chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth
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) 59 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 13-Oct-2015-unknown stop date, Batch no: U59208, Route of administration: Intramuscular, Dose: 0.5 ml, Site: right arm. Additional suspect drug (s): PNEUMOVAX (batch number: K006681), Indication: not provided. Both the vaccines were given in the right arm (medication error not explicitly reported). Reaction (s)/event (s) and outcome: On 14-Oct-2015, 2 days after starting/ treatment with AFLURIA the patient experienced swelling from injection site (RA) down to the elbow on back/side of arm (non serious, outcome: Unknown), Slight swelling from injection site (non serious, outcome: Unknown), Warm to touch (injection site) (non serious, outcome: Unknown). 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 Slight swelling from injection site and Warm to touch (injection site) are listed events of AFLURIA, the event swelling from injection site (RA) down to the elbow on back/side of arm is a unlisted event of AFLURIA. Case Causality: Possible.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: This case report was received from a(n) Health Professional and concerns a(n) 37 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 Hypertension, Hyperaldosterone, Anxiety, Asthma and Penicillin and aspirin allergy. The following drug history information  was reported: Penicillin (Indication: -, Reaction: Allergy) and Aspirin (indication: -, Reaction: Allergy). For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surround the onset of reaction(s)/event(s): The patient received AFLURIA. Indication not reported on 08-OCT-2015 - unknown stop date, Batch no: U58808, Route of administration: Intramuscular, Dose: 0.5 ml Site: left arm. Additional Suspect drug(s): PNEUMOVAX, Indication: Not provided, Site: left arm. Both the vaccines were given in the same arm (medication error not explicitly reported). Reaction(s)/event(s) and outcome: On 09-OCT-2015, 2 days after starting/treatment with AFLURIA the patient experienced inability to raise it (arm) (non serious, outcome: Recovered/Resolved. Sore arm (non serious, outcome: Recovered/Resolved, Mobility decreased (non serious, outcome: Recovered/Resolved, Arm was swollen from the administration site to the elbow (non serious, outcome: Recovered/Resolved, Red from the administration site to the elbow (non serious, outcome: Recovered/Resolved, Hot from the administration site to th4 elbow (non serious, outcome: Recovered/Resolved), Burning type pain (non serious, outcome: Recovered/Resolved), Injection site reaction (non serious, outcome: Recovered/Resolved). The patient continued to ice, use diphenhydramine and loratadine and over the course of the next few days the reactions dissipated. Reporter's assessment: The health authority assessed the events as non-serious. The authority reported events included injection site reaction and mobility decreased. Case correction (22-MAR-2016): AE1 recoded to "injected limb mobility decreased". Case correction 12-APR-2016: AE 3 verbatim changed to "(arm was)" swollen from the administration site (to the elbow), AE 4 verbatim changed to "red from the administration site (to the elbow)" and AE 5 verbatim changed to "hot from the administration site) to the elbow" with LLT "swelling arm", AE 10 "red (from the administration site) to the elbow" with LLT "redness" and AE 11 "hot (from the administration site) to the elbow" with LLT "skin warm".
