chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Arthralgia, Fatigue, Feeling cold, Musculoskeletal pain, Nausea
Clinical narrative: This case report was received from a Health Professional and concerns a 77 year old female patient. The patient has a medical history of Gallbladder disease. The patient had no illness at the tie of vaccination. The patient received AFLURIA (unknown dates, batch no. U46406, route of administration: Intramuscular, Dose: 0.5 ml). Patient also received PREVNAR13 (no other information provided). On 09-SEP-2015, 1 day after starting/treatment with AFLURIA the patient experienced felt cold (non serious, outcome: recovered/resolved), pain in shoulder (non serious, outcome: recovered/resolved); Pain in hp and knee joints and joints of hand/Arthralgia (non serious, outcome: recovered/resolved); Felt nauseous/Nausea (non serious, Outcome: recovered/resolved); Felt tired/Fatigue (non serious, Outcome: recovered/resolved). The health authority assessed the events as non-serious.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: This case report was received from a Health Professional and concerns a 77 year old female patient. The patient has a medical history of Gallbladder disease. The patient had no illness at the tie of vaccination. The patient received AFLURIA (unknown dates, batch no. U46406, route of administration: Intramuscular, Dose: 0.5 ml). Patient also received PREVNAR13 (no other information provided). On 09-SEP-2015, 1 day after starting/treatment with AFLURIA the patient experienced felt cold (non serious, outcome: recovered/resolved), pain in shoulder (non serious, outcome: recovered/resolved); Pain in hp and knee joints and joints of hand/Arthralgia (non serious, outcome: recovered/resolved); Felt nauseous/Nausea (non serious, Outcome: recovered/resolved); Felt tired/Fatigue (non serious, Outcome: recovered/resolved). The health authority assessed the events as non-serious.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Dry throat, Headache, Heart rate increased, Ocular hyperaemia
Clinical narrative: The case report was received from a(n) Health Professional and concerns a(n) female patient. Weight: not provided, Height: not provided. Linked case ID(s): US-BEH-2016058045 (same patient). St the time of the event the patient concomitantly suffered from allergies. Per concomitant medication and therapy dates refer to the appropriate report sections. Two years ago the patient received flu shot (unknown stop date, batch no: not provided). No additional drugs suspected. In 2014, after starting/treatment with flu shot the patient experienced Eyes bloodshot/Ocular hyperemia (non serious, outcome: unknown), Chills (non serious, outcome: unknown), Dry throat (non serious, outcome: unknown), Headache (non serious, outcome: unknown), Fast HB/Heart rate increased (non serious, outcome: unknown).
Age: 35.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Dry throat, Headache, Heart rate increased, Ocular hyperaemia
Clinical narrative: This health authority case was initially received on 26-Oct-2015. The case report was received from a (n) Health Professional and concerns a (n) 35 years old female patient. Weight: not provided, Height: not provided. Linked Case ID (s): US-BEH-2016058048 (Same patient). At the time of the event the patient concomitantly suffered from Allergies. For concomitant medication and therapy dates refer to the appropriate report sections. Two years ago, the patient had mild symptoms with the flu shot. The patient received AFLURIA on 09-Sep-2015 - unknown stop date, Batch no: not provided, Route of administration: Unknown, Dose: 0.5 ml. No additional drugs suspected. On 09-Sep-2015, 1 day after starting / treatment with AFLURIA the patient experienced Eyes bloodshot/Ocular hyperaemia (non serious, outcome: Recovered / Resolved), Chills (non serious, outcome: Recovered / Resolved), Dry throat (non serious, outcome: Recovered / Resolved), Headache (non serious, outcome: Recovered / Resolved). On 09-Sep-2015 14:00, after starting / treatment with AFLURIA the patient experienced Fast HR/Heart rate increased (non serious, outcome: Recovered / Resolved). For relevant test results see appropriate report section. Reporter's Assessment: The health authority assessed the events as non-serious. Seriousness criterion/criteria: Non serious. Listedness: According to the Reference Safety Information, the events Chills and Headache are listed events of AFLURIA, the events Eyes bloodshot/Ocular hyperaemia, Dry throat and Fast HR/Heart rate increased are unlisted events of AFLURIA. Case Causality: Possible.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: This case repot was received from a Health Professional and concerns a 55 year old male patient. The patient had no known allergy and no illness at the time of vaccination. The patient received AFLURIA on 11-SEP-2015 - (unknown stop date, batch number: U56206, route of administration: Intramuscular, dose: 0.5 ml) No additional drugs suspected. On 11-SEP-2015, 1 day after starting/treatment with AFLURIA the patient experienced feeling dizzy/dizziness (non serious, outcome: unknown).  VAERS ID: 594885. The health authority assessed the event as non-serious and the outcome of the events was reported as missing.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchospasm
Clinical narrative: The case report was received from a Health Professional and concerns a 59 year old female patient. Weight: not provided Height: not provided. The patient has a medical history of Hypertension; Hyperlipidemia and Hyperthyroidism. For concomitant medication and therapy dates refer to the appropriate report section. Reporting history also incudes the use of an SSRI but the patient is uncertain of exact prescriber diagnosis. The patient received AFLURIA on 10-SEP-2015 (unknown stop date, batch no: U55806, route of administration: Intramuscular, Dose: Right arm (RA). No additional drugs suspected. On 10-SEP-2015, 1 day after starting/treatment with AFLURIA the patient experienced Bronchospasms (non serious, outcome: not recovered/not resolved). Blood pressure may have been elevated (non serious, outcome: not recovered/not resolved). Patient stated she felt better especially  after breathing treatment administered at doctors visit but is not 100% better.
