chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Drug administered to patient of inappropriate age, Vomiting
Clinical narrative: Case number PHEH2016US028658, is an initial spontaneous report received from a consumer on 30 Oct 2016. This report refers to a 02 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: not reported) intramuscularly on 21 Oct 2016. On 24 Oct 2016, the patient experienced vomiting and diarrhoea. It was reported that vomiting started before diarrhoea. On 25 Oct 2016 and 26 Oct 2016, the patient was fine. On 27 Oct 2016, the patient started throwing up again and diarrhoea too started again. The final outcome of the events was unknown. The seriousness and causality of the events were not reported. The case was lost to follow up at initial.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2016US028432, is an initial spontaneous report received from a pharmacist on 27 Oct 2016. This report refers to a 64 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1618621) at a dose of 0.5 ml intramuscularly on 27 Oct 2016. It was reported that, the patient received more than once FLUVIRIN in the season (year) on separate occasions, by mistake. No adverse event was reported following this administration error.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US028413, is an initial spontaneous report received from a consumer on 26 Oct 2016. This report refers to a 63-year-old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with one single dose FLUVIRIN MDV (batch number: 1619301, expiry date: Apr 2017) at a dose of 05 ml intramuscular on 25 Oct 2016. FLUVIRIN reached to 77 F for 4 days was administered. No adverse event was reported following this medication error.
Age: 46.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023352, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 46 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in left arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error.
Age: 46.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023353, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 46 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in left arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error.
Age: 45.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023357, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 45 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in right arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error.
Age: 30.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023351, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 30 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in left arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error.
Age: 29.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023350, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 29 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, in right arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error.
Age: 58.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023345, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 58 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, in right arm on 12 Jan 2016. On 12 Jan 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error.
Age: 37.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029332, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 37 years old male patient. Past medical history and concomitant medications were not reported. The nurse stated that, first temperature excursion of FLUCELVAX QUADRIVALENT at 52 Fahrenheit for 01 hour occurred on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34 Fahrenheit and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2 Fahrenheit three times over the course of 12 hours. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 02 Nov 2016. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this medication error.
Age: 45.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023344, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 45 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, in left arm on 12 Jan 2016. On 12 Jan 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error.
Age: 41.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023343, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 41 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, in left arm on 12 Jan 2016. On 12 Jan 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this medication error.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023337, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 41 years old  male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, in left arm on 14 Jan 2016. On 14 Jan 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this medication error.
Age: 29.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023363, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 29 years old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, into right arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion was administered to patient. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse.
Age: 35.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023364, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 35 years old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, into right arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion was administered to patient. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse.
Age: 55.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US023362 is an initial spontaneous report received from a nurse on 13 Sep 2016. This case refers to 55 years old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one  single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, into right arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion was administered to patient. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse.
Age: 45.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US023374 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 45 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 01 Feb 2106. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error.
Age: 45.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US023373 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 45 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscular into left arm on 06 Feb 2016. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error.
Age: 44.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023372 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 44 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscular into left arm on 01 Jul 2016. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error.
Age: 61.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US023371 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to  61 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscular on left arm on 28 Feb 2015. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error.
Age: 60.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US023370 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 60 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 21 Jan 2016. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029329, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 57 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml intramuscularly on 01 Nov 2016 following temperature excursion at 52 Fahrenheit for 1 hour on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34 Fahrenheit and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2 Fahrenheit three times over the course of 12 hours. Vaccine had been administered. It was unknown if the vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029330, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 38 years old male patient. Past medical history and concomitant medications were not reported. The nurse stated that, first temperature excursion of FLUCELVAX QUADRIVALENT at 52 Fahrenheit for 01 hour occurred on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34 Fahrenheit and lasted 30 minutes each time. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 01 Nov 2016. Third temperature excursion occurred on 02 Nov 2016, down to 32.2 Fahrenheit three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this medication error.
