chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 91.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029271, is an initial spontaneous report received from a nurse on 07 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 FLUCELVAX Quadrivalent (seasonal influenza vaccine, 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 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: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US023776, is an initial spontaneous report received from a medical assistant on 14 Sep 2016. This report refers to a 61 years old male patient. Past medical history and concomitant medications were not reported. He 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 14 Sep 2016. On 14 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: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during breast feeding, No adverse event
Clinical narrative: Case number PHEH2016US029224, is a spontaneous report initially received from nurse on 04 Nov 2016. This report refers to 31 year old female patient. Medical history and concomitant medications were not reported. This breast feeding patient was inadvertently vaccinated with a single dose of FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml intramuscular on 06 Oct 2016. No adverse event was reported following this administration error (exposure during breast feeding). The nurse assessed the case as non serious. Follow up report received from a healthcare professional on 07 Nov 2016: Updated birthdate of patient (previously reported as 28 Jul 1985 was changed to 12 Jul 1985).
Age: 45.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023404 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 46-year-old patient of an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (seasonal influenza vaccine, batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 12 Jan 2016. It was reported that the patient received FLUVIRIN that had temperature excursion. The patient did not experience any adverse events following vaccination.
Age: 59.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023403 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 59-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 21 Jan 2016. It was reported that the patient received FLUVIRIN that had temperature excursion. The patient did not experience any adverse events following vaccination.
Age: 43.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023401 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 43 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 15 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 any adverse events following vaccination.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US023715, is an initial spontaneous report received from a medical assistant on 14 Sep 2016. This report refers to a 68 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1514801, expiry date: May 2016) at a dose of 0.5 ml intramuscularly in deltoid on 15 Sep 2016 (earlier reported as 14 Sep 2016). It was reported that 8 patients received expired FLUVIRIN vaccine from last year over several days. No adverse event was reported following this administration error. The case was assessed as non serious by the medical assistant. Follow up report received from a medical assistant on 18 Oct 2016: Updated reporter details and suspect drug information (vaccination date and anatomical location).
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023525, is an initial spontaneous report received from a healthcare professional on 12 Sep 2016. This report refers to a 46 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: April 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). Upon follow up the pharmacist reported, 5 doses were administered following first temperature excursion. FLUVIRIN vaccine underwent second maximum temperature excursion of 46.58 (units unspecified) for 10 minutes. No vaccine was administered after second excursion. Follow up report received from a pharmacist on 12 Sep 2016: Updated suspect drug information (expiry date) and pharmacist comments. Updated narrative accordingly.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US023674, is an initial spontaneous report from a medical assistant received on 14 Sep 2016. This report refers to a 62 years old female patient. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1514801, expiry date: May 2016) at a dose of 0.5 ml, intramuscularly on 09 Sep 2016. It was reported that, 8 patients received expired FLUVIRIN vaccine from last year over several days. It was reported that, the patient tolerated the vaccine in the past. No adverse event was reported following this administration error (expired product administered). This case was assessed as non serious by the medical assistant. Follow up report received from a medical assistant on 18 Oct 2016: Updated suspect drug information (anatomical location) and reporter comments on vaccine tolerance.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US023619, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a male patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1516501) at a dose of 0.5 ml intramuscularly on 13 Sep 2016. It was reported that, 2 employees were administered FLUVIRIN vaccine that expired in Jun 2016. No adverse event was reported following this administration error. The case was assessed as non serious by the nurse.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case PHEH2016US023585 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to female patient of an unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with expired FLUVIRIN, batch number: 1516501, expiry date: Jun 2016) at a dose of 0.5 ml single dose intramuscular on 13 Sep 2016. No adverse event was reported following this medication error (expired vaccine used). The seriousness of event was reported as non serious.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023523, is an initial spontaneous report received from a healthcare professional on 12 Sep 2016. This report refers to a 59 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. Upon follow up the pharmacist reported, 5 doses were administered following first temperature excursion. FLUVIRIN vaccine underwent second maximum temperature excursion of 46.58 (units unspecified) for 10 mins. No vaccine was administered after second excursion. No adverse event was reported following this medication error (incorrect product storage). Follow up report received from a pharmacist on 12 Sep 2016: Updated suspect drug information (expiry date) and pharmacist comments.
