chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram abnormal, Fatigue, Hypersomnia, Immediate post-injection reaction, Nephrolithiasis
Clinical narrative: Case number PHEH2015US025723, is an initial spontaneous report from a consumer (patient) received on 22 Dec 2014. This report refers to a 41-year-old female patient. Medical history and concomitant medications were not reported. She was vaccination with FLUVIRIN (batch number: 1411001) intramuscularly on 26 Sep 2014. On the same day, immediately after the vaccination, she experienced fatigue. A couple of weeks later, she consulted her physician as she had ongoing symptoms of "chronic/acute fatigue", felt like was sleeping 24 hours a day and could not keep herself awake. Laboratory values were normal. She went to a sleep center (no further information was provided). In Nov 2014, she had unexplained body pain in her lower back to her abdomen. She saw her physician who stated negative for any obstetrics and gynaecology problems. In Dec 2014 (18 or 19), she went to the emergency room due to pain in lower left side of back which was radiating to front of the abdominal area. The computerized tomogram (CT) performed indicated a tiny kidney stone on the right side, but nothing on the left side where she had a pain. At the time of this report, she had pin and needle pain down her neck and shoulders. The pain and achiness made her unable to sleep. Her body temperature had been low by 2 degrees and then high by 2 degrees; felt like she was on fire. She keeps getting bounced around and was suffering. The patient was on pain medications now for two months. The outcome, seriousness and causality of the events were not reported.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Paraesthesia, Sleep disorder
Clinical narrative: Case number PHEH2015US025723, is an initial spontaneous report from a consumer (patient) received on 22 Dec 2014. This report refers to a 41-year-old female patient. Medical history and concomitant medications were not reported. She was vaccination with FLUVIRIN (batch number: 1411001) intramuscularly on 26 Sep 2014. On the same day, immediately after the vaccination, she experienced fatigue. A couple of weeks later, she consulted her physician as she had ongoing symptoms of "chronic/acute fatigue", felt like was sleeping 24 hours a day and could not keep herself awake. Laboratory values were normal. She went to a sleep center (no further information was provided). In Nov 2014, she had unexplained body pain in her lower back to her abdomen. She saw her physician who stated negative for any obstetrics and gynaecology problems. In Dec 2014 (18 or 19), she went to the emergency room due to pain in lower left side of back which was radiating to front of the abdominal area. The computerized tomogram (CT) performed indicated a tiny kidney stone on the right side, but nothing on the left side where she had a pain. At the time of this report, she had pin and needle pain down her neck and shoulders. The pain and achiness made her unable to sleep. Her body temperature had been low by 2 degrees and then high by 2 degrees; felt like she was on fire. She keeps getting bounced around and was suffering. The patient was on pain medications now for two months. The outcome, seriousness and causality of the events were not reported.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Abdominal pain, Back pain, Chills, Computerised tomogram normal
Clinical narrative: Case number PHEH2015US025723, is an initial spontaneous report from a consumer (patient) received on 22 Dec 2014. This report refers to a 41-year-old female patient. Medical history and concomitant medications were not reported. She was vaccination with FLUVIRIN (batch number: 1411001) intramuscularly on 26 Sep 2014. On the same day, immediately after the vaccination, she experienced fatigue. A couple of weeks later, she consulted her physician as she had ongoing symptoms of "chronic/acute fatigue", felt like was sleeping 24 hours a day and could not keep herself awake. Laboratory values were normal. She went to a sleep center (no further information was provided). In Nov 2014, she had unexplained body pain in her lower back to her abdomen. She saw her physician who stated negative for any obstetrics and gynaecology problems. In Dec 2014 (18 or 19), she went to the emergency room due to pain in lower left side of back which was radiating to front of the abdominal area. The computerized tomogram (CT) performed indicated a tiny kidney stone on the right side, but nothing on the left side where she had a pain. At the time of this report, she had pin and needle pain down her neck and shoulders. The pain and achiness made her unable to sleep. Her body temperature had been low by 2 degrees and then high by 2 degrees; felt like she was on fire. She keeps getting bounced around and was suffering. The patient was on pain medications now for two months. The outcome, seriousness and causality of the events were not reported.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Feeling hot, General physical health deterioration, Head titubation, Hypersomnia
