chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Abdominal pain, Blood culture, Full blood count, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2017US034977 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 665424) website on 21 Feb 2017. This report refers to a 42 year old female patient. Historical condition included anemia iron deficiency and slow transit constipation. Current condition included fibroids and was reported that patient had no current illness. Concomitant medications were not reported. The patient was vaccinated with first dose of FLUVIRIN (batch number: 169402) intramuscularly into left arm on 04 Nov 2016. The patient was also vaccinated with PREVNAR 13 (other manufacturer, batch number: M79320) intramuscularly into right arm on 04 Nov 2016. On the same day after vaccination at 08:00 PM, patient experienced mild pain and swelling at injection site. On 05 Nov 2016 at 03:00 AM (reported as next day), the patient woke up with 10/10 pain scale and fever of 102.2 Fahrenheit (normal range not reported). On 05 Nov 2016, the body temperature of the patient reached to a maximum of 104 Fahrenheit (normal range not reported). Following the events patient visited emergency room on an unknown date. It was reported that patient was treated with ibuprofen and Acetaminophen with good effect. On 05 Nov 2016, the patient had abdominal cramping. It was reported that the fever and abdominal cramping resolved on 05 Nov 2016 while there was a continuous swelling and pain as of 07 Nov 2016. The patient had been ordered for complete blood count (CBC) and the blood culture tests (results unspecified). The final outcome of the events fever and abdominal cramping was reported as complete recovery on 05 Nov 2016, for the events injection site swelling, injection site pain and pain was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the events pain and pyrexia (medically significant) was upgraded based on CTCAE (grade 3).
Age: 42.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2017US034977 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 665424) website on 21 Feb 2017. This report refers to a 42 year old female patient. Historical condition included anemia iron deficiency and slow transit constipation. Current condition included fibroids and was reported that patient had no current illness. Concomitant medications were not reported. The patient was vaccinated with first dose of FLUVIRIN (batch number: 169402) intramuscularly into left arm on 04 Nov 2016. The patient was also vaccinated with PREVNAR 13 (other manufacturer, batch number: M79320) intramuscularly into right arm on 04 Nov 2016. On the same day after vaccination at 08:00 PM, patient experienced mild pain and swelling at injection site. On 05 Nov 2016 at 03:00 AM (reported as next day), the patient woke up with 10/10 pain scale and fever of 102.2 Fahrenheit (normal range not reported). On 05 Nov 2016, the body temperature of the patient reached to a maximum of 104 Fahrenheit (normal range not reported). Following the events patient visited emergency room on an unknown date. It was reported that patient was treated with ibuprofen and Acetaminophen with good effect. On 05 Nov 2016, the patient had abdominal cramping. It was reported that the fever and abdominal cramping resolved on 05 Nov 2016 while there was a continuous swelling and pain as of 07 Nov 2016. The patient had been ordered for complete blood count (CBC) and the blood culture tests (results unspecified). The final outcome of the events fever and abdominal cramping was reported as complete recovery on 05 Nov 2016, for the events injection site swelling, injection site pain and pain was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the events pain and pyrexia (medically significant) was upgraded based on CTCAE (grade 3).
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Facial paralysis, Paraesthesia, Swelling face
Clinical narrative: Case number PHHY2017US030404 is an initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting system (VAERS number: 665896) website on 21 Feb 2017. This report refers to 40 year male patient. Medical history included no known allergies and diet controlled hyperlipidemia. The patient was vaccinated with FLUVIRIN (batch number: 168604) at a dose of 2 ml into left arm on 01 Nov 2016. On the same after getting vaccine, Patient began to notice swelling and tingling sensation to right side of face. On 08 Nov 2016 patient made an appointment to see doctor (emergency visit). His doctor diagnosed him with Bell's palsy related to vaccine. The outcome of the events was complete recovery on an unknown date, seriousness of the events was non serious. Causality of the events was reported as suspected (related  to  vaccine). Seriousness assessment of the event facial paralysis was upgraded to (medically significant) based on information available in the NVS IME list.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Case number PHHY2017US014660, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 665901) website on 23 Jan 2017. This report refers to a 57 years old female patient. Past medical history was not reported. Current condition included sulfa allergy. Concomitant medications included clobetasol, levothyroxine, methylprednisolone, triamcinolone acetonide, Vitamin D3, Co Q10, Krill oil, MV and calcium. The patient was vaccinated with FLUVIRIN (batch number: 1619521) intramuscularly into right arm on 02 Nov 2016. On the same day after vaccination, the patient experienced allergic reaction from Flu vaccine and hives. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported. The seriousness assessment of the events hypersensitivity and urticaria was upgraded (medically significant) based on the information available in the source document.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Eyelid oedema, Headache, Malaise