Age: 70.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029333 is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 70 year old male patient. Medical history and concomitant medication was not reported. The nurse stated that first temperature excursion of FLUCELVAX QUADRIVALENT on 18 Oct 2016 at 52 Fahrenheit (F) for 1 hour, second excursion of FLUCELVAX QUADRIVALENT on 23 Oct 2016 dropped low 6 times to 34 Fahrenheit (F) and lasted 30 minutes each time, it was unknown if vaccine was frozen. Third time excursion on 02 Nov 2016 down to 32 Fahrenheit (F) 3 times over the course of 12 hour it was unknown if vaccine was frozen. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml intramuscularly on 03 Nov 2016. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
Age: 27.0
Sex: M
Vaccine: FLUC4
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2016US030167, is an initial spontaneous report received from a pharmacist on 14 Nov 2016. This report refers to a 27 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185284 and expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 09 Nov 2016. It was reported that, patient began to thrash arm about, and needle bent and part of the vaccine leaked out and patient did not receive a full dose of FLUCELVAX QUADRIVALENT on 09 Nov 2016. No adverse event was reported following this medication errors (needle issue and underdose). The case was assessed as non serious by the pharmacist.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Case number PHEH2016US029776 is an initial spontaneous report received from consumer on 09 Nov 2016. This report refers to 58 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml intramuscular on 19 Oct 2016. On the same day, at the time of injection the patient experienced pain in left arm from injection site all the way to the middle finger. The patient still had extreme pain in her left shoulder and elbow. The patient also felt like her left hand was asleep. The patient went to doctor and was prescribed with prednisone which helped for a while but pain and tingling sensation was back. The outcome of the events was reported as vaccination site pain, shoulder pain, tingling sensation, pain in elbow was condition unchanged, and numbness was reported as unknown. The final outcome of the events paraesthesia and arthralgia was condition unchanged. The seriousness and causality of the events was not reported.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Pruritus generalised, Urticaria
Clinical narrative: Case number PHEH2016US029892, is an initial spontaneous report received from a consumer on 10 Nov 2016. This report refers to a 64 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX QUADRIVALENT (batch number: 185285, expiry date: Apr 2017) intramuscularly on 06 Nov 2016. On 08 Nov 2016, the patient experienced itching all over with red patchy hives on shoulders and neck. The patient was treated with Hydrocortisone cream to treat hives. The outcome of the events itchy rash with hives was reported as condition unchanged and of the event itching all over with red patchy hives on shoulders and neck as condition improving as of 08 Nov 2016. The seriousness of the event itchy rash with hives was assessed as non serious by the consumer and of other events was not reported. The causality of the events was not reported.
Age: 72.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029262, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 72 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml intramuscularly following temperature excursion at 52F for 1 hour on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34F and last 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2F three times over the course of 12 hours. The vaccine had been administered. It was unknown if the vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029264, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 28 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscularly following temperature  excursion at 52 Fahrenheit for 1 hour on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34 Fahrenheit and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2 Fahrenheit three time over the course of 12 hours. Vaccine had been administered. It was unknown if the vaccine was frozen. Nurse did not know which lot given to which patient. No adverse event was reported following this administration error.
Age: 68.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US023369 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 68 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 21 Jan 2016. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029328 is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 61 year old male patient. Medical history and concomitant medication was not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent on 18 Oct 2016 at 52 Fahrenheit (F) for 1 hour, second excursion of FLUCELVAX Quadrivalent on 23 Oct 2016 dropped low 6 times to 34 Fahrenheit (F) and lasted 30 minutes each time, it was unknown if vaccine was frozen. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscularly on 31 Oct 2016. Third time excursion on 02 Nov 2016 down to 32 Fahrenheit (F) 3 times over the course of 12 hour it was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029323, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 48 years old female patient. Past medial history and concomitant medications were not reported. The nurse stated that, first temperature excursion of FLUCELVAX Quadrivalent at 52 Fahrenheit for 01 hour occurred on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34 Fahrenheit and lasted 30 minutes each time. The patient was vaccine with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 26 Oct 2016. Third temperature excursion occurred on 02 Nov 2016, down to 32.2 Fahrenheit three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this medication error.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029316, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 29 years old female patient. Past medical history and concomitant medications were not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent at 52F for 1 hour occurred on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34F and lasted 30 minutes each time. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscularly on 26 Oct 2016. Third temperature excursion occurred on 02 Nov 2016, down to 32.2F three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