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: This case report was received from a(n) Health Professional and concerns a(n) 37 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 Hypertension, Hyperaldosterone, Anxiety, Asthma and Penicillin and aspirin allergy. The following drug history information  was reported: Penicillin (Indication: -, Reaction: Allergy) and Aspirin (indication: -, Reaction: Allergy). For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surround the onset of reaction(s)/event(s): The patient received AFLURIA. Indication not reported on 08-OCT-2015 - unknown stop date, Batch no: U58808, Route of administration: Intramuscular, Dose: 0.5 ml Site: left arm. Additional Suspect drug(s): PNEUMOVAX, Indication: Not provided, Site: left arm. Both the vaccines were given in the same arm (medication error not explicitly reported). Reaction(s)/event(s) and outcome: On 09-OCT-2015, 2 days after starting/treatment with AFLURIA the patient experienced inability to raise it (arm) (non serious, outcome: Recovered/Resolved. Sore arm (non serious, outcome: Recovered/Resolved, Mobility decreased (non serious, outcome: Recovered/Resolved, Arm was swollen from the administration site to the elbow (non serious, outcome: Recovered/Resolved, Red from the administration site to the elbow (non serious, outcome: Recovered/Resolved, Hot from the administration site to th4 elbow (non serious, outcome: Recovered/Resolved), Burning type pain (non serious, outcome: Recovered/Resolved), Injection site reaction (non serious, outcome: Recovered/Resolved). The patient continued to ice, use diphenhydramine and loratadine and over the course of the next few days the reactions dissipated. Reporter's assessment: The health authority assessed the events as non-serious. The authority reported events included injection site reaction and mobility decreased. Case correction (22-MAR-2016): AE1 recoded to "injected limb mobility decreased". Case correction 12-APR-2016: AE 3 verbatim changed to "(arm was)" swollen from the administration site (to the elbow), AE 4 verbatim changed to "red from the administration site (to the elbow)" and AE 5 verbatim changed to "hot from the administration site) to the elbow" with LLT "swelling arm", AE 10 "red (from the administration site) to the elbow" with LLT "redness" and AE 11 "hot (from the administration site) to the elbow" with LLT "skin warm".
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Fear of injection, Hyperhidrosis, Syncope
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) 19 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 Syncope. The following drug history information was reported: Vaccine not specified (Indication: -, Reaction: syncope). For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and condition surrounding the onset of reaction(s) / event(s): The patient received AFLURIA (indication not reported on 15-OCT-2015) - unknown stop date, batch no: U58908, Route of administration: not provided, Dose: 0.5 ml, route: "SYR", Site: Left arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s) event(s) and outcome. Reaction(s)/event(s) and outcome: On 15-OCT-2015, 1 day after starting/treatment with AFLURIA the patient experienced Syncope, fainting (non serious, outcome: Recovered/Resolved), Sweating (non serious, outcome: Recovered/Resolved). Fear of needles (non serious, outcome: Recovered/Resolved). For relevant test results see appropriate section. #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:business criterion/criteria: Non serious. Listedness:  According to the Reference Safety Information, the events Syncope, fainting sweating and fear of needles are unlisted events of AFLURIA. Case Causality: Possible.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Feeling abnormal, 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) 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 Arthritis. 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 15-Oct-2015 at approximately 1.30 pm - unknown stop date, Batch no: U58207, 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 15-Oct-2015, 1 day after starting / treatment with AFLURIA the patient experienced Dizzy (non serious, outcome: Unknown), Very weak (non serious, outcome: Unknown), Nauseous (non serious, outcome: Unknown), Slightly mentally "foggy" (non serious, outcome: Unknown). For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 41.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Contusion
Clinical narrative: This case report was received from a(n) Health Professional and concerns a(n) 41 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 reaction(s)/event(s): The patient received AFLURIA on 10-Oct-2015 - unknown stop date, Batch no: U56206, route of administration: intramuscular, dose: 05 ml, site: left arm. Additional suspect drug(s): ADACEL, site: right arm. Reaction(s)/event(s) and outcome: On 11-Oct-2015, 2 days after starting / treatment with AFLURIA the patient experienced bruising (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: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphagia, Dyspnoea, Eye pruritus, Lacrimation increased
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 36-year old female patient. The patient's concurrent condition included slight cold. She had a medical history of allergies to sulfa drugs, peanuts and tree nuts. On 17-Oct-2015, the patient received intramuscular AFLURIA injection (batch number "333320015-01") in the left arm. On 17-Oct-2015, the patient experienced watery/itchy eyes, wheezing, difficulty breathing, difficulty swallowing, excessive coughing, severe sore/swelling in the throat, like it was closing up. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious. Case correction (26-Feb-2016): Date of last received updated to 26-Feb-2016 to reflect the date on which the event 'Pharyngeal oedema' was upgraded to serious.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pharyngeal oedema, Throat tightness, Wheezing
