chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Immunisation, No adverse event, Syringe issue, Underdose
Clinical narrative: The initial spontaneous case, received from other health professional (Pharmacist) on 19-Dec-2017, concerns a 15-year-old adolescent female patient. The patient's medical history and concomitant medication were not reported. On 18-Dec-2017, while administering the vaccine, about one-third to half of the FLUVIRIN vaccine was not injected into the arm (dose: less than 0.5ml (as reported), route of administration: intramuscular, anatomical location: deltoid, batch no: 179901P and expiry date: 31-May-2018) (explicitly coded as incomplete dose administered). It was reported that, the patient did not experience any adverse event and product complaint had been submitted. The patient was administered with second dose of FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid). The PTC (product technical complaint) number was 1026788. Based on the investigation performed, it was concluded that FLUVIRIN batch 179001P was manufactured in accordance with cGMP requirements and in compliance with approved procedures. No issues were identified in the manufacture of the product batch or the syringes used. The leakage location was reported that the fluid was leaking out through the locker device while the vaccine was administered, however, without a complaint sample available, sample analysis cannot be performed to verify a defect or determine a root cause. It was not possible to rule out that the cause was due to a defective needle or the use of an incompatible needle, however, this cannot be considered as a confirmed root cause. No CAPA(s) are required as a definitive root cause could not be determined. At this stage, although there has been a total of nine complaints received for leaking syringes, there was no indication of a trend for the manufacturing campaign. None of the implicated product batches share common syringe batches and there were range of different leakage locations reported. Six of the complaints have been deemed not to be justified and the other three cases concluded as not determinable, as no internal root cause could be confirmed and no complaint sample was available to confirm defect. The reporter assessed this case as non-serious. Follow up received from QA department on 27-Mar-2018: PTC (product technical complaint) results was received which was integrated in the case narrative. Non-significant case correction received 27-Mar-2018: The PTC result in follow-up line of version 1 (received on 27-Mar-2018) was deleted and added the sentence 'PTC (product technical complaint) results was received which was integrated in the case narrative' to signify the batch review report results received in FUP version. Update on 11-Nov-2018: Non-significant case correction (19-Dec-2017): The term 'PTC Reference Number' was added in the notes section of the additional information tab.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Crying, Irritability, Poor quality sleep, Pyrexia, Seborrhoea
Clinical narrative: 6-8 hrs after vaccination, pt woke from nap and cried for 3 hours. Felt warm to touch. At 11PM on 1/8/19, had fever to 102.5 degrees was fussy and slept poorly all night. Woke frequently during night. On AM of 1/9/19, had fever 101.5. By afternoon, temp dropped to 99. Slept better on night of 1/9/19. Awoke on AM of 1/10/19, fever was gone and he was less fussy. No rash. Appetite was normal throughout. Was not treated with TYLENOL. No signs or symptoms of cold. Patient seen in office 1/18/19. Exam normal except for 2cm patch of seborrhea on scalp and his known cardiac. Excessive fussiness resolved by 1/12/19 according to mother.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Skin warm
Clinical narrative: 6-8 hrs after vaccination, pt woke from nap and cried for 3 hours. Felt warm to touch. At 11PM on 1/8/19, had fever to 102.5 degrees was fussy and slept poorly all night. Woke frequently during night. On AM of 1/9/19, had fever 101.5. By afternoon, temp dropped to 99. Slept better on night of 1/9/19. Awoke on AM of 1/10/19, fever was gone and he was less fussy. No rash. Appetite was normal throughout. Was not treated with TYLENOL. No signs or symptoms of cold. Patient seen in office 1/18/19. Exam normal except for 2cm patch of seborrhea on scalp and his known cardiac. Excessive fussiness resolved by 1/12/19 according to mother.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injury, Nuclear magnetic resonance imaging abnormal, Pain, Rotator cuff syndrome
Clinical narrative: Pain after flu shot was given. Per patient she had MRI which showed direct impact trauma due to flu shot given too high. Per patient Dr. diagnosed with mild tendonitis and infraspinatus.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Contusion, Erythema, Myalgia, Nodule, Pain
Clinical narrative: Day after administration patient had red rash the size of an inch but as day progressed it became more prominent and swelling and pain became more severe. The deltoid muscle was sore and painful. By Saturday night the area of redness was the size of a baseball. She went to minute clinic and was prescribed KEFLEX by nurse practitioner. Her primary care doctor, was called by the patient on 12/31/18 and she told doctor that there was still knot in the middle of her arm and bruising in the surface but no soreness but still pain to touch/pressure.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Swelling, Tenderness
