chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Cough, Fatigue, Influenza like illness, Malaise
Clinical narrative: This initial spontaneous case, was received from other health professional via regulatory authority (FDA number: 714775), concerns a 53-year-old adult male patient. The patient's current conditions included diabetes type 2 and slight cold. On 13-Aug-2017, the patient had a cut on his finger, hence on 14-Aug-2017, tetanus vaccine was administered (historical vaccine). The patient's concomitant medication included, Metformin, Lisinopril, Aspirin, Glipizide, Lovastatin, Baclofen for an unknown indication. On 11-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On 12-Sep-2017, after 2 days of vaccination, the patient felt sick and experienced flu like symptoms for 2 weeks. It was reported that, the patient did not have fever, but he was very tired and could not get out of his bed and had uncontrollable coughing all night. The patient had weakness after little activity. The patient's treatment medication included Codeine with cough syrup for cough. At the time of this report, the patient was not recovered from the events. The reporter assessed the events as non-serious
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Eye movement disorder, Headache, Immediate post-injection reaction, Malaise, Muscle twitching
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, from health authority (VAERS ID: 714808) (reported to HA by other health professional) and concerns a 13-Year-old, adolescent female patient. The patient had a current condition of migraine (since an unspecified date) and concomitant medications included vitamin D and ibuprofen for an unknown indication. On 25-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (route of administration: injection, anatomical location: right arm, batch number: XF30306, expiry date: not reported). On 25-Sep-2017, the patient was administered with GARDASIL (dose: 1 (as reported), route of administration: injection, anatomical site: left arm, batch number and expiry date: not reported). On 25-Sep-2017, immediately after vaccination, the patient experienced the headache. On the next day (26-Sep-2017) morning at 06:15 hrs, the patient was unwell and felt nauseous. While rushing to the bath room, the patient fainted, and her eyes rolled back, and the muscles started to twitch. The patient got coherent immediately, following the events after vaccination. The outcome of the events was not reported. The reporter assessed the case as non-serious.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Nausea, Syncope
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, from health authority (VAERS ID: 714808) (reported to HA by other health professional) and concerns a 13-Year-old, adolescent female patient. The patient had a current condition of migraine (since an unspecified date) and concomitant medications included vitamin D and ibuprofen for an unknown indication. On 25-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (route of administration: injection, anatomical location: right arm, batch number: XF30306, expiry date: not reported). On 25-Sep-2017, the patient was administered with GARDASIL (dose: 1 (as reported), route of administration: injection, anatomical site: left arm, batch number and expiry date: not reported). On 25-Sep-2017, immediately after vaccination, the patient experienced the headache. On the next day (26-Sep-2017) morning at 06:15 hrs, the patient was unwell and felt nauseous. While rushing to the bath room, the patient fainted, and her eyes rolled back, and the muscles started to twitch. The patient got coherent immediately, following the events after vaccination. The outcome of the events was not reported. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: This non-serious initial spontaneous case, was received from a pharmacist via health authority (VAERS ID: 715005) on 05-Dec-2017, concerning a 31-year-old, adult female patient. The concomitant medications were not reported. On 13-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1 dose), route of administration: Intramuscular, anatomical location: left arm, batch number: 00944611A, expiry date not reported). On 14-Sep-2017, after 1 day of vaccination, the patient complained about radiating pain form her shoulder towards her arm and neck. On 27-Sep-2017, a couple weeks later, the patient still complained of lingering pain but concentrated primarily in her shoulder. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as non-serious.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dysphonia, Eye pain, Fatigue, Headache
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017 reported by regulatory authority (VAERS ID: 715071) via other health professional, concerning a 62-year-old female patient. The patient's historical condition included GERD (gastrooesophageal reflux disease). The patient's current conditions included blood pressure and no allergies. The patient' concomitant medications included PROTONIX, PREMARIN, LIBRAX, NORVASC, Multi vitamin. On 25-Sep-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 492810417 (as reported), expiry date: not reported). On the same day, after administration of AFLURIA QUADRIVALENT, the patient experienced hoarseness, sore red eyes, aches all over the body, headache, fatigue and weak. At the time of this report, the patient recovered from the event. The reporter assessed the case as serious. Significant case correction received with IRD 05-Dec-2017: The determined causality of the events eye pain and eye redness was corrected from unassessable to related. The case comment was added. The narrative was amended accordingly.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Ocular hyperaemia, Pain
