chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 728302), concerns a 72-year-old elderly female patient. The patient's current condition included hypothyroidism, hypertension and depression. On 21-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: right arm, batch number: 179401). On 22-Nov-2017, 1 day after vaccination, the patient visited the pharmacy with complaints of red welt at injection site. The patient was concerned so went to emergency room (ER) to have a check-up. The patient was prescribed with 7-days course of doxycycline. The outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 85.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: This non-serious spontaneous case, initially retrieved on 30-Mar-2018, reported by other health professional and concerns 85-year-old, elderly, female patient. The patient was allergic to codeine. The patient's current condition included high blood pressure. The patient had no lab data. The patient's concomitant medications included Amlodipine, Glucosamine, Calcium and B complex for an unknown indication. On 05-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: unknown, anatomical location; arm, batch number: 178301 and expiry date: not reported). On 06-Sep-2017, 1 day after vaccination, the patient experienced pain and her arm movement was restricted. The patient was treated with ibuprofen. After 2 mos of pain (as reported), the patient went to primary care where she was told that, the vaccine went into tendon of the arm and it would take months to resolve itself. At the time of this report, the outcome of the events was not recovered. The reporter assessed this case as non-serious.
Age: 72.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin tightness
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 728363), concerns a 72-year-old, elderly, female patient. The patient's historical conditions, allergies, current illness and concomitant medications were not reported. On 07-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (as reported 1), anatomical location: left arm, batch number: 179303, route of administration: unknown and expiry date: not reported) and non-company suspect product PREVNAR 13 (dose: 1 DF, anatomical location: right arm, batch number: S43277, route of administration: unknown and expiry date: not reported). On 08-Nov-2017, after 1 day of vaccination, the patient's entire arm appeared swollen and pink. The patient also complained of tight itchy feeling. At the time of this report, the outcome of the events was unknown. The reporter assessed the events as non-serious.
Age: 66.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 728365), concerns a 66-year-old, elderly, male patient. The patient's historical condition, allergies and concomitant medications were not reported. The patient had no current illness. On 13-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179523 and expiry date: not reported). On the same day, after the vaccination, the patient experienced soreness in arm, which worsened at night. The patient also experienced pain in left shoulder across the back of the neck. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypoaesthesia, Injection site nerve damage, Pain in extremity, Vaccination site pain, Vaccination site warmth
Clinical narrative: This spontaneous case, reported by other non health professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 728444), concerns a 71-year-old elderly female patient. On 27-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml (reported as unknown), route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On the same day of vaccination, the patient experienced pain and felt hot at the vaccination site. A couple of hours later, the patient experienced numbness in index, middle finger, later whole arm. The patient's arm also hurt. The patient suspected that, the events occurred as the injection hit a nerve. The patient reported to pharmacy and consulted a doctor, who recommended to go to emergency room. On the third day the patient felt almost normal and fourth day became normal. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site discomfort, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 728446), concerns a 67-year-old elderly female patient. The patient's current condition included penicillin allergy. On 29-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (unk as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 178607). On 30-Sep-2017, the patient experienced continual pain, discomfort, inflammation and redness at injection site since the vaccination date. At the time of this report, the patient was recovered from the events. The reporter assessed the case as non-serious.
Age: 80.0
Sex: F
Vaccine: FLUA3
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 728477), concerns 80-year-old elderly female patient. The patient had no medical history, current condition, concomitant medications and no allergies. On 15-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On the same day of vaccination, the patient experienced swelling, redness from the site of injection to down her elbow and headache, which was reported as bad and could not get out of the bed for few days. The patient had recovered from the events. The reporter assessed this case as non-serious.