Sex: F
Vaccine: FLUC3
Symptoms: Influenza like illness
Clinical narrative: Case number PHEH2016US026599, is an initial spontaneous report received from a consumer on 11 Oct 2016. This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX (unknown whether seasonal or pandemic influenza vaccine, batch number: not reported) at a dose of 0.5 ml, intramuscularly on an unknown date. On an unknown date, the patient stated that, whenever she gets the influenza vaccine, she experienced the influenza like symptoms for a while. Last year when she took the FLUCELVAX vaccination, the symptoms only lasted 02 days. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the event was reported as non serious by the consumer. The causality of the event was not reported. The case was lost to follow up at initial.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029303 is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 55 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 24 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 (incurred product storage).
Age: 41.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029301 is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 41 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 intramuscular on 24 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: 5.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHEH2016US026198, is an initial spontaneous report received from a healthcare professional on 10 Oct 2016. This report refers to a 05 years old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185327) on 08 Oct 2016. On the same day after vaccination, the patient experienced redness, swelling and heat was observed from shoulder to close to elbow and around the 3/4 of the arm. The outcome of the events was reported as condition improving. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 71.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029308 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 25 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 (incorrect product storage).
Age: 85.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029305 is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to 85 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 25 Oct 2016. Third 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: 51.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023368 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to a 51 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 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: 36.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US023367 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 36 year old patient of an unknown age. 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: 46.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US023366 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 46 years old patient of an 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 intramuscularly 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: 30.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023400 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 30 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 30 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 experienced any adverse events following vaccination.
Age: 29.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023298 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 concurrent 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 30 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 any adverse events following vaccination.
Age: 47.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023397 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 47 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 30 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 any adverse events following vaccination.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US023391, is an initial spontaneous report from a consumer received on 12 Sep 2016. This report refers to an 85 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, 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.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029275, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 20 years old female patient. Past medical history and concomitant medications were not reported. The nurse stated that first temperature excursion of FLUCUELVAX Quadrivalent at 52F for 1 hour occurred on 18 Oct 2016. The patient was vaccinated with FLUCELVAX QUADIRVALENT (batch number: not reported) at a dose of 0.5 ml intramuscularly on 18 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 (incorrect product storage).
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029267, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 53 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX 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 times over the course of 12 hours. Vaccine had been administered. It was unknown if the vaccine was frozen. Nurse did not which lot was given to which patient. No adverse event was reported following this administration error (incorrect product storage).
Age: 1.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US024598, is an initial spontaneous report received from a medical assistant on 22 Sep 2016. This report refers to a 1-year-old female patient (off label use). Past medical history and concomitant medications were not reported. The patient was accidentally administered one single dose of FLUCELVAX Quadrivalent (batch number: 1853258) at a dose of 0.5 ml, intramuscularly on 22 Sep 2016. No adverse was reported following this medication error. The case was assessed as non serious by the medical assistant.
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Case number PHEH2016US023809, is an initial spontaneous report received from a consumer on 15 Sep 2016. This is also a quality complaint report (QA reference number: 1016893). This report refers to a patient of unknown age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUCELVAX Quadrivalent (batch number: 185325A) at a dose of 0.4 ml, intramuscularly on 07 Sep 2016. It was reported that, the syringe leaked at the bottom during administration and feels that they are not giving a full vaccination at administration on 07 Sep 2016. Not sure how many doses are affected. No adverse event was reported following this medication error. The case was assessed as non-serious by the consumer.
Age: 15.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2016US008605 is an initial spontaneous report received from a nurse on 05 Apr 2016. This report refers to a 15 year old male patient. Past medical history and concomitant medications were not reported. This patient under the age of 18 was vaccinated with FLUCELVAX (batch number: 174087A) on 01 Dec 2015 instead of FLUARIX (batch number: 9JX2N, Expiry date: 16 Jun 2016) at 0.5 ml intramuscular. No adverse event was reported following this maladministration. The reporter stated that, there was no specific order for a specific flu vaccine. The order for unspecified flu vaccine and patient was administered FLUCELVAX. Follow up report from nurse received on 31 May 2016: Suspect drug FLUARIX and its details (dose and route) new event (wrong vaccine administered) and deleted the event inappropriate age at vaccine administration. Follow up report from nurse received on 22 Jun 2016: Added suspect drug FLUARIX details (batch number and expiry date).
Age: 6.0
Sex: M
Vaccine: FLUC3
Symptoms: No adverse event
Clinical narrative: Case number PHEH2016US008569 is an initial spontaneous report received from a nurse on 05 Apr 2016. This report refers to a 6 year old male patient. Past medical history and concomitant medications were not reported. This patient under the age of 18 was vaccinated with FLUCELVAX (batch number: 173991) intramuscularly on 03 Oct 2015. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).
