chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: The case report was received from a (n) Health Professional and concerns a (n) 57 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on 31-Oct-2015- unknown stop date, Batch no: U50709, Route of administration: Unknown, Dose: 0.5 ml, site: left arm. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 01-Nov-2015, 2 days after starting/treatment with AFLURIA the patient experienced Hives on arms and legs (non serious, outcome: Recovered/Resolved). For relevant test result see appropriate report section. #please add other relevant test results manually as appropriate#. Reporter's assessment: The health authority assessed the event as non-serious.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash papular, Rash pruritic
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a (n) Health Professional and concerns a (n) 51 years old female patient. Weight: not provided, Height: not provided. Concurrent medical history condition (s), medical and drug history: At the time of the event the patient concomitantly suffered from Diabetes and Hyperlipidemia. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on 10-Oct-2015- unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 11-Oct-2015, 2 days after starting / treatment with AFLURIA the patient experienced Red [papules] (non serious, outcome: Unknown), [Red] Papules (non serious, outcome: Unknown), Pruritic rash (non serious, outcome: Unknown). The patient took diphenhydramine for 5 days without relieve. The patient saw the doctor and was given treatment with hydroxyzine, fexofenadine and triamcinolone cream. For relevant test results see appropriate report section. #please add other relevant tests results manually as appropriate#.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. Concurrent medical conditions(s), medical and drug history: The patient has a medical history of High cholesterol and Acid reflux. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 14-Oct-2015- unknown stop date, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 14-Oct-2015, 1 day after starting / treatment with AFLURIA the patient experienced Fever 102 (non serious, outcome: Recovered/ Resolved). On 14-Oct-2015, after starting / treatment with AFLURIA the patient experienced Chills (non serious, outcome: Recovered/Resolved). For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Feeling hot
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a (n) Health Professional and concerns a (n) 54 years old female patient. Weight: not provided, Height: not provided. Concurrent medical condition (s), medical and drug history: The patient has a medical history of High blood pressure. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/ event (s): Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on 14-Oct-2015 - unknown stop date, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 14-Oct-2015, 1 day after starting /treatment with AFLURIA the patient experienced Cold-/hot (non serious, outcome: Recovered/ Resolved). For relevant test results see appropriate report section. #please add other relevant test results manually as appropriate#. Reporter's assessment: The health authority assessed the event as non-serious.
Age: 79.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 16-Dec-2015. The case report was received from a (n) Health Professional and concerns a (n) 79 years old female patient. The patient had no concurrent illness. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA (batch number: U57507) for indication not reported on 08-Oct-2015- unknown stop date, Batch no: U57507, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm. Additional suspect drug (s): PREVNAR 13 (batch number: L99261), Indication: not provided, Site: right arm. Reaction (s)/event (s) and outcome: On 09-Oct-2015, 2 days after starting/treatment with AFLURIA the patient experienced Right arm swelled (non serious, outcome: Recovered/Resolved), Right arm was red (non serious, outcome: Recovered/Resolved), Right arm was warm (non serious, outcome: Recovered/Resolved). It lasted two weeks.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site pain
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional in United States and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. Concurrent medical conditions(s), medical and drug history: The patient has a medical history of Sore muscle. The following drug history information was reported: AFLURIA (Indication: -, Reaction: Sore muscle). For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA for indication Indication not reported on 11-Sep-2015 - unknown stop date, Batch no: U55406, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): Zostavax (VARICELLA VACCINES), Indication: not provided. Reaction(s)/event(s) and outcome: On 13-Oct-2015, 3 weeks 3 days after starting / treatment with AFLURIA the patient experienced Deep muscle pain at injection site (non serious, outcome: Unknown). On an unknown date, after starting / treatment with AFLURIA the patient experienced Deep muscle soreness (non serious, outcome: Unknown). For relevant test results see appropriate report section. #please add other relevant test results manually as appropriate#. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS, FLU3, VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional in United States and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. Concurrent medical conditions(s), medical and drug history: The patient has a medical history of Sore muscle. The following drug history information was reported: AFLURIA (Indication: -, Reaction: Sore muscle). For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA for indication Indication not reported on 11-Sep-2015 - unknown stop date, Batch no: U55406, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): Zostavax (VARICELLA VACCINES), Indication: not provided. Reaction(s)/event(s) and outcome: On 13-Oct-2015, 3 weeks 3 days after starting / treatment with AFLURIA the patient experienced Deep muscle pain at injection site (non serious, outcome: Unknown). On an unknown date, after starting / treatment with AFLURIA the patient experienced Deep muscle soreness (non serious, outcome: Unknown). For relevant test results see appropriate report section. #please add other relevant test results manually as appropriate#. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Chills, Dizziness, Headache
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional in United States and concerns a(n) 57 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA for indication Indication not reported on 03-Nov-2015 - unknown stop date, Batch no: U50909, Route of administration: Intramuscular, Dose: 0.5 ml, Site; left arm. Additional suspect drug(s): Pneumovax (batch number: L003188, Left arm), Indication: not provided. Reaction(s)/event(s) and outcome: On 03-Nov-2015, at approximately 09.00 pm, the patient experienced chills. by 11.00 pm, she started experiencing headache, lightheadedness and a temperature of 104F. The outcome was recovered. For relevant test results see appropriate report section. #please add other relevant test results manually as appropriate#. Reporter's assessment: The health authority assessed the events as non-serious. The authority reported symptom included "body temperature increased".
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional in United States and concerns a(n) 39 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA for indication Indication not reported on 15-Oct-2015 - unknown stop date, Batch no: U56506, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting/treatment with AFLURIA the patient experienced L arm numbness x 2 weeks (non serious, outcome: Unknown). For relevant test results see appropriate report section. #please add other relevant test results manually as appropriate#. Reporter's assessment: The health authority assessed the event as non-serious.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: This health authority case was initially received on 16-Dec-2015. This case report was received from a(n) Health Professional in United States and concerns a(n) 30 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA for indication Indication not reported on 08-Oct-2015 - unknown stop date, Batch no: U56506, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 08-Oct-2015, after starting / treatment with AFLURIA the patient experienced Left arm numbness since vaccination (non serious, outcome: Recovered / Resolved). For relevant test results see appropriate report section. #please add other relevant test results manually as appropriate# Reporter's assessment: The health authority assessed the events as non-serious.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional in United States and concerns a(n) 21 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA for indication Indication not reported on 31-Oct-2015 - unknown stop date, Batch no: U56306, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 31-Oct-2015, after starting / treatment with AFLURIA the patient experienced Syncope (non serious, outcome: Recovered / Resolved). Patient had syncope about 3-4 minutes after getting flu shot. Paramedics arrived shortly after. The patient's basic vitals were monitored and he was evaluated to be well, so patient did not have to acquire any further treatment. For relevant test results see appropriate report section. #please add other relevant test results manually as appropriate#. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 16-Dec-2015. The case report was received from a (n) Health Professional and concerns a (n) 21 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on 12-Oct-2015- unknown stop date, Batch no: U57807, Dose: 3, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/ event (s) and outcome: On 12-Oct-2015, 1 day after starting/ treatment with AFLURIA the patient experienced Dizziness (non serious, outcome: Recovered/ Resolved), Nausea (non serious, outcome: Recovered/Resolved), Vomiting (non serious, outcome: Recovered/ Resolved), Fever (increased to 103 degrees) (non serious, outcome: Recovered/ Resolved), Chills, rigors (non serious, outcome: Recovered/ Resolved). Event treatment: Flu medicine. For relevant test results see appropriate report section. #please add other relevant test results manually as appropriate#.
