chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Urticaria, Vaccination site induration, Vaccination site reaction
Clinical narrative: Case number PHHY2016US008117, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 609059) website on 18 Jan 2016. This case also contains QA reference number: 1011496. This report refers to a 67-year-old female patient. Medical history was not reported. Vaccination history included administration of ZOSTAVAX (manufacturer unknown, batch number: not reported) and FLUZONE (manufacturer unknown, batch number: not reported) which caused eyes swelling when patient was 65 years old (the patient was not sure which of above vaccines caused swelling) and the patient never had a severe reaction to a FLUVIRIN (batch number: not reported) vaccine before. Concomitant medication included NORCO, bupropion, naproxen, estradiol, XANAX, duloxetine. The patient was vaccinated with FLUVIRIN (batch number: 157925) into left arm and PREVNAR 13 (other manufacturer), batch number: M06901) into right arm, both intramuscularly on 02 Nov 2015. After vaccination might be on 03 Nov 2015, the patient experienced circular red silver dollar sized welt at site of vaccination which felt hard, hot and itched in the very center. The final outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality not reported. Seriousness of the events "vaccination site warmth, vaccination site urticaria, vaccination site erythema, vaccination site induration and vaccination site pruritus" was upgraded based on the available information in the source document. The quality assurance department reported that, batch review report (reference number: 1011496) received from quality assurance department on 18 Feb 2016: Based on the document review, it was stated that the concerned FLUVIRIN, batch number: 157925, was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No anomalies were noted during this review. Non-significant follow up report from the QA department (QA reference number: 1011496) received on 27 Jan 2016: Updated QA reference number only. Non significant follow up report received from a Quality Assurance Department (QA reference number: 1011496) on 18 Feb 2016: Updated batch review report (Conclusion added).
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Vaccination site warmth
Clinical narrative: Case number PHHY2016US008117, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 609059) website on 18 Jan 2016. This case also contains QA reference number: 1011496. This report refers to a 67-year-old female patient. Medical history was not reported. Vaccination history included administration of ZOSTAVAX (manufacturer unknown, batch number: not reported) and FLUZONE (manufacturer unknown, batch number: not reported) which caused eyes swelling when patient was 65 years old (the patient was not sure which of above vaccines caused swelling) and the patient never had a severe reaction to a FLUVIRIN (batch number: not reported) vaccine before. Concomitant medication included NORCO, bupropion, naproxen, estradiol, XANAX, duloxetine. The patient was vaccinated with FLUVIRIN (batch number: 157925) into left arm and PREVNAR 13 (other manufacturer), batch number: M06901) into right arm, both intramuscularly on 02 Nov 2015. After vaccination might be on 03 Nov 2015, the patient experienced circular red silver dollar sized welt at site of vaccination which felt hard, hot and itched in the very center. The final outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality not reported. Seriousness of the events "vaccination site warmth, vaccination site urticaria, vaccination site erythema, vaccination site induration and vaccination site pruritus" was upgraded based on the available information in the source document. The quality assurance department reported that, batch review report (reference number: 1011496) received from quality assurance department on 18 Feb 2016: Based on the document review, it was stated that the concerned FLUVIRIN, batch number: 157925, was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No anomalies were noted during this review. Non-significant follow up report from the QA department (QA reference number: 1011496) received on 27 Jan 2016: Updated QA reference number only. Non significant follow up report received from a Quality Assurance Department (QA reference number: 1011496) on 18 Feb 2016: Updated batch review report (Conclusion added).
