chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: This initial spontaneous case, was received from other health professional via health authority (VAERS ID: 708638) on 05-Dec-2017, concerning a 46-year-old adult female patient. The patient had no medical history and allergies. The patient's concomitant medications included RELPAX and LIPITOR. On 13-Aug-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number, expiry date, route of administration and anatomical location: not reported). On the same day, after the vaccination, the patient had swelling and redness. It was reported that, the patient visited the physician office. At the time of this report, the patient had not yet recovered from the events. The reporter assessed the events as non-serious.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Dizziness, Headache, Nausea, Pruritus
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017 from health authority (VAERS ID: 710428) (reported to HA by other health professional) concerns a 69-year-old elderly female patient. The patient's current condition included asthma, COPD (chronic obstructive pulmonary disease), bipolar, coronary artery disease and allergic to penicillin, shellfish, pears, lactose, tricyclic anti-depressants, morphine, SINEQUAN, ATARAX, TOFRANIL, PERCOCET and DARVON. The patient's concomitant medications included CRESTOR, Aspirin, Vitamin D-3, Vitamin B-12, Iron and Gabapentin. On 25-Aug-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, anatomical location: left arm, route of administration, batch number, expiry date: not reported). On 27-Aug-2017, after 3 days of vaccination, the patient experienced acute burning rash on stomach and back, severe itching, nausea, light-headedness, severe joint aches and headache. No lab test was done to the patient. At the time of this report, the patient was not recovered from the events. The reporter assessed the events as non-serious.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Skin burning sensation
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017 from health authority (VAERS ID: 710428) (reported to HA by other health professional) concerns a 69-year-old elderly female patient. The patient's current condition included asthma, COPD (chronic obstructive pulmonary disease), bipolar, coronary artery disease and allergic to penicillin, shellfish, pears, lactose, tricyclic anti-depressants, morphine, SINEQUAN, ATARAX, TOFRANIL, PERCOCET and DARVON. The patient's concomitant medications included CRESTOR, Aspirin, Vitamin D-3, Vitamin B-12, Iron and Gabapentin. On 25-Aug-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, anatomical location: left arm, route of administration, batch number, expiry date: not reported). On 27-Aug-2017, after 3 days of vaccination, the patient experienced acute burning rash on stomach and back, severe itching, nausea, light-headedness, severe joint aches and headache. No lab test was done to the patient. At the time of this report, the patient was not recovered from the events. The reporter assessed the events as non-serious.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Chest pain, Dyspnoea, Headache, Influenza like illness
Clinical narrative: This spontaneous case, initially received from FDA (VAERS ID: 710520) (reported to HA by other health professional) on 05-Dec-2017, concerns a 62-year-old adult female patient. The patient's historical condition included arthritis (unspecified date). The patient had no current illness and allergies. The patient's concomitant medications included Isosorbide MN and amlodipine. On 13-Aug-2017, the patient was administered with AFLURIA QUDRIVALENT (dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location, batch number and expiry date: not reported) at the pharmacy. On the same day, after some minutes, the patient had burning sensation and it was like that, her left side was on fire, which moved to right side of her chest. The patient also had rash on arms, large bumps on chest, shortness of breath, headaches, severe itching, nausea and flu like symptoms. It was reported that, the patient visited the physician office. At the time of this report, the patient had not yet recovered form the events. The reporter assessed the event as non-serious. Non-significant case correction received with IRD 05-Dec-2017: The route of administration of the suspect vaccine was corrected from "SYR" to "injection" in narrative. The narrative was amended accordingly.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pruritus, Rash
Clinical narrative: This spontaneous case, initially received from FDA (VAERS ID: 710520) (reported to HA by other health professional) on 05-Dec-2017, concerns a 62-year-old adult female patient. The patient's historical condition included arthritis (unspecified date). The patient had no current illness and allergies. The patient's concomitant medications included Isosorbide MN and amlodipine. On 13-Aug-2017, the patient was administered with AFLURIA QUDRIVALENT (dose: 0.5 ml, route of administration: injection (reported as SYR), anatomical location, batch number and expiry date: not reported) at the pharmacy. On the same day, after some minutes, the patient had burning sensation and it was like that, her left side was on fire, which moved to right side of her chest. The patient also had rash on arms, large bumps on chest, shortness of breath, headaches, severe itching, nausea and flu like symptoms. It was reported that, the patient visited the physician office. At the time of this report, the patient had not yet recovered form the events. The reporter assessed the event as non-serious. Non-significant case correction received with IRD 05-Dec-2017: The route of administration of the suspect vaccine was corrected from "SYR" to "injection" in narrative. The narrative was amended accordingly.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure measurement, Chest pain, Dizziness, Fatigue, Injected limb mobility decreased
