chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US002909, is an initial spontaneous report received from a Healthcare Professional on 06 Feb 2015. This report refers to a 21 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1412801) intramuscularly at a dose of 0.5 ml on 11 Dec 2014. It was reported that before administration, the FLUVIRIN was stored at 34 degree Fahrenheit for 15 hours. No adverse event was reported following this maladministration.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2015US008501, is an initial spontaneous report from a pharmacist received on 30 Apr 2015 and with follow-up information from a pharmacist received on 30 Jul 2015. This report refers to a 70-year-old male patient. Medical history and concomitant medications were not reported. Previous vaccinations were well tolerated. He was vaccinated with FLUVIRIN (batch number: 1413401) at a dose of 0.5 ml intramuscularly on 23 Apr 2015 at 02:45 PM. It was reported that he was administered FLUVIRIN from an open multi-dose vial that was out of temperature range at 50F for up to a week. The final outcome of the event was unknown. The event was reported as non-serious. Causality was not reported. Follow-up information from pharmacist received on 30 Jul 2015: Vaccine details (dose, time and route) and other clinically relevant information updated in the narrative.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US004139 is an initial spontaneous report received from medical assistant on 27 Feb 2015: This case refers to a 09 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch numbers: U5036CA, U501BAA, U5018AA, UI173AB, UI207AB, UI2O7AB, 14511F) at a dose of 0.5 ml intramuscularly on 24 Feb 2015, which reached 31 F for two hours. No adverse event was reported following this administration error.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Feeling abnormal, Malaise, Myalgia
Clinical narrative: Case number PHEH2015US013965 is an initial spontaneous report from a consumer received on 15 Jul 2015 and a follow up report from the consumer received on 20 Aug 2015. This report refers to an adult female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 1205401) intramuscularly in Jan 2013. Since the vaccination in Jan 2013, she felt like there was cement throughout her body. She was active and agile before but not since the shot. She also experienced myalgia, malaise and fatigue after vaccination. The outcome of the event was reported as "ongoing". The seriousness and causality of the event was not reported. Follow up report from the consumer received on 20 Aug 2015: Added patient's age group and events (malaise, myalgia and fatigue).
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Fatigue, Feeling abnormal, Malaise, Myalgia
Clinical narrative: Case number PHEH2015US013965 is an initial spontaneous report from a consumer received on 15 Jul 2015 and a follow up report from the consumer received on 20 Aug 2015. This report refers to an adult female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 1205401) intramuscularly in Jan 2013. Since the vaccination in Jan 2013, she felt like there was cement throughout her body. She was active and agile before but not since the shot. She also experienced myalgia, malaise and fatigue after vaccination. The outcome of the event was reported as "ongoing". The seriousness and causality of the event was not reported. Follow up report from the consumer received on 20 Aug 2015: Added patient's age group and events (malaise, myalgia and fatigue).
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Parkinson's disease, Sensation of foreign body
Clinical narrative: Case number PHEH2015US013965 is an initial spontaneous report from a consumer received on 15 Jul 2015 and a follow up report from the consumer received on 20 Aug 2015. This report refers to an adult female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 1205401) intramuscularly in Jan 2013. Since the vaccination in Jan 2013, she felt like there was cement throughout her body. She was active and agile before but not since the shot. She also experienced myalgia, malaise and fatigue after vaccination. The outcome of the event was reported as "ongoing". The seriousness and causality of the event was not reported. Follow up report from the consumer received on 20 Aug 2015: Added patient's age group and events (malaise, myalgia and fatigue).
