chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Rash, Swelling
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 64 year old female patient. The patient has a medical history of 'penicillins, sulfa, zolpidem, carbamates derivatives, latex, hydrocodone but tolerates codeine'. For concomitant medication and therapy dates refer to the appropriate report sections. Concomitant medications also include BREO ELLIPTA. The patient received AFLURIA on 22-Sep-2015 - unknown stop date, Batch no: U56807, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm (LA). PNEUMOVAX, Indication: not provided, Site: left arm (LA). On 22-Sep-2015, 1 day after starting / treatment with AFLURIA the patient experienced Swelling, Burning sensation, Large rash that had been developed on the backside/tricep area of her arm. Fexofenadine, diphenhydramine, ice pack. Reporter's assessment: Non-serious.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 45 years old female patient. Weight: not provided, Height: not provided. The patient has a medical history of Anemia. For concomitant medication and therapy dates refer to the appropriate report sections. The patient had no current illness. The patient received AFLURIA on 23-Sep-2015 - unknown stop date, Batch no: U55406, Route of administration: Intramuscular, Dose: 0.5 ml, Site: right arm. On the same day the patient also received PNEUMOVAX (batch K008927) in the right arm, Indication: not reported. On 24-Sep-2015, 2 days after starting treatment with AFLURIA the patient experienced Severe swelling of the arm. The patient wanted both AFLURIA and PNEUMOVAX injected in same arm. For relevant test results see appropriate report section. Reporter's assessment: Non serious.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Myalgia, Pyrexia, Vomiting
Clinical narrative: This health authority case was initially received on 23-Nov-2015. 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. The patient had no current illness. The patient received AFLURIA on 19-Sep-2015, Batch no: U57907, Route of administration: Intramuscular, Dose: 0.5 ml. Site: left arm. No additional drugs suspected. On 23-Sep-2015, 5 days after starting treatment with AFLURIA the patient experienced fever, severe headache, cold chills, achy muscles and vomit. Reporter's assessment: Non serious.
Age: 63.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Back pain, Burning sensation, Musculoskeletal stiffness, Peripheral swelling, Rash erythematous
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 63 year old female patient. The patient had no applicable medical history and no illness at the time of vaccination. The patient received AFLURIA on 24-Sep-2015 - unknown stop date, Batch no: U56807, Route of administration: Intramuscular, Dose: 0.5 ml; site: right arm (RA). PREVNAR 13 and ZOSTAVAX. On 24-Sep-2015, 6 hours after starting treatment with AFLURIA the patient experienced Chest was on fire, Back felt like someone hit it with a hammer, Thumbs swelled up, Hands were stiff. On 26-Sep-2015, 3 days after starting treatment with AFLURIA the patient experienced Red dots / Red spots, Rash all over body mostly on her arms, chest and stomach, Itchy rash on her body. Naproxen, diphenhydramine and cetirizine. Reporter's assessment: Non-serious.
Age: 63.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 63 year old female patient. The patient had no applicable medical history and no illness at the time of vaccination. The patient received AFLURIA on 24-Sep-2015 - unknown stop date, Batch no: U56807, Route of administration: Intramuscular, Dose: 0.5 ml; site: right arm (RA). PREVNAR 13 and ZOSTAVAX. On 24-Sep-2015, 6 hours after starting treatment with AFLURIA the patient experienced Chest was on fire, Back felt like someone hit it with a hammer, Thumbs swelled up, Hands were stiff. On 26-Sep-2015, 3 days after starting treatment with AFLURIA the patient experienced Red dots / Red spots, Rash all over body mostly on her arms, chest and stomach, Itchy rash on her body. Naproxen, diphenhydramine and cetirizine. Reporter's assessment: Non-serious.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Local swelling, Upper extremity mass
Clinical narrative: This health authority case was initially received on 23-NOV-2015. The case report was received from a Health Professional and concerns a 35 year old male patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Ulcerative colitis. Concomitant medications comprised of "for #19". The patient had no current illness at the time of vaccination. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received ALFURIA on 25-SEP-2015 - unknown stop date, Batch no: U56106, Route of administration: Unknown, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 25-SEP-2015, after starting / treatment with AFLURIA the patient experienced Deltoid (immediately swelled) 1/2 in x 2 in circle raised lump / Upper extremity mass (non serious, ou6tcome: Not recovered / Not Resolved). Deltoid immediately swelled 1/2 in x 2 in (circle raised lump) / Peripheral swelling (non serious, outcome: Not Recovered / Not Resolved), immediate post injection reaction (non serious, outcome: Not Recovered / Not Resolved). Emergency medical services (EMS) attended to the patient. For relevant test results see appropriate report section. Patients vitals 118/72, HR = 84, PO: 98%. Reporter's assessment: Non-serious.
