chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of consciousness, Pallor, Skin laceration, Somnolence
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 732819), concerns a 07-year-old, male child. The patient had no medical history, allergies or current illness. The patient's medications at the time of vaccination were unknown. On 06-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 196498, expiry date: not reported). On the same day, after 5 minutes of vaccination, the patient lost consciousness (reported as passed out) and hit his head on the privacy screen. The patient was groggy and lost colour on his face. The skin was clammy and pulse was low. The patient had cut above the eye for which pressure and ice was applied. The patient regained colour when his feet were raised and was able to talk. Medical help was sought after contacting 911 and patient's blood pressure, electrocardiogram (EKG), and pulse was checked (all were within normal). Patient felt dizziness when he stood up and informed the EMT (emergency medical technician) that he did not felt abnormal (reported as didn't feel right). The patient visited physician at the urgent care. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Axillary pain, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 14-Mar-2018 by Seqirus from VAERS (VAERS ID: 732827), concerns a 62-year-old, adult, female patient. The patient's current condition included high cholesterol and the patient was allergic to sulfa (on an unspecified date). The concomitant medications were unknown. On 30-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195233 and expiry date: not reported). On 01-Dec-2017, after 1 day of vaccination, the patient experienced pain under her left armpit and left shoulder, since her vaccination. It was reported that, the pain moved from tip of left shoulder to down, which limited to certain positions and it hurt while lifting with left arm. The patient was recommended to consult a physician. It was reported that no lab tests were performed to the patient till 07-Jan-2018. At the time of the report, the outcome of the events (injection site pain, axillary pain, pain and sleep difficult) was unknown. The reporter assessed the case as non-serious. Non-significant case correction received 14-Mar-2018: The narrative and case comment were corrected.
Age: 28.0
Sex: M
Vaccine: FLUC4
Symptoms: Dysphagia, Swollen tongue
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 733852), concerns a 28-year-old, adult, male patient. The patient's historical condition included anxiety. The patient's current conditions included type 2 diabetes, depression, hyperlipidaemia and myalgia (reported as medical history). The patient had no known allergies. The patient's concomitant medications included fish oil, MVI, garlic, citalopram, vitamin D3, cyclobenzaprine, lisinopril, glipizide, metformin, atorvastatin and allopurinol. On 03-Jan-2018, the patient was administered FLUCELVAX QIV [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195216 and expiry date: not reported]. On 04-Jan-2018, one day after vaccination, the patient developed swollen tongue and experienced difficulty in swallowing. On an unspecified date, the patient made a physician office visit. No lab investigations were performed. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 733951), concerning a 50-year-old, adult, female patient. The patient's historical condition included: fatigue. The patient's current condition included: scoliosis and prediabetes (reported as medical history). The patient had no known allergies. The concomitant medications included: ibuprofen, VALTREX and phentermine for unknown indications. On 21-Dec-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml [frequency reported as 1], route of administration: intramuscular, anatomical location: right arm, batch number: 195219 and expiry date: not reported). On 16-Jan-2018, 26 days after the vaccination, the patient experienced pain in right upper extremity (reported as pain to RUE). On an unspecified date, the patient made an office visit. No lab investigations were performed. At the time of the report, the patient had not recovered from the event. The reporter assessed the case as non-serious. Update received on 27-Sep-2018: Non-significant case correction (IRD 12-Sep-2018): The sentence of the case comment was corrected from 'the causality of the event is assessed as related to the suspect vaccine due to the plausible temporal relationship' to 'the company assessed the causality of the event as related to the suspect vaccine due to the localized injection site reaction'.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734192), concerns a 50-year-old, adult female patient. The patient's current condition included bursitis in shoulder (reported as opposite shoulder). The patient's concomitant medication was unknown. On 11-Dec-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical site: right arm, batch number: 195239 and expiry date: not reported]. On the same day, after vaccination, the patient experienced pain in neck, shoulder and arm. The patient was unable to raise her arm above the shoulder level. It was reported that about a month afterwards, her arm still hurts. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Body temperature, Chest pain, Cough, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734205), concerns a 56-year-old, adult, female patient. The patent's medical history included temperature, runny nose and chest pain (on an unspecified date). On 22-Dec-2017, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml, anatomical location: arm, route of administration, batch number and expiry date: not reported]. On 24-Dec-2017, 2 days after vaccination, the patient experienced running nose, chest pain and cough. On the same day, the patient had temperature which persisted till 29-Dec-2017 (for 4 or 5 days as reported). On an unspecified date, the patient developed sore throat. It was reported that the events (sore throat, running nose, chest pain and cough) persisted till 09-Jan-2018. It was patient reported that she had no money to consult the doctor or to go to emergency room as it was too expensive. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Cold sweat, Fatigue, Headache, Nausea, Pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734210), concerns a 48-year-old, adult female patient. The patient had no any medical history. The patient was allergic to sulphur-based medications. The patient did not receive any concomitant medications. On 16-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 70461-0201-01 (as reported) and expiry date: not reported]. The reported batch number (70461-0201-01), does not match Seqirus batch numbers, however, because the reporter named Seqirus produce 'FLUCELVAX QIVc' as the suspect vaccine, this report has been conservatively entered as a Seqirus case. On 17-Jan-2018, 1 day after vaccination, the patient experienced severe debilitating headache which was worse than a migraine. The patient took TYLENOL, but it did not help. The patient also had cold sweats, nausea, body aches and fatigue. The patient called to the pharmacy to verify symptoms, severity, and expected duration of the events. At the time of this report, the patient had recovered from the events. The reporter had assessed the case as non-serious. Update received on 29-Sep-2018: Non-significant case correction (12-Sep-2018): The sentence in narrative 'The patient also had cold sweats, nausea, body aches and she was fatigue' was changed to 'The patient also had cold sweats, nausea, body aches and fatigue.'
Age: 57.0
Sex: F
Vaccine: FLUC4, PPV, TDAP
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Product administration error
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734216), concerns a 57-year-old, adult, female patient. The patient's current condition included diabetes (reported as medical history). The concomitant medications included LANTUS for an unknown indication. The patient had no relevant drug allergy and current illness was reported as unknown. On 16-Jan-2018, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml (frequency reported as 1), batch number: 195224, route of administration: intramuscular, anatomical location: left arm, expiry date: not reported]. The patient was also administered non-company suspect vaccines, one of which was BOOSTRIX [route of administration: intramuscular, anatomical location: left arm, batch number: 5H2H2, dose (frequency reported as 1), expiry date: not reported]. Both the vaccines (FLUCELVAX QIVc and BOOSTRIX) were given in the same arm (left arm) (explicitly coded as drug administration error). The other non-company co-suspect vaccine was PNEUMOVAX [dose (frequency reported as 1), route of administration: intramuscular, anatomical location: Right arm, batch number: N024384, expiry date: not reported]. On 17-Jan-2018, one day after vaccination, the patient experienced pain in right arm and the injection site was red and hot. The patient reported the symptoms during her visit to physician's office on 18-Jan-2018. The doctor prescribed the patient antibiotic for 7 days. The doctor did not order any lab test at that point of time. The doctor asked the patient to follow up if the pain had continued. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734234), concerns a 60-year-old, adult, female patient. The patient's concomitant medications included fluoxetine and MIRALAX. The patient's medical history was unknown and had no known allergies (NKA). On 02-Dec-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: right deltoid, batch number: 195211, expiry date: 31-Mar-2018]. On the same day of vaccination, the patient developed pain and palpable bump at the injection site. The soreness at the injection site worsened progressively. The patient thought it was probably due to the shot (related) which was administered too high up in the arm and asserted that in previous flu shots, she received the shot lower than what was given. On 18-Jan-2018, the patient called up pharmacy and narrated the events which occurred on the vaccination day to the pharmacist on duty. The patient stated that, she had planned a physician's office visit on 19-Jan-2018. It was reported that, the patient had an office visit. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious. Update received on 11-Oct-2018: Significant case correction (IRD: 12-Sep-2018): The onset date (Jan-2018) for event 'condition aggravated' was removed from the event tab.