Sex: F
Vaccine: FLUX
Symptoms: Computerised tomogram head normal, Hypoaesthesia
Clinical narrative: Case number PHHY2015US172469, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 609584) website on 29 Dec 2015. This report refers to a 59-year-old female patient. Current conditions included hypertension, seasonal allergies and hyperlipidemia. Concomitant medications included atenolol, lisinopril, fexofenadine, simvastatin. fluticasone and ASA. The patient was vaccinated with H1N1 influenza vaccine (manufacturer and batch number: not reported) on 07 Jan 2010. On the same day 30 min after vaccination, the patient experienced numbness in left face and hand. The patient had not received the influenza vaccine since that event. The patient's case was reviewed by two neurologists who had differing opinions on whether this was a TIA or not based on documented physical exam from that time and if it was related the vaccine. The patient's computerized tomogram of brain was normal. A third neurologist saw the patient and stated that patient should not receive the influenza vaccine again. Final outcome of the event was recovered. Event was reported as non-serious. Causality was not reported. Further the patient was vaccinated with AFLURIA (other manufacturer) and was observed for one hour. No neurologic events occurred then or within next 24 hours.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Headache, Injection site pain, Rash
Clinical narrative: Case number PHHY2016US008629, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 609674) website on 18 Jan 2016. This report refers to a 50 years old female patient. Past medical history was not reported. Current condition included penicillin allergy. Concomitant medications included losartan (manufacturer unknown). She was vaccinated with FLUVIRIN (batch number: 157925) intramuscularly in right arm and PNEUMOVAX (manufacturer unknown and batch number: L024132) intramuscularly in left arm both on 12 Nov 2015. On the same day, she reported headache, pain in arm where injection was given, rash on same arm and slight short of breath. She was treated with BENADRYL. She was advised to visit emergency room if face or mouth swells or breathing become difficult. The outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported. The seriousness of the events dyspnea and vaccination site rash was upgraded to medically significant based on the information available in the source document. The quality assurance department reported that, batch review report (reference number: 1011680) received from quality assurance department on 18 Feb 2016: Based on the document review, it was stated that the concerned FLUVIRIN, batch number: 157925, was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No anomalies were noted during this review. Non significant follow up report received from the QA department (QA reference number: 1011680) on 01 Feb 2016: Updated QA reference number only. Non significant follow up report received from Quality Assurance Department (QA reference number: 1011680) on 18 Feb 2016: Updated batch review report (conclusion added).
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased, Heart rate decreased, Syncope
Clinical narrative: Case number PHHY2016US027046, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 609919) on 29 Feb 2016. This report refers to a 15 years old male patient. Medical history and concurrent conditions were none. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157101) intramuscularly into left arm on 13 Nov 2015. On the same day after vaccination the patient walked away couple of steps and fainted. Further his blood pressure and heart rate dropped low. The patient was taken to emergency room. The patient was treated with steroids and released on same day. On the same day at 08:25 hours the patient was called and he was fine. Final outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "syncope" was upgraded based on information in the source document.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Pruritus, Rash
Clinical narrative: Case number PHHY2016US027002 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 609934) on 29 Feb 2016. This report refers to a 27 year old male patient. The patient's medical history, current conditions and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 157701) intramuscularly in the right arm on 11 Nov 2015. On the same day, 1 hour after vaccination, the patient was dizzy and sweaty. That night, the patient broke into a rash. He took BENADRYL by mouth which helped a little bit, but it was still really itchy. He went to emergency room. It was reported that the patient still had rash and itching at the time of reporting and that he would go to a doctor. The patient stated that he would report further updates after going to doctor. The events outcome was reported as condition unchanged. The events were reported as non-serious, but the events were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Case number PHHY2016US025301, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 609968) website on 19 Feb 2016. This was also a quality compliant report (QA reference number: 1012743). This report refers to a 26 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1515601) intramuscularly in left arm on 03 Nov 2015. On the same day after vaccination (Approximately 40 (unit not specified)), she experienced difficulty breathing. The outcome of the event was reported as complete recovery on an unknown date. The seriousness of the event was reported as non serious. The causality of the event was not reported. The event dyspnoea was upgraded to medically significant based on the information available in the source document. Batch review report (reference number [1012743] received from quality assurance department on [06 Mar 2016]: Based on the document review, it was stated that the concerned [FLUVIRIN] batch number [1515601] 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 (QA number: 1012743) on 29 Feb 2016: Updated QA reference number only. Non significant follow up report received from a Quality Assurance Department (QA reference number: 1012743) on 06 Mar 2016: Updated batch review report.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Case number PHHY2016US026533, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 610091) on 29 Feb 2016. This report refers to a 74 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515301) on 06 Nov 2015. On 07 Nov 2015 the patient developed rash and itchy all over body. The patient was seen at urgent care due to these events. The patient was treated with "steroid shot" and prednisone 40 mg. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "rash generalized" and "pruritus generalized" was upgraded based on information in the source document.