Clinical narrative: Case number PHEH2015US025723, is an initial spontaneous report from a consumer (patient) received on 22 Dec 2014. This report refers to a 41-year-old female patient. Medical history and concomitant medications were not reported. She was vaccination with FLUVIRIN (batch number: 1411001) intramuscularly on 26 Sep 2014. On the same day, immediately after the vaccination, she experienced fatigue. A couple of weeks later, she consulted her physician as she had ongoing symptoms of "chronic/acute fatigue", felt like was sleeping 24 hours a day and could not keep herself awake. Laboratory values were normal. She went to a sleep center (no further information was provided). In Nov 2014, she had unexplained body pain in her lower back to her abdomen. She saw her physician who stated negative for any obstetrics and gynaecology problems. In Dec 2014 (18 or 19), she went to the emergency room due to pain in lower left side of back which was radiating to front of the abdominal area. The computerized tomogram (CT) performed indicated a tiny kidney stone on the right side, but nothing on the left side where she had a pain. At the time of this report, she had pin and needle pain down her neck and shoulders. The pain and achiness made her unable to sleep. Her body temperature had been low by 2 degrees and then high by 2 degrees; felt like she was on fire. She keeps getting bounced around and was suffering. The patient was on pain medications now for two months. The outcome, seriousness and causality of the events were not reported.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscle spasms, Pain, Paraesthesia, Peripheral coldness, Temperature difference of extremities
Clinical narrative: Case number PHEH2015US025723, is an initial spontaneous report from a consumer (patient) received on 22 Dec 2014. This report refers to a 41-year-old female patient. Medical history and concomitant medications were not reported. She was vaccination with FLUVIRIN (batch number: 1411001) intramuscularly on 26 Sep 2014. On the same day, immediately after the vaccination, she experienced fatigue. A couple of weeks later, she consulted her physician as she had ongoing symptoms of "chronic/acute fatigue", felt like was sleeping 24 hours a day and could not keep herself awake. Laboratory values were normal. She went to a sleep center (no further information was provided). In Nov 2014, she had unexplained body pain in her lower back to her abdomen. She saw her physician who stated negative for any obstetrics and gynaecology problems. In Dec 2014 (18 or 19), she went to the emergency room due to pain in lower left side of back which was radiating to front of the abdominal area. The computerized tomogram (CT) performed indicated a tiny kidney stone on the right side, but nothing on the left side where she had a pain. At the time of this report, she had pin and needle pain down her neck and shoulders. The pain and achiness made her unable to sleep. Her body temperature had been low by 2 degrees and then high by 2 degrees; felt like she was on fire. She keeps getting bounced around and was suffering. The patient was on pain medications now for two months. The outcome, seriousness and causality of the events were not reported.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urine analysis normal, X-ray normal
Clinical narrative: Case number PHEH2015US025723, is an initial spontaneous report from a consumer (patient) received on 22 Dec 2014. This report refers to a 41-year-old female patient. Medical history and concomitant medications were not reported. She was vaccination with FLUVIRIN (batch number: 1411001) intramuscularly on 26 Sep 2014. On the same day, immediately after the vaccination, she experienced fatigue. A couple of weeks later, she consulted her physician as she had ongoing symptoms of "chronic/acute fatigue", felt like was sleeping 24 hours a day and could not keep herself awake. Laboratory values were normal. She went to a sleep center (no further information was provided). In Nov 2014, she had unexplained body pain in her lower back to her abdomen. She saw her physician who stated negative for any obstetrics and gynaecology problems. In Dec 2014 (18 or 19), she went to the emergency room due to pain in lower left side of back which was radiating to front of the abdominal area. The computerized tomogram (CT) performed indicated a tiny kidney stone on the right side, but nothing on the left side where she had a pain. At the time of this report, she had pin and needle pain down her neck and shoulders. The pain and achiness made her unable to sleep. Her body temperature had been low by 2 degrees and then high by 2 degrees; felt like she was on fire. She keeps getting bounced around and was suffering. The patient was on pain medications now for two months. The outcome, seriousness and causality of the events were not reported.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram abnormal, Fatigue, Hypersomnia, Immediate post-injection reaction, Nephrolithiasis
