chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Profession and concerns a 47 year old female patient. The patient had no medical history, concomitant medications or illness at the time of vaccination. The patient received AFLURIA on 22-Oct-2015 - unknown stop date, Batch no: U55306, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm (LA). No additional drugs suspected. On 22-Oct-2015, 1 day after starting/treatment with AFLURIA the patient experienced Hives bilateral over arms and chest. Reporter's assessment: Non serious. VAERS ID: 604518.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Swelling
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 71 year old female patient. The patient had no medical history and no illness at the time of the vaccination. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 23-Oct-2015 - unknown stop date, Batch no: U59208, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 23-Oct-2015, 1 day after starting treatment with AFLURIA the patient experienced Small amount of blood that came from the injection site, Tissue swelled slightly/Very slight swelled (in context of injection site). The patient said they felt nothing. After 20 minute period, patient was observed again for precaution and there was no change. Patient said they felt fine and was under no distress. The site was not red or inflamed. Lab data: None. Reporter's assessment: non serious. VAERS ID: 604563.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: The case report was received from a Health Professional and concerns a 64 years old female patient. At the time of the event the patient concomitantly suffered from Anemia. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 20-Oct-2015 - unknown stop date, Batch no: U56970, Route of administration: Intramuscular, Dose: 0.5 ml, site: Right arm. ZOSTAVAX, site: left arm. On 22-Oct-2015, 3 days after receiving AFLURIA the patient experienced Rash that itches at injection site, injection site reaction. Reporter's assessment: The health authority assessed the events as non-serious. VAERS ID: 604604
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Injection site rash, Myalgia, Nodule, Paraesthesia
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 46 years old male patient. The patient received AFLURIA on 14-Oct-2015 - unknown stop date, Batch no: U55806, Route of administration: Intramuscular, Dose: 0.5 ml, site: left arm. No additional drugs suspected. On 15-Oct-2015, 2 days after vaccination with AFLURIA the patient experienced Lump, (Lump) became harder. On 17-Oct-2015, 4 days after starting treatment with AFLURIA the patient experienced Rash spreading down from site, Felt like pins on back, Muscle soreness, Temperature >100, body temperature increased. Reporter's assessment: The health authority assessed the events as non-serious. VAERS ID: 604631.
Age: 23.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Erythema, Pruritus, Skin discolouration, Skin induration, Skin warm
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 23 years old female patient. The patient received AFLURIA on 23-Oct-2015, Batch no: U56606, Route of administration: Intramuscular, Dose: 0.5 ml, site: Right arm. Additional suspect drug(s): VARIVAX, batch number: L020216, site: right arm. Both the vaccines were given in the same arm. On 24-Oct-2015, 2 days after vaccination AFLURIA the patient developed big, red, swollen area that felt warm to touch and was hard. It itched and was a little discolored. The outcome was reported as recovered. Reporter's assessment: The health authority assessed the events as non-serious. VAERS ID: 604708.
Age: 23.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Swelling
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 23 years old female patient. The patient received AFLURIA on 23-Oct-2015, Batch no: U56606, Route of administration: Intramuscular, Dose: 0.5 ml, site: Right arm. Additional suspect drug(s): VARIVAX, batch number: L020216, site: right arm. Both the vaccines were given in the same arm. On 24-Oct-2015, 2 days after vaccination AFLURIA the patient developed big, red, swollen area that felt warm to touch and was hard. It itched and was a little discolored. The outcome was reported as recovered. Reporter's assessment: The health authority assessed the events as non-serious. VAERS ID: 604708.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Muscular weakness, Myalgia
Clinical narrative: This health authority case was initially  received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 49 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 12-Oct-2015 - unknown stop date, Batch no: U54606, Route of administration: Unknown, Dose: 0.5 ml, Site: Arm. No additional drugs suspected. On 12-Oct-2015, after receiving AFLURIA the patient experienced Sharp pain during injection. On an unknown date, he developed severe muscle pain/aching after and woke up next morning with weakness in his arm and limited range of motion. These effects had been ongoing. Reporter's assessment: The health authority assessed the events as non-serious. VAERS ID: 604724.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Scab, Skin warm
