chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Computerised tomogram, Fall, Fatigue, Gait disturbance
Clinical narrative: Case number PHHY2015US164850, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596826) website on 14 Dec 2015. This report refers to a 53 years old female patient. Past medical history included codeine allergy, type II diabetes and hypertension. Concomitant medications were included unspecified dental numbing medications. She was vaccinated with FLUVIRIN (batch number: not reported) on 03 Oct 2014. On 10 Oct 2014, she felt very weak, fatigued, trouble walking, leg weakness and falling, she dragged for about 2 months and more until she experienced leg paralysis. She experienced transverse myelitis on an unknown date. She was hospitalized for 20 days on an unknown date. Laboratory data included magnetic resonance imaging (MRI), computed tomography scan (CT scan), spinal taps and X rays (results unspecified). The outcome of the events was not reported. The seriousness of the events was reported as serious (permanent disability). The causality of the events was not reported. The quality assurance department stated that, the case was reported as FLUVIRIN, however the batch number 015011A was not valid for FLUVIRIN. Therefore, this standard request would not be investigated further. Following an internal review done for the data received on 14 Dec 2015, significant case correction was done: The suspect drug coding was changed to FLUVIRIN vaccine from influenza vaccine. Follow up report received from Quality Assurance Department on 01 Feb 2016: Added quality assurance department comments. Following an internal review done for the data received on 01 Feb 2016, non significant case correction was done: The earlier reported invalid batch number of FLUVIRIN was deleted from product tab and narrative.
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Monoplegia, Muscular weakness, Myelitis transverse, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2015US164850, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596826) website on 14 Dec 2015. This report refers to a 53 years old female patient. Past medical history included codeine allergy, type II diabetes and hypertension. Concomitant medications were included unspecified dental numbing medications. She was vaccinated with FLUVIRIN (batch number: not reported) on 03 Oct 2014. On 10 Oct 2014, she felt very weak, fatigued, trouble walking, leg weakness and falling, she dragged for about 2 months and more until she experienced leg paralysis. She experienced transverse myelitis on an unknown date. She was hospitalized for 20 days on an unknown date. Laboratory data included magnetic resonance imaging (MRI), computed tomography scan (CT scan), spinal taps and X rays (results unspecified). The outcome of the events was not reported. The seriousness of the events was reported as serious (permanent disability). The causality of the events was not reported. The quality assurance department stated that, the case was reported as FLUVIRIN, however the batch number 015011A was not valid for FLUVIRIN. Therefore, this standard request would not be investigated further. Following an internal review done for the data received on 14 Dec 2015, significant case correction was done: The suspect drug coding was changed to FLUVIRIN vaccine from influenza vaccine. Follow up report received from Quality Assurance Department on 01 Feb 2016: Added quality assurance department comments. Following an internal review done for the data received on 01 Feb 2016, non significant case correction was done: The earlier reported invalid batch number of FLUVIRIN was deleted from product tab and narrative.
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Case number PHHY2015US164850, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 596826) website on 14 Dec 2015. This report refers to a 53 years old female patient. Past medical history included codeine allergy, type II diabetes and hypertension. Concomitant medications were included unspecified dental numbing medications. She was vaccinated with FLUVIRIN (batch number: not reported) on 03 Oct 2014. On 10 Oct 2014, she felt very weak, fatigued, trouble walking, leg weakness and falling, she dragged for about 2 months and more until she experienced leg paralysis. She experienced transverse myelitis on an unknown date. She was hospitalized for 20 days on an unknown date. Laboratory data included magnetic resonance imaging (MRI), computed tomography scan (CT scan), spinal taps and X rays (results unspecified). The outcome of the events was not reported. The seriousness of the events was reported as serious (permanent disability). The causality of the events was not reported. The quality assurance department stated that, the case was reported as FLUVIRIN, however the batch number 015011A was not valid for FLUVIRIN. Therefore, this standard request would not be investigated further. Following an internal review done for the data received on 14 Dec 2015, significant case correction was done: The suspect drug coding was changed to FLUVIRIN vaccine from influenza vaccine. Follow up report received from Quality Assurance Department on 01 Feb 2016: Added quality assurance department comments. Following an internal review done for the data received on 01 Feb 2016, non significant case correction was done: The earlier reported invalid batch number of FLUVIRIN was deleted from product tab and narrative.
