chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Headache, Influenza like illness, Injection site pain, Insomnia, Malaise
Clinical narrative: It began yesterday at 3:30. I came home from having the TD shot and  had a massive headache. It went from that to left arm feeling tingly. A few hours later my head still hurts right shoulder started hurting. When I went to bed I experienced nausea, back pain, flushing. My left arm felt oddly sick as it felt the shots contents surging thru it for hours. It felt sick... and then my left leg felt ill too, oddly like flu but only on left side of my body. Felt swollen and odd, but it really didnt look swollen. I tried to sleep but couldn't due to feeling ill. And the pain. Today it went up to face tingly, left side only, eye tingly and continued arm. Leg seems ok. Headache still present.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Nausea, Nuclear magnetic resonance imaging brain normal, Paraesthesia, Swelling
Clinical narrative: It began yesterday at 3:30. I came home from having the TD shot and  had a massive headache. It went from that to left arm feeling tingly. A few hours later my head still hurts right shoulder started hurting. When I went to bed I experienced nausea, back pain, flushing. My left arm felt oddly sick as it felt the shots contents surging thru it for hours. It felt sick... and then my left leg felt ill too, oddly like flu but only on left side of my body. Felt swollen and odd, but it really didnt look swollen. I tried to sleep but couldn't due to feeling ill. And the pain. Today it went up to face tingly, left side only, eye tingly and continued arm. Leg seems ok. Headache still present.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Dad called complaining of pain in left arm the day after administration. No fever, swelling. Recommended ice and Motrin as needed.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Gingival swelling
Clinical narrative: Severe swollen gums. First left side (Jan 9th), then two days later right side (Jan 11th). Regular dentist patient, have cleanings every six months.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Swelling
Clinical narrative: Pain in the arm and minor swelling that lasted about  week.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Musculoskeletal pain, Pain, Pyrexia
Clinical narrative: Significant shoulder soreness: although started the day of the injection, got somewhat worse the next day. Took Aleve, may or may not have made much difference. General feverishness, body aches and low energy. Started to set in overnight after injection. Took Tylenol, helped quite a bit. All symptoms disappeared almost magically after 24 hours.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pain and minor swelling in her arm started after the vaccine. Patient said she had experienced pain from previous vaccine and usually a cold compress will resolve the issue. The patient refused treatment.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Patient called in to complain about  severe soreness in her arm as well as tingling in her hands and feet. She received the vaccine on 1/11/19 but starting experiencing the tingling on 1/13/19. She states it started in her hands and has progressed to her feet. She stated this is not her first time receiving a flu vaccine but is worried that the symptoms she is experiencing is GBS. She was counseled to take tylenol or advil to help with the soreness in her arm and to contact her doctor if the symptoms do not improve.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia
Clinical narrative: Nerve pain under arm.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Neuralgia
Clinical narrative: Nerve pain under arm.
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site bruising, Injection site rash, Injection site warmth
Clinical narrative: Patient came into pharmacy to show her right upper arm had rash/bruising which she stated was hot to the touch and had developed just this morning 1/15/19.  She had received the two vaccinations Pneumo23 and SHINGRIX (2nd dose) 7 days earlier on 1/8/19. Patient stated no other symptoms and was told by RPh to apply cold compresses and take OTC analgesics as needed.
