chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Myalgia, Neuropathy peripheral, Nuclear magnetic resonance imaging, Rash, Rash erythematous
Clinical narrative: Fatigue and muscle aches began on 9/26/2014. Still feel this way to date.  My cognitive processing began to get slower.  I have had a hard time concentrating.  On 10/19/2014 intense vertigo began at 11am.  Never had vertigo before.  Stayed in bed until 10/21/2014 at 3:30am when I had to have my wife who was still dealing with double vision possibly from the same vaccine, take me to Emergency Room.  I was admitted overnight as the anti-vertigo medicines were not working well.  I was discharged at 5:30 pm on 10/22/2014, still experiencing some vertigo as well as pressure in my head and ears.  To date I still have the pressure in my head, I cannot think quickly and feel like my central nervous system is out of whack.  Neuropathy began on both of my feet on 09/26/2014.  I still have this.  I have muscle twitches occuring since the vaccine.  On 12/04/2014 my heart went into a severe  arrhythmia sending me back to the ER.  The Dr's shocked my heart three times with no results.  They proceeded to do an emergency catherization which showed no blockages, but put my heart back into normal rhythm after a wire passed over my heart.  The Dr's are still not sure what caused the problem and said they can't rule out the vaccine, but it would be hard to prove.  I have had a red rash on my face on and off since the vaccine.  I was a healthy, strong male prior to getting the two Twinrix vaccines.  I am concerned about the pressure in my head I still have.  Could it be encephalitis?  Or something similar?  Dr's cannot find an answer for me or my wife who also had the vaccines and now severe health issues.
Age: 60.0
Sex: M
Vaccine: HEPAB, VARZOS
Symptoms: Vertigo
Clinical narrative: Fatigue and muscle aches began on 9/26/2014. Still feel this way to date.  My cognitive processing began to get slower.  I have had a hard time concentrating.  On 10/19/2014 intense vertigo began at 11am.  Never had vertigo before.  Stayed in bed until 10/21/2014 at 3:30am when I had to have my wife who was still dealing with double vision possibly from the same vaccine, take me to Emergency Room.  I was admitted overnight as the anti-vertigo medicines were not working well.  I was discharged at 5:30 pm on 10/22/2014, still experiencing some vertigo as well as pressure in my head and ears.  To date I still have the pressure in my head, I cannot think quickly and feel like my central nervous system is out of whack.  Neuropathy began on both of my feet on 09/26/2014.  I still have this.  I have muscle twitches occuring since the vaccine.  On 12/04/2014 my heart went into a severe  arrhythmia sending me back to the ER.  The Dr's shocked my heart three times with no results.  They proceeded to do an emergency catherization which showed no blockages, but put my heart back into normal rhythm after a wire passed over my heart.  The Dr's are still not sure what caused the problem and said they can't rule out the vaccine, but it would be hard to prove.  I have had a red rash on my face on and off since the vaccine.  I was a healthy, strong male prior to getting the two Twinrix vaccines.  I am concerned about the pressure in my head I still have.  Could it be encephalitis?  Or something similar?  Dr's cannot find an answer for me or my wife who also had the vaccines and now severe health issues.
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Reports fever of 100.2 F approx 12 hrs after injection lasting approx 6 hrs.
Age: 1.33
Sex: M
Vaccine: DTP, FLUX, HIBV, UNK
Symptoms: Hypertension, Insomnia, Middle insomnia, Screaming
Clinical narrative: Woke up at 3am with a with blood curtailing screaming. From that point on had high blood pressure, refused to lay down, when he finally could not stay awake he would stop crying and "rest" standing up in his crib. Just fyi this is a baby that has slept through the night since 3 months and napped like clock work! This was definitely from these shots. The worst part is u make kids get so many at once, which one did this???
Age: 31.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea, Faeces pale, Nausea
Clinical narrative: Explosive diarrhea, abdominal cramping.  Feeling sick to my stomach.  Diarrhea is a light grayish brown color.