Clinical narrative: Case number PHHY2017US028573, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 666232) on 21 Feb 2017. This report refers to a 9 years old male patient. Historical condition was not reported. Current condition included asthma. Concomitant medications included QVAR and Albuterol. The patient was vaccinated with FLUVIRIN (batch number: 1620401) intramuscularly into the right arm on 14 Nov 2016. On same day after vaccination, the patient experienced headache at 05:00 PM and was given MOTRIN and he kept saying he did not feel well, MOTRIN did not help his headache. At 7:00 PM, the patient's eyes started looking puffy and was given 25 mg of BENADRYL. At 7:15 PM the patient's eyes swelled shut and his face was swollen, had a difficult to breathe and his chest hurt. The patient was given Albuterol nebulizer and he was taken to the emergency room at 7:30 PM. Between 7:30 PM and 7:45 PM, the patient's facial swelling started to go down and his breathing became easier. The patient complained of chest pain for approximately 2 hours. While at the emergency room, the patient was given a double dose of steroids and the swelling came down to about 25 percent and the patient was discharged with instructions to continue BENADRYL every 6 hours for swelling, nebulizers for breathing difficulty and continue steroids at home. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the events eye swelling, swelling face, chest pain and difficulty breathing was upgraded (medically significant) based on information available in the source document.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Case number PHHY2017US028573, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 666232) on 21 Feb 2017. This report refers to a 9 years old male patient. Historical condition was not reported. Current condition included asthma. Concomitant medications included QVAR and Albuterol. The patient was vaccinated with FLUVIRIN (batch number: 1620401) intramuscularly into the right arm on 14 Nov 2016. On same day after vaccination, the patient experienced headache at 05:00 PM and was given MOTRIN and he kept saying he did not feel well, MOTRIN did not help his headache. At 7:00 PM, the patient's eyes started looking puffy and was given 25 mg of BENADRYL. At 7:15 PM the patient's eyes swelled shut and his face was swollen, had a difficult to breathe and his chest hurt. The patient was given Albuterol nebulizer and he was taken to the emergency room at 7:30 PM. Between 7:30 PM and 7:45 PM, the patient's facial swelling started to go down and his breathing became easier. The patient complained of chest pain for approximately 2 hours. While at the emergency room, the patient was given a double dose of steroids and the swelling came down to about 25 percent and the patient was discharged with instructions to continue BENADRYL every 6 hours for swelling, nebulizers for breathing difficulty and continue steroids at home. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the events eye swelling, swelling face, chest pain and difficulty breathing was upgraded (medically significant) based on information available in the source document.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Case number PHHY2017US031308 is initial spontaneous report received from other healthcare professional via Vaccine Adverse Event Reporting System (VAERS number: 667603) website on 21 Feb 2017. This report refers to 69 year old female patient. Historical drug included E-mycin and sulfa. Medical history was not reported, concurrent condition included multivitamin and simvastatin. The patient was vaccinated with FLUVIRIN (batch number: 1619601) intramuscular into left arm on 20 Sep 2016. On the same day, after receiving vaccination within hour she experienced rash on arms, legs and neck. On 21 Sep 2016 she had visited office (see ambulatory care) doctor prescribed MEDROL DOSE PAK and 1.0 ml injection of DEPO-MEDROL. On 26 Sep 2016 her rash was spreading, she was treated with prednisone 5 mg 3 tabs once daily. On 03 Oct 2016 she had visited office still had rash again; 20 Oct 2016 her rash was improving. The final outcome of the event rash was complete recovery on an unknown date, seriousness of the event was reported as non serious and causality of the event was not reported. Seriousness assessment of the event rash generalized was upgraded to (medically significant) based on information available in the source document.
