chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: FLUC3
Symptoms: No adverse event
Clinical narrative: Case number PHEH2015US021592, is an initial spontaneous report received from a other health professional on 22 Oct 2015. This report refers to a 16 year old female patient. Past medical history and concomitant medications were not reported. This 16 year old female patient was vaccinated with FLUCELVAX (batch number: 173253) on an unknown date. No adverse event was reported following this administration error (Inappropriate age at vaccine administration). Follow up information was received from a other health professional on 23 Dec 2015 and 24 Dec 2015: Patient's initials, age, date of birth and gender were updated.
Age: 64.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US025082, is an initial spontaneous report received from a healthcare professional (medical assistant) on 25 Nov 2015. This report refers to a 64-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 173538) at a dose of 0.5 ml intramuscularly on 21 Nov 2015 which was out of temperature range (35.4 F) for two days. 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 PHEH2016US023430, 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 18 Feb 2016. On 18 Feb 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 (incorrect product storage).
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during breast feeding, No adverse event
Clinical narrative: Case number PHEH2016US029284, is an initial spontaneous report received from a nurse on 03 Nov 2016. This report refers to a 13 years old female patient. Past medical history and concomitant medications were not reported. This 13 years old breast feeding patient was vaccinated with single dose of FLUCELVAX (batch number: 187276) at a dose of 0.5 ml, intramuscularly on 03 Nov 2016. No adverse event was reported following exposure during breast feeding. The case was assessed as non-serious by the nurse. Consent to contact was not provided.
Age: 29.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023459, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 29-year-old patient of an unknown gender. Medical history was not reported. Concomitant medication was not  reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN 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 (incorrect product storage).
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US023735, is an initial spontaneous report received from a medical assistant on 14 Sep 2016. This report refers to an 17 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with one single dose of FLUVIRIN (batch number: 1514801 and expiry date: May 2016) at a dose of 0.5 ml, intramuscularly on 13 Sep 2016. On 13 Sep 2016, 8 patients have received expired FLUVIRIN vaccine from last year over several days. No adverse event was reported following this medication error (expired product administered). The case was assessed as non-serious by the medical assistant.
Age: 46.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US023448 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to a 46 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 Dec 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 (incorrect product storage).
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during breast feeding
Clinical narrative: Case number PHEH2016US029280, is an initial spontaneous report received from a nurse on 03 Nov 2016. This report refers to a 40 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX (batch number: 187276) at a dose of 0.5 ml intramuscularly on 13 Oct 2016. The nurse reported that, the patient received FLUCELVAX while breastfeeding. The outcome of the event was reported as complete recovery on 13 Oct 2016. The seriousness of the event was reported as non serious. The causality of the event was not reported. The case was lost to follow up at initial.
Age: 25.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023462, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 25-year-old patient of an unknown gender. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscularly into left arm on 16 Feb 2016. It was reported that, the patient received FLUVIRIN 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 (incorrect product storage).
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023749, is an initial spontaneous report from a nurse received on 14 Sept 2016. This report refers to an 81 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619221) into right deltoid, at a dose of 0.5 ml, intramuscularly on 13 Sep 2016. It was reported that the vaccine administered had experienced several temperature excursions (-2.7C for 6 hours and 4 minutes -3.6C for 21 hours and 48 minutes -3.4C for 21 hours and 2 minutes -3.3C for 21 hours and 3 minutes -3.3C for 8 hours and 4 minutes 1.2 C for 1 hour and 1 minute 1.7C for 1 hour and 5 minutes). It was reported that the vaccine was not frozen. It was started that, patient was 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 (incorrect product storage). No additional information was provided.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023514, is an initial combined report spontaneous report received from a healthcare professional on 12 Sep 2016. This report refers to a 26 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with one single dose of FLUVIRIN (batch number: 1618701, expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 10 Sep 2016. It was stated that, patient received FLUVIRIN following 1st time temperature excursion of 52.9 Fahrenheit for 1 hour and 25 minutes. No adverse event was reported following this medication error (incorrect product storage).