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017 reported by regulatory authority (VAERS ID: 715071) via other health professional, concerning a 62-year-old female patient. The patient's historical condition included GERD (gastrooesophageal reflux disease). The patient's current conditions included blood pressure and no allergies. The patient' concomitant medications included PROTONIX, PREMARIN, LIBRAX, NORVASC, Multi vitamin. On 25-Sep-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number: 492810417 (as reported), expiry date: not reported). On the same day, after administration of AFLURIA QUADRIVALENT, the patient experienced hoarseness, sore red eyes, aches all over the body, headache, fatigue and weak. At the time of this report, the patient recovered from the event. The reporter assessed the case as serious. Significant case correction received with IRD 05-Dec-2017: The determined causality of the events eye pain and eye redness was corrected from unassessable to related. The case comment was added. The narrative was amended accordingly.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017 from other non-health professional via regulatory authority (VAERS ID: 715304), concerns a 68-year-old elderly female patient. The patient had no medical history and she was allergic to penicillin, chocolate and bee stings (hornet). The patient's concomitant medications included multi vitamin, simvastatin, clobetasol, calcium supplement, paroxetine HCL, glucosamine chondroitin, hydroxychloroquine, ZYRTEC, losartan potassium, aspirin and fenofibrate for unknown indications. On 15-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location: left arm, route of administration: SYR (as reported), batch number and expiry date: not reported). On the same day, within 2 hours of vaccination, the patient had injection site redness and swelling, which was hot and warm to touch. In 5 hours of vaccination, the patient was so fatigued and could barely walk and went to bed. It was reported that, in the morning, the patient's arm was still sore, but otherwise she felt better. No lab test was done. At the time of this report, the patient had recovered from the events fatigue, gait disturbance, injection site erythema, swelling, warmth and not recovered from the event pain in extremity. The reporter assessed the events as non-serious.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017 from other non-health professional via regulatory authority (VAERS ID: 715304), concerns a 68-year-old elderly female patient. The patient had no medical history and she was allergic to penicillin, chocolate and bee stings (hornet). The patient's concomitant medications included multi vitamin, simvastatin, clobetasol, calcium supplement, paroxetine HCL, glucosamine chondroitin, hydroxychloroquine, ZYRTEC, losartan potassium, aspirin and fenofibrate for unknown indications. On 15-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location: left arm, route of administration: SYR (as reported), batch number and expiry date: not reported). On the same day, within 2 hours of vaccination, the patient had injection site redness and swelling, which was hot and warm to touch. In 5 hours of vaccination, the patient was so fatigued and could barely walk and went to bed. It was reported that, in the morning, the patient's arm was still sore, but otherwise she felt better. No lab test was done. At the time of this report, the patient had recovered from the events fatigue, gait disturbance, injection site erythema, swelling, warmth and not recovered from the event pain in extremity. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Injection site bruising
Clinical narrative: This spontaneous case, initially received from other non-health professional via health authority (VAERS ID: 715306) on 05-Dec-2017, concerning a 63-year-old, adult, male patient. The patient did not have any current illness at the time of vaccination. Concomitant medication included Warfarin for an unknown indication. On 02-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch no: XF30306, expiry date: not reported). On 03-Sep-2017, approximately 24 hours after vaccination, the patient developed diffuse bruising on left arm, starting approximately half way between elbow and deltoid, and continuing approximately 5 inches down forearm from the elbow. Reportedly, the patient did not experience any redness, tenderness, or warmth/heat where bruising occurred and did not seek medical. At the time of this report, the patient had not recovered from the events. The reporter considered the report as non-serious. Non-significant case correction received with IRD 05-Dec-2017: The causality in the case comment was corrected from not related to related.
