chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026832, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 21-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 07 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Sex: U
Vaccine: MMR
Symptoms: Mumps, Vaccination failure
Clinical narrative: This spontaneous report was received from an unspecified reporter who ported an article in a web site concerning to a 193 students of an unknown age and gender. The patients's concurrent conditions, medical history, historical drugs and concomitant medication were not reported.  On unknown dates, the patients were vaccinated with two doses of M-M-R II (dose, route, lot number and expiration date were not reported) for prophylaxis. On unknown dates (August), the patients got mumps. It was reported that "in spite of two vaccines as a school requirement, the students got sick anyway" A reporter stated "a fact that we had mumps showing up in highly immunized populations likely reflects something about the effectiveness of the vaccine".  At the time of the report, the outcome of mumps and vaccination failure was not reported. The causal relationship between the events and M-M-R II was not reported. This is one of the several reports received from the same reporter. Additional information is not expected as there is not contact details of the reporter.; Sender's Comments: US-009507513-1701USA005463:         Original Case : 1701USA005463 US-009507513-1701USA006590:
Sex: U
Vaccine: MMR
Symptoms: Mumps, Vaccination failure
Clinical narrative: This spontaneous report was received from an unspecified reporter via a news concerning to over 2000 patients between school age children and adults of unknown age and gender. The patients's concurrent conditions, medical history, historical drugs and concomitant medication were not reported. On unknown dates, the patients were vaccinated  with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (dose, route, lot number and expiration date were not reported) for prophylaxis. On unknown dates since August 2016, the patients experienced mumps. It was reported that more than 90% percent affected children and 30 to 40 percent of affected adults were vaccinated but "those adult vaccination rates were typical and do not explain the outbreak" and "normally, people only received two doses of the vaccine, but they were recommending a third dose". At the time of the report, the outcome of mumps and vaccination failure was not reported. The causal relationship between the events and  Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) was not reported. This is one of the several reports from  the same reporter. Additional information is not expected as there is not contact details of the reporter.; Sender's Comments: US-009507513-1701USA006589: US-009507513-1701USA005463:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous report concerning a 62 year old female patient was received from the patient herself via an unspecified source. Her pertinent medical history and concurrent conditions were not reported. Notably though, she had no known drug reactions/ allergies. On 29-SEP-2016, the patient was vaccinated with ZOSTAVAX, intramuscularly, for prophylaxis (the dose, frequency, lot # and indication were unknown). Her concomitant therapies included an unspecified thyroid medication. Subsequently, on 03-OCT-2016, the patient began experiencing a tiny rash around her left eye and around the upper and lower lash area. The rash was itchy as well. Hence, she visited a physician who prescribed hydrocortisone and acyclovir (reported as "acyclozir"). The events resolved for a while, but returned. At the time of reporting, the events remained unresolved and the patient was consistently seeing the physician for a lasting treatment. Reportedly, no laboratory diagnostic studies were performed. The patient also failed to provide an explicit causal relationship between the events, and the vaccination with ZOSTAVAX. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026835 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 55-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 06 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked he temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US024667, is an initial spontaneous report received from a pharmacist on 20 Nov 2015 (combined report). This report refers to an 8 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514801, expiry date: May 2016) intramuscularly at a dose of 0.5 ml on 19 Nov 2015. It was reported that before administration the vaccine was exposed to up to 28 degree Fahrenheit for up to 8 hours. The case was reported as non-serious. No adverse events were reported following the inadvertent administration. Combined follow up information received from a pharmacist on 20 Nov 2015: Expiry date of vaccine updated.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US024720 is an initial spontaneous report received from a nurse on 24 Nov 2015. This report refers to a 3 year old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1517001) intramuscularly on 23 Nov 2015. No adverse events were reported following this maladministration (drug administered to patient of inappropriate age).