Age: 23.0
Sex: F
Vaccine: ANTH, FLU3
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: The case report was received from a(n) Health Professional and concerns a(n) 23 years old female patient. Weight: not provided Height: not provided. The patient received AFLURIA on 29-SEP-2015 (unknown stop date, batch no. U56106, route of administration: Intramuscular, dose: 0.5 ml.). Patient also received BIOTHRAX (route, site and batch no: not provided). On 11-SEP-2015, 3 days after starting/treatment with AFLURIA the patient experienced swelling (non serious, outcome: unknown), skin is hot to touch/skin warm (non serious, outcome: unknown), painful/pain (non serious, outcome: unknown). The swelling was spreading as the day progressed. The health authority assessed the events as non-serious and reported the outcome for the events as missing.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Feeling hot, Hyperhidrosis, Nausea, Pallor, Respiratory rate increased
Clinical narrative: This case report was received from a(n) Health Professional and concerns a(n) 59 years old female patient. Weight: not provided, Height: not provided. The patient's concurrent illness included "three months post shingles" and was otherwise feeling fine. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 12-SEP-2015 (unknown stop date, batch no: U57907, route of administration: Intramuscular, Dose: 0.5 ml). The patient also received PNEUMOVAX and ZOSTAVAX (not other information provided). On 12-SEP-2015, after starting/treatment with AFLURIA the patient experienced felt hot (non serious, Outcome: Recovered/Resolved), Got sweaty/Hyperhidrosis (non serious, outcome: Recovered/Resolved), breathing rapidly/Respiratory rate increased (non serious, outcome: Recovered/Resolved), Got very pale/Pallor (non serious, outcome: Recovered/Resolved, Felt like she would throw up/Nausea (non serious, outcome: Recovered/Resolved). The patient was given an ice pack and monitored. She sat until 4 PM (25-30 minutes). She left feeling relatively well. For relevant test results see appropriate report section.
Age: 60.0
Sex: F
Vaccine: FLUX, TD, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This health authority case was initially received on 26-Oct-2015. The case report was received from a Health Professional and concerns a 60 year old female patient. Suspect drug (s), timing and conditions surrounding the onset of reaction (s) / event (s): The patient received AFLURIA on 12-Sep-2015 - unknown stop date, Batch no: U57907, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): Tetanus Toxoid, Indication: not provided and ZOSTAVAX. Reaction (s) / event (s) and outcome: On 12-Sep-2015, 1 day after starting / treatment with AFLURIA the patient experienced Injection site swelling, (non serious, outcome: Not Recovered / Not Resolved), Injection site redness, (non serious, outcome: Not Recovered / Not Resolved), Injection site soreness / Ongoing pain (non serious, outcome: Not Recovered / Not Resolved). Event treatment: 2 ADVIL. Reporter's assessment: Non-serious. VAERS ID: 594935.
