chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: FLUA3, PNC13, PPV
Symptoms: Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 720817), concerns a 79-year-old, elderly, female patient. The patient's medical history and the concomitant medications were not reported. On 09-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 176502 and expiry date: not reported). On the same day (09-Oct-2017), the patient was administered with non-company suspect product, PREVNAR 13 (dose: 1 (as reported), route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported) and PNEUMOVAX (route of administration: intramuscular, anatomical location: right arm, dose, batch number and expiry date: not reported) which was scheduled after 1 year of PREVNAR 13 vaccine administration(coded as inappropriate schedule of drug administration). On the following day (10-Oct-2017), the patient experienced sore arm and no other reactions occurred. At the time of this report, the outcome of the event (pain in extremity) was not reported. The reporter assessed the case as non-serious. Significant case correction received with IRD on 20-Mar-2018: The listedness for the event (inappropriate schedule of drug administration) was changed from unlisted to unknown. Case comment was update. No changes were done in narrative.
Age: 84.0
Sex: F
Vaccine: FLUA3
Symptoms: Dyspnoea, Middle insomnia
Clinical narrative: This is a spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 720928), concerns an 84-year-old, elderly, female patient. The patient had no historical condition and no known drug allergy (NKDA). The patient's current condition included urinary tract infection (UTI). The patient's concomitant medications included BACTRIM DS. On 09-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179523 and expiry date: not reported). On 10-Oct-2017, after 1 day of vaccination, the patient woke up in middle of the night with shortness of breath which lasted in about 2 minutes. No lab investigation was done. On the same day, the patient had recovered from the events. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Gait disturbance, Muscular weakness, Pain in extremity
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 720998), concerns a 75-year-old elderly female patient. The patient had not medical history and no known allergies. The patient's concomitant medications included eszopiclone, LYRICA, fluticasone, oxycodone and venlafaxine for unknown indication. On 30-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5ml, route of administration: intramuscular, anatomical location: right arm, batch number: 179401, expiry date: not reported). On 08-Oct-2017, 8 days after vaccination, the patient experienced weakness and loss of strength in her hands. It was reported that, the patient was hardly able to walk to her right leg and left leg was painful. The patient had not recovered from the events. The reporter assessed this case as non-serious. Significant case correction received with the IRD 20-Mar-2018: The determined causality of the events weakness, pain in extremity and difficulty in walking was corrected from unassessable to related. Case comment updated accordingly.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 721681), concerns a 76-year-old elderly male patient. The patient had no known allergies. On 01-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179002, expiry date: not reported). On the same day, after vaccination, the patient experienced rash, which was long, thin and reddish underneath the injection site of the left arm. It was reported that, patient counseled to monitor the rash (to look out for severe symptoms such as swelling, itching and difficulty in breathing). At the time of this report, the patient was fine, and outcome of the event rash was unknown. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUA3
Symptoms: Malaise, Pyrexia
Clinical narrative: This is a spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 721736), concerns a 65-year-old, elderly, female patient. The patient's current condition included T2DM (Type 2 Diabetes mellitus) (since an unspecified date). The patient had been allergic to sulfamethoxazole. The patient's concomitant medications included ZOLPIDEM, VICTOZA, diclofenac potassium, glimepiride, Lisinopril; Metformin, FLONASE, Ranitidine and LORTAB. On 03-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, batch number: 179102, anatomical location and expiry date: not reported). On 04-Oct-2017, after 1 day of vaccination, the patient experienced fever for a week, which would be as high as 100 degrees at which point she would take ibuprofen to lower it. The patient also experienced malaise and went to the physician office. It was reported that, no other symptoms other than fever and malaise were reported. On an unspecified date, the patient had recovered from the events. The reporter assessed the events as non-serious.
Age: 70.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 722190), concerns a 70-year-old elderly female patient. The patient's medical history and concomitant medications were not reported. On 12-Oct-2017, the patient received FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: unknown batch number: 178302A and expiry date: not reported. On the same day, the patient received PNEUMOVAX (route of administration: intramuscular, anatomical location: unknown, batch number: N022650, dose, expiry date: not reported). On the same day, the patient developed large localized swelling in arm, and reported that entire bicep was swollen. The patient was advised to take BENADRYL OTC and was asked to revisit in the morning. The patient was prescribed with MEDROL. The outcome of the event was unknown. The reporter assessed this case as non-serious.
