chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: 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: 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.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Heart rate increased
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: 735764), concerns a 46-year-old, adult, female patient. The patient had no medical history. The patient had no current illness and no allergies. The patient did not receive any concomitant medications. On 29-Jan-2018, the patient received FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, route of administration: injection [reported as SYR], anatomical location: left arm, batch number: NDC 704610201, expiry date: not reported). The Seqirus confirmed that, it was NDC code fro FLUCELVAX NH17/18 QIV PFS LL 10X1. On the same day, after vaccination, the patient experienced fast heartbeat. On the following day (30-Jan-2018), the patient had aching joints. At the time of report, the patient had not yet recovered from the events (arthralgia and fast heartbeat). The reporter assessed the case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Discomfort, Injection site 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: 735864), concerns a 59-year-old, adult female patient. On 24-Jan-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as 1, anatomical site: left arm, batch number: 195243, route of administration: unknown, and expiry date: not reported). On the same day, after vaccination, the patient experienced pain at the injection site, and discomfort which had prolonged and continued for approximately 6 days. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest pain, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 12-Sep-2017 by Seqirus from VAERS (VAERS ID: 735906), concerns a 53-year-old, adult female patient. The patient's current conditions included borderline high blood pressure and elevated cholesterol (reported a historical condition) and allergy to sulfa drugs. The concomitant medications include verapamil, lovastatin and levothyroxine (reported as levothroxin). On 18-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, frequency reported as 1, route of administration: injection (reported as SYR), anatomical location: right arm, batch number: 1576201 (as reported) and expiry date: not reported]. Seqirus was unable to confirm the reported batch number (1576201) as FLUCELVAX (QIVc), however, as the reporter named Seqirus product 'FLUCELVAX' as the suspect vaccine, this report had been conservatively entered as a Seqirus case. On the same day, about 1 hour after vaccination, the patient experienced pain in arm over into her chest area. The patient didn't realize what it was and had forgotten that she had a vaccination, however when she realized it at about 7 pm (same day), she took an 800 mg ibuprofen which seemed to help her with the pain. The patient called the pharmacy and was told to continue with ibuprofen telling inflammation due to injection might be the cause. The patient took ibuprofen till the next day (reported as Thursday) and then stopped. The patient said that the pain had not gone away but was not as intense and continued throughout the next day (reported as Friday). On 21-Oct-2017, morning (reported as Saturday), the patient woke up with pain and throbbing going down into her hand. No doctor offices were open, so the patient went to the emergency room (ER) and was given a musclo relaxer and anti-inflammatory and told that the diagnosis might be muscle spasm. The patient only took that medication for 1-2 days which helped greatly. The patient did not want to take those prescribed (RX) drugs for a longer length of time. Since then, the patient's arm pain had continued, intensity varied, there was limited range of motion, sometimes hurt higher on the arm, other times into the top half of the arm and often extends into the elbow. The patient had tried creams, ibuprofen, and other medications. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Update received on 20-Sep-2018: Non-significant case correct (12-Sep-2018): It was reported that, Seqirus was unable to confirm the reported batch number (1576201) as FLUCELVAX (QIVc). No changes were made in the narrative.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood iron, Feeling abnormal, Full blood count, Tinnitus, Vitamin B12
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 735995), concerns a 41-year-old, adult, female patient. The patient had no historical conditions, current conditions and allergies. The patient's concomitant medications included CELEXA, trazodone, FLONASE, magnesium, multivitamin. On 01-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 an unspecified date in Jan-2018, 48 hours after vaccination, the patient developed ringing in the ears and a buzzing feeling in the head. On an unspecified date, the patient made an office visit. On an unspecified date, the complete blood count (CBC), blood iron and vitamin B12 tests were performed (results were not reported) to rule out other causes. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736004), concerns a 44-year-old, adult, female patient. The concomitant medication included multivitamins for an unknown indication. On 20-Nov-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195223 and expiry date: not reported]. On the same day after vaccination, the patient experienced severe to moderate pain in the left arm depending on the movement. On an unspecified date, the patient made an 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 the case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Lip swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736137), concerns a 64-year-old, adult female patient. The patient allergies were not reported. On 31-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: 195228 and expiry date: not reported]. On 02-Feb-2018, 2 days after vaccination, the patient experienced swollen lips. On an unspecified date, the patient had made a physician office visit. At the time of this report, the outcome of the event was unknown. The reporter assessed this case as non-serious.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Dizziness, Dyspnoea exertional, Eye swelling, Headache
