chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Case number PHHY2014US000913 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 511944) website on 06 Jan 2014. This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13405P) and GARDASIL (other manufacturer and batch number: H020901) both intramuscularly into left arm on 05 Nov 2013. On the same day, she was also vaccinated with MENVEO (batch number: M12097) and BOOSTRIX (other manufacturer and batch number: 2RY59) both intramuscularly into right arm. Next day when she woke up there was a rash that went from scalp, neck, back and down right arm. Her mother applied BENADRYL cream and seen by doctor in clinic. Outcome of the event was reported as recovered. Seriousness and causality of the event was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test negative, Dyspnoea, Full blood count normal, Metabolic function test normal, Palpitations
Clinical narrative: Case number PHHY2014US000922 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS, reference number: 511959) website on 06 Jan 2014. This report refers to a 47-year-old female patient. Her concurrent condition included allergy to sulfa drugs. Concomitant medication included TRI-SPRINTEC. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into right arm on 28 Oct 2013. On the same day, post vaccination, she experienced shortness of breath, palpitations and throat swelling. She went to emergency room due to these events. She underwent complete blood count (CBC) and basic metabolic panel (BMP) and was found to be normal; allergy panel showed no egg allergy. Outcome of the events was reported as condition unchanged as of 07 Nov 2013. Seriousness and causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: Case number PHHY2014US000922 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS, reference number: 511959) website on 06 Jan 2014. This report refers to a 47-year-old female patient. Her concurrent condition included allergy to sulfa drugs. Concomitant medication included TRI-SPRINTEC. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into right arm on 28 Oct 2013. On the same day, post vaccination, she experienced shortness of breath, palpitations and throat swelling. She went to emergency room due to these events. She underwent complete blood count (CBC) and basic metabolic panel (BMP) and was found to be normal; allergy panel showed no egg allergy. Outcome of the events was reported as condition unchanged as of 07 Nov 2013. Seriousness and causality of the events was not reported.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Paraesthesia, Pyrexia
Clinical narrative: Case number PHHY2014US000924 is an initial spontaneous report received from a consumer (patient's spouse) via Vaccine Adverse Event Reporting System (VAERS, reference number: 511987) website on 06 Jan 2014. This report refers to a 65-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1307601) intramuscularly on 19 Oct 2013. On 21 Oct 2013, two days after vaccination, he experienced fever, finger tingling and shortness of breath (SOB) and went on to the emergency room but was discharged soon after. Outcome of the events was reported as recovered. Seriousness and causality of the events was not reported.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Lip swelling
Clinical narrative: Case number PHHY2014US000953 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 512039) website on 06 Jan 2014. This report refers to a 25-year-old female patient. Her concurrent conditions included asthma and allergy to sulfa drugs. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: FJ94N) intramuscularly into right arm on 18 Oct 2013. On the same day, post vaccination, she experienced difficulty breathing and swelling of lips. She used her inhaler and took BENADRYL 50 mg oral. Outcome of the events was reported as recovered. Seriousness and causality of the events was not reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Hypertension, Syncope
Clinical narrative: Case number PHHY2014US000986 is an initial spontaneous report received from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 512188) website on 06 Jan 2014 and a follow up report from the QA department received on 10 Jul 2014. This case refers to 50-year-old female patient. Her medical history included penicillin allergy. The patient was vaccinated with FLUVIRIN (batch number: 1309301) intramuscularly in right arm on 11 Nov 2013. On 11 Nov 2013, after the vaccination, the patient complained of hoarseness. She initially had no shortness of breath, but later became syncopal. Her blood pressure was at 160/90, pulse at 76 and saturation was 100 percent on room air. She was treated with EPIPEN and oxygen mask at 4pm and she was taken to emergency room. The outcome of other events was reported as recovery as of 11 Nov 2013. The seriousness and causality of events was not reported. Based on the document review, it was stated that the FLUVIRIN, batch number 1309301 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 report from the QA department received on 10 Jul 2014: Updated batch review report.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Presyncope, Syncope