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 59 years old female patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 21-Oct-2015, Batch no: U54906, Route of administration: Unknown, Dose: 0.5 ml, site: ARM. No additional drugs suspected. On 21-Oct-2015, 1 day after receiving with AFLURIA the patient experienced red, hot, inflamed and crusted center in the postero-lateral fat of upper arm. On 24-Oct-2015, she received treatment with cephalexin (250 mg capsule).  Reporter's assessment: The health authority assessed the events as non-serious. VAERS ID: 604726.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Local swelling, Peripheral swelling
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 26 years old male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 27-Oct-2015 - unknown stop date, Batch no: 11049211A, Route of administration: Intramuscular, Dose: 0.5 ml, site: left arm. No additional drugs suspected. On 27-Oct-2015, 2 hours after vaccination the patient experienced Muscle aches, Headache, Swelling at shot site. On 28-Oct-2015, 1 day after receiving AFLURIA, the patient experienced Arm swollen to armpit area and chest. On an unknown date, after starting/treatment with AFLURIA the patient experienced Local swelling. For relevant test results see appropriate report section. Reporter's assessment: non-serious. The authority reported symptom included 'local swelling'. VAERS ID: 605676. Case correction (22-Mar-2016): Listedness for AE 5 (local swelling) changed to listed. Case correction 05-Apr-2016: AE 1 'arm swollen to armpit area and chest' changed to serious and medically significant. Case correction 12-Apr-2016: AE 1 verbatim changed from 'arm swollen to armpit area and chest' to 'arm swollen [to armpit area and chest]'. Addition of AE 6 '[arm] swollen to armpit area and chest' coded to LLT 'swelling' and re-ranked to AE 2.
Age: 32.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Pyrexia
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 32 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 27-Oct-2015 - unknown stop date, Batch no: U55206, Route of administration: Intramuscular, Dose: 0.5 ml, site; left arm. BOOSTRIX, batch # AC52B067EA, site: right arm. On 29-Oct-2015, after vaccination she had a reaction to the vaccine. She felt febrile last night and developed urticaria at the site of injection, swelling at the site of injection, erythema at the site of injection. The patient denied any other symptoms. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious. The patient believed that the it was the Tdap vaccine which was causing the reaction. VAERS ID: 605812
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: The health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 36 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 21-Oct-2015 - unknown stop date, Batch no: U57007, Route of administration: Intramuscular, Dose: 0.5 ml, site: left arm. No additional drugs suspected. On 23-Oct-2015, 3 days after starting/treatment with AFLURIA the patient experienced Rash on arms and legs. Event treatment: 5 day course of prednisone given by the doctor. For relevant test results see appropriate report section. Reporter's assessment: non-serious. VAERS ID: 605869.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 50 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 27-Oct-2015 - unknown stop date, Batch no: 11149221A, Route of administration: Intramuscular, Dose: 0.5 ml, site: left arm. No additional drugs suspected. On 28-Oct-2015, two days after receiving AFLURIA the patient experienced tenderness, redness and swelling at vaccination site which was well demarcated 35x60 mm. The outcome was reported as unknown. For relevant test results see appropriate report section. Reporter's assessment: non-serious. VAERS ID: 605897.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 60 years old female patient. Weight: not provided, Height: not provided. The patient has a medical history of Allergic to CLOROX, AUGMENTIN X/R, serotonin. The patient had no current illness. The patient received AFLURIA on 25-Sep-2015, Batch no: not provided, Route of administration: Intramuscular, Dose: Site: right arm. No additional drugs suspected. On 26-Sep-2015, 2 days after starting treatment with AFLURIA the patient experienced Tender area around injection site, Round and swollen around injection site, and Begun to itch. Reporter's assessment: Non serious. VAERS ID: 605987.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Headache, Hypoaesthesia, Nasal congestion
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 37 years old male patient. Weight: not provided, Height: not provided. The patient has a medical history of Low back pain. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 27-Oct-2105 - unknown stop date, Batch no: U56506, Route of administration: Intramuscular, Dose: 0.5 ml, site: right arm. No additional drugs suspected. On 27-Oct-2015, as soon as the patient left the building after the vaccination, he began to have dry cough and by the time he arrived on duty area (about 1 mile away), he had fullness of right side of his nose and was not able to breathe through the right nostril, but cough had resolved. On 27-Oct-2015, 2 hours after receiving AFLURIA the patient experienced Change in sensation in the right side of his jaw which progressed to include right side of the face up to the line between his ear and eye and included area around the right ear and right side of his tongue. This sensation was fully developed 2 hours post vaccination and lasted until he went to bed around midnight. The sensation was gone when he woke around 5.30. On 28-Oct-2015, the patient experienced slight headache when he awoke in the morning. He denied any further sensory changes. The headache dissipated towards the end of the day. The congestion in his right nostril followed the same time course as the numbness. On an unknown date, after starting treatment with AFLURIA the patient experienced Numbness. For relevant test results see appropriate report section. Reporter's assessment: non-serious. VAERS ID: 606066.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Sensory disturbance