Age: 0.25
Sex: F
Vaccine: PNC13, PPV, TDAP, TDAP
Clinical narrative: Patient's father reported pneumococcal and Tdap vaccines had been given "yesterday" at a well baby check up.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Discomfort, Injection site warmth, Mobility decreased, Pain, Pain in extremity
Clinical narrative: EXTREMELY SORE, not able to lift the arm upwards or sideways, extremely painful and sensitive, the injection site turned "HOT" after 24 hours or so. Patient extremely uncomfortable for over 4 to 5 days. Patient took Ibuprofen 600 mg a few times in a day starting 1/10/19, after consultations with the pharmacist and a follow up call was made each day to see if the condition was not getting deteriorated. Her condition started improving after the start of OTC, Ibuprofen doses. By 12th she was feeling a little better and by 13th she was much better.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Vomiting
Clinical narrative: Excessive vomiting for days after ROTATEQ given. Happened during first dose as well, yet parents did not recognize a pattern until the second ROTATEQ was given and the same symptoms happened. Patient is unable to keep anything down 24 hours following the ROTATEQ vaccine and vomits several times for a few days following. Refuses to eat. Also gets very irritable, fussy, and takes a few weeks to start acting like himself again.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Broke out with hives and redness at injection site, was given BENADRYL and over the counter ZANTAC, still has hives as of 1/15/19.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site erythema
Clinical narrative: (Started 11-9 - lasted until 11-14) chills, very tired, severe cramps, diarrhea, right arm swelled to elbow, weak, redness below injection site about 4"-spot about 4" to just above elbow, couldn't do anything but lie down, headache, nausea [took ADVIL, TYLENOL].
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Nausea, Peripheral swelling
Clinical narrative: (Started 11-9 - lasted until 11-14) chills, very tired, severe cramps, diarrhea, right arm swelled to elbow, weak, redness below injection site about 4"-spot about 4" to just above elbow, couldn't do anything but lie down, headache, nausea [took ADVIL, TYLENOL].
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Laboratory test normal, Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Severe headaches, pain in neck and shoulders. Started a few days after got SHINGRIX at a pharmacy. Headaches not fully resolved 3 months later.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Severe headaches, pain in neck and shoulders. Started a few days after got SHINGRIX at a pharmacy. Headaches not fully resolved 3 months later.
Age: 1.5
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Urticarial rash develop over the site of injection, spreading to inner thigh and to (L) thigh treated with BENADRYL, ZYRTEC and cool compress.
Age: 1.42
Sex: F
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Nickle size area of redness and swelling at the MMR and varicella sites.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Injection site scab, Injection site swelling, Purulent discharge
Clinical narrative: Injection site red/swollen/weeping pus/scabbed over. Arm sore.
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Pink, papular/rough rash on lateral aspect of left leg.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chills, Dizziness, Erythema, Feeling hot
Clinical narrative: Pain level #10 out of 10, swelling, unable to move arm. 2 red patches not raised. Arm pain from shoulder to elbow back of upper arm. Chills and warmth, light headed, some feeling of weakness. Ice pack; TYLENOL.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pain in extremity, Swelling
Clinical narrative: Pain level #10 out of 10, swelling, unable to move arm. 2 red patches not raised. Arm pain from shoulder to elbow back of upper arm. Chills and warmth, light headed, some feeling of weakness. Ice pack; TYLENOL.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Malaise, Pain in extremity, Vomiting
Clinical narrative: Pt C/O feeling really sick, vomiting, fatigue the day after the shot was given. There is a 2.5 -3 inch red spot at the site of the injection-arm is sore.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Paralysis
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: 703008), concerns a 58-year-old adult male patient. The patient's medical history and concomitant medication was not reported. On 06-Oct-2016, the patient received FLUVIRIN (dose: 0.5 ml [reported as 1 dose], route of administration: intramuscular, anatomical location: left arm, batch number: 168604 and expiry date: not reported). On 24-Oct-2016, 18 days after vaccination, the patient was paralyzed due to flu shot given at work. It was reported that, the patient visited emergency room and later got hospitalized for 25 days (total duration) due to the event. At the time of this report, the outcome of the event was unknown. The reporter assessed this case as serious due to hospitalization and disability.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Flushing, Hypersensitivity, Pruritus
Clinical narrative: This serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 28-May-2018 by Seqirus from VAERS (VAERS ID: 709197), concerns a 22-year-old, adult male patient. The patient's current condition included IgA deficiency, asthma and severe anaphylaxis to all dairy and multiple foods (since an unspecified date). The concomitant medications included BENADRYL, PEPCID, ZANTAC and CLARITIN for an unknown indication (since an unspecified date). On 21-Aug-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On the same day (21-Aug-2017), post vaccination, the patient experienced allergic reactions which included flushing, swelling to neck, mild dyspnoea, transitory shortness of breath, urticaria, itchiness to neck, hands, feet and throat. On an unspecified date, the patient treated with ADVAIR, SINGULAIR, NASACORT and Omeprazole for the events. At the time of this report, the patient had recovered from the event (anaphylactic reaction).