Clinical narrative: This spontaneous case, initially received from regulatory authority (VAERS ID: 712372) (reported to RA by other health professional) on 05-Dec-2017 concerning a 28 year-old adult female patient. The patient had no any current illness and medical history. The patient was using birth control pills at the time of vaccination. On 12-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF31307, expiry date: not reported). On the same day, after 2 hours of administration of vaccine, the patient experienced severe pain at the site (reported as shooting pain), lightheadedness, and had feelings of fatigue. The patient had difficulty to move her left arm. The patient also had a short period of sharp chest pain, which resolved. The patient's BP was 100/70 (unit and normal range not provided). The patient was given water, crackers, and MOTRIN. The patient used ice packs at the site of injection. The outcome of the events severe pain at the site (reported as shooting pain), lightheadedness, difficult to move her left arm also had feeling of fatigue was reported as not recovered and for the event a short period of sharp chest pain was reported as resolved. The reporter assessed this case as non-serious.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: This spontaneous case, initially received from regulatory authority (VAERS ID: 712372) (reported to RA by other health professional) on 05-Dec-2017 concerning a 28 year-old adult female patient. The patient had no any current illness and medical history. The patient was using birth control pills at the time of vaccination. On 12-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF31307, expiry date: not reported). On the same day, after 2 hours of administration of vaccine, the patient experienced severe pain at the site (reported as shooting pain), lightheadedness, and had feelings of fatigue. The patient had difficulty to move her left arm. The patient also had a short period of sharp chest pain, which resolved. The patient's BP was 100/70 (unit and normal range not provided). The patient was given water, crackers, and MOTRIN. The patient used ice packs at the site of injection. The outcome of the events severe pain at the site (reported as shooting pain), lightheadedness, difficult to move her left arm also had feeling of fatigue was reported as not recovered and for the event a short period of sharp chest pain was reported as resolved. The reporter assessed this case as non-serious.
Age: 25.0
Sex: F
Vaccine: FLUX, FLU4, FLU4
Symptoms: Malaise, Myalgia
Clinical narrative: This spontaneous case, reported by non-health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 712377), concerns a 25-year-old adult female patient. On an unspecified date in 2015, at the age of 23, the patient was administered with seasonal flu vaccine and experienced malaise. On an unspecified date in 2016, at the age of 24, the patient was administered with seasonal flu vaccine and experienced myalgias. On 28-Mar-2016, the patient was administered with Pneumococcal 23 and TDAP and experienced pain (reported as excessive). The patient's current conditions included asthma, attention deficit/hyperactivity disorder (ADHD). The patient was allergic to post-nasal drip, cats and walnuts. It was reported that, the patient had rash after takin sulfa drugs in the past. The patient's concomitant medications included SYMBICORT, MONONESSA, FLONASE, Fexofenadine, ADDERALL for an unknown indication. On 11-Sep-2017 at 02:30 pm, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml (reported as plus 7), route of administration: intramuscular, anatomical location: left arm, batch number: 00444621A, expiry date: not reported). On the same day of vaccination (11-Sep-2017), at 7:00 pm, the patient experienced sensation of rapid heart rate which was recorded by Fit-Bit 107 beats per minute (BPM). It was reported that, the patient was sitting calmly and was studying without any stress or anxiety which could explain the condition as tachycardia. The patient also experienced chest tightness, difficulty in breathing which was associated with asthma. It was reported that, albuterol inhaler was not comfortable to exacerbate for rapid heart rate. At 8:00 pm, the patient experienced myalgias and general malaise for which the patient was treated with half dose of acetaminophen. Aches made the patient uncomfortable to study and had to take rest (reported as vague HA, headed to bed). Myalgia progressed to cramping and weakness which were associated with nausea. At 09:00 pm, the patient experienced chills, fever of 100.5 (unit not reported) for which half dose of acetaminophen was given. The patient experienced severe pain, cramping, weakness in cervical, thoracic, lumbar regions and was unable to relieve with position changes in bed. It was reported that, continued to have nausea and had no vomiting, but felt alternating chills or diaphoresis. Reported that, the condition continued until 12 am and mostly resolved by 5 am the next day. It was reported that, the patient was able to work on the next day (12-Sep-2017). The reporter assessed this case as non-serious. Significant case correction received with IRD 21-Feb-2018: The causality of the events was corrected (weakness, myalgia, nausea, ache, and fever, malaise were considered as related and other events asthma, chills, condition aggravated, discomfort, difficulty breathing, headache, heart rate increased, diaphoresis, cramps as unassessable). Case comment was amended accordingly.