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 37 years old male patient. Weight: not provided, Height: not provided. The patient has a medical history of Low back pain. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 27-Oct-2105 - unknown stop date, Batch no: U56506, Route of administration: Intramuscular, Dose: 0.5 ml, site: right arm. No additional drugs suspected. On 27-Oct-2015, as soon as the patient left the building after the vaccination, he began to have dry cough and by the time he arrived on duty area (about 1 mile away), he had fullness of right side of his nose and was not able to breathe through the right nostril, but cough had resolved. On 27-Oct-2015, 2 hours after receiving AFLURIA the patient experienced Change in sensation in the right side of his jaw which progressed to include right side of the face up to the line between his ear and eye and included area around the right ear and right side of his tongue. This sensation was fully developed 2 hours post vaccination and lasted until he went to bed around midnight. The sensation was gone when he woke around 5.30. On 28-Oct-2015, the patient experienced slight headache when he awoke in the morning. He denied any further sensory changes. The headache dissipated towards the end of the day. The congestion in his right nostril followed the same time course as the numbness. On an unknown date, after starting treatment with AFLURIA the patient experienced Numbness. For relevant test results see appropriate report section. Reporter's assessment: non-serious. VAERS ID: 606066.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site pain, Pain, Pain in extremity, Rhinorrhoea
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 55 years old female patient. Weight: not provided, Height: not provided. The patient has a medical history of Allergic to penicillin and codeine, Asthma, Anemia and smoker. The following drug history information was reported: Penicillin (Indication: -, Reaction: Allergy) and Codeine (Indication: -, Reaction: Allergy). For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 15-Oct-2015 - unknown stop date, Batch no: U59208, Route of administration: Intramuscular, Dose: 0.5 ml, site: left arm.  PNEUMOVAX (batch number: L024132, site: right arm, Indication: not provided). On 16-Oct-2015, 2 days after starting/treatment with AFLURIA the patient experienced Body aches, Bruising (site of injection), (Site of injection) and pain [going down arm], Pain going down arm, Runny nose. Event treatment: Apply ice pack on bruising. For relevant test results see appropriate report section. Reporter's assessment: non-serious. VAERS ID: 606153.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Pain, Peripheral swelling
Clinical narrative: This health authority case was initially received on  16-Dec-2015. The case report was received from a Health Professional and concerns a 23 years old female patient. Weight: not provided, Height: not provided. The patient has a medical history of Asthma. For concomitant medication and therapy dates refer to the appropriate report sections. The patient had no current illness. The patient received AFLURIA on 29-Oct-2015 - Batch no: U59208, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm. On the same day the patient also received PNEUMOVAX (batch no: K021030) in the left arm. Both vaccines were administered in the left arm (medication error not explicitly reported). VAERS ID: 606268. On 30-Oct-2015, 2 days after starting treatment with AFLURIA the patient experienced Swelling of the left arm, Muscle pain extending past elbow, Left side also hurt. Nurse at doctor was called and told patient to take paracetamol and ibuprofen for soreness/pain. Reporter's assessment: Non serious.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 22 years old female patient. Weight: not provided, Height: not provided. The patient had no medical history, current illness, or medications at time of vaccination. The patient received AFLURIA on 10-Oct-2015 - unknown stop date, Batch no: U57907, Route of administration: Intramuscular, Dose: 0.5 ml, Site: right arm. No additional drugs suspected. On 10-Oct-2015, 1 day after starting/treatment with AFLURIA the patient experienced Limited ROM, Soreness at the site of injection. Medrol steroid pack and cyclobenzaprine. Physician outlook was for the soreness to dissipate within the next 4-6 weeks. Reporter's assessment: Non serious. VAERS ID: 606295.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Back pain, Body temperature increased, Crying, Fatigue