Age: 40.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Limb discomfort, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 40 year old female patient. The patient had no illness and no known pre-existing conditions at the time of vaccination. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 25-Sep-2015 - unknown stop date, Batch no: U56406, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm (LA). Additional suspect drug(s): PREVNAR 13, Site: left arm (LA). Reaction(s)/event(s) and outcome: On 26-Sep-2015, 2 days after starting / treatment with AFLURIA the patient experienced Arm was swollen / Swollen area is decreasing in size (non serious, outcome: Unknown), Arm [was swollen /Swollen area is] decreasing in [size and] discomfort (non serious, outcome: Unknown), Arm was painful / Painful area is decreasing in size (non serious, outcome: Unknown), Red area is decreasing in size (non serious, outcome: Unknown), Feverish (non serious, outcome: Unknown), Rash like in a 5 inch radius circle (non serious, outcome: Unknown). Event treatment: Patient put ice on red area and took ibuprofen, diphenhydramine and hydroxyzine. Reporter's assessment: Non-serious.
Age: 40.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Rash
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 40 year old female patient. The patient had no illness and no known pre-existing conditions at the time of vaccination. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 25-Sep-2015 - unknown stop date, Batch no: U56406, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm (LA). Additional suspect drug(s): PREVNAR 13, Site: left arm (LA). Reaction(s)/event(s) and outcome: On 26-Sep-2015, 2 days after starting / treatment with AFLURIA the patient experienced Arm was swollen / Swollen area is decreasing in size (non serious, outcome: Unknown), Arm [was swollen /Swollen area is] decreasing in [size and] discomfort (non serious, outcome: Unknown), Arm was painful / Painful area is decreasing in size (non serious, outcome: Unknown), Red area is decreasing in size (non serious, outcome: Unknown), Feverish (non serious, outcome: Unknown), Rash like in a 5 inch radius circle (non serious, outcome: Unknown). Event treatment: Patient put ice on red area and took ibuprofen, diphenhydramine and hydroxyzine. Reporter's assessment: Non-serious.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Headache, Vertigo
Clinical narrative: This health authority case was initially received on 23-NOV-2015. The case report was received from a(n) Health Professional and concerns a(n) 27 years old female patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Wheat allergy and May thurner syndrome (stent placed in groin). The patient had no current illness at the time of vaccination. 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: U54506, 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 Headache (non serious, outcome: Unknown), Dizziness (non serious, outcome: Unknown), Vertigo like symptoms/Vertigo (non serious, outcome: Unknown), Shortness of breath/Dyspnea (non serious, outcome: Unknown), Brain fog/Feeling abnormal (non serious, outcome: Unknown). Reporter's assessment: The health authority assessed the events as non-serious.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This health authority case was initially received on 23-NOV-2015. The case report was received from a Health Professional and concerns a 86 year old female patient. The patient has no medical history and had no illness at the time of vaccination. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 23-SEP-2015 - unknown stop date, Batch no: reported as "U1434AA", Route of administration: Intramuscular, Site: Left arm (LA). Additional suspect drug(s): No additional drugs suspected. Reaction(s)/events and outcome: On 25-SEP-2015, 3 days after starting/treatment with AFLURIA the patient experienced Swelling radiating down arm (away from injection site) (non serious, outcome: Recovered/Resolved with sequelae), Warmth on touch (non serious, outcome: Recovered/Resolved with sequelae), Injection site warmth (non serious, outcome: Recovered/Resolved with sequelae), Slight itching (non serious, outcome: Recovered/Resolved with sequelae), Swelling (radiating down arm away from) injection site (non serious, outcome: Recovered/Resolved with sequelae), Injection site pruritus (non serious, outcome: Recovered/Resolved with sequelae). Reporter's assessment: Non-serious. The health authority reported the symptoms: injection site warmth, injection site pruritus.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Eye irritation, Eye pruritus, Eye swelling, Headache
Clinical narrative: This health authority case was initially received on 23-Nov-2016. The case report was received from a Health Professional and concerns a 23 year old male patient. The patient had no medical history, current illness or concomitant medications at the time of vaccination. The patient received AFLURIA on 03-Oct-2015, Batch no: U56506, Route of administrations: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 03-Oct-2015, 1 hour 30 mins after starting treatment with AFLURIA the patient experienced Bilateral eye itching, swelling, burning, and redness, Ocular hyperaemia, and headache. On 03-Oct-2015, after starting treatment with AFLURIA the patient experienced itching and redness on his neck. Event treatment: 50 mg/ml diphenhydramine (lot #: 4296463, exp: Oct-2016). Reporter's assessment: Non-serious.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pruritus
Clinical narrative: This health authority case was initially received on 23-Nov-2016. The case report was received from a Health Professional and concerns a 23 year old male patient. The patient had no medical history, current illness or concomitant medications at the time of vaccination. The patient received AFLURIA on 03-Oct-2015, Batch no: U56506, Route of administrations: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 03-Oct-2015, 1 hour 30 mins after starting treatment with AFLURIA the patient experienced Bilateral eye itching, swelling, burning, and redness, Ocular hyperaemia, and headache. On 03-Oct-2015, after starting treatment with AFLURIA the patient experienced itching and redness on his neck. Event treatment: 50 mg/ml diphenhydramine (lot #: 4296463, exp: Oct-2016). Reporter's assessment: Non-serious.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bone pain, Neck pain, Pain in extremity
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 30 years old female patient. Linked case: 2016059214 (same patient). Weight: not provided, Height: not provided. Influenza (seasonal) vaccine (Reaction: Injection hit nerve). For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 06-Oct-2015 at 10.30 am- unknown stop date, Batch no: U54806, Route of administration: Unknown, Dose: 0.5 ml on the left deltoid. No additional drugs suspected. On 06-Oct-2015 (within 5 minutes), after starting treatment with AFLURIA the patient experienced Pain to (L) wrist. Within 15 minutes, the patient developed radiating pain in forearm to fingertips, Pain in collar bone, Pain (L) side of neck. Pain continued 3 hours after vaccination. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Swelling, Tenderness
Clinical narrative: This health authority case was initially received on 23-NOV-2015. The case report was received from a(n) Health Professional and concerns a(n) 49 years old female patient. The patient has no current illness or medical history. 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 29-SEP-2015 - unknown stop date, Batch no: 11149221A, 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, 3 days after starting / treatment with AFLURIA the patient experienced Right underarm felt swollen (non serious, outcome: Unknown), Right underarm felt tender (non serious, outcome: Unknown), Local swelling (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. The authority reported symptom included - "local swelling".