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 36-year old female patient. The patient's concurrent condition included slight cold. She had a medical history of allergies to sulfa drugs, peanuts and tree nuts. On 17-Oct-2015, the patient received intramuscular AFLURIA injection (batch number "333320015-01") in the left arm. On 17-Oct-2015, the patient experienced watery/itchy eyes, wheezing, difficulty breathing, difficulty swallowing, excessive coughing, severe sore/swelling in the throat, like it was closing up. The outcome was unknown. Reporter's comments: The health authority assessed the events as non-serious. Case correction (26-Feb-2016): Date of last received updated to 26-Feb-2016 to reflect the date on which the event 'Pharyngeal oedema' was upgraded to serious.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Bronchitis, Cough, Headache, Oropharyngeal pain, Respiratory tract congestion
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) 47 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refers to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 05-Oct-2015 - unknown stop date, batch no: 11049211A, route of administration: intramuscular, dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 05-Oct-2015, 1 day after starting/treatment with AFLURIA the patient experienced sore throat (non serious, outcome: unknown), headache (non serious, outcome: unknown), coughing (non serious, outcome: unknown), congestion (non serious, outcome: unknown). On 10-Oct 2015, 1 day after starting/treatment with AFLURIA the patient experienced bronchitis (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: 23.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
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) 23 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 03-Mar-2015 - unknown stop date, Batch no: T53109, Route of administration: Unknown, Dose: 0.5 ml, site: left arm. Additional suspect drug(s): PNEUMOVAX, batch no.: K015368, site: right arm. Reaction(s)/event(s) and outcome: On 10-Mar-2015, 1 week 1 day after receiving AFLURIA the patient experienced Pain in his left deltoid (non serious, outcome: recovered/resolved), Swelling in left deltoid (non serious, outcome: recovered/resolved). For relevant test results see appropriate report section. Reporter's assessment: non-serious.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: The case report was received from a(n) Health Professional and concerns a(n) 67 years old male patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 17-Oct-2015, Batch no: U56807. On an unknown date, after starting treatment with AFLURIA the patient experienced face swelling. The health authority assessed the event as non-serious.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, 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 and concerns a(n) 61 years old female patient. Weight: not provided, Height: not provided. The patient has a medical history of hypothyroidism and serotonin imbalance. The patient received AFLURIA on 29-Sept-2015, Batch no: U54806. On 29-Sep-2015, after starting treatment with AFLURIA the patient experienced immediate post-injection pain at injection site. Patient thought the injection was too high on her L arm; pain is sharp and tearing in nature and will at times radiate down to her L elbow. The health authority assessed the events as non-serious.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nerve damage, Musculoskeletal pain, 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) 53 years old female patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 23-Sep-2015, Batch no: U58508. On 23-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced, may have hit a nerve when administration, pain in (L) shoulder radiating down towards hand and hurts to lift arm. The health authority assessed the events as non-serious.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Platelet count decreased, Pruritus, Pyrexia
Clinical narrative: This health authority case was initially received on 16-DEC-2015. This case report was received from a(n) Health Professional and concerns a(n) 43 year old female patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received ALFLRIA on 12-OCT-2015 - unknown stop date, Batch no: U59518, Route of administration: Unknown, Dose: 0.5 ml, Site: Left arm (LA). 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 Low platelet count (non serious, outcome: Recovered / Resolved, Fever non serious, outcome: Recovered / Resolved, Itching (non serious, outcome: Recovered / Resolved).  Reporter's assessment: Non-serious. Company's evaluation and comment: Seriousness criterion/criteria: Non-serious; emergency visit. Listed ness: According to the Reference Safety Information, the events Fever and itching are listed events of AFLURIA, the event Low platelet count is a unlisted event of AFLURIA.  Case causality: Possible.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Conjunctivitis, Cough, Pharyngeal oedema, Urticaria