Sex: U
Vaccine: FLUA3
Symptoms: Electromyogram abnormal, Musculoskeletal disorder, Myalgia, Neuralgic amyotrophy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 728549), concerns a patient of an unspecified age and gender. The patient's historical conditions, allergies and concomitant medications were not reported. The patient had no current illness. On 05-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179002 and expiry date: not reported). On 13-Oct-2017, after 8 days of vaccination, the patient experienced soreness under right shoulder muscle. On 16-Oct-2017, after 11 days of vaccination, her hand froze up and she lost use of her hand. On an unspecified date, the patient went to the emergency room. The patient underwent MRI (magnetic resonance imaging), X-ray, EMG (electromyogram) which showed diagnosis of Parsonage-Turner syndrome. It was reported that the patient was diagnosed with Parsonage-Turner syndrome between 20 to 21 Oct-2017. The patient received physical therapy for the event. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the event as non-serious.
Sex: U
Vaccine: FLUA3
Symptoms: X-ray abnormal
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 728549), concerns a patient of an unspecified age and gender. The patient's historical conditions, allergies and concomitant medications were not reported. The patient had no current illness. On 05-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179002 and expiry date: not reported). On 13-Oct-2017, after 8 days of vaccination, the patient experienced soreness under right shoulder muscle. On 16-Oct-2017, after 11 days of vaccination, her hand froze up and she lost use of her hand. On an unspecified date, the patient went to the emergency room. The patient underwent MRI (magnetic resonance imaging), X-ray, EMG (electromyogram) which showed diagnosis of Parsonage-Turner syndrome. It was reported that the patient was diagnosed with Parsonage-Turner syndrome between 20 to 21 Oct-2017. The patient received physical therapy for the event. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the event as non-serious.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Oral mucosal blistering, Pain, Pyrexia, Urticaria
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 728566), concerns a 72-year-old, elderly, female patient. The patient's medical history was unknown, and the patient had no known allergies. The concomitant medications included Budesonide for an unknown indication (since an unspecified date). On 14-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On 15-Nov-2017, after 1 day of vaccination, the patient experienced blisters in mouth, red and welts on face, fever and aches. On an unspecified date in 2017, the patient went to physician. At the time of the report, the patient had recovered from the events blistering of mouth, redness, ache, fever and welts. The reporter assessed the case as non-serious.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 728613), concerning a 71-year-old, elderly female patient. The patient's historical condition included: fibromyalgia. The patient was allergic to codeine and penicillin. Concomitant medications included: levothyroxine, hydrocodone with APAP and alprazolam for an unknown indication. On 10-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as 1 dose), route of administration: injection (reported as SYR), anatomical location: left arm, batch number: 179301, expiry date: not reported). It was reported that, the injection was given close to her shoulder. On 27-Nov-2017, after 17 days of vaccination, the patient felt like the area was hurting her since then. The patient made a visit to the physician's office for the event and was scheduled to have an MRI (magnetic resonance imaging). No lab test was done. At the time of this report, the subject had not yet recovered from the event injection site pain. The reporter assessed this case as non-serious.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Pruritus
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 728765), concerns a 73-year-old, elderly female patient. The patient was vaccinated with influenza vaccine in past (every year) without any reaction. On 01-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: unknown, batch number: 179203, expiry date: not reported). On 03-Nov-2017, after 2 days of vaccination, the patient experienced itching on legs, chest and arms. It was reported that, the reaction was due to the flu shot and not due to any other medication. On an unspecified date, the patient had recovered from the event. The reporter assessed the case as non-serious.