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734315), concerns a 38-year-old, adult, female patient. The patient's historical condition included stage 3 kidney disease and Sjogren's syndrome. The patient did not have any current illnesses and allergies. The concomitant medications included sodium bicarbonate, PLAQUENIL, and CELEXA for unknown indications. On 01-Dec-2017, the patient was administered FLUCELVAX QIVc [route of administration: injection (SYR as reported), anatomical location: left arm, dose: 0.5 ml, batch number: 196498 and expiry date not reported). On the same day, right after the vaccination, the patient had pain in arm. On an unknown date in Dec-2018, the patient could not lift her arm for two days. The patient had loss of mobility three weeks later also. The patient had been to the doctor and was ordered for computed tomography (CT). At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734349), concerns a 07-year-old, female child. The patient had a history of injection site reaction, although very minor. The patient's concomitant medication included multivitamins. The patient's current illness was unknown. On 15-Jan-2018, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195243, expiry date: not reported]. On the same day of vaccination (evening), the patient began to show signs of swelling in upper arm with erythema. The patient subsequently taken to paediatrician and was given BENADRYL. As of 18-Jan-2018, the patient was improving, but the swelling persisted. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Dizziness postural, Musculoskeletal stiffness, Tinnitus, Vision blurred
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734406), concerns a 15-year-old, adolescent female patient. The patient's historical condition included asthma. The patient was allergic to penicillin. The patient no current illnesses. On 19-Jan-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 195241 and expiry date: not reported). On the same day after vaccination, the patient experienced dizziness, ringing in ear for a short time (briefly), blurred vision, stiffness in arm and felt like fainting when she stood up. The patient did not receive any treatment for the events. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious.
Age: 78.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Chills, Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734415), concerns a 78-year-old, adult, female patient. The patient's current illness included diabetes and had no known allergies. On 15-Jan-2018, the patient was administered FLUCELVAX (QIVc) (dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: right arm, batch number: 195245, expiry date: not reported) and a co-suspect product PNEUMOVAX [route of administration: intramuscular, anatomical location: left arm, batch number: N029303, dose: 1 (as reported) and expiry date: not reported]. On the same day of vaccination, the patient experienced fever and chills. The patient's left arm was swollen, and she could not move the arm. The patient only experienced fever on the day of administration. On 20-Jan-2018, the patient complained that she could only move the arm very little and felt the pain in the arm. Primary care provider prescribed anti-inflammatory medication Celecoxib and ULTRACET. The patient reported that she would visit physician on corresponding Monday again. On an unspecified date, the patient had an office visit. At the time of this report, the outcome of the events had not recovered. The reporter assessed this case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Fatigue
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734426), concerns a 62-year-old, adult female patient. The patient's current condition included high cholesterol (reported as historical condition) and the patient was allergic to antibiotics. The concomitant medications included ZOLOFT, LIVALO, Multi vitamin, and fish oil for unknown indications. On 06-Jan-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency: 1, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On the same day, after vaccination, the patient experienced dizziness, stomach ache, was fatigue and had weakness which lasted 7 days. The patient did not undergo any lab tests. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Cough, Headache, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734439), concerns a 36-year-old, adult, male patient. The patient received the flu shot annually and had adverse effects of flu symptoms every time. The patient did not take any medications at the time of vaccination. The patient did not have allergies or current illness. On 15-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported]. On 16-Jan-2017, one day after vaccination, the patient experienced headache, runny nose, cough, mucus, light fever, body aches and sneezing. On an unspecified date, the patient had made a physician office visit. The patient did not undergo any laboratory tests. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious. Update received on 11-Oct-2018: Non-significant case correction (12-Sep-2018): Physician office visit was checked for all the events in event tab.
Age: 36.0
Sex: M
Vaccine: FLUC4
Symptoms: Secretion discharge, Sneezing
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734439), concerns a 36-year-old, adult, male patient. The patient received the flu shot annually and had adverse effects of flu symptoms every time. The patient did not take any medications at the time of vaccination. The patient did not have allergies or current illness. On 15-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported]. On 16-Jan-2017, one day after vaccination, the patient experienced headache, runny nose, cough, mucus, light fever, body aches and sneezing. On an unspecified date, the patient had made a physician office visit. The patient did not undergo any laboratory tests. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious. Update received on 11-Oct-2018: Non-significant case correction (12-Sep-2018): Physician office visit was checked for all the events in event tab.
