # L013188, expiration date 02-NOV-2016). There was no adverse effect reported. This is one of several reports received from the same source. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-OCT-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-JAN-2016, the patient was vaccinated with an improperly stored VAQTA lot # L023232, 25-FEB-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JAN-2016, the patient was vaccinated with an improperly stored GARDASIL 9 lot # L016428, 30-JUL-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JAN-2016, the patient was vaccinated with an improperly stored VAQTA lot # L023232, 25-FEB-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 05-FEB-2016, the patient was vaccinated with improperly stored dose of ZOSTAVAX (temperature: 43 F, time frame: 44 days) (lot # L034736, exp. 01-FEB-2016, dose and route was not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the two reports from the same reporter link. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-JAN-2016, the patient was vaccinated with improperly stored Oral, ROTATEQ. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-JAN-2016, the patient was vaccinated with an improperly stored ROTATEQ lot # L027719, 28-APR-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-JAN-2016, the patient was vaccinated with an improperly stored GARDASIL 9 lot # L016428, 30-JUL-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JAN-2016, the patient was vaccinated with an improperly stored VAQTA lot # L023232, 25-FEB-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a certified medical assistant (healthcare worker) refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JAN-2016, the patient was vaccinated with an improperly stored GARDASIL 9 lot # L016428, 30-JUL-2017. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker referring to a 12 year old patient of unknown age and gender. Concurrent condition and medical history were not reported. On 03-FEB-2016 the patient was inadvertently vaccinated with a dose of PEDVAXHIB (lot # L033690, expiration date 14-JUN-2018, dose and route were unknown), instead of the intended vaccine MENACTRA (Sanofi-Pasteur) (Wrong drug administered). No adverse effects were reported. 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 medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 23-DEC-2015, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) after being improperly stored (incorrect product storage) (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. The outcome of incorrect product storage was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a female nurse of unknown age. The patient's medical history, concurrent conditions or drug reactions were not reported. It was reported that the nurse, attempted to withdraw a PNEUMOVAX 23 vial into a syringe. Due to vacuum pressure, the liquid "squirted" out where the needle was inserted. The liquid did get on the patient's hands, however she was wearing gloves at the time of the event. No adverse events were reported. Product quality complaint was filed. 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 medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 14-DEC-2015, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (incorrect product storage) (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. This is one of several reports received from the same source. 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 medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 17-DEC-2015, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) after being improperly stored (incorrect product storage) (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. The outcome of incorrect product storage was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant refers to a 24 year old healthy female patient. The patient had 1 living child. The patient had no concomitant medications or drug allergies/reactions. Para was 2, gravida was 1. At the time of the report, the patient's gestational age was 21 weeks and 4 days. The patient became pregnant with menstrual period (LMP) of 10-SEP-2015 and estimated delivery date (EDD) of 16-JUN-2016. On 09-FEB-2016, the patient was inadvertently vaccinated, while pregnant, with 0.5 ml dose of VARIVAX (Merck) lot # L034372, expiry date 08-SEP-2017, once, (route of administration was not reported). Initial exposure to VARIVAX (Merck) was at 21 week(s). The pregnancy outcome was outcome pending. No adverse effects were reported. No treatment was given for the event. No lab diagnostic studies were performed. 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 medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 10-DEC-2015, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot # L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored, No adverse effects were reported. This is one of several reports received from the same source. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-SEP-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot # L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. 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 medical assistant and refers to 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 unspecified dates in 2016, on or after 14-JAN-2016, the patients were vaccinated with improperly stored doses of ROTATEQ (exact dose was not reported, lot # reported as L023866 and L028366, expiration date 24-MAR-2017), orally. No adverse effects were reported. The administered doses of ROTATEQ experienced a temperature excursion of 34 Fahrenheit degrees (F) for 25 hours. The doses were not exposed for the previous temperature excursion. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 31-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. 