chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Incorrect route of drug administration, Lumbar puncture, Seizure
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 28 May 2015. A 16-year-old male patient, whose concomitant medications were not reported, had received a first dose of Yellow fever (batch number- UI092AA, expiry date: 07 August 2016, site of administration was not reported) intramuscularly and first dose of HEP A (Manufacturer: Other, Batch number- K004856, site of administration was not reported) intramuscularly on 12 May 2015. Illness at time of vaccination was reported as none. The patient did not have any known drug allergy. On 16 May 2015, four days after vaccination, the patient began having new onset seizures and had 4 seizures within 24 hour period. The patient was hospitalized due to the event and remained there for a number of days for testing and observation. Also it was a case of an inappropriate route of vaccination as patient received vaccine via intramuscular route. Laboratory investigation: spinal tap result was pending and corrective treatments were not reported. At the time of this report, the patient recovered from the event. Documents held by sender: none. Sender's Comments: Seizures are listed with YELLOW FEVER VACCINE. However, time to onset of 4 days seems to be long to be compatible with the role of the vaccine. However, investigation results including spinal tap results ruling out a concurrent infection and exploration of alternate etiologies as well as medical history of the patient would be helpful to further assess this case. It is to be noted that the patient received 2 vaccines concomitantly making it difficult to assess the role of one vaccine in particular.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
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 male patient. Weight: not provided, Height: not provided. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for unknown indication on 12-Dec-2014- unknown stop date, Batch no: T 50307, Route of administration: Unknown, Dose: Right arm (reported as RA). Additional suspect drug (s): PNEUMOVAX, Indication: not provided. Administered in left arm (reported as LA). Reaction (s)/ event (s) and outcome: On 14-Decc-2014, 3 days after starting/ treatment with AFLURIA the patient experienced [Urticaria] pruritus/Pruritus (non serious, outcome: Unknown), Urticaria/ Urticaria (non serious, outcome: Unknown).
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Fatigue, Feeling cold, Injection site pain, Injection site swelling, Myalgia
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 51 year old male patient. Weight: not provided, Height: not provided. Concomitant medications: Lisinopril, Digoxin, pantoprazole, tadalafil and "Dystolic". Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA for indication not reported on 04-AUG-2015 - unknown stop date. Batch no: U55106, Route of administration: Intramuscular, Dose: left arm (reported as LA). Additional suspect drug(s0: PNEUMOVAX, indication not provided. Reaction(s)/Event(s) and outcome: On 04-AUG-2015, 1 day after starting/treatment with AFLURIA the patient experienced Tired (achy leg muscles)/Fatigue (non serious, outcome: Recovered/Resolved, (Tired) achy leg muscles/Myalgia (non serious, outcome: Recovered/Resolved), Cold last night/Feeling cold (non serious, outcome: Recovered/Resolved), Shot site swollen (and painful to touch)/Injection site swelling (non serious, outcome: Recovered/Resolved). On 04-AUG-2015, after starting/treatment with AFLURIA the patient experienced (shot site swollen) and painful to touch/Injection site pain (non serious, outcome: Recovered/Resolved). Reporter's assessment: non serious.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Somnolence
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 24 year old female patient. Weight: not provided, Height: not provided. The patient has a medical history of latex allergy and cervical cancer. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 05-Aug-2015 - unknown stop date, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 05-Aug-2015, 2 hours after starting treatment with AFLURIA the patient experienced severe fatigue [and drowsiness], severe [fatigue and] drowsiness. Reporter's assessment: The Health Professional considered the event(s) severe fatigue [and drowsiness], severe [fatigue and] drowsiness as non-serious and related.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling
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 31 year old female patient. History reported as 'penicillin'. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 29-Jul-2015 - unknown stop date, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 29-Jul-2015, 1 day after starting treatment with AFLURIA the patient experienced swelling [and itching] at injection site, golf size ball / injection site swelling, itching at injection site / injection site pruritus. Reporter's assessment: The Health Professional considered the event swelling [and itching] at injection site, golf size ball / injection site swelling, itching at injection site / injection site pruritus as non-serious and related.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Malaise, Pain in extremity, Pyrexia
Clinical narrative: This health authority case was initially received on 23-Sep-2105. The case report was received from a(n) Health Professional and concerns a(n) 26 years old female patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 28-Jul-2015, Batch no: U55106, Route of administration: Unknown, Dose: Administered to left arm (reported as LA). No additional drugs suspected. On 28-Jul-2015, 1 day after starting treatment with AFLURIA the patient experienced fever, malaise entire body, redness, and sore arm for more than 24 hours post vaccination.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Condition aggravated, Dizziness, Flushing, Hypertension
Clinical narrative: This case report was received from a Health Professional and concerns a 48 year old female patient. Weight: not provided. Height: not provided. Concurrent medical condition(s), medical and drug history: The patient has a medical history of well controlled hypertension and a codeine allergy. For concomitant medications and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA for indication not reported on 15-AUG-2015 - unknown stop date, batch no: US6406 (although likely U56406), Route of administration: Intramuscularly Dose: 0.5 ml. Additional suspect drug(s):  No additional drugs suspected. Reaction(s)/event(s) and outcome: on 15-AUG-2015, 1 day after starting/treatment with AFLURIA the patient experienced dizziness (non serious, outcome: Recovered/Resolved), Mild chest tightness/Chest discomfort (non serious, outcome: Recovered/Resolved), Mild hypertension (167/94)/Hypertension (non serious, outcome: Recovered/Resolved). Flushing (non serious: outcome: Recovered/Resolved. Condition aggravated (non serious, outcome: Recovered/Resolved). These events persisted for almost 3 hours. Event treatment: Monitored BP levels, administered 12.5 mg liquid diphenhydramine for allergic prophylaxis pre-BP monitoring. Reporter's assessment: The Health Professional considered the event(s) Dizziness, mild check tightness/Chest discomfort, Mild hypertension (167/94)/Hypertension, Flushing, condition aggravated as non serious and related.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
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 27 year old female patient. The patient was not on any concomitant medications and had no current illness at the time of vaccination. The patient is reported to have no medical history and no lab data. The patient received AFLURIA on 17-Aug-2015, Batch no: U56406, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 17-Aug-2015, 1 day after starting treatment with AFLURIA the patient experienced generalized itching particularly both hands. Event treatment: loratadine, diphenhydramine. Reporter's assessment: Non-serious.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Nausea, Somnolence
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 62 year old female patient. Weight: not provided, Height: not provided. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 10-AUG-2015 - unknown stop date, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 10-AUG-2015, 1 day after starting/treatment with AFLURIA the patient experienced Extreme drowsiness/Somnolence (non serious, outcome: Recovered/Resolved), Dizziness (non serious, outcome: Recovered/Resolved), Shortness of breath/Dyspnoea Inon serious, outcome: Recovered/Resolved), Nausea (non serious, outcome: Recovered/Resolved). Normal pulse and observed breathing. Reporter's assessment: Non-serious.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia
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 33 year old female patient. The patient has a medical history of hiatal hernia, fibromyalgia, pseudotumor cerebri, 'BBP' and ketorolac (reported as 'Toradol'). The following drug history information was reported: TOPAMAX (Reaction: metallic taste in mouth). The patient was given AFLURIA on 19-Aug-2015, Batch no: U55506, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 19-Aug-2015, 15 mins after starting treatment with AFLURIA the patient experienced metallic taste in mouth. Patients claims to never had had this taste before other than when she began TOPAMAX in 2008. The tasted lasted a few months after topiramate. Reporter's assessment: Non-serious.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Bone pain, Cough, Lymphadenopathy, Pain in extremity