Age: 48.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Injection site paraesthesia, Muscular weakness, Paraesthesia, Sensory disturbance
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734444), concerns a 48-year-old, adult male patient. The patient had no historical condition, current condition and allergy. The patient did not receive any concomitant medication. On 19-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 70461-0201-01 (as reported) and expiry date: not reported). The reported batch number (70461-0201-01), does not match Seqirus batch numbers, however, because the reporter named Seqirus product 'FLUCELVAX QIVc' as the suspect vaccine, this report has been conservatively entered as the Seqirus case. On 21-Jan-2018, 2 days after vaccination, the patient woke up with a strange sensation in his left arm. The patient thought that it was asleep from sleeping in a weird position, but as he made a fist he had a severe weakness unlike anything I had ever felt. The patient felt like the tendons in his hand had no strength. The patient experienced a slight tingling on his arm from the point of injection. The patient was really scared as he had never felt this kind of weakness in his arm. The patient had no strength and he didn't know if this was going to get worse. The patient didn't want pain medication and said would see doctor if the events get worse. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 60.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Abdominal pain upper, Dizziness, Headache, Musculoskeletal pain, Nausea
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734527), concerns a 60-year-old, adult male patient. The patient had no historical condition and current condition. On 20-Jan-2018, at 5:30 PM the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration: intramuscular, batch number: 195238, anatomical site: unknown and expiry date: not reported). The patient was also administered a non-company co-suspect vaccine varicella zoster vaccine (reported as SHINGRIX) (route of administration: intramuscular, batch number: DK76P, frequency, anatomical site: unknown, dose and expiry date: not reported). On the same day, at about 7 PM (about 1 hr 30 min after vaccine administration), the patient experienced low grade fever (99 degrees F), worst stomach cramps, nausea, vomiting, headache, shoulders and neck ache and was dizzy. On an unspecified date, the patient made an emergency room/office visit. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Update received on 29-Sep-2018: Non-significant case correction (IRD: 12-Sep-2018): The co-suspect vaccine 'varicella zoster vaccine was added in the case comment. No changes were made in the narrative.
Age: 60.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Neck pain, Pyrexia, Vomiting
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734527), concerns a 60-year-old, adult male patient. The patient had no historical condition and current condition. On 20-Jan-2018, at 5:30 PM the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration: intramuscular, batch number: 195238, anatomical site: unknown and expiry date: not reported). The patient was also administered a non-company co-suspect vaccine varicella zoster vaccine (reported as SHINGRIX) (route of administration: intramuscular, batch number: DK76P, frequency, anatomical site: unknown, dose and expiry date: not reported). On the same day, at about 7 PM (about 1 hr 30 min after vaccine administration), the patient experienced low grade fever (99 degrees F), worst stomach cramps, nausea, vomiting, headache, shoulders and neck ache and was dizzy. On an unspecified date, the patient made an emergency room/office visit. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Update received on 29-Sep-2018: Non-significant case correction (IRD: 12-Sep-2018): The co-suspect vaccine 'varicella zoster vaccine was added in the case comment. No changes were made in the narrative.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734661), concerns a 61-year-old, adult, male patient. The patient had no allergies and current illnesses. The patient's concomitant medications were unknown. On 24-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: injection (SYR as reported), anatomical location: left arm, batch number: 195129 and expiry date: not reported). On 25-Oct-2017, 1 day after vaccination, the patient developed injection site pain and left shoulder pain. The patient also experienced decrease range of motion. On an unspecified date, the patient made an office visit. No lab tests were done. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734733), concerns a 49-year-old, adult, female patient. The patient's medical history and current illnesses were unknown. The patient did not have any known allergies. It was unknown if the patient took any medications at the time of vaccination. On 04-Jan-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml, batch number and expiry date not reported]. On the same day, after vaccination, patient reported that the pain in the arm did not subside after the shot and continued to bother her. (Pain rated as 7/10). The patient had tingling down in the fingers, general arm weakness, and limited mobility of the left arm. The patient was consulted and told to follow up with her primary care provider. The patient made an office visit. Patient did not undergo any laboratory tests. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 37.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Headache, Heart rate increased, Lethargy