Age: 25.0
Sex: F
Vaccine: FLUX, FLU4, FLU4
Symptoms: Asthenia, Asthma, Chest discomfort, Chills, Condition aggravated
Clinical narrative: This spontaneous case, reported by non-health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 712377), concerns a 25-year-old adult female patient. On an unspecified date in 2015, at the age of 23, the patient was administered with seasonal flu vaccine and experienced malaise. On an unspecified date in 2016, at the age of 24, the patient was administered with seasonal flu vaccine and experienced myalgias. On 28-Mar-2016, the patient was administered with Pneumococcal 23 and TDAP and experienced pain (reported as excessive). The patient's current conditions included asthma, attention deficit/hyperactivity disorder (ADHD). The patient was allergic to post-nasal drip, cats and walnuts. It was reported that, the patient had rash after takin sulfa drugs in the past. The patient's concomitant medications included SYMBICORT, MONONESSA, FLONASE, Fexofenadine, ADDERALL for an unknown indication. On 11-Sep-2017 at 02:30 pm, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml (reported as plus 7), route of administration: intramuscular, anatomical location: left arm, batch number: 00444621A, expiry date: not reported). On the same day of vaccination (11-Sep-2017), at 7:00 pm, the patient experienced sensation of rapid heart rate which was recorded by Fit-Bit 107 beats per minute (BPM). It was reported that, the patient was sitting calmly and was studying without any stress or anxiety which could explain the condition as tachycardia. The patient also experienced chest tightness, difficulty in breathing which was associated with asthma. It was reported that, albuterol inhaler was not comfortable to exacerbate for rapid heart rate. At 8:00 pm, the patient experienced myalgias and general malaise for which the patient was treated with half dose of acetaminophen. Aches made the patient uncomfortable to study and had to take rest (reported as vague HA, headed to bed). Myalgia progressed to cramping and weakness which were associated with nausea. At 09:00 pm, the patient experienced chills, fever of 100.5 (unit not reported) for which half dose of acetaminophen was given. The patient experienced severe pain, cramping, weakness in cervical, thoracic, lumbar regions and was unable to relieve with position changes in bed. It was reported that, continued to have nausea and had no vomiting, but felt alternating chills or diaphoresis. Reported that, the condition continued until 12 am and mostly resolved by 5 am the next day. It was reported that, the patient was able to work on the next day (12-Sep-2017). The reporter assessed this case as non-serious. Significant case correction received with IRD 21-Feb-2018: The causality of the events was corrected (weakness, myalgia, nausea, ache, and fever, malaise were considered as related and other events asthma, chills, condition aggravated, discomfort, difficulty breathing, headache, heart rate increased, diaphoresis, cramps as unassessable). Case comment was amended accordingly.
Age: 25.0
Sex: F
Vaccine: FLUX, FLU4, FLU4
Symptoms: Discomfort, Dyspnoea, Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: This spontaneous case, reported by non-health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 712377), concerns a 25-year-old adult female patient. On an unspecified date in 2015, at the age of 23, the patient was administered with seasonal flu vaccine and experienced malaise. On an unspecified date in 2016, at the age of 24, the patient was administered with seasonal flu vaccine and experienced myalgias. On 28-Mar-2016, the patient was administered with Pneumococcal 23 and TDAP and experienced pain (reported as excessive). The patient's current conditions included asthma, attention deficit/hyperactivity disorder (ADHD). The patient was allergic to post-nasal drip, cats and walnuts. It was reported that, the patient had rash after takin sulfa drugs in the past. The patient's concomitant medications included SYMBICORT, MONONESSA, FLONASE, Fexofenadine, ADDERALL for an unknown indication. On 11-Sep-2017 at 02:30 pm, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml (reported as plus 7), route of administration: intramuscular, anatomical location: left arm, batch number: 00444621A, expiry date: not reported). On the same day of vaccination (11-Sep-2017), at 7:00 pm, the patient experienced sensation of rapid heart rate which was recorded by Fit-Bit 107 beats per minute (BPM). It was reported that, the patient was sitting calmly and was studying without any stress or anxiety which could explain the condition as tachycardia. The patient also experienced chest tightness, difficulty in breathing which was associated with asthma. It was reported that, albuterol inhaler was not comfortable to exacerbate for rapid heart rate. At 8:00 pm, the patient experienced myalgias and general malaise for which the patient was treated with half dose of acetaminophen. Aches made the patient uncomfortable to study and had to take rest (reported as vague HA, headed to bed). Myalgia progressed to cramping and weakness which were associated with nausea. At 09:00 pm, the patient experienced chills, fever of 100.5 (unit not reported) for which half dose of acetaminophen was given. The patient experienced severe pain, cramping, weakness in cervical, thoracic, lumbar regions and was unable to relieve with position changes in bed. It was reported that, continued to have nausea and had no vomiting, but felt alternating chills or diaphoresis. Reported that, the condition continued until 12 am and mostly resolved by 5 am the next day. It was reported that, the patient was able to work on the next day (12-Sep-2017). The reporter assessed this case as non-serious. Significant case correction received with IRD 21-Feb-2018: The causality of the events was corrected (weakness, myalgia, nausea, ache, and fever, malaise were considered as related and other events asthma, chills, condition aggravated, discomfort, difficulty breathing, headache, heart rate increased, diaphoresis, cramps as unassessable). Case comment was amended accordingly.
