chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: DTAP, FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: This health authority case was initially received on 26-Oct-2015. The case report was received from a Health Professional and concern a 37 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 seizure disorder. The patient had no current illness. 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 for indication not reported on 03-Sep-2015- unknown stop date, Batch no: U55706, Route of administration: Intramuscular. Additional suspect drug (s): INFANRIX (batch number: H5299), Indication: not provided and PNEUMOVAX (batch number: L010598). Indication: not provided. Reaction (s)/event (s) and outcome: On 05-Sep-2015, 3 days after starting/treatment with AFLURIA the patient experienced arm was tender/tenderness (non serious, outcome: unknown), arm was red/erythema (non serious, outcome: unknown), arm was warm/skin warm (non serious, outcome: unknown), arm was swollen/peripheral swelling (non serious, outcome: unknown). Event treatment: The patient went to the emergency room and was prescribing antibiotics. For relevant test results see appropriate report section. Please add other relevant test result manually as appropriate.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Rash
Clinical narrative: This spontaneous case was initially received on 30-Nov-2015. The case report was received from a Non Health Professional and concerns a female patient. The patient has a medical history of High blood pressure. The patient has no drug reactions/allergies. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received Influenza vaccine in early Oct-2015, Batch no: not provided, Route of administration: Unknown, Dose: Unknown. PNEUMOVAX 23, Batch no: Unknown, Route: Intramuscular. On an unknown date, after starting treatment with Flu vaccine the patient experienced Rash. Reporter's assessment: Not reported.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous case was initially received on 08-Feb-2016. The case report was received from a Health Professional and concerns a 61 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 01-Feb-2016 - 01-Feb-2016, Batch no: U51309, Route of administration: intramuscular, Dose: 0.5 ml. No additional drugs suspected. A temperature excursion occurred with the AFLURIA PFS at 34.9 degrees Fahrenheit for 4 hours on 20-Jan-2016. On 01-Feb-2016, the patient experienced received AFLURIA administered by a medical assistant after first temperature excursion/medication error, (patient received) AFLURIA (administered by a medical assistant after] first temperature excursion. No vaccine has been administered after the second temperature excursion. No adverse event has been reported by the patient. AFLURIA was discontinued. For relevant tests results see appropriate report section. Reporter's assessment/comment: The reporter reported the term 'medication error'. Case correction 04-Mar-2016: AE re-coded to LLT vaccination error.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case was initially received on 25-Nov-2015. The case report was received from a Health Professional and concerns a female patient. Weight: not provided: Height: not provided. The patient has a medical history of Celiac. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received Influenza vaccine on unknown dates, Batch no: not provided, Route of administration: not provided, Dose: administered in 2014. No additional drugs suspected. In 2014, after starting treatment with Influenza vaccine the patient experienced Reaction as if she consumed gluten/Reaction to gluten from unspecified flu vaccine. For relevant test results see appropriate report section.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Feeling abnormal, Pruritus
Clinical narrative: This spontaneous case was initially received on 26-Oct-2015. The case report was received from a Health Professional and concerns a 58 year old female patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 25-Aug-2015 - unknown stop date, Batch no: U55806, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 25-Aug-2015, 1 day after starting treatment with AFLURIA the patient experienced Chest tightness / Chest discomfort, Did not feel she was in her usual health / Feeling abnormal, Itching / Pruritus. Oral diphenhydramine initiated on 25-Aug-2015, continued following day. Visited walk in clinic on 26-Aug-2015. Unknown drugs administered. Reporter's assessment: The Health Professional considered the event Did not feel she was in her usual health / Feeling abnormal, Itching / Pruritus as non-serious and related.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash generalised, Urticaria
Clinical narrative: This spontaneous case was initially received on 13-Jan-2016. The case report was received from a Health Professional and concerns an adult 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 unknown dates, Batch no: not provided, Route of administration: not provided, Dose: Start date: Nov-2014 or Dec-2014. No additional drugs suspected. In 2014, after starting treatment with AFLURIA the patient experienced Hives. She went to her OT the following day and was told it was not a reaction to the vaccine. She was treated with diphenhydramine. She had an allergic reaction to diphenhydramine and was then placed on prednisone which helped. For relevant test results see appropriate report section. Linked case: 2016057883 (same patient). Follow-up information received from HCP on 16-Mar-2016: The patient's medical history included reactions to penicillin/amoxicillin allergy and sulfa with tingly hands and slight puffiness, diphenhydramine allergy, migraine, hypertension, and globus. She had no history of asthma, sinusitis, or reactions to food. Her medications included pravastatin, nebivolol for hypertension, and vitamin D. Last year, less than 24 hours after receiving influenza vaccine, the patient developed a generalized rash with enlarging patches of erythema, minimal itch, and no palpable lesions. The eruption cleared after about 2 weeks and a course of prednisolone.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site extravasation, Underdose
Clinical narrative: This spontaneous case was initially received on 05-Oct-2015. The case report was received from a Health Professional and concerns a 23 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 02-Oct-2015, Batch no: U55906, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 02-Oct-2015, after starting treatment with AFLURIA the patient experienced Half of the vaccine coming out of injection site, [Half of the vaccine coming out of injection site] and running down the patient's arm. For relevant test results see appropriate report section. Reporter's assessment: The reporter considered events non serious.