Age: 2.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US025982, is an initial spontaneous report received from a nurse on 05 Oct 2016. This report refers to a 02 year old female patient. Medical history and concomitant medication were not reported. The 02 year old patient was vaccinated with single dose FLUCELVAX QUADRIVALENT (batch number: 185886) at a dose of 0.5 ml intramuscularly on 09 Sep 2016. No adverse event was reported following this medication error (inappropriate age at vaccine administration). The seriousness of the event was reported as non serious.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Condition aggravated, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Case number PHEH2016US025960 is an initial spontaneous report received from consumer on 06 Oct 2016. This report refers to 60-year-old female patient. Past medical history included herpes infection and breast cancer with lymphedema. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number and expiry date not reported) at a dose of 0.5 ml intramuscular on 27 Sep 2016. The three days after vaccination, on 29 Sep 2016, the patient experienced body aches all the way to her ankles, profuse sweating, lightheadedness, weakness, fatigue and lymphedema exacerbation (not in the injected arm). When symptoms started, patient began to take herpes medication (unspecified) to help with symptoms. It was reported that, no past reactions to flu vaccines. The outcome of events was reported as unknown. The seriousness and causality of events was not reported.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Lymphoedema, Pain
Clinical narrative: Case number PHEH2016US025960 is an initial spontaneous report received from consumer on 06 Oct 2016. This report refers to 60-year-old female patient. Past medical history included herpes infection and breast cancer with lymphedema. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number and expiry date not reported) at a dose of 0.5 ml intramuscular on 27 Sep 2016. The three days after vaccination, on 29 Sep 2016, the patient experienced body aches all the way to her ankles, profuse sweating, lightheadedness, weakness, fatigue and lymphedema exacerbation (not in the injected arm). When symptoms started, patient began to take herpes medication (unspecified) to help with symptoms. It was reported that, no past reactions to flu vaccines. The outcome of events was reported as unknown. The seriousness and causality of events was not reported.
Age: 77.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029298, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 77 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 20 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 (incorrect product storage).
Age: 68.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029294, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 68 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 20 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: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029292, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 47 years old female 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. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 20 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 vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this medication error (incorrect product storage).
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029281, is an initial spontaneous report received from a nurse on 07 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 FLUCELVAX Quadrivalent (batch number: not reported) at a dose of 0.5 ml, intramuscularly following temperature excursion at 52 Fahrenheit for 01 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 vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
Age: 8.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US008614 is an initial spontaneous report received from a nurse on 05 Apr 2016. This report refers to a 8 year old male patient. Medical history and concomitant medications were not reported. This patient under the age of 18 was vaccinated with FLUCELAX (batch number: 174087A) intramuscularly on 02 Dec 2015 instead of FLUARIX (manufacturer unknown, batch number: 9JX2N, expiry date: 16 Jun 2016) on an unknown date. No adverse event was reported following this maladministration. It was reported that, there were no reported adverse reactions or event of the FLUCELVAX. Follow up information received from nurse on 22 Jun 2016: Added new suspect drug FLUARIX and its details (lot number and expiry date), added new event (wrong drug administered), deleted the event inappropriate age at vaccine administration and updated narrative accordingly. Follow up information received from nurse on 23 Aug 2016: Updated reported comment.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site nodule, Injection site swelling
Clinical narrative: Case number PHEH2016US028338, is an initial spontaneous report received from a pharmacist on 27 Oct 2016. This report refers to a 51-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (lot number: 1618401, expiry date: Apr 2017) at a dose of 0.5 ml intramuscular on 27 Oct 2016. On the same day of vaccination, the pharmacist gave FLUVIRIN and the site immediately knotted up. The patient bled a little bit and now there was a round bump in the area. The outcome of the event was unknown. Seriousness of the event was not reported. Causality of the events was not reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case PHEH2016US027475 is initial spontaneous report received from nurse on 20 Oct 2016. This report refers to 50 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with double dose of FLUVIRIN (batch number: 1619221, expiry date: Apr 2017) 0.5 ml intramuscular on 20 Oct 2016 (overdose accidental). It was stated that, the two doses was given to patient and no adverse reaction noted. No adverse event was reported following this medication error (overdose accidental).