Age: 63.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Contusion, Pain, Swelling
Clinical narrative: This health authority case was initially received on 26-Oct-2015. The case report was received from a Health Professional and concerns a 63 year old male patient. The patient has a medical history of Surgery on rotator cuffs and Pain in shoulder area at tops of arms that was more severe in one arm than the other. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 08-Sep-2015, Batch no: U56206, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): PREVNAR 13, Indication: not provided. On 11-Sep-2015, 4 days after starting / treatment with AFLURIA the patient experienced Pain (non serious, outcome: Unknown), Swelling (non serious, outcome: Unknown), Bruising / Contusion (non serious, outcome: Unknown). Event treatment: Prednisone, diphenhydramine. Reporter's assessment: Non-serious. VAERS ID: 594944.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site swelling, Skin warm
Clinical narrative: This health authority case was initially received on 23-SEP-2015. The case report was received from a Health Professional and concerns a 56 year old female patient. The patient has a medical history of no allergies related to immunization. The patient had no illness at the tie of vaccination. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 14-SEP-2015 - unknown stop date, Batch no: U56807, Route of administration, Intramuscular, Dose: 0.5 ml: site: right arm (RA). Additional suspect drug(s): PNEUMOVAX, Indication: not provided; site: left arm (LA). Reaction(s)/event(s) and outcome: On 14-SEP-2015, 1 day after starting / treatment with AFLURIA the patient experienced Face (turned red and) hot as well (non serious, outcome: Recovered / Resolved), Face turned red (and hot as well) (non serious, outcome: Recovered / Resolved), Injection site swelled within hours of administration (non serious, outcome: Recovered / Resolved). VAERS ID: 595333 Reporter's assessment: Non-serious.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pain in extremity, Swelling face, Throat tightness
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 50 year old female patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 14-SEP-2015 - unknown stop date, Batch no: 11049211A, Route of administration: Intramuscular, Site: left arm (LA). Additional suspect drug(s): No additional drugs suspected. Reaction (s)/event(s) and outcome: On 14-SEP-2015, after starting / treatment with AFLURIA the patient experienced allergic reaction (non serious, outcome: Recovered / Resolved), allergic reaction to the flu shot (non serious, outcome: Recovered / Resolved). Her arm started hurting an  hour after the vaccine (non serious, outcome: Recovered / Resolved). About 2  hours later, her face started to swell (non serious, outcome: Recovered / Resolved) and her throat was closing (non serious, outcome: Recovered / Resolved). Event treatment: OTC pain medication, diphenhydramine. Most of the swelling had subsided.  VAERS ID: 595497. Reporter's assessment: Non-serious. The health authority added preferred term "allergic reaction".
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Myalgia, 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 24 year old female patient. The patient has a medical history of Microscopic lymphocytic colitis and Celiac disease. The patient received AFLURIA on 14-Sep-2015 - unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: Site: right arm (RA). No additional drugs suspected. On 15-Sep-2015, 2 days after starting treatment with AFLURIA the patient experienced Fatigue, Headache, Fever, Muscles aches. Reporter's assessment: Non-serious. VAERS ID: 595514.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site swelling, Malaise, Nausea
Clinical narrative: This health authority case was initially received on 23-Sep-2015. The case report was received from a Health Professional and concerns a 64 year old female patient. For concomitant medication and therapy dates refer to the appropriate report sections. The patient had no known medical history or illness at the time of vaccination. The patient received AFLURIA on 14-Sep-2015 - unknown stop date, Batch no: U56807, Route of administration: Intramuscular, Dose: 0.5 ml; site: right arm (RA). Additional suspect drug: ZOSTAVAX, Indication: not provided. Left arm (LA). On 16-Sep-2015, 3 days after starting/treatment with AFLURIA the patient experienced Generally not feeling well, Swelling around injection site, Nausea. Reporter's assessment: Non-serious. VAERS ID: 595805.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Fear of injection, 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 43 year old male patient. The patient received AFLURIA on 11-Sep-2015 -  unknown stop date, Batch no: U56406, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 11-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced Syncope. Dx at hospital was fear of needles; no meds needed. Reporter's assessment: Non-serious. VAERS ID: 595928.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Tremor
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 75 year old female patient. The patient has a medical history of ECT. For concomitant medication and therapy dates refers to the appropriate report sections. The patient had no current illness at the time of vaccination. 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 (LA). No additional drugs suspected. On 16-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced Tremor, Weakness of extremities. Reporter's assessment: Non-serious. VAERS ID: 596090.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, 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 30 year old female patient. The patient has no medical history and no current illness at the time of vaccination. The patient received AFLURIA on -02-Sep-2015 - unknown stop date, Batch no: U55006, Route of administration: intramuscular, Dose: 0.5 ml. No additional drugs suspected. On an unknown date, after starting treatment with AFLURIA the patient experienced shoulder is in excruciating pain when I lift it above my head reach in pocket. Patient believes the pharmacist administered the injection too high in the deltoid. Reporter's assessment: Non-serious. VAERS ID: 596110. Case correction (11-Mar-2016): AE 1 split into 2 AEs, new AE added (excruciating pain when I left it above my head reach in back pocket).