Sex: M
Vaccine: FLUA3
Symptoms: Swelling, Tenderness
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 728778), concerns a 71-year-old elderly male patient. The patient's medical history and concomitant medications were not reported. The patient did not have any current illness. On 16-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5ml (N/A as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 179601). On 22-Oct-2017, 6 days after vaccination, the patient experienced a half inch raised bump which was not red. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as non-serious. Significant case correction received on 30-Mar-2018: As determined causality of the events (swelling and tenderness) was corrected from related to unassessable and case comment was amended accordingly.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: C-reactive protein, Full blood count, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 728826), concerns a 69-year-old elderly female patient. The patient's historical condition included recurrent UTI. Due to unspecified Sulphonamide drug, the patient had experienced nausea. The patient's current conditions included seasonal allergies, anxiety, essential tremor, osteoarthritis, urinary tract infection (UTI), hypothyroidism and was allergic to sulpha drugs. The patient's concomitant medications included Alprazolam, fluticasone, Levothyroxine, Montelukast, Primidone and Sertiraline. On 17-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5ml (reported as unknown), route of administration: injection (SYR: as reported), anatomical location: left arm, batch number: 179303, expiry date: not reported). On the same day after vaccination, the patient experienced severe shoulder pain and inability to move left shoulder in full range. The patient thought, it was usual pain due to vaccination, but got worsened and limitation in range of motion became more apparent. The patient was treated with ibuprofen (800mg) which did not help the patient and felt like something was tearing inside the shoulder while moving. It was reported that, patient felt difficulty in sleeping due to pain. On examination, the patient's left shoulder was normal in appearance, without erythema, swelling and warmth. The patient's active range of motion of the left shoulder was greatly decreased with minimal ability to rotate internally, moderately decreased external rotation, abduction to 90, and forward flexion to approximately 100 and was with pain. Passive range of motion with slightly better than this but because of severe pain this testing was abandoned. The patient's left shoulder was tender to palpation anteriorly and laterally. Right shoulder was normal with full range of motion and no tenderness too palpation. Range of motion of cervical spine was intact as well. There was no muscle atrophy noted. The patient's abduction strength was decreased due to pain, but motor strength was intact in both upper extremities. The arms of the patient were neurovascularly intact. No rashes were noted. On 29-Nov-2017, x ray of left shoulder was performed, which was normal and complete blood count (CBC), comprehensive metabolic panel (CMP), sedimentation rate, C-reactive protein, and Magnetic resonance imaging (MRI) of the left shoulder was performed, results were pending. The patient was treated with MEDROL and tramadol for pain, subsequently advised to stop ibuprofen. The patient was advised to start hydrocodone if needed and referred for physical therapy. At the time of this report, the outcome of the events was not recovered. The reporter assessed this case as non-serious.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Metabolic function test, Nuclear magnetic resonance imaging, Pain, Red blood cell sedimentation rate, X-ray limb normal
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 728826), concerns a 69-year-old elderly female patient. The patient's historical condition included recurrent UTI. Due to unspecified Sulphonamide drug, the patient had experienced nausea. The patient's current conditions included seasonal allergies, anxiety, essential tremor, osteoarthritis, urinary tract infection (UTI), hypothyroidism and was allergic to sulpha drugs. The patient's concomitant medications included Alprazolam, fluticasone, Levothyroxine, Montelukast, Primidone and Sertiraline. On 17-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5ml (reported as unknown), route of administration: injection (SYR: as reported), anatomical location: left arm, batch number: 179303, expiry date: not reported). On the same day after vaccination, the patient experienced severe shoulder pain and inability to move left shoulder in full range. The patient thought, it was usual pain due to vaccination, but got worsened and limitation in range of motion became more apparent. The patient was treated with ibuprofen (800mg) which did not help the patient and felt like something was tearing inside the shoulder while moving. It was reported that, patient felt difficulty in sleeping due to pain. On examination, the patient's left shoulder was normal in appearance, without erythema, swelling and warmth. The patient's active range of motion of the left shoulder was greatly decreased with minimal ability to rotate internally, moderately decreased external rotation, abduction to 90, and forward flexion to approximately 100 and was with pain. Passive range of motion with slightly better than this but because of severe pain this testing was abandoned. The patient's left shoulder was tender to palpation anteriorly and laterally. Right shoulder was normal with full range of motion and no tenderness too palpation. Range of motion of cervical spine was intact as well. There was no muscle atrophy noted. The patient's abduction strength was decreased due to pain, but motor strength was intact in both upper extremities. The arms of the patient were neurovascularly intact. No rashes were noted. On 29-Nov-2017, x ray of left shoulder was performed, which was normal and complete blood count (CBC), comprehensive metabolic panel (CMP), sedimentation rate, C-reactive protein, and Magnetic resonance imaging (MRI) of the left shoulder was performed, results were pending. The patient was treated with MEDROL and tramadol for pain, subsequently advised to stop ibuprofen. The patient was advised to start hydrocodone if needed and referred for physical therapy. At the time of this report, the outcome of the events was not recovered. The reporter assessed this case as non-serious.