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736173), concerning a 49-year-old, adult, female patient. The patient's historical condition included glaucoma. The patient's concurrent conditions included alcohol intolerance, lactose intolerance, allergies to fruits (peaches and melons) and gluten sensitivity. The concomitant medications included omeprazole, Super B complex, fish oil (2000mg) and D3. On 30-Jan-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml (frequency reported as 1), route of administration: injection (SYR as reported), anatomical location: left arm, batch number and expiry date not reported). On 31-Jan-2018, one day after vaccination, the patient developed rash on chest, headaches, swelling mainly above left eye, fever, weakness and some dizziness. On 02-Feb-2018, 3 days after the vaccination, the patient developed difficulty in breathing during exercise. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736173), concerning a 49-year-old, adult, female patient. The patient's historical condition included glaucoma. The patient's concurrent conditions included alcohol intolerance, lactose intolerance, allergies to fruits (peaches and melons) and gluten sensitivity. The concomitant medications included omeprazole, Super B complex, fish oil (2000mg) and D3. On 30-Jan-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml (frequency reported as 1), route of administration: injection (SYR as reported), anatomical location: left arm, batch number and expiry date not reported). On 31-Jan-2018, one day after vaccination, the patient developed rash on chest, headaches, swelling mainly above left eye, fever, weakness and some dizziness. On 02-Feb-2018, 3 days after the vaccination, the patient developed difficulty in breathing during exercise. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736175), concerns a 61-year-old, adult male patient. On 10-Dec-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency: 1, route of administration: intramuscular, anatomical location: left arm, batch number: 195233 and expiry date: not reported). On the same day after vaccination, the patient's arm was sore. On 31-Jan-2018, the patient reported the aforementioned information to the pharmacy, where the registered pharmacist (RPh) suggested the patient to contact doctor (MD) to discuss and get evaluated. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 22.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Body temperature increased, 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 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736293), concerns a 22-year-old, adult male patient. The patient's historical condition included asthma. The patient did not have any known allergies or any current illness. The patient did not take any concomitant medications. On 01-Feb-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: left arm (reported as left upper arm deltoid), batch number: 195214, expiry date: not reported). The patient was also administered co-suspect vaccine PNEUMOVAX [frequency: 1, route of administration: intramuscular, anatomical location: left arm (reported as left lower deltoid), batch number: N029303, dose and expiry date: not reported]. On 02-Feb-2018, one day after vaccination, the patient experienced pain, swelling and redness at Pneumococcal site on left Deltoid along with an elevated temperature of 102.6. On the same day, the patient was treated by doctor on duty and was given TYLENOL 1000 milligram at 3:30 pm and ibuprofen 200 milligram at 4:00 pm. The patient was advised to continue taking TYLENOL 325 milligram, two tablets every four hours as needed, ibuprofen 600 milligram every 6 hours as needed for pain and ice pack to injection site. The patient was instructed to return to student health service, if any new or symptoms worsen in one day. No lab data was reported. The outcome of the events was reported as unknown. The reporter assessed this case as non-serious.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Chest pain, Cough, Decreased appetite, Diarrhoea, Hallucination
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736296), concerns a 59-year-old, adult, male patient. On 30-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195220 and expiry date not reported]. On the same day after vaccination, the patient experienced hallucinations, diarrhoea, chest pain, cough, night sweats and appetite loss. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Night sweats
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736296), concerns a 59-year-old, adult, male patient. On 30-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195220 and expiry date not reported]. On the same day after vaccination, the patient experienced hallucinations, diarrhoea, chest pain, cough, night sweats and appetite loss. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUC4
Symptoms: Contraindication to vaccination, Peripheral swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736383), concerns a 4-year-old, male child. The patient's current conditions included allergies to eggs, peanuts, dogs and cats. The patient's medication at the time of vaccination included EPIPEN, ZYRTEC, BENADRYL, EUCERIN cream and Hydrocortisone cream for unknown indications. On 02-Feb-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency: reported as 5), route of administration: intramuscular, anatomical location: left leg, batch number: 195248, expiry date: not reported) and non-company suspect vaccine KINRIX [dose: not reported (frequency: reported as 1], route of administration: intramuscular, anatomical location: left leg, batch number: 75F53, expiry date: not reported]. On the same day after vaccination, the patient developed swelling in his upper leg. It was reported that the patient was taken to emergency room by his mother. At the time of this report, the patient had recovered from the events.