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Abasia, Balance disorder, Electromyogram, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Case number PHHY2016US027777, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 610478) website on 29 Feb 2016. This report refers to a 52 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: U4694EA) and BOOSTRIX ((other manufacturer), batch number:3T549) both into right arm on 04 Feb 2014. On 07 Mar 2014 after vaccination, the patient experienced severe numbness and tingling in hands and feet, symptoms ascended up legs to thighs, resulted in imbalance and inability to walk and diagnosed as Guillain-Barre syndrome. Laboratory data revealed that, the patient had spinal puncture, electromyography and nerve conduction (results unknown). The patient was hospitalized and existing hospitalization was prolonged and he was hospitalized for 17 days. The final outcome of the events was reported as condition unchanged. Causality was not reported.
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Lumbar puncture, Nerve conduction studies, Paraesthesia
Clinical narrative: Case number PHHY2016US027777, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 610478) website on 29 Feb 2016. This report refers to a 52 years old male patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: U4694EA) and BOOSTRIX ((other manufacturer), batch number:3T549) both into right arm on 04 Feb 2014. On 07 Mar 2014 after vaccination, the patient experienced severe numbness and tingling in hands and feet, symptoms ascended up legs to thighs, resulted in imbalance and inability to walk and diagnosed as Guillain-Barre syndrome. Laboratory data revealed that, the patient had spinal puncture, electromyography and nerve conduction (results unknown). The patient was hospitalized and existing hospitalization was prolonged and he was hospitalized for 17 days. The final outcome of the events was reported as condition unchanged. Causality was not reported.
Age: 44.0
Sex: M
Vaccine: FLU3, HEPAB, IPV, TYP
Symptoms: Swelling face
Clinical narrative: Case number PHHY2016US027230 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 610490) on 29 Feb 2016. This report refers to a 44-year-old male patient. The patient had no medical history, current condition or concomitant medications. The patient received FLUVIRIN (batch number: 1517801) and TWINRIX (other manufacturer, batch number: DX7D3); both vaccines administered intramuscularly in the left arm on 06 Nov 2015 at 12:20 pm. On the same day at 12:20 pm, the patient also received IPOL (other manufacturer, batch number: K1513) and TYPHIM VI (batch number: K1536); both vaccines administered intramuscularly in the right arm. On 06 Nov 2015, 25 minutes later, the patient returned with right cheek swelling near the ear. It was reported that the swelling was of the size of a large orange. He was treated with diphenhydramine 50 mg and ice. The medicine and ice treatment was repeated later in day. There were no other problems and the patient had no difficulty in breathing or swallowing. No laboratory tests were done. The patient recovered from the event. The event was reported as non-serious, but it was upgraded as medically significant based on the information available in the source documents. The causality of the event was not reported.