Sex: F
Vaccine: FLU3
Symptoms: Cough, Decreased immune responsiveness, Nausea, Pyrexia, Vomiting
Clinical narrative: Case number PHEH2015US024751, is an initial spontaneous report from a consumer (patient) via Claim Management Services received on 23 Nov 2015. This report refers to a female patient of an unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515001, expiry date: 31 May 2016) on an unknown date. The patient was also vaccinated with seasonal influenza vaccine (manufacturer unknown and batch number: not reported) on an unknown date. On an unknown date, the patient received NEORAL at an unknown dose for an unknown indication. On 06 Nov 2015, the patient had a reaction to the flu vaccine which included nausea, vomiting and fever. The patient experienced severe cough and immune system decreased after receiving the vaccine. The outcome, seriousness and causality of the events were not reported. Follow up report received from a consumer on 07 Jan 2016: Updated suspect drug information (influenza vaccine and NEORAL) and event information (cough and immune system decreased).
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US024818, is an initial spontaneous report received from a healthcare professional on 23 Nov 2015. This report refers to a 46 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLURIVIN (batch number: 1515701) multi dose vial (MDV) into left deltoid, intramuscularly at a dose on 0.5 ml on 23 Nov 2015 at 08:48 am. It was reported that the vaccine administered was out of temperature range at 46.8 degree Fahrenheit for 24 hours. The case was reported as non-serious. No adverse events were reported following the medication error. Follow up report received from a healthcare professional on 21 Jan 2016: added suspect drug information (batch number, vaccination site and time).
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026843, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 23 years old female patient. Medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: 1514501, expiry date: May 2016) intramuscularly into left deltoid on 19 Oct 2015. It was reported that FLUVIRIN administered had a temperature excursion of 34 degrees Fahrenheit overnight. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026844, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 27 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 05 Oct 2015. It was reported that FLUVIRIN administered had a temperature excursion of 34 degrees Fahrenheit overnight. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026845, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 21 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 07 Oct 2015. It was reported that FLUVIRIN administered had a temperature excursion of 34 degrees Fahrenheit overnight. The reporter stated that she did not known why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026846, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 61 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 07 Oct 2015 which was out of temperature range (34 degrees Celsius). The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were not problems since the temperature excursion. No adverse even was reported following this medication error (incorrect storage of drug). Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026847, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 37 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 06 Oct 2015 which was out of temperature range (34 degrees Celsius). The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were not problems since the temperature excursion. No adverse event was reported following this medication error. Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026849, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 46-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 12 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degree). The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were not problems since the temperature excursion. No adverse event reported following this medication errors (incorrect storage of drug). Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026851, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 44-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 13 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degree). The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were not problems since the temperature excursion. No adverse event reported following this medication errors. Follow up information received via nurse on 26 Jan 2016: Reporter's comment updated.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026853, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 54-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 06 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degrees). The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day, the temperature was fine. It was a new refrigerator and there had not been any problems since the temperature excursion. No adverse event reported following this medication errors (incorrect storage of drug). No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US024665, is an initial spontaneous report from a pharmacist received on 20 Nov 2015. This report refers to a 6 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514801) 0.5 ml intramuscular on 19 Nov 2015. It was reported that the patient received FLUVIRIN that was exposed to temperatures up to 28 F for up to 8 hours before vaccination. The case was assessed as non-serious. No adverse event was reported.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US024666 is an initial spontaneous report received from a pharmacist on 20 Nov 2015. This report refers to a 39 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514801) intramuscularly at a dose of 0.5 ml on 19 Nov 2015. It was reported that the vaccine administered was exposed to temperatures up to 28 degree Fahrenheit for up to 8 hours. The case was reported as non-serious. No adverse events were reported following the inadvertent administration.
Age: 16.0
Sex: F
Vaccine: FLU4, MEN
Symptoms: Hypoaesthesia, Injection site swelling, Pain, Rash, X-ray
Clinical narrative: Rash, numbness, body aches, and swelling at injection site.
Age: 1.75
Sex: M
Vaccine: FLU4, HIBV
Symptoms: Disturbance in attention, Fatigue, Lethargy, Somnolence
Clinical narrative: Child was very tired and napped longer than usual.  After he woke up he was lethargic and had trouble concentrating.  EMT were called, but did not take child to ER.  Parent will call back tomorrow with update.