Age: 59.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: Case number PHHY2017US030236 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference  number: 668171) website on 21 Feb 2017. This report refers to a 59 year old female patient. Medical history was reported as none. Concomitant medications included SYNTHROID. The patient was vaccinated with FLUVIRIN (batch number: 1618621) intramuscularly into left arm on 23 Oct 2016. The patient was also vaccinated with ZOSTAVAX (other manufacturer, batch number: M019646) subcutaneously into left arm on 23 Oct 2016. After vaccination, patient developed vesicular rash that started all over the patient's body. It was reported that the patient had noticed it in the morning of 30 Oct 2016 and that it had already begun to resolve. It was reported that the rash was on her entire legs, back, stomach and arms. The lab data of the patient was reported as none. The final outcome of the events was reported as condition improving (already begun to resolve). The events were assessed as non serious by the reporter and causality was not reported. Seriousness assessment of the events rash generalized and rash vesicular (medically significant) was upgraded based on the information available in the source document.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Case number PHHY2017US030032, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 668505) website on 21 Feb 2017. This report refers to a 30 years old female patient. Historical condition included sleep apnea. Current conditions included epilepsy and asthma. Concomitant medications included ADVIL, SINGULAIR, BREO ELLIPTA, levocetirizine, Albuterol and BENADRYL. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly into the right arm on 28 Nov 2016. After vaccination, within 60 seconds, her heart started racing and her breathing became mildly labored. She had to go home and take a nebulizer treatment to reduce symptoms. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported. The seriousness assessment of the event dyspnoea was upgraded (medically significant) based on the information available in the source document.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal discomfort, Nodule, Pain
Clinical narrative: Case number PHHY2017US034251, is an initial spontaneous report received from a health care professional via vaccine adverse event reporting system (VAERS: 669614) on 21 Feb 2017. This report refers to a 57 years old female patient. Medical history was reported as none. Concomitant medications included metoprolol, Vit D and fish oil. The patient was vaccinated with FLUVIRIN (lot number: 1619301) into the left upper arm on 16 Nov 2016. After vaccination, over an hour later, she started feeling the pain. The pain did not go away after a week. The patient took pain medicines and warm compression on the site but there was no relief post 2 weeks. She felt a knot on the left arm and complained of muscles like being pulled. The Pain scale was 7/10. Outcome of the events was reported as condition unchanged and seriousness was reported as non serious. The causality of the events was not reported. Seriousness assessment of the event vaccination site pain was upgraded to serious (medically significant) based on the information available in the source document. Following an internal review of the data received on 21 Feb 2017, the following changes were done: Concomitant medication coding changed (concomitant drug metoprolol coding changed from metoprolol morphine to metoprolol) and events coding changed (events pain and nodule coding changed from pain and nodule to vaccination site pain and vaccination site nodule).
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Chills, Cold sweat, Pain, Tremor
Clinical narrative: Case number PHHY2017US016051, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 670738) on 23 Jan 2017. This report refers to a 30 years old female patient. Medical history was not reported. Past medications included morphine, related sulfa antibiotics and tetracyclines. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 169402) intramuscularly into left arm on 01 Dec 2016. On same day after vaccination, the patient experienced chills and body aches. Next day, on 02 Dec 2016, the patient threw up without warning, had some chest burning, feeling clammy and shaky. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the event chest pain was upgraded to medically significant based on the information available in the source document.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Case number PHHY2017US016051, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 670738) on 23 Jan 2017. This report refers to a 30 years old female patient. Medical history was not reported. Past medications included morphine, related sulfa antibiotics and tetracyclines. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 169402) intramuscularly into left arm on 01 Dec 2016. On same day after vaccination, the patient experienced chills and body aches. Next day, on 02 Dec 2016, the patient threw up without warning, had some chest burning, feeling clammy and shaky. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the event chest pain was upgraded to medically significant based on the information available in the source document.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Case number PHEH2016US032704, is an initial spontaneous report from a pharmacist received on 12 Dec 2016. This report refers to a 55 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1620401 and expiry date: May 2017) at a dose of 0.5 ml, intramuscularly on 10 Oct 2016. On the same day after vaccination, the patient experienced arm pain in the arm where the vaccine was administered. The pain began after the vaccine and has not decreased since then. No redness or tenderness to touch but the arm hurts when arm was lifted, left arm pain upon lifting on 10 Oct 2016. The patient did see a physician once since the problem has started. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as serious. The causality of the events was not reported.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Ageusia, Facial paralysis, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous case, initially received on 05-May-2017, which was reported by an other-non health professional via Regulatory Authority (VAERS ID: 683407) and concerns a 44 years old adult female patient. Patient's historical medication include labetalol, erythromycin and lisinopril  for  an  unknown  indication. Concomitant medications included NORVASC, LEXAPRO, SAXENDA, AMBIEN, triamterene and amitriptyline  for  an  unknown  indication. Administration of company suspect drug: On 14-Feb-2017, the patient was administered with influenza vaccine (route of administration: intramuscular, anatomical location: left arm, dose, batch no, expiry date: not reported). Adverse reactions/events and outcomes: On 20-Feb-2017, patient experienced facial paralysis. It was reported that the symptoms began on previous Friday with loss of taste. Action taken with the influenza vaccine was not reported. Outcome of the event was not recovered/ not resolved. Relevant test included MRI (nuclear magnetic resonance imaging) on an unspecified date and result was not provided. Reporter's Assessment: The other-non health professional did not provide any causality assessment between INN Flu Vaccine Seasonal and events. The event facial paralysis was considered as serious (medically significant) as IME list. This case was serious (medically significant).