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: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and 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-FEB-2016, the patient was vaccinated an the improperly stored dose of VAQTA (exact dose and route were not reported, lot # L039659, expiration date 15-MAR-2017). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. The nurse reported that since 19-NOV-2015 unspecified number of patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L030585, expiry date 10-FEB-2017). The temperature excursion was at -5C for 16 hours and -10C for 15 hours and administered to the patient with in a time frame of 1 hour 3 minutes. No adverse effect reported. No further information was provided. No product quality complaint (PQC) was involved. This is one of the two cases received from the same reporter. 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 medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. on 26-JAN-2016, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot # L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored. No adverse effects were reported. This was one of several reports received from the same source. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 24-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. 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: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 26-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot # L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of adult patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, each of the patients was vaccinated with two pediatric doses of VAQTA injection (dose, route of administration, lot# and expiry date were not reported) together, to equal an adult dose of VAQTA at the same office visit. There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 04-FEB-2016 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (incorrect product storage) (lot # L029631, expiry date 14-AUG-2017) (dosing regimen and frequency unknown) in the immunization series. No concomitant medications were reported. It was reported that the RECOMBIVAX HB experienced a temperature of minimum 1.64 degrees Centigrade to maximum of 8.36 degrees Centigrade for a 24 hours time frame. It was also reported that there was no previous temperature excursion. It was also reported that the nurse called to report because of a data logger. No adverse effects were reported. No product quality complaint was reported. The action taken with the therapy with RECOMBIVAX HB was unknown the outcome of the events was unknown. This is one of the two reports from the same source. 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 medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 22-JAN-2016, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (incorrect product storage)(Temperature: 9.5 F, Time frame: 2 hours). No adverse events were reported. This is one of several reports received from the same source. 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 medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-AUG-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot# L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. 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 nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 04-FEB-2016 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (incorrect product storage) (lot # L029631, expiry date 14-AUG-2017) (dosing regimen and frequency unknown) in the immunization series. No concomitant medications were reported. It was reported that the RECOMBIVAX HB experienced a temperature of minimum 1.64 degrees Centigrade to maximum of 8.36 degrees Centigrade for a 24 hours time frame. It was also reported that there was no previous temperature excursion. It was also reported that the nurse called to report because of a data logger. No adverse effects were reported. No product quality complaint was reported. The action taken with the therapy with RECOMBIVAX HB was unknown the outcome of the events was unknown. This is one of the two reports from the same source. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2015US119528, is an initial spontaneous report from a consumer via vaccine adverse event reporting system (VAERS reference number: 558285) received on 10 Sep 2015. This report refers to a 76-year-old female patient. Past medical history included high blood pressure, low thyroid and high  cholesterol. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1414001) intramuscularly into the arm on 20 Oct 2014. On the same day 1 to 2 hours after vaccination, the patient's entire arm became very sore. The patient's arm was hurting so bad. The pain subsided late that night. However the upper arm still hurts at times especially when the patient tries to pull on a shirt or extend arm any length. Final outcome of the events was not recovered. The events were reported as non-serious and causality was not reported.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Local swelling, Lymphadenopathy, Malaise, Rash, Rash erythematous
Clinical narrative: Case number PHHY2015US118044, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 558288) website on 10 Sep 2015. This report refers to a 41 year old female patient. Medical history included galactorrhea, degenerative joint disease, pneumonia and attention deficit/hyperactivity disorder. She also had opiates dependence, anxiety and asthma. The polymedicated patient was vaccinated with FLURIVIN (batch number: 1411501) intramuscular into the left arm on 11 Dec 2014. On the same day she also received PNEUMOVAX (other manufacturer, pneumococcal vaccine, batch number: K004483) intramuscular into left arm and ADACEL (other manufacturer, tdap, batch number: C4565AA) intramuscular into right arm. On the day of vaccination (evening) patient became ill with malaise. On 12 Dec 2014, patient noticed rash and swollen axillary nodes of left arm. Patient had experienced local area swelling and erythematous. On the same day patient visited emergency room by the time she felt better with regard to malaise. Patient was treated with ZITHROMAX 250 mg tablets, two tablets one day one then one table each day for four days. Outcome of the events was reported to be unknown. Case was reported to be non-serious and causality of the event was not reported. No further information was provided.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Smear cervix abnormal