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: This spontaneous case, initially received from the health authority (VAERS ID: 715560) (reported to health authority by other non-health professional), concerning a 42-year-old, adult female patient. The patient's current condition included hypertension, eczema (since an unspecified date). The patent was allergic to sulfa, CLARITIN, borderline milk and component which is used in inks, dyes, soaps, to tan leather and also found in latex products (unsure of the full chemical name but the last part was formaldehyde resin). The patient's concomitant medications included acetaminophen and Losartan potassium for an unknown indication. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose:0.5ml, route of administration: intramuscular, anatomical site: right arm, batch number: XF30306, expiry date: not reported). On 28-09-2017, after 07 days of vaccination, the patient experienced rash on her lower right part of face (kind of like hives), also tingling and numbness of lips and cheek. On the right side of her throat she felt little bit of tickling/tingling sensations. On the same day patient felt sensation of tingling/numbness on her face, below her lip and right side of the chin and slowly spread out to right cheek. It was reported that she was still found to have small rash on her chin below lower lip and very slight swelling. On unspecified date, at night time patient had taken two (as reported) BENADRYL and two BENADRYL at morning. No lab tests was done. At the time of this report, patient had not recovered from all the events. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Rash, Throat irritation, Urticaria
Clinical narrative: This spontaneous case, initially received from the health authority (VAERS ID: 715560) (reported to health authority by other non-health professional), concerning a 42-year-old, adult female patient. The patient's current condition included hypertension, eczema (since an unspecified date). The patent was allergic to sulfa, CLARITIN, borderline milk and component which is used in inks, dyes, soaps, to tan leather and also found in latex products (unsure of the full chemical name but the last part was formaldehyde resin). The patient's concomitant medications included acetaminophen and Losartan potassium for an unknown indication. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose:0.5ml, route of administration: intramuscular, anatomical site: right arm, batch number: XF30306, expiry date: not reported). On 28-09-2017, after 07 days of vaccination, the patient experienced rash on her lower right part of face (kind of like hives), also tingling and numbness of lips and cheek. On the right side of her throat she felt little bit of tickling/tingling sensations. On the same day patient felt sensation of tingling/numbness on her face, below her lip and right side of the chin and slowly spread out to right cheek. It was reported that she was still found to have small rash on her chin below lower lip and very slight swelling. On unspecified date, at night time patient had taken two (as reported) BENADRYL and two BENADRYL at morning. No lab tests was done. At the time of this report, patient had not recovered from all the events. The reporter assessed the case as non-serious.
Age: 41.0
Sex: F
Vaccine: DTAP, FLU4
Symptoms: Fatigue, Injection site pain, Malaise, Pain, Pyrexia
Clinical narrative: This spontaneous case, initially received from Health Authority (VAERS ID: 715635, reported to HA by the patient) on 05-Dec-2017, concerns a 41-year-old female patient. The patient's current included arthritis. She was allergic to tomatoes, bananas, oranges, potatoes (food allergy) and also to sulfas and septras (drug allergy). The patient's concomitant medications included gabapentin, aspirin and DRAMAMINE. On 01-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location: left arm, route of administration: injection (reported as SYR), batch no and expiry date: not reported). On the same day, the patient was administered with Non-company suspect vaccine, DAPTACEL (anatomical location: left arm, route of administration: injection (reports as "SYR"), batch number and expiry date: not reported). The patient stated that, she was fatigues within the hour of the shot. The patient left the work because she did not feel well, felt feverish and aching. On the next day of vaccination (02-Sep-2017), she had lots of pain at the injection site and complained of aches and fever. At the time of this report, the outcome of the events was not reported. The reporter assessed this case as non-serious. Case correction received with IRD 05-Dec-2017: The causality of the events fatigue, pain, malaise and pyrexia was changed from unassessable to related. The case comment was amended accordingly.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Burning sensation, Discomfort, Erythema, Insomnia