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 51 year old male patient. The patient received AFLURIA on 11-Aug-2015, Batch no: U55106, Route of administration: Unknown, Dose: 0.5 ml. No additional drugs suspected. On 13-Aug-2015, 2 days after starting treatment with AFLURIA the patient experienced swollen lymph nodes, bone aches, arm was sore, blistery (pimple like hives) on right underarm. Right chest feels fine now but still has hives. Reporter's assessment: Non-serious.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
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 51 year old male patient. The patient received AFLURIA on 11-Aug-2015, Batch no: U55106, Route of administration: Unknown, Dose: 0.5 ml. No additional drugs suspected. On 13-Aug-2015, 2 days after starting treatment with AFLURIA the patient experienced swollen lymph nodes, bone aches, arm was sore, blistery (pimple like hives) on right underarm. Right chest feels fine now but still has hives. Reporter's assessment: Non-serious.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Nervousness, Pain in extremity, Toothache
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 64 year old female patient. Weight: not provided, Height: not provided. The patient has a medical history of irritable bowel disease, periodontia disease, TMJ, dizziness, fibromyalgia, back problems, vein legs, herpes and rosaceas. Reported history also includes dicyclomine, codeine, penicillin, aspirin, pseudoephedrine/chlorpheniramine, meclizine. doxepin, minocycline, zolpidem, oxazepam, fluoxetine, ibuprofen, birth control pills, naproxen, fexofenadine, docosanol, olopatadine, Salicyclic acid, milk, witch hazel, vitamin supplement, fish oil, latex, smoke, coppertone, 'sulfa', 'Nizonal', 'Cloropatine' and "clonopate', Concomitant medications include probiotics. Refer to the appropriate report sections for additional concomitant medication and therapy dates. The patient received AFLURIA on 24-Jul-2015- unknown stop date, Batch no: U55106, Route of administration: Unknown, Dose: 0.5 ml. No additional drugs suspected. On 30-Jul-2015, 1 week 0 days after starting treatment with AFLURIA the patient experienced eyes blurry/vision blurred, (weak areas intensified/weak) dizzy/dizziness, nervous extremely/nervousness, more floaters/vitreous floaters, weak areas intensified/weak (dizzy)/asthenia, legs hurt/pain in extremity, teeth hurt-need crowns/toothache. Reporter's assessment: Non-serious.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred, Vitreous floaters
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 64 year old female patient. Weight: not provided, Height: not provided. The patient has a medical history of irritable bowel disease, periodontia disease, TMJ, dizziness, fibromyalgia, back problems, vein legs, herpes and rosaceas. Reported history also includes dicyclomine, codeine, penicillin, aspirin, pseudoephedrine/chlorpheniramine, meclizine. doxepin, minocycline, zolpidem, oxazepam, fluoxetine, ibuprofen, birth control pills, naproxen, fexofenadine, docosanol, olopatadine, Salicyclic acid, milk, witch hazel, vitamin supplement, fish oil, latex, smoke, coppertone, 'sulfa', 'Nizonal', 'Cloropatine' and "clonopate', Concomitant medications include probiotics. Refer to the appropriate report sections for additional concomitant medication and therapy dates. The patient received AFLURIA on 24-Jul-2015- unknown stop date, Batch no: U55106, Route of administration: Unknown, Dose: 0.5 ml. No additional drugs suspected. On 30-Jul-2015, 1 week 0 days after starting treatment with AFLURIA the patient experienced eyes blurry/vision blurred, (weak areas intensified/weak) dizzy/dizziness, nervous extremely/nervousness, more floaters/vitreous floaters, weak areas intensified/weak (dizzy)/asthenia, legs hurt/pain in extremity, teeth hurt-need crowns/toothache. Reporter's assessment: Non-serious.
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Pain, Pain in extremity
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 34 years old female patient. The patient had no medical history or current illness.  Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on unknown dates, Batch no: U56606, Route of administration: Intramuscular, Dose: 0.5 ml. BOOSTRIX (batch number: JSR2L), Indication: not provided. On 25-Aug-2015, 2 days after starting / treatment with AFLURIA the patient experienced Injection site nodule/Knot under skin at site of injection, Injection site erythema/Redness under skin at site of injection, Injection site swelling/Swelling under skin at site of injection, Pain in extremity/Arm is sore when moved, Slight fever/Pyrexia. The patient was counseled to use ibuprofen and apply ice pack. For relevant test results see appropriate report section.