Age: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029317, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 65 years old female patient. Past medical history and concomitant medications were not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent at 52F for 1 hour occurred on 18 Oct 2016. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscularly on 26 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34F and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2F three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not known which lot was given to which patient. No adverse event was reported following this administration error.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029318, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 25 years old female patient. Past medical history and concomitant medications were not reported. The nurse stated that first temperature excursion of FLUCELVAX QUADRIVALENT at 52F for 1 hour occurred on 18 Oct 2016. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml intramuscularly on 26 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34F and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2F three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
Age: 71.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029320 is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to 71 year old female patient. Medical history and concomitant medication was not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent on 18 Oct 2016 at 52 Fahrenheit (F) for 1 hour, second excursion of FLUCELVAX Quadrivalent on 23 Oct 2016 dropped low 6 times to 34 Fahrenheit (F) and lasted 30 minutes each time, it was unknown if vaccine was frozen. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscularly on 26 Oct 2016. Third time excursion on 02 Nov 2016 down to 32 Fahrenheit (F) 3 times over the course of 12 hour it was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
Age: 35.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029326, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 35 years old male patient. Past medical history and concomitant medications were not reported. The nurse stated that, first temperature excursion of FLUCELVAX Quadrivalent at 52 Fahrenheit for 01 hour occurred on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34 Fahrenheit and lasted 30 minutes each time. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 27 Oct 2016. Third temperature excursion occurred on 02 Nov 2016, dose to 32.2 Fahrenheit three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this medication error.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US028856, is an initial spontaneous report received from a nurse on 02 Nov 2016. This report refers to a 64 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1619221) at a dose of 0.5 ml intramuscularly in left deltoid on 12 Sep 2016. The patient was vaccinated with FLUVIRIN that had experienced several temperature excursions prior to administration (minus 2.7C for 6 hours and 4 minutes minus 3.6C for 21 hours and 48 minutes minus 3.4C for 21 hours and 2 minutes minus 3.3C for 21 hours and 3 minutes minus 3.3C for 8 hours and 4 minutes 1.2C for 1 hour and 1 minute 1.7C for 1 hour and 5 minutes was not frozen). The nurse also stated that, the patient has been revaccinated on an unknown date. No adverse event was reported following this administration error. The case was assessed as non serious by the nurse.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US028858, is an initial spontaneous report from a nurse received on 02 Nov 2016. This report refers to a 63 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619221) into left deltoid, at a dose of 0.5 ml, intramuscularly on 13 Sep 2016. It was reported that, the patient vaccinated with FLUVIRIN that had experienced several temperature excursions (-2.7 Celsius for 06 hours and 04 minutes -3.6 Celsius for 21 hours and 48 minutes -3.4 Celsius for 21 hours and 02 minutes -3.3 Celsius for 21 hours and 03 minutes -3.3 Celsius for 08 hours and 04 minutes 1.2 Celsius for 01 hours and 01 minute 1.7 Celsius for 01 hour and 05 minutes. It was reported that, the vaccine was not frozen. It was stated that, patient did not experienced any adverse drug reaction, patient was revaccinated FLUVIRIN that experienced temperature excursions prior to vaccination. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse. No additional information was provided.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US028860 is an initial spontaneous report received from nurse on 02 Nov 2016. This report refers to a adult female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619221) at a dose of 0.5 ml intramuscular in left deltoid on 13 Sep 2016. On an unspecified date, the patient experienced temperature excursion prior administration (minus 2.7 Celsius for 6 hours and 4 minutes minus 3.6 Celsius for 21 hours and 48 minutes minus 3.4 Celsius for 21 hours and 2 minutes minus 3.3 Celsius for 21 hours and 3 minutes minus 3.3 Celsius for 8 hours and 4 minutes 1.2 Celsius for 1 hour and 1 minute 1.7 Celsius for 1 hour and 5 minutes was not frozen). The patient had been notified will be revaccinated. No adverse event was reported following this medication error. The case was assessed as non serious by the nurse.