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2015US002936, is an initial spontaneous report received from a nurse on 06 Feb 20155. This report refers to a 46 year old male patient. Medical history and concomitant medication was not reported. On 14 Jan 2015, he received FLUVIRIN (batch number: 146525) 0.5 ml intramuscular that reached 48 degree Fahrenheit for 9 hours. Event outcome, seriousness and causality assessment was not reported. No further information was provided.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US002316, is an initial spontaneous report received from a physician on 30 Jan 2015. This report refers to a 45 year old female patient. Medical history and concomitant medication was not reported. She was vaccinated with Influenza vaccine INN (manufacturer and batch number unknown) on 30 Sep 2014 and also received FLUVIRIN (batch number: 135014) intramuscular on 02 Jan 2015. No adverse event was reported. No further information was provided.
Sex: M
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Case number PHEH2014US025838, is an initial spontaneous report received from a consumer (patient) on 23 Dec 2014. This report refers to a male patient of unknown age. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) in upper arm on an unknown date. After receiving the vaccine, he experienced sustained vertigo. Medical measures were taken by him. Final outcome, seriousness and causality of the event were not reported.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US010041, is an initial spontaneous report from a health care professional (pharmacy technician) received on 21 May 2015 with follow-up information from a health care professional (pharmacy technician) received on 25 Jun 2015. This report refers to a 23-year-old female patient. Medical history included pregnancy. Concurrent condition included allergy to sulfa drugs. Her vaccination history included administration of FLUVIRIN (batch number: unknown) on 14 Oct 2013 which was well tolerated. On 20 May 2015 the patient was vaccinated with a prefilled syringe of FLUVIRIN (batch number: 145621, expiration date: 30 Apr 2015) at a dose of 0.5 ml intramuscularly into right deltoid that expired on 30 Apr 2015. No adverse event was reported. Follow-up information from a health care professional received on 25 Jun 2015: Patient's demographics (weight and height), medical history, vaccination history and vaccine details (batch number, dose and site_ were reported.
Age: 0.63
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US019955, is an initial spontaneous report from a nurse received on 06 Oct 2015. This report refers to an 8 months old female. Past medical history and concomitant medications were not reported. The patient (8 months old neonate) was vaccinated with FLUVIRIN (batch number: 15735P, expiry date: not reported) at a dose of 0.25 ml intramuscularly on 05 Oct 2015. No adverse event was reported following this administration error.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019860, is an initial spontaneous report received from a pharmacist on 02 Oct 2015. This report refers to a 47 year old female patient. Historical conditions and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514801) intramuscularly at a dose of 0.5 ml on 02 Oct 2015. The pharmacist reported that the vaccine FLUVIRIN that had reached 52 degree for 30 minutes was administered to the patient. No adverse event was reported following the medication error.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US017646, is an initial spontaneous report received from a nurse o 09 Sep 2015. This report refers to a 39 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) in the past and was well tolerated. He was vaccinated with 0.5 ml of FLUVIRIN (batch number: 157103) pre-filled syringe (PFS) intramuscularly into the left deltoid on 08 Sep 2015. It was reported that the patient received vaccine which was out of temperature range at 33.2 degree Fahrenheit on 08 Sep 2015. The event was reported as non-serious. No adverse events were reported following the inadvertent administration. Follow up report received from the nurse on 27 Oct 2015: updated patient demographics, vaccination history, vaccination details and other clinically relevant information.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US017451, is an initial spontaneous report received from a physician via phone on 03 Sep 2015. This report refers to a patient of unknown age and gender. Medical history and concomitant medication was not reported. Physician reported that the pharmacist administered an expired FLUVIRIN (batch number: unknown) to the patient on an unknown date. No adverse event was reported. No further information was provided.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site