Age: 22.0
Sex: M
Vaccine: FLU3, HEPA, TDAP, TYP
Symptoms: Blood glucose normal, Dizziness, Syncope
Clinical narrative: Case number PHHY2016US029219, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 610575) on 29 Feb 2016. This report refers to a 22 years old male patient. Medical history and concurrent conditions were none. Concomitant medications were none. The patient was vaccinated with FLUVIRIN (batch number: 1515001) intramuscularly into right arm on 18 Nov 2015. On the same day the patient was also vaccinated with HAVRIX (other manufacturer, batch number: D23LP) intramuscularly into left arm, BOOSTRIX (batch number: X7DN3, other manufacturer) intramuscularly into left arm and TYPHIM VI (batch number: K1536, other manufacturer) intramuscularly into right arm. On the same day after vaccinations the patient felt light headed and fainted. Emergency (911) was called paramedics checked blood pressure and blood sugars and everything was normal. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "faint" was upgraded based on information in the source document.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test normal, Mouth swelling, Pain in extremity, Rash, Swelling
Clinical narrative: Case number PHEH2015US023419 is an initial spontaneous report received from a consumer on 05 Nov 2015. This report refers to a 43 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: unknown) on an unknown date in Sep 2014. Since the vaccination the patient had been experiencing hives and swelling every one to two days. Two days after vaccination, the patient developed rash followed by swelling in mouth and face area, hand pain and left foot pain. Following the events patient visited hospital and admitted to reduce swelling. The physician prescribed loratadine, ranitidine and store allergy medicine twice daily once symptoms started. The patient was taking these medicines over one year now. It was reported that when the patient tries to stop the treatment medicine the symptoms returns. Medical tests performed indicated negative results. The outcome and causality of the events were not reported.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Urticaria
Clinical narrative: Case number PHEH2015US023419 is an initial spontaneous report received from a consumer on 05 Nov 2015. This report refers to a 43 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: unknown) on an unknown date in Sep 2014. Since the vaccination the patient had been experiencing hives and swelling every one to two days. Two days after vaccination, the patient developed rash followed by swelling in mouth and face area, hand pain and left foot pain. Following the events patient visited hospital and admitted to reduce swelling. The physician prescribed loratadine, ranitidine and store allergy medicine twice daily once symptoms started. The patient was taking these medicines over one year now. It was reported that when the patient tries to stop the treatment medicine the symptoms returns. Medical tests performed indicated negative results. The outcome and causality of the events were not reported.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHHY2016US031110, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 611071) website on 29 Feb 2016. This report refers to 19 years old female patient. Past medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 157604) on 21 Oct 2015, intramuscularly on left arm. On same day, she broke out in hives a few hours after receiving the vaccination that got worse when she took a shower. She received BENADRYL, that seemed to help and they eventually went away. Outcome of the event was reported as complete recovery. Seriousness of the event was reported as non serious. The causality of the event was not reported. Seriousness of the event urticaria was upgraded based on available information in the source document.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Guillain-Barre syndrome, Intensive care
Clinical narrative: Case number PHHY2016US027057, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 611086) website on 29 Feb 2016. This report refers to an 85 year old female patient. Medical history was not reported. Concomitant medication included ZOLOFT. The patient was vaccinated with FLUVIRIN (batch number: 1515601) in left arm on 30 Oct 2015. On 15 Nov 2015, the patient experienced general weakness and was unable to walk. The patient was taken to an emergency room and was admitted to intensive care unit. The patient was diagnosed with Guillain-Barre syndrome. Outcome of the events was reported as condition unchanged. Events were reported as serious (life threatening). Causality was not reported.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2016US029220, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 611120) on 29 Feb 2016. This report refers to 42 years old male patient. Medical history was not reported. Concurrent conditions were none. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157904) intramuscularly into left arm on 14 Sep 2015. On an unknown date after vaccination the patient experienced Guillain Barre and was hospitalized. Approximately 3 weeks later the patient was transferred for another hospital (as reported). Outcome of the event was unknown. Causality of the event was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Injection site swelling