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Eye swelling, Peripheral swelling, Rash
Clinical narrative: Case number PHHY2015US164957 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 596951) website on 14 Dec 2015. This report refers to a 45-year-old female patient. Historical condition was not reported. Current condition included diabetes. Concomitant medications included KOMBIGLYZE. The patient was vaccinated with FLUVIRIN (batch number: 157701) into right arm on 17 Sep 2015. On 18 Sep 2015 the patient developed swelling of face, hands, eyes, redness, rash on hands (B), (B) arms, chest area, light rash and burning on thighs and legs. The patient was treated with BENADRYL, hydrocortisone cream (manufacturer unknown) and CLARITIN. The outcome of the events were unknown. Seriousness was reported as non serious. Causality of the events were not reported. Seriousness of the events eye swelling, peripheral swelling, swelling face and rash generalized was upgraded based on the information available in source document.
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Case number PHHY2015US164957 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 596951) website on 14 Dec 2015. This report refers to a 45-year-old female patient. Historical condition was not reported. Current condition included diabetes. Concomitant medications included KOMBIGLYZE. The patient was vaccinated with FLUVIRIN (batch number: 157701) into right arm on 17 Sep 2015. On 18 Sep 2015 the patient developed swelling of face, hands, eyes, redness, rash on hands (B), (B) arms, chest area, light rash and burning on thighs and legs. The patient was treated with BENADRYL, hydrocortisone cream (manufacturer unknown) and CLARITIN. The outcome of the events were unknown. Seriousness was reported as non serious. Causality of the events were not reported. Seriousness of the events eye swelling, peripheral swelling, swelling face and rash generalized was upgraded based on the information available in source document.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Case number PHHY2015US165476, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 597285) website on 14 Dec 2015. This report refers to an 8 years old female patient. Medical history and concurrent illness were none. Concomitant medications were none. The patient was vaccinated with FLUVIRIN (batch number: 15721P) into left arm on 20 Sep 2015. Immediately after the vaccination the patient had syncope and was made to lie on the floor. The patient recovered and left after about 10-15 minutes with her mother. The case was assessed as non-serious. Causality of the event was not reported. Seriousness assessment of "syncope" was upgraded based on the information in the source document.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash generalised, Skin warm
Clinical narrative: Case number PHHY2015US164846 is an initial spontaneous report received via Vaccine Adverse Events Reporting (VAERS reference number: 597289) on 14 Dec 2015. This report refers to a 68 year old female patient. Her medical history, current condition and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1316601) in the right arm and PNEUMOVAX (other manufacturer, batch number: K009874) in the left arm; both vaccines administered intramuscularly on 18 Sep 2015. On 19 Sep 2015, she had rash over entirety of body and it felt hot. She went to emergency room and the events were relatively unresponsive to antihistamines. The events outcome was unknown. The events were reported as non-serious, but the event rash over entirety of body was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Case number PHHY2015US166263, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 597557) website on 14 Dec 2015. This report refers to a 19-year-old male patient. Medical history was not reported. Current illness was none. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157903) into the right arm on 25 Sep 2015. On the same day after vaccination, the patient experienced syncope. The patient was counseled by the administering pharmacist over the phone. Final outcome of the event was complete recovery. Event was reported as non-serious. Causality was not reported. Seriousness of the event was upgraded based on information available in the source document.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain in extremity