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 21 years old female patient. Weight: no provided, Height: not provided. At the time of the event the patient concomitantly suffered from Sinus infection, seasonal allergies and acne. The patient has a medical history of Food allergies to peanuts and tree nuts. Flu shots - see case 2016060274. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 22-Oct-2015 - unknown stop date, Batch no: U55306, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 22-Oct-2015, upon receiving the flu shot, the patient felt soreness in the left arm near where it was administered. The patient told this was normal and experienced this symptom before. The pains worsened throughout the day, especially 2.30. By 4:00 the patient was experiencing strong stomach pains and back pains. The patient felt like someone took her and hit her into the metal locker over and over again. Approximately at 6.30 (when her parents returned from a walk), the patient was screaming and crying in pain which was unsual for her as she had a relatively high pain tolerance. Her temperature was checked by her father as the patient was holding a heating pad on her stomach and complaining that it was freezing. Her temperature was 103. She was taken to the emergency room where she screamed in pain for another 3 hours. Her fever had apparently gone down so she had to wait. At around 10 pm the patient was given morphine, diphenhydramine, antinausea medicine and an IV. After monitoring, the patient was released to go home at 1:40 am on 24-Oct-2015. The patient took acetaminophen and her temperature was 100.9 degrees when she went home. The patient continued to take acetaminophen for the next or so. The patient proceeded to sleep and watching TV for next 2 and half days since she was so tired from everything. The patient did not feel like doing anything and just had to wait a couple of days for the pain to go away. The outcome was recovered. For relevant test results see appropriate report section. Reporter's assessment: non-serious. VAERS ID: 606331. Linked case: 2016060274 (same patient).
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Feeling cold, Pain, Pain in extremity, Screaming
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a Health Professional and concerns a 21 years old female patient. Weight: no provided, Height: not provided. At the time of the event the patient concomitantly suffered from Sinus infection, seasonal allergies and acne. The patient has a medical history of Food allergies to peanuts and tree nuts. Flu shots - see case 2016060274. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 22-Oct-2015 - unknown stop date, Batch no: U55306, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 22-Oct-2015, upon receiving the flu shot, the patient felt soreness in the left arm near where it was administered. The patient told this was normal and experienced this symptom before. The pains worsened throughout the day, especially 2.30. By 4:00 the patient was experiencing strong stomach pains and back pains. The patient felt like someone took her and hit her into the metal locker over and over again. Approximately at 6.30 (when her parents returned from a walk), the patient was screaming and crying in pain which was unsual for her as she had a relatively high pain tolerance. Her temperature was checked by her father as the patient was holding a heating pad on her stomach and complaining that it was freezing. Her temperature was 103. She was taken to the emergency room where she screamed in pain for another 3 hours. Her fever had apparently gone down so she had to wait. At around 10 pm the patient was given morphine, diphenhydramine, antinausea medicine and an IV. After monitoring, the patient was released to go home at 1:40 am on 24-Oct-2015. The patient took acetaminophen and her temperature was 100.9 degrees when she went home. The patient continued to take acetaminophen for the next or so. The patient proceeded to sleep and watching TV for next 2 and half days since she was so tired from everything. The patient did not feel like doing anything and just had to wait a couple of days for the pain to go away. The outcome was recovered. For relevant test results see appropriate report section. Reporter's assessment: non-serious. VAERS ID: 606331. Linked case: 2016060274 (same patient).
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site pain, Injection site paraesthesia, Injection site swelling, Injection site warmth
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 32 year-old female patient who had no medical history and current illness. She was on citalopram at the time of vaccination. On 14-Oct-2015, the patient received AFLURIA injection (batch number U55106) via the intramuscular route on the right arm. On 14-Oct-2015, 4 hours following vaccination, the patient's injection site arm became swollen, hot to touch, tingling, aches, felt as if a tourniquet was above elbow, fingers were swollen, and her wrist and top of hand were swollen. She went to the emergency room and required doctor evaluation. She was diagnosed with cellulitis most likely from the flu vaccine. The outcome was recovered. Reporter's comments: The health authority assessed the case as not serious.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 32 year-old female patient who had no medical history and current illness. She was on citalopram at the time of vaccination. On 14-Oct-2015, the patient received AFLURIA injection (batch number U55106) via the intramuscular route on the right arm. On 14-Oct-2015, 4 hours following vaccination, the patient's injection site arm became swollen, hot to touch, tingling, aches, felt as if a tourniquet was above elbow, fingers were swollen, and her wrist and top of hand were swollen. She went to the emergency room and required doctor evaluation. She was diagnosed with cellulitis most likely from the flu vaccine. The outcome was recovered. Reporter's comments: The health authority assessed the case as not serious.