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Arthralgia, Borrelia test negative, Chills, Culture urine, Diarrhoea
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 729043), concerns a 72-year-old, elderly, male patient. The patient had a history of polio and biliary cirrhosis (on unspecified dates). The patient had allergy to NEXIUM. The patient had no current illness, however concomitant medications included CIALIS, vitamin B12, MVI, finasteride, ranitidine, aspirin, ursodiol, COLCRYS for unknown indications. On 15-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 178601, expiry date: not reported). On 17-Nov-2017, after 3 days of vaccination, the patient experienced chills, rash, joint pain, diarrhoea and dark urine. On 20-Nov-2017, the patient visited emergency room for consultation. The lab tests performed included, Borrelia test which was negative (for Lyme), Influenza A and B tests (results were not provided), urine culture and urine analysis. The patient was prescribed with loratadine 10 mg daily for rash, doxycycline 100 mg twice daily for 10 days for possible Lyme. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious. Non-significant case correction received with IRD 07-Apr-2018: Generic name was added for the drug NEXIUM in narrative and case comment. Narrative was amended accordingly.
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Influenza A virus test, Influenza B virus test, Rash, Urine analysis, Urine analysis abnormal
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 729043), concerns a 72-year-old, elderly, male patient. The patient had a history of polio and biliary cirrhosis (on unspecified dates). The patient had allergy to NEXIUM. The patient had no current illness, however concomitant medications included CIALIS, vitamin B12, MVI, finasteride, ranitidine, aspirin, ursodiol, COLCRYS for unknown indications. On 15-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 178601, expiry date: not reported). On 17-Nov-2017, after 3 days of vaccination, the patient experienced chills, rash, joint pain, diarrhoea and dark urine. On 20-Nov-2017, the patient visited emergency room for consultation. The lab tests performed included, Borrelia test which was negative (for Lyme), Influenza A and B tests (results were not provided), urine culture and urine analysis. The patient was prescribed with loratadine 10 mg daily for rash, doxycycline 100 mg twice daily for 10 days for possible Lyme. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious. Non-significant case correction received with IRD 07-Apr-2018: Generic name was added for the drug NEXIUM in narrative and case comment. Narrative was amended accordingly.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Bone pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: This initial spontaneous case, reported by other non-health care professional to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (regulatory reference number: 729046), concerning a 77-year-old, elderly, female patient. The patient's medical history and current illness were not reported. The patient did not have any known allergies. On 06-Oct-2014, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as 1), route administration: unknown, anatomical location: arm, batch number and expiry date: not reported). On an unspecified date, after vaccine administration, the patient experienced severe shoulder, arm, elbow and bone pain. On 12-Oct-2017, the patient consulted to physician who sent her to rheumatologist. Subsequently, on 20-Oct-2017, she was treated with cortisone and prednisone shot from which she got relief from the pain. Reportedly, the pain eased up for a while, but it continued. Consequently, she was treated with TYLENOL (500 mg, BID) from which she got relief from the pain for 3 hours. On an unspecified date, the patient again consulted physician for the events. Outcome of the events was not reported. The reporter considered the case as non-serious.