Clinical narrative: Case number PHHY2015US118044, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 558288) website on 10 Sep 2015. This report refers to a 41 year old female patient. Medical history included galactorrhea, degenerative joint disease, pneumonia and attention deficit/hyperactivity disorder. She also had opiates dependence, anxiety and asthma. The polymedicated patient was vaccinated with FLURIVIN (batch number: 1411501) intramuscular into the left arm on 11 Dec 2014. On the same day she also received PNEUMOVAX (other manufacturer, pneumococcal vaccine, batch number: K004483) intramuscular into left arm and ADACEL (other manufacturer, tdap, batch number: C4565AA) intramuscular into right arm. On the day of vaccination (evening) patient became ill with malaise. On 12 Dec 2014, patient noticed rash and swollen axillary nodes of left arm. Patient had experienced local area swelling and erythematous. On the same day patient visited emergency room by the time she felt better with regard to malaise. Patient was treated with ZITHROMAX 250 mg tablets, two tablets one day one then one table each day for four days. Outcome of the events was reported to be unknown. Case was reported to be non-serious and causality of the event was not reported. No further information was provided.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Case number PHHY2015US119503, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 559613) received on 10 Sep 2015. This report refers to a 38-year-old female patient. The patient had no spleen. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1414001) intramuscularly into the left arm on 13 Nov 2014. On the same day after vaccination, the patient left arm became red and swollen not near injection site. Further, the patient felt hot. The patient was treated with BENADRYL, fluids and was advised to apply ice pack. The patient had no compliance of SOB. Final outcome of the events was recovered. The events were reported as non-serious and causality was not reported.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Case number PHHY2015US119507, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 559865) received 10 Sep 2015. This report refers to a 33-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 161281) intramuscularly into the left arm on 13 Nov 2014. On the same day after vaccination, the patient experienced continued pain at the site in the night and was unable to lift the injected arm. The events improved after two months but still present. Final outcome of the events was improving. The events were reported as non-serious and causality was not reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHHY2015US134686, is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 559900) received on 10 Sep 2015. This report refers to a 29-year-old female patient. Historical conditions and current illnesses were none. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1414001) intramuscular on 11 Nov 2014. It was indicated on the consent form that the patient was pregnant. No adverse event was reported. The case was reported as non-serious and causality was not reported.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Neck pain
Clinical narrative: Case number PHHY2015US117757, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 560044) website on 10 Sep 2015. This report refers to a 54 years old male patient. Medical history and concurrent illness were none. Concomitant medications were unknown. The patient was vaccinated with FLUVIRIN (batch number: 1414101) intramuscularly into right arm on 12 Dec 2014. On 13 Dec 2014 the patient complained of neck pain that restricted movement. The patient used ibuprofen and heat to tolerate pain. The patient was recommended to consult physician if not feeling better after first 12 hours. The events lasted for 36 hours and recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Urticaria, Vomiting
Clinical narrative: Case number PHHY2015US117702, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 560325) on 10 Sep 2015. This report refers to a 26 year old male patient. Medical history included penicillin allergy. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 145905) intramuscularly into the right arm on 29 Dec 2014. On the same day, after vaccination the patient developed vomiting, diarrhea and hives. The events hives started that evening and continued through the next morning. Outcome of the events was reported as recovered. Events were reported as non-serious. Causality was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3, PNC13, FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US006884, is an initial spontaneous report received from a pharmacist on 07 Apr 2015. This report refers to a 62 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: unknown, expiry date: 31 Mar 2015) intramuscularly on 07 Apr 2015. No adverse event was reported following this maladministration. No further information was provided.