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site induration, 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 45 year old female patient. The patient has a medical history of allergy to cefaclor and sulfa drugs. The patient had no current illness at the time of vaccination. The following drug history information was reported: Cefaclor (Indication: -, Reaction: Anaphylaxis) and sulfa drugs (Indication: -, Reaction: Serum sickness). The patient received AFLURIA on 14-Sep-2015 - unknown stop date, Batch no: U56206, Route of administration: Intramuscular, Dose: 0.5 ml; site; left arm (LA). No additional drugs suspected. On 14-Sep-2015, 1 day after starting/treatment with AFLURIA the patient experienced Arthralgias, Fever, Chills, Localized injection site redness [, swelling and induration], Localized injection site [redness,] swelling [and induration], Localized injection site [redness, swelling and] induration, Myalgia. Reporter's assessment: Non-serious. VAERS ID: 596111.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, 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 45 year old female patient. The patient has a medical history of allergy to cefaclor and sulfa drugs. The patient had no current illness at the time of vaccination. The following drug history information was reported: Cefaclor (Indication: -, Reaction: Anaphylaxis) and sulfa drugs (Indication: -, Reaction: Serum sickness). The patient received AFLURIA on 14-Sep-2015 - unknown stop date, Batch no: U56206, Route of administration: Intramuscular, Dose: 0.5 ml; site; left arm (LA). No additional drugs suspected. On 14-Sep-2015, 1 day after starting/treatment with AFLURIA the patient experienced Arthralgias, Fever, Chills, Localized injection site redness [, swelling and induration], Localized injection site [redness,] swelling [and induration], Localized injection site [redness, swelling and] induration, Myalgia. Reporter's assessment: Non-serious. VAERS ID: 596111.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia
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 year old female patient. The patient had no illness at the time of vaccination and had no known drug allergies or medical conditions. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 14-Sep-2015 - unknown stop date, Batch no: U56406, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 14-Sep-2015, 1 day after starting / treatment with AFLURIA the patient experienced started to feel very week (non serious, outcome: Unknown). For relevant test results see appropriate report section. Reporter's assessment: The reporter considered events non serious. According to the Reference Safety Information, the event started to feel very weak is a unlisted event of AFLURIA. Case Causality: Possible.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Diarrhoea, Headache, Nausea, Pain, Pain in extremity
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) 52 years old female patient. The patient had no illness at the time of administration and a medical history of asthma. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 18-Sep-2015 - unknown stop date, Batch no: U56406, Route of administration: Intramuscular, Dose: 0.5 ml. On the same day, the patient received PNEUMOVAX. Both vaccines were given in the right arm (medication error not explicitly reported). On 19-Sep-2015, 2 days after starting / treatment with AFLURIA the patient experienced Very sore arm (non serious, outcome: Not Recovered / Not Resolved), (Very sore arm) painful to move (non serious, outcome: not Recovered / Not Resolved), Nausea (non serious, outcome: Not Recovered / Not resolved), Diarrhea (non serious, outcome: Not Recovered / Not Resolved), Headache (non serious, outcome: Not Recovered / Not Resolved). For relevant test results see appropriate report section. Seriousness criterion/criteria: Non-serious.  Listedness: According to the Reference Safety Information, the events Nausea and headache are listed events of AFLURIA, the events Very sore arm, (Very sore arm) painful to move and Diarrhea are unlisted events of AFLURIA. Case Causality: Possible. VAERS ID: 596240.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Headache, Nausea, Pain, Pain in extremity
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) 52 years old female patient. The patient had no illness at the time of administration and a medical history of asthma. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 18-Sep-2015 - unknown stop date, Batch no: U56406, Route of administration: Intramuscular, Dose: 0.5 ml. On the same day, the patient received PNEUMOVAX. Both vaccines were given in the right arm (medication error not explicitly reported). On 19-Sep-2015, 2 days after starting / treatment with AFLURIA the patient experienced Very sore arm (non serious, outcome: Not Recovered / Not Resolved), (Very sore arm) painful to move (non serious, outcome: not Recovered / Not Resolved), Nausea (non serious, outcome: Not Recovered / Not resolved), Diarrhea (non serious, outcome: Not Recovered / Not Resolved), Headache (non serious, outcome: Not Recovered / Not Resolved). For relevant test results see appropriate report section. Seriousness criterion/criteria: Non-serious.  Listedness: According to the Reference Safety Information, the events Nausea and headache are listed events of AFLURIA, the events Very sore arm, (Very sore arm) painful to move and Diarrhea are unlisted events of AFLURIA. Case Causality: Possible. VAERS ID: 596240.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Erythema, Fatigue, Peripheral swelling