Age: 66.0
Sex: M
Vaccine: DTP, FLU3
Symptoms: Dysphagia, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 66 year-old male patient who had medical history of elevated PSA (prostate-specific antigen), carpal tunnel, hypothyroidism, environmental allergies and diverticulosis. Concomitant conditions included clear runny drainage from nose and postnasal drainage, possible from allergies. On 03-Oct-2014, the patient received AFLURIA injection (batch number T50607) on the left arm and DTP (Sanofi Pasteur, batch number C4695AA) on the right arm. On an unspecified date in Jan-2015, the patient was traveling and experienced weakness in legs, which eventually resolved. He also had trouble swallowing as residual effects which had not fully resolved. The outcome was not recovered. VAERS case ID: 607691 Reporter's comments: The health authority assessed the case as serious (caused disability) and reported the term 'Guillain-Barre syndrome.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Fatigue, Hypoaesthesia oral, Musculoskeletal stiffness
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) 36 years old female patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 04-Nov-2015, Batch no: U57507, Route of administration: Intramuscular, Dose: 0.5 ml, site: left arm. No additional drugs suspected. On 04-Nov-2015, the patient developed numbness around the mouth, chin and cheek area. Within an hour, the patient started to have tingling, pins and needles in her fingers and toes. The patient felt overall very tired and weak. Within 12 hours, she had extreme pain with stiffness in the lower back area including the muscles along her spine. The patient was sent to ER the next day. The patient was evaluated by a neurologist and prescribed pain medicine. Five days post vaccination, her numbness and tingling sensation are 70% gone, but her back pain and stiffness were only 10% lower. The outcome was reported as not recovered. Reporter's assessment: non-serious. VAERS ID: 608516.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Paraesthesia
Clinical narrative: This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) 36 years old female patient. Weight: not provided, Height: not provided. The patient received AFLURIA on 04-Nov-2015, Batch no: U57507, Route of administration: Intramuscular, Dose: 0.5 ml, site: left arm. No additional drugs suspected. On 04-Nov-2015, the patient developed numbness around the mouth, chin and cheek area. Within an hour, the patient started to have tingling, pins and needles in her fingers and toes. The patient felt overall very tired and weak. Within 12 hours, she had extreme pain with stiffness in the lower back area including the muscles along her spine. The patient was sent to ER the next day. The patient was evaluated by a neurologist and prescribed pain medicine. Five days post vaccination, her numbness and tingling sensation are 70% gone, but her back pain and stiffness were only 10% lower. The outcome was reported as not recovered. Reporter's assessment: non-serious. VAERS ID: 608516.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This health authority case was initially received on 22-Jan-2016. The case report was received from a Health Professional and concerns a 63 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient had no current illness. The patient received AFLURIA on 04-Nov-2015 - unknown stop date, Batch no: U55006, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm. No additional drugs suspected. On 05-Nov-2015, 2 days after starting treatment with AFLURIA, the patient applied ice to the injection site. After the removing the ice, the following were noted: the patient experienced the area was blue/purple (injection site), Swollen area with a milk design (injection site), The area was red (injection site), Area later became hot to touch (injection site). Later that day the patient saw a doctor in local urgent care who diagnosed the patient with Allergic reaction to flu shot, Hypersensitivity. The redness subsided but area that was red is now black. Prednisone 5mg 1 twice a day. Reporter's assessment: Non serious. The health authority coded additional term hypersensitivity. VAERS ID: 609809.