Clinical narrative: Day after administration patient had red rash the size of an inch but as day progressed it became more prominent and swelling and pain became more severe. The deltoid muscle was sore and painful. By Saturday night the area of redness was the size of a baseball. She went to minute clinic and was prescribed KEFLEX by nurse practitioner. Her primary care doctor, was called by the patient on 12/31/18 and she told doctor that there was still knot in the middle of her arm and bruising in the surface but no soreness but still pain to touch/pressure.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This is spontaneous case, reported by Other Health Professional to VAERS and initially retrieved on 05-Mar-2018 by Seqirus from VAERS (VAERS ID: 691290), concerns a 54-year-old female patient. The patient had no medical history and concomitant medications received. On 25-Oct-2016, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5ml (unk as reported), route of administration: unknown, anatomical location: left arm, batch number: 1618621). On the same day, after vaccination, the patient had a constant pain and trouble to lay or sleep on the left arm. It was reported that, the frequent increased and worsened. The patient was having trouble getting shirt on/off and limited mobility with that arm. The patient consulted the doctor and as per the patient it was stated that events occurred after vaccination. At the time of this report, the patient had not yet recovered from the events (pain in extremity, injected limb mobility decreased, activities of daily living impaired). The reporter assessed the causality as related. The reporter assessed the case as non-serious.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 24-Apr-2018 by Seqirus from VAERS (VAERS ID: 692951), concerning a 63-year-old, adult, female patient. The patient stated that, she never experienced any symptoms with any of the previous flu shots over many decades. The patient's current condition included: Hashimoto's thyroiditis. Concomitant medication included: SYNTHROID. On 23-Oct-2016, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On an unspecified date, (reported as within few days), the patient developed unusual pain in the upper arm near injection site. The patient still had the symptoms 7 months later and could not fully extend the arm without pain. At the time of this report, the outcome of the events (pain upon movement and injection site pain) was not reported. The reporter assessed this case as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 24-Apr-2018 by Seqirus from VAERS (VAERS ID: 693680), concerns a male patient of unspecified age. On 21-Feb-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml (reported as unknown), route of administration: intramuscular, anatomical location: unknown, batch number 168601, expiry date: not reported). On 22-Feb-2017, 1 day after vaccination, the patient experienced weakness, sweating, dizziness, diarrhoea and shortness of breath. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Impaired work ability, Insomnia, Nuclear magnetic resonance imaging, Pain, Surgery
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 24-Apr-2018 by Seqirus from VAERS (VAERS ID: 694403), concerns a 46-year-old, adult, female patient. The patient's historical conditions were not reported. The patient had no current illness. The patient had been allergic to sulpha drugs and meloxicam. The patient's concomitant medications included SYNTHROID and Trazodone for an unknown indication. On 17-Nov-2016, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, batch number: 169303, anatomical location: unknown and expiry date: not reported). On the same day, after the vaccination, the patient experienced severe pain, loss of sleep and work. The patient was examined by the family physician, who referred the patient to ortho specialist (emergency room). The patient received anti-inflammatory drugs, which did not help. MRI (magnetic resonance image) was done for which results were not reported. The patient was also given steroid shot, which temporarily relief the patient and pain returned. On 02-Mar-2017, after 3 months 14 days of vaccination, the patient underwent surgery (unspecified) and physical therapy was done for 9 weeks. On an unspecified date, the subject had recovered from the events. The reporter assessed the events as non-serious.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Cough, Laryngitis, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: This is non-serious spontaneous case, reported by other non-healthcare professional to VAERS and initially retrieved on 28-May-2018 by Seqirus from VAERS (VAERS ID: 698542), concerns a 55-year-old, adult, female patient. The patient's historical vaccine included unspecified flu vaccine for which no reaction was noted, however experienced bad cold symptoms. The patient's current condition included environmental allergies, Gastroesophageal reflux disease (GERD) and migraine. On 04-Nov-2016, the patient received FLUVIRIN Thiomersal (dose: 0.5 ml, frequency reported as 2, batch number: 1619701, expiry date: 31-May-2017, route of administration: intramuscular, anatomical site: right arm). On 06-Nov-2016, 2 days after vaccination, the patient experienced congestion, cough and severe throat (reported as sharp, stabbing pain), laryngitis. It was reported that, the patient lost voice completely for 3 days. The patient had to take MEDROL DOSE Pak for a week to get over pain and inflammation in throat and larynx. The patient had a visit to the physician. On an unspecified date, the patient had recovered from all the events. The reporter assessed this case as non-serious. Update received on 19-Oct-2018: Significant case correction (IRD: 28-May-2018): The product was changed from 'FLUVIRIN' to 'FLUVIRIN Thiomersal' in the product tab. The narrative was amended accordingly.