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736454), concerning a male patient of unspecified age. On 27-Jan-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 195239, anatomical location: left arm, route of administration: unknown and expiry date: not reported). On the same day, after vaccination, the patient felt lightheaded. Eventually, the patient was placed on floor for short time. At the time of this report, the patient had recovered from the event. The reporter assessed the case as non-serious.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736493), concerns a 51-year-old, adult female patient. The patient's historical drug included influenza vaccine on an unspecified date in 2010 and developed red, raised area of approximately 2.5x1.5 which was painful and very warm to the touch. The patient's current condition included Ehlers-Danlos syndrome and bladder infection. The patient was allergic to erythromycin. The patient's concomitant medications included CENTRUM, CALTRATE, fish oil, Cranberry Extract pills, EVAMIST and progesterone. On 05-Feb-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency: 1, route of administration: intramuscular, anatomical location: right arm, batch number: 196498 and expiry date: not reported). On the same day after vaccination, the patient developed red, raised area of approximately 2.5x1.5 which was painful and very warm to the touch. The patient made an office visit, sought medical advice and was advised to ice the area and take anti-inflammatory medications for pain and swelling relief. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious. This case was cross-linked to the case: 201803962 (same patient).
Age: 6.0
Sex: M
Vaccine: FLUC4
Symptoms: Circumstance or information capable of leading to medication error, Injection site erosion
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736524), concerns a 06-year-old, male, child patient. The patient's historical condition, current illness and allergies were unknown. It was unknown if the patient took any medications at the time of vaccination. On 07-Feb-2018, during the administration of FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left upper arm (deltoid), dose: 0.5 ml, batch number: PN75E (as reported) and expiry date: not reported], the patient squirmed immediately prior to insertion of needle, causing the needle to scrape left upper arm, leaving an approximately 1-inch vertical abrasion. The reported batch number (PN75E),did not match Seqirus batch numbers, however, because the reporter named Seqirus product 'FLUCELVAX QIVc' as the suspect vaccine, this report had been conservatively entered as a Seqirus case. On an unspecified date, the patient made an office visit. The site was cleaned and bandaged by staff. The staff instructed the patient's mother to monitor the site when he returned home from school, asked to clean it and apply a topical bacitracin as necessary. Patient did not undergo any laboratory tests. At the time of this report, it was unknown if the patient recovered from the event-injection site erosion. The reporter assessed the case as non-serious. Update received on 02-Nov-2018: Non-significant case correction (IRD: 25-Sep-2018): The physician office visit was checked in the event tab. The narrative was amended accordingly.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736624), concerning a 61-year-old, adult female patient.  The patient had no known allergies. The patient's concomitant medication included CELEXA. On 31-Dec-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml [frequency reported as 1], batch number: 196498, route of administration: intramuscular, anatomical location: left arm and expiry date: not reported). On 01-Jan-2018, 1 day after vaccination, the patient experienced persistent soreness/pain and restriction of movement. No lab investigations were performed. At the time of the report, the patient had reported slight improvement (recovering) from the event, but no resolution. The reporter assessed the case as non-serious.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736733), concerns a 61-year-old, adult female patient. On 24-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration: intramuscular, anatomical site: left arm, batch number: 195224 and expiry date: not reported). On 01-Dec-2018, 1 month and 7 days after vaccination, the patient experienced soreness in the arm, especially at the injection site, the patient reported that pain occurred up to shoulder. The patient believed that the events were caused by vaccine but was still unsure (related). At the time of this report, the outcome of the events was not recovered (reported as continuing). The reporter assessed this case as non-serious.