Age: 65.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swollen area around injection site, redness, hard to touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Eye swelling, Hypersensitivity, Swelling face
Clinical narrative: Approximately 10 minutes after vaccine administration patient experienced mild allergic reaction.  Symptoms presented as swelling on face and puffiness around eyes. Patient was immediately checked by an MD.  Pulse ox and heartrate normal.  No respiratory distress.  Patient received Diphenhydramine and was monitored until swelling had reduced.  Once symptoms resolved patient was cleared to leave.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever/chills, body aches/malaise and developed searing pain in entire left arm. Anytime I tried to lift it, I got a jolt of excruciating pain.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity, Rotator cuff syndrome, Sleep disorder
Clinical narrative: For weeks I had severe arm pain and limited range of mobility - couldn't lift my arm to put on a shirt or coat. The pain woke me up several times during the night. It has slowly gotten better over time and after receiving a cortisone shot in my shoulder, but after 3 months, I still have pain when I lift my arm in a certain way. I had never had any shoulder/arm pain prior to receiving the flu shot.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray limb abnormal
Clinical narrative: For weeks I had severe arm pain and limited range of mobility - couldn't lift my arm to put on a shirt or coat. The pain woke me up several times during the night. It has slowly gotten better over time and after receiving a cortisone shot in my shoulder, but after 3 months, I still have pain when I lift my arm in a certain way. I had never had any shoulder/arm pain prior to receiving the flu shot.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient started to experience sharp pain in whole arm. Was unable to move arm. Took 800 mg of IBU. Followed up with patient on 1/19/17 and she is feeling better, the pain has stopped and she just feels sore.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Heart rate increased, Hyperhidrosis
Clinical narrative: I administered both the FLUZONE HD and PNEUMOVAX, one in each arm, after patient stood up she said she didn't feel well. I sat her down and she was unable to breathe. Her heart rate increased and blood pressure increased and she was dizzy and sweating.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise
Clinical narrative: I administered both the FLUZONE HD and PNEUMOVAX, one in each arm, after patient stood up she said she didn't feel well. I sat her down and she was unable to breathe. Her heart rate increased and blood pressure increased and she was dizzy and sweating.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Violent stomach pain and started to vomit. Lasted until 4AM. No medical attention was obtained.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Autonomic nervous system imbalance, Disturbance in attention, Dizziness, Fatigue, Headache
Clinical narrative: Patient began feeling dizzy about 2 weeks post vaccine. About a week later headache started. She has been fatigued continues to feel dizzy every day several times a day, her headache is daily all day long, she has episodes of tachycardia, feels forgetful and has trouble concentrating. She has been diagnosed with autonomic dysfunction.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Laboratory test normal, Memory impairment, Nuclear magnetic resonance imaging normal, Tachycardia
Clinical narrative: Patient began feeling dizzy about 2 weeks post vaccine. About a week later headache started. She has been fatigued continues to feel dizzy every day several times a day, her headache is daily all day long, she has episodes of tachycardia, feels forgetful and has trouble concentrating. She has been diagnosed with autonomic dysfunction.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Bright pink rash from wrist of right are extending onto the chest. (vaccine was given in the left arm- there was no reaction at the injection site).