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site
Clinical narrative: This spontaneous case was initially received on 05-Oct-2015. The case report was received from a Health Professional and concerns a female patient. The patient received AFLURIA on 30-Sep-2015 - unknown stop date, Batch no: 11449221A, Route of administration: Intramuscular, Site: Triceps muscle. No additional drugs suspected. On 30-Sep-2015, the patient experienced received the AFLURIA vaccine in the triceps muscle. The reporter denies any patient harm. Reporter's assessment: not reported.
Sex: M
Vaccine: FLU3
Symptoms: Administration related reaction, Wrong technique in product usage process
Clinical narrative: This spontaneous case was initially received on 06-Oct-2015. The case report was received from a Health Professional and concerns a male patient. The patient received AFLURIA on unknown dates, Batch no: Not provided, route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On an unknown date, after starting treatment with AFLURIA the patient flinched during administration, Administration of AFLURIA with air bubble. The pharmacist cannot remember if she expelled the air bubble out of an AFLURIA prefilled syringe prior to administration. The pharmacist states the patient is fine, he had no complaints. Reporter's assessment: Not reported.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Fatigue, Malaise, Pain, Urticaria
Clinical narrative: This spontaneous case was initially received on 17-Nov-2015. The case report was received from a Health Professional and concerns a female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received Influenza vaccine on 21-Oct-2015 - unknown stop date, Batch no: not provided, Route of administration: not provided, Dose: Site: Right arm. On 21-Oct-2015, the patient received the second dose of PNEUMOVAX 23, on the left arm. The first dose was administered on an unspecified date in 2015. On 21-Oct-2015, after starting treatment with Flu shot the patient experienced Feeling tired, Feeling sick, Feeling achy. The patient also developed a welt on her left arm. For relevant test results see appropriate report section. Reporter's assessment: n/a.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Influenza like illness, Injection site erythema
Clinical narrative: This spontaneous case was initially received on 06-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received Influenza Vaccine. ZOSTAVAX. On an unknown date, after starting treatment with Unspecified flu vaccination the patient experienced Flu-like symptoms, Blood red injection site reaction. For relevant test results see appropriate report section.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous case was initially received on 17-Nov-2015. The case report from a Health Professional and concerns a elderly female patient who was in her late sixties to early seventies. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received unspecified flu vaccine. PNEUMOVAX 23. On an unknown date, 6 days after starting treatment with unspecified flu vaccine and PNEUMOVAX vaccine, the patient experienced significant redness at the injection site, and significant swelling at the injection site. For relevant test results see appropriate report section.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: This spontaneous case was initially received on 06-Oct-2015. The case report was received from a Non Health Professional and concerns a 31 years old female patient. Weight: not provided, Height: not provided. At the time of the event the patient concomitantly suffered from Some degree of cold-like symptoms and Sore throat. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA via Pharma Jet injector on 05-Oct-2015, Batch no: not provided, Route of administration: intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 06-Oct-2015, after starting treatment with AFLURIA the patient experienced Symptoms began to worsen (some degree of cold-like symptoms), Symptoms began to worsen (sore throat). Action taken: Discontinued. For relevant test results see appropriate report section.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was initially received on 07-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on unknown dates, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On an unknown date, after starting treatment with AFLURIA the patient experienced patient given expired AFLURIA vaccine, medication error. For relevant test results see appropriate report section.