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling, Throat irritation, Urticaria
Clinical narrative: This serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 28-May-2018 by Seqirus from VAERS (VAERS ID: 709197), concerns a 22-year-old, adult male patient. The patient's current condition included IgA deficiency, asthma and severe anaphylaxis to all dairy and multiple foods (since an unspecified date). The concomitant medications included BENADRYL, PEPCID, ZANTAC and CLARITIN for an unknown indication (since an unspecified date). On 21-Aug-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On the same day (21-Aug-2017), post vaccination, the patient experienced allergic reactions which included flushing, swelling to neck, mild dyspnoea, transitory shortness of breath, urticaria, itchiness to neck, hands, feet and throat. On an unspecified date, the patient treated with ADVAIR, SINGULAIR, NASACORT and Omeprazole for the events. At the time of this report, the patient had recovered from the event (anaphylactic reaction).
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Malaise, Myalgia, Vomiting
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: 711660), concerns a 74-year-old, elderly, female patient. The patient's medical history and the concomitant medications were not reported. On 22-Aug-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml [second dose as reported], anatomical location: left arm, batch number: 1720801, route of administration and expiry date: not reported). On the same day (22-Aug-2017), after vaccination, the patient felt sick and had no fever. On 23-Aug-2017, after 1 day of vaccination, the patient experienced vomiting and on 24-Aug-2017, after 2 days of vaccination, the patient experienced muscle pain across shoulders, neck and upper back. At the time of this report, the patient had recovered from the events (feeling sick, vomited and muscle pain). The reporter assessed the case as non-serious.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Rash, Wheezing
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: 711743), concerns a 21-year-old, adult female patient. The patient's medical history, current illness and concomitant medications were not reported. The patient was allergic to ZOFRAN, propranolol and Cinnamon. On 08-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: left arm, batch number: 1720801, expiry date: not reported). On the same day of vaccination, approximately 3 to 4 minutes after vaccination, the patient experienced wheezing, shortness of breath, difficulty in breathing, rash on upper chest and on the area of throat. Subsequently, the patient visited emergency room and was hospitalized for 11 days. At the time of this report, the outcome of the events was unknown. The reporter considered the case as serious due to hospitalization.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pallor, Respiratory rate decreased, Syncope
Clinical narrative: This serious spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 13-Jun-2018 by Seqirus from VAERS (VAERS ID: 712299), concerns a 23-year-old, adult, female patient. The patient historical vaccine included unspecified vaccine which caused dizziness and fainting. The patient had been allergic to DEMEROL, fludrocortisone and garbanzo beans. The patient's concomitant medications were unknown. On 06-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, anatomical location: left arm, batch number: 1720801, route of administration: unknown and expiry date: not reported). On the same day (06-Sep-2017), couple of minutes after vaccination, the patient fainted, was breathing slowly and had become pale but she regained color. The patient went to the emergency room and received oxygen therapy. At the time of this report, the outcome of the events was unknown.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Abscess limb, Cellulitis, Limb discomfort, Peripheral swelling, Ultrasound scan normal
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: 712661), concerns a 52-year-old adult male patient. The patient's current conditions included diabetes and high blood pressure. Concomitant medications included, JANUVIA, amlodipine, lisinopril, glimepiride, metformin, HUMALOG MIX, ranitidine, simvastatin, vitamin D. However, at the time of the vaccination, the patient had no illness. On 30-Aug-2017, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml (reported as 2 dose), route of administration: injection (reported as syr), anatomical location: right arm, batch number: 1720801, expiry date: not reported). On 31-Aug-2017, the next day of vaccination, the patient experienced discomfort and swelling on right arm. On 01-Sep-2017, the patient was taken to the emergency room (ER) and the ultrasound was performed which showed result as normal. On 05-Sep-2017, the patient visited the ER due to increased swelling and was hospitalized on the same day subsequently. The patient was diagnosed with right arm abscess and cellulitis. On 11-Sep-2017, the patient was discharged from the hospital. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as serious due to hospitalization.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Skin tightness