Age: 38.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Arthralgia, Arthritis, Injection site hypoaesthesia, Injection site pruritus
Clinical narrative: Pain in knees and ankles every time I sit getting progressively worse as time passes. I had no knee or ankle pain before vaccination. Constant pain now. Just found out that this is from rubella vaccine. Numbness and deep crawling itch in location of vaccine. (deep itch has improved some over time and some sensation in shoulder has returned)
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Skin warm, Soft tissue necrosis
Clinical narrative: Large red localized wheal that was very hot and hard. Progressively got > hot, red, painful (kept me awake x 48 hrs. hurt so bad, even w/TYLENOL and hydrocodone for pain). No better w/ice, finally, oral and topical antihistamine decreased reaction. Wheal = 3 1/2 inches x 3 1/2 inches x 3-5 days. Didn't respond to TYLENOL and topical ice and steroids. The tissue was beginning to look necrotic b/4 I put BENADRYL cream on it. I am on BNIBSN x 38 yrs.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Large red localized wheal that was very hot and hard. Progressively got > hot, red, painful (kept me awake x 48 hrs. hurt so bad, even w/TYLENOL and hydrocodone for pain). No better w/ice, finally, oral and topical antihistamine decreased reaction. Wheal = 3 1/2 inches x 3 1/2 inches x 3-5 days. Didn't respond to TYLENOL and topical ice and steroids. The tissue was beginning to look necrotic b/4 I put BENADRYL cream on it. I am on BNIBSN x 38 yrs.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injection site pain, Musculoskeletal disorder
Clinical narrative: Patient states her arm is still sore where vaccine was given. Feels weak and doesn't have full function of her arm.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Nausea, Pain in extremity, Vomiting
Clinical narrative: Redness at injection site, arm aches all over. Patient reports nausea and vomiting beginning 12 to 18 hours post vaccination.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Computerised tomogram, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Injected arm swollen shoulder to elbow; Severe pain in muscle injected; immobility of injected arm; slept 40 hrs straight after injection, after that, extreme fatigue, loss of appetite, chills. Three days after shot daily bouts of diarrhea which continues.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site reaction, Injection site swelling, Myalgia, Myocardial necrosis marker
Clinical narrative: Injected arm swollen shoulder to elbow; Severe pain in muscle injected; immobility of injected arm; slept 40 hrs straight after injection, after that, extreme fatigue, loss of appetite, chills. Three days after shot daily bouts of diarrhea which continues.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Scan with contrast, Stress echocardiogram
Clinical narrative: Injected arm swollen shoulder to elbow; Severe pain in muscle injected; immobility of injected arm; slept 40 hrs straight after injection, after that, extreme fatigue, loss of appetite, chills. Three days after shot daily bouts of diarrhea which continues.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Pt presented with hard, red lump at inj site and red rash along upper arm. Advised pt to take BENADRYL. Area was also very tender. Followed up with pt on 1/4/15-Area much improved.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Episode of syncope occurred minutes after vaccine was administered. Pt laid on floor and elevated feet. No trouble breathing or seizures. Waited approximately 15 minutes and was well enough to leave with her father.
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure to product, Contact lens intolerance, Exposure via direct contact, Eye discharge, Eye irritation
Clinical narrative: This spontaneous report was received from a female healthcare worker of an unknown age reporting on herself. There was no information on pertinent medical history and drug reactions or allergies. On an unknown date, the healthcare worker went to administrate GARDASIL strength reported as 120 Y (unspecified units), dose, frequency, product lot#, expiry date not reported to an unspecified patient. She reported that the needle came off the syringe when she went to administrate GARDASIL to unspecified patient and all the vaccine sprayed out into her face. She stated some of the GARDASIL vaccine went into her eyes and at the time she did not feel any type of burning or stinging so she went about her day and did not flush her eyes or take any steps to take care of her eyes. She was wearing her contact lenses and did not remove at this time. On an unknown date, reported as approximately three weeks to one month later, she noticed her eyes were gummy, sticky and irritated in the morning when she wakes up, and now she cannot tolerate wearing her contact lenses because she can't see out them. She felt like her contact lens were clouding up. On an unknown date, the patient sought medical attention by visiting an unspecified ophthalmologist who treated her with a combination eye drop that consist of tobramycin and another unknown medication (name and manufacturer unknown). The ophthalmologist mentioned she had little bumps under eyelids that are secreting mucus. There was no product quality complaint involved. The outcome of the events her eyes gummy, sticky and irritated in the morning, she cannot tolerate wearing her contact lens because she cannot see out of them, she had little bumps under her eyelids that are secreting mucus was reported as not recovered. The outcome of the events she felt like her contact lens are clouding up and all vaccine sprayed out into her face was unknown. The healthcare worker also reported that there was no issues with unspecified patient that the GARDASIL was intended for. This GARDASIL that was sprayed out of the syringe during preparation did not come into contact with the unspecified patient. The unspecified patient went to receive full dose of GARDASIL, because she drew up another dose of GARDASIL after the situation. The causality of the events her eyes gummy, sticky and irritated in the morning, she cannot tolerate wearing her contact lens because she cannot see out of them, she had little bumps under her eyelids that are secreting mucus was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Eyelid rash, Secretion discharge