Sex: U
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This spontaneous case was initially received on 07-Oct-2015. The case report was received from a Health Professional  and concerns a patient with unknown age and gender. Weight: not provided, height: not provided. For concomitant medication and therapy refer to the appropriate report sections. The patient received AFLURIA. No additional drugs suspected. On an unknown date, after starting treatment with AFLURIA the patient experienced urticarial. For relevant tests results see appropriate report section.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was initially received on 08-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates 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 provided. 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 administration of expired vaccine (non serious, outcome: unknown). Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous consumer report (initial receipt 08-Oct-2015) concerns a patient (unknown demographics). On 17-Sep-2015, the patient received AFLURIA (batch number U59508) 0.5mL once via the intramuscular route. AFLURIA was stored correctly and indication for use was approved as per the Product Information leaflet. On 21-Sep-2015, the patient experienced shingles which persisted to date (at the time of reporting). Action taken with AFLURIA was discontinued. The outcome was not yet recovered. Reporter's comments: The reporter assessed the event as non-serious.
Sex: U
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: This spontaneous consumer report (initial receipt 08-Oct-2015) concerns a patient (unknown demographics). On 06-Oct-2015, the patient received AFLURIA (batch number U59508) 0.5mL once via the intramuscular route. AFLURIA was stored correctly and indication for use was approved as per the Product Information leaflet. On 08-Oct-2015, the patient experienced shingles which persisted to date (at the time of reporting). Action taken with AFLURIA was discontinued. The outcome was not yet recovered. Reporter's comments: The reporter assessed the event as non-serious.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was initially received on 08-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 06-Oct-2015, Batch no: T57505, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 06-Oct-2015, the patient inadvertently administered expired AFLURIA PFS. Reporter comments: The reporter stated that she heard no complaints from any of the 10 patients. She also confirmed that no patients were pregnant. For relevant test results see appropriate report section.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperaesthesia, Injection site erythema, Injection site haemorrhage, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous case was initially received on 09-Oct-2015. The case report was received from a Non Health Professional and concerns  61 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 via the Pharmajet Statis device o 07-Oct-2015 - unknown stop date, Batch no: not provided, Route of administration: intramuscular, Dose: no information provided.  No additional drugs suspected. On 07-Oct-2015, after starting treatment with AFLURIA the patient experienced bled a lot in context to injection site, a very large raised (red) area in context to injection site, a very large (raised) red area (that is sensitivity to touch)/redness in context to injection site, a very large (raised red) area that is sensitive to touch/slight sensitivity when touched in context to injection site. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was initially received on 09-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication protection against seasonal influenza virus on 08-Oct-2015- 08-Oct-2015, Batch no: T57505, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s); No additional drugs suspected. Reaction (s)/event (s) and outcome: On 08-Oct-2015, the patient experienced received an IM (intramuscular) dose of AFLURIA that had expired on 30-May-2015 (non serious, outcome: Unknown). Action taken: Discontinued. Event treatment: not provided. Rechallenge/Dechallenge information: not applicable. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was initially received on 09-Oct 2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. 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, Batch no: T57505, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 08-Oct-2015, the patient experienced received an IM (intramuscular) dose of AFLURIA that had expired on 30-May-2015. Action taken: Discontinued. Event treatment: not provided. For relevant test results see appropriate report section. Reporter's assessment/comment: The reporter reported the term 'medication error' and assessed the case as non-serious.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, Medication error
Clinical narrative: This spontaneous case was initially received on 09-Oct 2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. 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, Batch no: T57505, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 08-Oct-2015, the patient experienced received an IM (intramuscular) dose of AFLURIA that had expired on 30-May-2015. Action taken: Discontinued. Event treatment: not provided. For relevant test results see appropriate report section. Reporter's assessment/comment: The reporter reported the term 'medication error' and assessed the case as non-serious.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was initially received on 09-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication protection against seasonal influenza virus on 08-Oct-2015- 08-Oct-2015, Batch no: T57505, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/ event (s) and outcome: On 08-Oct-2015, the patient experienced received an IM (intramuscular) dose of AFLURIA that had expired on 30-May-2015 (non serious, outcome: Unknown). Action taken: Discontinued. Event treatment: not provided. Rechallenge/ Dechallenge information: not applicable. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was initially received on 09-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. 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 for indication protection against seasonal influenza virus on 08-Oct-2015- 08-Oct-2015, Batch no: T57505, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 08-Oct-2015, the patient experienced received an IM (intramuscular) dose of AFLURIA that had expired on 30-May-2015 (non serious, outcome: Unknown). Action taken: Discontinued. Event treatment: not provided. Rechallenge/ Dechallenge information: not applicable. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, Medication error
Clinical narrative: This spontaneous case was initially received on 09-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. 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 - 08-Oct-2015, Batch no: T57505, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 08-Oct-2015, the patient experienced received an IM (intramuscular) dose of AFLURIA that had expired on 30-May-2015. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment/comment: The reporter reported the term 'medication error' and assessed the case as non-serious.