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Headache, Hyperhidrosis, Injection site erythema, Injection site reaction
Clinical narrative: The health authority case was initially received on 23-NOV-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. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Allergies to Codeine, Compazine, Erythromycin, Inapsine, Penicillin. Sulfa-drugs, tequin. The patient received care at a different clinic. 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 06-OCT-2015 - unknown stop date, Batch no: U55306, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 06-OCT-2015, 1 day after starting / treatment with AFLURIA the patient experienced Looking flushed (non serous, outcome: Recovered / Resolved), Redness at site of injection/Injection site erythema (non serious, outcome: Recovered / Resolved), Blotchy spots on the neck area / Blotchy (spots) at injection site/Rash macular (non serious, outcome: Recovered / Resolved), Hives/Urticaria (non serious, outcome: Recovered / Resolved), (Blotchy) spots at site of injection/Injection site rash (non serious, outcome: Recovered / Resolved), Sweaty (non serious, outcome: Recovered / Resolved), Intense itching/Pruritus (non serious,  outcome: Recovered / Resolved), Headache (non serious, outcome: Recovered / Resolved).  For relevant test results see appropriate report section. Please add other relevant test results as appropriate. Reporter's assessment: The Health Authority assessed the events as non-serious.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash macular
Clinical narrative: The health authority case was initially received on 23-NOV-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. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Allergies to Codeine, Compazine, Erythromycin, Inapsine, Penicillin. Sulfa-drugs, tequin. The patient received care at a different clinic. 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 06-OCT-2015 - unknown stop date, Batch no: U55306, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 06-OCT-2015, 1 day after starting / treatment with AFLURIA the patient experienced Looking flushed (non serous, outcome: Recovered / Resolved), Redness at site of injection/Injection site erythema (non serious, outcome: Recovered / Resolved), Blotchy spots on the neck area / Blotchy (spots) at injection site/Rash macular (non serious, outcome: Recovered / Resolved), Hives/Urticaria (non serious, outcome: Recovered / Resolved), (Blotchy) spots at site of injection/Injection site rash (non serious, outcome: Recovered / Resolved), Sweaty (non serious, outcome: Recovered / Resolved), Intense itching/Pruritus (non serious,  outcome: Recovered / Resolved), Headache (non serious, outcome: Recovered / Resolved).  For relevant test results see appropriate report section. Please add other relevant test results as appropriate. Reporter's assessment: The Health Authority assessed the events as non-serious.
Age: 31.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Fall
Clinical narrative: This 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 Diabetes. 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. Indication not reported on 06-OCT-2015 - unknown stop date, Batch no: U5907, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s0: ADACEL(batch number: U5235AA), Indication: not provided. Reaction(s)/event(s) and outcome: On 06-OCT-2015, 1 day after starting/treatment with AFLURIA the patient experienced Fell over/Fall (non serious, outcome: Recovered/Resolved). The patient was sitting on the bench and fell over, but was conscious. The patient was given some sugar to take as patient was diabetic. The patient recovered over 15 minutes and choose to walk out of the store with a family member. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Fatigue, Hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a(n) Health Professional and concerns a(n) 48 years old male patient. The patient received AFLURIA on 04-Oct-2015, Batch no: U56506, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 05-Oct-2015, 2 days after starting treatment with AFLURIA the patient experienced swelling, redness, warmth to the area, tenderness, fatigue, allergic reaction, injection site erythema, injection site pain, injection site swelling, and injection site warmth. Event treatment: ROCEPHINE; DECADRON; BENADRYL; SEPTRA prescribed. Reporter's assessment: Non-serious.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Skin warm, Swelling, Tenderness
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a(n) Health Professional and concerns a(n) 48 years old male patient. The patient received AFLURIA on 04-Oct-2015, Batch no: U56506, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 05-Oct-2015, 2 days after starting treatment with AFLURIA the patient experienced swelling, redness, warmth to the area, tenderness, fatigue, allergic reaction, injection site erythema, injection site pain, injection site swelling, and injection site warmth. Event treatment: ROCEPHINE; DECADRON; BENADRYL; SEPTRA prescribed. Reporter's assessment: Non-serious.