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a (n) Health Professional and concerns a (n) female patient. Weight: not provided, Height: not provided. Concurrent medical condition (s), medical and drug history: The patient has a medical history of Pre-existing allergies. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on unknown dates, Batch no: 11649211A, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On an unknown date, after starting / treatment with AFLURIA the patient experienced Possible egg allergy (non serious, outcome: Recovered/ Resolved), Broke out in rash (non serious, outcome: Recovered/ Resolved). Event treatment: antihistamines and loratadine. For relevant test results see appropriate report section. #please add other relevant test results manually as appropriate#.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Musculoskeletal pain
Clinical narrative: Outcome is Unknown. Source of report and patient demography: This health authority case was initially received on 16-Dec-2015. The case report was received from a (n) Health Professional and concerns a (n) 42 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/ event (s): The patient received AFLURIA for indication not reported on 20-Oct-2015- unknown stop date, Batch no: U54606, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/ event (s) and outcome: On 22-Oct-2015, 3 days after starting/ treatment with AFLURIA the patient experienced Pain in her right shoulder (non serious, outcome: Unknown), Swelling at injection site (non serious, outcome: Unknown), Redness at injection site (non serious, outcome: Unknown). On an unknown date, after starting/ treatment with AFLURIA the patient experienced Pain in right elbow (non serious, outcome: Unknown). Event treatment: The patient was treated with antibiotics. For relevant test results see appropriate report section. #please add other relevant test results manually as appropriate#.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 16-Dec-2015. The case report was received from a (n) Health Professional and concerns a (n) 61 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on 06-Nov-2015- unknown stop date, Batch no: 12149211A, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/ event (s) and outcome: On 06-Nov-2015, couple of hours after AFLURIA injection the patient experienced Hives (non serious, outcome: Unknown). For relevant test results see appropriate report section. #please add other relevant test results manually as appropriate#.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) 51 years old female patient. Weight: not provided, Height: not provided. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Allergic to aspirin, NSAIDS, HCTZ and Tingling in feet/calves/hands. The following drug history information was reported: Aspirin (Indication: -, Reaction: Allergy), NSAIDS (Indication: -, Reaction: Allergy), HCTZ (Indication: -, Reaction: Allergy) and Dtap (Indication: -, Reaction: Tingling in feet/calves/hands). For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 24-Oct-2015 - unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 24-Oct-2015, 1 day after starting / treatment with AFLURIA the patient experienced it remained slightly discolored (injection site) (non serious, outcome: Recovered / Resolved), The shot was probably the most painful shot (non serious, outcome: Recovered / Resolved), Point of injection became quite itchy (non serious, outcome: Recovered/ Resolved), Had a large red mark (injection site) (non serious, outcome: Recovered / Resolved). For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) 24 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 07-Nov-2015 - unknown stop date, batch no: U56106, route of administration: intramuscular, dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 07-Nov-2015, after starting/treatment with AFLURIA the patient experienced received additional influenza shot (non serious, outcome: unknown). The patient received initial influenza vaccination on 11-Jul-2015. He was supposed to get IPPD but received additional influenza shot on 07-Nov-2015. No adverse reaction was noted. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious. The authority reported symptom included 'no adverse event'. Case correction (11-Mar-2016): AE 2 'no adverse event' deleted.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Hot flush, Nausea, Tremor
Clinical narrative: This health authority case was initially received on 16-DEC-2015. The case report was received from a(n) Health Professional in United States and concerns a(n) 30 years old female patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 07-Nov-2015. One day after starting treatment with ALFURIA the patient experienced dizziness, hot flushes, nausea, tremor, and headache. Patient used acetaminophen and had no residual symptoms. The health authority assessed the events as non-serious. According to the Reference Safety Information, the events nausea and headache are listed events of AFLURIA; the events dizziness, hot flushes and tremor are unlisted events of AFLURIA. Case causality: possible.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Diarrhoea, Fatigue, Gastrointestinal inflammation, Myalgia