Clinical narrative: Case number PHEH2015US018607 is a spontaneous report initially received from a nurse on 21 Sep 2015. This report refers to a 54 years old male patient. Historical condition and concomitant medication were not reported. The patient was vaccinated FLUVIRIN (batch number: 1514901) via intravenous route on 21 Sep 2015. The reporter stated that it was not an adverse reaction. No additional information was reported. Follow-up information received from nurse on 03 Nov 2015: Reporter's comment updated.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US018521 is an initial spontaneous report received from a health care professional on 17 Sep 2015. This case refers to a 63 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1514501) at a dose of 0.5 ml intramuscularly on 16 Sep 2015, which was left out of refrigerator from Friday night until Monday morning. It was reported that the vaccines were delivered on Friday and it stayed out of the fridge in the original packaging for the weekend. When the reporter called, she was informed that a temperature excursion was permitted for up to 72 hours and the excursion did not exceed this time frame. The case was reported as non-serious. No adverse reaction was experienced by the patients following this medication error (incorrect storage of drug). The reporter declined further follow up contract. Follow up information received from the health care professional on 27 Oct 2015: Clinical noted updated.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019754 is an initial spontaneous report received from a health care professional on 02 Oct 2015. This report refers to a patient whose identifiers were not reported. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 30 Sep 2015. It was reported that before administration the vaccine reached -3 to -4 degree Celsius for up to 8 hours which was its first temperature excursion. No adverse events were reported following the maladministration.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019410 is an initial spontaneous report received from a pharmacist on 29 Sep 2015. This report refers to a 25 year old male patient. Past medical history and concomitant medications were not reported. He received an intramuscular dose from FLUVIRIN (batch number: 1515101) multi dose vial (MDV) on 29 Sep 2015. It was reported that the dose underwent a temperature excursion at room temperature for 12 hours before administration. No adverse events were reported following the medication error.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Axillary pain, Pain in extremity
Clinical narrative: Case number PHEH2015US17899, is an initial spontaneous report received from a pharmacist on 10 Sep 2015. This report refers to a 55 year old male patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501) intramuscularly in upper arm on an unknown day (last week). On 04 Sep 2015, the patient developed pain in upper arm, pain in armpit and pain in both elbows. Outcome of the events was unknown. Seriousness and causality of the events were not reported.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019443, is an initial spontaneous report from a pharmacist received on 29 Sep 2015. This report refers to a 39 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN PFS (batch number: 157105) at a dose of 0.5 ml intramuscularly on 23 Sep 20155. It was reported that the patient received FLUVIRIN that was out of temperature range at 52 F for 25 days before administration. No adverse event was reported.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Influenza
Clinical narrative: Case number PHEH2015US018332, is a spontaneous report initial received from a consumer (patient) on 17 Sep 2015. This report refers to a 65 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1516101, expiry date: Jun 2016) at a dose of 0.5 ml intramuscularly into left arm on 15 Sep 2015. She got the vaccine at her work place. On 16 Sep 2015 she started experiencing flu symptoms and felt miserable. She had symptoms of flu for two and a half days after the flu shot. The patient was not treated by a physician. The outcome, seriousness and causality of the event were not reported. Follow up information received from the consumer on 26 Oct 2015: Updated expiry date of suspect vaccine and clinical notes.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019445, is an initial spontaneous report from a pharmacist received on 29 Sep 2015. This report refers to a 68 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157105) at a dose of 0.5 ml intramuscularly on 17 Sep 2015. It was reported that the patient received FLUVIRIN that was out of temperature range at 52 F for 25 days before administration. No adverse event was reported.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US017660, is an initial spontaneous report received from a nurse on 09 Sep 2015. This report refers to a 54 year old male patient. Medical history and concomitant medications were not reported. Vaccination history included administration of FLUVIRIN (batch numbers: not reported) in the past which was well tolerated. He was vaccinated with FLUVIRIN (batch number: 157103) prefilled syringe (PFS) intramuscularly at a dose of 0.5 ml in right deltoid on 08 Sep 2015 at 10:20 hour. The nurse stated that the vaccine administered was out of temperature range at 33.2 degree Fahrenheit. The event was reported as non-serious. No adverse events were reported following the maladministration. Follow up report received from the nurse on 27 Oct 2015: updated patient demographics, vaccination history and vaccination details.