Age: 59.0
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Induration, Skin warm, Tenderness, Urticaria
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 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 02-Oct-2015- unknown stop date, Batch no: not provided, Route of administration: not provided, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 03-Oct-2015, 2 days after starting / treatment with AFLURIA the patient experienced large circular red (non serious, outcome: Recovered/Resolved), Large circular welt (non serious, outcome: Recovered / Resolved), Large circular tender (non serious, outcome: Recovered / Resolved), Large circular hard (non serious, outcome: Recovered / Resolved), Hot to touch (non serious, outcome: Recovered/Resolved). For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness, Headache, Muscular weakness, Oropharyngeal pain
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 58 year old female patient. At the time of the event the patient concomitantly suffered from Factor 5 Leiden, runny left nostril, and facial and head pain. The patient received AFLURIA on 24-Sep-2015, Batch no: reported as U54580, Route of administration: Intramuscular, site: left arm. No additional drugs suspected. On 24-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced dizziness, vision change, cough, sore throat, and bad headache. On an unknown date two weeks later, after starting treatment with AFLURIA the patient experienced pain from neck to elbow, left arm aches badly, hurts to move, and muscular weakness. Reporter's assessment: Non-serious.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Visual impairment
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 58 year old female patient. At the time of the event the patient concomitantly suffered from Factor 5 Leiden, runny left nostril, and facial and head pain. The patient received AFLURIA on 24-Sep-2015, Batch no: reported as U54580, Route of administration: Intramuscular, site: left arm. No additional drugs suspected. On 24-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced dizziness, vision change, cough, sore throat, and bad headache. On an unknown date two weeks later, after starting treatment with AFLURIA the patient experienced pain from neck to elbow, left arm aches badly, hurts to move, and muscular weakness. Reporter's assessment: Non-serious.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Peripheral swelling
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 47 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 unknown dates, 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 an unknown date, in the morning, the patient experienced arm (left) bruised (non serious, outcome: Unknown), Arm (left) a little swollen (non serious, outcome: Unknown). For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 55 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 25-Sep-2015 - unknown stop date, Batch no: U56907, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 26-Sep-2015, 2 days after starting treatment with AFLURIA the patient experienced Rash across the top of chest. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the event as non-serious.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 19 years old female patient. The patient had no current illness nor medical history. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 24-Sep-2015 - unknown stop date, Batch no: 11449221A, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 24-Sep-2015, approximately 3 hours after starting / treatment with AFLURIA the patient experienced Hives. On 28-Sep-2015, the event of hives resolved with over the counter diphenhydramine and hydrocortisone cream. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious. Case correction (01-Apr-2016): This case concerns a 19 year old female patient.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypoaesthesia, Injection site pain
Clinical narrative: The case report was received from a(n) Health Professional and concerns a(n) 56 years old female patient. No illness or medical history was indicated by the 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 16-SEP-2015 - unknown stop date, Batch no: U55406, 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 16-SEP-2015, 1 day after starting / treatment with AFLURIA the patient experienced Numbness at injection site (non serious, outcome: Unknown), Pain at injection site (non serious, outcome: Unknown). Pain had not improved since. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Pain in extremity, Skin warm, Swelling