Sex: M
Vaccine: FLU3
Symptoms: Paralysis
Clinical narrative: This spontaneous case, initially received via health authority (VAERS ID: 686782) on 15-Jun-2017 and concerns a adult male patient. The patient had no current illness and had no medical history. The patient's concomitant medication included Metformin, VICTOZA, Omeprazole, COZAAR, Simvastatin, Aspirin 81 for unknown indication. On 07-Dec-2016, patient was administered with FLUVIRIN (reported as AFLURIA QUADRIVALENT) batch number: 1620301, route of administration and site: unknown, dose, anatomical location, indication: not reported). On 20-Dec-2016, after 13 days of vaccination, the patient got paralyzed from the waist down. On an unknown date, the patient was hospitalized for the event. It was reported that the patient was hospitalized for 7 days. The patient did not recover from the event. The reporter did not provide the causality assessment between event and suspect product. The health authority assessed the event as serious (hospitalisation and disability).
Sex: F
Vaccine: FLUX
Symptoms: Facial paralysis
Clinical narrative: This initial spontaneous case, was received on 10-Jul-2017 and reported via health authority (VAERS: 691625) concerning a female patient of unspecified age. The patient's current condition included asthma. The patient had no relevant concomitant medications. On an unspecified date, the patient was vaccinated with the influenza vaccine (dose, anatomical location, route of administration, batch number, expiry date, trade name, manufacture name: not reported). On an unspecified date, between 1 and 14 days after vaccination with unspecified inactivated influenza vaccine, the patient developed Bell's Palsy. Treatment was unknown. The outcome of the event was not reported. Reporter's comment: The health authority assessed the report as serious (medically significant). The reporter did not comment on the relationship between the event and unspecified inactivated influenza vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Facial paralysis
Clinical narrative: This serious initial spontaneous case, was received from pharmacist via health authority (VAERS ID: 693976) on Jul-2017, concerning a female patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, following the vaccination, the patient developed Bell's palsy. At the time of report, outcome of the event was not reported. Reporter's comments: Reporter considered Bell's palsy was suspected in this case after vaccination with Influenza Vaccine of unknown manufacturer. However, diagnosis was not confirmed. Time to onset was unknown. Additional information on investigation results ruling out a concurrent infection and exploration of alternate etiologies, name of vaccine administered, time to onset and patient's history of reaction after previous vaccinations were needed further to assess this case. Based on the information, role of vaccine could not be assessed. Health authority considered this report as serious (medically significant).
Age: 36.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Fatigue, Feeling abnormal, Vertigo
Clinical narrative: This initial spontaneous case, was received from other non-health professional via health authority (VAERS ID: 695844) on 09-Aug-2017, concerning a 36-year-old adult male patient. At the age of 34 years and in an unspecified age, the patient received INN flu vaccine and experienced vertigo, fatigue, light-headedness in both occasions. It was reported that, the patient was on no other medications and had no any medical problems at the time of vaccination. On 21-Apr-2017, the patient received third consecutive INN Flu Vaccine (anatomical location: right arm, route of administration: intramuscular, dose, batch number, trade name, manufacturer was not reported). On 15-May-2017, 25 days, after vaccination, the patient experienced vertigo, light-headedness, fatigue and a general mentally foggy feeling. It was reported that, in all three episodes, the events occurred at about 3 weeks of vaccination. At the time of this report, the outcome of the events vertigo, feeling abnormal, dizziness and fatigue was not reported. The health authority considered the report as non-serious. Significant case correction received on 24-Aug-2017: As determined causality of the events (vertigo, feeling abnormal, dizziness and fatigue) was corrected from unassessable to related.