Age: 25.0
Sex: F
Vaccine: FLUX, FLU4, FLU4
Symptoms: Malaise, Muscle spasms, Myalgia, Nausea, Pain
Clinical narrative: This spontaneous case, reported by non-health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 712377), concerns a 25-year-old adult female patient. On an unspecified date in 2015, at the age of 23, the patient was administered with seasonal flu vaccine and experienced malaise. On an unspecified date in 2016, at the age of 24, the patient was administered with seasonal flu vaccine and experienced myalgias. On 28-Mar-2016, the patient was administered with Pneumococcal 23 and TDAP and experienced pain (reported as excessive). The patient's current conditions included asthma, attention deficit/hyperactivity disorder (ADHD). The patient was allergic to post-nasal drip, cats and walnuts. It was reported that, the patient had rash after takin sulfa drugs in the past. The patient's concomitant medications included SYMBICORT, MONONESSA, FLONASE, Fexofenadine, ADDERALL for an unknown indication. On 11-Sep-2017 at 02:30 pm, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml (reported as plus 7), route of administration: intramuscular, anatomical location: left arm, batch number: 00444621A, expiry date: not reported). On the same day of vaccination (11-Sep-2017), at 7:00 pm, the patient experienced sensation of rapid heart rate which was recorded by Fit-Bit 107 beats per minute (BPM). It was reported that, the patient was sitting calmly and was studying without any stress or anxiety which could explain the condition as tachycardia. The patient also experienced chest tightness, difficulty in breathing which was associated with asthma. It was reported that, albuterol inhaler was not comfortable to exacerbate for rapid heart rate. At 8:00 pm, the patient experienced myalgias and general malaise for which the patient was treated with half dose of acetaminophen. Aches made the patient uncomfortable to study and had to take rest (reported as vague HA, headed to bed). Myalgia progressed to cramping and weakness which were associated with nausea. At 09:00 pm, the patient experienced chills, fever of 100.5 (unit not reported) for which half dose of acetaminophen was given. The patient experienced severe pain, cramping, weakness in cervical, thoracic, lumbar regions and was unable to relieve with position changes in bed. It was reported that, continued to have nausea and had no vomiting, but felt alternating chills or diaphoresis. Reported that, the condition continued until 12 am and mostly resolved by 5 am the next day. It was reported that, the patient was able to work on the next day (12-Sep-2017). The reporter assessed this case as non-serious. Significant case correction received with IRD 21-Feb-2018: The causality of the events was corrected (weakness, myalgia, nausea, ache, and fever, malaise were considered as related and other events asthma, chills, condition aggravated, discomfort, difficulty breathing, headache, heart rate increased, diaphoresis, cramps as unassessable). Case comment was amended accordingly.