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. Concurrent medical condition(s), medical and drug history: The patient has a medical history of finished 6 months of chemo and non-Hodgkin's lymphoma. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 29-Oct-2015 - unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 30-Oct-2015, 2 days after starting treatment with AFLURIA the patient experienced inflammation in bowel (non serious, outcome: Not Recovered / Not Resolved), Muscle pain (non serious, outcome: Not Recovered / Not Resolved), Joint pain (non serious, outcome: Not Recovered / Not Resolved), Fatigue (non serious, outcome: Not Recovered / Not Resolved), Diarrhea (non serious, outcome: Not Recovered / Not Resolved). These symptoms had continued for 10 days and counting. Reporter's assessment: The health authority assess the events as non-serious. Case correction (22-Mar-2016): AE 1 upgraded to a serious event.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: The case report was received from a(n) Health Professional in United States and concerns a(n) 47 years old male patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 07-Nov-2015, Batch no: U56506. On 07-Nov-2015, after starting treatment with AFLURIA the patient experienced LUE pain that radiated from arm [to neck], LUE pain that radiated [from arm] to neck. The pain was rated as 9/10. The health authority assessed the events as non-serious. According to the Reference Safety Information, the events LUE pain that radiated from arm [to neck] and LUE pain that radiated [from arm] to neck are unlisted events of AFLURIA. Case causality: possible.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Fatigue, Feeling of body temperature change, Nausea
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) 44 years old female patient. Weight: not provided, Height: not provided. The patient has a medical history of hypertension and depression. The patient received AFLURIA on 07-Nov-2015, Batch no: not provided. On 07-Nov-2015, 1 day after starting treatment with AFLURIA the patient experienced dizziness, fatigue, sore throat, congestion, pain, nausea, hot and cold, chills, and sneezing. The health authority assessed the events as non-serious.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Respiratory tract congestion, Sneezing
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) 44 years old female patient. Weight: not provided, Height: not provided. The patient has a medical history of hypertension and depression. The patient received AFLURIA on 07-Nov-2015, Batch no: not provided. On 07-Nov-2015, 1 day after starting treatment with AFLURIA the patient experienced dizziness, fatigue, sore throat, congestion, pain, nausea, hot and cold, chills, and sneezing. The health authority assessed the events as non-serious.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Dyspnoea, Full blood count, Headache
Clinical narrative: This health authority case was initially received on 16-DEC-2015. The case report was received from a(n) Health Professional and concerns a(n) 63 years old female patient. Weight: not provided, Height: not provided. At the time of the event the patient concomitantly suffered from COPD, emphysema, interstitial cystitis, Hep C free, ITP, atrial fibrillation, RA, fungal infection and encephalitis. The patient has a medical history of penicillin allergy, malnutrition, and multiple pneumonia. The patient received AFLURIA on 02-Nov-2015, Batch no: U50709. On 02-Nov-2015, about 4 hours after starting treatment with AFLURIA the patient experienced difficulty breathing, weakness, headache, fever, and soreness all over. On 03-Nov-2015, her breathing, body temperature and body pain had improved. The health authority assessed the events as non-serious.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Liver function test, Pain, Platelet count, Pyrexia
Clinical narrative: This health authority case was initially received on 16-DEC-2015. The case report was received from a(n) Health Professional and concerns a(n) 63 years old female patient. Weight: not provided, Height: not provided. At the time of the event the patient concomitantly suffered from COPD, emphysema, interstitial cystitis, Hep C free, ITP, atrial fibrillation, RA, fungal infection and encephalitis. The patient has a medical history of penicillin allergy, malnutrition, and multiple pneumonia. The patient received AFLURIA on 02-Nov-2015, Batch no: U50709. On 02-Nov-2015, about 4 hours after starting treatment with AFLURIA the patient experienced difficulty breathing, weakness, headache, fever, and soreness all over. On 03-Nov-2015, her breathing, body temperature and body pain had improved. The health authority assessed the events as non-serious.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Urticaria