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pyrexia
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 34 years old female patient. The patient had no medical history or current illness.  Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on unknown dates, Batch no: U56606, Route of administration: Intramuscular, Dose: 0.5 ml. BOOSTRIX (batch number: JSR2L), Indication: not provided. On 25-Aug-2015, 2 days after starting / treatment with AFLURIA the patient experienced Injection site nodule/Knot under skin at site of injection, Injection site erythema/Redness under skin at site of injection, Injection site swelling/Swelling under skin at site of injection, Pain in extremity/Arm is sore when moved, Slight fever/Pyrexia. The patient was counseled to use ibuprofen and apply ice pack. For relevant test results see appropriate report section.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Yellow skin
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 58 years old female patient. Weight: not provided, Height: not provided. The patient has a medical history of Diabetes. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 19-Aug-2015 - unknown stop date, Batch no: U55606, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 19-Aug-2015, 2 days after starting treatment with AFLURIA the patient experienced Bruise is fading from purple to yellowish/Contusion. For relevant test results see appropriate report section.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain
Clinical narrative: The health authority case was initially received on 26-Oct-2015. The case report was received from a Health Professional and concerns a 42 years old female patient. The patient had no current illness or medical history. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on28-Aug-2015 - unknown stop date, Batch no: U55806, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 31-Aug-2015, 4 days after starting treatment with AFLURIA the patient experienced Arthralgia/Pain in left shoulder joint, Injection site pain/Soreness at injection site. Laboratory data was not known. For relevant test results see appropriate report section.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Rash
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 50 years old male patient. Weight: not provided, Height: not provided. The patient has a medical history of HTN, Allergies to Anthrax vaccine, local itching, hay fever, allergy to cat hair, seasonal allergy, vasectomy, (R) knee meniscal repair and C5-C6 anterior cervical discectomy and fusion (in 2008) and removal of the C5-6 plate with C3-4, C4-5 anterior cervical discectomy and fusion with plate and independent C6-7 anterior cervical discectomy and fusion plate (Mar-2015). Anthrax (Indication: -; reaction: itching) and Anthrax (indication:- Reaction: redness). For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 31-Aug-2015 - unknown stop date, Batch no: U56206, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 31-Aug-2015, 1 day after starting treatment with AFLURIA the patient experienced erythema/5 {bumps} surrounded by redness on the (R) arm, Rash/5 bumps surrounded by [redness] on the (R) arm. The patient was monitored for 1 hour after the adverse reaction. He was administered liquid cetirizine (10 mg) and was treated and released. For relevant test results see appropriate report section.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site mass
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 48 years old female patient. The patient had no current illness or medical history. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 31-Aug-2015 - unknown stop date, Batch no: U56406, Route of administration: Intramuscular, Dose: 0.5 ml. PNEUMOVAX. On 01-Sep-2015, 2 days after receiving treatment with AFLURIA the patient experienced Erythema/ [Lump in the bicep and] redness radiating down injection arm, [Lump in the bicep and] redness radiating down injection arm. On 09-Sep-2015, 2 days after starting treatment with AFLURIA the patient experienced Injection site mass/Lump in the bicep and [redness] radiating down injection arm. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious. The authority reported symptom included 'erythema'.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Pain, Swelling, Tenderness
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) 25 years old female patient. The patient had no medical history or current illness. Weight: not provided, Height: not provided. The patient received AFLURIA on 09/01/2015, Batch no: U56106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 02-Sep-2015, 2 days after starting treatment with AFLURIA the patient experienced mild tenderness, redness, moderate pain without touching, swelling, size of induration at 7 cm by 5 cm. The patient had mild tenderness and redness for few hours following. Action taken: not reported. Event treatment: not reported.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood test normal, Decreased appetite, Feeling cold, Headache