Clinical narrative: This spontaneous case, reported by other non-health professional to VAERS and initially retrieved on 13-Jun-2018 by Seqirus from VAERS (VAERS ID: 713087), concerns a 59-year-old, adult female patient. The patient received flu shots in the past and experienced mild rash, redness of the area and some warm feeling in the arm. The patient's current condition included: type 2 diabetes mellitus (reported as medical history) but the patient was not using any medication. The patient was allergic to non-steroidal anti-inflammatory (NSAIDS) and codeine. Concomitant medication included: LIPITOR for an unknown indication. On 14-Sep-2017, the patient was administered FLUVIRIN (dose: 0.5 ml [first dose as reported], route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On the same day (14-Sep-2017), after vaccination, the patient's arm started to hurt and felt tight. On the next day, the pain got worse and by evening arm got swollen all the way to the elbow. The pain started to move close to the neck and down the whole arm. The patient visited clinic to avoid emergency care. However, they could not determine exactly what was going and was sent to another walk-in clinic. The patient was prescribed with Prednisone pills. 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 linked to case 201802364 (same patient). Update 22-Jul-2018: Non-significant case correction received with IRD 13-Jun-2018: The case comment was corrected. No changes were done in the narrative.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Injection site reaction, Myalgia, Weight bearing difficulty
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: 713816), concerns a 30-year-old, adult, female patient. The patient's medical history were not reported. On 15-Sep-2017, the patient received FLUVIRIN [dose: 0.5 ml, frequency: 1, route of administration: intramuscular, anatomical location: arm, batch number and expiry date: not reported]. On the same day (15-Sep-2017) after vaccination, the patient experienced muscle tenderness as expected. On 16-Sep-2017, the patient began to experience periods of muscle numbness at the site of injection which radiated from her shoulder to elbow. The patient mentioned that numbness is on and off but she experienced weakness during the numbness. On 21-Sep-2017, the patient said that her condition was worse and noticed difficulty in lifting heavier objects at the store. The patient was counseled and suggested to seek medical attention from a physician if the symptoms were being progressed. As the patient had no health insurance, she declined to consult MD. The patient was advised to follow up with any of the pharmacists for any further questions. At the time of this report, the outcome of the events (hypoaesthesia, injection site reaction, muscular weakness, myalgia and weight bearing difficulty) was unknown. The reporter assessed this case as non-serious. Update on 22-JUL-2018: Non-significant case correction was performed 13-Jun-2018: Added age at vaccination. Corrected verbatim and case comment.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age, Pyrexia, Wrong product administered
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: 713950), concerns a 03-year-old male child. The patient had no medical history and current illness at the time of vaccination. The patient was allergic to amoxicillin. On 20-Sep-2017, the patient [less than 4 years] was administered with FLUVIRIN (dose: 0.5 ml (reported as 1 DF), route of administration: intramuscular, anatomical location: right arm, batch number: 179602P, expiry date: not reported) instead of FLULAVAL. On the same day after vaccination, the patient experienced fever, 103 degrees. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as non-serious.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Contusion, Discomfort, Pain
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: 713992), concerns a 77-year-old, elderly, female patient. The patient had no medical history and the concomitant medications were unknown. On 07-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml [1 as reported], route of administration: intramuscular, anatomical location: left arm, batch number: 1720801 and expiry date: not reported). On 14-Sep-2017, 7 days after vaccination in the evening (as reported), the patient noticed the bruise on the arm. On 15-Sep-2017, the patient woke up with discomfort and felt pain. The pharmacist recommended to take TYLENOL and she took it. After few hours, the patient felt better and reported that pain had decreased significantly. At the time of this report, the patient had recovering from the events (contusion, discomfort and pain). The reporter assessed the case as non-serious.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Contusion, Pain, Swelling