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) 54 years old male patient. Weight: not provided, Height: not provided. Concurrent medical condition (s), medical and drug history: The patient has a medical history of Heart disease and Osteoarthritis. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on 01-Oct-2015- unknown stop date, Batch no: U55706, Route of administration: Intramuscular, Dose: 0.5 ml, site: Right arm. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 02-Oct-2015, 2 days after starting/ treatment with AFLURIA the patient experienced raised [welts or] blisters (non serious, outcome: Recovered/ Resolved), Raised welts [or blisters]/Hives all over the body (non serious, outcome: Recovered/Resolved). Event treatment: Treated with tropical steroids. For relevant test results see appropriate report second. #please add other relevant test results manually as appropriate#. Reporter's assessment: The health authority assessed the events as non-serious. Company's evaluation and comment: Seriousness criterion/criteria: Non serious. Listedness: According to the Reference Safety Information, the event Raised welts [or blisters]/Hives all over the body is a listed event of AFLURIA, the event Raised [welts or] blisters is a unlisted event of AFLURIA. Case Causality: Possible.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Influenza like illness, Insomnia, Pain
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 30-Oct-2015 - unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 30-Oct-2015, 1 day after starting / treatment with AFLURIA the patient experienced Insomnia (non serious, outcome: recovered/resolved), Terrible headache (non serious, outcome: recovered/resolved) , Chills (non serious, outcome: recovered/resolved), Aches, pains all over body (non serious, outcome: recovered/resolved), Flu-like symptoms (non serious, outcome: recovered/resolved). The events went on for 5 days. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Palpitations
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) 58 years old female patient. The patient had no medical history or current illness. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 02-Oct-2015 - unknown stop date, Batch no: U57507, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 02-Oct-2015, 1 day after starting /treatment with AFLURIA the patient experienced Burning eyes (non serious, outcome: recovered/resolved), Heart palpitations (non serious, outcome: recovered/resolved). For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Scab, Scratch
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) 22 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 19-Oct-2015 - unknown stop date, Batch no: U58407, Route of administration: Unknown, dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 21-Oct-2015, 3 days after starting / treatment with AFLURIA the patient experienced scabs (non-serious, outcome: Unknown), itching all over (non serious, outcome: Unknown), scratched head (non serious, outcome: unknown). The patient was itching all over causing to have scabs because of it. She scratched head so much that it took most skin off. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: This health authority case was initially received on 16-Dec-015. The case report was received from a(n) Health Professional and concerns a (n) 62 years old female patient. The patient had no current illness or medical history. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reactions(s) /event(s): The patient received AFLURIA on 10-Nov-2015 -unknown stop date, Batch no: U55906, Route of administration: intramuscular, dose: 0.5 ml, site: right arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 11-Nov-2015, 2 days after starting / treatment with AFLURIA the patient experienced patient's arm (lower deltoid) war (non-serious, outcome: Unknown), Patient's arm (lower deltoid) red (non serious, outcome: unknown), Patient's arm (lower deltoid) painful (nom serious, outcome: unknown). For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Bone pain, Injected limb mobility decreased, Lymphadenopathy, Malaise
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) 39 years old female patient. The patient received influenza (seasonal) vaccine last year and these symptoms occurred a week after the injection and were not as severe. The symptoms lasted about 2 weeks. Last year the patient got the injection in the right arm and the symptoms were on the right. In Jan-2015, the patient also got the flu (refer to case: 2016059814). Weight: not provided, Height: not provided. The following drug history information was reported: Influenza (seasonal) vaccine (indication: -, reaction: flu), Influenza (seasonal) vaccine (indication: -, reaction: malaise), Influenza (seasonal) vaccine (indication: -, reaction: low grade fever), Influenza (seasonal) vaccine (indication: -, reaction: pain under arm), Influenza (seasonal) vaccine (indication: -, reaction pain in neck), Influenza (seasonal) vaccine (indication: -, reaction: pain in clavicular area), Influenza (seasonal) vaccine (indication: -, reaction: pea sized swollen lymph nodes) and Influenza (seasonal) vaccine (indication: -, reaction: hardly raise my arm). For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reactions)/event(s): The patient received AFLURIA on 08-Oct-2015 - unknown stop date, batch no: 11049221A, route of administration: intramuscular, dose: 0.5 ml, site left arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 08-Oct-2015, after starting/treatment with AFLURIA the patient experienced malaise (non serious, outcome: recovered/resolved), low grade fever of 99.4 (non serious, outcome: recovered/resolved). On 09-Oct-2015, after starting/treatment with AFLURIA the patient experienced pain under my left arm (non serious, outcome: recovered/resolved), pain in my neck (non serious, outcome: recovered/resolved), pain in the left clavicular area (non serious, outcome: recovered/resolved). On an unknown date, after starting/treatment with AFLURIA the patient experienced pea sized swollen lymph nodes in the clavicular area and neck (non serious, outcome: recovered/resolved), could hardly raise my left arm (injected arm) (non serious, outcome: recovered/resolved). She could not palpate any lymph nodes in the left armpit area. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pyrexia
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) 39 years old female patient. The patient received influenza (seasonal) vaccine last year and these symptoms occurred a week after the injection and were not as severe. The symptoms lasted about 2 weeks. Last year the patient got the injection in the right arm and the symptoms were on the right. In Jan-2015, the patient also got the flu (refer to case: 2016059814). Weight: not provided, Height: not provided. The following drug history information was reported: Influenza (seasonal) vaccine (indication: -, reaction: flu), Influenza (seasonal) vaccine (indication: -, reaction: malaise), Influenza (seasonal) vaccine (indication: -, reaction: low grade fever), Influenza (seasonal) vaccine (indication: -, reaction: pain under arm), Influenza (seasonal) vaccine (indication: -, reaction pain in neck), Influenza (seasonal) vaccine (indication: -, reaction: pain in clavicular area), Influenza (seasonal) vaccine (indication: -, reaction: pea sized swollen lymph nodes) and Influenza (seasonal) vaccine (indication: -, reaction: hardly raise my arm). For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reactions)/event(s): The patient received AFLURIA on 08-Oct-2015 - unknown stop date, batch no: 11049221A, route of administration: intramuscular, dose: 0.5 ml, site left arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 08-Oct-2015, after starting/treatment with AFLURIA the patient experienced malaise (non serious, outcome: recovered/resolved), low grade fever of 99.4 (non serious, outcome: recovered/resolved). On 09-Oct-2015, after starting/treatment with AFLURIA the patient experienced pain under my left arm (non serious, outcome: recovered/resolved), pain in my neck (non serious, outcome: recovered/resolved), pain in the left clavicular area (non serious, outcome: recovered/resolved). On an unknown date, after starting/treatment with AFLURIA the patient experienced pea sized swollen lymph nodes in the clavicular area and neck (non serious, outcome: recovered/resolved), could hardly raise my left arm (injected arm) (non serious, outcome: recovered/resolved). She could not palpate any lymph nodes in the left armpit area. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Hyperhidrosis, Lethargy, Presyncope
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 16-Dec-2015. The case report was received from a (n) Health Professional and concerns a (n) 13 year old female patient. Concurrent medical condition (s), medical and drug history: The patient has a medical history of Learning disability 'of vaccine record'. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on 09-Nov-2015- unknown stop date, Batch no: U58808, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Left arm (LA). Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 09-Nov-2015, 1 day after starting/ treatment with AFLURIA the patient experienced Almost fainted (non serious, outcome: Recovered/Resolved), Lethargic (non serious, outcome: Recovered/Resolved), Sweaty (non serious, outcome: Recovered/Resolved). Did glucose level which was 80. The patient's mother stated that the patient had not been drinking water so may have been dehydrated. Reporter's assessment: None serious. Company's evaluation and comment: Seriousness criterion/criteria: Non serious. Listedness: According to the Reference Safety Information, the events Almost fainted, Lethargic and Sweaty are unlisted events of AFLURIA. Case Causality: Possible.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Jan-2015) concerns a 47 year old male patient. The patient has a medical history of asthma, hypertension, diabetes and acid reflux. Concomitant medications include fluticasone propionate, esomeprazole magnesium, carvedilol, metformin, montelukast and losartan potassium. The patient had no current illness at the time of vaccination. On 16-Nov-2015, the patient received an intramuscular injection of AFLURIA (batch number: U56206) to the right arm (RA). On 16-Nov-2015 at approximately 18:00, the patient experienced chills with headache that continued to worsen without temperature going up but not checked. An ambulance was called and he was taken to hospital, evaluated and admitted for 1 day. Lab work to include swab for influenza. The outcome was reported as unknown. Reporter comments: The health authority assessed the events as serious (hospitalisation).