Clinical narrative: Case number PHHY2014US001022 is an initial spontaneous report received from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 512290) website on 06 Jan 2014. This case refers to 11-year-old male patient. The patient was vaccinated with FLUVIRIN (batch number: 13405P) in left arm on 28 Oct 2013. On 28 Oct 2013, shortly after the vaccination, the patient fainted. As per patient's mother, the patient had a "feeling weird" after receiving flu shot. The patient went to emergency room for observation and was diagnosed with vasovagal response. The patient recovered completely from the events. The seriousness and causality of events was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Bronchitis, Neck pain, Syncope
Clinical narrative: Case number PHHY2014US001148 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 512859) website on 06 Jan 2014. This case refers to a 48-year-old patient female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number unknown) intramuscularly in her left arm on 30 Oct 2013. On the same date after vaccination she had syncope with upset stomach, neck pain lasting in waives up to one hour. She also had bronchitis within a week. The outcome of the events was reported as complete recovery as of 13 Nov 2013. The seriousness and causality assessment of the events was not reported.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Loss of consciousness
Clinical narrative: Case number PHHY2014US012647, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513167) website on 03 Feb 2014. This report refers to a 42-year-old female patient. Her medical history and concomitant medication were reported. She was vaccinated with FLUVIRIN (batch number: 1309701) intramuscularly into the arm 06 Nov 2013. On the same day, she returned about 15 minutes after vaccination and stated that she was feeling funny. A few minutes later she lost consciousness for about 5 seconds. Immediately emergency department was called. Paramedics found nothing (all vitals are ok) and she went home with her husband. The final outcome of the events was reported as complete recovery. The seriousness and causality of the events were not reported. No additional information was available.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Pruritus, Throat tightness, Urticaria
Clinical narrative: Case number PHHY2014US012622 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 513359) website on 03 Feb 2014. This report refers to a 60-year-old male patient. His medical history was not reported. Concomitant medications included ESTROGEL and PROMETRIUM. He was vaccinated with FLUVIRIN (batch number: 1308301) intramuscularly in the right arm on 11 Nov 2013. On the same day, post vaccination, he experienced itching and hives on left side of neck under left ear. Hives in front of neck and redness on front of neck were reported. He also experienced slight numbness feeling in left lower portion of face near mouth for a half an hour. He had a sensation of fullness in throat but could breathe all right. Outcome of the events were reported as recovered as of 15 Nov 2013. Seriousness and causality of the events were not reported.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Pharyngeal oedema
Clinical narrative: Case number PHHY2014US012637 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 513545) website on 03 Feb 2014. This report refers to a 22-year-old female patient. Her concurrent condition included allergic to CECLOR. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13425P) intramuscularly in the left arm on 15 Nov 2013. On the same day, post vaccination, she experienced throat swelling and difficulty swallowing. She went emergency room due to these events. Outcome of the events were reported as recovered as of 18 Nov 2013. Seriousness and causality of the events were not reported.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Case number PHHY2014US012762 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 514217) website on 03 Feb 2014. This report refers to a 23-year-old male patient. His concurrent conditions included asthma, upper respiratory infection and allergic rhinitis. Concomitant medications included salbutamol sulfate, CLARITIN and ZYRTEC. He was vaccinated with FLUVIRIN (batch number: 1308701) into left arm on 17 Oct 2013. On the same day, post vaccination, he experienced hives, fever, sweating, body aches, fatigue and shortness of breath which lasted for one month. However, he did not come in to be seen in emergency room till one month later. Outcome of the events was reported as condition unchanged as of 21 Nov 2013. Seriousness and causality of the events were not reported.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHHY2014US012762 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 514217) website on 03 Feb 2014. This report refers to a 23-year-old male patient. His concurrent conditions included asthma, upper respiratory infection and allergic rhinitis. Concomitant medications included salbutamol sulfate, CLARITIN and ZYRTEC. He was vaccinated with FLUVIRIN (batch number: 1308701) into left arm on 17 Oct 2013. On the same day, post vaccination, he experienced hives, fever, sweating, body aches, fatigue and shortness of breath which lasted for one month. However, he did not come in to be seen in emergency room till one month later. Outcome of the events was reported as condition unchanged as of 21 Nov 2013. Seriousness and causality of the events were not reported.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: Case number PHHY2014US007382, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number:  514341) website on 20 Jan 2014. This report refers to 32-year-old female patient. Her medical history included fish allergy (anaphylaxis). Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13373P) intramuscularly in the left arm on 08 Nov 2013 at 07:30. After vaccination, she went home and slept for two hours. She woke up after two hours and complained trouble breathing, itching and hives. She visited the emergency room at 14:00. She was treated with epinephrine, steroids and pain medications. The event outcome was completely recovered. The seriousness and causality was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised