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Eye swelling, Pyrexia, Swelling face, Urticaria
Clinical narrative: Hives covering body, fever, swollen face & eyes.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Chills, Headache, Injection site discomfort, Injection site pain
Clinical narrative: Vomitting, nausea, stomach pain, mild fever, body aches, muscle cramps, muscle fatigue, chills, headache, extreme pain and discomfort at injection site. Vomitting, nausea, stomach pain, and headache subsided after 6 hours. Fever, body aches, muscle cramps and fatigue, and chills treated with ibueprofen, but symptoms still occuring at 11:45PM on 1-19-17.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle fatigue, Muscle spasms, Nausea, Pain, Pyrexia
Clinical narrative: Vomitting, nausea, stomach pain, mild fever, body aches, muscle cramps, muscle fatigue, chills, headache, extreme pain and discomfort at injection site. Vomitting, nausea, stomach pain, and headache subsided after 6 hours. Fever, body aches, muscle cramps and fatigue, and chills treated with ibueprofen, but symptoms still occuring at 11:45PM on 1-19-17.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Vomitting, nausea, stomach pain, mild fever, body aches, muscle cramps, muscle fatigue, chills, headache, extreme pain and discomfort at injection site. Vomitting, nausea, stomach pain, and headache subsided after 6 hours. Fever, body aches, muscle cramps and fatigue, and chills treated with ibueprofen, but symptoms still occuring at 11:45PM on 1-19-17.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026938, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 25 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 07 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026958 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 21 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 19 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026946, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 55 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow-up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026948, is an initial spontaneous report   received from a nurse on 22 Dec 2015. This report refers to a 40 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into right deltoid on 26 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026950, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 45-years-old-male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into right deltoid on 17 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026952, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a patient of unknown age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 26 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026953, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 55 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) in left deltoid on 05 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026955, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 31 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into the right deltoid on 07 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026957, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 56 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) in left deltoid on 13 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026934 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 64 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLURIVIN (batch number: 1514501 and expiry date: May 2016) into the left deltoid on 08 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026935, is an initial spontaneous report  received from a nurse on 22 Dec 2015. This report refers to a 22 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) in left deltoid on 16 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026828 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 22 years old female patient. Medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 29 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026939, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 22 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) in left deltoid on 19 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026942, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 32 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 09 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026945, is an initial spontaneous report  received from a nurse on 22 Dec 2015. This report refers to a 47 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) in left deltoid on 12 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026932 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 21 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 24 Oct 2015. It was reported the FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 0.67
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US026933, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 08 months old male patient. Past medical history and concomitant medication were not reported. The male neonate of 08 months was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) in right deltoid on 13 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Blood glucose decreased, Dizziness, Electrocardiogram normal, Fall
Clinical narrative: This 31 yo patient advised he has recurrent worsening of commonly reported side effects to Influenza vaccine. Between 2010-2014 each annual flu shot, IIV or mist, resulted in headaches, sensation of fever, body aches, stomachaches/nausea wo vomiting, which could last 1-3 days. Vaccines were typically given prior to a 4 day weekend so he would spend the weekend in bed and was back to normal self by day 4. Symptoms were worse with the nasal flu. However following 2015 flu shot he had a syncopal episode about 12 hours post vaccination. He had been there for several months, had no current illness, no exposures to chemicals/gas, has no PMH, has an allergy to avocadoes; no true seasonal allergy (if pollen high has issues otherwise okay) and is on no medications. He advised he received annual flu about 1600 hr, went and ate dinner (same items prior to and after vaccine has no reaction), about 3-4 hours after vaccination he began to experience a diffuse headache, body aches, stomach ache and feverish similar to past reactions, but faster in onset and severity. He went to bed believing these were expected side effects he had before with every flu shot. About 2-230am he left home walked about 100 feet to a port a john to urinate. While urinating, he advised his head was throbbing 10/10, his nausea worsened to point he knew he was going to vomit, felt dizzy and then recalls nothing - he passed out. He was found by buddies about 3am outside of toilet against a barrier wall support, pants unzipped, no visible injuries from falling out of toilet. He had to be shaken for him to arouse. He was taken to medical center where he reported a severe headache and flu like symptoms. He was treated with ZOFRAN which relieved nausea within 5 minutes; however when he sat up to drink water as he was thirsty, he again wanted to pass out feeling lightheadedness/nauseated which resolved lying down. Providers then treated with PHENERGAN and 1 liter of D5NS. Medical records document BS of 69, BP 93-67 unknown heart rate, but BP reported as normal after 1 lither of fluid. CBC, CMP, UA, EKG all normal. He has not had any similar reaction since. He does admit to head injuries in past causing him to be dizzy, but nothing like this has ever happened. He questions relationship/allergy to flu vaccine. Vaccine site had no reported reaction.