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736922), concerns a 35-year-old, adult, female patient. The patient had no relevant medical history, allergies and current illness. The patient's concomitant medications included ORTHO TRI-CYCLEN and ZYRTEC for unknown indications. On 04-Nov-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: 195248, expiry date: not reported]. Soon after the vaccination, the patient experienced difficulty in moving the arm. It was reported that no swelling was noted after the injection. The condition improved one day after vaccination but worsened again. The patient went to urgent care and the physician found no swelling or fluid build up at the injection site. The patient was prescribed ibuprofen and planned to follow up with primary care physician. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Joint range of motion decreased, Neuralgia, Pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 736930), concerns a 27-year-old, adult, female patient. The patient current condition included depression (reported as medical history) (since an unspecified date) and allergies were unknown. The patient's concomitant medications included buspirone and sertraline. On 29-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 experienced pain at the injection site which progressed to extreme pain with limited range of motion. The patient also experienced shooting pain and nerve type pain. On 04-Feb-2018, the patient went to urgent care facility for medical evaluation. On an unspecified date, the patient made an office visit. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Chills, Myalgia, Rash maculo-papular, Skin burning sensation
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 737181), concerns a 32-year-old, adult female patient. The patient's historical condition included migraine. The patient's current condition included allergic rhinitis. The patient had no known drug allergies (reported as NKDA). Concomitant medications included norethindrone (oral tablet, dose: 0.35 mg daily). On 06-Feb-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: 195129 and expiry date: not reported). On the same day, 10-15 minutes after vaccination, the patient developed a maculopapular rash at the clinic. On an unspecified date in Feb-2018, the patient experienced myalgia, arthralgia, burning of the skin and chills and returned to the clinic 6 days after vaccination. The patient was treated with BENADRYL OTC (over-the-counter) [as needed (reported as prn)] and ZYRTEC. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Limb discomfort, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous case reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 737367), concerns a 62-year-old, adult female patient. The patient's current condition included ovarian cancer (not currently being treated). The patient had no allergies and current illness. The patient's concomitant medications included Pepsin (reported as pepcin, 2 daily) for an unknown indication. On 08-Dec-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, batch number: 195243, anatomical site: left arm and expiry date: not reported]. On 08-Dec-2017, on the same day after the vaccine administration, the patient developed a normal arm discomfort immediately after the injection. On 14-Dec-2017 (reported as two weeks later), the patient reported that she was having Magnetic resonance imaging (MRI) and she was asked to lift her arms above her head, had difficult time doing so, which caused her some discomfort. The patient wanted to wait a little longer and to see if it would resolve. The patient's discomfort was still noticeable sometimes until 13-Feb-2018. The patient was suggested to contact her primary care physician (PCP) for further evaluation. On an unknown date, the patient had office visit. The outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Swelling
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 737509), concerning a 57-year-old, adult, male patient. On 29-Jan-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 196498 and expiry date: not reported). On the next day after the vaccination, the patients experienced swelling on the chest after injection. At the time of the report, the outcome of the event was unknown. The reporter assessed the case as non-serious.
