chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Periarthritis
Clinical narrative: She reported pain the date she received the vaccination in her left arm. She reports pain progressively became worse, reporting limited range of motion. She pointed to the acromion area as the site of injection. Diagnosed with left deltoid bursitis. Symptoms improved with Physical Therapy (PT). Once physical therapy was completed, her symptoms gradually returned. She was referred to clinic and received a steroid injection on  6-29-17 and was diagnosed with left shoulder impingement and adhesive capsulitis, and to restart PT.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Rotator cuff syndrome, X-ray normal
Clinical narrative: She reported pain the date she received the vaccination in her left arm. She reports pain progressively became worse, reporting limited range of motion. She pointed to the acromion area as the site of injection. Diagnosed with left deltoid bursitis. Symptoms improved with Physical Therapy (PT). Once physical therapy was completed, her symptoms gradually returned. She was referred to clinic and received a steroid injection on  6-29-17 and was diagnosed with left shoulder impingement and adhesive capsulitis, and to restart PT.
Age: 34.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: Patient reported that 7-10 days after receiving 1st VARIVAX having small red dots that were kind of like blisters and were very itchy that lasted for a week.
Age: 30.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left arm became swollen, red,painful, itching from shoulder to elbow. There was no definition from shoulder to elbow d/t swelling.
Age: 31.0
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 05/23/2017 patient left upper arm 3 cm circumferential area of redness, mild swelling and tender to the touch. No induration, or warmth to the touch. 05/24/2017 patient left upper arm 5.5 cm circumferential area of redness, moderate swelling and very tender. Center is now indurated and warmth to the touch.
Age: 31.0
Sex: F
Vaccine: TYP, YF
Symptoms: Injection site warmth
Clinical narrative: 05/23/2017 patient left upper arm 3 cm circumferential area of redness, mild swelling and tender to the touch. No induration, or warmth to the touch. 05/24/2017 patient left upper arm 5.5 cm circumferential area of redness, moderate swelling and very tender. Center is now indurated and warmth to the touch.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Hypoaesthesia, Neuralgia, Pain in extremity, Paraesthesia
Clinical narrative: 15 minutes after the vaccine L arm tingling to hand then sensation change in upper shoulder neck and back. Face numb feeling, then upper and lower back affected and painful as "nerve pain"  Pain going to right and left leg shin areas. Has doctor appt on 5/24/2017.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Lymphadenopathy
Clinical narrative: SWOLLEN LYMPH NODE ON LT SIDE OF NECK.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Rash
Clinical narrative: Rash to bilateral earlobes and upper Right arm with redness in color. Injection site had raised area, with redness.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Swelling and heat below injection site, patient described as a welt the size of an orange (diameter).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Around 5 minutes after immunization was given, child presented with one hive 3/4 of in inch in size at the site of injection with surrounding redness. Treated with ice pack at the site and the one hive and redness went away. Provider also gave BENADRYL. Child monitored in clinic for 20 minutes prior to leaving.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Activated partial thromboplastin time shortened, Alanine aminotransferase increased, Ammonia normal, Anion gap
Clinical narrative: The patient initiated dose #1 of the oral typhoid vaccine on 5/18, took dose #2 on 5/20, then in the early morning of 5/21, woke from sleep with acute onset abdominal/chest/back pain. He went to the ED and was found to have transaminitis (elevated AST/ALT/GGT, mild bili elevation) and gallbladder thickening, but no stones and or other obvious etiology. He was admitted for acute liver injury and discharged after 1 day of admission with labs showing spontaneously improving transaminitis.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Aspartate aminotransferase increased, Back pain, Basophil count decreased, Bilirubin conjugated increased, Blood albumin decreased
Clinical narrative: The patient initiated dose #1 of the oral typhoid vaccine on 5/18, took dose #2 on 5/20, then in the early morning of 5/21, woke from sleep with acute onset abdominal/chest/back pain. He went to the ED and was found to have transaminitis (elevated AST/ALT/GGT, mild bili elevation) and gallbladder thickening, but no stones and or other obvious etiology. He was admitted for acute liver injury and discharged after 1 day of admission with labs showing spontaneously improving transaminitis.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin increased, Blood calcium decreased, Blood chloride normal, Blood creatinine normal
Clinical narrative: The patient initiated dose #1 of the oral typhoid vaccine on 5/18, took dose #2 on 5/20, then in the early morning of 5/21, woke from sleep with acute onset abdominal/chest/back pain. He went to the ED and was found to have transaminitis (elevated AST/ALT/GGT, mild bili elevation) and gallbladder thickening, but no stones and or other obvious etiology. He was admitted for acute liver injury and discharged after 1 day of admission with labs showing spontaneously improving transaminitis.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Blood fibrinogen decreased, Blood fibrinogen normal, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: The patient initiated dose #1 of the oral typhoid vaccine on 5/18, took dose #2 on 5/20, then in the early morning of 5/21, woke from sleep with acute onset abdominal/chest/back pain. He went to the ED and was found to have transaminitis (elevated AST/ALT/GGT, mild bili elevation) and gallbladder thickening, but no stones and or other obvious etiology. He was admitted for acute liver injury and discharged after 1 day of admission with labs showing spontaneously improving transaminitis.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Blood urea increased, Carbon dioxide normal, Ceruloplasmin, Chest pain, EGFR status assay