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) 52 years old female patient. The patient had no illness at the time of administration and a medical history of asthma. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 18-Sep-2015 - unknown stop date, Batch no: U56406, Route of administration: Intramuscular, Dose: 0.5 ml. On the same day, the patient received PNEUMOVAX. Both vaccines were given in the right arm (medication error not explicitly reported). On 19-Sep-2015, 2 days after starting / treatment with AFLURIA the patient experienced Very sore arm (non serious, outcome: Not Recovered / Not Resolved), (Very sore arm) painful to move (non serious, outcome: not Recovered / Not Resolved), Nausea (non serious, outcome: Not Recovered / Not resolved), Diarrhea (non serious, outcome: Not Recovered / Not Resolved), Headache (non serious, outcome: Not Recovered / Not Resolved). For relevant test results see appropriate report section. Seriousness criterion/criteria: Non-serious.  Listedness: According to the Reference Safety Information, the events Nausea and headache are listed events of AFLURIA, the events Very sore arm, (Very sore arm) painful to move and Diarrhea are unlisted events of AFLURIA. Case Causality: Possible. VAERS ID: 596240.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Diarrhoea, Headache, Nausea, 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 52 years old male patient. Weight: not provided, Height: not provided. The patient has a medical history of Heart attack. The patient had no current illness. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 18-Sep-2015 - unknown stop date, Batch no: U56406, Route of administration: Intramuscular, Dose: 0.5 ml. On the same day the patient received PNEUMOVAX, Both vaccine were given in the right arm (medication error not explicitly reported). On 19-Sep-2015, 2 days after starting/treatment with ALFURIA the patient experienced Very sore arm, painful to move, Nausea, Headache. For relevant test results see appropriate report section. Reporter's assessment: The reporter considered events non serious. VAERS ID: 596243.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Headache, Nausea, 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 52 years old male patient. Weight: not provided, Height: not provided. The patient has a medical history of Heart attack. The patient had no current illness. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 18-Sep-2015 - unknown stop date, Batch no: U56406, Route of administration: Intramuscular, Dose: 0.5 ml. On the same day the patient received PNEUMOVAX, Both vaccine were given in the right arm (medication error not explicitly reported). On 19-Sep-2015, 2 days after starting/treatment with ALFURIA the patient experienced Very sore arm, painful to move, Nausea, Headache. For relevant test results see appropriate report section. Reporter's assessment: The reporter considered events non serious. VAERS ID: 596243.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3
Symptoms: Erythema, Fatigue, 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 52 years old male patient. Weight: not provided, Height: not provided. The patient has a medical history of Heart attack. The patient had no current illness. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 18-Sep-2015 - unknown stop date, Batch no: U56406, Route of administration: Intramuscular, Dose: 0.5 ml. On the same day the patient received PNEUMOVAX, Both vaccine were given in the right arm (medication error not explicitly reported). On 19-Sep-2015, 2 days after starting/treatment with ALFURIA the patient experienced Very sore arm, painful to move, Nausea, Headache. For relevant test results see appropriate report section. Reporter's assessment: The reporter considered events non serious. VAERS ID: 596243.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Paraesthesia, Paraesthesia oral, Urticaria
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) 21 years old female patient. For concomitant medication and therapy dates refers to the appropriate report sections. Suspect drug (s), timing and condition surrounding the onset of reaction (s) / event (s): The patient received AFLURIA on 20-Sep-2015 - unknown stop date, Batch no: U54906, Route of administration: not provided, Dose: 0.5 ml, Site: left arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s) /event(s) and outcome: On 20-Sep-2015, 1 day after starting / treatment with AFLURIA the patient experienced Tingling of face and tongue (non serious, outcome: Recovered / Resolved), Itching at site of injection [that spread to the other arm] / Injection site pruritus (non serious, outcome: Recovered / Resolved), Itching [at site of injection] that spread to the other arm / Pruritus (non serious, outcome: Recovered / Resolved), Broke out in hives on arms, chest and back / Urticaria (non serious, outcome: Recovered / Resolved). Event treatment: Patient took 50 mg diphenhydramine. Medical provider administered epinephrine and SOLU-MEDROL. Reporter's assessment: Non-serious. VAERS ID: 596339.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Eye pain, Eye pruritus, Headache, Ocular hyperaemia
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) 38 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 reported on 21-Sep-2015 - unknown stop date, Batch no: U55906, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 21-Sep-2015, 1 day after starting / treatment with AFLURIA the patient experienced Hoarse throat (non serious, outcome: Recovered / Resolved), Sore eyes (non serious, outcome: Recovered / Resolved), Red eyes (non serious, outcome: Recovered / Resolved), Itchy eyes (non serious, outcome: Recovered / Resolved), Headache (non serious, outcome: Recovered / Resolved), Body aches (non serious, outcome: Recovered / Resolved). For relevant test results see appropriate report section. Reporter's assessment: The reporter considered the events non serious. Seriousness criterion/criteria: Non serious. Listedness: According to the Reference Safety Information, the event Headache is a listed event of AFLURIA, the events Hoarse throat, Sore eyes, Red eyes, Itchy eyes and Body aches are unlisted events of AFLURIA. Case Causality: not provided. VAERS ID: 596611.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: 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) 38 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 reported on 21-Sep-2015 - unknown stop date, Batch no: U55906, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 21-Sep-2015, 1 day after starting / treatment with AFLURIA the patient experienced Hoarse throat (non serious, outcome: Recovered / Resolved), Sore eyes (non serious, outcome: Recovered / Resolved), Red eyes (non serious, outcome: Recovered / Resolved), Itchy eyes (non serious, outcome: Recovered / Resolved), Headache (non serious, outcome: Recovered / Resolved), Body aches (non serious, outcome: Recovered / Resolved). For relevant test results see appropriate report section. Reporter's assessment: The reporter considered the events non serious. Seriousness criterion/criteria: Non serious. Listedness: According to the Reference Safety Information, the event Headache is a listed event of AFLURIA, the events Hoarse throat, Sore eyes, Red eyes, Itchy eyes and Body aches are unlisted events of AFLURIA. Case Causality: not provided. VAERS ID: 596611.