Age: 77.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Asthenia, Bone pain, Fatigue, Injected limb mobility decreased, Injection site pain
Clinical narrative: This initial spontaneous case, was received on 09-Aug-2017 from other non-health professional via health authority (VAERS ID: 696503), concerning a 77-year-old, elderly, female patient. The patient had no relevant medical history. The patient's concomitant medication included lisinopril and simvastatin for unknown indication. On 27-Oct-2016, the patient was administered with Influenza virus vaccine polyvalent, dose: (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient was also administered with PREVNAR 13 (dose: (reported as 1), route of administration: intramuscular, anatomical location: right arm, manufacturer: Pfizer\Wyeth, batch number, expiry date: not reported). On 03-Nov-2016, after vaccination, the patient experienced continuous pain in shoulder where shot was given. The patient did not experience any redness or swelling, but felt deep bone and muscle ache, and pain in rotating and moving arm/shoulder. On an unspecified date, after 4 weeks the patient was prompted to call the clinic and advised that these are common side effects and to take ibuprofen or TYLENOL if the events continued. On an unspecified date in Nov-2016, the patient also consulted the doctor in clinic, examined by a physician, and underwent X-ray for 3 times where abnormalities were not found. The physician advised to continue with the pain medication. The symptoms had for 7 months and pain continued, waked her up at night if she slept on the arm and limited to use of it. The patient had pain for normal activities and she stated that the pain was like a deep-seated toothache and some time it event sharpens. As the patient did not like to take pain medication, she takes only when she can't sleep or if activities have over-stressed on her shoulder. Even though, there was no external indication for the cause of the events, still she was effected with her activities. The patient felt fatigue and loss of energy to do normal work. The patient should change her way to sleep at night by covering the shoulder with shirt or jacket. It was reported that the patient was very healthier, active and tried to not let these events major factors in her life but as many got worsened which made her bother. At the time of this report, the patient had not recovered from the events. The health authority assessed this case as non-serious. Significant case correction received on 05-Sep-2017: 'As determined' causality of the events bone pain, shoulder pain, nocturnal awakening, pain, activities of daily living impaired, pain in arm, injected limb mobility decreased, muscle ache and injection site pain was corrected from related to unassessable. The listedness of the event fatigue was corrected from listed to unlisted in EU SPC flu vaccine egg split CSL.
Age: 77.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site reaction, Loss of personal independence in daily activities, Sleep disorder, X-ray normal
Clinical narrative: This initial spontaneous case, was received on 09-Aug-2017 from other non-health professional via health authority (VAERS ID: 696503), concerning a 77-year-old, elderly, female patient. The patient had no relevant medical history. The patient's concomitant medication included lisinopril and simvastatin for unknown indication. On 27-Oct-2016, the patient was administered with Influenza virus vaccine polyvalent, dose: (reported as 1), route of administration: intramuscular, anatomical location: left arm, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient was also administered with PREVNAR 13 (dose: (reported as 1), route of administration: intramuscular, anatomical location: right arm, manufacturer: Pfizer\Wyeth, batch number, expiry date: not reported). On 03-Nov-2016, after vaccination, the patient experienced continuous pain in shoulder where shot was given. The patient did not experience any redness or swelling, but felt deep bone and muscle ache, and pain in rotating and moving arm/shoulder. On an unspecified date, after 4 weeks the patient was prompted to call the clinic and advised that these are common side effects and to take ibuprofen or TYLENOL if the events continued. On an unspecified date in Nov-2016, the patient also consulted the doctor in clinic, examined by a physician, and underwent X-ray for 3 times where abnormalities were not found. The physician advised to continue with the pain medication. The symptoms had for 7 months and pain continued, waked her up at night if she slept on the arm and limited to use of it. The patient had pain for normal activities and she stated that the pain was like a deep-seated toothache and some time it event sharpens. As the patient did not like to take pain medication, she takes only when she can't sleep or if activities have over-stressed on her shoulder. Even though, there was no external indication for the cause of the events, still she was effected with her activities. The patient felt fatigue and loss of energy to do normal work. The patient should change her way to sleep at night by covering the shoulder with shirt or jacket. It was reported that the patient was very healthier, active and tried to not let these events major factors in her life but as many got worsened which made her bother. At the time of this report, the patient had not recovered from the events. The health authority assessed this case as non-serious. Significant case correction received on 05-Sep-2017: 'As determined' causality of the events bone pain, shoulder pain, nocturnal awakening, pain, activities of daily living impaired, pain in arm, injected limb mobility decreased, muscle ache and injection site pain was corrected from related to unassessable. The listedness of the event fatigue was corrected from listed to unlisted in EU SPC flu vaccine egg split CSL.