Age: 20.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Case number PHHY2015US124521 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 579180) website on 05 Oct 2015. This report refers to a 20-year-old male patient. Historical condition and concomitant medication were not reported. The patient had no current illness. The patient was vaccinated with FLUVIRIN (batch number: 1412401) into right arm, PNEUMOVAX (batch number: K007773) into right arm and BOOSTRIX (batch number: D4DC7) into left arm on 27 Oct 2014. On 28 Oct 2014, the patient experienced pain blotchy redness in the right arm deltoid area. The patient was recommended ice application, oral diphenhydramine 25mg and ibuprofen (OTC). If the events do not better by 30 Oct 2014, the patient was asked to see a doctor. The outcome of events was unknown. The events were reported as non-serious and causality was not reported.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pruritus, Urticaria
Clinical narrative: Case number PHHY2015US124527 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 579573) website on 05 Oct 2015. This report refers to a 61 year-year-old female patient. She had no known drug allergy (NDKA). No long term health problems were reported. Her concomitant medication was unknown. The patient was vaccinated with FLUVIRIN (batch number: 1309601) intramuscularly into the left arm on 10 Jan 2014 morning. After couple of hours she called the pharmacy and reported hives on back, arm and scalp, itching and light headache. The patient treatment included BENADRYL. Outcome of the event was complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Case number PHHY2015US124619, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 580212) on 05 Oct 2015. This report refers to a 63 year old male patient. Concurrent conditions included bilateral knee pain and hypertension. Past medical history included pain in joint involving lower leg, osteoarthritis, tobacco use and nummular dermatitis. The patient underwent routine general medical examination at a health care for health maintenance. The patient was vaccinated with FLUVIRIN (batch number: 123433) into the left arm and PNEUMOVAX (other manufacturer, batch number: H017801) into the right arm on 08 Jan 2013. On 09 Jan 2013, the patient developed headache, myalgia, redness, swelling and tenderness at injection site. The patient was treated with ibuprofen bid and BAG to affected area PRN. The outcome of these events was reported as recovered. The events were reported as non-serious and causality was not reported.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pyrexia, White blood cell count normal
Clinical narrative: Case number PHHY2015US142564, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 582359) website on 23 Oct 2015. This report refers to a 41 years old female patient. Medical history included left ptosis, right foot neuroma, hypothyroidism, depression along with rash flares on left lower abdomen and chronic daily headache. Drug history included use of IMITREX 6mg, penicillin, cephalothin, zolmitripan, sulfonamides, hydroxyzine, ZOLOFT (100mg), PAXIL, PROZAC (10mg) and vancomycin. Concomitant medication was not provided. Patient was vaccinated with FLUVIRIN (batch number: 1205901) and PNEUMOVAX (batch number: H010661) into the right arm on 04 Oct 2012 (both on same side). On the same day, the patient had experienced pain, rash at injection site (right deltoid) along with redness lasted for more than 24 hours. She also developed fever at a body temperature of 100.0 degree F after 24 hours of post vaccination. Patient had visited emergency room and was treated with doxycycline 100mg twice daily. On 06 Oct 2012 white blood cell (WBC) count was tested which was normal 8.3 (units not provided). Outcome of the events was reported as complete recovery. Events were reported to be non-serious and causality of the events was not reported.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Death, Malaise, Vomiting
Clinical narrative: Case number PHHY2016US006705 is a spontaneous report initially received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 609504) on 18 Jan 2016. This report refers to an 87 years old male patient. Past medical history included sepsis (Apr 2015). The patient's concurrent conditions included vomiting and loss of appetite. The patient was vaccinated with FLUVIRIN (batch number: not reported) on 20 Oct 2015. On the same day after the vaccination the patient became ill. Further the patient experienced vomiting and shivering. Outcome of the events was reported as not recovered. Seriousness of the events vomiting, ill and shivering was not reported. The patient died the day after receiving flu shot on 21 Oct 2015. Autopsy denied at hospital by medical examiner. Causality of the events was not reported. The reported FLUVIRIN batch number: 66521011802 was not a valid number. The QA department stated that without the batch number, a batch specific review could not be performed. This review was based on a general review of the Quality requirements for FLUVIRIN. Based on the Annual Product Review (APR) of FLUVIRIN, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for FLUVIRIN. From this conclusion there was no reason or explanation to account  for the reported adverse event. Non significant follow up report from the QA department (reference number: 1011175) received on 20 Jan 2016: Updated QA reference number only. Follow up received from Quality Assurance Department (QA, reference number: 1011175) on 04 Feb 2016: updated batch review report.