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 28-May-2018 by Seqirus from VAERS (VAERS ID: 701035), concerns a 44-year-old, adult male patient. The patient's current condition included, schizophrenia (reported as schizophrenia or similar condition). The concomitant medication included Fluphenazine 5 mg for an unknown indication. The patient had no known allergy. On 10-Mar-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On 27-Jun-2017, after 109 days of vaccination, the patient experienced soreness in the left arm where the vaccine was given. The reporter assessed the case as non-serious.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This spontaneous case, reported by Non-healthcare professional (other) to VAERS and initially retrieved on 28-May-2018 by Seqirus from VAERS (VAERS ID: 702372), concerns a 50-year-old, adult, female patient. The patient had no medical history, current condition and concomitant medications. On 21-Oct-2016, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 1618701, expiry date: not reported). On the same day after the administration of vaccine, the patient experienced muscle ache at the site of injection and down the arm. The patient was treated with Ibuprofen but did not relieved the pain. At the time of this report, the patient had not recovered from the event. The reporter assessed the event as non-serious.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Vasodilatation
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 28-May-2018 by Seqirus from VAERS (VAERS ID: 702425), concerns a 59-year-old, adult male patient. The patient's concomitant medications included, Lisinopril, Hydrocodone/APAP, SYMBICORT, folic acid, levothyroxine and phenytoin all for unknown indications. The patient's medical history and allergy was unknown. The patient had no other current illness. On 10-Jan-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml (reported as unknown), route of administration: intramuscular, anatomical location: right arm, batch number: 169221, expiry date: not reported). On the same day, approximately 30 minutes or later, the patient experienced burning sensation in neck or right side where the injection was given and bulged veins. On 11-Jan-2017 (in morning), the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 28-May-2018 by Seqirus from VAERS (VAERS ID: 702661), concerns a 56-year-old, adult, female patient. The patient was allergic to penicillin. On 14-Oct-2016, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 169305, expiry date: not reported). On 15-Oct-2016, 1 day after administration of the vaccine, the patient experienced severe and prolonged pain. The patient was treated with pain medications and steroid injection. It was reported that, the patient was on physical therapy. At the time of this report, the outcome of the event was unknown. The reporter assessed the event as non-serious.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Muscular weakness, Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 28-May-2018 by Seqirus from VAERS (VAERS ID: 704303), concerns a 22-year-old, adult, female patient. The patient's medical history and allergies were not reported. The concomitant medication included APRI. On 25-Sep-2016, the patient was administered with FLUVIRIN (dose: 0.5 ml [reported as 1st dose], route of administration: intramuscular, anatomical location: left arm, batch number: UI684AE [as reported] and expiry date: not reported). Seqirus Quality Assurance have confirmed that the batch number reported (UI684AE) is not a Seqirus batch number, however because the reporter named Seqirus product 'FLUVIRIN' as the suspect vaccine, this report has been conservatively entered as a Seqirus case. On 26-Sep-2016, 1 day after vaccination, the patient experienced pain in the left arm, muscle weakness, slight swelling in the left deltoid. The patient experiencing the pain while lifting the things or moving the arm in forward or backward direction. It was reported that, it was very painful while doing the simple tasks (putting on a jacket or buckling a seatbelt as reported), it was hard, impossible to lift