Age: 14.0
Sex: M
Vaccine: FLUX, HPV4
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Malaise, Mental impairment
Clinical narrative: This initial spontaneous case, was received on 09-Aug2017, from other non-health professional via health authority (VAERS ID: 698117) concerning a 14-year-old, adolescent, male patient. The patient was allergic to cat/dog dander, dust mites, peanuts and oysters. On 21-Oct-2011, the patent was administered with influenza virus vaccine polyvalent, dose, route of administration: SYR (as reported), anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day (at same time: as reported), the patient was administered with GARDASIL (co-suspect, dose, route of administration, anatomical location, batch number, expiry date: not reported). On 27-Dec-2011, after 2 months 7 days of vaccination, the patient experienced fatigue, unrestful sleep and chronic fatigue. The patient had trouble in concentrating, thinking and had brain fog. The patient felt unwell and rested. The outcome of the events was not reported. The health authority assessed the events as non-serious. Significant follow-up received on 24-Aug-2017: The listedness of the events fatigue and mental impairment were corrected.
Age: 14.0
Sex: M
Vaccine: FLUX, HPV4
Symptoms: Poor quality sleep
Clinical narrative: This initial spontaneous case, was received on 09-Aug2017, from other non-health professional via health authority (VAERS ID: 698117) concerning a 14-year-old, adolescent, male patient. The patient was allergic to cat/dog dander, dust mites, peanuts and oysters. On 21-Oct-2011, the patent was administered with influenza virus vaccine polyvalent, dose, route of administration: SYR (as reported), anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day (at same time: as reported), the patient was administered with GARDASIL (co-suspect, dose, route of administration, anatomical location, batch number, expiry date: not reported). On 27-Dec-2011, after 2 months 7 days of vaccination, the patient experienced fatigue, unrestful sleep and chronic fatigue. The patient had trouble in concentrating, thinking and had brain fog. The patient felt unwell and rested. The outcome of the events was not reported. The health authority assessed the events as non-serious. Significant follow-up received on 24-Aug-2017: The listedness of the events fatigue and mental impairment were corrected.
Age: 61.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Back pain, Biopsy muscle, Blood pressure increased, Blood test, Computerised tomogram
Clinical narrative: This initial spontaneous case, was received on 09-Aug-2017, from other non-health professional via health authority  (VAERS ID: 698288), concerning a 61-year-old, adult, female patient. The patient had no relevant medical history. The patient's concomitant medication included Multivitamin, Probiotic, Flaxseed oil capsule, levothyroxine and metronidazole. On 07-Nov-2016, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient was also administered with PREVNAR 13 (manufacturer: Pfizer/Wyeth, dose, route of administration, anatomical location, batch number, expiry date: not reported). On 22-Nov-2016, 4 months 12 days after vaccination, the patient experienced sensation of exaggerated cold sensitivity in fingers. On 05-Dec-2016, 4 months 25 days after vaccination, the patient noted numbness and tingling in fingers which was spread to feet, tongue, lips and face. On the next day, the patient experienced severe back pain. On 12-Dec-2016, 5 months 2 days after vaccination, the patient's blood pressure got elevated, all the movements were limited and her legs were very weak. On 25-Jan-2017, the patient underwent X-ray, CT (computed tomography) scan, blood work, spinal tap returned for muscle biopsy (outpatient). It was reported that the symptoms started to subside since 17-Feb-2017.
Age: 61.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Lumbar puncture, Mobility decreased, Muscular weakness
Clinical narrative: This initial spontaneous case, was received on 09-Aug-2017, from other non-health professional via health authority  (VAERS ID: 698288), concerning a 61-year-old, adult, female patient. The patient had no relevant medical history. The patient's concomitant medication included Multivitamin, Probiotic, Flaxseed oil capsule, levothyroxine and metronidazole. On 07-Nov-2016, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient was also administered with PREVNAR 13 (manufacturer: Pfizer/Wyeth, dose, route of administration, anatomical location, batch number, expiry date: not reported). On 22-Nov-2016, 4 months 12 days after vaccination, the patient experienced sensation of exaggerated cold sensitivity in fingers. On 05-Dec-2016, 4 months 25 days after vaccination, the patient noted numbness and tingling in fingers which was spread to feet, tongue, lips and face. On the next day, the patient experienced severe back pain. On 12-Dec-2016, 5 months 2 days after vaccination, the patient's blood pressure got elevated, all the movements were limited and her legs were very weak. On 25-Jan-2017, the patient underwent X-ray, CT (computed tomography) scan, blood work, spinal tap returned for muscle biopsy (outpatient). It was reported that the symptoms started to subside since 17-Feb-2017.