Age: 25.0
Sex: F
Vaccine: FLUX, FLU4, FLU4
Symptoms: Pyrexia
Clinical narrative: This spontaneous case, reported by non-health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 712377), concerns a 25-year-old adult female patient. On an unspecified date in 2015, at the age of 23, the patient was administered with seasonal flu vaccine and experienced malaise. On an unspecified date in 2016, at the age of 24, the patient was administered with seasonal flu vaccine and experienced myalgias. On 28-Mar-2016, the patient was administered with Pneumococcal 23 and TDAP and experienced pain (reported as excessive). The patient's current conditions included asthma, attention deficit/hyperactivity disorder (ADHD). The patient was allergic to post-nasal drip, cats and walnuts. It was reported that, the patient had rash after takin sulfa drugs in the past. The patient's concomitant medications included SYMBICORT, MONONESSA, FLONASE, Fexofenadine, ADDERALL for an unknown indication. On 11-Sep-2017 at 02:30 pm, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml (reported as plus 7), route of administration: intramuscular, anatomical location: left arm, batch number: 00444621A, expiry date: not reported). On the same day of vaccination (11-Sep-2017), at 7:00 pm, the patient experienced sensation of rapid heart rate which was recorded by Fit-Bit 107 beats per minute (BPM). It was reported that, the patient was sitting calmly and was studying without any stress or anxiety which could explain the condition as tachycardia. The patient also experienced chest tightness, difficulty in breathing which was associated with asthma. It was reported that, albuterol inhaler was not comfortable to exacerbate for rapid heart rate. At 8:00 pm, the patient experienced myalgias and general malaise for which the patient was treated with half dose of acetaminophen. Aches made the patient uncomfortable to study and had to take rest (reported as vague HA, headed to bed). Myalgia progressed to cramping and weakness which were associated with nausea. At 09:00 pm, the patient experienced chills, fever of 100.5 (unit not reported) for which half dose of acetaminophen was given. The patient experienced severe pain, cramping, weakness in cervical, thoracic, lumbar regions and was unable to relieve with position changes in bed. It was reported that, continued to have nausea and had no vomiting, but felt alternating chills or diaphoresis. Reported that, the condition continued until 12 am and mostly resolved by 5 am the next day. It was reported that, the patient was able to work on the next day (12-Sep-2017). The reporter assessed this case as non-serious. Significant case correction received with IRD 21-Feb-2018: The causality of the events was corrected (weakness, myalgia, nausea, ache, and fever, malaise were considered as related and other events asthma, chills, condition aggravated, discomfort, difficulty breathing, headache, heart rate increased, diaphoresis, cramps as unassessable). Case comment was amended accordingly.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pruritus, Rash macular
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional via health authority (VAERS ID: 712449) on 05-Dec-2017, concerns a 56-year-old, adult female patient. The patient's current condition included: hypertension, migraines. The patient was allergic to sulfa, hydrocodone and peppermint. Concomitant medications included: lisinopril and IMITREX. On 12-Sep-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: Intramuscular, anatomical location: left arm, batch no: XF3087 (as reported) and expiry date: not reported). On the same day, the patient developed redness and swelling on left upper arm at the injection site. Both arms were reddened and itching. It was reported that arms, head and trunk of the body were itching, throat was funny and scratchy. She had taken BENADRYL (dose: 50 mg via oral route) at home which showed good results. It was reported that both arms looked sun burned, red and blotchy. The patient recovered from the events. The reporter assessed the events as non-serious.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional via health authority (VAERS ID: 712449) on 05-Dec-2017, concerns a 56-year-old, adult female patient. The patient's current condition included: hypertension, migraines. The patient was allergic to sulfa, hydrocodone and peppermint. Concomitant medications included: lisinopril and IMITREX. On 12-Sep-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: Intramuscular, anatomical location: left arm, batch no: XF3087 (as reported) and expiry date: not reported). On the same day, the patient developed redness and swelling on left upper arm at the injection site. Both arms were reddened and itching. It was reported that arms, head and trunk of the body were itching, throat was funny and scratchy. She had taken BENADRYL (dose: 50 mg via oral route) at home which showed good results. It was reported that both arms looked sun burned, red and blotchy. The patient recovered from the events. The reporter assessed the events as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Vertigo
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional via health authority (VAERS ID: 712535) on 05-Dec-2017, concerning a 53-year-old, adult female patient. The patient's medical history, allergies and current illness were not reported. Concomitant medication included: EFFEXOR for an unknown indication. On 12-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location: left arm, route of administration, batch number, expiry date: not reported). On 13-Sep-2017, at 01:00 am, 24 hours after vaccine was administered, the patient experienced vertigo which was continuing through the night. At the time of this report, the patient had not yet recovered from the event (still ongoing). The reporter assessed the events as non-serious and assessed the causality as related to the suspect vaccine.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: This spontaneous case, initially received from FDA authority (VAERS ID: 713128) (reported to HA by other health professional) received on 05-Dec-2017 and concerns 63-year-old adult male patient. The patient had no medical history and allergies. The patient had not received any concomitant medications. On 11-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location, route of administration, batch number and expiry date: not reported). On the same day, after the vaccination, the patient's shoulder was sore. It was reported that, patient's shoulder was still sore. At the time of this report, the patient had not yet recovered from the event. The reporter assessed the case as non-serious. Significant case correction received with IRD 05-Dec-2017: The onset date for the event (shoulder pain) was captured. The narrative was amended accordingly.