Clinical narrative: Case number PHEH2014US025794, is an initial spontaneous report received from a consumer on 22 Dec 2014. This report refers to a 41 year old female patient. Medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1411001). Post vaccination on 29 Sep 2014, she experienced extreme fatigue, nodding off at stop lights sleeping all day functional about 3-4 hours total. Temperature difference of extremities, feet cold upper body hot shiver randomly. On 23 Oct 2014, she developed chills and outcome was condition deteriorated. On 13 Nov 2014, she developed lower left side back pain cannot walk and move extreme pain worse in the morning, cannot bend or squat, pain began to feel like it was starting in the front of abdomen and stabbing through back x-rays and CT scan shows nothing unusual. On 15 Dec 2014, being awakened by a Charlie horse like cramping in the muscles at the base of neck that extend across shoulders tingle sensation in arms that is like needles of pain all over arms. On 17 Dec 2014, experienced abdominal pain generalized. She went to the ER on 19 Dec 2014. Labs and urinalysis were unremarkable. CT scan inconclusive lower left side. Outcome of the other events was condition unchanged. Seriousness and causality assessment was not reported. Following an internal review on 06 Jan 2015, of the information received on 22 Dec 2014. Event unable to walk was added.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Paraesthesia, Sleep disorder
Clinical narrative: Case number PHEH2014US025794, is an initial spontaneous report received from a consumer on 22 Dec 2014. This report refers to a 41 year old female patient. Medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1411001). Post vaccination on 29 Sep 2014, she experienced extreme fatigue, nodding off at stop lights sleeping all day functional about 3-4 hours total. Temperature difference of extremities, feet cold upper body hot shiver randomly. On 23 Oct 2014, she developed chills and outcome was condition deteriorated. On 13 Nov 2014, she developed lower left side back pain cannot walk and move extreme pain worse in the morning, cannot bend or squat, pain began to feel like it was starting in the front of abdomen and stabbing through back x-rays and CT scan shows nothing unusual. On 15 Dec 2014, being awakened by a Charlie horse like cramping in the muscles at the base of neck that extend across shoulders tingle sensation in arms that is like needles of pain all over arms. On 17 Dec 2014, experienced abdominal pain generalized. She went to the ER on 19 Dec 2014. Labs and urinalysis were unremarkable. CT scan inconclusive lower left side. Outcome of the other events was condition unchanged. Seriousness and causality assessment was not reported. Following an internal review on 06 Jan 2015, of the information received on 22 Dec 2014. Event unable to walk was added.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Abdominal pain, Back pain, Chills, Computerised tomogram normal
Clinical narrative: Case number PHEH2014US025794, is an initial spontaneous report received from a consumer on 22 Dec 2014. This report refers to a 41 year old female patient. Medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1411001). Post vaccination on 29 Sep 2014, she experienced extreme fatigue, nodding off at stop lights sleeping all day functional about 3-4 hours total. Temperature difference of extremities, feet cold upper body hot shiver randomly. On 23 Oct 2014, she developed chills and outcome was condition deteriorated. On 13 Nov 2014, she developed lower left side back pain cannot walk and move extreme pain worse in the morning, cannot bend or squat, pain began to feel like it was starting in the front of abdomen and stabbing through back x-rays and CT scan shows nothing unusual. On 15 Dec 2014, being awakened by a Charlie horse like cramping in the muscles at the base of neck that extend across shoulders tingle sensation in arms that is like needles of pain all over arms. On 17 Dec 2014, experienced abdominal pain generalized. She went to the ER on 19 Dec 2014. Labs and urinalysis were unremarkable. CT scan inconclusive lower left side. Outcome of the other events was condition unchanged. Seriousness and causality assessment was not reported. Following an internal review on 06 Jan 2015, of the information received on 22 Dec 2014. Event unable to walk was added.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Fatigue, Feeling hot, General physical health deterioration, Head titubation, Hypersomnia
Clinical narrative: Case number PHEH2014US025794, is an initial spontaneous report received from a consumer on 22 Dec 2014. This report refers to a 41 year old female patient. Medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1411001). Post vaccination on 29 Sep 2014, she experienced extreme fatigue, nodding off at stop lights sleeping all day functional about 3-4 hours total. Temperature difference of extremities, feet cold upper body hot shiver randomly. On 23 Oct 2014, she developed chills and outcome was condition deteriorated. On 13 Nov 2014, she developed lower left side back pain cannot walk and move extreme pain worse in the morning, cannot bend or squat, pain began to feel like it was starting in the front of abdomen and stabbing through back x-rays and CT scan shows nothing unusual. On 15 Dec 2014, being awakened by a Charlie horse like cramping in the muscles at the base of neck that extend across shoulders tingle sensation in arms that is like needles of pain all over arms. On 17 Dec 2014, experienced abdominal pain generalized. She went to the ER on 19 Dec 2014. Labs and urinalysis were unremarkable. CT scan inconclusive lower left side. Outcome of the other events was condition unchanged. Seriousness and causality assessment was not reported. Following an internal review on 06 Jan 2015, of the information received on 22 Dec 2014. Event unable to walk was added.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscle spasms, Pain, Paraesthesia, Peripheral coldness, Temperature difference of extremities