Clinical narrative: This spontaneous report was received from a female healthcare worker of an unknown age reporting on herself. There was no information on pertinent medical history and drug reactions or allergies. On an unknown date, the healthcare worker went to administrate GARDASIL strength reported as 120 Y (unspecified units), dose, frequency, product lot#, expiry date not reported to an unspecified patient. She reported that the needle came off the syringe when she went to administrate GARDASIL to unspecified patient and all the vaccine sprayed out into her face. She stated some of the GARDASIL vaccine went into her eyes and at the time she did not feel any type of burning or stinging so she went about her day and did not flush her eyes or take any steps to take care of her eyes. She was wearing her contact lenses and did not remove at this time. On an unknown date, reported as approximately three weeks to one month later, she noticed her eyes were gummy, sticky and irritated in the morning when she wakes up, and now she cannot tolerate wearing her contact lenses because she can't see out them. She felt like her contact lens were clouding up. On an unknown date, the patient sought medical attention by visiting an unspecified ophthalmologist who treated her with a combination eye drop that consist of tobramycin and another unknown medication (name and manufacturer unknown). The ophthalmologist mentioned she had little bumps under eyelids that are secreting mucus. There was no product quality complaint involved. The outcome of the events her eyes gummy, sticky and irritated in the morning, she cannot tolerate wearing her contact lens because she cannot see out of them, she had little bumps under her eyelids that are secreting mucus was reported as not recovered. The outcome of the events she felt like her contact lens are clouding up and all vaccine sprayed out into her face was unknown. The healthcare worker also reported that there was no issues with unspecified patient that the GARDASIL was intended for. This GARDASIL that was sprayed out of the syringe during preparation did not come into contact with the unspecified patient. The unspecified patient went to receive full dose of GARDASIL, because she drew up another dose of GARDASIL after the situation. The causality of the events her eyes gummy, sticky and irritated in the morning, she cannot tolerate wearing her contact lens because she cannot see out of them, she had little bumps under her eyelids that are secreting mucus was unknown. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US018794, is an initial spontaneous report from a nurse received on 17 Sep 2014. This report refers to 33 months and 22 days old female patient. Past medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1412201) intramuscularly from a multiple dose vial (MDV) on 16 Sep 2014. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, OPV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome per pt. hx. onset 1-2 months following vaccination.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Apparent life threatening event, Pruritus, Rash
Clinical narrative: Case number PHHY2013US127794 is an initial spontaneous report received from a consumer via vaccine adverse event reporting system (VAERS reference number: 499970) web site on 11 Nov 2013. This report refers to a 36-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1205201) intramuscularly in the left arm on 25 Oct 2012. On 27 Oct 2012, her skin broke out in severe skin rash and she had extremely itchy skin. She went back to pharmacy and she was recommended to take PANADOL. The treatment worked, but she had to take it every day. She was also recommended to take CLARITIN 10 mg. CLARITIN 10 mg worked and she took it initially every 2 days and then reduced it to 3 days. She reported that she had to take it at least once a week and the rash and itchy skin returned whenever she stopped it. She did not undergo any laboratory tests. The events were assessed as life-threatening. The outcome of the events was reported as condition unchanged. The causality was not reported.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Guillain-Barre syndrome, Nerve injury, Vaccination site pain
Clinical narrative: Case number PHHY2013US127886, is an initial report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 500785) website on 11 Nov 2013. This report refers to 45-year-old female patient. Her medical history included pain in left arm - nerve following vaccination with FLUVIRIN (batch number: not reported) on an unspecified date (see case number: PHHY2013US129294). Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in the left arm on 26 Dec 2012. On 02 Jan 2013, she experienced severe pain in left arm around where vaccination was given. It was also reported that same pain started in left hip on the hip bone. It started about a week after vaccination and pain got progressively worse and peaked at four weeks after flu vaccine was administered. She called the pharmacist and the pharmacist said her nerve was affected by vaccine and suggested to apply ice on it and take pain medication. She reported that the treatment worked and she was feeling a little better. Even after eight months, she was still experiencing constant pain in the left arm and hip. She reported that she had never a problem with the flu vaccine until H1N1 was added to it. She suspected that she had Guillain-Barre syndrome. She planned to visit a different doctor to confirm this and try to seek treatment. The event outcome was condition unchanged as of 28 Aug 2013. The seriousness and causality were not reported. No additional information was available.