the weights heavier than few pounds. On 19-Dec-2016, the patient went to doctor and treated with prednisone 10 mg, 6-day taper pack and baclofen. On an unspecified date, the patient stopped prednisone. The prednisone helped a while but in last few days of the taper pack, the pain returned. On 30-Dec-2016, the patient again went to doctor due to no progress was observed after prednisone stopped. The x-ray was performed, and the result found to be negative. The patient was prescribed with Tramadol which did not help to reduce pain. Upon recommendation, the patient went to orthopaedist on 11-May-2017 and treated with Cortisone shot and physical exercises were recommended. The cortisone helped a little, but the pain continued. The patient was referred to centers for disease control and prevention to proceed further. At the time of this report, the patient had not recovered from the events (pain, pain in arm, muscle weakness and swelling of injection site). The reporter assessed this case as non-serious. Update on 03-Jul-2018: Non-significant case correction was received on 28-May-2018: The sentences 'the prednisone helped a while but in last few days due to taper pack the pain returned' was corrected to 'the prednisone helped a while but in last few days of the taper pack, the pain returned' and 'the patient prescribed with Tramadol which did not help to pain' was corrected to 'the patient was prescribed with Tramadol which did not help to reduce pain' in the narrative.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 28-May-2018 by Seqirus from VAERS (VAERS ID: 704303), concerns a 22-year-old, adult, female patient. The patient's medical history and allergies were not reported. The concomitant medication included APRI. On 25-Sep-2016, the patient was administered with FLUVIRIN (dose: 0.5 ml [reported as 1st dose], route of administration: intramuscular, anatomical location: left arm, batch number: UI684AE [as reported] and expiry date: not reported). Seqirus Quality Assurance have confirmed that the batch number reported (UI684AE) is not a Seqirus batch number, however because the reporter named Seqirus product 'FLUVIRIN' as the suspect vaccine, this report has been conservatively entered as a Seqirus case. On 26-Sep-2016, 1 day after vaccination, the patient experienced pain in the left arm, muscle weakness, slight swelling in the left deltoid. The patient experiencing the pain while lifting the things or moving the arm in forward or backward direction. It was reported that, it was very painful while doing the simple tasks (putting on a jacket or buckling a seatbelt as reported), it was hard, impossible to lift the weights heavier than few pounds. On 19-Dec-2016, the patient went to doctor and treated with prednisone 10 mg, 6-day taper pack and baclofen. On an unspecified date, the patient stopped prednisone. The prednisone helped a while but in last few days of the taper pack, the pain returned. On 30-Dec-2016, the patient again went to doctor due to no progress was observed after prednisone stopped. The x-ray was performed, and the result found to be negative. The patient was prescribed with Tramadol which did not help to reduce pain. Upon recommendation, the patient went to orthopaedist on 11-May-2017 and treated with Cortisone shot and physical exercises were recommended. The cortisone helped a little, but the pain continued. The patient was referred to centers for disease control and prevention to proceed further. At the time of this report, the patient had not recovered from the events (pain, pain in arm, muscle weakness and swelling of injection site). The reporter assessed this case as non-serious. Update on 03-Jul-2018: Non-significant case correction was received on 28-May-2018: The sentences 'the prednisone helped a while but in last few days due to taper pack the pain returned' was corrected to 'the prednisone helped a while but in last few days of the taper pack, the pain returned' and 'the patient prescribed with Tramadol which did not help to pain' was corrected to 'the patient was prescribed with Tramadol which did not help to reduce pain' in the narrative.