Clinical narrative: Case number PHHY2014US012836, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514399) website on 03 Feb 2014. This report refers to 48-year-old female patient. Her medical history was not reported and concomitant medications included acyclovir. She was vaccinated with FLUVIRIN (batch number: 1308201) in the left arm on 18 Nov 2013. On 19 Nov 2013, she experienced rash on legs which then spread to entire body including face. She felt itchy and took BENADRYL which helped relieved symptoms. The patient had not yet recovered completely as of 22 Nov 2013. The seriousness and causality were not reported.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Mechanical ventilation, Muscular weakness, Tracheo-oesophageal fistula
Clinical narrative: Case number PHHY2014US012797 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 514436) on 03 Feb 2014. This report refers to a 44-years-old male patient. His medical history included chronic kidney stones, chronic kidney disease, hypertension and morbid obesity. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1308101) intramuscularly in the left arm on 04 Oct 2013. On 17 Nov 2013, he experienced numbness and weakness in upper extremities that progressed to lower extremities. He went to emergency room and was diagnosed with Guillain Barre syndrome (GBS). He was on ventilator and would undergo tracheotomy. The outcome was reported as condition unchanged. The seriousness of the events were reported as life-threatening and permanently disabling. The causality of the event was not reported.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Neck pain, Pain in extremity
Clinical narrative: Case number PHHY2014US006496, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514437) website on 20 Jan 2014, with a follow up received from vaccine adverse event reporting system on 24 Jul 2014, with a non-significant follow-up information received from Quality Assurance Department (reference number: 315903) on 05 Sep 2014. This report refers to 72-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1308301) intramuscularly into left arm on 06 Nov 2013. On 10 Nov 2013, she experienced radiating pain in left chest, left arm, left neck, left upper back. It was reported that pain sensation increased upon applying pressure to chest. She was hospitalized for six days. The diagnostic lab data was to be further evaluated by the neurologist. The events outcome was condition unchanged as of 21 Nov 2013. Causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1308301) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from vaccine adverse event reporting system on 24 Jul 2014: Updated suspect product as FLUVIRIN, route, site of vaccination and batch number. Non-significant follow-up information received from the Quality Assurance Department (reference number: 315903) on 30 Jul 2014: QA reference number updated. Non-significant follow-up information received from the Quality Assurance Department (reference number: 315903) on 05 Sep 2014: Updated batch review report.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Urticaria
Clinical narrative: Case number PHHY2014US006538 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514608) on 20 Jan 2014 and a follow up report received on 24 Jul 2014. This report refers to a 53-year-old female patient. Her medical history included allergy to penicillin. This poly-medicated patient was vaccinated with FLUVIRIN (batch number: 1308701) in the left arm on 19 Nov 2013. On 22 Nov 2013, she developed hives in the right cheek and her right side of face was slightly swollen. The outcome of the event was reported as condition unchanged as of 25 Nov 2013. The events were reported as non serious but the agency has considered the events as serious. The causality of the events was not reported. Follow up information received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514608) website on 24 Jul 2014: Updated vaccine name, batch number, and seriousness.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care, Malaise
Clinical narrative: Case number PHHY2014US012804 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS, reference number: 514611) website on 03 Feb 2014. This report refers to a 69 year old male patient. His medical history included mild hypertension and concomitant medication included COZAAR for mild hypertension at a dose of 25 mg. He was vaccinated with FLUVIRIN (batch number: 1101801) intramuscularly into left arm on 22 Dec 2011. On 24 Dec 2011, he generally felt unwell initially. On 28 Dec 2011, he visited a physician. On 31 Dec 2011, he was diagnosed with ascending paralysis. On 02 Jan 2012, he was hospitalized. On 07 Jan 2012 he was moved to ICU and was treated with intravenous immunoglobulins till 11 Jan 2012. The final diagnosis was Guillain Barre Syndrome. The outcome of the event was reported as condition unchanged. The seriousness of the events was reported as permanent disability resulting in hospitalization. The causality of the event was not reported.