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: This spontaneous case was initially received on 10-Nov-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication prevention of influenza on 09-Nov-2015- 09-Nov-2015, 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 09-Nov-2015, the patient experienced Did not get full dose because the needle came off the syringe/Partial administration of AFLURIA/Medication error (non serious, outcome: Unknown). The nurse confirmed the patient did not get the full dose. For relevant test results see appropriate report section.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was initially received on 09-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. 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, Batch no: T57505, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 08-Oct-2015, the patient experienced received an IM (intramuscular) dose of AFLURIA that had expired on 30-May-2015. Action taken: Discontinued. Event treatment: not provided. For relevant test results see appropriate report section. Reporter's assessment/comment: The reporter reported the term 'medication error' and assessed the case as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, Exposure during pregnancy, Medication error
Clinical narrative: This spontaneous case was initially received on 09-Oct-2015. The case report was received from a Health Professional and concerns a pregnant patient with unknown age and gender. 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 - 08-Oct-2015, Batch no:T57505, Route of administration: intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 08-Oct-2015, the patient experienced received an IM (intramuscular) dose of AFLURIA that had expired on 30-May-2015. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment/comment: The reporter reported the term 'medication error' and assessed the case as non-serious.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: This spontaneous case was initially received on 12-Oct 2015. The case report was received from a Health Professional and concerns a 17 year old female patient. The patient has a medical history of Anxiety. The patient is otherwise healthy with no chronic illnesses. The patient has received the flu vaccine in 2010 that covers swine flu. The reporter confirms the patient has always received intramuscular flu immunisations and has never had the intranasal one, FLUMIST. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 09-Oct-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On Oct-2015, after starting treatment with AFLURIA the patient experienced Swelling, Aches, Redness, Fever / Fever is 103.6/Temperature oral was 103.6 degrees Fahrenheit/Oral temperature 103 F. On 10-Oct-2015, after starting treatment with AFLURIA the patient experienced Dizziness, Felt tired, Headaches, Redness at the injection site / Injection site redness. On 11-Oct-2015, after starting treatment with AFLURIA the patient experienced Chills. The patient has received the flu shot before but it was the first time she has had this reaction. The reporter is unsure if the patient has had AFLURIA before. The patient has not received any other vaccinations in the last three months. Acetaminophen 1000 mg and ibuprofen. The patient's mother was able to get the fever down using cold cloths. On 11-Oct-2015, the patient was treated with ibuprofen 600 mg. The mother states she would be taking her daughter to the hospital now. Reporter's assessment: Not reported.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pain, Pyrexia, Swelling
Clinical narrative: This spontaneous case was initially received on 12-Oct 2015. The case report was received from a Health Professional and concerns a 17 year old female patient. The patient has a medical history of Anxiety. The patient is otherwise healthy with no chronic illnesses. The patient has received the flu vaccine in 2010 that covers swine flu. The reporter confirms the patient has always received intramuscular flu immunisations and has never had the intranasal one, FLUMIST. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 09-Oct-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On Oct-2015, after starting treatment with AFLURIA the patient experienced Swelling, Aches, Redness, Fever / Fever is 103.6/Temperature oral was 103.6 degrees Fahrenheit/Oral temperature 103 F. On 10-Oct-2015, after starting treatment with AFLURIA the patient experienced Dizziness, Felt tired, Headaches, Redness at the injection site / Injection site redness. On 11-Oct-2015, after starting treatment with AFLURIA the patient experienced Chills. The patient has received the flu shot before but it was the first time she has had this reaction. The reporter is unsure if the patient has had AFLURIA before. The patient has not received any other vaccinations in the last three months. Acetaminophen 1000 mg and ibuprofen. The patient's mother was able to get the fever down using cold cloths. On 11-Oct-2015, the patient was treated with ibuprofen 600 mg. The mother states she would be taking her daughter to the hospital now. Reporter's assessment: Not reported.