Clinical narrative: This is a non-serious spontaneous case, initially received on 05-Dec-2017, from health authority (reported to health authority by other health professional) (VAERS ID: 715677), concerning a 62 year-old, adult, female patient. The patient's current condition included: type 1 diabetes mellitus (for 30 years) and current illness included tick disease. Concomitant medications included: EFFEXOR, SYNTHROID, Insulin, unspecified cholesterol and kidney medications. On 29-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported). On the same day, the patient received non-company suspect product PNEUMOVAX (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date in Sep-2017, the patient experienced hives, burning sensation in arm, extreme pain when touching or moving arm, fever of 100.4 (unit not reported), body ache including legs, left and right arm. Furthermore, the patient had nausea, weakness, insomnia, pain and hence, couldn't get comfortable in any position. The patient received BENADRYL and TYLENOL for 2 days. It was reported that, the patient's arm was still red, fever was 99.5, but pain had lessened. The patient recovered from the event hives but had not recovered from red rash. The patient had recovered from the events weakness, burning sensation, insomnia, discomfort, nausea, tenderness and hives. The patient was still recovering from the event general body pain. The patient had not yet recovered from the events fever, redness and erythematous rash.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: This is a non-serious spontaneous case, initially received on 05-Dec-2017, from health authority (reported to health authority by other health professional) (VAERS ID: 715677), concerning a 62 year-old, adult, female patient. The patient's current condition included: type 1 diabetes mellitus (for 30 years) and current illness included tick disease. Concomitant medications included: EFFEXOR, SYNTHROID, Insulin, unspecified cholesterol and kidney medications. On 29-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported). On the same day, the patient received non-company suspect product PNEUMOVAX (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date in Sep-2017, the patient experienced hives, burning sensation in arm, extreme pain when touching or moving arm, fever of 100.4 (unit not reported), body ache including legs, left and right arm. Furthermore, the patient had nausea, weakness, insomnia, pain and hence, couldn't get comfortable in any position. The patient received BENADRYL and TYLENOL for 2 days. It was reported that, the patient's arm was still red, fever was 99.5, but pain had lessened. The patient recovered from the event hives but had not recovered from red rash. The patient had recovered from the events weakness, burning sensation, insomnia, discomfort, nausea, tenderness and hives. The patient was still recovering from the event general body pain. The patient had not yet recovered from the events fever, redness and erythematous rash.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Tenderness, Urticaria
Clinical narrative: This is a non-serious spontaneous case, initially received on 05-Dec-2017, from health authority (reported to health authority by other health professional) (VAERS ID: 715677), concerning a 62 year-old, adult, female patient. The patient's current condition included: type 1 diabetes mellitus (for 30 years) and current illness included tick disease. Concomitant medications included: EFFEXOR, SYNTHROID, Insulin, unspecified cholesterol and kidney medications. On 29-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration, anatomical location, batch number, expiry date: not reported). On the same day, the patient received non-company suspect product PNEUMOVAX (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date in Sep-2017, the patient experienced hives, burning sensation in arm, extreme pain when touching or moving arm, fever of 100.4 (unit not reported), body ache including legs, left and right arm. Furthermore, the patient had nausea, weakness, insomnia, pain and hence, couldn't get comfortable in any position. The patient received BENADRYL and TYLENOL for 2 days. It was reported that, the patient's arm was still red, fever was 99.5, but pain had lessened. The patient recovered from the event hives but had not recovered from red rash. The patient had recovered from the events weakness, burning sensation, insomnia, discomfort, nausea, tenderness and hives. The patient was still recovering from the event general body pain. The patient had not yet recovered from the events fever, redness and erythematous rash.
Sex: F
Vaccine: FLUA3
Symptoms: Oropharyngeal pain
Clinical narrative: This spontaneous case, reported by other health care professional to VAERS and initially retrieved on 20-Mar-2018 by Seqirus from VAERS (VAERS ID: 716012), concerning a 72-year-old, elderly female patient. The patient's medical history and concomitant medications were not reported. On 01-Oct-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: left arm, batch number: 179401, expiry date: not reported). On 02-Oct-2017, after 1 day of vaccination, the patient complained that she woke up with sore throat and reported that, she was not intending to seek medical care. At the time of this report, the outcome of the event was unknown. The reporter assessed the case as non-serious.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Feeling abnormal, Full blood count normal, Influenza virus test negative, Malaise