Clinical narrative: The patient initiated dose #1 of the oral typhoid vaccine on 5/18, took dose #2 on 5/20, then in the early morning of 5/21, woke from sleep with acute onset abdominal/chest/back pain. He went to the ED and was found to have transaminitis (elevated AST/ALT/GGT, mild bili elevation) and gallbladder thickening, but no stones and or other obvious etiology. He was admitted for acute liver injury and discharged after 1 day of admission with labs showing spontaneously improving transaminitis.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Eosinophil count normal, Flow cytometry, Gallbladder enlargement, Gamma-glutamyltransferase increased, Haematocrit normal
Clinical narrative: The patient initiated dose #1 of the oral typhoid vaccine on 5/18, took dose #2 on 5/20, then in the early morning of 5/21, woke from sleep with acute onset abdominal/chest/back pain. He went to the ED and was found to have transaminitis (elevated AST/ALT/GGT, mild bili elevation) and gallbladder thickening, but no stones and or other obvious etiology. He was admitted for acute liver injury and discharged after 1 day of admission with labs showing spontaneously improving transaminitis.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Haemoglobin normal, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative, International normalised ratio increased, Lipase normal
Clinical narrative: The patient initiated dose #1 of the oral typhoid vaccine on 5/18, took dose #2 on 5/20, then in the early morning of 5/21, woke from sleep with acute onset abdominal/chest/back pain. He went to the ED and was found to have transaminitis (elevated AST/ALT/GGT, mild bili elevation) and gallbladder thickening, but no stones and or other obvious etiology. He was admitted for acute liver injury and discharged after 1 day of admission with labs showing spontaneously improving transaminitis.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Liver injury, Lymphocyte count normal, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal
Clinical narrative: The patient initiated dose #1 of the oral typhoid vaccine on 5/18, took dose #2 on 5/20, then in the early morning of 5/21, woke from sleep with acute onset abdominal/chest/back pain. He went to the ED and was found to have transaminitis (elevated AST/ALT/GGT, mild bili elevation) and gallbladder thickening, but no stones and or other obvious etiology. He was admitted for acute liver injury and discharged after 1 day of admission with labs showing spontaneously improving transaminitis.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Monocyte count normal, Mononucleosis heterophile test negative, Neutrophil count normal, Platelet count normal, Protein total decreased
Clinical narrative: The patient initiated dose #1 of the oral typhoid vaccine on 5/18, took dose #2 on 5/20, then in the early morning of 5/21, woke from sleep with acute onset abdominal/chest/back pain. He went to the ED and was found to have transaminitis (elevated AST/ALT/GGT, mild bili elevation) and gallbladder thickening, but no stones and or other obvious etiology. He was admitted for acute liver injury and discharged after 1 day of admission with labs showing spontaneously improving transaminitis.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Prothrombin time prolonged, Red blood cell count normal, Reticulocyte count, Shift to the left, Transaminases increased
Clinical narrative: The patient initiated dose #1 of the oral typhoid vaccine on 5/18, took dose #2 on 5/20, then in the early morning of 5/21, woke from sleep with acute onset abdominal/chest/back pain. He went to the ED and was found to have transaminitis (elevated AST/ALT/GGT, mild bili elevation) and gallbladder thickening, but no stones and or other obvious etiology. He was admitted for acute liver injury and discharged after 1 day of admission with labs showing spontaneously improving transaminitis.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: White blood cell count normal
Clinical narrative: The patient initiated dose #1 of the oral typhoid vaccine on 5/18, took dose #2 on 5/20, then in the early morning of 5/21, woke from sleep with acute onset abdominal/chest/back pain. He went to the ED and was found to have transaminitis (elevated AST/ALT/GGT, mild bili elevation) and gallbladder thickening, but no stones and or other obvious etiology. He was admitted for acute liver injury and discharged after 1 day of admission with labs showing spontaneously improving transaminitis.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Patient developed tenderness, redness, and swelling two days after receiving the vaccines. Area was also warm to the touch on exam in the office.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Crying, Erythema, Haemorrhage, Peripheral swelling
Clinical narrative: On 5/15/17: mother reported that in the late afternoon of 3/13/17, infants feet swelled bilaterally. Later that evening, both feet became red and their was bleeding between her toes and she was crying. The parents contemplated taking her to the ED but did not. They did not call our clinic. The next morning, the infant awoke with symptoms resolved.