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US017661 is an initial spontaneous report from a nurse received on 09 Sep 2015. This report refers to a 49-year-old male patient. The patient was vaccinated with 0.5 ml of FLUVIRIN (batch number: 157103) intramuscularly at left deltoid on 08 Sep 2015 (at 10:10). It was reported that patient received an out of temperature range FLUVIRIN which was stored at a temperature range of 33.2F. No adverse event reported following this medication error. Follow up report from the nurse received on 27 Oct 2015. Updated patient's DOB, vaccination time and site.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US019684, is a combined initial and follow-up spontaneous report from a nurse received on 10 Oct 2015 and on 02 Oct 2015. This report refers to a 54 year old female patient. Past medical history and concomitant medications were not reported. Nurse reported that the patient was vaccinated with expired FLUVIRIN (batch number: 1413801, expiry date: Jun 2015) 0.5 ml intramuscular on 30 Sep 2015. No adverse event was reported. No further information was provided.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US017659, is an initial spontaneous report from a nurse received on 09 Sep 2015. This report refers to a 53 year old male patient. Medical history was not reported. Vaccination history included administration of FLUVIRIN (batch number: not reported) two times and the patient tolerated those vaccinations. Concomitant medications was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157103) intramuscularly at a dose of 0.5 ml into left deltoid on 08 Sep 2015 at 13:40 hour. It was reported that patient received an out of temperature range FLUVIRIN which was stored at a temperature range of 33.2 degree Fahrenheit. No adverse event reported following this medication error.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019625, is an initial spontaneous report received from a healthcare professional on 01 Oct 2015 and with follow-up information from healthcare professional on 01 Oct 2015. This report refers to a 42 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516101, expiry date: Jun 2016) intramuscularly at a dose of 0.5 ml on 30 Sep 2015. It was reported that the unopened Multi Dose Vials (MDVs) were placed in a refrigerator and few of them were frozen (14 out of 35 vials). However, they had other vaccines which did not freeze. Vaccine was administered from one of those MDVs which were not freeze. No adverse event was reported. Follow up information received from the health care professional on 01 Oct 2015: Expiry date of suspect vaccine updated.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US017658, is an initial spontaneous report received from a nurse on 09 Sep 2015. This report refers to a 51 year old male patient. Medical history was not reported. Vaccination history included administration of FLUVIRIN (batch number: not reported) two times and the patient tolerated those vaccinations. Concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 157103) pre-filled syringe (PFS) intramuscularly at a dose of 0.5 ml into left deltoid on 08 Sep 2015 at 10:05 hours. It was reported that the patient received vaccine which was out of temperature range at 33.2 degree Fahrenheit on 08 Sep 2015. The event was reported as non-serious. No adverse events were reported following the inadvertent administration. Follow up received from the nurse on 27 Oct 2015: updated patient demographics, vaccination history, vaccination time, vaccination site and other clinically relevant information in the narrative.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025162 is an initial spontaneous report received from a pharmacist on 11 Dec 2014. This report refers to a 34 years old female patient. Past medical history and concomitant medications were not reported. On 10 Dec 2014, she was vaccinated with FLUVIRIN (batch number: 146701) intramuscularly that had been stored at 33.4F prior to administration. No adverse event was reported following this administration error.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Pruritus, Rash
Clinical narrative: Case number PHHY2015US139890 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 582265) website on 20 Oct 2015. This report refers to a 55 year old female patient. Medical history was not reported. Current conditions included asthma, sickle cell disease and beta thalassaemia. Concomitant medications included VICODIN, PERCOCET, ADVAIR 250, SINGULAIR, FLONASE, ALLEGRA, Vitamins D3, folic acid, biotin and calcium. The patient was vaccinated with FLUVIRIN (batch number: 141301) intramuscularly into the arm on 02 Oct 2014. On 03 Oct 2014 the patient developed rash that was large as an apple, itching and pain in arm. Further the patient developed redness on the shot area. The outcome of the events was reported as complete recovery. The events were reported as non-serious. Causality of the events was not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US017922, is an initial spontaneous report from a pharmacist received on 10 Sep 2015. This report refers to a 55 year old female patient. Historical conditions were not reported. No concomitant medication was reported. Pharmacist reported that the patient received FLUVIRIN (batch number: 15722P) IM and FLUARIX (other manufacturer, influenza vaccine, batch number: unknown)) within a month apart on 10 Sep 2015. No adverse event was reported following the inappropriate schedule of vaccine administration. No further information was provided.