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) 67 years old male patient. The patient had no current illness. Weight: not provided, Height: not provided. The patient received AFLURIA on 28-Aug-2015, Batch no: U54305, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 29-Aug-2015, 2 days after starting treatment with AFLURIA the patient experienced severe mental depression, headache, sweating, feeling cold, loss of appetite, weakness, shaky, and nightmare. The patient underwent blood test to check for infection and the results were normal. Action taken: not reported. Event treatment: not reported.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Intellectual disability, Nightmare, Tremor
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) 67 years old male patient. The patient had no current illness. Weight: not provided, Height: not provided. The patient received AFLURIA on 28-Aug-2015, Batch no: U54305, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 29-Aug-2015, 2 days after starting treatment with AFLURIA the patient experienced severe mental depression, headache, sweating, feeling cold, loss of appetite, weakness, shaky, and nightmare. The patient underwent blood test to check for infection and the results were normal. Action taken: not reported. Event treatment: not reported.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
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) 38 years old female patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 04-Sep-2015, Batch no: U56406, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 04-Sep-2015, 15 mins after starting treatment with AFLURIA the patient experienced itchiness at and around the site of injection.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: The case was received from a Health Professional and concerns a 73 years old female patient. Weight: not provided, Height: not provided. Concurrent medical condition (s), medical and drug history: At the time of the event the patient concomitantly suffered from sore throat. The patient has a medical history of heart disease, diabetes and anemia. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on 07-Sep-2015- unknown stop date, Batch no: U56606, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 07-Sep-2015, 1 day after starting/treatment with AFLURIA the patient experienced rash developed on lower back (non serious, outcome: Recovered/Resolved). For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Eye swelling, Headache, Injection site pain
Clinical narrative: This health authority case was initially received on 26-Oct02915. The case report was received from a Health Professional and concerns a 45 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 30-Aug-2015 - unknown stop date, Batch no: U54806, Route of administration: not provided, Dose: 0.5 ml. No additional drugs suspected. On 30-Aug-2015, 1 day after starting treatment with AFLURIA the patient experienced weakness/asthenia, pain and tenderness at injection site/injection site pain, severe headache by 13:00, body aches/pain/aches. On 30-Aug-2015, after starting treatment with AFLURIA the patient experienced 102 degree fever/pyrexia/100 degree temperature and bad sore throat/oropharyngeal pain at 18:00, cough. On 31-Aug-2015, after starting treatment with AFLURIA the patient experienced swollen eyes. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious. Case correction (23-Feb-2016): Core assessment for AE 5 changed to listed.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This health authority case was initially received on 26-Oct02915. The case report was received from a Health Professional and concerns a 45 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 30-Aug-2015 - unknown stop date, Batch no: U54806, Route of administration: not provided, Dose: 0.5 ml. No additional drugs suspected. On 30-Aug-2015, 1 day after starting treatment with AFLURIA the patient experienced weakness/asthenia, pain and tenderness at injection site/injection site pain, severe headache by 13:00, body aches/pain/aches. On 30-Aug-2015, after starting treatment with AFLURIA the patient experienced 102 degree fever/pyrexia/100 degree temperature and bad sore throat/oropharyngeal pain at 18:00, cough. On 31-Aug-2015, after starting treatment with AFLURIA the patient experienced swollen eyes. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious. Case correction (23-Feb-2016): Core assessment for AE 5 changed to listed.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Noninfective gingivitis, Oral mucosal erythema
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 female patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 17-Aug-2015, Batch no: U55906, Route of administration: Unknown, Dose: 0.5 ml. Additional suspect drug(s): ZOSTAVAX. On 19-Aug-2015, 2 days after starting treatment with AFLURIA the patient experienced swelling of the tongue, [Red] mouth that was raw, inflamed gums, red mouth [that was raw], injection site swelling, injection site erythema, and local site reaction. Reporter's assessment: Non-serious.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Stomatitis, Swollen tongue