Sex: F
Vaccine: FLUA3
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: This spontaneous case, reported  by other healthcare professional to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 729073), concerns an 89-year-old, elderly female patient. The historical condition included, breast cancer and mastectomy was done for it. The patient never had any issues with the high dose flu vaccine and received FLUZONE in the past. The patient had no other current illnesses, but she checked blood sugar (result not reported). The patient was allergic to penicillin and fish allergy. On 24-Aug-2017, the patient was administered with FLUAD (TIV) first time (dose: 0/5 ml (as reported N/A), route of administration: intramuscular, anatomical location: right arm, batch number 178502, expiry date: not reported). On 14-Sep-2017, after 21 days, the patient experienced throbbing pain in right arm which disturbed her sleep. The patient was right handed so did not feel pain during the day since she used it most of the time. The patient felt pain when the arm was at rest. On 01-Dec-2017, the patient visited the pharmacy for the reported event. The patient consulted MD (doctor of medicine) and thought that vaccine injected into muscle had something to do wit the events. The patient was treated with TYLENOL 650 mg for pain. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 65.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Insomnia, Myalgia
Clinical narrative: This initial spontaneous case, reported by a other health care professional to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (regulatory reference number: 729170), concerning a 65-year-old, elderly, male patient. It was reported that the patient did not have any current illness. However, it was also reported that the patient's current condition included diabetes and hypertension since an unspecified date. The patient also had allergy to penicillin since an unspecified date. Concomitant medication included metformin, testosterone cypionate and ergocalciferol for an unknown indication. On 28-Aug-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 178301, and expiry date: not reported). On the same day, the patient was also vaccinated with PREVNAR 13 (dose: reported as 1, route of administration: intramuscular, anatomical location: right arm, batch number: R33239, and expiry date: not reported). On an unspecified date in 2017, within a week of  receiving the vaccines his right arm developed muscular pain which worsened at night when he used to sleep on that arm (as reported). Reportedly, the same had continued for the last 3 months with no improvement and he was unable to sleep with his weight on that side anymore. At the time of this report, the patient had not recovered from the events. The reporter considered this case as non-serious.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain in extremity, Wrong drug administered
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 729442), concerns a 69-year-old, male patient. On 04-Dec-2017, approximately 11:45 AM, the patient was administered with FLUAD (TIV) (route of administration, anatomical location, batch number, expiry date: not reported) instead of PREVNAR 13. At 12:15 PM the patient realized the receipt of FLUAD vaccine. On 05-Dec-2017, approximately at 09:50 AM, the next day of vaccination, the patient reported the pharmacy about arm pain. On an unspecified date, the patient recovered from the event. The reporter assessed the case as non-serious. Significant case-correction received with IRD 30-Mar-2018: The causality was changed from unassessable to related and case comment was amended accordingly. No changes were made in the narrative.
Age: 84.0
Sex: M
Vaccine: FLUA3
Symptoms: Dizziness, Fatigue, Loss of consciousness, Malaise
Clinical narrative: This spontaneous case, reported by other non healthcare professional to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 729460), concerns an 84-year-old, elderly male patient. The patient's current conditions included, angina, atherosclerotic heart disease, essential hypertension, allergic rhinitis and no other current illness was reported. The patient's concomitant medications included, metoprolol succinate ER, amlodipine, isosorbide mononitrate ER, clopidogrel, aspirin, nitroglycerin for unknown indications. No lab data was reported. On 13-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 178503, expiry date: not reported). On the same day, approximately 45 minutes after vaccination, while patient was walking, experienced dizziness and passed out. The patient lost consciousness for a few seconds. The patient felt dizzy and was tired for several minutes afterward and felt unwell completely for 2 days. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUA3
Symptoms: Bursitis, Pain
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VSERS ID: 729520), concerns an 89-year-old, elderly, female patient. The patient's historical conditions, allergies, current illness and concomitant medications were not reported. On 04-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 178601 and expiry date: not reported). On 29-Nov-2017 after 1 month 26 days of vaccination, the patient experienced pain. The patient went to the physician office and started the therapy (unspecified). the patient's doctor and therapist reported that, it was an inflammation of shoulder bursa. At the time of this report, the outcome of the events was unknown. The reporter assessed the event as non-serious. Significant case correction received on 07-Apr-2018: As determined causality of the event shoulder bursitis was corrected from unassessable to related and case comment was amended accordingly.