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head normal, Facial paralysis, Full blood count normal, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Jan-2015) concerns a 52 year old female patient. The patient has a medical history of allergy to thimerosal, benzoates, sulfates, nitrites and 'medical condition doing well'. Concomitant medications include fluticasone and salmeterol combination, ranitidine, mesalazine and azathioprine for autoimmune hepatitis. The patient had no current illness at the time of vaccination. On 16-Nov-2015, the patient received an intramuscular injection of AFLURIA (batch number: unknown) to the left arm (LA). On 23-Nov-2015, the patient experienced Bell's Palsy. Lab data: Negative head CT and negative MRI. Normal chemistries and CBC (complete blood count). The outcome was reported as not recovered. Reporter comments: The health authority assessed the events as non-serious (emergency room visit).
Age: 60.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: The case report was received from a(n) Health Professional and concerns a(n) 60 years old female patient. Weight: not provided, Height: not provided. The patient had no current illness or medical history. The patient received AFLURIA on 23-AUG-2015, Batch no: U55806. On the same day the patient received PREVNAR13. On 23-AUG-2015, after starting treatment with AFLURIA the patient experienced right upper arm painful. Reporter's assessment: Non serious.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Axonal neuropathy, Electromyogram abnormal, Guillain-Barre syndrome, Mental status changes
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Jan-2016) concerns a 78 year old female patient. The patient had medical history of congestive heart failure (CHF), hypertension (HTN) and chronic kidney disease (CKD). The patient had no current illness at the time of vaccination. On 26-Oct-2015, the patient received an intramuscular AFLURIA injection (batch number: U59408) to the left arm. On 22-Nov-2015, the patient experienced altered mental status and generalised weakness and was found to have severe Guillain-Barre Syndrome. The EMG (electromyogram) electrodiagnostic findings are consistent with acute inflammatory demyelinating polyneuropathy (e.g. AIDP or Guillain-Barre Syndrome) with severe secondary axon loss. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as serious (life threatening, hospitalised, existing hospitalisation prolonged).
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Fatigue, Malaise, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 34 year old female patient. The patient's medical history was reported as- 'latex, prednisone'. She had no current illness. Her concomitant medications included estradiol, fexofenadine, ibuprofen, bupropion, paroxetine hydrochloride and alprazolam. On 15-Dec-2015, the patient received intramuscular AFLURIA (batch number U54405) in the left arm. She also received intramuscular PNEUMOVAX (batch number: K019386) in the left arm. On 16-Dec-2015, the patient developed soreness in her arm and malaise. Soon she also developed redness and more severe pain in her arm approximately 4 cm below the injection site. This worsened over the next few days. Four days after the injection, she visited the emergency room due to severe left arm pain, fever and severe malaise/fatigue. She was diagnosed with cellulitis and was treated with intravenous antibiotics. 1-2 days later, she felt much better and the pain, malaise, fever and fatigue started to subside. At this time she only had minor left arm soreness and only a slight redness to the skin. The outcome was recovered. Reporter's comments: The health authority assessed the events as serious due to hospitalisation.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Feb-2016) concerns a 34 year old female patient. The patient's medical history was reported as- 'latex, prednisone'. She had no current illness. Her concomitant medications included estradiol, fexofenadine, ibuprofen, bupropion, paroxetine hydrochloride and alprazolam. On 15-Dec-2015, the patient received intramuscular AFLURIA (batch number U54405) in the left arm. She also received intramuscular PNEUMOVAX (batch number: K019386) in the left arm. On 16-Dec-2015, the patient developed soreness in her arm and malaise. Soon she also developed redness and more severe pain in her arm approximately 4 cm below the injection site. This worsened over the next few days. Four days after the injection, she visited the emergency room due to severe left arm pain, fever and severe malaise/fatigue. She was diagnosed with cellulitis and was treated with intravenous antibiotics. 1-2 days later, she felt much better and the pain, malaise, fever and fatigue started to subside. At this time she only had minor left arm soreness and only a slight redness to the skin. The outcome was recovered. Reporter's comments: The health authority assessed the events as serious due to hospitalisation.