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 61 year old male patient. The patient had no current illness or medical history. On 15-Dec-2015, the patient received AFLURIA injection (batch number U59208) in the right arm. On 15-Dec-2015, the patient developed hives of face, cough, conjunctivitis and edema throat (treated with prednisone). The outcome was recovered. Reporter's comments: The health authority assessed the events as non-serious. Case correction (26-Feb-2016): Date of last received updated to 26-Feb-2016 to reflect the date on which the event 'Pharyngeal oedema' was upgraded to serious.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Influenza like illness, Myalgia, Pain, Pyrexia
Clinical narrative: The health authority case was initially received on 16-Dec-3015. The case report was received from a(n) Health Professional and concerns a(n) 52 year old female patient. The patient had no illness at the time of vaccination. Concurrent medical condition(s), medical and drug history: The patient has a medical history of kidney transplant. 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: not provided, route of administration: Intramuscular, site: left arm (LA). Additional suspect drug(s): No additional drugs suspected. Reactions(s)/event(s) and outcome: On 15-Oct-2015, 2 days after starting / treatment with AFLURIA the patient experienced strong flu like symptoms (non serious, outcome: Recovered / Resolved), Body aches (non serious, outcome: Recovered / Resolved), Muscle aches (non serious, outcome: Recovered / Resolved), Fever (non serious, outcome: Recovered/ Resolved), chills (non serious, outcome: Recovered / Resolved). Reporter's assessment: non serious.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Influenza, Pain
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 51 year old female patient. The patient has a medical history of allergy to mercury and hepatitis B vaccine. At the time of vaccination, the patient had no current illness nor were they on any medications. On 05-Oct-2015, the patient received an intramuscular injection of AFLURIA (batch number U57807; first dose) to the left arm. At 10:00 on 08-Oct-2015, the patient experienced minor flu symptoms previous to acute chills and rigors with a body ache. The patient made an emergency room visit and was hospitalised for a period of seven (7) days. The outcome was unknown. Reporter's comments: The health authority assessed the events as serious (hospitalisation, life threatening).
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: The case report was received from a (n) Health Professional and concerns a (n) 38 year old female patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Allergies to sulfa drugs, Remeron, Topamax, Bactrim, Levaquen. Allergies to latex, Bipolar, PTSD, Anxiety disorder, Borderline personality disorder, Degenerative disc disease and Permanent nerve damage on right side. The following drug history information was reported: Sulfa drugs, Remeron, Topamax, Bactrim, Levaquin (Indication - Reaction: Allergies). For c oncomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and concomitant surround the onset of reaction(s) / event (s): The patient received AFLURIA on 19-OCT-2015 - unknown stop date, batch no: not provided, Route of administration: Intramuscular, Site: Right arm (RA). 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 itch all over (non serious, outcome: Recovered  / Resolved. Reporter's assessment: Non serious. Company's evaluation and comment: Seriousness criterion/criteria: Non serious. Listedness: According to the Reference Safety Information, the event itch all over is a listed event of AFLURIA Case Causality: Unassessable/unclassifiable due to insufficient information
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
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. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 22-Oct-2015 - unknown stop date, Batch no: U58808, 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 23-Oct-2015, 2 days after receiving AFLURIA the patient experienced soreness of arm (non serious, outcome: Unknown). Reporter's assessment: The health authority assessed the event as non-serious.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dyskinesia, Eye movement disorder, Facial paralysis, Lacrimation increased
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 57 year old female patient. The patient had a medical history of hypersensitivity to penicillin (reported at 'PCN') and ampicillin. The patient did not suffer from any current illness at the time of the vaccination nor was she using any concomitant medications. On 12-Oct-2015, the patient received an intramuscular injection of AFLURIA (batch no: U55906; dose number: 1) to the left arm. On 13-Oct-2015, the patient experienced a decrease in control of the left side of the mouth, left arm and left eye. In addition, the left eye kept tearing. Consultation with a MD a few days later and subsequent follow-up with an ophthalmologist resulted in a diagnosis of Bells' Palsy. Both medical professionals were unsure if the events were coincidental. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as non-serious. The health authority reported preferred terms: Dyskinesia, eyelid function disorder. Case correction (12-Jan-2016): Listedness assessment added for AE #4.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, 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 and concerns a(n) 38 years old female patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 19-Oct-2015, Batch no: U56306, Route of administration: Unknown, Dose: 0.5 ml. No additional drugs suspected. On 19-Oct-2015, 1 day after starting treatment with AFLURIA the patient experienced a bit woozy, pain in arm at location of flu shot. Pain lasted through the next day. The health authority assessed the events as non-serious.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle fatigue, Muscular weakness