Age: 49.0
Sex: M
Vaccine: FLUC4
Symptoms: Acoustic stimulation tests, Nausea, Vertigo, Vertigo positional
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 737604), concerning a 49-year-old, adult, male patient. The patient had no historical condition and allergies. The patient did not have any current illness and haven't received any concomitant medications. On 15-Nov-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml (frequency reported as 1), route of administration: intramuscular, anatomical location: arm, batch number: 195781 and expiry date: not reported]. On 17-Nov-2017, 2 days after the vaccination, the patient developed vertigo. On 18-Nov-2017, 3 days after the vaccination, the patient went to an urgent care clinic with vertigo and nausea. On 20-Nov-2017, the patient continued to have vertigo and hence saw a primary care physician, which was of no help. The physician suggested an ENT (ear, nose and throat) specialist. On 22-Nov-2017, seven days after the vaccination, the ENT had done some initial work and suggested it was most likely (diagnosed) to be Benign paroxysmal positional vertigo (BPPV) and stated it would go after some time, which did not. The patient's hearing was checked, and other tests (acoustic stimulation tests) were performed, which was of no help. On 29-Nov-2017, the patient saw the same ENT, who suggested a physical therapy (PT). On 06-Dec-2017, the patient went to a physical therapist and did some physical therapy (PT), which helped in clearing up. At the time of this report, the outcome of the event was reported as unknown. The reporter assessed the case as non-serious.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Cough, Headache, Oropharyngeal pain, Pain
Clinical narrative: This spontaneous case, reported by other non-health care professionals to VAERS and initially retrieved on 25-Sep-2017 by Seqirus from VAERS (VAERS ID: 737629), concerns a 36-year-old female patient. On an unspecified date, the patient experienced rash and swelling at the injection site, after administration of unspecified vaccine, which resolved within two days. The patient's medical history included asthma and arthritis. The patient's allergies included penicillin and avocado, since an unspecified date. The patient had no current illness. The patient did not administer any concomitant medications. On 10-Feb-2018, patient was administered with FLUCELVAX QIVc [dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number and expiry date: not reported]. On an unspecified date in Feb-2018, after vaccination, the patient experienced circular rash, skin was hard, swollen and painful to touch. On 13-Feb-2018, 3 days after vaccination, the patient experienced sore throat, cough, fever, chills, and headache. On 14-Feb-2018 (reported as Wednesday early evening), the patient's symptoms have not lessened. At the time of the report, the patient had not recovered from the events. The health authority assessed this case as non-serious.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia, Rash, Skin induration, Swelling
Clinical narrative: This spontaneous case, reported by other non-health care professionals to VAERS and initially retrieved on 25-Sep-2017 by Seqirus from VAERS (VAERS ID: 737629), concerns a 36-year-old female patient. On an unspecified date, the patient experienced rash and swelling at the injection site, after administration of unspecified vaccine, which resolved within two days. The patient's medical history included asthma and arthritis. The patient's allergies included penicillin and avocado, since an unspecified date. The patient had no current illness. The patient did not administer any concomitant medications. On 10-Feb-2018, patient was administered with FLUCELVAX QIVc [dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location: left arm, batch number and expiry date: not reported]. On an unspecified date in Feb-2018, after vaccination, the patient experienced circular rash, skin was hard, swollen and painful to touch. On 13-Feb-2018, 3 days after vaccination, the patient experienced sore throat, cough, fever, chills, and headache. On 14-Feb-2018 (reported as Wednesday early evening), the patient's symptoms have not lessened. At the time of the report, the patient had not recovered from the events. The health authority assessed this case as non-serious.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Limb discomfort
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 738432), concerns a 36-year-old, adult, female patient. The patient had no relevant medical history, allergies and current illness. The patient did not receive any concomitant medications. On 29-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: UT5902AA (as reported), expiry date: not reported). The reported batch number (UT5902AA), dose 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 case. The Seqirus confirmed that the batch number of the product does not match with Seqirus products. On 01-Feb-2018, 3 days after vaccination, the patient had complained of arm discomfort which she believed was related to flu vaccine. This information was reported on 20-Feb-2018, after she visited workmen's comp clinic. The staff member reported that the patient was given steroids. At the time of this report, the outcome of the event was unknown. The reporter assessed this case as non-serious. Update received on 12-Oct-2018: Non-significant case correction (25-Sep-2018) Grammatical correction was done in the narrative wherein the first part of the event description was modified from 'had the complaint' to 'had complained of'.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Dysphonia, Pharyngeal oedema