Clinical narrative: Case number PHEH2014US025794, is an initial spontaneous report received from a consumer on 22 Dec 2014. This report refers to a 41 year old female patient. Medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1411001). Post vaccination on 29 Sep 2014, she experienced extreme fatigue, nodding off at stop lights sleeping all day functional about 3-4 hours total. Temperature difference of extremities, feet cold upper body hot shiver randomly. On 23 Oct 2014, she developed chills and outcome was condition deteriorated. On 13 Nov 2014, she developed lower left side back pain cannot walk and move extreme pain worse in the morning, cannot bend or squat, pain began to feel like it was starting in the front of abdomen and stabbing through back x-rays and CT scan shows nothing unusual. On 15 Dec 2014, being awakened by a Charlie horse like cramping in the muscles at the base of neck that extend across shoulders tingle sensation in arms that is like needles of pain all over arms. On 17 Dec 2014, experienced abdominal pain generalized. She went to the ER on 19 Dec 2014. Labs and urinalysis were unremarkable. CT scan inconclusive lower left side. Outcome of the other events was condition unchanged. Seriousness and causality assessment was not reported. Following an internal review on 06 Jan 2015, of the information received on 22 Dec 2014. Event unable to walk was added.
Age: 41.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urine analysis normal, X-ray normal
Clinical narrative: Case number PHEH2014US025794, is an initial spontaneous report received from a consumer on 22 Dec 2014. This report refers to a 41 year old female patient. Medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1411001). Post vaccination on 29 Sep 2014, she experienced extreme fatigue, nodding off at stop lights sleeping all day functional about 3-4 hours total. Temperature difference of extremities, feet cold upper body hot shiver randomly. On 23 Oct 2014, she developed chills and outcome was condition deteriorated. On 13 Nov 2014, she developed lower left side back pain cannot walk and move extreme pain worse in the morning, cannot bend or squat, pain began to feel like it was starting in the front of abdomen and stabbing through back x-rays and CT scan shows nothing unusual. On 15 Dec 2014, being awakened by a Charlie horse like cramping in the muscles at the base of neck that extend across shoulders tingle sensation in arms that is like needles of pain all over arms. On 17 Dec 2014, experienced abdominal pain generalized. She went to the ER on 19 Dec 2014. Labs and urinalysis were unremarkable. CT scan inconclusive lower left side. Outcome of the other events was condition unchanged. Seriousness and causality assessment was not reported. Following an internal review on 06 Jan 2015, of the information received on 22 Dec 2014. Event unable to walk was added.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US0225122, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 92-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US001040 is an initial spontaneous report received from a nurse on 09 Jan 2015. This report refers to a 29 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13443P, expiry date: not reported) intramuscularly on 09 Jan 2015. It was reported that the vaccine administered was expired. No adverse events were reported following the maladministration.
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2014US026064, is an initial spontaneous report from a pharmacist received on 23 Dec 2014. This report refers to a male patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in a hospital approximately two months after receiving FLUVIRIN (batch number: not reported) in 2014. No adverse event was reported following the maladministration.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025121, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 67-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 21 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site swelling
Clinical narrative: Case number PHEH2015US001351, is an initial spontaneous report from a physician received on 14 Jan 2015. This report refers to a 26-year-old female patient. Medical history and concomitant medications were not reported. On 11 Jan 2015, she was vaccinated with FLUVIRIN (batch number: 1413901) via intradermal route in error. On the same day, after vaccination, the patient experienced swelling at the injection site. Outcome of the events was not reported. Seriousness and causality of the events was not reported.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025358, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 69 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the right deltoid on 16 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error (incorrect storage of drug).