Clinical narrative: This case report was received from a (n) Health Professional and concerns a 66 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 12-OCT-2015 - unknown stop date, Batch no: "459508", 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 Muscle fatique ( non serious, outcome: Unknown), Muscle weakness (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. Company's evaluation and comment: Seriousness criterion/criteria: Emergency visit. Listed ness: According to the Reference Safety Information, the events Muscle fatigue and Muscle weakness are unlisted events of AFLURIA. Case Causality: Possible.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This health authority case was initially received on 16-Dec-2015. Follow up information received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) 58 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. 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 01-Oct-2015 - unknown stop date, batch no: U56907, route of administration: intramuscular, dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 01-Oct-2015, 1 day after starting/treatment with AFLURIA the patient experienced pain in extremity (non serious, outcome: not recovered/not resolved), muscle pain/soreness in the arm he got the flu shot (non serious, outcome: not recovered/not 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: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This case report was received from a (n) Health Professional and concerns a (n) 50 years old female patient; The patient had no current illness. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drugs: timing and conditions surround the onset of reaction (s) / event (s): The patient received AFLURIA on 11-OCT-2015 - unknown stop date, Batch no: U59208, 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, 2 days after starting / treatment with AFLURIA the patient experienced sore arm (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. Company's evaluation and comment: Seriousness criterion/criteria: Non serious. Listed ness: According to the Reference Safety Information, the event sore arm is an unlisted event of AFLURIA. Case causality: Possible.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Rash, Throat irritation
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 41 year old male patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of asthma. The patient had no illness at no concomitant medications at the time of vaccination. 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: U55306, route of administration: intramuscular, dose: 0.5 ml, site: right arm (RA). Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 19-Oct-2015, 1 day after starting/treatment with AFLURIA the patient experienced swollen lips (non serious, outcome: recovered/resolved), progressing to itchy throat (non serious, outcome: recovered/resolved), progressing to rash (non serious, outcome: recovered/resolved). No SOB. Reporter's assessment: Non-serious.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal discomfort, Influenza like illness, Injection site reaction, Nausea, 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) 60  years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report section. Suspect drug(s), timing and conditions surrounding the onset of reaction(s) / event(s): THE patient received AFLURIA on 22-OCT-2015 - unknown stop date. Batch no: U56206, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): PNEUMOVAX vaccine. Reaction(s)/event(s) and outcome: On 23-OCT-2015, 2 days after starting / treatment with AFLURIA the patient experienced Sick to stomach (non serious, outcome: Recovered / Resolved), Flu like symptoms (non serious, outcome: Recovered / Resolved), Body ache (non serious, outcome: Recovered / Resolved), Injection site reaction (non serious, outcome: Recovered / Resolved), Nausea (non serious, outcome: Recovered / Resolved). For relevant test results was 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 nausea. Company's evaluation and comment: Seriousness criterion/criteria: Non serious. Listed ness: According to the Reference Safety Information, the events flu like symptoms, Injection site reaction and Nausea are listed events of AFLURIA, the events Sick to Stomach and Body ache are unlisted events of AFLURIA. Case Causality: Possible.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: The case report was received from a(n) Health Professional in United States and concerns a(n) 49 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 Allergies: Aspirin, Penicillin (Inferred, based on prescription history), Upper respiratory problems, Asthma and Depression. 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 27-Oct-2015 - unknown stop date, Batch no: U56406, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 28-Oct-2015, 2 days after starting/treatment with AFLURIA the patient experienced Whole body ache, soreness (non serious, outcome: Unknown), Soreness at injection site (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: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling abnormal, Throat tightness