Age: 74.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This is a spontaneous case, reported by pharmacist to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 722218), concerns a 74-year-old, elderly, female patient. The patient's historical condition was not reported. The patient had been allergic to penicillin and was prophylactic. The patient's concomitant medications included carvedilol, Atorvastatin, SINGULAIR, Ramipril and PRILOSEC for an unknown indication. On 04-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, batch number: 178901, anatomical location and expiry date: not reported) and ZOSTAVAX 19,400 PLU (plaque-forming units) (dose: 1 DF, route of administration: subcutaneous, batch number: N020939, expiry date: 26-Oct-2018 and anatomical location: not reported) reconstituted with sterile diluent (batch number: M016886 and expiry date: 07-Dec-2018). It was reported that, patient had no illness at the time of vaccinations. On the same day, after the vaccination, the patient developed red circle and itching at the injection site. On 09-Oct-2017, patient still had red circle at injection site. It was reported that, injection site itching had dissipated. The patient did not receive any treatment for the events and seek medical attention. This case was not associated with product quality complaint. At the time of this report, the patient was recovering from the events. The reporter assessed the events as non-serious.
Sex: U
Vaccine: FLUA3
Symptoms: Pyrexia, Urticaria
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 722315), concerns 80-year-old, elderly patient of unspecified gender. The patient's relevant medical history, current illnesses, allergies and concomitant medications were not reported. On 13-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5ml, route of administration: unknown, anatomical location: right arm, batch number: 179203, expiry date: not reported). On the same day (13-Oct-2017) after vaccination, the patient experienced fever and hives. At the time of this report, patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 81.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Rash
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 723385), concerning an 81-year-old, elderly female patient. The patient's current condition included blood pressure. Concomitant medications included CENTRUM, Cinnamon, PLAVIX, IMDUR, Metoprolol, LASIX and Losartan. On 23-Oct-2017 (reported as on Tuesday), the patient received FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 179601 and expiry date: not reported). On the same day, the patient was administered with non-company suspect drug PREVNAR 13 (route of administration: intramuscular, anatomical location: left arm, batch number S51635, dose, expiry date: not reported). On 28-Oct-2017, after 5 days of vaccination, the patient noticed red arm from top of shoulder to elbow and rash did not appear until Saturday. However, it was noticed on Sunday (as reported). The patient made a visit to physician for the events but no lab test was performed. The outcome of the events injection site erythema and rash was not recovered. The reporter assessed this case as non-serious.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Body temperature increased, Fatigue, Feeling abnormal, Tremor
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: 724856), concerns a 77-year-old elderly female patient. The patient's medical history, current illnesses was not reported. On 30-Oct-2017, the patient was administered with FLUAD (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179102, expiry date: not reported). On 02-Nov-2017, 3 days after vaccination, the patient felt tired, and shaky. On the same day, the patient's body temperature was elevated to 101.6 F and had a terrible feeling (as reported). The outcome of all the events was unknown. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUA3
Symptoms: 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: 724857), concerns a 79-year-old elderly female patient. The patient's medical and medication history were not reported. On 31-Oct-2017, the patient received FLUAD (TIV) (dose: 0.5 ml (dose: 1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 179603 and expiry date: not reported). On 02-Nov-2017 after 2 days of vaccination, the patient developed hives in both arms. The outcome of the event urticarial was unknown. The reporter assessed this case as non-serious.
Sex: M
Vaccine: DTAPHEPBIP, FLUA3, HEPA, MENB, MMR, VARCEL
Symptoms: Anger, Bronchitis, Condition aggravated, Disturbance in attention, Headache
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: 724987), concerns a 23-year-old, adult, male patient. The patient's current condition included minor cold (since an unspecified date). The patient had no concomitant medications. On 23-Mar-2016, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On the same day, the patient was administered with non-company suspect products PEDIARIX (route of administration: injection, dose, anatomical location, batch number and expiry date: not reported), HAVRIX (dose: 1 (as reported), route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported), MMR II (route of administration: injection, dose, anatomical location, batch number and expiry date: not reported), BEXSERO (route of administration: injection, dose, anatomical location, batch number and expiry date: not reported), VARIVAX (route of administration: injection, dose, anatomical location, batch and expiry date: not reported) and two unknown vaccines. On 24-Mar-2016, the next morning after vaccination, the patient experienced cold which was quickly progressed into bronchitis, severe headache for several days. The patient also experienced personality changes like more angry, impulsive and attention issues which were not experienced before. It was reported that, the patient went to emergency room to consult a physician. At the time of the report, the patient had not recovered from the events (bronchitis, cold, headache, personality change, anger, impulsive behaviour and disturbance in attention). The reporter assessed the case as non-serious.