Age: 73.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Gingival swelling, Mouth swelling, Rash generalised
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 729545), concerns a 73-year-old, elderly, female patient. The patient's historical conditions and concomitant medications were not reported. The patient had no current illness. The patient had been allergic to penicillin (PCN), cephalosporin, sulpha drugs and macrolide (self diagnosed). On 04-Dec-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 178601 and expiry date: not reported) and non-company suspect product PREVNAR 13 (dose: 1 DF (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: S39S64 and expiry date: not reported). On the same day, after the vaccination, the patient experienced swelling of gums, mouth and rash on the body. The patient received unspecified antihistamine drugs. On 05-Dec-2017 (next morning), the patient called the pharmacy and she was recommended to go to the PCP (primary care physician). It was reported that, the patient felt better. At the time of this report, the patient was recovering from the events. The reporter assessed the events as non-serious.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 729773), concerns a 69-year-old, elderly, female patient. The patient's historical conditions, allergies, current illness and concomitant medications were not reported. On 02-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as 1), anatomical location: left arm, batch number: 179523, route of administration: unknown and expiry date: not reported). On the same day, after the vaccination, the patient complained of sore and painful arm. At the time of this report, the outcome of the event was unknown. The reporter assessed the event as non-serious.
Age: 73.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: This initial spontaneous case, reported by a other health care professional to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (regulatory reference number: 729829), concerning a 73-year-old, elderly, female patient. The patient's medical history, allergies, current illness and concomitant medication was not reported. On 21-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as N/A), route of administration: intramuscular, anatomical location: left arm, batch number: 179523, and expiry date: not reported). On the same day, the patient was also vaccinated with PNEUMOVAX (dose: reported as N/A, route of administration: intramuscular, anatomical location: right arm, batch number: N019983, and expiry date: not reported). On the same day after vaccination, the patient experienced a strong aching pain with pressure upon injection. Reportedly, the pain was a constant throbbing pain that ran down her entire right arm. Outcome of the events was not reported. The reporter considered this case as non-serious.
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Pain, Pruritus, Vaccination site nodule, Vaccination site swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 729922), concerns an 82-year-old, elderly, male patient. The patient's historical conditions included Meniere's disease, DVT (deep vein thrombosis). The patient's current conditions included lung cancer (reported as CA lung [radiation on 29-Oct-2017]). The patient's concomitant medications included Fluid pill, K+ and ELIQUIS. On 17-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5ml [1 as reported], route of administration: intramuscular, anatomical location: left arm, batch number: 178903 and exp date: not reported). On 22-Nov-2017, 5 days after vaccination, the patient experienced itching and soreness. Additionally, the site of vaccination was raised, nodules and redness appeared. The patient denied any soreness and itching, but the pharmacist has given BENADRYL 25 mg per oral and apply warm moist heat after going home. The patient was expected to return on 29-Nov-2017. At time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Non-significant case correction was received with IRD 07-Apr-2018: The lead sentence was corrected, and the batch number ass added in the product section. The narrative was amended accordingly.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Arthralgia, Asthenia, Lethargy, Nodule, Temperature intolerance
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 729950), concerns a 72-year-old, elderly female patient. The patient had a history of fever and hives due to unspecified vaccine, approximately at 10 year of age. The patient's historical conditions included, diabetes, thyroid, enlarged heart and current condition included, allergy to nuts. No lab data was reported. On 16-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as unknown), route of administration: injection (reported as SYR), anatomical location: right arm, batch number, expiry date: not reported). On 17-Nov-2017, the next day of vaccination, the patient experienced lethargy for a week, weakness, aches in joints. On the same day, the patient also developed knot in armpit and was cold sensitive. The patient visited the physician for the events. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous case, reported by a other health professional to VAERS and initially retrieved on 07-APr-2018 by Seqirus from VAERS (regulatory reference number: 729975), concerning a 68-year-old, elderly, female patient. The patient was allergic to tetracycline since an unspecified date. It was reported that the patient had no relevant medical history and no current illness. However, it was also reported that the patient's concomitant medications included Aspirin, topiramate, Atorvastatin, omeprazole, fluoxetine, HCTZ, hydrocodone bit and homatropine meth, amlodipine, Tessalon perle and potassium chloride. On 27-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as UNK), route of administration: intramuscular, anatomical location: left arm, batch number: 179302, and expiry date: not reported). On 29-Nov-2017, two days after vaccination, the patient experienced redness in her left arm which was halfway down her arm and pain was noted with touch. On an unspecified date, the patient recovered from the events. The reporter considered this case as non-serious.