Sex: U
Vaccine: FLU3
Symptoms: Burning sensation, Fall, Guillain-Barre syndrome, Hypoaesthesia, Mobility decreased
Clinical narrative: Case number PHHY2013US127913, is an initial report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 501778) website on 11 Nov 2013. This report refers to a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 111770P1) on an unspecified date. On an unspecified date after vaccination, the patient experienced tingling and burning sensation in legs, feet. She also experienced numbness and tingling in hands and across back. It was reported that the patient had muscle loss in legs which caused the patient to fall three times. The patient lost the use of the legs and had a hard time using hands. The patient was diagnosed with Guillain-Barre Syndrome. The event outcome was condition unchanged as of 09 Sep 2013. The seriousness and causality was not reported. No additional information was available.
Sex: U
Vaccine: FLU3
Symptoms: Muscle atrophy, Musculoskeletal disorder, Paraesthesia
Clinical narrative: Case number PHHY2013US127913, is an initial report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 501778) website on 11 Nov 2013. This report refers to a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 111770P1) on an unspecified date. On an unspecified date after vaccination, the patient experienced tingling and burning sensation in legs, feet. She also experienced numbness and tingling in hands and across back. It was reported that the patient had muscle loss in legs which caused the patient to fall three times. The patient lost the use of the legs and had a hard time using hands. The patient was diagnosed with Guillain-Barre Syndrome. The event outcome was condition unchanged as of 09 Sep 2013. The seriousness and causality was not reported. No additional information was available.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hot flush, Nausea, Neck pain, Pain in extremity
Clinical narrative: Case number PHHY2013US127928, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 501922) website on 11 Nov 2013. This report refers to 28-year-old female patient. Her medical history included drug allergy (sulfa) and latex allergy. Her concomitant medications included vitamin B12, D and C. She was vaccinated with FLUVIRIN (batch number: 1308301) intramuscularly in the right arm on an unspecified date. Thirty minutes after vaccination, she developed moderately - severe arm pain at the site of vaccination which radiated to neck and to finger tips. She also experienced nausea as well as light-headed, fainting and hot flashes. The events were resolved by bed time (10:30 pm). The event outcome was completely recovered. The seriousness and causality were not reported. No additional information was available.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope, Vaccination site pain
Clinical narrative: Case number PHHY2013US127928, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 501922) website on 11 Nov 2013. This report refers to 28-year-old female patient. Her medical history included drug allergy (sulfa) and latex allergy. Her concomitant medications included vitamin B12, D and C. She was vaccinated with FLUVIRIN (batch number: 1308301) intramuscularly in the right arm on an unspecified date. Thirty minutes after vaccination, she developed moderately - severe arm pain at the site of vaccination which radiated to neck and to finger tips. She also experienced nausea as well as light-headed, fainting and hot flashes. The events were resolved by bed time (10:30 pm). The event outcome was completely recovered. The seriousness and causality were not reported. No additional information was available.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Flushing, Neck pain, Pain in extremity, Syncope
Clinical narrative: Case number PHHY2013US127930, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 501925) website on 11 Nov 2013. This report refers to 58-year-old female patient. Her medical history was not reported. Her drug history included penicillin and codeine. Her concomitant medications included PREMARIN gel and vitamin D. She was vaccinated with FLUVIRIN (batch number: 1308301) intramuscularly in the left arm on 10 Sep 2013. On the same day, fifteen minutes after the vaccination she experienced extreme pain in the arm into neck. She felt flushed and was just not feeling right. The patient fainted. The event outcome was completely recovered on the same day. The seriousness and causality were not reported.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Erythema, Influenza like illness, Injected limb mobility decreased
Clinical narrative: Case number PHHY2013US127730 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 502353) website on 11 Nov 2013: This report refers to a 30-year-old female patient. Her medical history included a therapy course for kidney infection, and her concomitant medications included unspecified medications for anemia. She was vaccinated with FLUVIRIN (batch number: 1307601) into the left arm along with PNEUMOVAX (other manufacturer, batch number: H010515) in to the left arm on 10 Sep 2013. On 11 Sep 2013 she fainted in shower. She went to hospital because she was feeling weak and "flu like" with chills. She was monitored and was given fluids. Next day her arm was red, painful and swollen. She could not lift her left arm laterally. She visited the emergency room (ER) following these events. Final outcome of the events was reported as complete recovery as of 12 Sep 2013. No further information about seriousness and causality was reported.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling, Syncope