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Case number PHEH2015US019478 is an initial spontaneous report received from a medical assistant on 29 Sep 2015. This report refers to a 56 year old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN, (batch number: 1516201) multi dose vial intramuscularly at a dose of 0.5 ml in the deltoid on 17 Sep 2015. It was reported that the patient reported immediate itching down the arms and redness and swelling in the deltoid muscle. The events outcome was unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019407, is an initial spontaneous report from a nurse received on 29 Sep 2015. This report refers to a 36 years old female patient. Medical history and concomitant medications were not reported. On 28 Sep 2015 the patient received intramuscular dose of FLUVIRIN, (batch number: 157102) that reached 65F inside refrigerator for 12 hours before administration. It was reported that the patient had been administered the vaccine after first temperature excursion. No adverse event was reported.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US019667, is a combined initial and follow-up spontaneous report from a nurse received on 01 Oct 2015 and on 02 Oct 2015. This report refers to a 39-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with expired FLUVIRIN (batch number: 1413801, expiry date: Jun 2015) at a dose of 0.5 ml intramuscularly on 30 Sep 2015. No adverse event was reported. No further information was provided.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US019853, is an initial spontaneous report received from a pharmacist on 02 Oct 2015. This report refers to a 56 year old female patient. Historical conditions and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514801) intramuscularly at a dose of 0.5 ml on 02 Oct 2015. The pharmacist reported that the vaccine FLUVIRIN that had reached 52 degree for 30 minutes was administered to the patient. No adverse event was reported following the medication error.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US018520 is an initial spontaneous report received from a health care professional on 17 Sep 2015. This case refers to a 63 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN, (batch number: 1514501) at a dose of 0.5 ml intramuscular on 14 Sep 2015, which was left out of refrigerator from Friday night until Monday morning. It was reported that the vaccines were delivered on Friday and it stayed out of the fridge in the original packaging for the weekend. When the reporter called, she was informed that a temperature excursion was permitted for up to 72 hours and the excursion did not exceed this time frame. No adverse reaction was experienced by the patient following this medication error (incorrect storage of drug). The reporter declined further follow up contact. Follow up information received from the health care professional on 27 Oct 2015: Clinical notes updated.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2015US019138, is an initial spontaneous report from a consumer received on 25 Sep 2015. This report refers to patient of unknown demographics. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN, (batch number: not reported) intramuscularly on an unknown date. The reporter was not sure if the patient had received FLUVIRIN at a dose of 1 ml. No adverse event was reported.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2015US019806, is an initial spontaneous report received from a pharmacist on 02 Oct 2015. This report refers to a patient of unknown age and gender. Medical history and concomitant medication was not reported. The patient went to receive annual TB skin test and Influenza vaccination. The HCP inadvertently administered a 0.1 ml dose of FLUVIRIN, (batch number: unknown) intradermally thinking it was the TB preparation. No adverse event was reported. No further information was provided.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US017500, is an initial spontaneous report from a consumer received on 03 Sep 2015. This report refers to a 30 years old female patient. Past medical history and concomitant medication was not reported. She was vaccinated with intramuscular dose of FLUVIRIN (batch number: 1514501) that had a temperature excursion of 50 Fahrenheit for 2 hours on 03 Sep 2015. Reporter stated the temperature excursion was due to a power failure at the store and further there was no issue with temperature since then. No further information was provided. No adverse event was reported following the maladministration. Follow up information received from the consumer on 02 Oct 2015: Narrative comments updated.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US018519 is an initial spontaneous report received from a health care professional on 17 Sep 2015. This case refers to a 63 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN, (batch number: 1514501) at a dose of 0.5 ml intramuscularly on 14 Sep 2015, which was left out of refrigerator from Friday night until Monday morning. It was reported that the vaccines were delivered on Friday and it stayed out of the fridge in the original packaging for the weekend. When the reporter called, she was informed that a temperature excursion was permitted for up to 72 hours and the excursion did not exceed this time frame. No adverse reaction was experienced by the patient following this medication error (incorrect storage of drug). The reporter declined further follow up contact. Follow up information received from the health care professional on 27 Oct 2015: Clinical notes updated.