Age: 30.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Headache, Oculorespiratory syndrome
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 28-May-2018 by Seqirus from VAERS (VAERS ID: 705902), concerns a 30-year-old, adult, male patient. The patient had no relevant medical history. On 07-Oct-2014, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: injection (SYR as reported), batch number, expiry date, manufacturer and trade name: not reported and anatomical location: unknown). On the same day (07-Oct-2014), the patient experienced recurrent severe headache which was accompanied with oculorespiratory syndrome and the patient went to the emergency room. It was reported that the symptoms began in few hours and resolved by 36 hours post vaccination. At the time of this report, the patient had recovered from the events (oculorespiratory syndrome and headache). The reporter assessed the events as non-serious. This case 201802128 was cross 201802129 reported by the same reporter. Update 20-Jul-2018: Non-significant case correction was received with IRD on 28-May-2018: The anatomical location was changed from not reported to unknown. The sentence 'symptoms began in few hours and resolved by 36 hours post vaccination' was added in the narrative.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Alopecia, Antiphospholipid antibodies negative, Arthralgia, Fatigue, Thyroid function test normal
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 28-May-2018 by Seqirus from VAERS (VAERS ID: 707075), concerns a 47-year-old, adult, male patient. On 12-Oct-2016, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 168602 and expiry date: not reported). On 18-Oct-2016, 6 days after vaccination, the patient experienced pain in knee joints, fatigue and hair loss. It was reported that, the patient made a visit to the physician. On an unspecified date, lupus test (antiphospholipid antibodies) and thyroid functional test was performed, and results were found to be negative. At the time of this report, the patient had not recovered from the events (hair loss, arthralgia and fatigue). The reporter assessed this case as non-serious. Update 03-Jul-2018: Non-significant case correction was performed 28-May-2018: The phrase in narrative was changed from '6 days of vaccination' to '6 days after vaccination'. Narrative was amended accordingly. Update on 20-Jul-2018: Case correction was performed 28-May-2018: The sentence 'on 12-Oct-2016, the patient was administered with FLUVIRIN' was corrected to 'on 12-Oct-2016, the patient was administered FLUVIRIN'. Lab tests were entered in the relevant tests (on an unspecified date, lupus test (antiphospholipid antibodies) and thyroid functional test was performed, and results were found to be negative (added in the patient tab). Upon internal review it was realized that, the LLT of the event (pain in knee joints) was wrongly coded as arthralgia. Hence, it was corrected to 'pain in knee' in the event tab. The narrative was amended accordingly.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Urticaria
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 13-Jun-2018 by Seqirus from VAERS (VAERS ID: 711407), concerns a 69-year-old, elderly, female patient. The patient's historical, current conditions, allergies and concomitant medications were not reported. On 01-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml [reported as 1], route of administration: intramuscular, anatomical location: right arm, batch number: 1720801 and expiry date: not reported). On the same day, after vaccination, the patient experienced hives and flu-like symptoms (aches and pains). It was reported that, flu-like symptoms were normal, but hives were a new adverse event for her. On an unspecified date, the patient had recovered from the events. The reporter assessed the events as non-serious.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 13-Jun-2018 by Seqirus from VAERS (VAERS ID: 712364), concerns a 68-year-old elderly female patient. The patient's medical history was not reported and had no allergies. On 06-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: right arm, batch number: 1720801, expiry date: not reported). On 08-Sep-2017, after 2 days of vaccination, the patient developed swelling, redness and felt warm (reported as, fevered) at the site of injection. A couple of days later, the patient reported these events to the pharmacy. It was reported that, these events were dissipating. The outcome of the events was unknown. The reporter assessed the case as non-serious.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Urticaria
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 13-Jun-2018 by Seqirus from VAERS (VAERS ID: 712998), concerns a 49-year-old adult male patient. The patient's current conditions and concomitant medications were not reported. On 14-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5ml, reported as 1, route of administration: intramuscular, anatomical location: left arm, batch number: 179601P). On the same day, after vaccination, 25 minutes later, the patient returned to the clinic with hives on neck and headache. It was reported that, the breathing of the patient was ok. The pharmacist stepped out for a few minutes. The patient reported the incident and left the clinic. Patient was contacted after 10-15 min during which he informed that symptoms had been improved. The patient was suggested to take BENADRYL, however the patient said that he would take it at home. The case was assessed as non-serious. Update 03-Jul-2018: Non-significant case correction performed 13-Jun-2018: In the narrative 'good' was replaced with ok. 'The patient reported the symptoms and left from the clinic. After 10-15 minutes, the patient was contacted for which he reported the symptoms to be improved' was changed to 'The patient reported the incident and left the clinic. Patient was contacted after 10-15 min during which he informed that symptoms had been improved'. Amended narrative accordingly.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 13-Jun-2018 by Seqirus from VAERS (VAERS ID: 714893), concerns a 44-year-old, adult, female patient. The patient had no historical and current conditions. The patient did not receive any concomitant medications. On 31-Aug-2017, the patient was administered FLUVIRIN (dose; 0.5 ml, frequency: 1, route of administration: intramuscular, anatomical location: right arm, batch number: 179601P and expiry date: not reported). On the same day (31-Aug-2017), after vaccination, the patient complained of pain and soreness, which lasted more than a month. At the time of this report, the patient had not yet recovered from the event. The reporter assessed the event as non-serious. Update on 22-Jul-2018: Case correction was performed with IRD 13-Jun-2018: The case comment was changed from "A 44-year-old, adult, female patient complained of pain and soreness on the same day after vaccination, company assessed the causality of the event as related to the suspect vaccine due to close temporal relationship" to "A 44-year-old, adult, female patient complained of pain and soreness on the same day after vaccination. The company assessed the causality of the event as related to the suspect vaccine due to close temporal relationship between vaccination to events onset". Upon internal review it was realized that, the lower level term (LLT) was incorrect. Hence, it was corrected from 'pain NOS' to 'pain' in the event tab. The event verbatim was changed from 'complained of pain and soreness that lasted more than a month' to 'pain and soreness' in the event tab.