Age: 58.0
Sex: M
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 58 year old male patient. The patient 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 for indication not reported on 21-Sep-2015 - unknown stop date, Batch no: U58808, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm (LA). Additional suspect drug (s): No additional drugs suspected. Reaction (s) / event (s) and outcome: On 21-Sep-2015 06:45, 1 hour after starting / treatment with AFLURIA the patient experienced Hive noted on left side of face (non serious, outcome: Recovered / Resolved). Event treatment: Diphenhydramine 25 mg orally given with effect. Examined in ED (emergency department), cortisone given returned to work. VAERS ID: 596645. Reporter's assessment: Non-serious. Company's evaluation and comment: Seriousness criterion/criteria: Non-serious (emergency visit). Listedness: According to the Reference Safety Information, the event Hive noted on left side of face is a listed event of AFLURIA. Case Causality: Possible. VAERS ID: 596645.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: 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 35 year old female patient. The patient received AFLURIA on 17-Sep-2015 - unknown stop date, Batch no: U54606, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Unknown. No additional drugs suspected. On 17-Sep-2015, 1 day after starting / treatment with AFLURIA the patient experienced swelling at injection site (non serious, outcome: Unknown). VAERS ID: 596651. Reporter's assessment: Non-serious. Company's evaluation and comment: Seriousness criterion/criteria: Non-serious. Listedness: According to the Reference Safety Information, the event swelling at injection site is a listed event of AFLURIA. Case Causality: Possible.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, 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 35 year old female patient. The patient received AFLURIA on 17-Sep-2015 - unknown stop date, Batch no: U54606, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Unknown. No additional drugs suspected. On 17-Sep-2015, 1 day after starting / treatment with AFLURIA the patient experienced swelling at injection site (non serious, outcome: Unknown). VAERS ID: 596651. Reporter's assessment: Non-serious. Company's evaluation and comment: Seriousness criterion/criteria: Non-serious. Listedness: According to the Reference Safety Information, the event swelling at injection site is a listed event of AFLURIA. Case Causality: Possible.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from Health Professional and concerns a 45 year old female patient. The patient has no medical history and had no illness at the time of vaccination. The patient received AFLURIA on 22-Sep-2015 - unknown stop date, Batch no: U56907, Route of administration: Intramuscular, Dose: 0.5 ml, Site: right arm (RA). Additional suspect drug (s): PNEUMOVAX, Site: right arm (RA). Both vaccines were administered in the same arm (medication error not explicitly reported). On 23-Sep-2015, 2 days after starting / treatment with AFLURIA the patient experienced Local swelling [and redness] gradually becoming larger (non serious, outcome: Not Recovered / Not Resolved), Local [swelling and] redness gradually becoming larger (non serious, outcome: Not Recovered / Not Resolved). VAERS ID: 597014. Reporter's assessment: Non-serious. Seriousness criterion/criteria: Non-serious. Listedness: According to the Reference Safety Information, the events Local swelling [and redness] gradually becoming larger and Local [swelling and] redness gradually becoming larger and unlisted events of AFLURIA. Case Causality: Possible. Case correction (23-Feb-2016): Listedness for AE 1 and 2 changed to listed. Listedness: Listed.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Lacrimation increased, Oropharyngeal pain, Paranasal sinus hypersecretion, Rhinorrhoea
Clinical narrative: This health authority case was initially received on 23-Nov-2015. This case report was received from a Health Professional and concerns a 46 year old male patient. The patient had no current illness, no concomitant medication and no medical history at the time of vaccination. The patient received AFLURIA on 24-Sep-2015 - unknown stop date, Batch no: reported as 'NDC49281-374-15', Route of administration: Intramuscular, Dose: no information provided. No additional suspect drugs. On 25-Sep-2015, 2 days after starting treatment with AFLURIA the patient experienced Cough, Sinus drainage / Paranasal sinus hypersecretion, Wet eyes / Lacrimation increased, Probable inflamed trachea/airway / Tracheal inflammation, Nose dripping / Rhinorrhea, Sore throat / Oropharyngeal pain. No medical advice was sought. Reporter's assessment: Non-serious. VAERS ID: 597505.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Tracheal inflammation
Clinical narrative: This health authority case was initially received on 23-Nov-2015. This case report was received from a Health Professional and concerns a 46 year old male patient. The patient had no current illness, no concomitant medication and no medical history at the time of vaccination. The patient received AFLURIA on 24-Sep-2015 - unknown stop date, Batch no: reported as 'NDC49281-374-15', Route of administration: Intramuscular, Dose: no information provided. No additional suspect drugs. On 25-Sep-2015, 2 days after starting treatment with AFLURIA the patient experienced Cough, Sinus drainage / Paranasal sinus hypersecretion, Wet eyes / Lacrimation increased, Probable inflamed trachea/airway / Tracheal inflammation, Nose dripping / Rhinorrhea, Sore throat / Oropharyngeal pain. No medical advice was sought. Reporter's assessment: Non-serious. VAERS ID: 597505.