Clinical narrative: Case number PHHY2016US113286, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 611219) website on 18 Aug 2016. This report refers to a female patient of an unknown age. Historical condition was not reported. Current condition included allergy to amoxicillin and other illness at time of vaccination was unknown. Concomitant medication was not reported. The patient was vaccinated with Influenza Virus Vaccine (H1N1) (manufacturer unknown, batch number not reported) intramuscularly on an unspecified date in 2009. Post vaccination, on an unknown date in 2009 the patient experienced shortness of breath and swelling of the injection site. Laboratory data and corrective treatment was not reported. On an unspecified date, the patient recovered from the above mentioned events. Seriousness of the event was reported as non serious and causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test normal, Swelling face
Clinical narrative: Case number PHHY2016US027641, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 611229) on 29 Feb 2016. This report refers to a 48 years old female patient. Medical history included "adhesive". Historical drug included Aspirin. Current illnesses were none. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1518101) into left arm on 20 Oct 2015. On 21 Oct 2015 the patient stated that her face blew up because of the flu shot. The patient was hospitalized due to this event. During hospitalization the patient underwent various tests and nothing found wrong. The patient called and spoke to the store manager on 26 Oct 2015 and said she was just discharged from the hospital. Duration of the hospitalization was 5 days. Outcome of the events was recovered. Causality of the events was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Areflexia, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness
Clinical narrative: Case number PHHY2016US027199, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 611528) on 29 Feb 2016. This report refers to a 34 years old male patient. Past medical history included sour stomach and mild diarrhea on 04 Nov 2015 which lasted for a day. Current conditions included back pain and allergy to raspberries. Concomitant medication included ibuprofen. He was vaccinated with FLUVIRIN (batch number: 1517801) intramuscularly into the left arm on 11 Nov 2015. After vaccination, on 14 Nov 2015, he experienced bilateral leg and arm weakness and numbness, it felt like pins and needles, ascending paralysis and he was areflexic. As of 24 Nov 2015, patient was severely disabled as per rehabilitation physician notes. Nerve conduction studies performed on 19 Nov 2015 revealed that there was electro diagnostic evidence most consistent with a moderate, length dependent, demyelinating polyneuropathy. Given that the bilateral sural nerves were spared, the diagnosis was most likely acute inflammatory demyelinating polyneuropathy (Guillain Barre Syndrome). He received treatment with intravenous immunoglobulin therapy for 5 days. The patient was hospitalized due to the events for 8 days. The outcome of the events was unknown. All the events were assessed as serious (life threatening) and disability is also marked for paralysis and areflexic and causality was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Nerve conduction studies abnormal, Paraesthesia
Clinical narrative: Case number PHHY2016US027199, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 611528) on 29 Feb 2016. This report refers to a 34 years old male patient. Past medical history included sour stomach and mild diarrhea on 04 Nov 2015 which lasted for a day. Current conditions included back pain and allergy to raspberries. Concomitant medication included ibuprofen. He was vaccinated with FLUVIRIN (batch number: 1517801) intramuscularly into the left arm on 11 Nov 2015. After vaccination, on 14 Nov 2015, he experienced bilateral leg and arm weakness and numbness, it felt like pins and needles, ascending paralysis and he was areflexic. As of 24 Nov 2015, patient was severely disabled as per rehabilitation physician notes. Nerve conduction studies performed on 19 Nov 2015 revealed that there was electro diagnostic evidence most consistent with a moderate, length dependent, demyelinating polyneuropathy. Given that the bilateral sural nerves were spared, the diagnosis was most likely acute inflammatory demyelinating polyneuropathy (Guillain Barre Syndrome). He received treatment with intravenous immunoglobulin therapy for 5 days. The patient was hospitalized due to the events for 8 days. The outcome of the events was unknown. All the events were assessed as serious (life threatening) and disability is also marked for paralysis and areflexic and causality was not reported.
Age: 39.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Case number PHHY2016US027646, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 611587) on 29 Feb 2016. This report refers to a 39 years old female patient. Medical history included migraines and anemia. Current illnesses were none. Concomitant medications included RELPAX, TOPAMAX, Vitamin B and naproxen. The patient was vaccinated with FLUVIRIN (batch number: 15751P) intramuscularly into right arm and MMR II (batch number: K024825 and other manufacturer) subcutaneously into left arm on 07 Oct 2015. The patient developed mild itchy, red, raised rash, started the following morning on abdomen then spread covering body. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "redness generalized", "pruritus generalized" and "rash generalized" were upgraded based on information in the source document.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Case number PHHY2016US028412, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 611589) on 29 Feb 2016. This report refers to a 21 years old female patient. Medical history was not reported. Current conditions included allergy to dairy and latex. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517801) intramuscularly into left arm on 13 Nov 2015. On the same day, three hours after the vaccination, the patient called to inform that she had hives and itching that was spreading all over her body. She was told to take diphenhydramine and go to doctor's office. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "hives and itching all over body" was upgraded based on information in the source document.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypersensitivity, Pyrexia, Vaccination site pain