Age: 23.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Anxiety, Computerised tomogram normal, Confusional state, Fatigue, Intentional self-injury
Clinical narrative: After flu vaccine, went on camp retreat for 3 days, came home low fever, fatigue and confusion over next month - seen in ER multiple times, (-) CT, neg blood test - by Jan - seemed no longer confused - back to old self. But became more anxious, hitting himself. He high functioning autism.
Age: 23.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Laboratory test normal, Nuclear magnetic resonance imaging normal, Pyrexia
Clinical narrative: After flu vaccine, went on camp retreat for 3 days, came home low fever, fatigue and confusion over next month - seen in ER multiple times, (-) CT, neg blood test - by Jan - seemed no longer confused - back to old self. But became more anxious, hitting himself. He high functioning autism.
Age: 23.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Abnormal behaviour, Anxiety, Apathy, Blood pressure increased, Communication disorder
Clinical narrative: After flu vaccine, went on camp retreat for 3 days, came home low fever, fatigue and confusion over next month - seen in ER multiple times, (-) CT, neg blood test - by Jan - seemed no longer confused - back to old self. But became more anxious, hitting himself. He high functioning autism.
Age: 23.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Confusional state, Craniocerebral injury, Delirium, Disorientation, Electroencephalogram
Clinical narrative: After flu vaccine, went on camp retreat for 3 days, came home low fever, fatigue and confusion over next month - seen in ER multiple times, (-) CT, neg blood test - by Jan - seemed no longer confused - back to old self. But became more anxious, hitting himself. He high functioning autism.
Age: 23.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Head injury, Headache, Hypertension, Insomnia, Intentional self-injury
Clinical narrative: After flu vaccine, went on camp retreat for 3 days, came home low fever, fatigue and confusion over next month - seen in ER multiple times, (-) CT, neg blood test - by Jan - seemed no longer confused - back to old self. But became more anxious, hitting himself. He high functioning autism.
Age: 23.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Loss of personal independence in daily activities, Nuclear magnetic resonance imaging, Paraesthesia, Tinnitus
Clinical narrative: After flu vaccine, went on camp retreat for 3 days, came home low fever, fatigue and confusion over next month - seen in ER multiple times, (-) CT, neg blood test - by Jan - seemed no longer confused - back to old self. But became more anxious, hitting himself. He high functioning autism.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: 05-19-17 immunization. 05-21-17 call a nurse - patient contact. 05-22-17 called off, made same day appt. 05-22-17 Dr saw patient.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis, Vision blurred
Clinical narrative: Blurry vision, profuse sweating, light-headedness.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Injection site movement impairment, Musculoskeletal stiffness
Clinical narrative: For 3 hours his legs were stiff as a board, would not/could not move his legs.
Age: 0.75
Sex: F
Vaccine: HEP, IPV
Symptoms: Eyelid oedema, Urticaria
Clinical narrative: Here with mother. Was seen in office on 5/17 for 9 month checkup. Received IPV and Hep B. Next day started with hives. This morning hives worse with eyes swollen shut. No problems breathing. No illnesses prior to 9 month checkup. No new foods.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Rash generalised, Rash maculo-papular, Rash pruritic
Clinical narrative: Redness, swelling at itching at vaccine site, persisting at 13 days after vaccine given. Generalized itchy macular papular rash - treated w/IM KENALOG, oral Prednisone and BENADRYL.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: Redness, swelling at itching at vaccine site, persisting at 13 days after vaccine given. Generalized itchy macular papular rash - treated w/IM KENALOG, oral Prednisone and BENADRYL.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site rash
Clinical narrative: Developed bumps in her thighs after vaccines -now resolved.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Peripheral swelling, Skin warm
Clinical narrative: This medically confirmed health authority report (initial receipt 15-Dec-2014) concerns a 29 year-old female patient. On 23-Oct-2014, the patient received intramuscular AFLURIA injection (batch number 09449221A in the left arm and PNEUMOVAX (batch number K00681) in the right arm. On 24-Oct-2014, the patient experienced swollen right arm. On 25-Oct-2015, her arm was red and warm to the touch which spread downward. She took diphenhydramine which improved the symptoms. By 27-Oct-2014, the symptoms resolved. The outcome was recovered on 27-Oct-2014. Reporter's comments: The regulatory authority assessed the case as non-serious, reported the tem 'local swelling', and reported the patient presented at the Emergency Room. Follow-up received 23-Sep-2015: The health authority reported PNEUMOVAX to be a concomitant medication and not a suspect. The health authority considered all events as non-serious and reported the preferred term peripheral swelling. Automated Data Corrections (01-JUN-2016 14:31:13) Create history record and set the last received date for corrected cases.