Sex: M
Vaccine: DTAPHEPBIP, FLUA3, HEPA, MENB, MMR, VARCEL
Symptoms: Impulsive behaviour, Nasopharyngitis, Personality change
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: 724987), concerns a 23-year-old, adult, male patient. The patient's current condition included minor cold (since an unspecified date). The patient had no concomitant medications. On 23-Mar-2016, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On the same day, the patient was administered with non-company suspect products PEDIARIX (route of administration: injection, dose, anatomical location, batch number and expiry date: not reported), HAVRIX (dose: 1 (as reported), route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported), MMR II (route of administration: injection, dose, anatomical location, batch number and expiry date: not reported), BEXSERO (route of administration: injection, dose, anatomical location, batch number and expiry date: not reported), VARIVAX (route of administration: injection, dose, anatomical location, batch and expiry date: not reported) and two unknown vaccines. On 24-Mar-2016, the next morning after vaccination, the patient experienced cold which was quickly progressed into bronchitis, severe headache for several days. The patient also experienced personality changes like more angry, impulsive and attention issues which were not experienced before. It was reported that, the patient went to emergency room to consult a physician. At the time of the report, the patient had not recovered from the events (bronchitis, cold, headache, personality change, anger, impulsive behaviour and disturbance in attention). The reporter assessed the case as non-serious.
Age: 32.0
Sex: M
Vaccine: FLUA3, PPV, UNK
Symptoms: Arthralgia, Chills, Erythema, Muscle spasms, Pain
Clinical narrative: This is spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 725002), concerns a 32-year-old adult male patient. The patient's historical conditions included rheumatoid arthritis, chronic venous insufficiency, low back pain, sciatica, hearing and vision impairment, 2 hernias (inguinal and umbilical). The patient's concomitant medication included ibuprofen. On 09-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5ml (UNK as reported), route of administration, anatomical location, batch number was not reported), PNEUMOVAX 23 (dose: UNK as reported, anatomical location: right arm, route of administration, batch number was not reported) and unknown vaccines (dose: UNK as reported), anatomical location: left arm, route of administration, batch number was not reported, unknown manufacturer) for whooping cough. On 10-Oct-2017 and 11-Oct-2017, two days after vaccination, the patient experienced fever (102.7F), chills, pain throughout the body and worse in joints. Subsequently, the right arm of the patient was swollen, red, hot to touch and painful and the patient consulted doctor and prescribed with antibiotic and pain killer. On 12-Oct-2017, the pain and redness continued which persisted for about a week, but fever broke. It was stated that, the wife of the patient had pictures of the arm documented as evidence on each day. The patient's legs continued to spasm before going to bed. The outcome of all the events was recovered. The reporter assessed the case as non-serious.
Age: 32.0
Sex: M
Vaccine: FLUA3, PPV, UNK
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: This is spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 725002), concerns a 32-year-old adult male patient. The patient's historical conditions included rheumatoid arthritis, chronic venous insufficiency, low back pain, sciatica, hearing and vision impairment, 2 hernias (inguinal and umbilical). The patient's concomitant medication included ibuprofen. On 09-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5ml (UNK as reported), route of administration, anatomical location, batch number was not reported), PNEUMOVAX 23 (dose: UNK as reported, anatomical location: right arm, route of administration, batch number was not reported) and unknown vaccines (dose: UNK as reported), anatomical location: left arm, route of administration, batch number was not reported, unknown manufacturer) for whooping cough. On 10-Oct-2017 and 11-Oct-2017, two days after vaccination, the patient experienced fever (102.7F), chills, pain throughout the body and worse in joints. Subsequently, the right arm of the patient was swollen, red, hot to touch and painful and the patient consulted doctor and prescribed with antibiotic and pain killer. On 12-Oct-2017, the pain and redness continued which persisted for about a week, but fever broke. It was stated that, the wife of the patient had pictures of the arm documented as evidence on each day. The patient's legs continued to spasm before going to bed. The outcome of all the events was recovered. The reporter assessed the case as non-serious.