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: 713992), concerns a 77-year-old, elderly, female patient. The patient had no medical history and the concomitant medications were unknown. On 07-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml [1 as reported], route of administration: intramuscular, anatomical location: left arm, batch number: 1720801 and expiry date: not reported). On 14-Sep-2017, 7 days after vaccination in the evening (as reported), the patient noticed the bruise on the arm. On 15-Sep-2017, the patient woke up with discomfort and felt pain. The pharmacist recommended to take TYLENOL and she took it. After few hours, the patient felt better and reported that pain had decreased significantly. At the time of this report, the patient had recovering from the events (contusion, discomfort and pain). The reporter assessed the case as non-serious.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Contusion, Discomfort, Pain
Clinical narrative: This non-serious spontaneous case, initially received on 15-Sep-2017, reported by other health professional (pharmacist) and concerns a 77-year-old, elderly female patient. The patient's current condition included hypothyroidism. On 07-Sep-2017, the patient received FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, batch number: 1720801, expiry date: 30-Apr-2018, anatomical location: not reported). On 15-Sep-2017, after 9 days of vaccination, the patient complained about significant bruising, swelling and pain when she tried to put pants on. It was reported that, the patient told about this to the pharmacist while she reported about the adverse events. However, the pharmacist inquired on the delayed reactions. The patient was treated with TYLENOL and ice packs. The patient had recovered from the events. The reporter assessed the event as non-serious. Follow up report received on 08-Nov-2017: Route of administration of vaccine was added. The patient's treatment was updated. The outcome of the event was changed from not recovered to recovered. The narrative was amended accordingly. Non-significant case correction received with IRD 15-Sep-2017: The expiry date was updated from Apr-2018 to 30-Apr-2018. The narrative was amended accordingly.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Contusion, Pain, Swelling
Clinical narrative: This non-serious spontaneous case, initially received on 15-Sep-2017, reported by other health professional (pharmacist) and concerns a 77-year-old, elderly female patient. The patient's current condition included hypothyroidism. On 07-Sep-2017, the patient received FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, batch number: 1720801, expiry date: 30-Apr-2018, anatomical location: not reported). On 15-Sep-2017, after 9 days of vaccination, the patient complained about significant bruising, swelling and pain when she tried to put pants on. It was reported that, the patient told about this to the pharmacist while she reported about the adverse events. However, the pharmacist inquired on the delayed reactions. The patient was treated with TYLENOL and ice packs. The patient had recovered from the events. The reporter assessed the event as non-serious. Follow up report received on 08-Nov-2017: Route of administration of vaccine was added. The patient's treatment was updated. The outcome of the event was changed from not recovered to recovered. The narrative was amended accordingly. Non-significant case correction received with IRD 15-Sep-2017: The expiry date was updated from Apr-2018 to 30-Apr-2018. The narrative was amended accordingly.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 13-June-2018 by Seqirus from VAERS (VAERS ID: 714069), concerns a 59-year-old, adult, female patient. The patient had no current illness. The patient's historical condition and concomitant medications were not reported. On 15-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number: 1720801, expiry date: not reported). On the same day (15-Sep-2017), after vaccination, the patient experienced redness, swelling, hard knot, white circle around the area of injection site which was warm to touch. The patient was treated with TYLENOL and ice pack. At the time of this report, the patient had not recovered from the events. The reporter assessed this case as non-serious.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
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: 714780), concerns a 42-year-old, adult, female patient. The patient's current condition included mild cold symptoms (since an unspecified date in 2017) (1 week ago as reported). The patient had no concomitant medications. On 25-Sep-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration, anatomical location, batch number, and expiry date: not reported). On the same day (25-Sep-2017), the patient experienced severe pain in the right arm which affected the mobility. The patient was instructed to schedule ibuprofen (every 8 hours) for the next day or 2 and she was taking TYLENOL as needed. The patient was advised to do frequent icing and keep moving as tolerated. At the time of this report, the outcome of the events (painful R arm and mobility decreased) was unknown. The reporter assessed the case as non-serious. Update 09-Aug-2018: Non-significant case correction was performed with IRD 13-Jun-2018: The sentence in the narrative was corrected from 'the patient went to clinic and instructed to take ibuprofen (for every 8 hours) for next day or 2 days (as reported) and TYLENOL as needed. The patient recommeded for frequent icing and keep moving the arm as tolerated' to 'the patient was instructed to schedule ibuprofen (every 8 hours) for the next day or 2 and she was taking TYLENOL if needed. The patient was advised to do frequent icing and keep moving as tolerated'.