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Mobility decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: This health authority case was initially received on 23-Nov-2015. The case report was received from a Health Professional and concerns a 38 year old female patient. For concomitant medication and therapy dates refers to the appropriate sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 11-Sep-2015 - unknown stop date, Batch no: U55506, Route of administration: Intramuscular, Dose : 05 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 11-Sep-2015, 1 day after starting/treatment with AFLURIA the patient experienced Vein in my arm and hand were [stinging and] burning (non serious, outcome: Not Recovered/Not Resolved), Vein in my arm and hand were stinging [and burning] (non serious, outcome: Not Recovered/Not Resolved), Not able to do what I need to do for regular daily things without pain (non serious, outcome: Not Recovered/Not Resolved), Enough pain in my arm where I can't raise it over my head easily (non serious, outcome: Not Recovered/Not Resolved), Heat in my injection arm and hand (non serious, outcome: Not Recovered/Not Resolved). On 12-Sep-2015, 1 day after starting/treatment with AFLURIA the patient experienced Sore muscle feeling (non serious, outcome: Not Recovered/Not Resolved. Reporter's assessment: Non-serious. Case correction (22-Mar-2016): AE 4 (enough pain in my arm where I can't raise it over my head easily) re-coded to 'pain upon movement'. Report comments: The health authority reported the symptom of 'mobility decreased'. Case correction 12-Apr-2016: LLT AE 5 'heat in my arm and injection hand' changed from 'feeling hot' to 'skin warm'.
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
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 38 year old female patient. For concomitant medication and therapy dates refers to the appropriate sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 11-Sep-2015 - unknown stop date, Batch no: U55506, Route of administration: Intramuscular, Dose : 05 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 11-Sep-2015, 1 day after starting/treatment with AFLURIA the patient experienced Vein in my arm and hand were [stinging and] burning (non serious, outcome: Not Recovered/Not Resolved), Vein in my arm and hand were stinging [and burning] (non serious, outcome: Not Recovered/Not Resolved), Not able to do what I need to do for regular daily things without pain (non serious, outcome: Not Recovered/Not Resolved), Enough pain in my arm where I can't raise it over my head easily (non serious, outcome: Not Recovered/Not Resolved), Heat in my injection arm and hand (non serious, outcome: Not Recovered/Not Resolved). On 12-Sep-2015, 1 day after starting/treatment with AFLURIA the patient experienced Sore muscle feeling (non serious, outcome: Not Recovered/Not Resolved. Reporter's assessment: Non-serious. Case correction (22-Mar-2016): AE 4 (enough pain in my arm where I can't raise it over my head easily) re-coded to 'pain upon movement'. Report comments: The health authority reported the symptom of 'mobility decreased'. Case correction 12-Apr-2016: LLT AE 5 'heat in my arm and injection hand' changed from 'feeling hot' to 'skin warm'.