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US002913, is an initial spontaneous report from a health care professional received on 06 Feb 2015. This report refers to a 70-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with a dose of FLUVIRIN (batch number: 1412801) at a dose of 0.5 ml intramuscularly on 12 Jan 2015. It was reported that the FLUVIRIN MDV dose administered to the patient reached temperature to 34 Fahrenheit for 15 hours. No adverse events were reported following the maladministration.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000670 is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 64-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN, (batch number: 145205) intramuscularly at a dose of 0.5 ml on 11 Oct 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist did not believe that the vaccine was frozen instead thought it was thermometer malfunction. No adverse event was reported following the maladministration (incorrect storage of drug). No further information was provided.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US017650, is an initial spontaneous report received from a nurse on 09 Sep 2015. This report refers to a male patient of unspecified age. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157103) intramuscularly at a dose of 0.5 ml on 08 Sep 2015. It was reported that before administration the FLUVIRIN prefilled syringe was stored at 33.2 degrees Fahrenheit. No adverse event was reported following this maladministration. Follow-up report received from a nurse on 27 Oct 2015. Updated patient height and weight.
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2015US019175, is an initial spontaneous report from a nurse received on 28 Sep 2015. This report refers to a male patient of an unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515101) at a dose of 1 ml intramuscularly on 28 Sep 2015. No adverse event was reported.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US017653, is an initial spontaneous report from a nurse received on 09 Sep 2015. This report refers to a 57-year-old male patient. Medical history was not reported. Vaccination history included administration of FLUVIRIN, (batch number: not reported) two times and the patient tolerated the vaccinations. Concomitant medication was not reported. The patient was vaccinated with 0.5 ml of FLUVIRIN, (batch number: 157103) intramuscularly at left deltoid on 08 Sep 2015 (at 12:45). It was reported that patient received an out of temperature range FLUVIRIN pre filled syringe which was stored at a temperature range of 33.2F. The case was reported as non-serious. No adverse reaction was experienced by the patient following this medication error (incorrect storage of drug). Follow up report from the nurse received on 27 Oct 2015. Updated patient demographics, vaccination history, vaccination time, vaccination site and other clinically relevant information in the narrative.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US017654, is an initial spontaneous report from a nurse received on 09 Sep 2015. This report refers to a 64-year-old male patient. Medical history was not reported. Concomitant medication was not reported. Vaccination history included administration of FLUVIRIN (batch number: not reported) two times and the patient tolerated the vaccinations. Concomitant medication was not reported. The patient was vaccinated with 0.5 ml of FLUVIRIN (batch number: 157103) intramuscularly at left deltoid on 08 Sep 2015 (at 12:45). It was reported that patient received an out of temperature range FLUVIRIN pre filled syringe which was stored at a temperature range of 33.2F. The case was reported as non-serious. No adverse reaction was experienced by the patient following this medication error.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US25331, is an initial spontaneous report from a medical assistant received on 16 Dec 2014. This report refers to a 56-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. On 22 Oct 2014, the patient was vaccinated with 0.5 ml of FLUVIRIN (batch number 145701, expiry date: Mar 2015) intramuscularly into right deltoid muscle that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse reaction was reported following this medication error.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2015US017655, is an initial spontaneous report from a nurse received on 09 Sep 2015. This report refers to a 55-year-old male patient. Medical history was not reported. Concomitant medication was not reported. Vaccination history included administration of FLUVIRIN (batch number: not reported) three times and the patient tolerated the vaccinations. Concomitant medication was not reported. The patient was vaccinated with 0.5 ml of FLUVIRN (batch number: 1557103) intramuscular at left deltoid on 10 Sep 2015 (at 09:00). It was reported that patient received an out of temperature range FLUVIRIN pre filled syringe which was stored at a temperature range of 33.2F. The case was reported as non-serious. No adverse reaction was experienced by the patient following this medication error. Follow up report from the nurse received on 27 Oct 2015. Updated patient's demographics, vaccination history, vaccination time, vaccination sire and other clinically relevant information in the narrative.