Sex: F
Vaccine: FLU3
Symptoms: Cardiac failure congestive, Dyspnoea, Laboratory test, Rash
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 13-Jun-2018 by Seqirus from VAERS (VAERS ID: 715093), concerns a 62-year-old, adult female patient. The patient's concomitant medications included VENTOLIN HFA, fluticasone and SPIRIVA RESPIMAT. The patient had no history of adverse reaction to vaccines. On 06-Sep 2017, the patient was administered FLUVIRIN (dose: 0.5 ml, batch number: 1720801, route of administration: unknown, anatomical location: left arm). On 16-Sep-2017, 10 days after vaccination, the patient went to pharmacy, where within 30 minutes, the patient broke out with a rash and experienced difficulty in breathing. The patient visited the emergency room and doctor prescribed BACTRIM DS. The patient had an inhaler which helped in shortness of breath (SOB). It was reported that, the patient was undergoing some laboratory tests and workup related to congestive heart failure (CHF). At the time of report, the outcome of the events (difficulty breathing and rash) was unknown. The case was assessed as non-serious. Update 11-Jul-2018: Significant case correction was performed with IRD 13-Jun-2018: The 'as determined causality' of the event rash was corrected from related to not related and event difficulty breathing from unassessable to not related in the event assessment tab. The case comment was corrected accordingly.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 13-Jun-2018 by Seqirus from VAERS (VAERS ID: 715568), concerns a 63-year-old adult female patient. The patient's current conditions included asthma, hypertension, high cholesterol, acid reflux, insomnia, pain (reported as medical history) and penicillin allergy. The patient's concomitant medications included SPIRIVA, Omeprazole, Ibuprofen, BREO ELLIPTA, Amitriptyline, Diltiazem, Lovastatin, Lisinopril and Ventolin. On 28-Sep-2017, the patient received FLUVIRIN Thiomersal [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: 1720801 and expiry date: not reported] and non-company suspect PNEUMOVAX (route of administration: intramuscular, anatomical site: left arm, batch number: M038216 as reported, dose and expiry date: not reported). On 29-Sep-2017, 1 day after vaccination, the patient complained of redness, swelling and pain at the injection site. It was reported that, the area of redness almost wrapped completely around her upper arm. It was suspected to be an injection site reaction and the patient was advised to take Ibuprofen for pain and BENADRYL for the reaction. The patient was advised to follow up with her primary care physician, if the redness worsened or the area would become more painful and swollen. At the time of this report, the patient had not recovered from the events (injection site erythema, injection site pain and injection site swelling). The reporter assessed this case as non-serious. Update 11-Jul-2018: Non-significant case correction performed 13-Jun-2018: Co-suspect (pneumococcal vaccine) was added in case comment.