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 female patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 17-Aug-2015, Batch no: U55906, Route of administration: Unknown, Dose: 0.5 ml. Additional suspect drug(s): ZOSTAVAX. On 19-Aug-2015, 2 days after starting treatment with AFLURIA the patient experienced swelling of the tongue, [Red] mouth that was raw, inflamed gums, red mouth [that was raw], injection site swelling, injection site erythema, and local site reaction. Reporter's assessment: Non-serious.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
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 67 year old female patient. Weight: not provided, Height: not provided. The patient has a medical history of Diabetes. The patient received AFLURIA on 05-Sep-2015, Batch no: U54606, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 06-Sep-2015, 2 days after starting treatment with AFLURIA the patient experienced started to shake violently, and fever. Reporter's assessment: Non-serious.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cold sweat, Confusional state, Discomfort, Dizziness
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 39 year 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 04-Sep 2015 - unknown stop date, Batch no: U55706, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 05-Sep-2015, 2 days after starting treatment with AFLURIA the patient experienced [Pressure that caused confusion, blurry vision] and dizziness, [Pressure that caused confusion,] blurry vision [and dizziness] / Vision blurred, Pressure [that caused confusion, blurry vision and dizziness] / Head discomfort, Intense migraine [/headache] pain, [Pressure that caused] confusion [, blurry vision and dizziness] / Confusional state, [103 degree fever, chills,] cold sweats throughout two nights, Intense [migraine/] headache pain, 103 degree fever [, chills, cold sweats throughout two nights] / Pyrexia, [103 degree fever,] chills, [cold sweats throughout two nights]. Reporter's assessment: Non-serious.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Head discomfort, Migraine, Pain, Pyrexia, Vision blurred
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 39 year 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 04-Sep 2015 - unknown stop date, Batch no: U55706, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 05-Sep-2015, 2 days after starting treatment with AFLURIA the patient experienced [Pressure that caused confusion, blurry vision] and dizziness, [Pressure that caused confusion,] blurry vision [and dizziness] / Vision blurred, Pressure [that caused confusion, blurry vision and dizziness] / Head discomfort, Intense migraine [/headache] pain, [Pressure that caused] confusion [, blurry vision and dizziness] / Confusional state, [103 degree fever, chills,] cold sweats throughout two nights, Intense [migraine/] headache pain, 103 degree fever [, chills, cold sweats throughout two nights] / Pyrexia, [103 degree fever,] chills, [cold sweats throughout two nights]. Reporter's assessment: Non-serious.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Extensive swelling of vaccinated limb, Mobility decreased, Myalgia
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 71 year old female patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 27-Aug-2015, Batch no: U56206, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm. On the same day the patient received PNEUMOVAX in the right arm. On 27-Aug-2015, 1 day after starting treatment with AFLURIA the patient experienced swelling between neck and elbow in right arm, limited mobility in right arm, muscle pain in right arm after receiving PNEUMOVAX 23, and injection site swelling. Reporter's assessment: Non-serious.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle tightness, Paraesthesia oral
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 28 year old female patient. Weight: not provided, Height: not provided. At the time of the event the patient concomitantly suffered from migraines and UTIs. The patient has a medical history of anal sphincterotomy, endoscopic transnasal brain surgery and thyroglossal duct cysts removed. Patient history was reported - 'Cobalt, fruit seeds, tree nuts, cinnamon, nickle, clindamycin, oxycodone/paracetamol, hydromorphone, morphine, meperidine'. The patient received AFLURIA on 11-Sep-2015, Batch no: 11249221A, 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 tightness in jaw, muscle tightness, tingling in tongue/Paraethesia oral. Event treatment: Self administered BENADRYL at 10:00 followed by personal Epipen at 10:10. The Health Professional considered the event(s) Tightness in jaw/muscle tightness, tingling in tongue/Paraethesia oral as non-serious and related.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site mass, 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 62 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refers to the appropriate report sections. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on 14-Sep-2015 - unknown stop date, Batch no: U56907, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/event (s) and outcome: On 14-Sep-2015, after starting/ treatment with AFLURIA the patient experienced firm bump the size of dime formed at the site of injection/Injection site swelling (non serious, outcome: Recovered/ Resolved), Immediate post-injection reaction (non serious, outcome: Recovered/ Resolved). Event treatment: An ice pack was placed on the injection site and the patient was asked to observe for 15 minutes. After 10 minutes of observation, the bump reduced in size and the patient insisted that she felt fine and left the facility against the pharmacist's advise. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Head injury, Malaise, Syncope