Sex: U
Vaccine: FLU3
Symptoms: Underdose
Clinical narrative: This spontaneous case was initially received on 05-Nov-2015. The case report was received from a consumer and concerns a patient with unknown age and gender. The patient received AFLURIA on an unknown date, Batch no: U55406, Route of administration: Intramuscular, Dose: less than 0.5 ml. No additional drugs suspected. On an unknown date, after starting treatment with AFLURIA the patient experienced Received less than 0.5 mL dose / Less than 0.5 mL once. Reporter's assessment: Non serious.
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal chest pain, Musculoskeletal stiffness, Swelling
Clinical narrative: This spontaneous case was initially received on 13-Oct-2015. The case report was received from a Non Health Professional and concerns a male 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 beginning stages of osteoarthritis. The patient has a medical history of Heavy metal (arsenic) poisoning years ago and Lost 23% lung capacity (reason unknown to his doctors). the patient was very careful what he consumed. He only ate natural foods with on preservatives and they are labeled non-GMO. He was not allowed to drink alcohol. When he consumed alcohol, he got rib cage pain. It had taken him a long time to recover from the heavy metal poisoning. At the time of reporting, he was on drugs to help his liver and oxygen at night. For concomitant medication and therapy dates. CREON (6 tablets a day orally depending on diet) for the liver, TMG; trimethylgycine) for the liver, milk thistle for the liver, acetylcysteine, unspecified oral inhaler, and unspecified nasal inhaler. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA at pharmacy for the prevention of influenza on 09-Oct-2015, Batch no; either U55106 or U58908, Route of administration: Intramuscular: Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 09-Oct-2015, after starting/ treatment with AFLURIA, the patient experienced pains under my rib cage/pain under right rib cage feels swollen to the touch/right rib cage pain (non serious, outcome: Not Recovered/Not Resolved). His neck also felt stiff (non serious, outcome: Not Recovered/Not Resolved). He compared his AFLURIA rib cage pain as similar to his alcohol pain. Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy to vaccine, Rash
Clinical narrative: This spontaneous case was initially received on 05-Nov-2015. The case report was received from a Health Professional and concerns a 38 years old female patient. The patient did not normally get her flu shots annually. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 04-Nov-2015 - 04-Nov-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On an unspecified date after vaccination, the patient complained of an allergic reaction to the vaccine. The reaction was from an egg allergy. The patient was having symptoms of rash. AFLURIA was the only injection that the patient received that day. The outcome was not reported. For relevant tests results see appropriate report section.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous medically confirmed report (initial receipt: 13-Oct-2015) concerns a 4.5 year old patient. On the 03-Oct-2015, the patient who was under five years of age received AFLURIA (batch number not reported) 0.5 mL annually via intramuscular route. The outcome was not reported. Follow-up (21-Oct-2015): It was reported that a 4.5 year old patient (weight: 34 lb, height: 3.35 inches), received AFLURIA (batch number: U56907). There was no adverse effect. Reporter's comments: The case was classified as off-label use.
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Feeling abnormal
Clinical narrative: This spontaneous case was initially received on 14-Oct-2015. The case report was received from a Non Health Professional and concerns a 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 12-Oct-2015 - 12-Oct-2015, Batch no: 11049211A (thiomersal containing), Route of administration; Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 12-Oct-2015, after starting treatment with AFLURIA the patient experienced administration of vaccine from multidose vial of 9 doses/able to got 9 doses out of instead of 10 (AFLURIA MDV). On 13-Oct-2015, after starting treatment with AFLURIA the patient experienced joints ached, and felt like a "Mac" truck hit her. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: Non-serious. The patient was not concerned as this was an expected side effect.