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025119, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 49-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 27 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this administration (incorrect storage od drug).
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025360, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 59 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 20 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error (incorrect storage of drug).
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025334, is an initial spontaneous report from a medical assistant received on 16 Dec 2014. This report refers to a 65-year-ild female 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 20 Oct 2014, the patient was vaccinated with 0.5 ml FLUVIRIN (batch number: 145701, expiry date: Mar 2015) intramuscularly into left 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 (incorrect storage of drug).
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025115, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 17-year-old male patient. Historical conditional were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at  a dose of 0.5 ml on 24 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following the maladministration (incorrect storage of drug).
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025335, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 29 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 23 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error (incorrect storage of drug).
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025336, is an initial spontaneous report received from a medical assistant on 16 DEC 2014. This report refers to a 32 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 29 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error (incorrect storage of drug).
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025132, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 74-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 11 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration (incorrect storage of drug).
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Muscular weakness, Myalgia, Sleep disorder
Clinical narrative: Case number PHEH2015US002898, is an initial spontaneous report received from a consumer on 06 FEB 2015. This report refers to a 41 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145304) intramuscularly on an unknown date. On 18 OCT 2014 (after unknown interval of vaccination), the patient experienced soreness at site, muscle pain and exhaustion. She used other arm at times due to weakness of the injected arm. She also woke up during night due to pain. The patient was planning to visit a physician. Final outcome of the events was unknown. Seriousness and causality of the events were not reported.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025157, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 65 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 28 OCT 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration (incorrect storage of drug).
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2015US002938, is an initial spontaneous report received from a nurse on 06 FEB 2015. This report refers to a 27 year old female patient. Medical history and concomitant medication was not reported. On 14 JAN 2015, she received FLUVIRIN 2014/2015 (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: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025344, is an initial spontaneous report received from a medical assistant on 16 DEC 2014. This report refers to a 79 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701, expiry date: MAR 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 16 OCT 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error (incorrect storage of drug and inappropriate age of vaccine administration).
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025153, is an initial spontaneous report from a nurse received on 08 DEC 2014. This report refers to a 52 years old female patient. Historical conditions were not reported. No concomitant medications was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 22 OCT 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration (incorrect storage of drug).
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2015US003469, is an initial spontaneous report from a medical assistant received on 18 FEB 2015. This report refers to a 53 years old female patient. Medical history and concomitant medications were not reported. On 12 FEB 2015, the patient mistakenly received FLUVIRIN 2014/2015 (batch number: 1410801) intradermally instead of PPD (tuberculin) skin test. No adverse event was reported.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2014US025345, is an initial spontaneous report received from a pharmacist on 15 DEC 2014 and follow up report received from health care professional on 27 FEB 2015. This report refers to a 37 years old female pregnant patient. Her medical history was not reported. Concomitant medications included prenatal vitamins. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 141401) intramuscularly in error instead of the corporate approved flu vaccine for expectant mothers on 13 DEC 2014. No adverse events reported after the maladministration. Upon follow up it was reported that on an unknown date the patient delivered a normal baby. No further information was reported. Follow up report received from health care professional on 27 FEB 2015: Pregnancy outcome was update and new event (normal newborn) was coded.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2015US009004 is an initial incomplete report from a nurse received on 07 May 2015 with a follow up spontaneous report from a nurse received on 18 Jun 2015. This report refers to a 62-year-old male patient. Medical history included ethyl alcohol (ETOH) abuse. Concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number 14511P) on 24 Mar 2015 in his left deltoid which was outside of normal temperature range at 19.1 C for 68 hours. No further information was reported. Follow up report from a nurse received on 18 Jun 2015: Update patient demographics, medical history and data of vaccination.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025346, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 54 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 21 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025152, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 55 years old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 22 Oct 2014. The nurse reported FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration (incorrect storage of drug).