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure measurement, Dizziness, Posture abnormal, Pulse abnormal, Staring
Clinical narrative: This spontaneous case, was received from other health professional via health authority (VAERS ID: 713199) on 05-Dec-2017, concerning a 46-year-old adult female patient. The patient's medical history and concomitant were not reported. On 14-Sep-2017, at approximately 04:35 pm, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 00144621A and expiry date: not reported). On the same day, after the vaccination, the patient began to feel light-headedness, faint and was able to seat herself and slumped backward in the chair. Her eyes were open and fixed. Pulse was weak in the right wrist and upon evaluation it was estimated around 50. On evaluation by automatic BP (blood pressure) cuff, her BP was 90/70 and pulse rate was 58 (normal range and units were not provided). After 3-5 minutes, the patient began to look and interact with the staff and was alert at that time. On second evaluation, with BP kit, BP was 101/79 and pulse was 65 (normal range and units were not provided). It was reported that, the patient's light-headedness went away, and she felt better. At 5:15 pm, the patient was able to leave on her own without an assistance. At 6:30 pm, the pharmacy made contact with the patient. The outcome of the events was reported as recovered. The reporter assessed the events as non-serious and causality as related between the events and suspect vaccine.
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: This spontaneous case, was received from other health professional via health authority (VAERS ID: 713199) on 05-Dec-2017, concerning a 46-year-old adult female patient. The patient's medical history and concomitant were not reported. On 14-Sep-2017, at approximately 04:35 pm, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number: 00144621A and expiry date: not reported). On the same day, after the vaccination, the patient began to feel light-headedness, faint and was able to seat herself and slumped backward in the chair. Her eyes were open and fixed. Pulse was weak in the right wrist and upon evaluation it was estimated around 50. On evaluation by automatic BP (blood pressure) cuff, her BP was 90/70 and pulse rate was 58 (normal range and units were not provided). After 3-5 minutes, the patient began to look and interact with the staff and was alert at that time. On second evaluation, with BP kit, BP was 101/79 and pulse was 65 (normal range and units were not provided). It was reported that, the patient's light-headedness went away, and she felt better. At 5:15 pm, the patient was able to leave on her own without an assistance. At 6:30 pm, the pharmacy made contact with the patient. The outcome of the events was reported as recovered. The reporter assessed the events as non-serious and causality as related between the events and suspect vaccine.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Pruritus, Rash, Throat irritation
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, reported by other health professional via health authority (VAERS ID: 713200), concerns a 31-year-old adult female patient. The patient's current illness included heart murmur and idiopathic tachycardia. The concomitant medications included amphetamine and atenolol. On 18-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch no: XF30907, route of administration, anatomical location and expiry date: not reported). On the same day, the patient developed rash on hands, arms, chest, throat, itching on arms and face. She felt flushed and a little scratchy in throat, but not tight. It was reported that the patient had no trouble in breathing. It was reported that the outcome of the events was not recovered. The reported assessed this case as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site pain, Pain in extremity, Product administered at inappropriate site, Skin infection
Clinical narrative: This initial spontaneous case, received on 05-Dec-2017, reported by other non-health professional (via regulatory authority VAERS ID: 713470) and concerns 37-year-old, adult, female patient. The patient's medical history and allergies were not reported. The patient's concomitant medication was reported as ZOLOFT since an unspecified date. On 09-Sep-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location: left arm, batch number, route of administration: not reported). The vaccine was administered at a site which was lower to the actual site of injection. The patient stated that, normally the flu shot was given in the upper arm, 3 fingers below the shoulder (as reported). It was reported that, the pharmacist wiped the upper arm of the patient with alcohol and then proceeded to administer the flu shot in the lower part of the arm. The injection itself was very painful than it was normally and thought it was due to inappropriate site of injection. On the following day, the patient had a sore arm, which was slightly red in colour. Two days later, the patient's arm was extremely sore and very hot to touch. The patient contacted the pharmacy and showed the injection site, which alarmed and thought the site could be "Mersa" (as reported). To rule out the condition, the patient was advised to contact emergency facility immediately. The doctor informed the patient, that she had skin infection. Unspecified antibiotics and pain medications (sulfameth and naproxen) were prescribed and instructed to take the medications as soon as possible. At the time of this report, the patient had recovered from the events. The reporter assessed the case as serious (medically significant).