Age: 58.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Eye swelling, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 715743), concerns a 58-year-old, adult, female patient. The patient had no current conditions. On 30-Aug-2017, the patient was administered FLUVIRIN Thiomersal (dose: 0.5 ml, anatomical location: right arm, batch number: 1720801, expiry date and route of administration: not reported) and BOOSTRIX (anatomical location: left arm, batch number: 7Y292, dose, route of administration, expiry date: not reported). On the same day, 30 minutes after vaccination, the patient felt her right arm was sore and swollen. It didn't look swollen, but patient was advised to use pain killers. On 31-Aug-2017, the patient's left eye was swollen. At the time of this report, the outcome of the events was unknown. The reporter assessed this case as non-serious. Update 22-Jul-2018: Case correction was performed with IRD 20-Jun-2018: The sentence in the case comment was corrected from 'female patient experienced swollen arm, eyes swollen and pain in arm after vaccination' to 'female patient experienced swollen arm, left eye swelling and pain in arm after vaccination'.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Local reaction
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 13-Jun-2018 by Seqirus from VAERS (VAERS ID: 715887), concerns a 21-year-old, adult, female patient. The patient's historical conditions, concomitant medications were not reported. On 26-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 1720701 and expiry date: not reported). On 27-Sep-2017, 1 day after vaccination, the patient experienced redness at the injection site. On 28-Sep-2017, (2 days after vaccination), the patient experienced local site reaction. On an unspecified date, the patient had recovered from the events. The reporter assessed the events as non-serious.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Vomiting
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 715932), concerns a 49-year-old, adult, female patient. On 18-Sep-2017, the patient was administered FLUVIRIN Thiomersal (dose: 0.5 ml, anatomical location: left arm, batch number: 1720801, route of administration and expiry date: not reported). On 19-Sep-2017, 1 day after vaccination, the patient experienced chills, headache, vomiting, stomach-ache and diarrhoea. At the time of this report, the outcome of the events (chills, headache, vomiting, stomach-ache and diarrhoea) was unknown. The reporter assessed the case as non-serious. Update on 09-Aug-2018: Non-significant case correction was performed 20-Jun-2018: Age at vaccination (49 years) was captured in the product tab. No changes were made in the narrative.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: This initial spontaneous case, reported by other-health care professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (regulatory reference number; 716326), concerning a 49-year-old, adult, male patient. The patient's current illness, medical history, concomitant medications and allergies were unknown at the time of this report. On 03-Oct-2017, the patient was administered FLUVIRIN [dose: 0.5 ml (reported as 1), route of administration: intramuscular, batch number: 179701P, anatomical location: unknown (reported as UN) and expiry date: not reported]. On the same day, while vaccination, immediately after removing the injection from auto-retract method (as reported), the patient's arm began to bleed, and bump formed. The reporter suspected that it must have hit a blood vessel. The health care professional advised the patient to apply cool compress and take TYLENOL for discomfort. Outcome of the events were unknown at the time of this report. The reporter assessed the report as non-serious.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 716337), concerns a 52-year-old, adult female patient. The patient's current conditions included allergic to latex, lactose, wheat, morphine. The patient's concomitant medications were not reported. On 02-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5ml [2 as reported], route of administration: intramuscular, anatomical location: unknown, batch number: 1720801). On the same day, after vaccination the patient experienced itchiness which lasted from 10:30 am to about 1:45 pm. It was reported that, itchiness started on the arm spread to the head and belly. The patient improved after taking ZYRTEC. On an unspecified date, the patient recovered from pruritus. The reporter assessed the case as non-serious.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Ligament injury, Pain, Product administered at inappropriate site, Tearfulness
Clinical narrative: This spontaneous case, reported by other non-healthcare professional (consumer) to VAERS and initially received on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 716352), concerns a 28-year-old, adult, female patient. The patient historical condition included thyroid cancer, which was removed on an unspecified date in 2001. The patient had been allergic to amoxicillin, penicillin and tramadol. The patient's concomitant medications included YAZ for birth control and Levothyroxine for an unknown indication. The patient had no illness one month prior and at the time of vaccination. On 21-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml [reported as 1st dose], route of administration: injection [reported as SYR], anatomical location: right arm, batch number and expiry date: not reported) which was given too high in arm and hit deltoid ligament. On the same day, after vaccination, the patient experienced more pain than usual. On 22-Sep-2017, after one day of vaccination, the patient experienced extreme pain at injection site in right arm. The patient was in tears due to pain on move her arm to remove or put on a shirt. The pain subsided (from 23-Sep-2017 to 04-Sep-2017), but it hurt while using of muscle in which injection was given. On 03-Oct-2017, at 08:15 AM, the patient went to the doctor and doctor suggested ibuprofen around the clock, ice compresses, and taught physical therapy stretches to aid in recovery. It was reported that, tests would be scheduled, if pain did not subside in two weeks. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 716388), concerns a 58-year-old, adult, female patient. The patient was allergic to sulfa and penicillin. On 26-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: unknown, anatomical location: left arm, batch number: 1720701 and expiry date: not reported). On 27-Sep-2017, 1 day after vaccination, the patient experienced soreness/pain, redness and swelling for more than 2 diameters at the site of injection. No other symptoms were noted. At the time of this report, the outcome of the events was unknown. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dizziness, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 716628), concerns a 61-year-old, adult, female patient. The patient's current condition included asthma (since an unspecified date). The patient had been allergic to iodine. The patient received an unspecified concomitant medication. On 29-Sep-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179701P and expiry date: not reported) and non-company suspect product PREVNAR 13 (route of administration: intramuscular, anatomical location: left arm, batch number: S39564, dose and expiry date: not reported). On 30-Sep-2017, after one day of vaccination, the patient experienced dizziness and medium size redness and swelling at injection site in left arm. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the case as non-serious.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Induration
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 716642), concerns a 68-year-old, elderly, female patient. On 03-Oct-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml (reported as unknown), route of administration: intramuscular, anatomical location: left arm, batch number: 1721201, expiry date: not reported). On 05-Oct-2017, 2 days after vaccination, the patient developed 11x6 cm mild induration (top margin, about 2 cm) below site of injection. At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 716728), concerns a 09-year-old, male child patient. The patient had no medical history, concomitant medications and allergies. The patient had no illness at the time of vaccination. On 01-Oct-2017, the patient was administered FLUVIRIN (dose 0.5 ml [frequency reported a 1], route of administration: intramuscular, anatomical location: right arm, batch number, expiry date: not reported). On the same day, after vaccination, the patient developed fever (warmth), lump, soreness and significant rash covering more than 120 CM2 (as reported) at the injection site. On an unspecified date, the patient consulted the physician for the event and no lab investigations were performed. At the time of this report, the patient had not yet recovered from the events. The reporter assessed this case as non-serious. Update 22-Jul-2018: Case correction was performed with IRD 20-Jun-2018: The sentence was corrected from 'rash covering more than 120 cmE2' to 'significant rash covering more than 120 CM2' in narrative and in case comment.
Age: 17.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 717976), concerns a 17-year-old, male adolescent patient. The patient's current condition included peanut allergy and did not receive any concomitant medications. On 06-Oct-2017, the patient was administered FLUVIRIN (dose: 0.5 ml [frequency reported as 1], route of administration: intramuscular, anatomical location: left arm, batch number: 179704P and expiry date: not reported). On the same day, the patient also received MENVEO (dose: 2 [frequency reported as 2], route of administration: intramuscular, anatomical location: left arm, batch number: M16165 and expiry date: not reported). On the same day (06-Oct-2017), after vaccination, the patient experienced an impressive swelling and redness of upper arm surrounding the site of administration. It was reported that, the patient also had a mild itch (reported as itchy) but not painful. The patient had not recovered from the events (injection site erythema, injection site pruritus, injection site swelling). The report assessed the case as non-serious. Update 22-Jul-2018: Non-significant case correction received with IRD 20-Jun-2018: The co-suspect was added in the case comment.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Myalgia, Nausea, Pain
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 718051), concerns a 63-year-old, adult, male patient. On 28-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 1720701, expiry date: not reported). On the same day (28-Sep-2017) 5 hours after vaccination, the patient experienced severe muscle ache that moved all over the body (arms, back and chest), nausea but no vomiting, headache. The patient experienced occasional aches and fatigue. Hence, the patient made a visit to the physician's office for the events. It was reported that, the patient was still having the symptoms but not severe (not recovered). The reporter assessed the case as non-serious.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Ocular hyperaemia, Vaccination complication
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 718078), concerns a 61-year-old, adult female patient. The patient's current illness was unknown. The patient was allergic to steroids, KEFLEX, Beef and milk products. On 26-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml (reported as unknown), anatomical location: right arm, batch number: 1720801, route of administration, expiry date: not reported). On 27-Sep-2017, the next day of vaccination, the patient's right eye was very red and painful. The patient visited the emergency room and was told that the events were due to the immune reaction or response to flu vaccine. It was reported that, the patient will be reviewed again after 2 weeks. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.