Clinical narrative: Case number PHHY2016US028415, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 611620) on 29 Feb 2016. This report refers to a 57 years old female patient. Medical history was unknown. Concurrent conditions were not reported. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515001) intramuscularly on 30 Oct 2015. On an unknown date after vaccination the patient experienced fever, headache and pain at the vaccination site. Further the patient experienced allergy on the body. The patient went to emergency room due to these events. The patient was treated with ALLEGRA 180 and beclomethasone dipropionate. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "allergy" was upgraded based on information in the source document.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Facial paralysis
Clinical narrative: Case number PHHY2016US026544 is a spontaneous report initially received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 611897) on 29 Feb 2016. This report refers to a 42 years old female patient. Medical history was not reported. Concurrent conditions included hypertension and hyperlipidemia. Concomitant medications included PRINZIDE and atenolol. The patient was vaccinated with FLUVIRIN (batch number: 1516001) intramuscularly into left arm on 24 Nov 2015. On 25 Nov 2015, within 24 hours of vaccination, the patient developed Bell's palsy. The patient went to emergency room due to this event. The case was assessed as non-serious. Outcome and causality of the event was not reported. Seriousness assessment of Bell's palsy was upgraded based on the NVD key event list. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1516001) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information from quality assurance department (QA reference nr. 1012862) received 02 Mar 2016: Updated QA reference number only. Non-significant follow-up received from a quality assurance department on 14 Mar 2016: Updated batch review report.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Case number PHHY2016US028882, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 611930) website on 29 Feb 2016. This report refers to a 20 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516501) intramuscularly in right arm on 23 Nov 2015. On the same day, 5 minutes after vaccination, the patient developed syncope. The patient regained consciousness within 30 seconds. Final outcome of the event was reported as complete recovery. Event was reported as non-serious. Seriousness assessment of the event syncope was upgraded based on the information available in the source document. Causality was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eyelid oedema, Injection site swelling, Pruritus generalised
Clinical narrative: Case number PHHY2016US028728, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 612055) on 29 Feb 2016. This report refers to a 53 years old female patient. Past medical history was not reported. Current conditions included allergy to onions and whey. Concomitant medications included vitamins (unspecified) and meloxicam (manufacturer unknown). It was reported that the patient was in emergency room before onion allergy. She was vaccinated with FLUVIRIN (batch number: 158425) into the right arm on 04 Nov 2015. 30 minutes after vaccination, her hands, face and arms began to turn red, her eye lids became swollen, she developed swelling at injection sight, and it started itching all over her body. She received treatment with BENADRYL at a dose of 25 mg. The outcome of the events was reported as complete recovery on an unknown date. The seriousness assessment of the events erythema, eyelid oedema, vaccination site swelling and pruritus generalised were upgraded (medically significant) based on the information available in the source document.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Facial paralysis
Clinical narrative: Case number PHHY2016US029910, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 612266) website on 29 Feb 2016. This report refers to a 76 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517501) intramuscularly into arm on 06 Nov 2015. Three days after vaccination, the patient experienced Bell's palsy on left face. The final outcome of the event was reported as condition unchanged. Seriousness of the event was reported as non serious and causality not reported. Seriousness of the event VII th nerve paralysis was upgraded based on information available in the source document. Batch review report reference number (1012991) received from quality assurance department on 21 Mar 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (1517501) 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 (QA reference number: 1012991) on 07 Mar 2016: Updated QA number only. Non-significant follow up received from quality assurance department (QA reference number: 1012991) on 21 Mar 2016: Added investigation summary.