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 61 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 02-Oct-2015- unknown stop date, Batch on: U57907, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): PREVENAR 13, Indication: not provided and ZOSTAVAX. Indication: not provided. Reaction (s)/event (s) and outcome: On 03-Oct-2015, 2 days after starting/ treatment with AFLURIA the patient experienced arm began to feel painful (non serious, outcome: Not recovered/Not Resolved), Local reaction (non serious, outcome: Not Recovered/Not Resolved), Swelling (non serious, outcome: Not Recovered/Not Resolved), Redness (non serious, outcome: Not Recovered/ Not Resolved), Hot to touch (non serious, outcome: Not Recovered)/ Not resolved). For relevant test results see appropriate report section, please add other relevant test results manually as appropriate.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Headache, Heart rate increased, Malaise
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a(n) Health Professional and concerns a(n) 57 years old female patient. Complete physical with primary physician revealed all normal, no illness at the time of vaccination. The patient received AFLURIA on 06-Oct-2015, Batch no: Unknown, Route of administration: Intramuscular, Site: left arm. No additional drugs suspected. On 06-Oct-2015, 1 day after starting treatment with AFLURIA the patient experienced restless, rapid heart beat, sinus congestion, weakness, low appetite, throat irritation, headache, and malaise. Event treatment: Dosed with normal TYLENOL and allergy decongestant, cough drops. Reporter's assessment: Non-serious.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Restlessness, Sinus congestion, Throat irritation
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a(n) Health Professional and concerns a(n) 57 years old female patient. Complete physical with primary physician revealed all normal, no illness at the time of vaccination. The patient received AFLURIA on 06-Oct-2015, Batch no: Unknown, Route of administration: Intramuscular, Site: left arm. No additional drugs suspected. On 06-Oct-2015, 1 day after starting treatment with AFLURIA the patient experienced restless, rapid heart beat, sinus congestion, weakness, low appetite, throat irritation, headache, and malaise. Event treatment: Dosed with normal TYLENOL and allergy decongestant, cough drops. Reporter's assessment: Non-serious.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 34 years old female patient. No current illness or medical history was reported. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 08-Oct-2015 - unknown stop date, Batch no: U59108, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 09-Oct-2015, 2 days after starting / treatment with AFLURIA the patient experienced Soreness to right arm, the injection site, Stiffness in right arm, the injection site, Limited movement to her right arm. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious. Case correction 04-Mar-2016: AE 1 'soreness to right arm[, the injection site]' split and re-coded to LLT 'painful R arm' and AE 4 'soreness to [right arm,] the injection site'. AE 4 is listed for Core assessments.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site bruising, Pruritus generalised
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 60 years old female patient. Weight: not provided, Height: not provided. The patient has a medical history of Allergic reaction and Psoriatic arthritis. The following drug history information was reported: DTP vaccine (Indication: -, Reaction: Allergic reaction). For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 02-Oct-2015 - unknown stop date, Batch no: U55906, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug: ZOSTAVAX, Indication: not provided. On 03-Oct-2015, 2 days after starting / treatment with AFLURIA the patient experienced Mild general pruritus, Bruise approximately 2 to 3 inches in diameter at injection site on left tricep. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 55.0
Sex: M
Vaccine: FLU3, HEPAB, TDAP
Symptoms: Hyperhidrosis, Hypotension, Presyncope
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 55 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 10-Oct-2015 - unknown stop date, Batch no: U59108, Route of administration: Intramuscular, Dose: 0.5 ml. TWINRIX and ADACEL. On 10-Oct-2015, 1 day after starting treatment with AFLURIA the patient experienced Vasovagal reaction, Low blood pressure, Sweating. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site nodule, Injection site swelling