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US023861, is an initial spontaneous report received from a medical assistant on 14 Sep 2016. This report refers to an 8-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514801, expiry date: May 2016) at a dose of 0.5 ml intramuscularly on 13 Sep 2016. Medical assistant reported that 8 patients have received expired FLUVIRIN vaccine from last years over several days. No adverse event was reporting following this maladministration (Expired vaccine used).
Age: 56.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023469, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 56 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 19 Mar 2016. On 19 Mar 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. The case was assessed as non serious by the nurse.
Age: 61.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023454, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 61-year-old patient of an unknown gender. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscularly into right arm on 01 Dec 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 (incorrect product storage).
Age: 51.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023415 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 51 year old patient whose gender was not specified. The patient's 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 the left arm on 29 Apr 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
Age: 43.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2016US023466, is an initial spontaneous report received from a nurse on 12 Sep 2016. This report refers to a 43 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: 1618401) at a dose of 0.5 ml, intravenous on 12 Sep 2016. It was stated that, patient was administered FLUVIRIN vaccine through intravenously instead of intramuscular. No adverse event was reported following this medication error (incorrect route of drug administration). The case was assessed as non-serious by the nurse.
Age: 48.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023417 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 48 year old patient whose gender was not specified. The patient's 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 the left arm on 31 Mar 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
Age: 53.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023418 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 53 year old patient whose gender was not specified. The patient's 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 the right arm on 31 Mar 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experienced any adverse events following vaccination.
Age: 39.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023419 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 39 year old patient whose gender was not specified. The patient's 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 the left arm on 24 Mar 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US023842, is an initial spontaneous report received from a medical assistant on 14 Sep 2016. This report refers to a 47-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with one single dose FLUVIRIN (batch number: 1514801, expiry date: May 2016) at a dose of 0.5 ml intramuscularly on 13 Sep 2016. Medical assistant reported that 8 patients received expired FLUVIRIN vaccine from last year over several days. No adverse event was reported following this maladministration (expired vaccine used).
Age: 29.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023420 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 29 year old patient whose gender was not specified. The patient's 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 the right arm on 18 Mar 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
Age: 44.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023422, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 44 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 left arm on 01 Feb 2016. On 01 Feb 2016, 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 (incorrect product storage). The case was assessed as non-serious by the nurse.
Age: 48.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023423, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 48 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 left arm on 09 Mar 2016. On 09 Mar 2016, 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 (incorrect product storage). The case was assessed as non-serious by the nurse.
Age: 65.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US025083, is an initial spontaneous report received from a healthcare professional (medical assistant) on 25 Nov 2015. This report refers to a 65-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 173538) at a dose of 0.5 ml intramuscularly on 21 Nov 2015 which was out of temperature range (35.4 F) for two days. 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 PHEH2016US023424, 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. 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 left arm on 08 May 2016. On 08 May 2016, 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 (incorrect product storage). The case was assessed as non-serious by the nurse.
Age: 59.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023426, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 59 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 left arm on 29 Feb 2016. On 29 Feb 2016, 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: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number Case number PHEH2016US023522, is an combined report initial spontaneous report received from a healthcare professional on 12 Sep 2016. This report refers to a 52 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: 1618701, expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 09 Sep 2016. It was stated that, patient received FLUVIRIN following 1st time temperature excursion of 52.9 Fahrenheit for 1 hour and 25 minutes. No adverse event was reported following this medication error (incorrect product storage).
Age: 22.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023427, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 22 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 left arm on 04 Mar 2016. On 04 Mar 2016, 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: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US023428, is an initial spontaneous report from a consumer received on 12 Sep 2016. This report refers to a 46 years old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with one single dose of expired FLUVIRIN (batch number: 157104) at a dose of 0.5 ml, intramuscularly on 12 Sep 2016. It was stated that, expired vaccine was administered to 05 patients on 12 Sep 2016. No adverse event was reported following this medication error. The case was assessed as non-serious by the consumer.
Age: 35.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case PHEH2016US023446 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 35 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 Dec 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: 27.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023431, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 27 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 18 Feb 2016. On 18 Feb 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 (incorrect product storage). The case was assessed as non serious by the nurse.