Clinical narrative: Case number PHHY2015US164992, is a spontaneous report initially received from the Vaccine Adverse Event Reporting System (VAERS reference number: 597638) website on 14 Dec 2015. This report refers to a 49-years-old male patient. Past medical history included vancomycin allergy, chronic lymphocytic leukemia, skin hypersensitivity, meningitis due to herpes simplex virus, herpes simplex virus (HSV) conjunctivitis and keratitis and right arm and hand cellulitis as current condition. Concomitant medications included Valacyclovir (1 mg per oral every 8 hours) and prednisone (manufacturer unknown) (5 mg per oral daily). On 24 Sep 2015, he was admitted to hospital with right hand and arm cellulitis, pruritus, possible underlying herpes simplex virus (HSV) or Varicella zoster virus (VZV) vesicles and white blood cells elevated. He was vaccinated with second dose of FLUVIRIN (manufacturer  unknown  and  batch  number: 157702) intramuscularly in right upper arm on 26 Sep 2015. On 26 Sep 2015, he experienced chills. On 27 Sep 2015, his right arm ached (pain). He was discharged from hospital after treatment with acetaminophen for chills, ibuprofen for pain, antivirals (unknown) and antibiotics (unknown). The events caused  prolonged hospitalization. The outcome of the events was unknown. The causality of the events was not reported. Batch review report (reference number: 1010489) received from quality assurance department on 14 Jan 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (157702) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report received from Quality Assurance department (QA reference number: 1010489) on 22 Dec 2015: QA reference number updated. Non-significant follow-up information from quality assurance department received on 21 Jan 2016: Added investigation summary.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Erythema, Injection site erythema, Throat irritation
Clinical narrative: Case number PHHY2015US164873 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting (VAERS reference number: 597764) on 14 Dec 2015. This report refers to a 26 year old female patient. Her medical history was not reported. Her current conditions included allergy to latex and asthma. Her concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516101) intramuscularly in the left arm on 28 Sep 2015. On the same day after vaccination, her face, chest and arm around the injection site became very red for a solid half hour. She felt that her chest was tight as if her asthma was acting up and her throat was slightly itchy. The events outcome was complete recovery. The events were reported as non-serious, but the event chest felt tight, throat itching and face and chest became very red was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling, Vertigo
Clinical narrative: Case number PHHY2015US164710, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 597838) website on 14 Dec 2015. This report refers to a 65 years old female patient. Medical history and concurrent illness were none. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly into left arm on 18 Sep 2015. On 19 Sep 2015 the patient developed vertigo and her eyes and lips were swollen. The patient then took ALLEGRA for 3 days until symptoms resolved on 22 Sep 2015. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "eye swelling" and "lip swelling" was upgraded based on information in the source document.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Swelling face
Clinical narrative: Case number PHHY2015US168628, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 598082) on 14 Dec 2015. This report refers to a 44 years old female patient. Medical history was not reported. This polymedicated patient was vaccinated with a FLUVIRIN (batch number: 15755P) intramuscularly on 30 Sep 2015. On the same day after vaccination, the patient developed swelling of lips and face. The patient was taken to an emergency room. The outcome of the events was unknown. Events were reported as non-serious. Seriousness assessment of "swelling of lips and face" was upgraded based on information in the source document.