Age: 65.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injected limb mobility decreased
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: 725014), concerns a 65-year-old, elderly, female patient. The patient's medical history and the concomitant medications were not reported. On 31-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 179302 and expiry date: not reported). On the same day, the patient was also administered with non-company suspect product, PREVNAR 13 (dose: 1 (as reported), route of administration: intramuscular, anatomical location: right arm, batch number: S51635, and expiry date: not reported). On 01-Nov-2017, after 1 day of vaccination, the patient was unable to lift the arms. It was reported that, the symptoms were improved daily and the patient regained all function. At the time of the report, the patient had recovered from the event (injected limb mobility decreased). The reporter assessed this case as non-serious.
Sex: M
Vaccine: FLUA3
Symptoms: Eye pruritus, 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: 725075), concerns a 76-year-old, elderly male patient. On 30-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as unknown), route of administration: intramuscular, anatomical location: left arm, batch number: 179302, expiry date: not reported). On 31-Oct-2017, the next day of vaccination, the patient developed itching on forehead and in eyes (extremely). The patient had recovered from the events (reported as lasted for almost 23 hours). On 02-Nov-2017, the patient reported the event. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
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: 725099), concerns a 68-year-old, elderly, female patient. This report was linked to case 201801347. The patient's historical vaccine included flu vaccine. The patient's historical conditions included injection site redness, swelling and warmth to flu vaccine, which worsened every year than the last year. The patient had no current illness. The patient had been allergic to latex and had no allergy to food and medications. However, the patient's concomitant medications included omeprazole, Levothyroxine, Citalopram and vitamins NOS. On 30-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 178701 and expiry date: not reported). On 31-Oct-2017, after 1 day of vaccination, the patient's injection site became red, swollen and warm to touch. The patient went to the physician office. After 2 days of vaccination, red area was measured 13 cm by 9 cm. The patient received CLARITIN and applied ice to the injection site. On an unspecified date in Nov-2017 (reporter as after 2 days of onset of event), the patient had recovered from the event injection site redness. On an unspecified date, the patient had recovered from the events injection site swelling and warmth. The reporter assessed the events as non-serious.
Age: 67.0
Sex: M
Vaccine: FLUA3, PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity, Thirst
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: 725200), concerns a 67-year-old elderly male patient. The patient's medical and medication history were not reported. On 05-Nov-2017, the patient received FLUAD (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 179601 and expiry date: not reported) and PREVNAR 13 (route of administration: intramuscular, anatomical location: left arm, batch number: 558704, dose and expiry date: not reported). On the same day, the patient developed soreness in left arm due to which he could not lift his left arm. It was also reported that the patient had been drinking excess amount of water from yesterday. The outcome of the events injected limb mobility decreased, pain in extremity and thirst was not recovered. The reporter assessed this case as non-serious. Significant case correction received 30-Mar-2018: As determined causality of the event excessive thirst was corrected from related to unassessable and case comment was corrected accordingly.
Age: 78.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Inflammation, Peripheral swelling, Skin warm
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: 725231), concerns a 78-year-old elderly female patient. The patient's current condition included asthma. The patient's concomitant medications included ADVAIR and atorvastatin for an unknown indication. On 02-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (unk as reported), route of administration: unk (as reported), anatomical location: left arm, batch number: 179301) and PNEUMOVAX (dose: unk as reported, route of administration: unk (as reported), anatomical location: left arm, batch number: as reported N019983). On 03-Nov-2017, 1 day after vaccination, the patient's upper arm was swollen very much and inflamed hot red. The patient consulted doctor and received MEDROL DOSEPAK (as reported). The outcome of the events was unknown. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Nausea, Rash erythematous, Skin warm
Clinical narrative: This is a spontaneous case, reported by a other health professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (regulatory reference number: 725234), concerning a 74-year-old, elderly female patient. The patient's historical conditions, allergies, current illness and concomitant medications were not reported. On 30-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml (reported as 2), route of administration: intramuscular, anatomical location: left arm, batch number: 178903 and expiry date: not reported). On the same day, the patient was also vaccinated with PNEUMOVAX (dose: reported as 2, route of administration: intramuscular, anatomical location: left arm, batch number: N019348 and expiry date: not reported). On 31-Oct-2017, 01 day after the vaccination, the patient experienced red and hot rash, felt sick to her stomach which lasted about 3 days. On an unspecified date in Nov-2017, the patient recovered from the events. The reporter considered this case as non-serious.