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: This serious spontaneous case, reported by other health professional to VAERS and initially retrieved on 13-Jun-2018 by Seqirus from VAERS (VAERS ID: 714910), concerns a 37-year-old, adult, female patient. The patient's medical history was unknown, current illness and the concomitant medications were not reported. On 18-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179602P [reported as 179602E] and expiry date: not reported). On the same day (18-Sep-2017), after vaccination, the patient fainted momentarily. Patient was fine afterwards. Patient sat in the pharmacy for few minutes before leaving. It was reported that patient did not suffer any injuries. On the same day, after few minutes, the patient had recovered from the event.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
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: 715097), concerns a 79-year-old, elderly, male patient. The patient's medical history and current illnesses were not reported. On 25-Sep-2017, the patient was administered FLUVIRIN (dose: 0.5 ml [reported as unk], route of administration, anatomical location, batch number and expiry date: not reported]. On 01-Oct-2017, 6 days after vaccination, the patient experienced redness and swelling of left bicep. The patient had not recovered from the events. The reporter assessed the events as non-serious. Update 01-Aug-2018: Non-significant case correction was performed with IRD 13-Jun-2018: The word "thiomersal' was deleted from the narrative.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
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: 715127), concerns a 63-year-old, adult, female patient. The patient's medical history and the concomitant medications were not reported. On 14-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml [7 as reported], route of administration: intramuscular, batch number: 1720801 anatomical location and expiry date: not reported). On 16-Sep-2017, 2 days after vaccination, the patient experienced swelling of the left hand with redness which required hospitalization. At the time of this report, the patient had recovered from the events (redness and hand swelling). The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Skin warm
Clinical narrative: This spontaneous case, reported by other non-healthcare professional (consumer) to VAERS and initially retrieved on 13-Jun-2018 by Seqirus from VAERS (VAERS ID: 715464), concerns a female patient of an unspecified age. The patient's current conditions included diabetes, PCOS (polycystic ovarian syndrome), IBS-D (irritable bowel syndrome with diarrhea), complex migraines and chronic liver disease (since an unspecified date). The patient's concomitant medications included EXCEDRIN, metformin, omeprazole, ondansetron, Sertraline, topiramate, atorvastatin, Vitamin D, Loperamide and COLACE. On 20-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: subcutaneous, anatomical location: arm, batch number and expiry date: not reported). On the same day, within ten minutes of vaccination, patient's arm was extremely hot and within two hours of vaccination, the patient experienced severe nausea. As of 23-Sep-2017, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Muscle spasms, Pain
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: 715471), concerns a 61-year-old, adult male patient. The patient's vaccination history included both FLUVIRIN and pneumonia vaccines and had no record of pneumonia (as alert). The patient's medical history was unknown and had no current illness or allergies. Concomitant medications included morphine sulfate for an unknown indication. On 26-Sep-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, 1720701, expiry date: not reported). On the same day, the patient was also administered with PNEUMOVAX (dose: 1 dose, route of administration: intramuscular, anatomical location: left arm, batch number: M042785, expiry date: not reported). On the same day night, after vaccination, the patient developed mild swelling in the upper left arm and redness in left deltoid with muscle spasms and soreness over whole body. The patient used marijuana oil (CBD oil) which was effective. The patient reported that, muscle spasms and aches were mostly resolved. The patient had no symptoms of respiratory distress, itching around injection site or nausea. At the time of this report, the patient had recovered from the events. The reporter assessed this case as non-serious.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Heart rate increased