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Anxiety, Hyperhidrosis, Insomnia, Sleep disorder
Clinical narrative: This spontaneous case was initially received on 05-Nov-2015. The case report was received from a Non Health Professional and concerns a 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 08-Oct-2015, Batch no: 12149211A, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On an unknown date, 1 week 0 days after starting treatment with AFLURIA the patient experienced anxiety, sweaty palms of hand, sweaty feet, Insomnia/Has not been able to sleep for weeks, may be about to get about 2 hours of sleep at maximum. On an unknown date, after starting treatment with AFLURIA the patient experienced Affecting his daily life. He had been to the primary care doctor, a psychiatrist, emergency room and crisis center but nothing was working. Adverse reaction persisted to date (at the time of reporting). For relevant test results see appropriate report section. Please add other relevant tests results manually as appropriate. Reporter's assessment: non-serious.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Cold sweat, Dizziness, Eye swelling, Fatigue
Clinical narrative: This medically confirmed spontaneous report (initial receipt 23-Nov-2015) concerns a 34 year old male patient. His concomitant medication included lisinopril. The patient received seasonal influenza vaccine in the past and tolerated it well. The patient did not receive any other recent immunisations. On 10-Nov-2015 at 01:00 pm, the patient received intramuscular AFLURIA (batch number U55806). The patient received AFLURIA for the first time. On 10-Nov-2015, 3-4 hours after vaccination, the patient experienced tightening in the chest, wheezing, dry and scratchy throat, itchy swollen tongue/ gums, swelling around the eyes, increased heart rate, dizziness and was tired. The patient received diphenhydramine. 4-six hours later, the patient woke up with cold sweats and fever at 100-101 F. The patient did not take any antipyretic treatment. 12-16 hours after receiving vaccine, the patient felt better and at 24 hours he was back to normal. The outcome was reported as recovered on 11-Nov-2015.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Gingival swelling, Heart rate increased, Pyrexia, Swollen tongue, Throat irritation
Clinical narrative: This medically confirmed spontaneous report (initial receipt 23-Nov-2015) concerns a 34 year old male patient. His concomitant medication included lisinopril. The patient received seasonal influenza vaccine in the past and tolerated it well. The patient did not receive any other recent immunisations. On 10-Nov-2015 at 01:00 pm, the patient received intramuscular AFLURIA (batch number U55806). The patient received AFLURIA for the first time. On 10-Nov-2015, 3-4 hours after vaccination, the patient experienced tightening in the chest, wheezing, dry and scratchy throat, itchy swollen tongue/ gums, swelling around the eyes, increased heart rate, dizziness and was tired. The patient received diphenhydramine. 4-six hours later, the patient woke up with cold sweats and fever at 100-101 F. The patient did not take any antipyretic treatment. 12-16 hours after receiving vaccine, the patient felt better and at 24 hours he was back to normal. The outcome was reported as recovered on 11-Nov-2015.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Tongue pruritus, Wheezing
Clinical narrative: This medically confirmed spontaneous report (initial receipt 23-Nov-2015) concerns a 34 year old male patient. His concomitant medication included lisinopril. The patient received seasonal influenza vaccine in the past and tolerated it well. The patient did not receive any other recent immunisations. On 10-Nov-2015 at 01:00 pm, the patient received intramuscular AFLURIA (batch number U55806). The patient received AFLURIA for the first time. On 10-Nov-2015, 3-4 hours after vaccination, the patient experienced tightening in the chest, wheezing, dry and scratchy throat, itchy swollen tongue/ gums, swelling around the eyes, increased heart rate, dizziness and was tired. The patient received diphenhydramine. 4-six hours later, the patient woke up with cold sweats and fever at 100-101 F. The patient did not take any antipyretic treatment. 12-16 hours after receiving vaccine, the patient felt better and at 24 hours he was back to normal. The outcome was reported as recovered on 11-Nov-2015.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous case was initially received on 10-Nov-2015. The case report was received from a Health Professional and concerns a female, pregnant patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on unknown dates, Batch no: not provided, Route of administration: intranasal, Dose: 0.5 ml. No additional drugs suspected. On an unknown date, a pregnant patient was administered AFLURIA intranasally. The patient was not experiencing an adverse reaction due to receiving the vaccine intranasally. For relevant test results see appropriate report section.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This non-serious medically confirmed spontaneous report (initial receipt 08-Oct-2015) concerns a 62 year-old male patient who had tolerated AFLURIA in the past. On 08-Oct-2015, the patient received AFLURIA vaccine (batch number U59208) 0.5 mL via the intramuscular route in the left arm. The patient received excursioned AFLURIA, which was kept at 63 F sometime overnight, and reported that he seemed fine. Action taken was reported as 'maintained'. The outcome was unknown. Reporter's comments: The reporter assessed the case as non-serious, causality s unlikely in relation to AFLURIA and reported the term of 'Off-label use - not stored correctly for short period of time'.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Blepharospasm, Injection site mass, Injection site reaction, Muscle spasms