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially received on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 738512), concerning a 43-year-old, adult, female patient. The patient was allergic to penicillin, ZOFRAN, tramadol, eggs. The patient had latex sensitivity. The patient's concomitant medication included Doxepin. On 16-Jan-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195212 and expiry date: not reported]. On the same day, after vaccination, the patient experienced facial burning and throat swelling. On an unspecified date, the examination of patient's mouth, throat and neck was done, which revealed swollen throat and hoarseness. The patient had no shortness of breath, no wheezing, no cough and the lungs were clear to auscultation. The patient was given one dose of BENADRYL and methylprednisolone (intravenously). The symptoms were improved, and the patient was discharged with a tapering dose of prednisone. At the time of this report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site indentation
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 738810), concerns a 61-year-old, adult female patient. The patient had no known drug allergies. The patient's concomitant medications included tramadol, alprazolam and escitalopram. On 17-Jan-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195126 and expiry date: not reported). On 31-Jan-2018, 14 days after vaccination, the patient developed an indentation in the upper right arm. The patient did not have any pain or loss of function, but just a dent in the right upper arm. The patient reported that, she had no other signs or symptoms and stated that, she did not have the indentation evaluated by her doctor and had not reported it. At the time of this report, the outcome of the event was reported as unknown. The reporter assessed this case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Muscular weakness, Pain
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially received on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 738812), concerns 62-year-old, female, adult patient. The patient's current condition included high blood pressure for a year. The patient had no allergy. The patient's concomitant medications included: lisinopril, Zolpidem and Vit B/C. On 15-Feb-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 an unspecified date in Feb-2018, after vaccination, the patient experienced soreness and swelling at injection site. After 3-4 days, the patient experienced muscle pain in left arm, between elbow and shoulder. The patient also experienced muscular weakness (reported as still present). The patient had pain and difficulty while raising her left arm. The act of pulling a top off and over her head was almost impossible due to pain. The patient felt it as minor and annoying. On 26-Feb-2018, it was up to the point that, she could not lift her arm straight up. The patient did not undergo any laboratory investigations. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 21.0
Sex: M
Vaccine: ADEN_4_7, FLUC4, MEN, TDAP
Symptoms: Lip swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 739160), concerns a 21-year-old, adult male patient. The patient had no known allergies prior to the day of the event. On 27-Feb-2018, the patient was administered suspect vaccine FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 195247, expiry date: not reported]. The patient was administered non-company suspect vaccines, Adenovirus type 4 and type 7 vaccine, live, oral [dose: not reported, route of administration: per-oral, anatomical location: mouth, batch number: 34600340, expiry date: not reported], MENOMUNE [dose: not reported (frequency: 1), route of administration: intramuscular, anatomical location: left arm, batch number: U5836BA, expiry date: not reported] and BOOSTRIX [dose: not reported (frequency: 1), route of administration: intramuscular, anatomical location: right arm, batch number: 22X79, expiry date: not reported] and BICILLIN [dose, frequency, route of administration, anatomical location, batch number and expiry date: not reported]. On the same day within 10 minutes after the last injection (which was reported as BICILLIN), the patient developed swollen lower lip. The patient was treated with BENADRYL at a dose of 50 mg intramuscularly and ZYRTEC per-oral. It was reported that, the patient had office visit. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 22.0
Sex: M
Vaccine: ADEN_4_7, FLUC4, HEPA, MMR, MNQ, TDAP, UNK, VARCEL
Symptoms: Unevaluable event