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: This initial spontaneous case, received on 05-Dec-2017, reported by other non-health professional (via regulatory authority VAERS ID: 713470) and concerns 37-year-old, adult, female patient. The patient's medical history and allergies were not reported. The patient's concomitant medication was reported as ZOLOFT since an unspecified date. On 09-Sep-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location: left arm, batch number, route of administration: not reported). The vaccine was administered at a site which was lower to the actual site of injection. The patient stated that, normally the flu shot was given in the upper arm, 3 fingers below the shoulder (as reported). It was reported that, the pharmacist wiped the upper arm of the patient with alcohol and then proceeded to administer the flu shot in the lower part of the arm. The injection itself was very painful than it was normally and thought it was due to inappropriate site of injection. On the following day, the patient had a sore arm, which was slightly red in colour. Two days later, the patient's arm was extremely sore and very hot to touch. The patient contacted the pharmacy and showed the injection site, which alarmed and thought the site could be "Mersa" (as reported). To rule out the condition, the patient was advised to contact emergency facility immediately. The doctor informed the patient, that she had skin infection. Unspecified antibiotics and pain medications (sulfameth and naproxen) were prescribed and instructed to take the medications as soon as possible. At the time of this report, the patient had recovered from the events. The reporter assessed the case as serious (medically significant).
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site reaction, Loss of personal independence in daily activities, Pain, Tendonitis
Clinical narrative: This non-serious spontaneous case, initially received on 05-Dec-2017, reported by health authority (VAERS ID: 713685) via other health professional, concerning a 27-year-old, adult, female patient. The patient had NKDA (no known drug allergy) and no current illness. Concomitant medications were not reported. On 28-Aug-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 number, expiry date: not reported). On 29-Aug-2017, after 1 day of vaccination, the patient had tendinitis and bursitis in the right shoulder joint. She was unable to dress herself due to pain. The patient did not visit to physician but was using ice and ibuprofen for pain. She was instructed to make appointment with physician for steroids. The health authority provided the preferred term as injection site reaction. At the time of this report, the outcome of the events was not recovered. The reporter assessed the events as non-serious. Non-significant case correction received with IRD 05-Dec-2017: The outcome of the events was corrected from not reported to not recovered in narrative. The treatment received was corrected from unknown to yes in event tab. The narrative was amended accordingly.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Influenza virus test negative, Malaise, Mononucleosis heterophile test negative
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, reported by health authority (VAERS ID: 713777) via health professional, concerning a 24-year-old female patient. The patient was allergic to strawberries and raspberries. The patient had sinus infection and bronchitis (since an unspecified date in Aug-2017). Her concomitant medications included lo lo estrone birth control (as reported), OMNICEF for sinus infection and bronchitis. On 18-Sep-2017 (Monday), the patient was administered with ALFURIA QUADRIVALENT (anatomical location: left arm, route of administration: injection, dose, batch number and expiry date: not reported). On 20-Sep-2017 (Wednesday), the patient felt ill in the morning. She developed chills, severe body aches, pain when touched or bumped, sore throat, tonsils swollen, extreme fatigue. On the same day in the evening, symptoms were severe that frightened her and made to visit emergency room. It was reported that influenza virus test, mononucleosis heterophile test and streptococcus test was negative. On an unspecified date, blood was drawn, throat swabbed (as reported). The patient received IV fluids, pain medication through IV and steroids. At the time of this report, the patient recovered from the events. The reporter assessed the case as non-serious. Non-significant case correction received 05-Dec-2017: The route of administration in the narrative was corrected from SYR to injection. The narrative was amended accordingly.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pain, Streptococcus test negative, Tenderness, Tonsillar hypertrophy
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, reported by health authority (VAERS ID: 713777) via health professional, concerning a 24-year-old female patient. The patient was allergic to strawberries and raspberries. The patient had sinus infection and bronchitis (since an unspecified date in Aug-2017). Her concomitant medications included lo lo estrone birth control (as reported), OMNICEF for sinus infection and bronchitis. On 18-Sep-2017 (Monday), the patient was administered with ALFURIA QUADRIVALENT (anatomical location: left arm, route of administration: injection, dose, batch number and expiry date: not reported). On 20-Sep-2017 (Wednesday), the patient felt ill in the morning. She developed chills, severe body aches, pain when touched or bumped, sore throat, tonsils swollen, extreme fatigue. On the same day in the evening, symptoms were severe that frightened her and made to visit emergency room. It was reported that influenza virus test, mononucleosis heterophile test and streptococcus test was negative. On an unspecified date, blood was drawn, throat swabbed (as reported). The patient received IV fluids, pain medication through IV and steroids. At the time of this report, the patient recovered from the events. The reporter assessed the case as non-serious. Non-significant case correction received 05-Dec-2017: The route of administration in the narrative was corrected from SYR to injection. The narrative was amended accordingly.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Pain of skin, Tenderness
Clinical narrative: This initial spontaneous case, was received from other health professional via health authority (FDA number: 714085) on 05-Dec-2017, concerning a 42-year-old adult male patient. The patient had no medical history. The patient had environmental allergy. The patient's concomitant medications included CLARITIN. 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: 00644623A and expiry date: not reported). On 13-Sep-2017, after 2 days of vaccination, the patient experienced lateral tenderness, (L) left axillary pain, which radiated down distribution of brachial vein to distal bicep with sore skin. It was reported that, the patient visited the physician office. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as non-serious.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Pallor, Posture abnormal, Syncope
Clinical narrative: This non-serious initial spontaneous case, was received from Other Health Professional via health authority (VAERS ID: 714214) on 05-Dec-2017, concerning a 34-year, adult, male patient. The patient's historical condition included: he got dizzy and syncope after getting shots or donating blood but was not specific. On 22-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number XF32908, expiry date: not reported). On the same day, patient developed syncope within a minute or 2 after getting flu shot. Was sitting down and complained about getting dizzy, turned pale and started sliding off the chair. He opened his eyes immediately and was asked to bend down and keep his head between his legs. He said he felt better but after few min of sitting straight, he turned pale again. Hence, he was asked to keep his head down till paramedics came. The patient recovered from all the events. The reporter assessed the events as non-serious and causality as related between events and AFLURIA QUATRIVALENT.