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant referring to a 69 year old male patient with type 2 diabetes mellitus, anxiety, sleep disorder, coronary artery disease; dyslipidaemia and osteoarthritis. On 19-JAN-2016 at 12:02 hours, the patient was vaccinated with the first dose of PNEUMOVAX 23, injection, intramuscular in the left deltoid, lot # L033707, (dose, concentration and expiration date were not provided), vaccinated at private doctor's office/hospital with private funds. Concomitant therapies included the third dose of FLUZONE, intramuscular in the right deltoid, lot# UI507AAA. On 19-JAN-2016 at 20:00 hours, the patient experienced erythema, swelling with itching and warmth on the left upper and lower extremity. The patient was treated with BENADRYL every 4 hours as needed. At the time of the report, the outcome of the erythema, the feeling hot, the pruritus and the peripheral swelling was unknown. This is one of several reports received from the same source (linked report MARRS#1512USA008017, 1602USA001350 and 1512USA003027). Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Information has been received from a certified medical assistant referring to a 69 year old male patient with type 2 diabetes mellitus, anxiety, sleep disorder, coronary artery disease; dyslipidaemia and osteoarthritis. On 19-JAN-2016 at 12:02 hours, the patient was vaccinated with the first dose of PNEUMOVAX 23, injection, intramuscular in the left deltoid, lot # L033707, (dose, concentration and expiration date were not provided), vaccinated at private doctor's office/hospital with private funds. Concomitant therapies included the third dose of FLUZONE, intramuscular in the right deltoid, lot# UI507AAA. On 19-JAN-2016 at 20:00 hours, the patient experienced erythema, swelling with itching and warmth on the left upper and lower extremity. The patient was treated with BENADRYL every 4 hours as needed. At the time of the report, the outcome of the erythema, the feeling hot, the pruritus and the peripheral swelling was unknown. This is one of several reports received from the same source (linked report MARRS#1512USA008017, 1602USA001350 and 1512USA003027). Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Fatigue, Generalised oedema, Headache, Influenza virus test negative, Injection site erythema
Clinical narrative: Information has been received from a certified medical assistant referring to a 14 year old female patient with mild persistent asthma, well controlled. On 18-JAN-2016 at 11:36, the patient was vaccinated with the first dose of PNEUMOVAX 23, injection, intramuscular in the left deltoid, lot # L033707, (dose, concentration and expiration date were not provided), indicated, vaccinated at private doctor's office/hospital with private funds. Concomitant therapies included the first dose of FLUZONE, intramuscular in the right deltoid, lot# UI507AAA. On 20-JAN-2016 at 08:00 (reported as "2 days after injection"), the patient experienced rash generalized, fatigue, headache, nausea, myalgia, pyrexia, generalized oedema, injection site swelling (reported as "raised and swollen at injection site") and generalized erythema. On an unknown date in January 2016, was performed a "flu test" with negative results. At the time of the report, the outcome of generalized erythema, fatigue, headache, myalgia, pyrexia, injection site swelling, nausea, rash generalized and generalized oedema was unknown. This is one of two reports received from the same source (linked report MARRS#1512USA008017, 1602US001349 and 1512USA003027). Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: FLU4, PPV, FLU3, PPV
Symptoms: Injection site rash, Injection site swelling, Myalgia, Nausea, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant referring to a 14 year old female patient with mild persistent asthma, well controlled. On 18-JAN-2016 at 11:36, the patient was vaccinated with the first dose of PNEUMOVAX 23, injection, intramuscular in the left deltoid, lot # L033707, (dose, concentration and expiration date were not provided), indicated, vaccinated at private doctor's office/hospital with private funds. Concomitant therapies included the first dose of FLUZONE, intramuscular in the right deltoid, lot# UI507AAA. On 20-JAN-2016 at 08:00 (reported as "2 days after injection"), the patient experienced rash generalized, fatigue, headache, nausea, myalgia, pyrexia, generalized oedema, injection site swelling (reported as "raised and swollen at injection site") and generalized erythema. On an unknown date in January 2016, was performed a "flu test" with negative results. At the time of the report, the outcome of generalized erythema, fatigue, headache, myalgia, pyrexia, injection site swelling, nausea, rash generalized and generalized oedema was unknown. This is one of two reports received from the same source (linked report MARRS#1512USA008017, 1602US001349 and 1512USA003027). Additional information is not expected.