Age: 36.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023432, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 36 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 intramuscularly in left arm on 18 Feb 2016. On 18 Feb 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. The case was assessed as non serious by the nurse.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Case number PHEH2016US029955, is an initial spontaneous report received from a consumer on 10 Nov 2016. This report refers to a 48 years old female 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) at a dose of 0.5 ml intramuscularly on 06 Nov 2016. On 08 Nov 2016, the wife of reporter experienced itching all over and hives on back. The patient was treated with Hydrocortisone to treat hives. The outcome of the events was reported as condition improving. The seriousness of the events was reported as non serious by the consumer. The causality of the events was not reported.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US023589 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a patient of unknown demographics. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516501, expiry date: Jun 2016) at a dose of 0.5 ml intramuscularly on 13 Sep 2016. It was reported that the vaccine administered was expired. No adverse events were reported following this maladministration.
Age: 46.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023433, 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 11 Feb 2016. On 11 Feb 2106, 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 (incorrect product storage). The case was assessed as non serious by the nurse.
Age: 58.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023408 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 58-year-old patient of an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 01 Dec 2015. It was reported that the patient received FLUVIRIN that had temperature excursion. The patient did not experience any adverse events following vaccination.
Age: 26.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023409 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 26-year-old patient of an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 01 Dec 2015. It was reported that the patient received FLUVIRIN that had temperature excursion. The patient did not experience any adverse events following vaccination.
Age: 65.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023410 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 65-year-old patient of an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 01 Dec 2015. It was reported that the patient received FLUVIRIN that had temperature excursion. The patient did not experience any adverse events following vaccination.
Age: 27.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023411 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 29-year-old patient of an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the right arm on 01 Dec 2015. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
Age: 51.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023412 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 51 year old patient whose gender was not specified. The patient's 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 the left arm on 01 Dec 2015. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
Age: 31.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023413 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 31 year old patient whose gender was not specified. The patient's 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 the right arm on 01 Dec 2015. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023414 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 58 year old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) on an unknown date. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia
Clinical narrative: Case number PHEH2016US026756, is an initial spontaneous report received from a pharmacist on 13 Oct 2016. This report refers to a 58 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with single dose of FLUCELVAX (batch number: 185325A and expiry date: Apr 2017) at a dose of 0.5 ml, intramuscularly on 19 Sep 2016. On the same day after vaccination, the patient experienced thumb became numb. It was reported that, thumb was still numb. The outcome of the event was reported as unknown. The seriousness of the event was reported as non-serious. The causality of the event was not reported.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US026991, is an initial spontaneous report from a nurse received on 17 Oct 2016. This report refers to a 53 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number: 185888) at a dose of 0.5 ml, intramuscularly on 17 Oct 2016. It was reported that, a temperature excursion occurred with FLUCELVAX Pre-filled syringe in a closed refrigerator, vaccines were cool to touch upon discovery. The patient estimates the time of excursion was 02 to 03 days and max temperature was estimated to be less than 77 degrees Fahrenheit. This was the first temperature excursion. It was stated that, vaccine has been given to 07 people this morning on 17 Oct 2016. No adverse event was reported following this medication error.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US027017, is an initial spontaneous report from a nurse received on 17 Oct 2016. This report refers to a 33 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX (batch number: 185888) at a dose of 0.5 ml, intramuscularly on 17 Oct 2016. It was reported that, a temperature excursion occurred with FLUCELVAX Pre-filled syringe in a closed refrigerator, vaccines were cool to touch upon discovery. The patient estimates the time of excursion was 02 to 03 days and max temperature was estimated to be less than 77 degrees Fahrenheit. This was the first temperature excursion. It was stated that, vaccine has been given to 07 people this morning on 17 Oct 2016. No adverse event was reported following this medication error.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US027034, is an initial spontaneous report from a nurse received on 17 Oct 2016. This report refers to a 44 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number: 185888) at a dose of 0.5 ml, intramuscularly on 17 Oct 2016. It was reported that, a temperature excursion occurred with FLUCELVAX Pre-filled syringe in a closed refrigerator, vaccines were cool to touch upon discovery. The patient estimates the time of excursion was 02 to 03 days and max temperature was estimated to be less than 77 degrees Fahrenheit. This was the first temperature excursion. It was stated that, vaccine has been given to 07 people this morning on 17 Oct 2016. No adverse event was reported following this medication error (incorrect product storage).