Age: 22.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Altered state of consciousness, Hypoaesthesia oral, Nausea, Rash
Clinical narrative: Case number PHHY2014US013384, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 515180) website on 03 Feb 2014 with a follow up information received from quality assurance department (QA reference number: 279591) on 03 Jul 2014. This report refers to 22-year-old male patient. His medical history was not reported and his concomitant medications included ibuprofen at 800 mg TID, Dicyclomine at 20 mg TID. He was vaccinated with FLUVIRIN (batch number: 13375P) intramuscularly and PNEUMOVAX (batch number: H017759) subcutaneously on 30 Nov 2013. Approximately 10 minutes after vaccination, he complained of numb tongue. He was prescribed 25 mg diphenhydramine solution. Fifteen minutes later he complained of slight nausea and could pass out. Five minutes after that he experienced slight rash on neck. He was taken to the emergency room, where he was prescribed 25 mg diphenhydramine solution. He had no complaint of breathing issue and there was no change in tongue numbness. The event outcome was condition unchanged as of 30 Nov 2013. The seriousness and causality was not reported. Upon follow up information received from the quality assurance department (QA reference number: 279591) on 03 Jul 2014, it was reported that based on the document review, it was concluded that the FLUVIRIN batch number 13375P 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 information received from quality assurance department on 03 Jul 2014: Batch summary updated.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Immediate post-injection reaction, Sinusitis, Swelling face, Vaccination complication
Clinical narrative: Case number PHHY2014US006376 is an initial spontaneous report received from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 515438) website on 20 Jan 2014 and a follow up report received on 24 Jul 2014. This case refers to 55-year-old female patient. Her medical history included allergies and concurrent condition included sinus infection. The patient was vaccinated with FLUVIRIN (batch number: 1308101) on 13 Nov 2013. On 13 Nov 2013, immediately after the vaccination, she developed swelling of the face. On the same day night, the patient had trouble breathing. She went to emergency room for the events where it was confirmed that it was a reaction to the vaccine but on the report it was reported as due to sinusitis. The outcome of events was reported as complete recovery as of 03 Dec 2013. The events were reported as non serious but the agency has considered the events as serious (medically significant) and causality of events was not reported. Follow up information was received from the Vaccine Adverse Event Reporting System (VAERS reference number: 515438) website on 24 Jul 2014: Updated vaccine name, and batch number.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Electrocardiogram, Hypoaesthesia
Clinical narrative: Case number PHHY2014US013428 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 515500) website on 03 Feb 2014. This case refers to a 28 year old female patient. She had no known history of allergies and two months ago she had undergone a Caesarean section. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1338) into arm on 02 Dec 2013. On the same day few minutes after vaccination, she returned to urgent care (emergency room) and complaining of numbness of arms and legs as well as chest tightness and dyspnea. She also experienced dizziness and tongue numbness. On an unknown date, 12 lead electrocardiography was performed (no data provided). The treatment was rendered with DEPO-MEDROL at a dose of 40 mg, oxygen and one liter of RINGERS LACTATE. The outcome of the events was reported as complete recovery. The seriousness and causality of the events were not reported.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral
Clinical narrative: Case number PHHY2014US013428 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 515500) website on 03 Feb 2014. This case refers to a 28 year old female patient. She had no known history of allergies and two months ago she had undergone a Caesarean section. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1338) into arm on 02 Dec 2013. On the same day few minutes after vaccination, she returned to urgent care (emergency room) and complaining of numbness of arms and legs as well as chest tightness and dyspnea. She also experienced dizziness and tongue numbness. On an unknown date, 12 lead electrocardiography was performed (no data provided). The treatment was rendered with DEPO-MEDROL at a dose of 40 mg, oxygen and one liter of RINGERS LACTATE. The outcome of the events was reported as complete recovery. The seriousness and causality of the events were not reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye swelling, Eyelid oedema, Swelling face, Throat tightness