Age: 0.7
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Urticaria
Clinical narrative: This medically confirmed health authority report (initial receipt 22-Jan-2016) concerns an 8 months old female patient. The patient had medical history of allergy to sulfa and anesthetic. Her current illness included stomach pain in the past week for which lab was ordered by 'GYN'. On 07-Nov-2015, the patient received intramuscular AFLURIA injection (batch number: U56506) in the right arm. On 07-Nov-2015, the patient developed hives, dizziness and blood pressure of 112/70. She was treated with diphenhydramine (50 mg IM x 1). The outcome was recovered. Reporter comments: non-serious. VAERS ID: 610082.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Erythema, Rash generalised
Clinical narrative: This health authority case was initially received on 22-Jan-2016. The case report was received from a Health Professional and concerns a 35 years old female patient. Weight: not provided, Height: not provided. The patient has a medical history of NEOSPORIN; PCN; SEPTRA (allergy) and Scleroderma. The following drug history information was reported: NEOSPORIN (Indication: -, Reaction: Allergy), PCN (Indication: -, Reaction: Allergy), and SEPTRA (Indication: -, Reaction: Allergy). The patient had no listed medications at time of vaccination and denies current illness. The patient received AFLURIA for indication. Indication not reported on 13-Oct-2015 - unknown stop date, Batch no: U54606, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm. No additional drugs suspected. On 13-OCT-2015, 1 day after starting/treatment with AFLURIA the patient experienced some blistering between fingers and toes, rash-face, neck, trunk, buttocks, groin, hands and feet, red, raised. Reporter's assessment: Non serious. VAERS ID: 610131
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy skin abnormal, Drug eruption, Hypersensitivity, Rash, Rash pruritic
Clinical narrative: This health authority case was initially received on 22-Jan-2016. 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 refer to the appropriate report sections. The patient had no medical history or current illness. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported on 17-Oct-2015- unknown stop date, Batch no: U54506, 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 23-Ot-2015, 1 week 0 days after starting/ treatment with AFLURIA the patient experienced Allergic reaction to the flu vaccine (non serious, outcome: Recovered/ Resolved), Rash started on legs and neck; by morning covered with rash (non serious, outcome: Recovered/Resolved), (Rash) very itchy (non serious, outcome: Recovered/ Resolved), Biopsy result showed drug eruption (non serious, outcome: Recovered/ Resolved), Hypersensitivity (non serious, outcome: Recovered/Resolved), Biopsy skin abnormal (non serious, outcome: Recovered/ Resolved). The patient saw her allergies and she had no idea what it was. It was suggested the patient see the dermatologist who did a biopsy on the right arm. Results showed 'drug eruption' and he concluded that the patient had an allergic reaction to the flu vaccine. Nothing else was different- no change in food, meds, detergent etc.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Cold sweat, Dry throat, Eyelid oedema, Gingival disorder
Clinical narrative: This health authority case was initially received on 22-Jan-2016. The case report was received from a Health Professional and concerns a 34 years old male patient. Weight: not provided, Height: not provided. The patient has a medical history of Hypertension. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 10-Nov-2015 - unknown stop date, Batch no: U55806, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm. No additional drugs suspected. On 10-Nov-2015, 3-4 hours after starting treatment with AFLURIA the patient experienced Chest tightness, Wheeze, Dry throat, Scratchy throat, Itchy tongue, Swollen tongue, Swollen around eyes, Itchy gums, Increased heart rate, Dizzy, Swollen gums, Gingival disorder. On 10-Nov-2015, 4-6 hours after starting treatment with AFLURIA the patient experienced Cold sweat, Fever 100-101. Took diphenhydramine. Reporter's assessment: Non serious. VAERS ID: 611309. Case correction (22-Mar-2016): Company comments: updated 31-Mar-2016. Seriousness: Serious. Medically significant.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia, Throat irritation, Wheezing
Clinical narrative: This health authority case was initially received on 22-Jan-2016. The case report was received from a Health Professional and concerns a 34 years old male patient. Weight: not provided, Height: not provided. The patient has a medical history of Hypertension. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 10-Nov-2015 - unknown stop date, Batch no: U55806, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm. No additional drugs suspected. On 10-Nov-2015, 3-4 hours after starting treatment with AFLURIA the patient experienced Chest tightness, Wheeze, Dry throat, Scratchy throat, Itchy tongue, Swollen tongue, Swollen around eyes, Itchy gums, Increased heart rate, Dizzy, Swollen gums, Gingival disorder. On 10-Nov-2015, 4-6 hours after starting treatment with AFLURIA the patient experienced Cold sweat, Fever 100-101. Took diphenhydramine. Reporter's assessment: Non serious. VAERS ID: 611309. Case correction (22-Mar-2016): Company comments: updated 31-Mar-2016. Seriousness: Serious. Medically significant.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Dizziness, Muscle disorder