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US027049, is an initial spontaneous report received from a nurse on 17 Oct 2016. This report refers to a 59 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX QUADRIVALENT (batch number: 185888) at a dose of 0.5 ml intramuscularly on 17 Oct 2016. The nurse reported that, temperature excursion occurred with FLUCELVAX pre filled syringes (PFS) in an closed refrigerator. The vaccines were cool when touched. The nurse estimated, the time of excursion was 2 to 3 days. The maximum temperature was estimated to be less than  77 degrees F. That was the first temperature excursion. The vaccine was administered to 7 people. No adverse event was reported following this administration error.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US027158 is an initial spontaneous report received from nurse on 17 Oct 2016. This report refers to a 52 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185888) at a dose of 0.5 ml intramuscular on 17 Oct 2016. On the same day, it was reported that temperature excursion occurred with FLUCELVAX prefilled syringe (PFS) in a closed refrigerator. The vaccines were cool to touch upon discovery. She estimates the time of excursion was 2 to 3 days, max temperature was estimated to be less than 77 degrees Fahrenheit (F). This was first excursion (vaccination error). No adverse event was reported following this medication error (incorrect storage of drug).
Age: 3.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case PHEH2016US022994, is an initial spontaneous report received from a nurse on 07 Sep 2016. This report refers to a 3 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185886) at a dose of 0.5 ml intramuscularly on 07 Sep 2016, when she was at 03 years old. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US027162, is an initial spontaneous report from a nurse received on 17 Oct 2016. This report refers to a 24 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX QUADRIVALENT (batch number: 185888) at a dose of 0.5 ml, intramuscularly on 17 Oct 2016. It was reported that, a temperature excursion occurred with FLUCELVAX Pre-filled syringe in a closed refrigerator, vaccines were cool to touch upon discovery. The patient estimates the time of excursion was 02 to 03 days and max temperature was estimated to be less that 77 degrees Fahrenheit. This was the first temperature excursion. It was stated that, vaccine has been given to 07 people this morning  on 17 Oct 2016. No adverse event was reported following this medication error.
Sex: U
Vaccine: FLUC4
Symptoms: Immunisation, No adverse event, Syringe issue, Underdose
Clinical narrative: Case PHEH2016US027405 is initial spontaneous report received from consumer on 19 Oct 2016. This report refers to unknown demographics patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number and expiry date not reported) intramuscular on an unknown date. On an unspecified date, it was stated that 2 prefilled syringe (PFS) become stuck and the patient did not administered full vaccine amount. The partial vaccine was administered and the patient was revaccinated with a full dose on an unknown date. No adverse event was reported following this medication error (underdose and dose administration).
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2016US027471, is an initial spontaneous report received from a health care professional on 20 Oct 2016. This report refers to a female patient of an unknown age. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX Quadrivalent (batch number 185325A) at a dose of 0.5 ml subcutaneously instead of intramuscularly on 19 Oct 2016. No adverse event was reported following this maladministration. This case was considered lost to follow up at initial
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2016US027473, is an initial spontaneous report received from a health care professional on 20 Oct 2016. This report refers to a female patient of an unknown age. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX Quadrivalent (batch number 185325A) at a dose of 0.5 ml subcutaneously instead of intramuscularly on 19 Oct 2016. No adverse event was reported following this maladministration. This case was considered lost to follow up at initial.
Age: 64.0
Sex: F
Vaccine: FLUC3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US025081, is an initial spontaneous report received from a healthcare professional (medical assistant) on 25 Nov 2015. This report refers to a 64-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 173538) at a dose of 0.5 ml intramuscularly on 21 Nov 2015 which was out of temperature range (35.4 F) for two days. No adverse event was reported following this administration error (incorrect storage of drug).