Sex: F
Vaccine: FLUX
Symptoms: Local reaction
Clinical narrative: Case number PHHY2015US160769 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 598394) on 24 Nov 2015. This report refers to a female patient whose age was not specified. Her current conditions included systemic lupus erythematosus and pollen allergy. Her concomitant medications were not reported. The patient was vaccinated with influenza virus vaccine (manufacturer and batch number: not reported) on an unknown date. After vaccination, the patient had local reaction. The event outcome, seriousness and causality were not reported.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Injection site swelling, Oral pruritus, Pyrexia
Clinical narrative: Case number PHHY2015US165424 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 598495) website on 14 Dec 2015. This report refers to a 45 years old female patient. Concurrent conditions included asthma and allergy. Concomitant medications included SINGULAIR and vitamins. The patient was vaccinated with FLUVIRIN (batch number: 1514901) subcutaneously into left arm on 21 Sep 2015. On the same day after vaccination the patient presented with fever, mouth itch, throat closed, sweaty, dizzy and swelling at injection site. 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 "throat closed", "mouth itch" and "dizziness" was upgraded based on the source document.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Case number PHHY2015US165424 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 598495) website on 14 Dec 2015. This report refers to a 45 years old female patient. Concurrent conditions included asthma and allergy. Concomitant medications included SINGULAIR and vitamins. The patient was vaccinated with FLUVIRIN (batch number: 1514901) subcutaneously into left arm on 21 Sep 2015. On the same day after vaccination the patient presented with fever, mouth itch, throat closed, sweaty, dizzy and swelling at injection site. 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 "throat closed", "mouth itch" and "dizziness" was upgraded based on the source document.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Case number PHHY2015US165584, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 600892) website on 14 Dec 2015. This report refers to a 53-year-old female patient. Historical condition was not reported. Current conditions included seasonal allergies, hypertension and current illness reported as none. Concomitant medication included metoprolol (manufacturer unknown), meloxicam (manufacturer unknown), fish oil (manufacturer unknown), Aspirin, Multivitamin, vitamin D 2000 IU, Calcium 600mg +D, magnesium (manufacturer unknown). The patient was vaccinated with FLUVIRIN (batch number: 1514801) intramuscularly in to right arm on 18 Sep 2015. On same day after vaccination, the patient experienced muscle soreness in right upper arm, limited mobility, constant sharp pain in upper shoulder and felt like shoulder was dislocated. The outcome of the events was reported as unknown. Seriousness of the event was reported as non serious and causality not reported. Seriousness assessment of the events musculoskeletal pain was upgraded based on information available in the source document.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Case number PHHY2015US167187, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 601213) on 14 Dec 2015. This report refers to a 30 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 158401) intramuscularly in left arm on 07 Oct 2015. On the same day after vaccination, the patient developed itching and rash on upper torso and bilateral upper extremities. The outcome of the events was unknown. Events were reported as non-serious. Seriousness assessment of the event rash on upper torso and bilateral upper extremities (generalised rash) was upgraded based on the information available in the source document. Causality was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Hypersensitivity, Throat tightness, Vision blurred
Clinical narrative: Case number PHHY2015US164824, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 601720) on 14 Dec 2015. This report refers to a 32 year old female patient who was pregnant. Historical conditions included complex regional pain syndrome, narcolepsy and migraine with aura. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157101) intramuscularly in left arm on 05 Oct 2015. On the same day after vaccination, the patient experienced blurry vision and tightness in throat. The patient was taken to an emergency room and was diagnosed with an allergic reaction. The patient was treated with oral steroids. Outcome of the event was complete recovery. Event was reported as serious (life threatening). Causality of the event was not reported. Follow up information received 17 Aug 2016: No further information received as reporter was anonymous. This case is considered as lost to follow up.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chest pain, Chills, Epistaxis
Clinical narrative: Case number PHHY2015US164221 is a spontaneous report initially received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601852) website on 14 Dec 2015. This report refers to a 59 years old male patient. Concurrent condition included acid reflux. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157605) intramuscularly into left arm on 03 Oct 2015. On the same day after vaccination the patient experienced chest pain in the middle of the night. Further the patient experienced daily nosebleeds, stomach pain and chills. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the event was not reported. Seriousness assessment of "chest pain" was upgraded based on information in the source document. The quality assurance department reported that, batch review report (reference number: 1011654) received from quality assurance department on 21 Feb 2016: Based on the document review, it was stated that the concerned FLUVIRIN, batch number: 157605, 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 information received from quality assurance department (QA reference nr. 1011654) on 29 Jan 2016: Updated QA reference number only. Non significant follow up report received from a Quality Assurance Department (QA reference number: 1011654) on 21 Feb 2016: Updated batch review report (Conclusion added).