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 31-year-old male patient. On 03-Oct-2015, the patient received intramuscular AFLURIA (batch number: U56506) in the right arm. On 03-Oct-2015, the patient's right arm was hurting. The patient told the nurse after administration of the shot that it was hurting pretty bad. He thought he hit a nerve. It hurt to raise the arm above his head. The patient would continue to stretch the shoulder out and see if that worked. The outcome was reported as unknown. Reporter's comments: The health authority assessed the events as non-serious. Case correction (26-Feb-2016): Date of last received updated to 26-Feb-2016 to reflect the date on which the case was upgraded to serious. Adverse event 'Thought he hit the nerve' re-coded from 'Nerve injury' to 'injection site nerve damage'. Case correction (22-Mar-2016): Case downgraded to non-serious. Reporter comments: The health authority reported symptom included 'pain'. Case correction 12-Apr-2016: AE 1 verbatim changed from 'right arm hurts / hurts to raise my arm above my head in context to injected arm' to 'right arm hurts' and coded to LLT 'painful R arm'. AE 2 verbatim changed from 'pain' to 'pain / hurts to raise my arm above my head in context to injected arm' and coded to LLT 'pain upon movement'.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous case was initially received on 19-Oct-2015. The case report was received from a(n) Health Professional and concerns a(n) 63 year od female patient. The patient has received the flu shot in the past, specifically the AFLURIA vaccine, on 02-Oct-2014 and 08-Sep-2013, without any issues. The patient states she is "super sensitive to vaccines." She had gotten this reaction years ago. The following drug history information was reported: Unspecified vaccine (indication:- reaction: muscle soreness). The patient received AFLURIA on 11-Sep-2015 - 11-Sep-2015, Batch no: U55406, Route of administration: intramuscular, dose 0.5 ml, Site: left deltoid. ZOSTAVAX, Batch no: indication; not provided, site: right arm. On 11-Sep-2015, after starting / treatment with AFLURIA the patient experienced muscle soreness in the left arm where AFLURIA was administered / muscle soreness in the left arm where the AFLURIA was administered. The soreness is not felt all the time. When the patient  lifts weights, she does not notice it. However, it is when she is laying down in bed that she can feel it. She states it does not feel better or worse. Reporter's assessment: not reported. AE 1 split, new AE added.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Rash pustular
Clinical narrative: Source of report and patient demography: This spontaneous case was initially received on 28-Oct-2015. The case report was received from a(n) Health Professional and concerns a(n) 65 year old male patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Shingles, High blood pressure and High cholesterol. The patient has no drug reactions/allergies. His concomitant medications included sterile diluent (Lot number K024557, expiry 10-Oct-2016) and 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 14-Oct-2015 - unknown stop date, Batch no. U55806, Route of administration: not provided, Dose: 0.5 ml, Site: Opposite arm to ZOSTAVAX administration. Additional suspect drug(s): ZOSTAVAX, Batch no: L012478, Expiry: 10-Jul-2016, Route: Subcutaneous, Indication: not provided and diluent (Batch no: K024557, Expiry: 10-Oct-2017). Reaction(s)/event(s) and outcome: On 15-Oct-2015, 2 days after starting/treatment with AFLURIA the patient experienced [Rash, ovular, 2 inches across by 1 inch with] pustules at the edges that are flat and dry (non serious, outcome: Unknown), Rash ovular, 2 inches across by 1 inch [with pustules at the edges that are flat and dry] (non serious, outcome: Unknown). The patient stated the rash was "not like usual shingles he had in the past". Reporter's assessment: non-serious. Company's evaluation and comment: Seriousness criterion/criteria: Non serious. VAERS: 609885. Listedness: According to the Reference Safety Information, the event Rash, ovular, 2 inches across by 1 inch [with pustules at the edges that are flat and dry] is a listed event of AFLURIA, the event [Rash, ovular, 2 inches across by 1 inch with] pustules at the edges that are flat and dry is a unlisted event of AFLURIA. Case Causality: Possible. Case correction (31-Mar-2016): AE 1 unsplit and recoded to 'rash pustular'.
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 16-Mar-2016. The case report was received from a(n) Health Professional and concerns a(n) 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 ALFURIA not reported on 20-Nov-2015 - unknown stop date, Batch no: U58508, Route of administration: Intramuscular, Dose: 0.5 ml, site: right arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 20-Nov-2015, 1 day after starting / treatment with AFLURIA the patient experienced Intolerable pain in (R) arm (non serious, outcome: Not Recovered / Not Resolved). The patient described intolerable pain in the right arm and was getting worse at night. Pain stayed constant. The doctor recommended physician therapy for relief. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the event as non-serious. Listedness: According to the Reference Safety Information, the event intolerable pain in (R) arm is a unlisted event of AFLURIA. Case Causality: Possible.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This health authority case was initially received on 16-Mar-2016. The case report was received from a Health Professional and concerns a 62 year old male patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of DM. 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 19-Jan-2016 - unknown stop date, Batch no: U55206, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Right deltoid. Additional suspect drug(s): PNEUMOVAX, Batch no: L014458, Site: Right deltoid. AFLURIX and PNEUMOVAX administered to same arm (medication error not explicitly reported). Reaction(s)/event(s) and outcome: On 20-Jan-2016, 2 days after starting / treatment with AFLURIA the patient experienced Reddened posterior deltoid red area and under arm and anterior bicep reddened area (non serious, outcome: Recovered/Resolved), 15cm x 15cm raised, swollen, [and red] area on R deltoid (injected arm) (non serious, outcome: Recovered/Resolved), 15cm x 15cm [raised, swollen, and] red area on R deltoid (injected arm) (non serious, outcome: Recovered/Resolved). Reporter's assessment: Non serious.