Age: 74.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023402 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 74 year old patient whose gender was not specified. The patient's 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 the left arm on 20 Jan 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience an adverse events following vaccination.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US027648 is an initial incomplete spontaneous report received from a nurse on 21 Oct 2016. This report refers to multiple patients whose identifiers were not reported. Past medical history and concomitant medications were not reported. The patients received FLUCELVAX Quadrivalent vaccine (batch number: 185887, expiry date: unknown) prefilled solution (PFS) at a dose of 0.5 ml intramuscularly on 21 Oct 2016. It was reported that the vaccine had temperature excursions. The first excursion was at 34.3 Fahrenheit for unknown time and the vaccine was not frozen. The second excursion was at 46.4 Fahrenheit for unknown time. The patient's received the vaccine after the temperature excursion. No adverse events were reported following the maladministration. the reporter provided consent for follow up contact.
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US027654, is an initial spontaneous report received from a nurse on 21 Oct 2016. This report refers to a female patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX Quadrivalent (batch number: 185887) at a dose of 0.5 ml intramuscularly on 21 Oct 2016. The nurse stated that, the patient received a dose of FLUCELVAX that experienced a multiple temperature excursion above and below the recommended temperature (temperature range unspecified). No adverse event was reported following this administration error.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US023506, is an initial spontaneous report from a consumer received on 12 Sep 2016. This report refers to a 77 years old of unknown gender patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of expired FLUVIRIN (batch number:157104) at a dose of 0.5 ml, intramuscularly on 12 Sep 2016. It was stated that, 2015/2016 expired vaccine was administered to 05 patients on 12 Sep 2016. No adverse event was reported following this medication error (expired product administered). The case was assessed as non-serious by the consumer.
Sex: U
Vaccine: FLUC4
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: Case number PHEH2016US028566, is an initial spontaneous report received from a health care professional on 26 Oct 2016. This report refers to a patient of an unknown age and an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with one single dose of FLUCELVAX (lot number: 185887, expiry date: Apr 2017) at a dose of 0.5 ml subcutaneous on 24 Oct 2016. On 25 Oct 2016 the patient experienced 7 cm patch of erythema around the injection site. The patient used cold compresses and ice for the erythema. It was unknown if the erythema was improving. Final outcome of the event was unknown. Seriousness of the event was reported as non serious and causality was not reported.
Age: 56.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029210, is an initial spontaneous report received from a pharmacist on 06 Nov 2016. This report refers to a 56 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with a single dose of FLUCELVAX QUADRIVALENT (batch number: 185205, Expiry: Apr 2017) 0.5 ml intramuscularly on 05 Nov 2016. It was reported that the vaccine was administered following a temperature excursion of 33.8 Fahrenheit for an unknown duration of time (vaccine was not frozen). No adverse event was reported following this medication error (incorrect storage of drug).
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US023488, is an initial spontaneous report from a consumer received on 12 Sep 2016. This report refers to a 43 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with one single dose of expired FLUVIRIN (batch number: 157104) at a dose of 0.5 ml, intramuscularly on 12 Sep 2016. It was stated that, expired vaccine was administered to 05 patients on 12 Sep 2016. No adverse event was reported following this medication error. The case was assessed as non-serious by the consumer.
Age: 40.0
Sex: F
Vaccine: FLUC3
Symptoms: Feeling abnormal, Musculoskeletal stiffness, Pain, Paraesthesia
Clinical narrative: Case number PHEH2015US026240, is an initial spontaneous report received from a nurse on 10 Dec 2015. This report refers to a 40 year old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 174273) at a dose of 0.5 ml intramuscular on 04 Dec 2015. On 07 Dec 2015, the patient developed hand tingling, stiffness in upper back/neck and pain in the same side as injection, felt of being locked up in jaw. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported. Following an internal review done on 05 Feb 2016 for data received 10 Dec 2015: Suspect drug coding changed from seasonal influenza vaccine to FLUCELVAX.
Age: 62.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US023444 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 62 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 Dec 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 (incorrect product storage).
Age: 24.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023388, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 24-year-old patient of an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN 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: 37.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023436, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 37 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 15 Jan 2016. On 15 Jan 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion was administered to patient. The nurse stated that, no adverse event was reported following this administration error. The case was assessed as non serious by the nurse.
Age: 48.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023434, is an spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 48 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 Feb 2016. On 12 Feb 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 (incorrect product storage). The case was assessed as non serious by the nurse.