Age: 70.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise
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: 725075), concerns a 70-year-old, elderly male patient. The patient's current conditions included cholesterol, high blood pressure (HBP), diabetes. The patient did not have any other current illnesses. The patient had no known drug allergies. The concomitant medications included, allopurinol, metformin, Lisinopril, latanoprost, citalopram, pravastatin, alprazolam all for an unknown indications. On 06-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 m (as reported 1), route of administration: intramuscular, anatomical location: right arm, batch number: 179601, expiry date: not reported) and PNEUMOVAX (dose:1 (as reported), route of administration: intramuscular, anatomical location: right arm, batch number: N019983, expiry date: not reported). On the same of vaccination, the patient developed red, hot and swollen upper right arm. The patient felt unwell. At the time of the report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pain, Swelling, Thrombosis
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: 725462), concerns a 68-year-old elderly female patient. The patient had no historical conditions, allergies and current illnesses. The patient did not receive any concomitant medications. On 24-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179601 and expiry date: not reported) and non-company suspect product PNEUMOVAX (dose: 2 (as reported), route of administration: intramuscular, anatomical location: left arm, batch number: N019983 and expiry date: not reported). On the same day, after the vaccinations, the patient experienced swelling and pain. The same day, it was determined that, the patient developed a calcified thrombus, which formed because the injection passed through the cephalic vein. It was reported that, patient went to the urgent care twice, where she was misdiagnosed both the times. Later, her primary care physician discovered the thrombus. The patient was treated with heat therapy, pain medications and suggested the physical therapy. At the time of this report, the outcome of the events was unknown. The reporter assessed the events as non-serious.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site induration, Injection site mass
Clinical narrative: This initial spontaneous case, reported by a other health care professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (regulatory reference number: 725472), concerns a 69-year-old, elderly, female patient. The patient medical history was not reported. The patient had no known drug allergies. On 07-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: 179403 and expiry date: not reported). On the same day following the vaccination, the patient immediately developed a golf-ball sized hard mass around the injection site. Reportedly, there was a little blood, but the mass didn't appear red or warm after 10 minutes of monitoring. The patient was advised to go home and apply ice at the injection site with the treatment of ibuprofen. Outcome of the events was unknown. The reporter considered this case as non-serious.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
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: 725482), concerns a 76-year-old, elderly female patient. The patient experienced nausea upon taking pain medications (unspecified). The patient had no relevant medical history, concomitant medications and current illness. On 26-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179301, expiry date: not reported). On 23-Oct-2017, after 27 days of vaccination (roughly 3 weeks), the patient developed raised, red nodule at the site of injection. The nodule was not painful, but had increased in size (over last 14 days). At the time of the report, the patient was not recovered from the events. The reporter assessed the case as non-serious.
Age: 90.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pruritus
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: 725551), concerns a 90-year-old, elderly, female patient. The patient had no known historical condition, allergies and current illness. However, the patient's concomitant medications included Metoprolol, Lisinopril, warfarin, ferrous sulfate, amlodipine, famotidine and alendronate. Ln 24-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179203 and expiry date: not reported). On the same day, after the vaccination, the patient experienced redness and itching at injection site which spread to elbow (reported after 15 days of vaccination). It was reported that, patient would receive BENADRYL for the events. At the time of this report, the patient had recovered from the event injection site itching and was recovering from the event injection site redness. The reporter assessed the events as non-serious.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Hypersensitivity, Pain, Swelling
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: 725628), concerns a 67-year-old, elderly, female patient. The patient's historical conditions, current illness and concomitant medications were unknown. The patient's allergies were not reported. On 01-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179203 and expiry date: not reported) and non-company product PNEUMOVAX (dose: 1 DF, route of administration: intramuscular, anatomical location: left arm, batch number: N023651 and expiry date: not reported). On 02-Nov-2017, after one day of vaccination, in middle of night, the patient complained of red ring, swelling and soreness. The patient went to the emergency room and doctor stated that, it was an allergic reaction. The patient started the treatment with BENADRYL and warm compresses. At the time of this report, the outcome of the event was unknown. The reporter assessed the event as non-serious.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS ID: 725631), concerns 71-year-old elderly female patient. The patient's medical history and concomitant medications were not reported. On 29-Sep-2017, the patient was administered with FLUAD (dose: 0.5ml (unk as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 179523). On 30-Sep-2017, after one day of vaccination, the patient experienced redness, swelling (3in wide x 7in long) and pain at the injection site. It was reported, that the patient did not consult doctor. The outcome of all the events was unknown. The reporter assessed the case as non-serious.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Chest pain, Depression, Peripheral swelling
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: 725664), concerns a 73-year-old, elderly, female patient. The patient's current condition included allergic to MACROBID (since an unspecified date). It was reported that the patient had no relevant medical history. However, it was also reported that the patient's concomitant medications included levothyroxine, lisinopril, hydrochlorothiazide and potassium chloride for an unknown indication (since an unspecified date). On 31-Oct-2017, the patient was administered with FLUAD (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 179301 and expiry date: not reported). On 01-Nov-2017, after 1 day of vaccination, the patient left arm was swollen for about 2 days. Subsequently, she also experienced chest pain under her breast and severe depression that occurred for few days after the vaccination. The lab investigations were not reported. At the time of the report, the patient had recovered from the events (chest pain, depression and swollen arm). The reporter assessed this case as non-serious. Significant case correction received 30-Mar-2018: The as determined causality of the events (chest pain and depression) was corrected from related to unassessable.