Clinical narrative: Case number PHHY2014US013512 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS, reference number: 515834) website on 03 Feb 2014. This report refers to a 55-year-old female patient. Her medical history included gastrointestinal disorder and concomitant medication included omeprazole. She was vaccinated with FLUVIRIN (batch number: 1308401) intramuscularly in the left arm on 24 Sep 2013. Same day after vaccination, her cheeks and eyes became swollen. At 10:00 p.m. she experienced throat tightness. On 25 Sep 2013 at 07:30 a.m. she woke up with sticky and swollen eyelids. The final outcome of the events was reported as complete recovery without the need of any treatment. The causality and seriousness of the events were not reported.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Borrelia test negative, HIV test negative, Hypoaesthesia, Laboratory test normal, Paraesthesia
Clinical narrative: Case number PHHY2014US013233, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516124) web site on 03 Feb 2014. This report refers to a 45-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13454P) intramuscularly into the right arm on 30 Oct 2013. On 10 Nov 2013, she experienced numbness and tingling all over. On 13 Nov 2013, she had an emergency department (ED) visit. She underwent lyme disease, human immune-virus (HIV) 1 and 2 and rickettsia test; However all the tests were negative (non-reactive). The final outcome of the events was reported as not recovered. The seriousness of the events was reported as life threatening and causality of the events was not reported.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Typhus rickettsia test
Clinical narrative: Case number PHHY2014US013233, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516124) web site on 03 Feb 2014. This report refers to a 45-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13454P) intramuscularly into the right arm on 30 Oct 2013. On 10 Nov 2013, she experienced numbness and tingling all over. On 13 Nov 2013, she had an emergency department (ED) visit. She underwent lyme disease, human immune-virus (HIV) 1 and 2 and rickettsia test; However all the tests were negative (non-reactive). The final outcome of the events was reported as not recovered. The seriousness of the events was reported as life threatening and causality of the events was not reported.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Headache
Clinical narrative: Case number PHHY2014US007064, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516551) website on 20 Jan 2014. This report refers to 30-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 005031A) intramuscularly in the left arm on 07 Dec 2013 at 11:00 AM. At 11:50 AM, he was presented to the vaccination table with shortness of breath, dizziness, weakness, diaphoretic, headache, shaky hands, chills and cant breath good. At 11:50 AM, his blood pressure was 162/100, pulse rate was 76 and respiratory rate was 24. At 12:07 PM, his blood pressure was 150/86, pulse rate was 70 and respiratory rate was 20. At 12:15 PM, his blood pressure was 148/88, pulse rate of 72 and respiratory rate of 20. At 12:22 PM, he was given Epipen and was transferred to the emergency room at 12:45 PM. The event outcome was condition unchanged as of 07 Dec 2013. The seriousness and causality were not reported.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Tremor
Clinical narrative: Case number PHHY2014US007064, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516551) website on 20 Jan 2014. This report refers to 30-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 005031A) intramuscularly in the left arm on 07 Dec 2013 at 11:00 AM. At 11:50 AM, he was presented to the vaccination table with shortness of breath, dizziness, weakness, diaphoretic, headache, shaky hands, chills and cant breath good. At 11:50 AM, his blood pressure was 162/100, pulse rate was 76 and respiratory rate was 24. At 12:07 PM, his blood pressure was 150/86, pulse rate was 70 and respiratory rate was 20. At 12:15 PM, his blood pressure was 148/88, pulse rate of 72 and respiratory rate of 20. At 12:22 PM, he was given Epipen and was transferred to the emergency room at 12:45 PM. The event outcome was condition unchanged as of 07 Dec 2013. The seriousness and causality were not reported.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pruritus, Urticaria
Clinical narrative: Case number PHHY2014US091695 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516766) website on 24 Jul 2014. This report refers to a 16-year-old male patient. His medical history included asthma and allergies to AUGMENTIN, penicillins, sulfa, cephalosporins and erythromycin. His concomitant medications were not reported. His vaccination history included flu vaccine (manufacturer and batch number: not reported) last 6 to 7 years without any adverse event. He was vaccinated with FLUVIRIN (batch number: 1310201) intramuscularly in the left arm deltoid on 09 Dec 2013. On the same day, while in shower, he experienced diffuse pruritus with generalized urticaria as well as throat swelling. He had no dyspnea, wheezing or stridor. He went to the emergency room and was treated with BENADRYL 25 mg peroral twice and urticaria and pruritus resolved. He also had prednisone 40 mg peroral. He still had noticeable throat swelling when swallowing. The final outcome of the events pruritus and urticaria was complete recovery and that of throat swelling was condition improving. The events as non-serious, but was internally upgraded as medically significant by the agency. The causality of the event was not reported.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fall, Malaise, Syncope