Age: 61.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Paraesthesia, Paraesthesia oral, Peripheral coldness, X-ray
Clinical narrative: This initial spontaneous case, was received on 09-Aug-2017, from other non-health professional via health authority  (VAERS ID: 698288), concerning a 61-year-old, adult, female patient. The patient had no relevant medical history. The patient's concomitant medication included Multivitamin, Probiotic, Flaxseed oil capsule, levothyroxine and metronidazole. On 07-Nov-2016, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On the same day, the patient was also administered with PREVNAR 13 (manufacturer: Pfizer/Wyeth, dose, route of administration, anatomical location, batch number, expiry date: not reported). On 22-Nov-2016, 4 months 12 days after vaccination, the patient experienced sensation of exaggerated cold sensitivity in fingers. On 05-Dec-2016, 4 months 25 days after vaccination, the patient noted numbness and tingling in fingers which was spread to feet, tongue, lips and face. On the next day, the patient experienced severe back pain. On 12-Dec-2016, 5 months 2 days after vaccination, the patient's blood pressure got elevated, all the movements were limited and her legs were very weak. On 25-Jan-2017, the patient underwent X-ray, CT (computed tomography) scan, blood work, spinal tap returned for muscle biopsy (outpatient). It was reported that the symptoms started to subside since 17-Feb-2017.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Asthenia, Blood culture negative, Blood electrolytes normal, Breath holding, Chills
Clinical narrative: Patient is a 15-month-old female in her usual state of health until Wednesday, 06/21 when she had her immunizations from her primary care physician. At that point the primary care physician's office did a rapid strep test that was positive after Mother reported that the child attended daycare. She was given a prescription for ZITHROMAX which she took for the next 5 days. On 06/21 she had 4 vaccinations that mother reports to me were Haemophilus influenzae, PREVNAR, MMR and diphtheria, tetanus, acellular pertussis. She was crying during the vaccinations and very upset. A few minutes after the shots her eyes rolled back, she turned bright red, held her breath, and had convulsions. Mother felt sure it was a seizure and the primary care physician staff thought it was a breath holding spell. From Wednesday, 06/21 to Saturday, 06/24 patient had less energy and was a little confused at times but no further activity that looked like seizures. On Saturday, 06/24 patient had a fever of 101.9 treated with MOTRIN. The next day it was 99 and she was acting more like herself with improved appetite and she was more playful. Mother took her back to daycare on 06/26 but that afternoon at 3:30 she was called with shaking chills and a fever of 102. Mother picked her up, and they took her to the primary care physician where she was referred to the emergency room. Here, she had a blood culture and urine culture done that were negative as well as CBC and electrolytes. She was discharged that evening from the emergency department. Throughout the week she had persistent fever. Her fluid intake has been poor. She was fussy and uncomfortable. She has not been walking since Wednesday, 06/28. Her fever has been as high as 104 degrees and she was taken to the urgent care center last night, then back to the emergency room, and now admitted to the Infectious Diseases Service.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Confusional state, Crying, Culture urine negative, Discomfort, Emotional distress
Clinical narrative: Patient is a 15-month-old female in her usual state of health until Wednesday, 06/21 when she had her immunizations from her primary care physician. At that point the primary care physician's office did a rapid strep test that was positive after Mother reported that the child attended daycare. She was given a prescription for ZITHROMAX which she took for the next 5 days. On 06/21 she had 4 vaccinations that mother reports to me were Haemophilus influenzae, PREVNAR, MMR and diphtheria, tetanus, acellular pertussis. She was crying during the vaccinations and very upset. A few minutes after the shots her eyes rolled back, she turned bright red, held her breath, and had convulsions. Mother felt sure it was a seizure and the primary care physician staff thought it was a breath holding spell. From Wednesday, 06/21 to Saturday, 06/24 patient had less energy and was a little confused at times but no further activity that looked like seizures. On Saturday, 06/24 patient had a fever of 101.9 treated with MOTRIN. The next day it was 99 and she was acting more like herself with improved appetite and she was more playful. Mother took her back to daycare on 06/26 but that afternoon at 3:30 she was called with shaking chills and a fever of 102. Mother picked her up, and they took her to the primary care physician where she was referred to the emergency room. Here, she had a blood culture and urine culture done that were negative as well as CBC and electrolytes. She was discharged that evening from the emergency department. Throughout the week she had persistent fever. Her fluid intake has been poor. She was fussy and uncomfortable. She has not been walking since Wednesday, 06/28. Her fever has been as high as 104 degrees and she was taken to the urgent care center last night, then back to the emergency room, and now admitted to the Infectious Diseases Service.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Erythema, Eye movement disorder, Fluid intake reduced, Full blood count normal, Gait inability