Sex: M
Vaccine: FLUA3
Symptoms: Fatigue, Nasopharyngitis, Rhinorrhoea
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: 725831), concerns a 69-year-old, elderly, male patient. The patient had no historical conditions, allergies and current illness. The patient did not receive any concomitant medications. On 28-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, anatomical location: arm, route of administration: unknown, batch number and expiry date: not reported). On 29-Sep-2017, after 1 day of vaccination, the patient experienced runny nose, cold like symptoms and fatigue, which lasted 3 weeks. No lab investigations were performed. On an unspecified date, the patient had recovered from the events. The reporter assessed the events as non-serious.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Fatigue, Nasopharyngitis, Rhinorrhoea
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: 725855), concerns a 69-year-old elderly female patient. The patient had no current conditions and concomitant medications. On 26-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported). On 27-Sep-2017, after 1 day of vaccination, the patient experienced fatigue, runny nose and cold like symptoms, which had lasted for 3 weeks. No lab investigations were performed. The patient recovered from the events. The reporter assessed this case as non-serious. Non-significant case correction with IRD 30-Mar-2018: Narrative sentence was changed from 'on 27-Sep-2017, after 1 day of vaccination, the patient experienced fatigue, runny nose and cold like symptoms, which was lasted for 3 weeks' to 'on 27-Sep-2017, after 1 day of vaccination, the patient experienced fatigue, runny nose and cold like symptoms, which had lasted for 3 weeks'. No other changes were made in the narrative.
Age: 89.0
Sex: F
Vaccine: FLUA3
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 30-MMar-2018 by Seqirus from VAERS (VAERS ID: 725865), concerns 89-year-old elderly female patient. The patient's historical conditions included Meniere's disease and vertigo. It was reported that, the patient was hospitalized and convalescence for about 1 month and released 1 week prior to vaccine for Meniere's disease. On 02-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179502). On the same day, after vaccination, the patient left consultation room without cane accompanied by a lady friend. The patient was in aisle of the store for some shopping, then came back to pharmacy waiting area after 10-15 minutes, with complaints of neck and shoulder pain. The patient sat down, was asked if she needed 911. The patient had no complaints of allergic reactions, wheezing, redness. The patient was speaking clearly. EMTs (emergency medical technicians) arrived and urged patient to go to ER (emergency room), but patient declined. Later (3 to 4 hours), the patient was consulted via phone, in which she reported to be fine. The outcome of all the events were recovered. The reporter assessed the case as non-serious.
Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: Musculoskeletal pain, Pain in extremity
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: 725947), concerns a 77-year-old, elderly, male patient. The patient's medical history and the concomitant medications were not reported. On 27-Sep-2017, the patient was administered with FLUAD (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: 178323 and expiry date: not reported). On the same day, after vaccination, the patient experienced pain in shoulder and arm which got worsen at night. At the time of the report, the patient had not recovered from the events (pain in arm and shoulder pain). The reporter assessed the case as non-serious.