Age: 55.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2015US168670, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601894) website on 14 Dec 2015. This report refers to a 55-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (manufacturer unknown and batch number: 1516901) in left arm and PREVNAR 13 (manufacturer unknown and batch number: L77780) in right arm both received on 04 Oct 2015. On 07 Oct 2015, she reported that her whole arm from shoulder to elbow was inflamed, painful and hot to touch. She was taken to the emergency room. Outcome of the events was reported as unknown. Seriousness of the events was reported as non serious. Causality of the events was not reported. Seriousness of the events vaccination site inflammation, vaccination site warmth and vaccination site pain was upgraded based on information available in the source document. Batch review report (reference number: 1010579) received from quality assurance department on 21 Jan 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (1516901) 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 received from a Quality Assurance department (QA reference number: 1010579) on 28 Dec 2015: QA reference number updated. Non significant follow up report received from a Quality Assurance department (QA reference number: 1010579) on 21 Jan 2016: Updated batch review report.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Pruritus generalised, Urticaria
Clinical narrative: Case number PHHY2015US164234, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601900) website on 14 Dec 2015. This report refers to a 49 years old female patient. Medical history and concurrent illness were none. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516701) intramuscularly into right arm on 06 Oct 2015. On 09 Oct 2015 the patient experienced itching and hives over entire body with inflammation. The patient went to emergency room due to these events. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "itching and hives over entire body" was upgraded based on information in the source document.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Headache, Injection site rash, Musculoskeletal stiffness, Myalgia
Clinical narrative: Case number PHHY2015US165639, is a spontaneous report initially received from Vaccine Adverse Event Reporting System (VAERS reference number: 601955) website on 14 Dec 2015. This report refers to a 61 years old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated FLUVIRIN (batch number: 1514601) along with PNEUMOVAX (other manufacture, batch number: K009874) both given intramuscularly in left arm spaced about 1 inch apart into the deltoid muscle at 2:00 pm on 03 Sep 2015. Later in the day, he developed a stiff arm but still had full range of movement. He slept on his right side to avoid the painful arm that night. The following night by 8:30 pm he had developed headache, myalgia, pain upon moving the arm and a painful (not itchy) red raised rash on his arm in the area between the shoulder and elbow. The largest of the patches was about 3 to 4 inches round. The rash did not appear directly at the injection site but it did appear below it. The patient's physician suspected that patient experienced cellulitis so had prescribed cephalexin for the time being and to follow up with his physician after the weekend. The seriousness of the events was reported as non serious. The final outcome of the events was reported as condition unchanged. The causality of the events were not reported. The seriousness assessment of the events cellulitis was upgraded based on Novartis Important Medical Events list. Batch review report (reference number: 1010523) received from quality assurance department on 04 Feb 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (1514601) 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 received from the Quality Assurance Department (QA, reference number: 1010523) on 23 Dec 2015: Updated QA reference number. Follow up received from Quality Assurance Department (QA reference number: 1010523) on 04 Feb 2016: Updated batch review report.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Pain in extremity, Rash, Rash erythematous
Clinical narrative: Case number PHHY2015US165639, is a spontaneous report initially received from Vaccine Adverse Event Reporting System (VAERS reference number: 601955) website on 14 Dec 2015. This report refers to a 61 years old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated FLUVIRIN (batch number: 1514601) along with PNEUMOVAX (other manufacture, batch number: K009874) both given intramuscularly in left arm spaced about 1 inch apart into the deltoid muscle at 2:00 pm on 03 Sep 2015. Later in the day, he developed a stiff arm but still had full range of movement. He slept on his right side to avoid the painful arm that night. The following night by 8:30 pm he had developed headache, myalgia, pain upon moving the arm and a painful (not itchy) red raised rash on his arm in the area between the shoulder and elbow. The largest of the patches was about 3 to 4 inches round. The rash did not appear directly at the injection site but it did appear below it. The patient's physician suspected that patient experienced cellulitis so had prescribed cephalexin for the time being and to follow up with his physician after the weekend. The seriousness of the events was reported as non serious. The final outcome of the events was reported as condition unchanged. The causality of the events were not reported. The seriousness assessment of the events cellulitis was upgraded based on Novartis Important Medical Events list. Batch review report (reference number: 1010523) received from quality assurance department on 04 Feb 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (1514601) 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 received from the Quality Assurance Department (QA, reference number: 1010523) on 23 Dec 2015: Updated QA reference number. Follow up received from Quality Assurance Department (QA reference number: 1010523) on 04 Feb 2016: Updated batch review report.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling face, Urticaria