Clinical narrative: This spontaneous case was initially received on 09-Oct-2015. The case report was received from a Non Health Professional and concerns a 55 years old female patient. No changes in her routine. 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 the left arm for indication prevention of influenza on 07-Oct-2015- 07-Oct-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: 0.5 ml. She received AFLURIA through work. This was the first time being vaccination with CSL and did not know if she had received AFLURIA in the past. No other vaccinations were received on 07-Oct-2015. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On the evening of 07-Oct-2015, after starting/ treatment with AFLURIA, the patient experienced spasms at injection site arm/ The (spasms) "kept coming"/At the injection site of left arm, she can feel her "artery bounce up and down"/She can feel the spasm-it feels like pulse (non serious, outcome: Not Recovered/ Not Resolved). When she was working, she could sometimes see her bumps moving (injection site) (non serious, outcome: Not Recovered/ Not Resolved). They were mild and compared them to 'eye spasms'. Event treatment: She had not self-treated with spasms. For relevant test results see appropriate report section.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: This spontaneous case was initially received on 28-Oct-2015. The case report was received from a Health Professional and concerns a male patient. Weight: not provided, Height: not provided. The patient has a medical history of High blood pressure and Unspecified nasal problem. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received Influenza vaccine. PNEUMOVAX. On an unknown date, after starting treatment with Unspecified flu vaccine the patient experienced Unspecified swollen glands, Achiness all over his body, Fever. Paracetamol 500 mg every six hours for the fever. For relevant test results see appropriate report section.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Feeling abnormal, Hyperaesthesia, Injection site reaction
Clinical narrative: This spontaneous case was initially received on 28-Oct-2015. The case report was received from a Non Health Professional and concerns a 71 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 22-Oct-2015 - 22-Oct-2015, Batch no: U50809, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 22-Oct-2015, 1 day after starting treatment with AFLURIA the patient experienced Extremely tired/fatigue/Extreme tiredness, Have not been feeling good/feeling bad, Chills, Injection site was sensitive/injection site sensitive. Discontinued. For relevant test results see appropriate report section. Reporter's assessment: The reporter was not sure if these events were caused by AFLURIA.
Sex: U
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site pain
Clinical narrative: This spontaneous case was initially received on 09-Oct-2015. The case report was received from a Non Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA via Pharmajet-Stratis on 07-Oct-2015, Batch no: not provided, Route of administration: not provided, Dose: needle free flu shot. No additional drugs suspected. On Oct-2015, after starting treatment with AFLURIA the patient experienced The bandage was very bloody when I took it off, so much that it stuck to my skin (injection site), Bruise/Bruising/still bruised in context of injection site, It is still very tender (injection site)/Tenderness (injection site). For relevant test results see appropriate report section.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Needle issue
Clinical narrative: This spontaneous case was initially received on 27-Oct-2015. The case report was received from a Health Professional and concerns a 25 years old female patient. Weight: not provided, Height: 64 inches. 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 prevention of influenza on 22-Oct-2015- unknown stop date, Batch no: 11749211A, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/ event (s) and outcome: On 22-Oct-2015, after starting/ treatment with AFLURIA the patient experienced partial dose of the AFLURIA vaccine/didn't get the full dose, part of it was running down her arm (non serious, outcome: Unknown), the needles were loose and needed to be tightened/needle loose on syringe (non serious, outcome: Unknown). Action taken: not applicable. For relevant test results see appropriate report section.