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site erythema, Pain, Pain in extremity
Clinical narrative: This health authority case was initially received on 16-Mar-2016. The case report was received from a Health Professional and concerns a 46 year old female patient. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 22-Dec-2015 - unknown stop date, Batch no: U57807, 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 11-Jan-2016, 3 weeks 0 days after starting/treatment with ALFURIA the patient experienced Soreness to (L) wrist (non serious, outcome: Not Recovered/Not Resolved). On 23-Dec-2015, 2 days after starting/treatment with AFLURIA the patient experienced Soreness to (L) arm the day after injection lasting the entire next week, from elbow to shoulder (non serious, outcome: Not Recovered/Not Resolved), Soreness with ROM to upper arm (non serious, outcome: Not Recovered/Not Resolved). Condition is improving - no tenderness or redness reported to injection site at any time. Reporter's assessment: Non serious.
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Back pain, Dysstasia, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Mar-2016) concerns a 66 year-old male patient who had medical history of high blood pressure, high cholesterol, DVT (deep vein thrombosis) right leg and gout. He had no current illness. Concomitant medications included allopurinol, vitamin B1, folic acid, warfarin, simvastatin and lisinopril. On 02-Jan-2015, the patient received AFLURIA injection (batch number T58006) via the intramuscular route on the right arm. On 16-Feb-2015, the patient experienced back and leg pain especially on the left side. He had foot pain when walking and lower left side back pain. On 19-Feb-2015, he found it hard to walk and stand upright. The primary care physician prescribed oral steroids. He was unable to go to work. On 25-Feb-2015, the pain progressed to inability to walk without assistance and total inability to use his legs. He went to the emergency room and was admitted for 24 days. He also had Guillain-Barre syndrome. The outcome was not recovered. Reporter's comments: The health authority assessed the case as serious (required hospitalisation for 24 days). VAERS case ID: 620458.
Sex: M
Vaccine: FLU3
Symptoms: Impaired work ability, Pain in extremity, Walking aid user
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Mar-2016) concerns a 66 year-old male patient who had medical history of high blood pressure, high cholesterol, DVT (deep vein thrombosis) right leg and gout. He had no current illness. Concomitant medications included allopurinol, vitamin B1, folic acid, warfarin, simvastatin and lisinopril. On 02-Jan-2015, the patient received AFLURIA injection (batch number T58006) via the intramuscular route on the right arm. On 16-Feb-2015, the patient experienced back and leg pain especially on the left side. He had foot pain when walking and lower left side back pain. On 19-Feb-2015, he found it hard to walk and stand upright. The primary care physician prescribed oral steroids. He was unable to go to work. On 25-Feb-2015, the pain progressed to inability to walk without assistance and total inability to use his legs. He went to the emergency room and was admitted for 24 days. He also had Guillain-Barre syndrome. The outcome was not recovered. Reporter's comments: The health authority assessed the case as serious (required hospitalisation for 24 days). VAERS case ID: 620458.
Sex: F
Vaccine: FLU3
Symptoms: Flushing
Clinical narrative: This health authority case was initially received on 16-Mar-2016. The case report was received from a(n) Health Professional and concerns a(n) 12 years old female patient. The patient had no known allergies. Weight: not provided, Height: not provided. 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 on 23-Jan-2016 - unknown stop date, Batch no: U55406, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Right arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: Reaction(s)/event(s) and outcome: On 23-Jan-2016, 1 day after starting / treatment with AFLURIA the patient experienced Flushing to face, hands and lower arms bilat (non serious, outcome: Recovered / Resolved). The patient was treated with oral diphenhydramine. For relevant test results see appropriate report section. Report's assessment: The health authority assessed the events as non-serious.