Clinical narrative: Source of report and patient demography: This healthy authority case was initially received on 16-Dec-2015. The case report was received from a (n) Health Professional and concerns a (n) 53 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 Hypertension. 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 28-Oct-2015- unknown stop date, Batch no: U57907, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 28-Oct-2015, 1 day after starting / treatment with AFLURIA the patient experienced Tightness in throat (non serious, outcome: Recovered / Resolved), Feeling a little off (non serious, outcome: Recovered/ Resolved), Redness developed on chest (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: 26.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Abdominal distension, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a(n) 26 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 Seasonal allergies and Slight lactose intolerance. The patient had APLISOL (batch number 992982) on the left arm which was placed intradermally. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 26-Oct-2015 - unknown stop date, Batch no: U56606, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): VARIVAX. Reaction(s)/event(s) and outcome: On 27-Oct-2015, 2 days after starting / treatment with AFLURIA the patient experience Swollen (red bump that was itchy) (non serious, outcome: Recovered / Resolved), Red bump (non serious, outcome: Recovered / Resolved), Itchy (non serious, outcome: Recovered / Resolved), Warm to touch (non serious, outcome: Recovered / Resolved), Erythema (non serious, outcome: Recovered / Resolved), Pruritus (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: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage
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) 87 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. He had no current illness. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 06-Oct-2015 - unknown stop date, Batch no: U57707, Route of administration: Intramuscular, Dose: 0.5 ml, Site: arm. 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 Blood pooled around the injection site and travelled down his arm and up around his shoulder (non serious, outcome: recovered/resolved). The patient was on warfarin and had a similar reaction when he was in a car accident. Reporter's assessment: Non serious.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Increased upper airway secretion, Inflammation, Mobility decreased, Musculoskeletal stiffness
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) 37 years old female patient. Weight: not provided, height: not provided. Concurrent medical condition(s), medical and drug history: At the time of the event the patient concomitantly suffered from asthma. 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 22-Oct-2015 8:30 - unknown stop date, batch no: U58407, route of administration: intramuscular, dose: 0.5 ml, site: right arm. Additional suspect drug(s): On the same day, the patient also received PNEUMOVAX (batch no: K010465) in the right arm via intramuscular route. Reaction(s)/event(s) and outcome: On 22-Oct-2015 15:15, after starting/treatment with AFLURIA the patient experienced severe swollen arm (non serious, outcome: unknown), received PNEUMOVAX 23 and AFLURIA vaccine in the same arm 1 inch apart (non serious, outcome: unknown), severe sore arm (non serious, outcome: unknown), arm warm to touch (non serious, outcome: unknown), arm stiff (non serious, outcome: unknown), (arm) with limited ability of movement (non serious, outcome: unknown), mucus sensation in her chest (non serious, outcome: unknown), chest discomfort (non serious, outcome: unknown), inflammation (non serious, outcome: unknown), mobility decreased (non serious, outcome: unknown). Event treatment: Advised to take ibuprofen for the inflammation and pain. Reporter's assessment: Non serious. The health authority also coded additional terms chest discomfort and mobility decreased. Case correction (29-Mar-2016): AE 2 re-coded to 'drug administration error'.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Peripheral swelling, Skin warm
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) 37 years old female patient. Weight: not provided, height: not provided. Concurrent medical condition(s), medical and drug history: At the time of the event the patient concomitantly suffered from asthma. 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 22-Oct-2015 8:30 - unknown stop date, batch no: U58407, route of administration: intramuscular, dose: 0.5 ml, site: right arm. Additional suspect drug(s): On the same day, the patient also received PNEUMOVAX (batch no: K010465) in the right arm via intramuscular route. Reaction(s)/event(s) and outcome: On 22-Oct-2015 15:15, after starting/treatment with AFLURIA the patient experienced severe swollen arm (non serious, outcome: unknown), received PNEUMOVAX 23 and AFLURIA vaccine in the same arm 1 inch apart (non serious, outcome: unknown), severe sore arm (non serious, outcome: unknown), arm warm to touch (non serious, outcome: unknown), arm stiff (non serious, outcome: unknown), (arm) with limited ability of movement (non serious, outcome: unknown), mucus sensation in her chest (non serious, outcome: unknown), chest discomfort (non serious, outcome: unknown), inflammation (non serious, outcome: unknown), mobility decreased (non serious, outcome: unknown). Event treatment: Advised to take ibuprofen for the inflammation and pain. Reporter's assessment: Non serious. The health authority also coded additional terms chest discomfort and mobility decreased. Case correction (29-Mar-2016): AE 2 re-coded to 'drug administration error'.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site cellulitis