Clinical narrative: Case number PHHY2013US127730 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 502353) website on 11 Nov 2013: This report refers to a 30-year-old female patient. Her medical history included a therapy course for kidney infection, and her concomitant medications included unspecified medications for anemia. She was vaccinated with FLUVIRIN (batch number: 1307601) into the left arm along with PNEUMOVAX (other manufacturer, batch number: H010515) in to the left arm on 10 Sep 2013. On 11 Sep 2013 she fainted in shower. She went to hospital because she was feeling weak and "flu like" with chills. She was monitored and was given fluids. Next day her arm was red, painful and swollen. She could not lift her left arm laterally. She visited the emergency room (ER) following these events. Final outcome of the events was reported as complete recovery as of 12 Sep 2013. No further information about seriousness and causality was reported.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Fatigue, Pain
Clinical narrative: Case number PHHY2013US127721, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502899) on 11 Nov 2013. This report refers to 50-years-old male patient. His current illness included chronic rheumatoid arthritis and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 13421P) intramuscularly in the left arm on 16 Sep 2013. He was also vaccinated with PNEUMOVAX (other manufacturer, batch number: H018441) intramuscularly in the left arm on 16 Sep 2013. On 17 Sep 2013, he experienced difficulty breathing, tiredness and achy. He had an emergency room visit due to these events. The outcome of the events was reported as condition improving as 17 Sep 2012. The seriousness and causality of the events was not reported.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysarthria, Dysphagia, Paraesthesia oral, Swollen tongue
Clinical narrative: Case number PHHY2013US140274 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 503306) website on 03 Dec 2013. This report refers to a 38-year-old female patient. Her medical history included allergic to Shellfish and Iohexol. Her concomitant medication included TRI-PREVIFEM. She was pre-medicated with TAGAMET and BENADRYL at 0930 on the day of the event. She was vaccinated with FLUVIRIN (batch number: 1340) intramuscularly into left arm on 18 Sep 2013. On the same day, after vaccination, she experienced dry, non productive cough with throat irritation, tongue feeling "fuzzy" progressed into swelling, slurred speech and difficulty swallowing. She received DECADRON 10 mg intramuscularly in the emergency room, after symptoms developed. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Case number PHHY2013US140274 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 503306) website on 03 Dec 2013. This report refers to a 38-year-old female patient. Her medical history included allergic to Shellfish and Iohexol. Her concomitant medication included TRI-PREVIFEM. She was pre-medicated with TAGAMET and BENADRYL at 0930 on the day of the event. She was vaccinated with FLUVIRIN (batch number: 1340) intramuscularly into left arm on 18 Sep 2013. On the same day, after vaccination, she experienced dry, non productive cough with throat irritation, tongue feeling "fuzzy" progressed into swelling, slurred speech and difficulty swallowing. She received DECADRON 10 mg intramuscularly in the emergency room, after symptoms developed. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Syncope
Clinical narrative: Case number PHHY2013US140368 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 503632) website on 03 Dec 2013. This report refers to a 16-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1308601) intramuscularly into right arm on 17 Sep 2013. On the same day, she fainted a few minutes after receiving shot and then said that her arm was hurt. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Eye swelling, Urticaria
Clinical narrative: Case number PHHY2013US139941 is an initial spontaneous report via vaccine adverse event reporting system (VAERS reference number: 503704) on 03 Dec 2013. This report refers to a 52 years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1337SP) intramuscularly in the right the right arm and PNEUMOVAX (batch number: H022280) intramuscularly in the left arm on 20 Sep 2013. On 21 Sep 2013, she experienced welts on left arm and her left eye was swollen. She was treated with BENADRYL for treatment. The outcome was reported as complete recovery.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Vaccination site swelling