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 21 year old female patient. Weight: not provided, Height: not provided. The patient has a medical history of allergies to sulfa. The patient had no allergies to eggs or latex. She received flu shots in the past with no issues. No current illness was stated and the patient felt well. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 10-Oct-2015 - unknown stop date, Batch no: U59208, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 10-Dec-2015, 1 day after starting treatment with AFLURIA the patient experienced localized swelling at injection site. On 10-Oct-2015, 1 day after starting treatment with AFLURIA the patient experienced immediate post-injection reaction, localized nodule at injection site. The patient was treated with cold pack and was monitored, there was no change following 30 minutes. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 34.0
Sex: M
Vaccine: FLU3, HEPAB
Symptoms: Pallor, Presyncope, Seizure, Syncope
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 34 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 10-Oct-2015 - unknown stop date, Batch no: U59208, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug: TWINRIX, Indication: not provided. On 10-Oct-2015, after starting / treatment with AFLURIA the patient experienced Syncope, Paleness, Vasovagal response. The patient had what seemed like 2 short minute (10-20 second) seizures. The labs and tests did not reveal anything unusual. The doctor decided that the patient had syncope because he had done extensive working out prior to vaccines and had not eaten any food for about 12 hours, which was not reported to the immunizer. He did not have seizures but had a vasovagal response. For the 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: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Ear discomfort, Fatigue, Injection site erythema
Clinical narrative: This medically confirmed health authority report (initial) receipt 23-NOV-2015) concerns a 58 year old female patient. The patient had medical history hypertension, depression, seasonal allergies, diabetes, hypothyroidism and allergies to penicillin, sulfa, tetracycline, macrobid, lantus insulin, macrolides, NSAIDS, codeine, cephalosporins, quinolones, albuterol and metformin. On 10-OCT-2015, the patient received intramuscular AFLURIA injection (batch number: U56206) in the right arm. On 11-OCT-2015, in the morning, the patient noticed that the injection site was red and hot, but no other symptom was reported. The patient was advised to apply cold compress and take a dose of acetaminophen. On 11-OCT-2015, around 3 PM, the patient returned to the pharmacy and stated that she felt clammy, tired, dizzy and her ears stopped up. The patient was advised to lay down and rest. The outcome was reported as unknown. Reporter's comments: The healthy authority assessed the events as non-serious.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: This medically confirmed health authority report (initial) receipt 23-NOV-2015) concerns a 58 year old female patient. The patient had medical history hypertension, depression, seasonal allergies, diabetes, hypothyroidism and allergies to penicillin, sulfa, tetracycline, macrobid, lantus insulin, macrolides, NSAIDS, codeine, cephalosporins, quinolones, albuterol and metformin. On 10-OCT-2015, the patient received intramuscular AFLURIA injection (batch number: U56206) in the right arm. On 11-OCT-2015, in the morning, the patient noticed that the injection site was red and hot, but no other symptom was reported. The patient was advised to apply cold compress and take a dose of acetaminophen. On 11-OCT-2015, around 3 PM, the patient returned to the pharmacy and stated that she felt clammy, tired, dizzy and her ears stopped up. The patient was advised to lay down and rest. The outcome was reported as unknown. Reporter's comments: The healthy authority assessed the events as non-serious.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 58 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA for indication. Indication not reported on  23-SEP-2015 - unknown stop date, Batch no: 11149211A, Route of administration: not provided, Dose: 0.5ml. No additional drugs suspected. On 23-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced Severe soreness in shoulder around area of vaccine administration. It had continued for almost 3 weeks. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious.
Age: 1.4
Sex: M
Vaccine: FLU3
Symptoms: Exposure during breast feeding, Urticaria
Clinical narrative: This  medically confirmed health authority report (initial receipt 23-NOV-2015) concerns a 1.4 years old male patient. The patient's concomitant condition included eczema. On 14-SEP-2015, the patient received AFLURIA injection (batch number not reported) via the mother's breast milk. The patient's mother received AFLURIA vaccine at the drug store and was breast feeding. On 14-SEP-2015, 2-3 hours after breastfeeding, the patient developed hives. The outcome was reported as recovered. Reporter's comments: The health authority assessed the events as non-serious.