Age: 53.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023361, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 53 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 excursions was administered to patient. No adverse event was reported following this medication error. The case was assessed as non-serious by the nurse.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US028354, is an initial spontaneous report received from a consumer on 26 Oct 2016. This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1619301, Expiry date: Apr 2017) at a dose of 0.5 intramuscularly on 25 Oct 2016. It was reported that, 2 employees were administered FLUVIRIN MDV that reached 77 F for 4 days. No adverse event was reported following this administration error (incorrect product storage). The case was assessed as non serious by the consumer.
Age: 28.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US023440 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 28 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: 49.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US023375 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 49 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 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: 23.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023387, 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 (incorrect product storage).
Age: 22.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023384, is an initial spontaneous report received form a nurse on 13 Set 2016. This report refers to a 22-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 right 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: 33.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023382, is an initial spontaneous report received from a nurse on 13 Sep 2016. This case refers to a 33 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 intramuscularly into left arm on 01 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 administration error.
Age: 23.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US028665 is an initial spontaneous report received from other health care professional (medical assistant) on 31 Oct 2016. This case refers to 23 year old patient of unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1620001) at a dose of 0.5 ml intramuscular on 31 Oct 2016. It was stated that, the power outage over the weekend and were not sure about the temperature of the fridge. Currently simple thermometer was used and that reads the temperature only at the time. The possible situation was 12 Celsius for up to 3 hour. This was first time excursion. They were checking with the building company to get a better assessment on the outage and if there really was a temperature excursion. The vaccine was administered to one patient in morning after the possible excursion. The medical assistant calling back on case and reports they spoke to the electric company and discover there was a power surge and electricity was only out for at most 19 minutes. Therefore, a temperature excursion did not occur. No adverse event was reported following this medication error. The seriousness of the event was reported as non serious. Follow up received from other health care professional on 02 Nov 2016: Temperature excursion did not occur and updated narrative accordingly.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US028814 is an initial spontaneous report received from pharmacist on 01 Nov 2016. This case refers to 21 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 168805, expiry date: Apr 2017) at a dose of 0.5 ml intramuscular on 15 Oct 2016. On the same day, it was reported that the patient received FLUVIRIN following a temperature excursion of 47.5 Fahrenheit (F). The vaccine had been given since first excursion. No adverse event was reported following this medication error.
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US023342, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 70 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: 1.08
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2016US028530, is an initial spontaneous report received from a consumer on 28 Oct 2016. This report refers to an infant male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number not reported) on an unknown date in Oct 2016 and booster dose was administered 2 weeks off label use on 28 Oct 2016. No adverse event was reported following this medication error.
Age: 53.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US023365 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 53 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: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Gastric disorder, Headache, Influenza like illness
Clinical narrative: Case number PHEH2016US028372, is an initial spontaneous report received from a consumer on 26 Oct 2016. This report refers to a 63-year-old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number not reported) at a dose of 0.5 ml intramuscular on 19 Oct 2016. The patient experienced following flu like symptoms: headaches, fever, stomach issues, muscle pain, fatigue and weakness. The outcome of the event was condition unchanged. Seriousness of the events was not reported. Causality of the events was not reported.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia
Clinical narrative: Case number PHEH2016US028372, is an initial spontaneous report received from a consumer on 26 Oct 2016. This report refers to a 63-year-old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number not reported) at a dose of 0.5 ml intramuscular on 19 Oct 2016. The patient experienced following flu like symptoms: headaches, fever, stomach issues, muscle pain, fatigue and weakness. The outcome of the event was condition unchanged. Seriousness of the events was not reported. Causality of the events was not reported.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case PHEH2016US028823 is an initial spontaneous report received from nurse on 02 Nov 2016. This report refers to elder female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619221) at a of 0.5 ml intramuscular in left deltoid on 13 Sep 2016. It was reported that the patients have been vaccinated with FLUVIRIN that had experienced several temperature excursions (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 (C) for 1 hour and 1 minute 1.7 Celsius for 1 hour and 5 minutes was not frozen). The nurse states she did not have any patient information at this time. The nurse also stated that, the patient had been revaccinated on an unknown date. No adverse event was reported following this medication error. The seriousness of the event was reported as non serious.
Age: 78.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US029325, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 78 years old female 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, 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: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US028827, is an initial spontaneous report received from a nurse on 02 Nov 2016. This report refers to a 60 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 13 Sep 2016. The patient was vaccinated with FLUVIRIN that had experienced several temperature excursions (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). No adverse event was reported following this administration error. The case was assessed as non serious by the nurse.