Clinical narrative: This health authority case was initially received on 22-Jan-2016. 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 refer to the appropriate report sections. The patient had no stated or documented current illness. The patient received AFLURIA on 24-Nov-2015 - unknown stop date, Batch no: U50709, Route of administration: Intramuscular, Dose: 0.5 ml Site: left arm. No additional drugs suspected. On 24-Nov-2015, shortly after starting/treatment with AFLURIA the patient experienced Confusion, Dizziness, Reaction involving their muscles, patient unsure if seizures or convulsions. It occurred every half hour for a while. She did not seek medical advice or consultation. The patient felt better on 27-Nov-2015 3 pm. Reporter's assessment: Non serious. VAERS ID: 612164.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Heart rate increased, Hyperhidrosis, Lethargy
Clinical narrative: This health authority case was initially received on 22-Jan-2016. The case report was received from a Health Professional and concerns a 23 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient had no current illness and medical history was not applicable. Suspect drug (s)), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA indication not reported on 01-Dec-2015- unknown stop date, Batch no: U50909, 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 01-Dec-2015 17:30, after starting/ treatment with AFLURIA the patient experienced Wheeze (non serious, outcome: Recovered/ Resolved), Dry cough (non serious, outcome: Recovered/ Resolved), Fast heart beat (non serious, outcome: Recovered/Resolved) and chest tightness (non serious, outcome: recovered/ resolved). At 6:30pm the patient had Rash shoulder to shoulder, chest (non serious, outcome: Recovered/ Resolved) and took 1 diphenhydramine. She called MD (medical doctor) friend at approximately 7pm. At 8pm, she had sweating (non serious, outcome: Recovered/Resolved) and took 2 diphenhydramine. On 02-Dec-2015 1-2am, the patient experienced Eyes swollen (non serious, outcome: Recovered/ Resolved), Lips swollen (non serious, outcome: Recovered/Resolved), rash was worse, and she vomited three times (non serious, outcome: Recovered/Resolved). The morning of 02-Dec-2015, she was lethargic (non serious, outcome: Recovered/Resolved) but no rash and no cough. Event treatment: diphenhydramine two doses.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Rash, Vomiting, Wheezing
Clinical narrative: This health authority case was initially received on 22-Jan-2016. The case report was received from a Health Professional and concerns a 23 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient had no current illness and medical history was not applicable. Suspect drug (s)), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA indication not reported on 01-Dec-2015- unknown stop date, Batch no: U50909, 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 01-Dec-2015 17:30, after starting/ treatment with AFLURIA the patient experienced Wheeze (non serious, outcome: Recovered/ Resolved), Dry cough (non serious, outcome: Recovered/ Resolved), Fast heart beat (non serious, outcome: Recovered/Resolved) and chest tightness (non serious, outcome: recovered/ resolved). At 6:30pm the patient had Rash shoulder to shoulder, chest (non serious, outcome: Recovered/ Resolved) and took 1 diphenhydramine. She called MD (medical doctor) friend at approximately 7pm. At 8pm, she had sweating (non serious, outcome: Recovered/Resolved) and took 2 diphenhydramine. On 02-Dec-2015 1-2am, the patient experienced Eyes swollen (non serious, outcome: Recovered/ Resolved), Lips swollen (non serious, outcome: Recovered/Resolved), rash was worse, and she vomited three times (non serious, outcome: Recovered/Resolved). The morning of 02-Dec-2015, she was lethargic (non serious, outcome: Recovered/Resolved) but no rash and no cough. Event treatment: diphenhydramine two doses.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Middle insomnia, Mobility decreased, Tremor
Clinical narrative: This health authority case was initially received on 22-Jan-2016. The case report was received from a(n) Health Professional and concerns a(n) 56 years old female patient. Weight: not provided, Height: not provided. The patient has a medical history of Asthma. The patient received AFLURIA on 22-Oct-2015, Batch no: U51009, Route of administration: SYR, Dose: 0.5 ml, Site: left arm. No additional drugs suspected. On 22-Oct-2015, a few hours after starting treatment with AFLURIA the patient experienced Left shoulder started to hurt, Couldn't lift arm above 50 degree angle, Hand and arm shakes when lifted above 50 degrees, Awakens at night because of pain, Injection site pain. The shot itself was painless. Reporter's assessment: Non serious. The health authority coded additional term injection site pain.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Injected limb mobility decreased, Injection site discomfort, Injection site pain, Mobility decreased
Clinical narrative: This health authority case was initially received on 22-Jan-2016. The case report was received from a Health Professional and concerns a 50 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient had no medical history or current illness. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported as 22-Oct-2015- unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: Site: left arm. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/ event (s) and outcome: On 22-Oct-2015, within a couple of hours starting/ treatment with AFLURIA the patient experienced shoulder hurt at the injection site (non serious, outcome: Unknown). Over the next few days the patient experienced Pulled a muscle in shoulder (non serious, outcome: Unknown), Significant discomfort (non serious, outcome: Unknown), Decreased mobility (non serious, outcome: Unknown). Now six weeks later, the patient was almost completely recovered, with very minor mobility limitation and muscle weakness (non serious, outcome: unknown). The patient also experienced injected limb mobility decreased (non serious, outcome: Unknown), Injection site discomfort (non serious, outcome: Unknown).