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US028861, is an initial spontaneous report from a nurse received on 02 Nov 2016. This report refers to a 60 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619221) into right deltoid, at a dose of 0.5 ml, intramuscularly on 13 Sep 2016. It was reported that, the patient vaccinated with FLUVIRIN that had experienced several temperature excursions (-2.7 Celsius for 06 hours and 04 minutes -3.6 Celsius for 21 hours and 48 minutes -3.4 Celsius for 21 hours and 02 minutes -3.3 Celsius for 21 hours and 03 minutes -3.3 Celsius for 08 hours and 04 minutes 1.2 Celsius for 01 hour and 01 minute 1.7 Celsius for 01 hour and 05 minutes). It was reported that, the vaccine was not frozen. It was stated that, patient did not experienced any adverse drug reaction, patient had been notified and will be revaccinated, FLUVIRIN that experienced temperature excursions prior to administration. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse. No additional information was provided.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US028921, is an initial spontaneous report from a nurse received on 02 Nov 2016. This report refers to a 57 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619221) into right deltoid, at a dose of 0.5 ml, intramuscularly on 13 Sep 2016. It was reported that, the patient vaccinated with FLUVIRIN that had experienced several temperature excursions (-2.7 Celsius for 06 hours and 04 minutes -3.6 Celsius for 21 hours and 48 minutes -3.4 Celsius for 21 hours and 02 minutes -3.3 Celsius for 21 hours and 03 minutes -3.3 Celsius for 08 hours and 04 minutes 1.2 Celsius for 01 hour and 01 minute 1.7 Celsius for 01 hour and 05 minutes). It was reported that, the vaccine was not frozen. It was stated that, patient did not experienced any adverse drug reaction, patient had been notified and will be revaccinated, FLUVIRIN that experienced temperature excursions prior to administration. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse. No additional information was provided.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US028929 is an initial spontaneous report received from nurse on 02 Nov 2016. This report refers to 65 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619221) 0.5 ml in left deltoid on 13 Sep 2016. On an unspecified date, the patient experienced temperature excursion prior administration (minus 2.7 Celsius for 6 hours and 4 minutes minus 3.6 Celsius for 21 hours and 48 minutes minus 3.4 Celsius for 21 hours and 2 minutes minus 3.3 Celsius for 21 hours and 3 minutes minus 3.3 Celsius for 8 hours and 4 minutes 1.2 Celsius for 1 hour and 1 minute 1.7 Celsius for 1 hour and 5 minutes was not frozen). The patient had been notified will be revaccinated. No adverse event was reported following this medication error. The case was assessed as non serious by the nurse.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US028941, is an initial spontaneous report from a nurse received on 02 Nov 2016. This report refers to a 62 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619221) into left deltoid, at a dose of 0.5 ml, intramuscularly on 13 Sep 2016. It was reported that, the patient vaccinated with FLUVIRIN that had experienced several temperature excursions (-2.7 Celsius for 06 hours and 04 minutes -3.6 Celsius for 21 hours and 48 minutes -3.4 Celsius for 21 hours and 02 minutes -3.3 Celsius for 21 hours and 03 minutes -3.3 Celsius for 08 hours and 04 minutes 1.2 Celsius for 01 hour and 01 minute 1.7 Celsius for 01 hour and 05 minutes). It was reported that, the vaccine was not frozen. It was stated that, patient did not experienced any adverse drug reaction, patient had been notified and will be revaccinated, FLUVIRIN that experienced temperature excursions prior to administration. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse. No additional information was provided.
Age: 86.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US028948, is an initial spontaneous report received from a nurse on 02 Nov 2016. This report refers to an 86 years old patient of an unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619221) 0.5 ml intramuscularly into the left deltoid on 13 Sep 2016. The administered vaccine had several temperature excursions prior administration (minus 2.7 Celsius for 6 hour and 4 minutes minus 3.6 Celsius for 21 hours and 48 minutes minus 3.4 Celsius for 21 hours and 2 minutes minus 3.3 Celsius for 21 hours and 3 minutes minus 3.3 Celsius for 8 hours and 4 minutes 1.2 Celsius for 1 hour and 1 minute 1.7 Celsius for 1 hour and 5 minutes was not frozen). It was reported that the patient had been revaccinated FLUVIRIN. No adverse event was reported following this medication error (incorrect storage of drug). The case was assessed as non serious by the nurse.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US028954, is an initial spontaneous report received from a pharmacist on 02 Nov 2016. This report refers to a female patient of an unknown age. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly, on 02 Nov 2016. The pharmacist stated that, the patient was administered a dose of expired FLUVIRIN from last year's formulation. No adverse event was reported following this administration error. The case was lost to follow up at initial.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US029019, is an initial spontaneous report received from a consumer on 03 Nov 2016. This report refers to a 30 years old male patient. Past medical history and concomitant medication were not reported. She was vaccinated with a single dose of expired FLUVIRIN (batch number: 15733P, Expiry: May 2016) 0.5 ml intramuscularly on an unknown date in mid Jun 2016. No adverse event was reported following this maladministration. The case was considered as lost to follow up as consent to contact the reporter was not provided.