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: This health authority case was initially received on 16-Mar-2016. The case report was received from a Health Authority and concerns a 58 year old female patient who had no current illness. The patient has a medical history of asthma. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 24-Dec-2015 - unknown stop date, Batch no: U59208, Route of administration: Intramuscular, Dose: 0.5 ml, site: left arm. Additional suspect drug(s): On 24-Dec-2015, the patient also received PREVNAR 13, batch: M56442, route: intramuscular, site: left arm. Both AFLURIA and PREVNAR 13 were administered to the left arm (medication error not explicitly reported). Reaction(s)/event(s) and outcome: On 24-Dec-2015, after starting / treatment with AFLURIA, the patient experienced injection site pain (non serious, outcome: Not Recovered / Not Resolved). The patient visited the emergency room. Reporter's assessment: Non-serious. VAERS ID: 620465.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Musculoskeletal pain, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 16-Mar-2016. The case report was received from a Health Authority and concerns a 26 year old female patient who had no current  illness at the time of vaccination. Concurrent medical condition(s), medical and drug history: The patient has a medical history of psoriasis and no known drug allergies. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 22-Jan-2016 - unknown stop date, Batch no: U54305, Route of administration: intramuscular, dose: 0.5 ml, site: Arm. Additional suspect drug(s). No additional drugs suspected. Reaction(s)/events(s) and outcome: On 23-Jan-2016, after starting / treatment with AFLURIA, the patient experienced severe pain at the left shoulder radiating to left deltoid (non serious, outcome: not recovered / not resolved). There is less strength (non serious, outcome: not recovered / not resolved). The patient required an emergency room visit. Reporter's assessment: The health authority assessed the events as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This health authority case was initially received on 16-Mar-2016. The case report was received from a Health Professional and concerns a 25 years old female patient. The patient has no known drug allergies (reported as 'NKDA'). Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 08-Jan-2016 - unknown stop date, Batch no: 12149221A, Route of administration: Intramuscular, Site: Left arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 09-Jan-2016, 2 days after starting / treatment with AFLURIA the patient experienced increased pain in arm (non serious, outcome: Recovered / Resolved). The pain progressed over the course of 3 weeks and now starting to improve. Reporter's assessment: Non serious.
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This health authority case was initially received on 16-Mar-2016. The case report was received from a Health Professional and concerns a 61 year old female patient. The patient had no current illness at the time of vaccination. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Sarcoidosis and Allergies: morphine and vancomycin. The following drug history information was reported: Morphine (Indication: -, Reaction: Allergy) and Vancomycin (Indication: -, Reaction: Allergy). Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 13-Jan-2016 - unknown stop date, Batch no: U55206, Route of administration: Intramuscular, Dose: 0.5 ml, site: left arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 14-Jan-2016, 2 days after starting/treatment with AFLURIA the patient experienced Sore arm/Severe pain [and unable to move] her arm (L) (non serious, outcome: Unknown), [Severe pain and] unable to move her arm (L) in context of injected arm (non serious, outcome: Unknown). Reporter's assessment: The health authority assessed the events as non-serious.
Sex: U
Vaccine: FLU3
Symptoms: Bursa injury, Pain
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 16-Mar-2016. The case report was received from a Health Professional and concerns a 66 years old patient with unknown gender. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 29-Oct-2015 - unknown stop date, Batch no: U56006, Route of administration: 'SYR'. Dose: 0.5 ml, Site: Arm reported as 'AR'. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: The patient went to the doctor on 25-Nov-2015. The patient had pain and said that the shot hit the bursa in arm. Reporter's assessment: Non-serious. Listedness: According to the Reference Safety Information, the events Has pain says and Shot hit the bursa in arm are unlisted events of AFLURIA. Case Causality: Possible. VAERS ID: 621457.
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 16-Mar-2016. The case was received from a Health Professional and concerns a 45 year old female patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Asthmatic and Allergic to PCN, quinolones, steroid. The following drug history information was reported: PCN, quinolones, steroid (Indication: -, Reaction: Allergy). The patient had no concomitant medications and no illness at the time of vaccination. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 04-Jan-2016 - unknown stop date, Batch no: 11749221A reported as 'I1749221A', Route of administration: Intramuscular, Site: Left arm (LA). Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 05-Jan-2016, 2 days after starting / treatment with AFLURIA the patient experienced Rash spread to arms chest etc... (non serious, outcome: Not Recovered / Not Resolved), Itching around lower legs / Itching spread to arms chest etc... (non serious, outcome: Not Recovered / Not Resolved). Lab data: None. Reporter's assessment: Non serious.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pruritus, Rash generalised
Clinical narrative: This health authority case was initially received on 16-Mar-2016. The case report was received from a Health Professional and concerns a 42 year old female patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Pollen allergies. For concomitant medication and therapy dates refer to the appropriate report sections. The patient had no illness at the time of vaccination. Suspect drug(s), timing and conditions surrounding the onset of reactions(s)/event(s): The patient received AFLURIA on 27-Oct-2015 - unknown stop date, Batch no: U57107, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Right arm (RA). Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 27-Oct-2015, 1 day after starting / treatment with AFLURIA the patient experienced Broke out into hives (non serious, outcome: Recovered / Resolved), Rash all over body (non serious, outcome: Recovered / Resolved), Rash at left arm site (non serious, outcome: Recovered / Resolved), At left arm site redness (non serious, outcome: Recovered / Resolved), At left arm site swelling (non serious, outcome: Recovered / Resolved), Itch (non serious, outcome: Recovered / Resolved). Patient reported no fever or dyspnea and no new sudden onset dyspnea. Action taken: Patient took diphenhydramine for relief which was help. Reporter's assessment: Non serious. VAERS ID: 621883.