Clinical narrative: This is spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734752), concerns a 37-year-old, adult male patient. The patient had underwent splenectomy (had no spleen). The patient did not receive any concomitant medications. On 20-Jan-2018, the patient received the suspect FLUCELVAX QIVc (dose: 0.5ml, route of administration: injection (SYR as reported), batch number, expiry date was not reported). On the same day, few hours after vaccination, the patient felt rapid heart rate, headache and dizziness. The patient had a visit to the physician's office on the following day (21-Jan-2018), nurse noted the blood pressure of the patient to be normal. The patient had no fever at that time. Nurse was told to monitor. At the time of report, the patient felt lethargic. At the time of report, the outcome of the events was unknown except for the event lethargy as not recovered. The reporter assessed the case as non-serious.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Fall, Fatigue, Nausea, Nervousness
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734805), concerns a 28-year-old, adult, female patient. The patient's historical vaccine included flu shot (reported as a long time ago). The patient was allergic to dairy products and gluten. It was reported that, the patient was not allergic to eggs, gelatin, neomycin or thiomersal. The patient had no relevant medical history and current illness. No concomitant medication was listed at the time of vaccination. On 22-Jan-2018, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195230, expiry date: not reported]. On the same day, the patient approached the consultation area, and appeared tired. The patient fell down slowly and was down for a couple of seconds. The reporter approached the patient to confirm if she was well and asked if she had any trouble in breathing. The patient stated that she had no trouble in breathing. However, the patient complained of nausea and lightheadedness. The reporter offered her water and asked if she wanted anything to eat. Also, the reporter called 911. The EMT and local cop came into the store. The EMT assessed her blood pressure, checked the vitals and confirmed it to be normal. According to the paramedic, the patient was just nervous, stressed and it may be due to vasovagal reaction. The patient was sent home shortly. The patient visited the physician's office on an unspecified date. On the same day, the patient had recovered from the events. The reporter assessed this case as non-serious. Update received on 11-Oct-2018: Significant case correction (IRD: 12-Sep-2018)- Events- nervousness, stress and vasovagal reaction were added. The listedness was done accordingly.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Stress
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734805), concerns a 28-year-old, adult, female patient. The patient's historical vaccine included flu shot (reported as a long time ago). The patient was allergic to dairy products and gluten. It was reported that, the patient was not allergic to eggs, gelatin, neomycin or thiomersal. The patient had no relevant medical history and current illness. No concomitant medication was listed at the time of vaccination. On 22-Jan-2018, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195230, expiry date: not reported]. On the same day, the patient approached the consultation area, and appeared tired. The patient fell down slowly and was down for a couple of seconds. The reporter approached the patient to confirm if she was well and asked if she had any trouble in breathing. The patient stated that she had no trouble in breathing. However, the patient complained of nausea and lightheadedness. The reporter offered her water and asked if she wanted anything to eat. Also, the reporter called 911. The EMT and local cop came into the store. The EMT assessed her blood pressure, checked the vitals and confirmed it to be normal. According to the paramedic, the patient was just nervous, stressed and it may be due to vasovagal reaction. The patient was sent home shortly. The patient visited the physician's office on an unspecified date. On the same day, the patient had recovered from the events. The reporter assessed this case as non-serious. Update received on 11-Oct-2018: Significant case correction (IRD: 12-Sep-2018)- Events- nervousness, stress and vasovagal reaction were added. The listedness was done accordingly.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Hyperhidrosis, Hypoacusis, Nausea, Presyncope