Clinical narrative: Case number PHHY2013US139988 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 503851) on 03 Dec 2013. This report refers to an 86 years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308601) intramuscularly in the left arm on 18 Sep 2013. On 18 Sep 2013, within 30 seconds after vaccination, she had severe swelling at vaccination site which was of the size of half of a plum. She also experienced shortness of breath. She went to emergency room and was administered Epipen. The swelling slowed down instantly following administration of Epipen. The outcome was reported as condition unchanged as of 19 Sep 2013.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Case number PHHY2013US140012 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 503875) website on 03 Dec 2013. This report refers to a 50-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1308501) intramuscularly into right arm on 24 Sep 2013. On the same day, after vaccination, she experienced shortness of breath and received treatment with epinephrine and ambulance was called. She went to the emergency room due to this event. Outcome of the event was reported as not recovered as of 24 Sep 2013. No seriousness and causality was reported for the event.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHHY2013US140028 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 503899) website on 03 Dec 2013. This report refers to a 41-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1308501) intramuscularly on 24 Sep 2013. On the same day, after vaccination she experienced anaphylactic reaction. She went to the emergency room due to this event. Outcome of the event was reported as not recovered as of 24 Sep 2013. No seriousness and causality was reported for the event.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Feeling of body temperature change, General physical health deterioration, Heart rate increased
Clinical narrative: Case number PHHY2013US140113 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 504040) website on 03 Dec 2013. This report refers to a 28-year-old female patient. Her medical history included allergy to iodine. Her concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1307601) intramuscularly into left arm on 17 Sep 2013. On the same day, five minutes after vaccination, she felt dizzy and had elevated heart rate and blood pressure. Her symptoms continued and she was very cold, then very warm. An ambulance was called where it was reported that while waiting, her condition seemed to deteriorate. She had a wave of nausea and was shaking. She complained that her throat was hurt and felt tight, so she was administered with EPIPEN. At that point about 25 minutes had passed. Several minutes later, paramedics arrived and took her to ER (emergency room) where she received BENADRYL and steroids at ER. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oropharyngeal pain, Throat tightness, Tremor
Clinical narrative: Case number PHHY2013US140113 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 504040) website on 03 Dec 2013. This report refers to a 28-year-old female patient. Her medical history included allergy to iodine. Her concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1307601) intramuscularly into left arm on 17 Sep 2013. On the same day, five minutes after vaccination, she felt dizzy and had elevated heart rate and blood pressure. Her symptoms continued and she was very cold, then very warm. An ambulance was called where it was reported that while waiting, her condition seemed to deteriorate. She had a wave of nausea and was shaking. She complained that her throat was hurt and felt tight, so she was administered with EPIPEN. At that point about 25 minutes had passed. Several minutes later, paramedics arrived and took her to ER (emergency room) where she received BENADRYL and steroids at ER. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHHY2013US140221 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 504266) on 03 Dec 2013. This report refers to a 17 years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1307701) intramuscularly in the left arm on 25 Sep 2013. On 25 Sep 2013, he fainted. Emergency medical technicians were called and all his vitals were checked and reported as normal. The outcome was reported as complete recovery.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Paraesthesia, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: Case number PHHY2013US140293 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 504424) on 03 Dec 2013. This report refers to a 29 years-old female patient. Her medical history included allergy to pineapple. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13373P) in the left arm on 27 Sep 2013. On the same date, 15 minutes after vaccination, she had tingling of lips and left cheek. She was given BENADRYL 25 mg. She also took BENADRYL HS 75 mg once daily. Her symptoms were not abating. 20 minutes later she was feeling hot and had throat swelling. Emergency medical service were called to hospital. The outcome was reported as condition unchanged.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Flushing, Heart rate increased, Hypertension
Clinical narrative: Case number PHHY2013US140357 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 504462) on 03 Dec 2013. This report refers to a 63 years-old female patient. Her medical history included hypertension, emphysema and hypothyroidism. Her concomitant medications included SYNTHROID, metoprolol ER, PROAIR and ALLEGRA D. She was vaccinated with FLUVIRIN (batch number: 1308601) intramuscularly in the right arm on 22 Sep 2013. On the same day, 10 minutes after vaccination, she complained of flushing and of difficulty catching her breath. She refused the emergency medical services offered. She remained in pharmacy for 40 minutes after vaccination. It was reported that flushing and dyspnea resolved. She refused BENADRYL or water. The pharmacist checked her blood pressure twice and it was reported as 145/98. Her pulse rate was 84. The patient said that her normal blood pressure was 145/98. The outcome was reported as complete recovery.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Ear swelling, Erythema, Eye pruritus, Eye swelling, Lip swelling