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 716240) on 05-Dec-2017, concerning a 76-year-old, elderly male patient. The patient's medical history included: Atrial fibrillation, Atrial flutter, primary malignant neoplasm of conjunctiva, diverticulosis, chronic back pain, neuropathy, cervical spondylosis and nephrolithiasis. The patient's current illness included: hemorrhoids with some bleeding, intestinal gas and diarrhea. The patient was allergic to Tramadol, Nortripyline, Indomethacin. Concomitant medications included: Gabapentin, Finasteride, Simvastatin, Tamulosin, Dabigatran etexilate, Ascorbic acid and multivitamin. On 26-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF33008, expiry date: not reported). On the same day, the patient became violently ill after receiving the flu shot. The patient also had cough, runny nose, generalized body ache, pain and felt crappy. On 02-Oct-2017, CBC (complete blood count), BMP (basic metabolic panel), urinalysis and flu screen were found to be within limits. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Metabolic function test normal, Pain, Rhinorrhoea, Urine analysis normal
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 716240) on 05-Dec-2017, concerning a 76-year-old, elderly male patient. The patient's medical history included: Atrial fibrillation, Atrial flutter, primary malignant neoplasm of conjunctiva, diverticulosis, chronic back pain, neuropathy, cervical spondylosis and nephrolithiasis. The patient's current illness included: hemorrhoids with some bleeding, intestinal gas and diarrhea. The patient was allergic to Tramadol, Nortripyline, Indomethacin. Concomitant medications included: Gabapentin, Finasteride, Simvastatin, Tamulosin, Dabigatran etexilate, Ascorbic acid and multivitamin. On 26-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF33008, expiry date: not reported). On the same day, the patient became violently ill after receiving the flu shot. The patient also had cough, runny nose, generalized body ache, pain and felt crappy. On 02-Oct-2017, CBC (complete blood count), BMP (basic metabolic panel), urinalysis and flu screen were found to be within limits. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, from health authority (VAERS ID: 716356) via other health professional, and concerns a 63-year-old, adult, male patient. The patient had no known drug allergies (NKDA). The patient's current illness included GERD (Gastroesophageal reflux disease) and DVT (Deep vein thrombosis) (since unspecified dates). His concomitant medication included folic acid for an unknown indication. On 03-Oct-2017, the patient was administered with 2 doses of AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch no and expiry date: not reported), instead of one flu vaccine and one pneumo vaccine (explicitly considered as extra dose administered). It was reported that the patient had not experienced any adverse reactions to the double flu shots. The reporter assessed this case as non-serious.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Hypoaesthesia, Pallor, Rash erythematous
Clinical narrative: This initial spontaneous case, was received from other health professional via health authority (VAERS ID: 716492) on 05-Dec-2017, concerns a 50-year-old, adult male patient. The patient's current condition included: hypertension, hypercholesterolemia, hypothyroidism and degenerative joint disorder. Concomitant medications included: etodolac, hydrochlorothiazide, SYNTHROID, simvastatin and tramadol for unknown indication. On 04-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0. 5 ml (reported as 1 dose), route of administration: intramuscular, anatomical location: right arm, batch no: XF33008 and expiry date: not reported). On the same day, 20 minutes post vaccination, the patient developed numbness of right upper extremity from elbow to hand. After 50 minutes of vaccination, the patient developed nasal rash, which was dark red initially and slowly fading in colour but remained red the next day. At 2:30 PM, he developed light-headedness, was clammy and looked pale. He drank a bottle of water and rested for an hour. Light-headedness, clamminess and numbness of right upper extremity slowly improved and resolved when patient woke up the next day morning at 5:30. Nasal rash persists but much less red. The patient did not receive treatment for the events. The patient was recovered from the events numbness of upper extremities, light headedness, clammy, pale and was still recovering from the event rash erythematous. The reporter assessed the events as non-serious.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: This spontaneous case, initially received from health authority (VAERS ID: 716538) (reported to health authority by other health professional) on 05-Dec-2017, concerning a 44-year-old, adult, female patient. The patient's medical history was not reported. On 03-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF32708, expiry date: not reported). On the same day (03-Oct-2017) about 1 hour of vaccination the patient developed redness in left arm which was warm to touch and tender. As of 05-Oct-2017, the patient's arm was still red and tender. At the time of this report, the patient had not recovered from the events. The reporter assessed the events as non-serious.