Clinical narrative: Case number PHHY2015US155893 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 602140) received on 24 Nov 2015. This report refers to a 34 year old female patient. Her current condition included allergy to medicine and foods. She had no previous reaction to flu vaccine. Concomitant medications were TOPROL XL, ADDERALL XR, CARDIZEM and ZYRTEC. She was vaccinated with FLUVIRIN (batch number: 1518101) intramuscularly in the left arm on 13 Oct 2015. On the same day, she had hives and redness in the same arm in which vaccine was administered. She also had facial swelling, itching, and hives on neck which began shortly thereafter. She went to emergency room. The outcome of the events was reported as complete recovery. The events were reported as non-serious, but the event facial swelling was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Case number PHHY2015US169121, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 602172) website on 14 Dec 2015. This report refers to a 50 years old female patient. Past medical and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 15754P) intramuscularly in the left arm on 05 Oct 2015. On 06 Oct 2015, the patient experienced pruritus and bumps beginning under arm and on forehead later it was spreading to the back of the neck. Outcome of the events was reported as condition unchanged. Events were reported as non serious and causality was not reported. Seriousness of the events "Pruritus generalized and Rash generalised" was reported serious based on the available information in the source document.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Back pain, Burning sensation, Chest pain, Hypersensitivity
Clinical narrative: Case number PHHY2015US165615, is a spontaneous report initially received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602250) website on 14 Dec 2015. This report refers to a 26 years old female patient. Past medical history included hiatal hernia. Past vaccination included HPV vaccination and experienced nausea and fainting. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN vaccine (manufacturer unknown and batch number: 1515401) intramuscularly in right arm on 08 Oct 2015. On 09 Oct 2015, the patient experienced hypersensitive skin on back and underside of arm, goose bumps feel mildly painful, persistent dull pain in arm, armpit, shoulder blade and chest, Intense pain on left side of arm and left side of armpit when touched, intermittent stabbing pain in underside of arm and shoulder, pain from armpit radiates down into chest, pain from shoulder radiates across back and up to neck and occasional burning sensation in shoulder blade and up neck. The patient was taken to the emergency room. 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 assessment of the events hypersensitivity and chest pain was upgraded to medical significant based on the information available in the source document. Batch review report (reference number: 1010484) received from quality assurance department on 20 Jan 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (1515401) 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 received from a Quality Assurance department (QA reference number: 1010484) on 22 Dec 2015: QA reference number updated. Non-significant follow-up information from quality assurance department received on 20 Jan 2016: Added investigation summary.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity, Piloerection
Clinical narrative: Case number PHHY2015US165615, is a spontaneous report initially received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602250) website on 14 Dec 2015. This report refers to a 26 years old female patient. Past medical history included hiatal hernia. Past vaccination included HPV vaccination and experienced nausea and fainting. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN vaccine (manufacturer unknown and batch number: 1515401) intramuscularly in right arm on 08 Oct 2015. On 09 Oct 2015, the patient experienced hypersensitive skin on back and underside of arm, goose bumps feel mildly painful, persistent dull pain in arm, armpit, shoulder blade and chest, Intense pain on left side of arm and left side of armpit when touched, intermittent stabbing pain in underside of arm and shoulder, pain from armpit radiates down into chest, pain from shoulder radiates across back and up to neck and occasional burning sensation in shoulder blade and up neck. The patient was taken to the emergency room. 