Sex: M
Vaccine: FLU4
Symptoms: Nasopharyngitis, Paraesthesia
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, reported by health authority (VAERS ID: 714215) via other non-health professional (consumer), concerning a 12-year-old adolescent male patient. On 31-Aug-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 1), route of administration: injection, anatomical location: left arm, batch number and expiry date: not reported). On 16-Sep-2017, after 16 days of vaccination, patient had a cold shortly and tingling feeling. The patient did not receive any treatment. It was reported that, patient's school did not start at that time and he did not go out. The symptom had worsened due to patient's PE (physical education) class, and he finally complained to the parents. At the time of this report, the patient had not yet recovered from the event. The reporter assessed the case as non-serious. Non-significant case correction received with IRD 05-Dec-2017: The route of administration in the narrative was changed from SYR to injection. The narrative was amended accordingly. Non-significant case correction received with IRD 05-Dec-2017: Biological implausibility was removed in the case comment.
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, from the other health care professional via health authority (VAERS ID: 714262), concerning a 23-year-old-adult female patient. On 20-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml (dose - 1 as reported), route of administration: intramuscular, anatomical location: right arm, batch number: XF30607, expiry date: not reported). On 21-Sep-2017, the patient developed redness, swelling, and itching around the area where she got flu shot. The patient complained numbness of whole arm. She applied anti-itch cream and felt a bit better, but it was still warm to touch. She was advised to consult MD. It was reported that the event itching was resolving (bit better) while the outcome of the other events was not reported. The reporter assessed this case as non-serious.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous case, initially received on 05-Dec-2017, was reported by regulatory authority (VAERS ID: 714677) via other health professional, concerning an 83-year-old elderly female patient. The patient's medical history included: glaucoma, claudication, congestive heart failure, carotid artery stenosis. The patient's historical drugs included LASIX, OXYCONTON. At the time of the event the patient had type 2 diabetes mellitus, hypertension, hypercholesterolemia. On 18-Sep-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml (UNK as reported), route of administration: intramuscular, anatomical location: right arm, batch number: 00744622A, expiry date: not reported). It was reported that, the patient was administered with incorrect dose (explicitly coded as incorrect dose administered). No adverse events occurred. The reporter assessed the case as non-serious. Nonsignificant case correction received with IRD 05-Dec-2017: In narrative medication history was changed to medical history. Narrative was corrected "expiry date" was added. The narrative was amended accordingly.
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Pain, Respiratory tract congestion
Clinical narrative: This serious initial spontaneous case, was received from other health professional via health authority (VAERS ID: 714715) on 05-Dec-2017, concerning a 58-year-old adult female patient. The patient had no medical history and allergies. The patient did not receive any concomitant medications. On 22-Sep-2017, the patient was administered with AFLURIA Quadrivalent (dose: 0.5 ml, route of administration: syr (as reported), anatomical location: arm, batch number and expiry date: not reported). On 23-Sep-2017, after 1 day of vaccination, the patient had worsening of flu-like symptoms - acute bodily aches and respiratory congestion, which were continued for 4 days. It was reported that, the duration and increased severity of the symptoms were atypical, and patient visited to emergency outpatient clinic. At the time of this report, the patient had not yet recovered from the event.