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: This spontaneous case, initially received from other health professional via health authority (VAERS ID: 716637) on 05-Dec-2017, concerning a 46-year-old adult male patient. The patient had no medical history and allergies. The patient's concomitant medications included bupropion and duloxetine for an unknown indication. On 02-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On the same day, after the vaccination, the patient started to feel chilled with no fever initially. At 11:00 pm, the patient had muscle aches and nausea. At the same time, the patient also had slight fever, which was recorded as 99.6-degree F and continues all night. The patient received ADVIL at 5:00 am. It was reported that, the patient was fatigue for another 36-hours. The outcome of the event was recovered. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This is a spontaneous case, initially received from regulatory authority (VAERS ID: 716727) (reported to RA by other health professional) on 05-Dec-2017, concerning a 32-year-old, adult, female patient. The patient's medical history was not reported. On 03-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, anatomical location: right arm, route of administration: injection, batch number: XF32708, expiry date: not reported). On 04-Oct-2017, after 2 days of vaccination, swelling appeared on patient's skin which was raised approximately 80mm of circular area, red and warm to touch. The patient denied any systemic complaints and recommended to follow-up with PCP. No lab test was done. The patient was advised to take antihistamine as a treatment. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as non-serious. Non-significant case correction received with IRD 05-Dec-2017: The statement "patient's skin had raised circulating in an area approximately 80mm" to "swelling appeared on patient's skin which was raised, approximately 80 mm of circular area. Narrative amended accordingly.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Muscle tightness, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: This initial spontaneous case was received on 05-Dec-2017 from other health professional via health authority (VAERS ID: 717893), concerns a 06-year-old female child patient. The patient had no allergies. The patient's historical condition included exercise induced asthma. The patient's current condition included diarrhea. The patient did not receive any concomitant medications. On 04-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location: right arm, route of administration: SYR (as reported), batch number, expiry date: not reported). On the same day, at 20:00 hrs, after 20 hrs of vaccine administration, the patient had right arm bump of dime size and her arm was sore to touch. On 05-Oct-2017, at 07:00 hrs, the bump size was of quarter size. At 11:00 hrs, the patient right arm was swollen to small egg and applied ice pack. On the same day, after 2 days of vaccination, the patient had muscle pain, temperature was 100 (units not reported) and received TYLENOL at 19:00 hrs. On 06-Oct-2017, no fever or pain was reported. It was reported that, arm was still sore, and swelling was almost gone. On 07-Oct-2017, at 04:00 hrs, after 3 days of vaccination, the patient had tightness and tenderness in muscle. The patient recovered from all the events. The reporter assessed the events as non-serious.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: This initial spontaneous case was received on 05-Dec-2017 from other health professional via health authority (VAERS ID: 717893), concerns a 06-year-old female child patient. The patient had no allergies. The patient's historical condition included exercise induced asthma. The patient's current condition included diarrhea. The patient did not receive any concomitant medications. On 04-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location: right arm, route of administration: SYR (as reported), batch number, expiry date: not reported). On the same day, at 20:00 hrs, after 20 hrs of vaccine administration, the patient had right arm bump of dime size and her arm was sore to touch. On 05-Oct-2017, at 07:00 hrs, the bump size was of quarter size. At 11:00 hrs, the patient right arm was swollen to small egg and applied ice pack. On the same day, after 2 days of vaccination, the patient had muscle pain, temperature was 100 (units not reported) and received TYLENOL at 19:00 hrs. On 06-Oct-2017, no fever or pain was reported. It was reported that, arm was still sore, and swelling was almost gone. On 07-Oct-2017, at 04:00 hrs, after 3 days of vaccination, the patient had tightness and tenderness in muscle. The patient recovered from all the events. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLU4
Symptoms: Rash generalised, Rash macular