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: 715622), concerns a 47-year-old, adult, female patient. The patient's historical conditions were not reported. The patient had no allergies. The patient's current illness and concomitant medications were unknown. On 30-Sep-2017, approximately at 1:30 pm, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 1720701 and expiry date: not reported). On the same day, after vaccination, approximately at 04:30 pm, the patient developed redness from neck to both arms and experienced increased heart rate. No specific local reaction was observed around the injection site. The patient was advised to take BENADRYL and consult the closest emergency room. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
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: 715784), concerns a 52-year-old, adult, female patient. The patient had no relevant medical history and current illnesses. On 18-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, batch number: 1720701, anatomical location, expiry date: not reported). The patient was also administered with non-company suspect drug ADACEL (route of administration: intramuscular, dose, anatomical location, batch number, expiry date: not reported) and ZOSTAVAX (route of administration: subcutaneous, dose, anatomical location, batch number, expiry date: not reported). On the following day of vaccination (19-Sep-2017), the patient developed redness of 5 inches across left arm which lasted for two days, warm to touch for 1 day and later soreness at the site of ZOSTAVAX shot. In addition, the patient also experienced redness at the site of injection in the right arm for 2 days. 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 13-Jun-2018: The causality of the events 'injection site warmth and injection site pain' was corrected from not related to related. The case comment was amended accordingly.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pallor, Syncope
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: 715928), concerns a 11-year-old, female child patient. The patient had no medical history and the patient did not receive any concomitant medications. On 15-Sep-2017, the patient was administered FLUVIRIN Thiomersal (dose: 0.5ml, route of administration: unknown, anatomical location: left arm, batch number: 1720701, expiry date: not reported). On the same day (reported as 5 to 10 minutes) after vaccine administration, the patient experienced dizziness while walking and then fainted. However, the patient did not lose consciousness and got up right away. It was reported that, the patient appeared very pale. The patient sat down for 15 minutes and colour of her skin returned. Later, the patient's guardian took her home. On an unspecified date, the patient had recovered from the event. The reporter assessed this case as non-serious. Update 09-Aug-2018: Non-significant case correction was performed with IRD 20-Jun-2018: Added reporter's (health authority) assessment about the seriousness of the case (The reporter assessed this case as non-serious). Onset latency (1 day) for the event syncope was deleted in the event section. Narrative was amended accordingly.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Peripheral swelling, Skin warm
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: 715937), concerns a 60-year-old, adult male patient. The patient's relevant medical history, concomitant medications and allergies were not reported. On 27-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, batch number: 1720801, anatomical location, expiry date: not reported). On the same day, the patient was also administered with non-company suspect drug PNEUMOVAX (route of administration: intramuscular, batch number: M024673, dose, anatomical location, expiry date: not reported). On 28-Sep-2017, one day after vaccination, the patient's body temperature was 104 degrees. The patient also experienced swelling of arm, redness and hot to touch. The patient made a physician's office visit for the events. At the time of this report, the outcome of the events was unknown. The report assessed the case as non-serious.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Dizziness, Impaired driving ability, Nausea
Clinical narrative: This is a serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 716201), concerns a 60-year-old, adult, female patient. The patient had no known drug allergies. On 18-Sep-2017, at 8:00 am, the patient was administered with FLUVIRIN (dose: 0.5 ml [reported as not applicable], route of administration: intramuscular, anatomical location: arm, batch number: 179601P, expiry date: not reported). On the same day (18-Sep-2017) after vaccination, around 2:00 pm, the patient suddenly experienced nausea, lightheadedness and felt like she was going to pass out. Around 4:30 pm to 5 pm, another episode occurred, while the patient was standing and felt like blacked out shortly. These symptoms continued throughout the rest of afternoon, approximately every 20 minutes. The patient realized that, she could not drive home due to these symptoms and informed her husband, who drove her home. As of 19-Sep-2017, the patient felt she was fine (recovered).