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Pharyngeal oedema, Urticaria
Clinical narrative: This case report was received from a Health Professional and concerns an adult male patient. On an unknown date, the patient received influenza seasonal (no brand name, batch no: not provided, route of administration: not provided, Dose: no information provided). No additional drugs suspected. On an unknown date in 2014, after starting/treatment with influenza (seasonal): (no brand name) the patient experienced swollen throat (non serious, outcome:  unknown) and Hives (non serious, outcome: unknown, Duration: 10 days). Patient was give high dose of prednisone about three weeks after the flu shot. Reporter's assessment: Non-serious.
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Fatigue, Headache, Hypersomnia, Nausea, Pharyngeal oedema
Clinical narrative: This case report was received from a Health Professional and concerns an adult male patient. On an unknown date, the patient received influenza seasonal (no brand name, batch no: not provided, route of administration: not provided, Dose: no information provided). No additional drugs suspected. On an unknown date in 2014, after starting/treatment with influenza (seasonal): (no brand name) the patient experienced swollen throat (non serious, outcome:  unknown) and Hives (non serious, outcome: unknown, Duration: 10 days). Patient was give high dose of prednisone about three weeks after the flu shot. Reporter's assessment: Non-serious.
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Throat irritation
Clinical narrative: This case report was received from a Health Professional and concerns an adult male patient. On an unknown date, the patient received influenza seasonal (no brand name, batch no: not provided, route of administration: not provided, Dose: no information provided). No additional drugs suspected. On an unknown date in 2014, after starting/treatment with influenza (seasonal): (no brand name) the patient experienced swollen throat (non serious, outcome:  unknown) and Hives (non serious, outcome: unknown, Duration: 10 days). Patient was give high dose of prednisone about three weeks after the flu shot. Reporter's assessment: Non-serious.
Age: 24.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Pharyngeal oedema, 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 24 year old male patient. In 2014, the patient experienced hives an a swollen throat following administration of an influenza vaccine (brand and batch unspecified). The patient has a history of sulfa drugs and penicillin. The patient had no current illness at the time of vaccination. The patient received AFLURIA on 08-SEP-2015 (unknown stop date, batch no: U54906, route of administration: Intramuscular, Dose: 0.5 ml). No additional drugs suspected. On 15-Sep-2015, 1 week 0 days after starting / treatment with AFLURIA the patient experienced severe fatigue (non serious, outcome: Unknown), sleeping 16 hours or more / I can barely stay awake (non serious, outcome: Unknown), terrible itch in my throat (non serious, outcome: Unknown), throat was swollen (non serious, outcome: Unknown), headache (non serious, outcome: Unknown), nausea (non serious, outcome: Unknown). Event treatment: Allergy medicine. Reporter's assessment: Non-serious.
Age: 24.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Fatigue, Headache, Hypersomnia, Nausea, Pharyngeal oedema
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 24 year old male patient. In 2014, the patient experienced hives an a swollen throat following administration of an influenza vaccine (brand and batch unspecified). The patient has a history of sulfa drugs and penicillin. The patient had no current illness at the time of vaccination. The patient received AFLURIA on 08-SEP-2015 (unknown stop date, batch no: U54906, route of administration: Intramuscular, Dose: 0.5 ml). No additional drugs suspected. On 15-Sep-2015, 1 week 0 days after starting / treatment with AFLURIA the patient experienced severe fatigue (non serious, outcome: Unknown), sleeping 16 hours or more / I can barely stay awake (non serious, outcome: Unknown), terrible itch in my throat (non serious, outcome: Unknown), throat was swollen (non serious, outcome: Unknown), headache (non serious, outcome: Unknown), nausea (non serious, outcome: Unknown). Event treatment: Allergy medicine. Reporter's assessment: Non-serious.