Age: 82.0
Sex: M
Vaccine: FLUA3
Symptoms: Muscle contractions involuntary, Pyrexia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 729990), concerns an 82-year-old, elderly male patient. The patient's current conditions included, dementia, stenosis, chronic anxiety. The patient had no known allergies. The concomitant medications included, hydrocodone-acetamin (as reported), venlafaxine, risperidone, trazodone, loperamide for unknown indications. On 08-Dec-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number: 6882121 (as reported), expiry date: not reported). [The reported batch number (6882121), does not match Seqirus batch numbers, however, because the reporter named Seqirus product 'FLUAD (TIV)' as the suspect vaccine, this report has been conservatively entered as a Seqirus case]. On the same day, after vaccination, the patient experienced fever and loss of muscle control. At the time of this report, the patient had not recovered from all the events. The reporter assessed this case as non-serious. Non-significant case correction received with IRD on 07-Apr-2018: The sentence 'the had no known allergies' was corrected to 'the patient had no known allergies' in the narrative.
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Immediate post-injection reaction, Injection site induration, Injection site nodule
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 729997), concerns a 74-year-old, elderly, male patient. The patient's historical conditions, current illness, allergies and concomitant medications were not reported. On 09-Dec-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: 179601 and expiry date: not reported). On the same day, immediately after the vaccination, the patient developed a nodule at the injection site. The nodule was of marble size and firm. The patient did not experience any different feeling and pain. The area was massaged and monitored. After 3 minutes (at 11:33 AM), nodule was rechecked, and it was not growing, no redness and nodule was less firm than 3 min prior (as reported). The patient was continued to monitor, and no other signs/symptoms of allergic reaction were observed. Nodule was rechecked after 5 more min (11:38 AM) and it had dissipated, but was not completely gone. It was stated that, reporter was able to massage the nodule and it was not firm in the center. At the time of this report, the outcome of the events was unknown. The reporter assessed the events as non-serious.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Mass, Mobility decreased, Muscular weakness, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 730075), concerning a 65-year-old, elderly, female patient. The patient's historical condition included: high blood pressure, fibromyalgia, GERD (gastroesophageal reflux disease), mitral valve prolapse. Current conditions included: diabetes, hypothyroidism and osteoarthritis. Concomitant medications included: Vitamin D, Baby aspirin, Hydrocodone with ibuprofen, Omega 3, Metformin, Clonidine, Glipizide, SYNTHROID, Hydrochlorothiazide with losartan, Amlodipine and Omeprazole for an unknown indication. On 06-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as 3 dose), route of administration: intramuscular, anatomical location: left arm, batch number: 179301, expiry date: not reported). On the same day within 2 hours of vaccination, the patient developed lump that was described as golf ball size which was aching. However, no treatment was received. In addition, the patient was unable to move arm, was throbbing like a toothache and had weakness. The pain in arm was increased and was almost unbearable. The patient made physician's office visit for the events. However, no lab test was done. The patient had scheduled an appointment with physician on 13-Dec-2017. At the time of this report, the patient had not yet recovered from all the events. The reporter assessed the case as non-serious. Non-significant case correction received with the IRD 07-Apr-2018: The sentence in the narrative was corrected from "the patient had appointed with the physician on 13-Dec-2017" to "the patient had scheduled an appointment with physician on 13-Dec-2017".