Clinical narrative: Case number PHHY2013US140027 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 504488) web site on 03 Dec 2013. This report refers to a 27-year-old female patient. Her medical history included allergy to penicillin. Her concomitant medications included birth control one tablet a day and gummy vitamins two chews a day. She was vaccinated with a FLUVIRIN (batch number: 1308501) intramuscularly in to the left arm on 25 Sep 2013. On 26 Sep 2013, she woke up itching and broke out in hives on her legs, back, and stomach. Her ears and eyes were slightly red and itching with a little swelling. Her upper lip was also swollen. However, it was described as a mild reaction. She went to see a nurse practitioner and received a steroid and BENADRYL injection and was better later that day. Final outcome of the events was reported as complete recovery on an undetermined date. No further information about causality and seriousness was reported.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pruritus, Urticaria
Clinical narrative: Case number PHHY2013US140027 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 504488) web site on 03 Dec 2013. This report refers to a 27-year-old female patient. Her medical history included allergy to penicillin. Her concomitant medications included birth control one tablet a day and gummy vitamins two chews a day. She was vaccinated with a FLUVIRIN (batch number: 1308501) intramuscularly in to the left arm on 25 Sep 2013. On 26 Sep 2013, she woke up itching and broke out in hives on her legs, back, and stomach. Her ears and eyes were slightly red and itching with a little swelling. Her upper lip was also swollen. However, it was described as a mild reaction. She went to see a nurse practitioner and received a steroid and BENADRYL injection and was better later that day. Final outcome of the events was reported as complete recovery on an undetermined date. No further information about causality and seriousness was reported.
Age: 27.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Pharyngeal oedema, Rash generalised, Swelling face
Clinical narrative: Case number PHHY2013US140029 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 504508) web site on 03 Dec 2013. This report refers to a 27-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with a FLUVIRIN (batch number: 13383P) intramuscularly in to the left arm along with MMR II (other manufacturer, batch number: H012572) subcutaneously in to the left arm on 25 Sep 2013. On 26 Sep 2013, she experienced facial and throat swelling along with a body rash. Oral steroids were administered as treatment measure. She visited the emergency room (ER) following these events. Final outcome of the events was reported as condition unchanged as on 27 Sep 2013. No further information about causality and seriousness was reported.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Case number PHHY2013US140079 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 504575) web site on 03 Dec 2013. This report refers to a 51-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1307601) intramuscularly in to the right upper arm on 07 Sep 2013. On 21 Sep 2013, he experienced hives at injection site and all over body, on arms, back, and left leg. He developed more hives and extreme itching feeling, for one week and the condition remained unchanged. Pharmacist advised him to take BENADRYL. Final outcome of the events was reported as condition unchanged as on 29 Sep 2013. No further information about causality and seriousness was reported.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: Case number PHHY2013US140112 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 504629) web site on 03 Dec 2013. This report refers to a 68-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1307901) in to the left arm on 27 Sep 2013. On 28 Sep 2013, she developed swelling and itching around eyes. Patient took BENADRYL and her condition was improving. No further information about causality and seriousness was reported.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Flushing, Vomiting, Wheezing
Clinical narrative: Case number PHHY2013US140271, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 504884) website on 03 Dec 2013. This report refers to a 56-year-old female patient. Her medical history included chronic obstructive pulmonary disease (COPD) and hypothyroidism. Her concomitant medications included SINGULAIR, Vitamin B6 and SYMBICORT. She was vaccinated with FLUVIRIN (batch number: 1308601) intramuscularly into her left arm and PNEUMOVAX (other manufacturer, batch number: H014561) intramuscularly into her right arm on 30 Sep 2013. On the same day after vaccination, she experienced wheezing, difficulty in breathing, flushing and vomiting. The outcome of the events was reported as complete recovery on an unknown date. The causality and seriousness were not reported. No further information was available.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Case number PHHY2013US140331, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 505096) website on 03 Dec 2013. This report refers to a 55-years-old adult male patient. He was allergic to PROZAC. His concomitant medications were not reported. On 01 Oct 2013, he was vaccinated with FLUVIRIN (batch number: 13375P) intramuscularly in his left arm. On the same date after vaccination, he experienced red itching rash visible on arms, shortness of breath and had a "woozy feeling". On an unknown date he visited the emergency room or physician. His treatment medication included AUVI-Q. The outcome of the events was reported as condition unchanged as of 01 Oct 2013. The seriousness and causality of the events were not assessed. No additional information was available.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Facial paresis, VIIth nerve paralysis