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 assessment of the events hypersensitivity and chest pain was upgraded to medical significant based on the information available in the source document. Batch review report (reference number: 1010484) received from quality assurance department on 20 Jan 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (1515401) 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 received from a Quality Assurance department (QA reference number: 1010484) on 22 Dec 2015: QA reference number updated. Non-significant follow-up information from quality assurance department received on 20 Jan 2016: Added investigation summary.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Case number PHHY2015US165615, is a spontaneous report initially received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602250) website on 14 Dec 2015. This report refers to a 26 years old female patient. Past medical history included hiatal hernia. Past vaccination included HPV vaccination and experienced nausea and fainting. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN vaccine (manufacturer unknown and batch number: 1515401) intramuscularly in right arm on 08 Oct 2015. On 09 Oct 2015, the patient experienced hypersensitive skin on back and underside of arm, goose bumps feel mildly painful, persistent dull pain in arm, armpit, shoulder blade and chest, Intense pain on left side of arm and left side of armpit when touched, intermittent stabbing pain in underside of arm and shoulder, pain from armpit radiates down into chest, pain from shoulder radiates across back and up to neck and occasional burning sensation in shoulder blade and up neck. The patient was taken to the emergency room. 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 assessment of the events hypersensitivity and chest pain was upgraded to medical significant based on the information available in the source document. Batch review report (reference number: 1010484) received from quality assurance department on 20 Jan 2016: Based on the document review, it was stated that the concerned FLUVIRIN batch number (1515401) 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 received from a Quality Assurance department (QA reference number: 1010484) on 22 Dec 2015: QA reference number updated. Non-significant follow-up information from quality assurance department received on 20 Jan 2016: Added investigation summary.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Pharyngeal erythema, Pharyngeal oedema, Tachycardia
Clinical narrative: Case number PHHY2015US164251, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602474) website on 14 Dec 2015. This report refers to a 37 years old male patient. Medical history included asthma and hyperlipidemia. Concurrent illnesses were none. Concomitant medications included oxcarbazepine, polyvinyl alcohol and gemfibrozil. The patient was vaccinated with FLUVIRIN (batch number: 1515701) intramuscularly into left arm on 09 Oct 2015. On the same day at 10:00 AM the patient had face flushed and throat moderately swollen and red. At 03:40 PM the patient had dizziness and tachycardia. 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 "throat swelling", "red throat", "flushed face", "dizziness" and "tachycardia" was upgraded based on information in the source document.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hypersensitivity, Lip pruritus
Clinical narrative: Case number PHHY2015US166214, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 602489) website on 14 Dec 2015. This report refers to a 30-year-old female patient. Historical condition included mild lupus. Current conditions included allergic to almonds, oats, pecans, all squash, all melon, cherries, grapes, feathers, molds, grass, and certain trees. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157404) into left arm intramuscularly on 05 Oct 2015. On the same day of vaccination the patient experienced, dizziness, lightheadedness, muscle weakness/tingling, swollen/burning/itchy lips and mouth, tightness and difficulty breathing and serious allergic reaction. The patient had visited emergency room. Outcome of the events was complete recovery. Seriousness of the event was reported as non serious and causality was not reported. Seriousness of the events serious allergic reaction, tingling, chest tightness, difficulty breathing, swollen lips, swollen mouth, muscle weakness, burning lips and dizzy was upgraded based on the information available in the source document.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Mouth swelling, Muscular weakness, Oral discomfort, Oral pruritus
Clinical narrative: Case number PHHY2015US166214, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 602489) website on 14 Dec 2015. This report refers to a 30-year-old female patient. Historical condition included mild lupus. Current conditions included allergic to almonds, oats, pecans, all squash, all melon, cherries, grapes, feathers, molds, grass, and certain trees. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157404) into left arm intramuscularly on 05 Oct 2015. On the same day of vaccination the patient experienced, dizziness, lightheadedness, muscle weakness/tingling, swollen/burning/itchy lips and mouth, tightness and difficulty breathing and serious allergic reaction. The patient had visited emergency room. Outcome of the events was complete recovery. Seriousness of the event was reported as non serious and causality was not reported. Seriousness of the events serious allergic reaction, tingling, chest tightness, difficulty breathing, swollen lips, swollen mouth, muscle weakness, burning lips and dizzy was upgraded based on the information available in the source document.