Clinical narrative: This health authority case was initially received on 23-Sep-2016. The case report was received from a Health Professional and concerns a 62 year old male patient. The patient has a medical history of Hypertension and Diabetes. 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: U56807, 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 [hit his head when he] fainted, hit his head [when he fainted], coughing, got sick at work. Ct scan and x-ray since he hit his head. Reporter's assessment: Non-serious. Case correction (23-Feb-2015): Assessment for AE. 3 cough corrected to listed.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: 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 22 year old male patient. At the time of the event the patient concomitantly suffered from Narcolepsy. The patient received AFLURIA on 14-Sep-2015 - unknown stop date, Batch no: U56807, 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 patient [got faint after getting immunization [and fainted]. Reporter's assessment: Non-serious.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Dyspnoea, Eye pruritus, Ocular hyperaemia
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 34 year old male patient. The patient has a medical history of 'amoxicillin' and 'penicillin'. The patient had no illness at the time of vaccination. The patient received AFLURIA on 15-Sep-2015 - unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: Lot: 'U55Y06'; site: left arm (LA). No additional drugs suspected. On 15-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced Weakness, Difficulty taking deep breaths, Tightness in chest, Bloodshot [itchy] eyes, [Bloodshot] itchy eyes, Unable to focus. Reporter's assessment: Non-serious.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 34 year old male patient. The patient has a medical history of 'amoxicillin' and 'penicillin'. The patient had no illness at the time of vaccination. The patient received AFLURIA on 15-Sep-2015 - unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: Lot: 'U55Y06'; site: left arm (LA). No additional drugs suspected. On 15-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced Weakness, Difficulty taking deep breaths, Tightness in chest, Bloodshot [itchy] eyes, [Bloodshot] itchy eyes, Unable to focus. Reporter's assessment: Non-serious.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 43 year old female patient. The patient had no allergies, concomitant medications or illness at the time of vaccination. The patient received AFLURIA on 15-Sep-205 - unknown stop date, Batch no: U56807, Route of administration: Intramuscular, Dose: 0.5 ml; site: left arm (LA). No additional drugs suspected. On 16-Sep-2015, 2 days after starting treatment with AFLURIA the patient experienced rash, itch. Diphenhydramine, hydrocortisone cream. Reporter's assessment: Non-serious.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Malaise, Nausea
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 37 year old female patient. The patient had no medical history or illness at the time of vaccination. The patient received AFLURIA on 31-Aug-2015, Batch no: U55906 reported as U155906, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 31-Aug-2015, 1 day after starting treatment with AFLURIA the patient experienced lips were swollen, spent the night sick in bed after the flu shot, and nauseous. Reporter's assessment: Non-serious.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site swelling, Mobility decreased
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 58 year old female patient. The patient received AFLURIA on 14-Sep-2015 - unknown stop date, Batch no: U54506, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 17-Sep-2015, 4 days after starting / treatment with AFLURIA the patient experienced Fatigue, Weak, [to the point of not being able to get up] / Asthenia, [Weak to the point of] not being able to get up / Mobility decreased, Nausea, Redness, [swelling] at injection site / Injection site erythema, [Redness] swelling at injection site / Injection site swelling. Reporter's assessment: Non-serious.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: 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 58 year old female patient. The patient received AFLURIA on 14-Sep-2015 - unknown stop date, Batch no: U54506, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 17-Sep-2015, 4 days after starting / treatment with AFLURIA the patient experienced Fatigue, Weak, [to the point of not being able to get up] / Asthenia, [Weak to the point of] not being able to get up / Mobility decreased, Nausea, Redness, [swelling] at injection site / Injection site erythema, [Redness] swelling at injection site / Injection site swelling. Reporter's assessment: Non-serious.