Age: 78.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 730092), concerns a 78-year-old, elderly, female patient. The patient's current condition included type 2 diabetes mellitus (since an unspecified date). The patient had no known allergies. The patient's concomitant medications included Levothyroxine, lisinopril, and rosuvastatin. On 04-Dec-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 179201 and expiry date: not reported) and non-company product PREVNAR 13 (dose: 1 DF (reported as 1), route of administration: intramuscular, anatomical location: right arm (right shoulder), batch number: 848403 and expiry date: not reported). On 08-Dec-2017, after 4 days of vaccination, the patient's right shoulder started to become tender, swollen and developed light red circle of approximately 3 inches in diameter around the injection site. It was reported that, her shoulder felt warm to touch and the red area was somewhat swollen. No bruising, bleeding or other adverse effects were noted. The pharmacist instructed the patient to seek medical attention if she noted a fever, worsening/spreading of the red mark on her shoulder or any difficulty breathing. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Immediate post-injection reaction, Injection site pain, Rash, Rash pruritic, Swelling
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 730168), concerns a 72-year-old, elderly, female patient. The patient's current condition included allergic to KEFLEX (since an unspecified date). The concomitant medications included Sertraline, Meloxicam and Clonazepam (since an unspecified date). On an unspecified date, the patient received an unspecified vaccine and experienced dizziness. On 03-Dec-2017, the was administered with FLUAD (dose: 0.5 ml (1 as reported), route of administration: intramuscular, batch number: 179103, anatomical location and expiry date: not reported. On the same day (03-Dec-2017) after vaccination, the patient experienced immediate burning at injection site. The symptoms included baseball size swelling and itchy rash which was painful but not bruise. The patient was treated with BENADRYL and hydrocortisone which had given some relief. It was reported that, swelling was decreasing. The lab tests were not reported. At the time of this report, the patient had recovered from the event (immediate post-injection reaction) and the patient was recovering from the event (swelling). The reporter assessed this case as non-serious. Non-significant case correction received 07-Apr-2018: The sentence in the narrative was corrected from "the patient treated with BENADRYL' to 'the patient was treated with BENADRYL'.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: Muscular weakness, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 730251), concerns a 71-year-old, elderly, male patient. The patient had no medical history, current illness, allergies or concomitant medications. On 10-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as unknown), route of administration: injection (syr), anatomical location: left arm, batch number: 179502, expiry date: not reported). On 12-Oct-2017, after 2 days of vaccination, the patient experienced muscle pain in left arm described as dull continuous pain and felt weakness in left hand. The patient consulted a physician and was prescribed with 10 days of prednisone and physical therapy. The patient had soreness in shoulder. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 84.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 07-Apr-2018 by Seqirus from VAERS (VAERS ID: 730279), concerns an 84-year-old, elderly, male patient. The patient's historical conditions were not reported. The patient had no current illness. The patient had been allergic to sulpha and penicillin allergy. However, patient's concomitant medications included amlodipine, LESCOL, DIOVAN, JANUVIA, Metformin, ASA, Metoprolol, gabapentin, ZANTAC and fenofibrate for an unknown indication. On 18-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, batch number: 179001, anatomical location: unknown and expiry date: not reported). On the same day, after the vaccination, the patient experienced severe soreness in arm, which was intermittent on arm movement and slight redness at the injection site which was discernable. No other symptoms were reported. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.