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Case number PHHY2016US028879, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 612352) website on 29 Feb 2016. This report refers to a 65 years old male patient. Past medical history was not reported. Concomitant medication included allopurinol (manufacturer unknown). The patient was vaccinated with FLUVIRIN (batch number: 158303) into right arm, intramuscularly on 01 Dec 2015. On the same day 05 minutes after vaccination, the patient experienced felt dizzy and fainted. The patient regained consciousness immediately and he was sweating. The patient's blood pressure at time of event was 80/60 (unit unspecified). The patient was given ice pack as well as orange juice and wafers for strength and blood pressure became to 126/84 (unit unspecified) within 15 minutes. Outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious. Causality of the events was not reported. Seriousness of the events syncope, hyperhidrosis, blood pressure decreased and dizziness was upgraded to medically significant based on the information available in the source document.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: Case number PHHY2016US029221, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 612374) on 29 Feb 2016. This report refers to a 54 years old male patient. Medical history and concurrent conditions were none. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 158104) intramuscularly into left arm on 20 Oct 2015. On 29 Oct 2015 the patient had an allergic reaction to the flu shot. Two days after the vaccination the patient noticed itchiness in bilateral antecubital fossae and rash on neck, back, chest, groin. The patient went to emergency room due to these events. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "allergic reaction" was upgraded based on information in the source document.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: Case number PHHY2016US029222, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 612813) on 29 Feb 2016. This report refers to a 16 years old female patient. Medical history was none. The patient had no current illness. Concomitant medications were unknown. The patient was vaccinated with FLUVIRIN (batch number: 158303) intramuscularly into left arm on 01 Dec 2015. On the same day after vaccination the patient had dizziness and then fainted immediately. Emergency medical service (EMS) checked her pulse, blood pressure and some other signs within 15 minutes and they were normal or near normal. The patient refused further medical help and said will go to emergency room (ER) if necessary. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "faint" was upgraded based on information in the source document.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blood creatinine normal, Dizziness, Feeling abnormal, Full blood count normal
Clinical narrative: Case number PHHY2016US029615, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 612977) website on 29 Feb 2016. This report refers to a 62 years old female patient. Past medical history was not reported. Concomitant medication included as warfarin (manufacturer unknown). The patient was vaccinated with FLUVIRIN (batch number: 157701) into upper left arm on 27 Oct 2015. For a second, she felt faint and a heavy rush feeling through arm. Later that evening, her arm began to hurt with certain movements. During the night, the patient pain grew more severe and woke me up every hour; pain was a sharp ache mostly in inner bicep area. The patient experienced tenderness in shoulder and elbow joint, tender when pressure applied. After 07 days, the patient still had severe pain through the night and off and on during the day, she saw the physician on 09 Nov 2015, physician prescribed Gabapentin (manufacturer unknown) 100 mg and Hydrocodone/Acetaminophen 5/325. On 25 Nov 2015, the patient still experiencing pain and could not raise arm over her head without pain. The patient visited to the emergency room. The patient performed lab tests such as complete blood count (CBC), creatinine and sedimentation rate (results unspecified) (reported as results within normal limits (WNL)). The outcome of the events was unknown. The seriousness of the events was reported as non serious and causality was not reported. The seriousness assessment of dizziness was upgraded to medically significant based on the information available in the source document.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Pain in extremity, Red blood cell sedimentation rate normal, Sleep disorder
Clinical narrative: Case number PHHY2016US029615, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 612977) website on 29 Feb 2016. This report refers to a 62 years old female patient. Past medical history was not reported. Concomitant medication included as warfarin (manufacturer unknown). The patient was vaccinated with FLUVIRIN (batch number: 157701) into upper left arm on 27 Oct 2015. For a second, she felt faint and a heavy rush feeling through arm. Later that evening, her arm began to hurt with certain movements. During the night, the patient pain grew more severe and woke me up every hour; pain was a sharp ache mostly in inner bicep area. The patient experienced tenderness in shoulder and elbow joint, tender when pressure applied. After 07 days, the patient still had severe pain through the night and off and on during the day, she saw the physician on 09 Nov 2015, physician prescribed Gabapentin (manufacturer unknown) 100 mg and Hydrocodone/Acetaminophen 5/325. On 25 Nov 2015, the patient still experiencing pain and could not raise arm over her head without pain. The patient visited to the emergency room. The patient performed lab tests such as complete blood count (CBC), creatinine and sedimentation rate (results unspecified) (reported as results within normal limits (WNL)). The outcome of the events was unknown. The seriousness of the events was reported as non serious and causality was not reported. The seriousness assessment of dizziness was upgraded to medically significant based on the information available in the source document.