Clinical narrative: Patient is a 15-month-old female in her usual state of health until Wednesday, 06/21 when she had her immunizations from her primary care physician. At that point the primary care physician's office did a rapid strep test that was positive after Mother reported that the child attended daycare. She was given a prescription for ZITHROMAX which she took for the next 5 days. On 06/21 she had 4 vaccinations that mother reports to me were Haemophilus influenzae, PREVNAR, MMR and diphtheria, tetanus, acellular pertussis. She was crying during the vaccinations and very upset. A few minutes after the shots her eyes rolled back, she turned bright red, held her breath, and had convulsions. Mother felt sure it was a seizure and the primary care physician staff thought it was a breath holding spell. From Wednesday, 06/21 to Saturday, 06/24 patient had less energy and was a little confused at times but no further activity that looked like seizures. On Saturday, 06/24 patient had a fever of 101.9 treated with MOTRIN. The next day it was 99 and she was acting more like herself with improved appetite and she was more playful. Mother took her back to daycare on 06/26 but that afternoon at 3:30 she was called with shaking chills and a fever of 102. Mother picked her up, and they took her to the primary care physician where she was referred to the emergency room. Here, she had a blood culture and urine culture done that were negative as well as CBC and electrolytes. She was discharged that evening from the emergency department. Throughout the week she had persistent fever. Her fluid intake has been poor. She was fussy and uncomfortable. She has not been walking since Wednesday, 06/28. Her fever has been as high as 104 degrees and she was taken to the urgent care center last night, then back to the emergency room, and now admitted to the Infectious Diseases Service.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Irritability, Nuclear magnetic resonance imaging brain, Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: Patient is a 15-month-old female in her usual state of health until Wednesday, 06/21 when she had her immunizations from her primary care physician. At that point the primary care physician's office did a rapid strep test that was positive after Mother reported that the child attended daycare. She was given a prescription for ZITHROMAX which she took for the next 5 days. On 06/21 she had 4 vaccinations that mother reports to me were Haemophilus influenzae, PREVNAR, MMR and diphtheria, tetanus, acellular pertussis. She was crying during the vaccinations and very upset. A few minutes after the shots her eyes rolled back, she turned bright red, held her breath, and had convulsions. Mother felt sure it was a seizure and the primary care physician staff thought it was a breath holding spell. From Wednesday, 06/21 to Saturday, 06/24 patient had less energy and was a little confused at times but no further activity that looked like seizures. On Saturday, 06/24 patient had a fever of 101.9 treated with MOTRIN. The next day it was 99 and she was acting more like herself with improved appetite and she was more playful. Mother took her back to daycare on 06/26 but that afternoon at 3:30 she was called with shaking chills and a fever of 102. Mother picked her up, and they took her to the primary care physician where she was referred to the emergency room. Here, she had a blood culture and urine culture done that were negative as well as CBC and electrolytes. She was discharged that evening from the emergency department. Throughout the week she had persistent fever. Her fluid intake has been poor. She was fussy and uncomfortable. She has not been walking since Wednesday, 06/28. Her fever has been as high as 104 degrees and she was taken to the urgent care center last night, then back to the emergency room, and now admitted to the Infectious Diseases Service.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC13
Symptoms: Seizure, Streptococcus test positive, Viral rash
Clinical narrative: Patient is a 15-month-old female in her usual state of health until Wednesday, 06/21 when she had her immunizations from her primary care physician. At that point the primary care physician's office did a rapid strep test that was positive after Mother reported that the child attended daycare. She was given a prescription for ZITHROMAX which she took for the next 5 days. On 06/21 she had 4 vaccinations that mother reports to me were Haemophilus influenzae, PREVNAR, MMR and diphtheria, tetanus, acellular pertussis. She was crying during the vaccinations and very upset. A few minutes after the shots her eyes rolled back, she turned bright red, held her breath, and had convulsions. Mother felt sure it was a seizure and the primary care physician staff thought it was a breath holding spell. From Wednesday, 06/21 to Saturday, 06/24 patient had less energy and was a little confused at times but no further activity that looked like seizures. On Saturday, 06/24 patient had a fever of 101.9 treated with MOTRIN. The next day it was 99 and she was acting more like herself with improved appetite and she was more playful. Mother took her back to daycare on 06/26 but that afternoon at 3:30 she was called with shaking chills and a fever of 102. Mother picked her up, and they took her to the primary care physician where she was referred to the emergency room. Here, she had a blood culture and urine culture done that were negative as well as CBC and electrolytes. She was discharged that evening from the emergency department. Throughout the week she had persistent fever. Her fluid intake has been poor. She was fussy and uncomfortable. She has not been walking since Wednesday, 06/28. Her fever has been as high as 104 degrees and she was taken to the urgent care center last night, then back to the emergency room, and now admitted to the Infectious Diseases Service.