Clinical narrative: This initial spontaneous case, received on 05-Dec-2017, reported by other health professional via regulatory authority (VAERS ID: 717913) and concerns 68-year-old male patient. The patient's medication history included: HCV (Hepatitis C virus), multiple myeloma and historical drug was CHLOR-TRIMETON. The patient's current conditions included hypertension, adenocarcinoma of prostate. The patient's concomitant medications included acyclovir, clonidine, gabapentin, ZOFRAN, MIRALAX, HCTZ, Heparin lock flush, COZAAR, Metoprolol. On 29-Sep-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5ml, batch number: 00544611A, route of administration: intramuscular). On 01-Oct-2017, 3 days, after administration of AFLURIA QUADRIVALENT, the patient had macular rash all over without dyspnea and itching. At the time of this report, the patient recovered from the event. The reporter assessed the case as non-serious.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: This spontaneous case, was initially received on 05-Dec-2017 from other health professional via health authority (VAERS ID: 717990), concerns a 43-year-old adult female patient. The patient had no medical history. The patient had no medical history. The patient had no known drug and food allergies. On 29-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, anatomical location: left arm, route of administration: intramuscular, batch number: XF32908, expiry date: not reported). On the same day, after vaccine administration, the patient experienced headaches, dizziness, joint pain, exhaustion, racing heartbeat, hives on face, chest and arms; injection site swelling and redness, which was hot to touch. At the time of this report, the patient was recovered from the events. The reporter assessed the events as non-serious.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth, Palpitations, Urticaria
Clinical narrative: This spontaneous case, was initially received on 05-Dec-2017 from other health professional via health authority (VAERS ID: 717990), concerns a 43-year-old adult female patient. The patient had no medical history. The patient had no medical history. The patient had no known drug and food allergies. On 29-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, anatomical location: left arm, route of administration: intramuscular, batch number: XF32908, expiry date: not reported). On the same day, after vaccine administration, the patient experienced headaches, dizziness, joint pain, exhaustion, racing heartbeat, hives on face, chest and arms; injection site swelling and redness, which was hot to touch. At the time of this report, the patient was recovered from the events. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site macule, Injection site rash, Pruritus, Rash, Rash macular
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, was reported by health authority (VAERS ID: 718028) via other health professional and concerns a 53-year-old adult female patient. The patient had no history. The patient's current conditions included allergy to oral food (melon, cucumber, squash, and banana) which lead to in poison ivy type reaction. The patient also had allergy to latex and nickel which resulted in contact dermatitis. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid (arm), batch number: XF31507, expiry date: not reported). On 28-Sep-2017, after 8 days of vaccination, the patient had rash on her arm, near the site of the injection, trunk, forehead and scalp. The trunk lesions measured 0.5 to 2.0 cm with red macules red and central cleaning. It had significant itching. Few of the macules were on left deltoid region at the site of the injection and a total of 6 lesions on trunk. The patient had diffused maculopapular rash on scalp and forehead described as flesh coloured, covering the enter forehead, scalp, back of neck with itching. At the time of the report, the patient had not recovered from the events. It was reported that the event rash has not worsened. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Rash maculo-papular
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, was reported by health authority (VAERS ID: 718028) via other health professional and concerns a 53-year-old adult female patient. The patient had no history. The patient's current conditions included allergy to oral food (melon, cucumber, squash, and banana) which lead to in poison ivy type reaction. The patient also had allergy to latex and nickel which resulted in contact dermatitis. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid (arm), batch number: XF31507, expiry date: not reported). On 28-Sep-2017, after 8 days of vaccination, the patient had rash on her arm, near the site of the injection, trunk, forehead and scalp. The trunk lesions measured 0.5 to 2.0 cm with red macules red and central cleaning. It had significant itching. Few of the macules were on left deltoid region at the site of the injection and a total of 6 lesions on trunk. The patient had diffused maculopapular rash on scalp and forehead described as flesh coloured, covering the enter forehead, scalp, back of neck with itching. At the time of the report, the patient had not recovered from the events. It was reported that the event rash has not worsened. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site macule, Injection site rash, Rash, Rash macular, Rash maculo-papular
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, was reported by health authority (VAERS ID: 718028) via other health professional and concerns a 53-year-old adult female patient. The patient had no history. The patient's current conditions included allergy to oral food (melon, cucumber, squash, and banana) which lead to in poison ivy type reaction. The patient also had allergy to latex and nickel which resulted in contact dermatitis. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid (arm), batch number: XF31507, expiry date: not reported). On 28-Sep-2017, after 8 days of vaccination, the patient had rash on her arm, near the site of the injection, trunk, forehead and scalp. The trunk lesions measured 0.5 to 2.0 cm with red macules red and central cleaning. It had significant itching. Few of the macules were on left deltoid region at the site of the injection and a total of 6 lesions on trunk. The patient had diffused maculopapular rash on scalp and forehead described as flesh coloured, covering the enter forehead, scalp, back of neck with itching. At the time of the report, the patient had not recovered from the events. It was reported that the event rash has not worsened. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Rash pruritic