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Case number PHHY2015US166214, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 602489) website on 14 Dec 2015. This report refers to a 30-year-old female patient. Historical condition included mild lupus. Current conditions included allergic to almonds, oats, pecans, all squash, all melon, cherries, grapes, feathers, molds, grass, and certain trees. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157404) into left arm intramuscularly on 05 Oct 2015. On the same day of vaccination the patient experienced, dizziness, lightheadedness, muscle weakness/tingling, swollen/burning/itchy lips and mouth, tightness and difficulty breathing and serious allergic reaction. The patient had visited emergency room. Outcome of the events was complete recovery. Seriousness of the event was reported as non serious and causality was not reported. Seriousness of the events serious allergic reaction, tingling, chest tightness, difficulty breathing, swollen lips, swollen mouth, muscle weakness, burning lips and dizzy was upgraded based on the information available in the source document.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Case number PHHY2015US172087, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602732) website on 29 Dec 2015. This report refers to a 38 years old female patient. Medical history included asthma and migraines. Concurrent condition included latex allergy. The patient was vaccinated with FLUVIRIN (batch number: 1516601) intramuscularly on 15 Oct 2015. Within 5 to 10 minutes after vaccination the patient had complaints of throat closing and difficulty breathing. The patient was treated with one dose of EPIPEN. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "difficulty breathing" and "throat closing" was upgraded based on information in the source document.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Case number PHHY2016US005784, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 603159) on 18 Jan 2016. This report refers to a 64 years old male patient. Concurrent conditions included asthma and respiratory issues. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157903) intramuscularly into left arm on 13 Oct 2015. On the same day, approximately 12 hours after vaccination, the patient experienced wheezing and shortness of breath. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "shortness of breath" and "wheezing" was upgraded based on information in the source document.
Age: 22.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Presyncope, Syncope, Vomiting
Clinical narrative: Case number PHHY2016US006715, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 603470) website on 18 Jan 2015. This report refers to a 22 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516201) intramuscular into right arm on 19 Oct 2015. The patient experienced vasovagal symptoms after FLUVIRIN vaccination. The patient was then vaccinated with HAVRIX (other manufacture, batch/lot number: 023LP) intramuscularly into left arm on 19 Oct 2015. The patient fainted about 5 seconds after receiving HAVRIX. The patient received water and threw up. The patient was fully recovered after 30 minutes. Seriousness of the events was reported as non serious and causality was not reported. Seriousness of the events syncope and pre syncope was upgraded based on information available in source document.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Heart rate abnormal, Heart rate irregular, Visual acuity reduced
Clinical narrative: Case number PHHY2016US008095, is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 603730) on 18 Jan 2016. This report refers to a 46-year-old female patient. The patient had no current illness. Concomitant medication included OCELLA contraceptive. The patient was vaccinated with FLUVIRIN (batch number: 1518101) intramuscularly at a dose of 0.5 ml into the right arm on 19 Oct 2015. On the same day after vaccination (exact time not remembered), the patient experienced tightness in chest and difficulty catching breath. On 20 Oct 2015 (day 2), the patient experienced irregular heart rate and poor vision. Final outcome of events was not reported. Events were reported as non-serious. Causality was not reported. Seriousness of the events was upgraded based on information available in the source document.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Cough, Pyrexia, Wheezing
Clinical narrative: Case number PHHY2016US008100, is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 604073) on 18 Jan 2016. This report refers to a 40-year-old female patient. Historical conditions included hypothyroidism, lactose intolerance and pernicious anemia. Concomitant medications included SYNTHROID, cyanocobalamin and probiotics. The patient was vaccinated with FLUVIRIN (batch number: 1517701) intramuscularly into the left arm on 16 Oct 2015. On the same day after vaccination the patient experienced back pain, joint pain, fever, cough and wheezing. The patient was treated with NSAIDS and THERAFLU. Final outcome of events was not recovered. Events were reported as non-serious. Causality was not reported. Seriousness of the events was upgraded based on information available in the source document.