Age: 24.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Throat irritation
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 24 year old male patient. In 2014, the patient experienced hives an a swollen throat following administration of an influenza vaccine (brand and batch unspecified). The patient has a history of sulfa drugs and penicillin. The patient had no current illness at the time of vaccination. The patient received AFLURIA on 08-SEP-2015 (unknown stop date, batch no: U54906, route of administration: Intramuscular, Dose: 0.5 ml). No additional drugs suspected. On 15-Sep-2015, 1 week 0 days after starting / treatment with AFLURIA the patient experienced severe fatigue (non serious, outcome: Unknown), sleeping 16 hours or more / I can barely stay awake (non serious, outcome: Unknown), terrible itch in my throat (non serious, outcome: Unknown), throat was swollen (non serious, outcome: Unknown), headache (non serious, outcome: Unknown), nausea (non serious, outcome: Unknown). Event treatment: Allergy medicine. Reporter's assessment: Non-serious.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Chills, Head discomfort, Headache
Clinical narrative: This medically confirmed health authority report (initial receipt 23-NOv-2015) concerns a 26-year-old mal patient. His concomitant medication included oxaprozin. On 02-OCT-2015, the patient received intramuscular AFLURIA injection (Batch number not reported) in the left arm. On 02-OCT-2015, within one hour of vaccination, the patient developed headache and weakness, by midnight, he developed chills and shaking so bad that it felt like a seizure, pressure in head increased, nausea and vomiting and very achy joints. The patient was treated with acetaminophen. The outcome was reported as recovered.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Tremor, Vomiting
Clinical narrative: This medically confirmed health authority report (initial receipt 23-NOv-2015) concerns a 26-year-old mal patient. His concomitant medication included oxaprozin. On 02-OCT-2015, the patient received intramuscular AFLURIA injection (Batch number not reported) in the left arm. On 02-OCT-2015, within one hour of vaccination, the patient developed headache and weakness, by midnight, he developed chills and shaking so bad that it felt like a seizure, pressure in head increased, nausea and vomiting and very achy joints. The patient was treated with acetaminophen. The outcome was reported as recovered.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Dyspnoea, Electrocardiogram normal, Hypertension, Hypoaesthesia
Clinical narrative: This medically confirmed health authority report (initial receipt 23-NOV-2015) concerns a 38 year old female patient. The patient had medical history of penicillin allergy: "otherwise unknown". Her current illness was unknown. On 22-SEP-2015, the patient received intramuscular AFLURIA injection (batch number: U54806, in the left arm). On 22-SEP-2015, the patient experienced numbness of left arm and left side of face, shortness of breath, tachycardia and was hypertensive. The patient presented to the EC at 1300. The patient received treatment with acetylsalicylic acid, "NTG" and lorazepam. She underwent electrocardiogram, CT scan and laboratory tests to rule out myocardial infarction or cerebrovascular accident. No issues were noted with any tests. The patient was discharged from the EC at 1625. The outcome was reported as recovered.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test normal, Tachycardia
Clinical narrative: This medically confirmed health authority report (initial receipt 23-NOV-2015) concerns a 38 year old female patient. The patient had medical history of penicillin allergy: "otherwise unknown". Her current illness was unknown. On 22-SEP-2015, the patient received intramuscular AFLURIA injection (batch number: U54806, in the left arm). On 22-SEP-2015, the patient experienced numbness of left arm and left side of face, shortness of breath, tachycardia and was hypertensive. The patient presented to the EC at 1300. The patient received treatment with acetylsalicylic acid, "NTG" and lorazepam. She underwent electrocardiogram, CT scan and laboratory tests to rule out myocardial infarction or cerebrovascular accident. No issues were noted with any tests. The patient was discharged from the EC at 1625. The outcome was reported as recovered.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: The case report was received from a(n) Health Professional and concerns a patient of unknown age and gender. Weight: not provided. Height: Not provided. The patient received AFLURIA on 01-OCT-2105 (batch no: not provided, route of administration: not provided, Dose: 1 ml). No additional drugs suspected. On 01-OCT-2105, after starting/treatment with AFULURIA the patient received 1 ml dose of AFLURIA instead of 0.5 ml/Overdose (non serious, outcome: unknown). On an unknown date, after starting/treatment with AFLURIA the patient experienced error (non serious, outcome: unknown). The reporter stated that all the patients seemed fine, and confirmed that none of the patients were pregnant. The 1 ml dose was due to clinical error, which did not confirm the dosage.