Clinical narrative: Case number# PHHY2014US092055, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516917) website on 24 Jul 2014. This report refers to a 66-year-old female patient. Past medical history included dizziness and hypertension (HTN). No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 1310201), along with PNEUMOVAX (other manufacturer, batch number: H022063) on 15 Nov 2013. On 16 Nov 2013, she was very sick and experienced fainting and falling on floor twice. She was seen in emergency room for syncopal episode on 16 Nov 2013. The outcome of the events was complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Causality was not reported.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Disability, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging normal
Clinical narrative: This medically confirmed health authority report (initial receipt- 16-Jun-2014) concerns a 77-year old female patient. On 07-Nov-2013, the patient received intramuscular AFLURIA (Batch number: R52406) in the right arm. On 07-Nov-2013, the patient developed extreme pain at the injection site, loss of strength in shoulder and loss of mobility of the right arm. 48 hours after the injection, the patient developed extreme pain. Pain and decreased mobility continued to this date. Her treatment included gabapentin, naproxen, VICODEN, myofacial release and physical therapy. On 15-Nov-2013, the patient underwent ultrasound scan and X-ray, both were ok and nothing was found. On 22-Apr-2014, she underwent magnetic resonance imaging (MRI). Outcome was reported as not recovered. Reporter's comments: The health authority assessed the events as serious as it led to permanent disability. The authority reported preferred terms nuclear magnetic resonance imaging, ultrasound scan normal and X-ray normal.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound scan normal, X-ray normal
Clinical narrative: This medically confirmed health authority report (initial receipt- 16-Jun-2014) concerns a 77-year old female patient. On 07-Nov-2013, the patient received intramuscular AFLURIA (Batch number: R52406) in the right arm. On 07-Nov-2013, the patient developed extreme pain at the injection site, loss of strength in shoulder and loss of mobility of the right arm. 48 hours after the injection, the patient developed extreme pain. Pain and decreased mobility continued to this date. Her treatment included gabapentin, naproxen, VICODEN, myofacial release and physical therapy. On 15-Nov-2013, the patient underwent ultrasound scan and X-ray, both were ok and nothing was found. On 22-Apr-2014, she underwent magnetic resonance imaging (MRI). Outcome was reported as not recovered. Reporter's comments: The health authority assessed the events as serious as it led to permanent disability. The authority reported preferred terms nuclear magnetic resonance imaging, ultrasound scan normal and X-ray normal.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Injection site erythema, Injection site nodule, Injection site rash, Myalgia
Clinical narrative: Case number PHHY2014US094592 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516990) website on 24 Jun 2014. This report refers to a 45-year-old female patient. Her medical history and concomitant medication were not reported. She had no known drug allergy. She was vaccinated with FLUVIRIN (batch number: 1308601) intramuscularly in the arm on 13 Nov 2013. On the same day after vaccination she felt lousy which lasted for a week. She experienced erythema near the injection site, rash all over her body, muscle pain and soreness described as "being punched in the arm". She developed a nodule near the injection site. She still had muscle soreness and a slight rash on the arm of the injection site. She denied any fever. Final outcome was reported as condition unchanged. The event was reported as non-serious. However, the event 'rash generalized' was internally upgraded to medically significant by agency. Causality was not reported.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Rash generalised
Clinical narrative: Case number PHHY2014US094592 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 516990) website on 24 Jun 2014. This report refers to a 45-year-old female patient. Her medical history and concomitant medication were not reported. She had no known drug allergy. She was vaccinated with FLUVIRIN (batch number: 1308601) intramuscularly in the arm on 13 Nov 2013. On the same day after vaccination she felt lousy which lasted for a week. She experienced erythema near the injection site, rash all over her body, muscle pain and soreness described as "being punched in the arm". She developed a nodule near the injection site. She still had muscle soreness and a slight rash on the arm of the injection site. She denied any fever. Final outcome was reported as condition unchanged. The event was reported as non-serious. However, the event 'rash generalized' was internally upgraded to medically significant by agency. Causality was not reported.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Nausea, Oral pruritus, Oropharyngeal pain