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Case number PHHY2016US029615, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 612977) website on 29 Feb 2016. This report refers to a 62 years old female patient. Past medical history was not reported. Concomitant medication included as warfarin (manufacturer unknown). The patient was vaccinated with FLUVIRIN (batch number: 157701) into upper left arm on 27 Oct 2015. For a second, she felt faint and a heavy rush feeling through arm. Later that evening, her arm began to hurt with certain movements. During the night, the patient pain grew more severe and woke me up every hour; pain was a sharp ache mostly in inner bicep area. The patient experienced tenderness in shoulder and elbow joint, tender when pressure applied. After 07 days, the patient still had severe pain through the night and off and on during the day, she saw the physician on 09 Nov 2015, physician prescribed Gabapentin (manufacturer unknown) 100 mg and Hydrocodone/Acetaminophen 5/325. On 25 Nov 2015, the patient still experiencing pain and could not raise arm over her head without pain. The patient visited to the emergency room. The patient performed lab tests such as complete blood count (CBC), creatinine and sedimentation rate (results unspecified) (reported as results within normal limits (WNL)). The outcome of the events was unknown. The seriousness of the events was reported as non serious and causality was not reported. The seriousness assessment of dizziness was upgraded to medically significant based on the information available in the source document.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea, Heart rate decreased, Injection site pruritus
Clinical narrative: Case number PHHY2016US028495 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 613949) on 29 Feb 2016. This report refers to a 30 year old female patient. Her current condition included psychiatric health condition, allergy to shell fish and polycystic ovarian syndrome (PCOS). Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1517001) intramuscularly in the left arm on 21 Nov 2015. On the same day, within 10 minutes she walked into the clinic stating that she felt it harder to breathe and swallow. The patient was alert and oriented. She stated that she also had severe itching at the site of her injection. The nurse administered EPIPEN 0.3 mg at 13:00 and called Emergency Medical Services (EMS). She stated that 1 minute after EPIPEN administration, she was feeling better and easier to breathe. Her vital signs were reported as follows: heart rate: 70, oxygen saturation on right atrium (RA): 100%. Emergency Medical Assistance (EMA) arrived within 5 to 10 minutes after EPIPEN and took over care. They took her to the emergency room of nearby hospital to be observed. She walked out of clinic on her own with EMS at her side. The events outcome was reported as complete recovery. The events were reported as non-serious. The events hard to breathe and swallow were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLU3, HEPA, TDAP
Symptoms: Rash
Clinical narrative: Case number PHHY2016US029013, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 614107) website on 29 Feb 2016. This report refers to 52 years old female patient. Past medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 157601) on 08 Dec 2015, intramuscularly on right arm. On same date, she was also vaccinated with HAVRIX (other manufacturer, batch number: 5D952) intramuscularly on left arm and with BOOSTRIX (other manufacturer, batch number: ED2EN) intramuscularly on left arm. On 09 Dec 2015, she had rashes on chest, back and shoulder. The outcome of the event was not reported. The seriousness of the event was reported as non serious. The causality of the event was not reported. Seriousness of the events rash generalized was upgraded based on the information available in the source document.
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pharyngeal oedema
Clinical narrative: Case number PHHY2016US028569 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 614574) on 29 Feb 2016. This report refers to a 19 year old female patient. Her current conditions included asthma, birth control and allergy to peanuts and lactose. Her concomitant medications were ADVAIR, SINGULAIR, ALLEGRA, FLONASE, Vitamin D, and Multivitamin. She was vaccinated with FLUVIRIN (batch number: 157925) intramuscularly in the right arm on 12 Dec 2015. On 12 Dec 2015, after vaccination the patient experienced swelling of throat making breathing difficult. She had two doses of BENADRYL with no effect. She was administered EPIPEN. The events outcome was reported as complete recovery. The events were reported as non-serious, but were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2016US029225, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 614834) on 29 Feb 2016. This report refers to a 24 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515001) intramuscularly into left arm on 29 Oct 2015. On 09 Nov 2015 the patient experienced Guillain Barre syndrome. The patient was hospitalized for 7 days due to this event. Outcome of the event was recovered. Causality of the event was not reported.