Clinical narrative: This medically confirmed spontaneous report (initial receipt 16-Oct-2015) concerns a female patient. On 12-Oct-2015, the patient received AFLURIA (batch number U58908) 0.5mL once via the intramuscular route. On 16-Oct-2015, the patient contacted the pharmacy where she received the vaccine to stated that she was diagnosed with cellulitis at the injection site. The adverse reaction had not resolved to date (at the time of reporting). The outcome was not yet recovered. Reporter's comments: The reporter assessed the event as non-serious. The patient was 56 years old. The patient had completely recovered.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This medically confirmed spontaneous report (initial receipt 16-Oct-2015) concerns a female patient. On 12-Oct-2015, the patient received AFLURIA (batch number U58908) 0.5mL once via the intramuscular route. On 16-Oct-2015, the patient contacted the pharmacy where she received the vaccine to stated that she was diagnosed with cellulitis at the injection site. The adverse reaction had not resolved to date (at the time of reporting). The outcome was not yet recovered. Reporter's comments: The reporter assessed the event as non-serious. The patient was 56 years old. The patient had completely recovered.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site cellulitis
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 56 year-old female patient who had no current illness, medical history and medications at the time of vaccination. On 12-Oct-2015, the patient received AFLURIA injection (batch number U58908) via the intramuscular route on the left arm. On 13-Oct-2015, the patient experienced swelling and redness at the injection site. Cellulitis treatment of antibiotics was given. The outcome was recovered. Reporter's comments: The health authority assessed the case as non-serious.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 56 year-old female patient who had no current illness, medical history and medications at the time of vaccination. On 12-Oct-2015, the patient received AFLURIA injection (batch number U58908) via the intramuscular route on the left arm. On 13-Oct-2015, the patient experienced swelling and redness at the injection site. Cellulitis treatment of antibiotics was given. The outcome was recovered. Reporter's comments: The health authority assessed the case as non-serious.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site rash
Clinical narrative: The case report was received from a(n) Health Professional and concerns a(n) 65 years old female patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 10-Oct-2015, Batch no: U58407. The patient also received PREVNAR13 on 10-Oct-2015, Batch number L99271. Both vaccines were given in the left arm. On an unknown date, after starting treatment with AFLURIA the patient experienced localized rash on the arm below the injection site. The health authority assessed the events as non-serious.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Swelling
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) 60 years old female patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 10-Oct-2015, Batch no: U58407. On 10-Oct-2015, 1 day after starting treatment with AFLURIA the patient experienced swelling. On an unknown date, 3 weeks after starting treatment with AFLURIA the patient experienced soreness. The health authority assessed the events as non-serious.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Flushing
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. Concurrent medical conditions (s), medical and drug history: At the time of the event the patient concomitantly suffered from Tooth problem and was on a methylprednisolone pack. The patient has a medical history of Rubber (allergy). For concomitant medication and therapy dates refers 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 22-Oct-2015- unknown stop date, Batch no: U57807, 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 22-Oct-2015, 1 day after starting/treatment with AFLURIA the patient experienced Rash over torso, ears, head, neck (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: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash
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. Concurrent medical conditions (s), medical and drug history: At the time of the event the patient concomitantly suffered from Tooth problem and was on a methylprednisolone pack. The patient has a medical history of Rubber (allergy). For concomitant medication and therapy dates refers 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 22-Oct-2015- unknown stop date, Batch no: U57807, 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 22-Oct-2015, 1 day after starting/treatment with AFLURIA the patient experienced Rash over torso, ears, head, neck (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: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest pain, Dizziness, Nausea, 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) 64 years old male patient. Weight: not provided, Height: not provided. The patient has a medical history of depression, elevated cholesterol, secondary Parkinson and Essential tremor. The patient received AFLURIA on 06-Oct-2015, Batch no: 10949221A, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 06-Oct-2015, after starting treatment with AFLURIA the patient experienced dizziness, aching, nausea, atypical chest pain, and blood pressure increased. The patient was treated at the emergency room. The health authority assessed the events as non-serious.