Clinical narrative: Case number PHHY2014US094371 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 517354) on 24 Jul 2014. This report refers to a 15 years old female patient. Her medical history included exercise induced asthmas. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1310301) intramuscularly in right arm on 09 Dec 2013. It was reported that on the same date, she experienced nauseous feeling and lightheadedness at 5.25 PM. She laid flat on a mat which helped her little. At 6:00 PM she had sip of water because her throat was hurting. She had little trouble in breathing. Her vitals were normal. There was no change in the condition even after 20 minutes. She also had itching of her mouth. She visited emergency room where she was treated with some medication for nausea and pain and she was resting at home. The outcome of the event was reported as complete recovery. The events were reported as non-serious, but were internally upgraded as medically significant by the agency. The causality of the events was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Syncope
Clinical narrative: Case number PHHY2014US091772, is an initial spontaneous report from Vaccine Adverse Event Reporting website (VAERS id: 517406) received on 24 Jul 2014 with a follow up information received from the quality assurance department (QA reference number: 315886) on 30 Jul 2014, and with a non-significant follow-up information received from Quality Assurance Department (reference number: 315886) on 29 Aug 2014. This report refers to a 60 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 13415P) into left arm on 20 Dec 2013. On the same she also received ZOSTAVAX (batch number: J007209, other manufacturer) subcutaneous into left arm. Approximately 10-15 seconds post vaccination she experienced syncope. It was reported that this was normal occurrence for her. Outcome of the event was recovered. Causality assessment was not reported. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 13415P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non significant follow up information received from the quality assurance department on 30 Jul 2014: QA reference number updated. Non-significant follow-up information received from the Quality Assurance Department (reference number: 315886) on 29 Aug 2014: Updated batch review report.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Facial spasm, Muscle spasms, VIIth nerve paralysis
Clinical narrative: Case number PHHY2014US091353 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 517608) website on 24 Jul 2014 with a follow up information received from the quality assurance department (QA reference number: 315249) on 28 Jul 2014. This report refers to a 53-year-old female patient. Her medical history and concomitant medications were not reported. On 21 Oct 2013, she was vaccinated with FLUVIRIN (batch number: 1309701) intramuscularly in the left arm. Following the vaccination, on 22 Oct 2013, she experienced spasms in face, legs, and arms and facial paralysis and was taken to the emergency room. The final outcome for the events was reported as complete recovery. The reporter assessed the events as non-serious but the agency considered event facial paralysis as serious. The causality of the events was not reported. Non significant follow up information received from the quality assurance department on 28 Jul 2014: QA reference number updated.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Case number PHHY2014US093931 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 517632) website on 24 Jul 2014. This report refers to a 26-year-old female patient. Her past medication included aspirin. She received FLUVIRIN (batch number: 08649221A) intramuscularly into left arm on 17 Sep 2013. On 07 Oct 2013, twenty days after vaccination, she developed rash on whole body. She had a visit to emergency room due to this event for medical assistance. The event was reported as non-serious; however the case was internally upgraded as medically significant by the agency. Outcome of the event was reported as recovered. Causality of the event was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Fatigue, Food allergy, Hypersensitivity, Oropharyngeal pain
Clinical narrative: Case number# PHHY2014US092108, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 517977) website on 24 Jul 2014. This report refers to a 53-year-old female patient. Past medical history included egg allergies, asthma and hives. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 24 Nov 2013. On 17 Dec 2013, she experienced deep strong sneezing, tickle in sinus/upper throat area, shortness of breath, difficulty breathing even to eat, fatigue, large hives on the upper torso, burning/pain in sinus/upper throat area, slight fever ranging from 100/101 degrees, was unable to stay away out of it and allergic reactions. She was sent to emergency room. She received double shot for allergic reactions, antihistamines PEPCID, updraft medication XOPENEX and cromolyn solution. It was reported that this order came to full reaction by 20 Dec 2013. On 21 Dec 2013, she started nebulizer treatment. The outcome of the events was complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Causality was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Sinus headache, Sneezing, Throat irritation, Urticaria