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, was reported by health authority (VAERS ID: 718028) via other health professional and concerns a 53-year-old adult female patient. The patient had no history. The patient's current conditions included allergy to oral food (melon, cucumber, squash, and banana) which lead to in poison ivy type reaction. The patient also had allergy to latex and nickel which resulted in contact dermatitis. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid (arm), batch number: XF31507, expiry date: not reported). On 28-Sep-2017, after 8 days of vaccination, the patient had rash on her arm, near the site of the injection, trunk, forehead and scalp. The trunk lesions measured 0.5 to 2.0 cm with red macules red and central cleaning. It had significant itching. Few of the macules were on left deltoid region at the site of the injection and a total of 6 lesions on trunk. The patient had diffused maculopapular rash on scalp and forehead described as flesh coloured, covering the enter forehead, scalp, back of neck with itching. At the time of the report, the patient had not recovered from the events. It was reported that the event rash has not worsened. The reporter assessed the events as non-serious.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site macule, Injection site rash, Pruritus, Rash, Rash macular
Clinical narrative: This non-serious spontaneous case, was initially received on 05-Oct-2017, from other health professional, concerning a 53-year-old, adult female patient. The medical history of the patient had, three years of allergy to oral food which included cucumber, banana, malar, squash and developed poison ivy type of reaction, and lifelong allergy to latex and nickel that resulted in contact dermatitis. The concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF31507, expiry date: 30-Jun-2018). On 28-Sep-2017, after 8 days of vaccination, the patient developed rash near injection site on arm and rash on trunk, forehead and scalp. The trunk lesions were described as 0.5 to 0.2 cm macules - red with central clearing and had significant itching. One of the macule was on left deltoid region at the injection site. The patient had a total of 6 lesions on trunk. The patient had diffused maculopapular rash, flesh coloured, covering entire forehead, scalp, back of neck and very itchy. At the time of the report, the events were neither recovered nor worsened. The reporter assessed the report as non-serious. Non-significant case correction received with IRD 05-Oct-2017: Batch number (XF31507) was added on the screen. The narrative was amended accordingly.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Rash maculo-papular
Clinical narrative: This non-serious spontaneous case, was initially received on 05-Oct-2017, from other health professional, concerning a 53-year-old, adult female patient. The medical history of the patient had, three years of allergy to oral food which included cucumber, banana, malar, squash and developed poison ivy type of reaction, and lifelong allergy to latex and nickel that resulted in contact dermatitis. The concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF31507, expiry date: 30-Jun-2018). On 28-Sep-2017, after 8 days of vaccination, the patient developed rash near injection site on arm and rash on trunk, forehead and scalp. The trunk lesions were described as 0.5 to 0.2 cm macules - red with central clearing and had significant itching. One of the macule was on left deltoid region at the injection site. The patient had a total of 6 lesions on trunk. The patient had diffused maculopapular rash, flesh coloured, covering entire forehead, scalp, back of neck and very itchy. At the time of the report, the events were neither recovered nor worsened. The reporter assessed the report as non-serious. Non-significant case correction received with IRD 05-Oct-2017: Batch number (XF31507) was added on the screen. The narrative was amended accordingly.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site macule, Injection site rash, Rash, Rash macular, Rash maculo-papular
Clinical narrative: This non-serious spontaneous case, was initially received on 05-Oct-2017, from other health professional, concerning a 53-year-old, adult female patient. The medical history of the patient had, three years of allergy to oral food which included cucumber, banana, malar, squash and developed poison ivy type of reaction, and lifelong allergy to latex and nickel that resulted in contact dermatitis. The concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF31507, expiry date: 30-Jun-2018). On 28-Sep-2017, after 8 days of vaccination, the patient developed rash near injection site on arm and rash on trunk, forehead and scalp. The trunk lesions were described as 0.5 to 0.2 cm macules - red with central clearing and had significant itching. One of the macule was on left deltoid region at the injection site. The patient had a total of 6 lesions on trunk. The patient had diffused maculopapular rash, flesh coloured, covering entire forehead, scalp, back of neck and very itchy. At the time of the report, the events were neither recovered nor worsened. The reporter assessed the report as non-serious. Non-significant case correction received with IRD 05-Oct-2017: Batch number (XF31507) was added on the screen. The narrative was amended accordingly.