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Conjunctivitis, Eye discharge, Eye pain, Ocular discomfort, Photophobia
Clinical narrative: This medically confirmed health authority report (initial receipt 23-Nov-2015) concerns a 35 year old female patient. The patient had no medical history and her current illness included laryngitis. Her concomitant medication included cetirizine. On 12-Oct-2015, the patient received intramuscular AFLURIA injection (batch number U58407) and intramuscular ADACEL (batch number U5278AA). On 12-Oct-2015, the patient experienced several conjunctivitis, drainage, eye pressure and pain as well as light sensitivity. The outcome was reported as unknown.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Breast pain, Lymphadenopathy, Rash
Clinical narrative: This health authority case was initially received on 23-Oct-2015. The case report was received from a Health Professional and concerns a 66 years old female patient. Medical history was reported as 'penicillin'. The patient had no current illness at the time of vaccination. The patient received AFLURIA on 09-Oct-2015 - unknown stop date, Batch no: U57907, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 10-Oct-2015, 2 days after starting treatment with AFLURIA the patient experienced Swollen lymph node under left arm / Lymphadenopathy, Pain in left armpit [radiating to side of breast] / Axillary pain, Pain [in left armpit] radiating to side of breast / Breast pain. On 12-Oct-2015, 4 days after starting treatment with AFLURIA the patient experienced Rash on left side near breast / Rash. Reporter's assessment: Non-serious.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eye swelling, Lip swelling, Vomiting
Clinical narrative: This healthy authority case was initially received on 23-Nov-2015. The case report was received from a(n) Health Professional and concerns a(n) 34 year old female patient. The patient had not current illness at the time of vaccination. The patient received AFLURIA for indication not reported on 07-Oct-2015 unknown stop date, Batch no: U57707, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On an unknown date, after starting / treatment with AFLURIA the patient experienced Dizziness (non serious outcome: Recovered / Resolved), (Eyes,) lips became swollen / Lip swelling (non serious, outcome: Recovered / Resolved), Eyes, (lips) became swollen / Eye swelling (non serious, outcome: Recovered / Resolved), Vomiting (non serious, outcome: Recovered / Resolved). Reporter's assessment: Non-serious. Seriousness criterion/criteria: Non-serious (emergency visit).
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Dizziness, Myalgia, Oropharyngeal pain
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 49 year old female patient. The patient had no medical history and no illness at the time of vaccination. 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: not provided, Route of administration: Intramuscular, Site: left arm (LA). Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 13-Oct-2015, 2 days after starting/ treatment with AFLURIA the patient experienced Light-headed (non serious, outcome: Not Recovered/ Not Resolved), Cough (non serious, outcome: Not Recovered/ Not Resolved), Weakness (non serious, outcome: Not Recovered/ Not Resolved), Sore throat (non serious, outcome: Not Recovered/ Not Resolved), Muscle aches & pains (non serious, outcome: Not Recovered/ Not Resolved), high fever (102) (non serious, outcome: Not recovered/ Not resolved). As on 14-Oct-2015, the patient was still experiencing symptoms. Event treatment: Acetaminophen.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 49 year old female patient. The patient had no medical history and no illness at the time of vaccination. 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: not provided, Route of administration: Intramuscular, Site: left arm (LA). Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 13-Oct-2015, 2 days after starting/ treatment with AFLURIA the patient experienced Light-headed (non serious, outcome: Not Recovered/ Not Resolved), Cough (non serious, outcome: Not Recovered/ Not Resolved), Weakness (non serious, outcome: Not Recovered/ Not Resolved), Sore throat (non serious, outcome: Not Recovered/ Not Resolved), Muscle aches & pains (non serious, outcome: Not Recovered/ Not Resolved), high fever (102) (non serious, outcome: Not recovered/ Not resolved). As on 14-Oct-2015, the patient was still experiencing symptoms. Event treatment: Acetaminophen.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: The case report was received from a health professional and concerns a 20 year old female patient. The patient had no medical history and no illness at the time of vaccination. Concomitant medications include GILDES FE. The patient received AFLURIA on 12-Oct-2015 - unknown stop date, Batch no: U58508, Route of administration: intramuscular, Dose: 0.5 ml, Site: left arm (LA). No additional drugs suspected. On 12-Oct-2015, 1 hour after starting treatment with AFLURIA the patient experienced hives all over body. Event treatment: Oral loratadine. Reporter's assessment: Non-serious.