Age: 69.0
Sex: F
Vaccine: DTP, FLU3, PNC13
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case report was received from a Health Professional and concerns a 69 year old female patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 26-AUG-2015 - unknown stop date, Batch no: U55506, Route of administration: intramuscular, Dose: 0.5 ml. Additional suspect drug(s): Pertussis vaccine (no brand name), Indication: not provide and PREVNAR13, indication not provided. Reaction(s)/Event(s) and outcome: On 28-AUG-2015, 3 days after starting/treatment with AFLURIA the patient experienced Swelling/Peripheral swelling (non serious, outcome: Unknown), Upper arm pain/Pain in extremity (non serious, outcome: Unknown). Reporter's assessment:  Non-serious.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a(n) Health Professional and concerns a(n) 48 years old female patient with no current illness or medical history. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 16-Sep-2015 - unknown stop date, Batch no: U55506, Route of administration: Intramuscular, Dose: 0.5 ml. Both vaccines were injected in the left arm (medication error not explicitly reported). Additional suspect drug(s): PNEUMOVAX. Reaction(s)/event(s) and outcome: On 16-Sep-2015, 1 day after starting / treatment with AFLURIA the patient experienced Arm of injection was swollen (non serious, outcome: Unknown), Arm of injection was warm to the touch(non serious, outcome: Unknown), Arm of injection had red patches  (non serious, outcome: Unknown). For relevant test results see appropriate report section. Reporter's assessment:.
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a(n) Health Professional and concerns a(n) female patient. Weight: not provided, Height: not provided. The patient has a medical history of Chronic urticaria. The patient received AFLURIA on unknown dates, Batch no:U55106, Route of administration: Unknown, Dose: 0.5 ml. Additional suspect drug(s): ZOSTAVAX. On an unknown date, after starting treatment with AFLURIA the patient experienced Hives. The patient was treated with BENADRYL and prednisone and made a full recovery. The reporter considered the events non serious.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling
Clinical narrative: This medically confirmed spontaneous report (initial receipt 18-Sep-2015) concerns a female patient. The patient had no known drug allergies. The patient had received AFLURIA last year and was well tolerated with no adverse reaction. On 17-Sep-2015, the patient received intramuscular AFLURIA (batch number U54506) at 0.5 ml once. On 17-Sep-2015, immediately after receiving the vaccine, the patient's arm got swollen and red at the injection site. The patient remained in the pharmacy area and was monitored. By the time, she left the pharmacy, the swelling and redness had appeared to lessen. The outcome was reported as unknown. Reporter's comments: The reporter assessed the events as non-serious and considered the causality as probable to the use of AFLURIA.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This medically confirmed spontaneous report (initial receipt 18-Sep-2015) concerns a female patient. The patient had no known drug allergies. The patient had received AFLURIA last year and was well tolerated with no adverse reaction. On 17-Sep-2015, the patient received intramuscular AFLURIA (batch number U54506) at 0.5 ml once. On 17-Sep-2015, immediately after receiving the vaccine, the patient's arm got swollen and red at the injection site. The patient remained in the pharmacy area and was monitored. By the time, she left the pharmacy, the swelling and redness had appeared to lessen. The outcome was reported as unknown. Reporter's comments: The reporter assessed the events as non-serious and considered the causality as probable to the use of AFLURIA.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Injection site swelling, Injection site warmth, 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 42 year old female patient. The patient received AFLURIA on 22-Sep-2016, Batch no: U56807, Route of administration: Intramuscular, Dose: 0.5 ml. Additional suspect drug: PNEUMOVAX. On 22-Sep-2015, 1 day after starting treatment with AFLURIA the patient experienced Chest pains, closing of throat, fever at injection site, and large swollen right arm at injection site. Examined by ER physician and was given PERCOCET, clindamycin, and MEDROL dose pack and a shot of steroids. Reporter's assessment: Non-serious.