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 734816), concerns a 34-year-old, adult female patient. The patient's current condition included thyroid (reported as medical history), unspecified addiction and no known drug allergy. The patient's concomitant medications included SUBOXONE, levothyroxine and LARIN FE for unknown indications. On 24-Jan-2018, the patient received FLUCELVAX QIVc (dose: 0.5ml, frequency: 1, batch number: 195234, route of administration: intramuscular, anatomical location: left arm). On the same day, after vaccination, the patient experienced nausea, lightheadedness, dizziness and felt like she was going to pass out. Patient was not having breathing complication but was sweating and her ears were muffled for about 30 seconds. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Axillary pain, Injection site reaction, Muscle strain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 735077), concerns a 31-year-old, adult female patient. The patient's historical conditions included asthma and chronic bronchitis. The patient had no known allergies. On 23-Jan-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195220 and expiry date: not reported). On the same day after vaccination, the patient remained in her chair for 5 minutes. When the patient left the pharmacy, she spoke to the pharmacist and was feeling fine. It was reported that the patient lifted heavy objects at work and therefore, left early to rest her arm. The patient went home and had a normal evening. On 24-Jan-2018, the next morning (approximately 12 hours later), the patient experienced pain in her armpit and underside of the vaccination arm. After 24 hours, the patient made an office visit and consulted the physician about the pain. The patient was diagnosed with a strained deltoid muscle and was provided a prescription for naproxen. The patient was told to rest the arm for several days. At no time, the patient had fever, experienced shortness of breath or had any other symptoms other than the arm pain and muscle pain. The patient did not have any lab investigations. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious. Update received on 11-Oct-2018: Significant case correction (IRD: 12-Sep-2018): The events pain in extremity and axillary pain were changed to separate diagnosis. No changes were made in the narrative.
Age: 11.0
Sex: M
Vaccine: FLUC4, HPV9, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 735125), concerns a 11-year-old, male child patient. The patient had no medical history, current illness, allergies and concomitant medications. On 25-Jan-2018, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 933M4 (as reported) and expiry date: not reported]. The reported batch number (933M4), does not match Seqirus batch numbers, however, because the reporter named Seqirus product 'FLUCELVAX QIVc' as the suspect vaccine, this report has been conservatively entered as a Seqirus vase. On the same day, the patient administered non-company suspect vaccine BOOSTRIX [dose: unknown, route of administration: intramuscular, anatomical location: left arm, batch number: 3K799 and expiry date: not reported], it was reported that both the vaccines (FLUCELVAX QIVc and BOOSTRIX) were given in the same arm (left arm). The patient also administered other non-company suspect product GARDASIL [dose: unknown, route of administration: intramuscular, anatomical location: right arm, batch number: N021571 and expiry date: not reported] and MENACTRA [dose: unknown, route of administration: intramuscular, anatomical location: right arm, batch number: U5833AA and expiry date: not reported]. On the same day (25-Jan-2018), after vaccination, the patient walked out of the room without any problem. After a few minutes, the patient felt dizzy and taken back to the exam room and was laid down. As per the doctor, the patient had a possible vasovagal reaction. The patient was taken to the examination room and the vital signs were checked. The patient was observed and left the clinic with feeling good. At the time of this report, the patient had recovered from the event. The reporter assessed this case as non-serious.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: Dyspnoea, Erythema, Pruritus
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 735255), concerns a 38-year-old, adult female patient. The patient's current condition included asthma (since an unspecified age). The patient had been allergic to latex, REGLAN and AMBIEN. The patient's concomitant medications included carbamazepine, clonazepam, escitalopram, gabapentin and fluconazole for unknown indications. On 24-Jan-2018, the patient received FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195221, expiry date: not reported). On the same day, within 10 minutes of vaccination, the patient experienced itchiness, redness on injected arm and shortness of breath. On an unspecified date, the patient had made an emergency room visit. At the time of this report, the patient had recovered from all the events. The reporter assessed the case as non-serious.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 735277), concerns a 63-year-old, adult female patient. It was reported that in the past 12 years, the patient administered influenza vaccine and experienced a slight red in a small area around the injection site. On 02-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 195231 and expiry date: not reported). On 03-Jan-2018, 1 day after vaccination, the patient reported that the area around the injection site was bright red, hot to touch, burned and swelled to a tennis ball size. The events continued for a couple of weeks after the vaccination. It was reported that, the patient had applied heating pads on the area and no other treatment was received. On 27-Jan-2018, by the time the patient presented to the pharmacy, the swelling and redness had subsided, and the area was back to normal. It was reported that the pharmacy was not aware of the incident till 27-Jan-2018. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious. This case (201803829) was cross-linked to the case: 201803830 (same patient). Update received on 11-Oct-2018: Non-significant case correction (IRD: 12-Sep-2018): The sentence in the narrative 'the patient had heating pads on the area' was corrected to 'the patient had applied heating pads on the area'.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 735385), concerns a 55-year-old, adult, female patient. The patient experienced rash due to sulfonamide drug in the past. The patient's current condition included hypothyroidism and hypertension (reported as medical history). The patient was allergic to Sulfa drugs. The concomitant medications included PROVIGIL during night shift, COZAAR and SYNTHROID. The patient had no current illness. On 20-Oct-2017, the patient was administered FLUCELVAX (QIVc) [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: right deltoid, batch number, expiry date: not reported]. On 21-Oct-2017, one day after vaccination, the patient experienced redness, increased heat and swelling in right upper arm with pain radiating to her fingers. The patient treated herself with TYLENOL, BLUE EMU and VICKS. On an unspecified date, the red, hot and swollen area resolved. However, the patient had continuous the pain in the right arm/shoulder. Subsequent, the patient consulted a primary care physician who referred her back to occupational health. The patient was administered with PENETREX and was sent to physical therapy. At the time of this report, the patient had pain (not recovered). The reporter assessed this case as non-serious.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Palpitations
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 735434), concerning a 54-year-old, adult, female patient. The patient's allergies and current illness were unknown. The patents concurrent condition included hypothyroidism (reported as medical history). The concomitant medications included levothyroxine and calcium w/vitamin D. It was reported that the patient never had this reaction (palpitations) in the past while receiving a vaccine. On 15-Nov-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, batch number: 195247, route of administration: intramuscular, anatomical location: right arm and expiry date: not reported]. On the same day, approximately 5 minutes after the vaccination, the patient developed a racing heart which continued for about an hour. It was reported that the patient did not experience this event prior to the vaccine or since this one instance. No lab investigations were done. At the time of this report, the patient had recovered from the event. The reporter assessed the case as non-serious.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Diplopia, Limb mass, Paraesthesia
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 735437), concerns a 57-year-old, adult male patient. On 13-Jan-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195243, expiry date: not reported). On the same day, after vaccination, the patient experienced tingling in left hand, double vision and bump on the back of his hand. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 735506), concerns an 8-year-old, child, female patient. The patient had no historical condition, current condition or allergies. The patient was not taking any medication at the time of vaccination. On 26-Jan-2018, the patient was administered suspect vaccine FLUCELVAX QIVc [dose: 0.5 ml (frequency: unknown), route of administration: injection (reported as SYR), anatomical location: left arm, batch number: 196498, expiry date: not reported]. On 27-Jan-2018, 1 day after vaccination, the patient developed rash with intense itching, redness and swelling. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Insomnia, Neck pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 12-Sep-2018 by Seqirus from VAERS (VAERS ID: 735533), concerns a 40-year-old, adult, female patient. The patient's current condition included high cholesterol (reported as medical history). The patient was allergic to penicillin, aspirin, codeine, PERCOCET, VICODIN, ULTRAM, FLEXERIL, Z-PAK, clindamycin, vancomycin, doxycycline, strawberries, cherries, red pepper flakes and pineapple. The patient's concomitant medication included CRESTOR for an unknown indication. On 18-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number and expiry date not reported]. On 25-Jan-2018, seven days after vaccination, the patient woke up with mild to moderate left arm and neck pain. The patient thought she might have slept wrong on it. The pain had progressively gotten and she could hardly lift or use her arm. The patient had numbness and tingling from the top of her shoulder down to her middle two fingers. The pain kept the patient awake at night and was making her life very difficult (as reported). The patient rated the pain at 8 out of 10 during the day and 10 out of 10 at night. The patient reported that ibuprofen barely helped it and the heating pad provided very little relief. It had been 5 days since these symptoms began and were continuing to worsen. It was reported that the patient would seek medical care by weekend if it did not get better. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.