Age: 66.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Chills, Decreased appetite, Fatigue, Hyperhidrosis, Injected limb mobility decreased
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 725966), concerns a 66-year-old, elderly, male patient. The patient's historical conditions included, bad sinuses, postnasal drip, spinal fusion and related unspecified problems and had no allergies. The concomitant medications included, vitamins, vitamin C, vitamin B12, vitamin E, SUDAFED, Baby aspirin, glucosamine, atorvastatin, pantoprazole, metoprolol, ropinirole for unknown indications. On 06-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as unknown), route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported) and non-company suspect PNEUMOVAX (dose, route of administration: intramuscular, anatomical location: right arm, batch number, expiry date: not reported). On the same day (06-Nov-2017), after vaccinations, the patient experienced severe pain in right shoulder and limited movement. The patient also experienced fever, chills, sweating, fatigue, loss of appetite, nausea, inability to sleep. The patient called physician (reported as first afternoon) and took NORCO and meloxicam (the next day). The patient visited the physician. The patient used ice, cool cloth on head, took bed rest and was on fluids. Most of the symptoms slowly reduced after three and half day. The pain was severe initially and later it was moderate. The patient could not lift hand above waist or reach more than a few inches. The patient had constant pain in upper arm and shoulder. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 66.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Injection site pain, Insomnia, Nausea, Pyrexia
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 30-Mar-2018 by Seqirus from VAERS (VAERS ID: 725966), concerns a 66-year-old, elderly, male patient. The patient's historical conditions included, bad sinuses, postnasal drip, spinal fusion and related unspecified problems and had no allergies. The concomitant medications included, vitamins, vitamin C, vitamin B12, vitamin E, SUDAFED, Baby aspirin, glucosamine, atorvastatin, pantoprazole, metoprolol, ropinirole for unknown indications. On 06-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as unknown), route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported) and non-company suspect PNEUMOVAX (dose, route of administration: intramuscular, anatomical location: right arm, batch number, expiry date: not reported). On the same day (06-Nov-2017), after vaccinations, the patient experienced severe pain in right shoulder and limited movement. The patient also experienced fever, chills, sweating, fatigue, loss of appetite, nausea, inability to sleep. The patient called physician (reported as first afternoon) and took NORCO and meloxicam (the next day). The patient visited the physician. The patient used ice, cool cloth on head, took bed rest and was on fluids. Most of the symptoms slowly reduced after three and half day. The pain was severe initially and later it was moderate. The patient could not lift hand above waist or reach more than a few inches. The patient had constant pain in upper arm and shoulder. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased
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: 726069), concerns a 65-year-old elderly female patient. The patient's medical history, current illness was unknown and had no known allergies. On 30-Oct-2017, the patient was administered with FLUAD (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179502, expiry date: not reported). On 31-Oct-2017, 1 day after vaccination, the patient experienced pain, limited range of motion, swelling at injection site and entire upper arm. The outcome of all the events was unknown. The reporter assessed the case as non-serious.
Age: 70.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Headache, Musculoskeletal 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: 726082), concerns a 70-year-old elderly male patient. The patient underwent shoulder replacement (unspecified date). The patient's historical condition and current illness were not reported. The patient's concomitant medications were unknown. The patient had no known drug allergies (NKDA). On 09-Nov-2017, the patient was administered with FLUAD (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 179102 and expiry date: not reported) and non-company suspect product PNEUMOVAX (dose: 1 DF (reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: N022704 and expiry date: not reported). It was reported that, patient had no pain at the time of PNEUMOVAX. On the same day, after the vaccination, later at night, the patient developed severe pain in bicep, shoulder, neck and head of 9-10 on pain scale. The patient used ice therapy and received ibuprofen for the events. It was reported that, in morning, the pain decreased to 6-7 on pain scale. The patient went to the physician office visit. At the time of this report, the patient was not recovered from the events. The reporter assessed the events as non-serious. Significant case-correction received 30-Mar-2018: The causality was changed from not related to unassessable and case comment was amended accordingly. No changes were made in the narrative.
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Dizziness, Erythema, Fatigue, Peripheral swelling, Skin warm
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: 726207), concerns a 69-year-old elderly female patient. On 08-Nov-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 179301 and expiry date: not reported) and was also administered with PNEUMOVAX (route of administration: intramuscular, anatomical location: left arm, batch number: N0199983, expiry date and dose: not reported). On 09-Nov-2017, 1 day after vaccination, patient experienced extreme fatigue, light-headedness. The patient's left arm was very red, swollen and was warm to touch. The patient consulted the doctor and was advised to use cold compresses. It was reported that, the patient's arm was much better than before. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.