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029321, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 42 years old male patient. Past medical history and concomitant medications were not reported. The nurse stated that first temperature excursion of FLUCELVAX Quadrivalent at 52F for 1 hour occurred on 18 Oct 2016. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscularly on 26 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34F and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2F three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US028831, is an initial spontaneous report from a nurse received on 02 Nov 2016. This report refers to a 91 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619221) into right deltoid, at a dose of 0.5 ml, intramuscularly on 13 Sep 2016. It was reported that, the patient vaccinated with FLUVIRIN that had experienced several temperature excursions (-2.7 Celsius for 06 hours and 04 minutes -3.6 Celsius for 21 hours and 48 minutes -3.4 Celsius for 21 hours and 02 minutes -3.3 Celsius for 21 hours and 03 minutes, -3.3 Celsius for 08 hours and 04 minutes 1.2 Celsius for 01 hour and 01 minute 1.7 Celsius for 01 hour and 05 minutes). It was reported that, the vaccine was not frozen. It was stated that, patient did not experienced any adverse drug reaction, patient was revaccinated FLUVIRIN that experienced temperature excursions prior to vaccination. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse. No additional information was provided.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US028832 is an initial spontaneous report received from nurse on 02 Nov 2016. This report refers to adult female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619221) at a dose of 0.5 ml intramuscular in right deltoid on 12 Sep 2016. On an unspecified date, the patient experienced temperature excursion prior administration (minus 2.7 Celsius for 6 hours and 4 minutes minus 3.6 Celsius for 21 hours and 48 minutes minus 3.4 Celsius for 21 hours and 2 minutes minus 3.3 Celsius for 21 hours and 3 minutes minus 3.3 Celsius for 8 hours and 4 minutes 1.2 Celsius for 1 hour and 1 minute 1.7 Celsius for 1 hour and 5 minutes was not frozen). The patient had been notified will revaccinated. No adverse event was reported following this medication error. The case was assessed as non serious by the nurse.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US028836, is an initial spontaneous report received from a nurse on 02 Nov 2016. This report refers to a 58 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1619221) at a dose of 0.5 ml intramuscularly in right deltoid on 12 Sep 2016. The patient was vaccinated with FLUVIRIN that had experienced several temperature excursions prior administration (minus 2.7 C for 6 hours and 4 minutes 3.6 C for 21 hours and 48 minutes minus 3.4 C for 21 hours and 2 minutes minus 3.3 C for 21 hours and 3 minutes minus 3.3 C for 8 hours and 4 minutes 1.2 C for 1 hour and 1 minute 1.7 C for 1 hour and 5 minutes was not frozen). The nurse also stated that, the patient had been notified and would be revaccinated. No adverse event was reported following this administration error. The case was assessed as non serious by the nurse.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US028837, is an initial spontaneous report from a nurse received on 02 Nov 2016. This report refers to a 67 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619221) into left deltoid, at a dose of 0.5 ml, intramuscularly on 12 Sep 2016. It was reported that, the patient vaccinated with FLUVIRIN that had experienced several temperature excursions (-2.7 Celsius for 06 hours and 04 minutes -3.6 Celsius for 21 hours and 48 minutes -3.4 Celsius for 21 hours and 02 minutes -3.3 Celsius for 21 hours and 03 minutes -3.3 Celsius for 08 hours and 04 minutes 1.2 Celsius for 01 hour and 01 minute 1.7 Celsius for 01 hour and 05 minutes). It was reported that, the vaccine was not frozen. It was stated that, patient did not experienced any adverse drug reaction, patient had been notified and will be revaccinated, FLUVIRIN that experienced temperature excursions prior to administration. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse. No additional information was provided.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US028840 is an initial spontaneous report received from nurse on 02 Nov 2016. This report refers to adult male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619221) at a dose of 0.5 ml intramuscular in right deltoid on 12 Sep 2016. On an unspecified date, the patient experienced temperature excursion prior administration (minus 2.7 Celsius for 6 hours and 4 minutes minus 3.6 Celsius for 21 hours and 48 minutes minus 3.4 Celsius for 21 hours and 2 minutes minus 3.3 Celsius for 21 hours and 3 minutes minus 3.3 Celsius for 8 hours and 4 minutes 1.2 Celsius for 1 hour and 1 minute 1.7 Celsius for 1 hour and 5 minutes was not frozen). The patient had been revaccinated. No adverse event was reported following this medication error. The case as assessed as non serious by the nurse.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US028841, is an initial spontaneous report received from a nurse on 02 Nov 2016. This report refers to a 71 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1619221) at a dose of 0.5 ml intramuscularly in left deltoid on 13 Sep 2016. The patient was vaccinated with FLUVIRIN that had experienced several temperature excursions prior to administration (minus 2.7C for 6 hours and 4 minutes minus 3.6C for 21 hours and 48 minutes minus 3.4C for 21 hours and 2 minutes minus 3.3C for 21 hours and 3 minutes minus 3.3C for 8 hours and 4 minutes 1.2C for 1 hour and 1 minute 1.7C for 1 hour and 5 minutes was not frozen). The nurse also stated that, the patient had been notified and would be revaccinated. No adverse event was reported following this administration error. The case was assessed as non serious by the nurse.