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 739336), concerns a 22-year-old, adult, male patient. The patient had no relevant medical history, allergies, current illness and concomitant medications at the time of vaccination. On 01-Mar-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: 195247, expiry date: not reported]. The patient was also administered non-company suspect vaccines, HAVRIX [dose, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 5D952, expiry date: not reported] and MENACTRA [dose, frequency reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: U5836BA, expiry date: not reported]. The other non-company suspect vaccines administered included MMR II [dose, frequency reported as 1, route of administration: subcutaneous, anatomical location: right arm, batch number: N023151, expiry date: not reported], BOOSTRIX [dose, frequency reported as 1, route of administration: intramuscular, anatomical location: right arm, batch number: 22X79, expiry date: not reported], VARIVAX [dose: reported as 1, route of administration: subcutaneous, anatomical location: right arm, batch number: N021719, expiry date: not reported], Adenovirus type 4 and 7 [dose, frequency reported as 1, route of administration: oral, anatomical location: mouth, batch number: 34600338, expiry date: not reported] and unknown vaccine [dose, frequency reported as 1, route of administration: intramuscular, anatomical location: other, batch number: T22935, expiry date: not reported]. On an unspecified date, the patient experienced unevaluable event (as reported). At the time of this report, the patient had recovered from the event 'unevaluable event'. The reporter assessed this case as non-serious. Update received on 02-Nov-2018: Significant case correction (IRD: 25-Sep-2018): The classification 'special case with no AE' was removed from the general tab. The event 'Unevaluable event' was added in the event tab. The narrative and case comment were amended accordingly.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 739439), concerning a 36-year-old, adult, female patient. The patient's current conditions included: anxiety (reported as medical history) and allergy to antibiotics (amoxicillin and penicillin). The concomitant medications included: dicyclomine and LEXAPRO for unknown indications. On 27-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 the next day after the vaccination, the patient's arm got sore beyond the normal tenderness of getting a vaccine. The patient felt as if her arm was hit by a hard object and there was no swelling, redness or heat. It was reported that, this was not a bad reaction to the vaccine itself but the way it was administered. The patient waited for few days, thinking that it would get better as some people assured her some soreness was normal. But the patient stated that, it wasn't a normal soreness and as the days passed, the pain worsened. The patient was unable to get clothes on and off, brush hair or to perform any other motion that required her to lift arm. The shoulder joint ached and mobility was limited. After weeks of pain getting worse and not better, the patient addressed her chiropractor who made an appointment with her general physician to have it looked at. On an unspecified date, the patient made an office visit. No lab investigation was performed. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious and considered the causality of the events as related to suspect vaccine. Update received on 30-Oct-2018: Non-significant case correction (IRD: 25-Sep-2018): The onset latency was added in the case comment. No changes were made in the narrative.
Age: 58.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Anxiety, Depression
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 739523), concerns a 58-year-old, adult, male patient. The patient's historical condition included asthma. The patient had no known drug allergies. The concomitant medications included simvastatin and glaucoma eye drops. On 22-Feb-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency: unknown, route of administration: intramuscular, anatomical location: right arm, batch number: 195244 and expiry date: not reported). On the same day, the patient was also administered non-company suspect vaccine, varicella zoster vaccine (frequency: 1, route of administration: intramuscular, anatomical location: left arm, batch number: T5242, dose and expiry date: not reported). On 23-Feb-2018, one day after vaccination, the patient experienced depression and anxiety. The patient reported that shingle vaccines made him experience the events. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 739549), concerns a 08-year-old, female child patient. The patient was allergic to amoxicillin. On 03-Mar-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration: subcutaneous, anatomical location: left arm, batch number and expiry date: not reported). On 04-Mar-2018, 1 day after vaccination, the patient experienced a small red, red, swollen wheal around the injection site. The patient states that it hurts but she had no fever. The patient was treated with TYLENOL and BENADRYL. The reporter advised the patient's mother to take the patient to an emergency room (ER) if it gets worsened and spreads. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.