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025348, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 37 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the right deltoid on 22 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US005323, is an initial spontaneous report from a pharmacist received on 17 Mar 2015. This report refers to a patient of unknown age and gender. Past medical history and concomitant medication were not reported. On an unknown date, the patient was vaccinated with FLUVIRIN (batch number: unknown) via intradermal. No adverse event was reporting following this administration error.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025349, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to an 87 years old male patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the right deltoid on 20 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025151, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 10 years old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at ta dose of 0.5 ml on 22 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025353, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 53 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 21 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US005104, is an initial spontaneous report received from a health care professional on 12 Mar 2015. This report refers to a 73-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with expired FLUVIRIN (batch number: 1204801A, expiry date: 31 May 2013) intramuscularly on 28 Nov 2014 in error. No adverse event was reported following this medication error.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025354, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to an 80 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 27 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error (incorrect storage of drug).
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025355, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 73 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 28 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025313, is an initial spontaneous from a medical assistant received on 16 Dec 2014. This report refers to a 60 year old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015) 0.5 ml intramuscular into right deltoid that was stored at minus 0.6 degrees Celsius for 2  hours and 50 minutes. No adverse event was reported. No further information was provided.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025318, is an initial spontaneous report from a medical assistant received on 16 Dec 2014. This report refers to a 72 year old female patient. Historical conditions were not reported.  No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015) 0.5 intramuscular into left deltoid that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes on 27 Oct 2014. No adverse event was reported. No further information was provided.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025319, is an initial spontaneous report from a medical assistant received on 16 Dec 2014. This report refers to an 81 year old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015) 0.5 ml intramuscular into left deltoid that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes on 28 Oct 2014. No adverse event was reported. No further information was provided.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US010838 is an initial spontaneous report received from a medical assistant on 29 May 2015, and with a follow-up report received from medical assistant on 30 Jul 2015. This report refers to a 16 year old male patient. Past medical history and concomitant medications were not reported. The medical assistant reported that the refrigerator reached 14 degree Celsius in the month of Jan 2015 and the patient was vaccinated with FLUVIRIN (batch number: 1412201) multi dose vial (MDV) intramuscularly on 03 Feb 2015 which underwent one temperature excursion. No adverse events were reported following the maladministration. Follow-up report received from medical assistant on 30 Jul 2015. Updated patient weight.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025321, is an initial spontaneous report from a medical assistant received on 16 Dec 2014. This report refers to a 71-year-old female 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 16 Oct 2014, the patient was vaccinated with 0.5 ml of FLUVIRIN (batch number: 145701, expiry date: Mar 2015) into left 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 (incorrect storage of drug).
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2015US011796 is an initial spontaneous report from a nurse received on 18 Jun 2015. This report refers to a 32-year-old male patient. Medical history included vaccination with TD booster in 2005. Concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number unknown) in his left deltoid on 23 March 2015 which was outside of normal temperature range at 19.1 C for 68 hours. No further information was reported.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025322, is an initial spontaneous report from a medical assistant received on 16 Dec 2014. This report refers to an 89-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 17 Oct 2014, the patient was vaccinated with 0.5 ml of FLUVIRIN (batch number: 145701, expiry date: Mar 2015) intramuscularly into left 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 (incorrect storage of drug).
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US002910, is an initial spontaneous report received from a Healthcare Professional on 06 Feb 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: 1412801) intramuscularly at a dose of 0.5 ml on 12 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: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Overdose
Clinical narrative: Case number PHEH2015US006775 is an initial combined spontaneous report received from a pharmacist on 07 Apr 2015 with a follow up information received from the pharmacist on the same date. This report refers to a 34 years old male patient. His medical history and concomitant medications were not reported. The pharmacist reported that the nurse administered the patient with 1 ml FLUVIRIN (batch number: 1413801) intramuscularly on 07 Apr 2015 instead of 0.5 ml of FLUVIRIN. No adverse events were reported following the maladministration.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort
Clinical narrative: Case number PHEH2015US004680, is an initial spontaneous report from the consumer (patient) received on 09 Mar 2015. This report refers 46-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly on 01 Dec 2013. It was reported that, she is still experiencing the arm discomfort at the date of reporting. The final outcome of the event was unknown. The seriousness and causality assessment of the event was not reported.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025138, is an initial spontaneous report from a nurse received on 09 Dec 2014. 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 FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 27 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration (incorrect storage of drug).