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Wheezing
Clinical narrative: This serious spontaneous case, reported by other healthcare professional to VAERS and initially received on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 716487), concerns a 33-year-old adult, female patient. The patient's historical conditions, current conditions and concomitant medications were not reported. The patient had been allergic to latex, shellfish, penicillin, sulfa drugs, iodine, azithromycin and cephalosporins. On 03-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml [reported as 1], route of administration: intramuscular, anatomical location: left arm, batch number: 179705P and expiry date: not reported). On the same day, within one hour of vaccination, the patient experienced wheezing, chest pain and tightness. The patient was taken to the (emergency room) ER to rule out all other causes such as a heart attack and pulmonary embolism, which all were ruled (findings not reported). At the time of this report, the outcome of the events was unknown.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration
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: 719614), concerns a 62-year-old adult, female patient. On 03-Oct-2017, the patient was administered FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 179604P and expiry date: not reported). On 06-Oct-2017, 3 days after vaccination, the patient developed black and blue coloration at injection site (about 2 inches in diameter). On the same day, the patient had recovered from the event. The reporter assessed the event as non-serious. Update 09-Aug-2018: Non-significant case correction was performed with IRD 20-Jun-2018: Added age at vaccination in patient tab. The word 'with' was removed before the word FLUVIRIN. The verbatim of the event (injection site discoloration) was changed from 'Patient reported black and blue about 2 inch in diameter at site of injection' to 'Black and blue about 2 inches in diameter at site of injection'. Narrative was amended accordingly.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Heart rate increased
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: 719917), concerns a 52-year-old adult, female patient. The patient's concomitant medications included levothyroxine, Valacyclovir and MICROGESTIN for an unknown indication. On 10-Oct-2017, the patient received FLUVIRIN (dose: 0.5 ml [reported as 2nd dose], route of administration: intramuscular, batch number: 179605P, anatomical location: unknown and expiry date: not reported]. On the same day, after vaccination, the patient experienced dizziness, light headedness, rapid heartbeat and elevated blood pressure. The patient's blood pressure was found to be 140/50. The patient was given water and rest to pick her up. At the time of this report, the patient had recovered from the events (blood pressure increased, dizziness and heart rate increased). The reporter assessed this case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Computerised tomogram head normal, Eye pain, Facial paralysis, Headache
Clinical narrative: This is a serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 720194), concerns a 58-year-old, adult, female patient. The patient had received influenza vaccine in the past and did not experience any reactions. The patient was allergic to bee stings, CEFTIN and DEMEROL. It was reported that, no contraindications were noted upon screening. On 19-Oct-2016, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 1515101 and expiry date: not reported). On 28-Oct-2016, 09 days after vaccination, the patient experienced severe weakness, right sided facial numbness, blurred vision, headache and right eye ache. On an unspecified date the patient went to the emergency room and was diagnosed with Bell's Palsy. The patient sought treatment in the emergency room. On an unspecified date, computed tomography (CT) of head performed, which showed negative findings (as reported). At the time of this report, the patient had recovered from the event.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Vision blurred
Clinical narrative: This is a serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 20-Jun-2018 by Seqirus from VAERS (VAERS ID: 720194), concerns a 58-year-old, adult, female patient. The patient had received influenza vaccine in the past and did not experience any reactions. The patient was allergic to bee stings, CEFTIN and DEMEROL. It was reported that, no contraindications were noted upon screening. On 19-Oct-2016, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 1515101 and expiry date: not reported). On 28-Oct-2016, 09 days after vaccination, the patient experienced severe weakness, right sided facial numbness, blurred vision, headache and right eye ache. On an unspecified date the patient went to the emergency room and was diagnosed with Bell's Palsy. The patient sought treatment in the emergency room. On an unspecified date, computed tomography (CT) of head performed, which showed negative findings (as reported). At the time of this report, the patient had recovered from the event.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Feeling hot, Flushing, Hot flush
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: 720449), concerns a 53-year-old, adult, female patient. The patient's current condition included allergies and received the allergy shots weekly from allergist (as reported). The concomitant medications were not reported. On 01-Oct-2016, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 1721001 and expiry date: not reported). On the same day (On 01-Oct-2016), the patient experienced flushing, warmth and clammy skin on face which was similar to hot flashes. At the time of this report, the patient had recovered from the events (clammy, flushing, feeling of warmth and hot flashes). The reporter assessed the case as non-serious.