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: This health authority case was initially received on 22-Jan-2016. The case report was received from a Health Professional and concerns a 50 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient had no medical history or current illness. Suspect drug (s), timing and conditions surrounding the onset of reaction (s)/event (s): The patient received AFLURIA for indication not reported as 22-Oct-2015- unknown stop date, Batch no: not provided, Route of administration: Intramuscular, Dose: Site: left arm. Additional suspect drug (s): No additional drugs suspected. Reaction (s)/ event (s) and outcome: On 22-Oct-2015, within a couple of hours starting/ treatment with AFLURIA the patient experienced shoulder hurt at the injection site (non serious, outcome: Unknown). Over the next few days the patient experienced Pulled a muscle in shoulder (non serious, outcome: Unknown), Significant discomfort (non serious, outcome: Unknown), Decreased mobility (non serious, outcome: Unknown). Now six weeks later, the patient was almost completely recovered, with very minor mobility limitation and muscle weakness (non serious, outcome: unknown). The patient also experienced injected limb mobility decreased (non serious, outcome: Unknown), Injection site discomfort (non serious, outcome: Unknown).
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Pain
Clinical narrative: This health authority case was initially received on 22-Jan-2016. The case report was received from a Health Professional and concerns a 60 years old male patient. Weight: not provided, Height: not provided. The patient has a medical history of Asthma. For concomitant medication and therapy dates refer to the appropriate report section. The patient received AFLURIA on 07-Oct-2015 - unknown stop date, Batch no: U59508, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm. No additional drugs suspected. On 08-Oct-2015, 2 days after starting/treatment with AFLURIA the patient experienced Numbness, Pain, Inability to move arm as he did before vaccination. Patient was going to see a physical therapist. Reporter's assessment: Non serious. VAERS ID: 613657.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site haemorrhage, Mobility decreased, Muscular weakness
Clinical narrative: This health authority case was initially received on 22-Jan-2016. The case report was received from a(n) Health Professional and concerns a(n) 69 years old female patient. Weight: not provided, Height: not provided. The patient has a medical history of Seasonal allergies. The patient had no previous side effects after any of 20 or more annual flu vaccinations. The patient received AFLURIA on 22-Oct-2015, Batch no: U59508, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm. No additional drugs suspected. On 22-Oct-2015, 1 day after starting treatment with AFLURIA the patient experienced Sore arm. On 22-Oct-2015, after starting treatment with AFLURIA the patient experienced Shot high on my deltoid muscle, Immediately bled, It was black and blue, Weak arm, Limited motion, Immediate post injection reaction, and Mobility decreased. The patient still had weak arm and limited motion since that day and it was now 08-Dec-2015. Reporter's assessment: Non serious. The health authority coded additional terms immediate post injection reaction and mobility decreased.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This health authority case was initially received on 22-Jan-2016. The case report was received from a(n) Health Professional and concerns a(n) 69 years old female patient. Weight: not provided, Height: not provided. The patient has a medical history of Seasonal allergies. The patient had no previous side effects after any of 20 or more annual flu vaccinations. The patient received AFLURIA on 22-Oct-2015, Batch no: U59508, Route of administration: Intramuscular, Dose: 0.5 ml, Site: left arm. No additional drugs suspected. On 22-Oct-2015, 1 day after starting treatment with AFLURIA the patient experienced Sore arm. On 22-Oct-2015, after starting treatment with AFLURIA the patient experienced Shot high on my deltoid muscle, Immediately bled, It was black and blue, Weak arm, Limited motion, Immediate post injection reaction, and Mobility decreased. The patient still had weak arm and limited motion since that day and it was now 08-Dec-2015. Reporter's assessment: Non serious. The health authority coded additional terms immediate post injection reaction and mobility decreased.