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US002907, is an initial spontaneous report received from a Healthcare Professional on 06 Feb 2015. This report refers to a 33 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1412801) intramuscularly at a dose of 0.5 ml on 14 Jan 2015. It was reported that before administration, the FLUVIRIN was stored at 34 degree Fahrenheit for 15 hours. No adverse event was reported following this maladministration.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US017656, is an initial spontaneous report from a nurse received on 09 Sep 2015. This report refers to a 30 years old male patient. Historical conditions were not reported. Vaccination history included administration of FLUVIRIN (batch number: not reported) once and the patient tolerated the vaccination well. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157103) pre-filled syringe (PFS) intramuscularly at a dose of 0.5 ml on 08 Sep 2015. It was reported that the patient received vaccine which was out of temperature range at 33.2 degree Fahrenheit on 08 Sep 2015. The event was reported as non-serious. No adverse events were reported following the inadvertent administration. Follow up report received from the nurse on 27 Oct 2015: Updated patient demographics, vaccination history, vaccination time, vaccination site and other clinically relevant information in the narrative.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US002903, is an initial spontaneous report received from a Healthcare Professional on 06 Feb 2015. This report refers to a 59 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1412801) intramuscularly at a dose of 0.5 ml on 12 Dec 2014. It was reported that before administration, the FLUVIRIN was stored at 34 degree Fahrenheit for 15 hours. No adverse event was reported following this maladministration.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Case number PHEH2015US002444, is an initial spontaneous report received from a pharmacist on 02 Feb 2015. This report refers to an adult male patient. Medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 14554D) 0.5 ml intramuscular on 12 Nov 2014. On an unknown date post vaccination he developed difficulty in moving arm at the injection site, muscle pain and stiffness. Outcome of the events, seriousness and causality assessment was unknown.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015017657, is an initial spontaneous report received from a nurse on 09 Sep 2015. This report refers to a 42 years old male patient. Past medical history and concomitant medications were not reported. His vaccination history included administration of FLUVIRIN, (batch number: not reported) for thrice on unknown dates which were well tolerated. He was vaccinated with FLUVIRIN (batch number: 157103) pre-filled syringe (PFS) intramuscularly into the left deltoid at a dose of 0.5 ml on 08 Sep 2015. It was reported that the patient received vaccine which was out of temperature range at 33.2 degree Fahrenheit on 08 Sep 2015. The event was reported as non-serious. No adverse events were reported following the inadvertent administration. Follow-up information received from a nurse on 27 Oct 2015: updated patient's demographics, vaccination history, time of vaccination, site of vaccination and other clinically relevant information in the narrative.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US017927, is an initial spontaneous report from a pharmacist received on 11 Sep 2015. This report refers to a 45 years old female patient. Medical history and concomitant medications were not reported. On 10 Sep 2015 the patient was vaccinated with FLUVIRIN PFS (batch number: 15754P) that was out of temperature range at 34 F for 10 minutes. No adverse event was reported.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US019680 is a combined initial and follow-up spontaneous report from a nurse received on 01 Oct 2015 and on 02 Oct 2015. This report refers to a 34 years old female patient. Past medical history and concomitant medications were not reported. Nurse reported that the patient was vaccinated with expired FLUVIRIN (batch number: 1413801, expiry date: Jun 2015) 0.5 ml intramuscular on 30 Sep 2015. No adverse event was reported. No further information was provided.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH201500089, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 59 years old male patient. Medical history and concomitant medications were not reported. On 18 Nov 2014, the patient received FLUVIRIN, (batch number: 145205) at a dose of 0.5 ml intramuscularly. It was reported that the patient received FLUVIRIN that reached below 36 F for 3.5 non-consecutive days; vaccine reached 33.1 F for less than 12 hours. Reporter did not believe that the vaccine was frozen. She thought it might be due to thermometer malfunction. The case was assessed non-serious. No adverse event was reported following this medication error (incorrect storage of drug).