Clinical narrative: Case number# PHHY2014US092108, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 517977) website on 24 Jul 2014. This report refers to a 53-year-old female patient. Past medical history included egg allergies, asthma and hives. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 24 Nov 2013. On 17 Dec 2013, she experienced deep strong sneezing, tickle in sinus/upper throat area, shortness of breath, difficulty breathing even to eat, fatigue, large hives on the upper torso, burning/pain in sinus/upper throat area, slight fever ranging from 100/101 degrees, was unable to stay away out of it and allergic reactions. She was sent to emergency room. She received double shot for allergic reactions, antihistamines PEPCID, updraft medication XOPENEX and cromolyn solution. It was reported that this order came to full reaction by 20 Dec 2013. On 21 Dec 2013, she started nebulizer treatment. The outcome of the events was complete recovery. The events were reported as non-serious; however the case was internally upgraded as medically significant by the agency. Causality was not reported.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Case number PHHY2014US094487, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518016) website on 24 Jul 2014. This report refers to a 74-year-old male patient. Past medical history included seasonal allergies. No concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 13385P) into the left arm on 11 Oct 2013. On 12 Oct 2013, he developed systemic reaction of whole body rash. The outcome of the event was complete recovery. The event was reported as non-serious. However the case was internally upgraded as medically significant by the agency. Causality was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Peripheral paralysis
Clinical narrative: Case number PHHY2014US027627, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518538) website on 06 Mar 2014. This report refers to a 48-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1309201) intramuscularly on 06 Nov 2013. On 07 Nov 2013, the patient experienced Guillain Barre syndrome and feet paralyzed. She had been in and out hospital few times during past 2 months. Her symptoms would come and go. The final outcome of the events reported as not recovered. The seriousness and causality of the events were not reported.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Injection site pruritus, Throat tightness
Clinical narrative: Case number PHHY2014US027595, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 518626) website on 06 Mar 2014. This report refers to a 61-year-old female patient. Her medical history included Grave's disease and she had no known allergies. Concomitant drugs included SYNTHROID, lorazepam, zolpidem and meclizine. She was vaccinated with FLUVIRIN (batch number: 1309301) intramuscularly in the arm on 04 Jan 2014. On the same date, after vaccination she had itching at the site followed by difficulty breathing (throat constriction). She received EPI-PEN 0.3 and referred to ER for additional treatment. The final outcome of the events reported as recovered. The events were reported as serious (life-threatening). The causality of the events was not reported.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Chest discomfort, Dizziness, Dyspnoea, Electrocardiogram normal
Clinical narrative: Case number PHHY2014US027723 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 519060) on 06 Mar 2014: This report refers to a 37-year-old female patient. Past medical history included allergies to PREMARIN, SEPTRA, Gabapentin and Nortriptyline. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309301) intramuscularly in to the left arm on 10 Jan 2014. Five minutes after getting the vaccination she became nauseous, her chest felt tight, she got a headache, became lightheaded and her arms and legs began to shake. She had slight shortness of breath. Laboratory tests included electrocardiogram, chest X-ray and rapid influenza test. Results for the tests were reported to be normal. She visited the emergency room (ER) following these events. Outcome of the events was reported as complete recovery. No further information about seriousness and causality was reported.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Influenza virus test negative, Nausea, Tremor
Clinical narrative: Case number PHHY2014US027723 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 519060) on 06 Mar 2014: This report refers to a 37-year-old female patient. Past medical history included allergies to PREMARIN, SEPTRA, Gabapentin and Nortriptyline. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309301) intramuscularly in to the left arm on 10 Jan 2014. Five minutes after getting the vaccination she became nauseous, her chest felt tight, she got a headache, became lightheaded and her arms and legs began to shake. She had slight shortness of breath. Laboratory tests included electrocardiogram, chest X-ray and rapid influenza test. Results for the tests were reported to be normal. She visited the emergency room (ER) following these events. Outcome of the events was reported as complete recovery. No further information about seriousness and causality was reported.