Clinical narrative: Case number PHHY2013US140337 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 505128) web site on 03 Dec 2013 with a follow-up received from a quality assurance department (QA ref. no: 268990) on 09 Dec 2013 and 03 Jul 2014: This report refers to a 9-year-old male child. He had no known drug allergies. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13404P) intramuscularly in to the right arm on 24 Sep 2013. On 26 Sep 2013 he developed facial weakness and was diagnosed with Bell's palsy by a physician on 27 Sep 2013. He visited the emergency room (ER) following these events. Final outcome of the events was reported as condition unchanged as on 01 Oct 2013. No further information about causality and seriousness was reported. Batch review report concluded that, based on the document review, it was stated that the concerned FLUVIRIN (batch number: 13404P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from quality assurance department (reference number: 268990) on 09 Dec 2013: Updated QA reference number only. Non significant follow up information received from the quality assurance department on 03 Jul 2014: Updated batch review report.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Dizziness, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: Case number PHHY2013US140030 is an initial spontaneous report from a Vaccine Adverse Event Reporting System (reference number: 505675) received on 03 Dec 2013. This report refers to a 36-year-old female patient. Her concurrent condition included type 1 diabetes mellitus. Concomitant medications included NOVOLOG, YAZ, ramipril and atorvastatin. She was vaccinated with FLUVIRIN (batch number: 1309601) intramuscularly in the left arm on 01 Oct 2013. On the same day, post vaccination, she experienced dizziness, sweating, nausea, throat tightness, labored breathing, pale complexion and confusion. She was given EPIPEN before paramedics arrived. She had a visit to emergency room due to these events. Outcome of the events was reported as recovered. Seriousness and causality of the events were not reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pallor, Throat tightness
Clinical narrative: Case number PHHY2013US140030 is an initial spontaneous report from a Vaccine Adverse Event Reporting System (reference number: 505675) received on 03 Dec 2013. This report refers to a 36-year-old female patient. Her concurrent condition included type 1 diabetes mellitus. Concomitant medications included NOVOLOG, YAZ, ramipril and atorvastatin. She was vaccinated with FLUVIRIN (batch number: 1309601) intramuscularly in the left arm on 01 Oct 2013. On the same day, post vaccination, she experienced dizziness, sweating, nausea, throat tightness, labored breathing, pale complexion and confusion. She was given EPIPEN before paramedics arrived. She had a visit to emergency room due to these events. Outcome of the events was reported as recovered. Seriousness and causality of the events were not reported.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Case number PHHY2013US140184 is an initial spontaneous report from a Vaccine Adverse Event Reporting System (reference number: 505877) received on 03 Dec 2013. This report refers to a 41-year-old female patient. Her concurrent conditions included allergy to BACTRIM. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308001) intramuscularly in the left arm on 06 Oct 2013. On the same day, 20 minutes after vaccination, she experienced heavy sensation within the chest and difficulty breathing. The site of injection had no unusual appearance. She did not appear seem to have elevated temperature. The incident occurred over approximately 2 hours. She was immediately instructed to sit down, and emergency was alerted. Outcome of the events was reported as condition unchanged as of 06 Oct 2013. Seriousness and causality of the events were not reported.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine, Myalgia, Pharyngeal oedema, Pruritus generalised
Clinical narrative: Case number PHHY2013US140083, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 506192) website on 03 Dec 2013. This report refers to a 44-year-old female patient. Current condition included asthma. She was vaccinated with FLUVIRIN (batch number: 13432P) intramuscularly in the left arm on 04 Oct 2013. On an unknown date, after vaccination she had all over body itching and felt as if her throat had swelling. there was no swelling or redness at the injection site. She had severe muscle pains. She felt she was allergic to the shot. The outcome of the events reported as not recovered as of 07 Oct 2013. The seriousness and causality of the events were not reported.