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Formication, Malaise, Neurological symptom, Pain, Pain in extremity
Clinical narrative: Case number PHEH2015US019712, is an initial spontaneous report from a physician received on 02 Oct 2015. This report refers to a 64-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 157601) intramuscularly on 15 Sep 2015. On the same day couple hours after vaccination, the patient experienced tingling all over, shooting pains, did not feel well, pain in extremities, felt like her skin was crawling and neurologic reaction. They got better 1.5 weeks and later they got worse. The events had not gone away. Seriousness and causality were not reported.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Case number PHEH2015US019712, is an initial spontaneous report from a physician received on 02 Oct 2015. This report refers to a 64-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 157601) intramuscularly on 15 Sep 2015. On the same day couple hours after vaccination, the patient experienced tingling all over, shooting pains, did not feel well, pain in extremities, felt like her skin was crawling and neurologic reaction. They got better 1.5 weeks and later they got worse. The events had not gone away. Seriousness and causality were not reported.
Age: 38.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000687, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 38 years old male patient. Medical history and concomitant medications were not reported. On 31 Oct 2014, the patient received FLUVIRIN (batch number: 145205) at a dose of 0.5 ml intramuscularly. It was reported that the patient received FLUVIRIN that reached below 36 F for 3.5 non-consecutive days; vaccine reached 33.1 F for less than 12 hours. Reporter did not believe that the vaccine was frozen. She thought it might be due to thermometer malfunction. The case was assessed as non-serious. No adverse event was reported following this medication error.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US019688, is a combined initial and follow-up spontaneous report from a nurse received on 01 Oct 2015 and on 02 Oct 2015. This report refers to a 47 year old male patient. Past medical history and concomitant medications were not reported. Nurse reported that the patient was vaccinated with expired FLUVIRIN (batch number: 1413801, expiry date: Jun 2015) 0.5 ml intramuscular on 30 Sep 2015. No adverse event was reported. No further information was provided.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000685, is an initial spontaneous report received from a pharmacist on 05 Jan 2015. This report refers to a 62 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 01 Nov 2014. It was reported that the patient received FLUVIRIN which reached temperature below 36 degree F for 3.5 non-consecutive days and 33.1 degree F for less than 12 hours. Reporter did not believe that the vaccine was frozen. She thought that it could be due to thermometer malfunction. But she was not sure. No adverse event was reported following this medication error.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000672, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 54-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 11 Oct 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist does not believe that the vaccine was frozen instead thinks it was thermometer malfunction. No adverse event was reported following the maladmistration. No further information was provided.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case PHEH2015US019685 is a combined initial and follow-up spontaneous report from a nurse received on 01 Oct 2015 and on 02 Oct 2015. This report refers to a 30 years old female patient. Past medical history and concomitant medications were not reported. Nurse reported that the patient was vaccinated with expired FLUVIRIN (batch number: 1413801, expiry date: Jun 2015) 0.5 ml intramuscular on 30 Sep 2015. No adverse event was reported. No further information was provided.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000671, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 54-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 12 Oct 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist does not believe that the vaccine was frozen instead thinks it was thermometer malfunction. No adverse event was reported following the maladministration. No further information was provided.