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This health authority case was initially received on 16-Mar-2016. The case report was received from a Health Professional and concerns a 42 year old female patient. Concurrent medical condition(s), medical and drug history: The patient has a medical history of Pollen allergies. For concomitant medication and therapy dates refer to the appropriate report sections. The patient had no illness at the time of vaccination. Suspect drug(s), timing and conditions surrounding the onset of reactions(s)/event(s): The patient received AFLURIA on 27-Oct-2015 - unknown stop date, Batch no: U57107, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Right arm (RA). Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 27-Oct-2015, 1 day after starting / treatment with AFLURIA the patient experienced Broke out into hives (non serious, outcome: Recovered / Resolved), Rash all over body (non serious, outcome: Recovered / Resolved), Rash at left arm site (non serious, outcome: Recovered / Resolved), At left arm site redness (non serious, outcome: Recovered / Resolved), At left arm site swelling (non serious, outcome: Recovered / Resolved), Itch (non serious, outcome: Recovered / Resolved). Patient reported no fever or dyspnea and no new sudden onset dyspnea. Action taken: Patient took diphenhydramine for relief which was help. Reporter's assessment: Non serious. VAERS ID: 621883.
Sex: F
Vaccine: FLU3, MMR
Symptoms: Arthralgia, Chills, Pyrexia, Tremor
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 16-Mar-2016. The case report was received from a Health Professional and concerns a 52 year old female 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 on 04-Feb-2016 - unknown stop date. Batch no: 11549211A, Route of administration: Intramuscular, Site: Right arm (RA). Additional suspect drug(s): MMR II, Batch no: L012481, Dose no: 1, Indication: not provided, Site: Left arm (LA). Reaction(s)/event(s) and outcome: On 05-Feb-2016, 2 days after starting / treatment with AFLURIA the patient experienced Joints aching (non serious, outcome: Unknown), Shaking (non serious, outcome: Unknown), Fever of 101F (non serious, outcome: Unknown), Chills (non serious, outcome: Unknown). Will call doctor if fever stays high until noon. Event treatment: Pushing fluids and resting. Reporter's assessment: Non serious.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Nausea, Vomiting
Clinical narrative: Source of report and patient demography: This health authority case was initially received on 21-Apr-2016. The case report was received from a Health Professional and concerns a 63 year old female patient. The patient's complete medical history was unknown, however the patient was recently prescribed tramadol 50 mg. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 15-Feb-2016 - unknown stop date, Batch no: U51209, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 15-Feb-2016, 1 day after starting / treatment with AFLURIA the patient experienced Constant sharp pains in chest (non serious, outcome: Unknown), Nausea (non serious, outcome: Unknown), Vomiting (non serious, outcome: Unknown). Reporter's assessment: The health authority assessed the events as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Eye pruritus, Ocular hyperaemia, Swelling face
Clinical narrative: This medically confirmed health authority report (initial receipt 21-Apr-2016) concerns a 58 year-old female patient who had no current illness and no medications at the time of vaccination. She was allergic to sulfa, cephalexin, pollens and mold. On 21-Oct-2015, the patient received AFLURIA vaccine injection (batch number reported as 'NDC: 3332-0015-0') via the intramuscular route on the left arm. On 21-Oct-2015, the patient experienced red itchy eyes, swollen face and throat hoarseness. The outcome was recovered. Reporter comments: The health authority assessed the case as non-serious. VAERS case ID: 622859.
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Dizziness, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: This medically confirmed health authority report (initial receipt 21-Apr-2016) concerns a 23 year old male patient. The patient has no medical history and had no illness at the time of vaccination. On 05-Feb-2015, the patient received an intramuscular injection of AFLURIA (batch number: not reported). Four days after receiving the injection, the patient began to experience a sore throat which progressed into a sinus infection by the next day and lasted for five days. On day 6, the patient began to experience dizziness, tinnitus, fever and aching joints. The night of day 7 the fever worsened at night and then broke and disappeared over the course of the next day, along with the joint aches and dizziness. On the 8th day the patient noticed an unidentified rash on the outer pinna of both ears that has continued without abate until the present (day 11). The outcome was reported as unknown. Reporter comments: The health authority assessed the events as non-serious. VAERS ID: 622860.