chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Myalgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Monday evening:  Initially, pain and swelling at injection site, followed, within 30 minutes, by severe pain and stiffness in entire arm.  Tingling in middle, index fingers and thumb.  Inability to move arm due to severe pain.  Unable to lie down.   Tuesday:  Pain still present, but I could move my fingers and hand, although tingling continued Sunday: ( 7 days later,) arm has improved, but I am still unable to raise arm forward or to the side.  Tingling/numbness in fingers continues.  Throbbing pain in shoulder and muscles around neck on left side.. Swelling is diminished only as of today.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Lethargy, Musculoskeletal disorder, Pain in extremity
Clinical narrative: In addition to a sore arm, patient reports legs would not work.  Patient had trouble walking.  Patient reports extreme lethargy on Friday, November 1st, 2019.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Headache, Loss of control of legs, Muscular weakness, Musculoskeletal disorder
Clinical narrative: In addition to a sore arm, patient reports legs would not work.  Patient had trouble walking.  Patient reports extreme lethargy on Friday, November 1st, 2019.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Paralysis, Speech disorder, Syncope
Clinical narrative: In addition to a sore arm, patient reports legs would not work.  Patient had trouble walking.  Patient reports extreme lethargy on Friday, November 1st, 2019.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Migraine
Clinical narrative: migraine > 48 hours
Age: 61.0
Sex: F
Vaccine: FLUR4
Symptoms: Cellulitis, Erythema, Full blood count, Injection site erythema, Metabolic function test normal
Clinical narrative: Patient received vaccine 10/28 at PCP office. She noted some redness near site of injection 10/29. It continued to get worse next several days.  She saw her PCP 11/1 and was started on antibiotic.  It continued to get worse, she came to ER 11/3. There was extensive erythema, swelling, pain to entire right arm, worse from just above the elbow, down to wrist area.  patient admitted for cellulitis and started on IV ancef.
Age: 61.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain in extremity, Peripheral swelling, White blood cell count increased
Clinical narrative: Patient received vaccine 10/28 at PCP office. She noted some redness near site of injection 10/29. It continued to get worse next several days.  She saw her PCP 11/1 and was started on antibiotic.  It continued to get worse, she came to ER 11/3. There was extensive erythema, swelling, pain to entire right arm, worse from just above the elbow, down to wrist area.  patient admitted for cellulitis and started on IV ancef.
Age: 0.92
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Her right arm around where the shot was administered became very red, swollen, and itchy.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Back pain, Headache, Sinus disorder
Clinical narrative: Severe back ache in the Kidney area on both sides. This pain lasted for 6 days. Headache and sinus type issues which lasted for 3-4 days.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site swelling, Pain in extremity, Paraesthesia
Clinical narrative: Pt first reported sx on Oct 15, 2019. Pt reported lingering pain in arm and tingling sensation in hand since receiving vaccinations. Pt also had raised bump at site of Shingles injection. Discussed OTC options and following up with PCP, but to my knowledge pt has not attempted to seek medical attention or treat symptoms. Pt returned approx 2 weeks later to pharmacy on Oct 28, 2019 to report that sx still persist, although have gotten better with time. Pt's suspected PCP contacted on 11/1/19 to report adverse event.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Aphasia, Dyspraxia, Hypersomnia
Clinical narrative: Our son was 1 years old at the time of this vaccine and he was hitting every milestone and a completely normal child, babbling and cooing and starting to talk. After the vaccine, he slept for an entire day and woke up and hasn't talked since. He has been seen by various doctors and specialists and now diagnosed with CAS - childhood apraxia of speech.
Age: 40.0
Sex: F
Vaccine: FLUR4
Symptoms: Hypoaesthesia, Injection site pain, Joint range of motion decreased, Magnetic resonance imaging, X-ray limb normal
Clinical narrative: Painful and decreased range of motion of right shoulder.  Numbness goes down right arm to fingers, mostly 4th and 5th fingers. Diclofenac 1% topical was prescribed. Patient was directed to use 2 mg, 4 times a day as needed for shoulder pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Asthma, Hypersensitivity, Tic, Wrong product administered
Clinical narrative: Nurse practitioner wrongly gave Kinrix as a catch up dose of DTaP and polio. Daughter is now having asthma and allergy symptoms daily as well as nervous tics. All new onset
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Biopsy muscle abnormal, Gait disturbance, Gait inability, Immunology test, Inflammatory marker test
Clinical narrative: About 9 months after receiving these vaccines, my son started having chronic joint and muscle pain in right thigh/groin area.  The pain was so debilitating, he was often unable to walk,  he would limp or crawl due to pain.  Almost a year later and after extensive testing,  a muscle biopsy revealed Macrophages and Aluminum crystals striated throughout my son?s right thigh muscle, in the same area her received his vaccines.  The biopsy results showed that my son has Macrophagic Myofasciitis (MMF),  caused by the aluminum in his 2017 DTaP vaccine.  He has chronic, debilitating pain that has spread throughout his body and now he also has pain in both legs, arms, feet and hands.  He?s been living with this pain for almost two years.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site joint pain, Injection site pain, Injection site reaction, Magnetic resonance imaging abnormal, Myofascitis
Clinical narrative: About 9 months after receiving these vaccines, my son started having chronic joint and muscle pain in right thigh/groin area.  The pain was so debilitating, he was often unable to walk,  he would limp or crawl due to pain.  Almost a year later and after extensive testing,  a muscle biopsy revealed Macrophages and Aluminum crystals striated throughout my son?s right thigh muscle, in the same area her received his vaccines.  The biopsy results showed that my son has Macrophagic Myofasciitis (MMF),  caused by the aluminum in his 2017 DTaP vaccine.  He has chronic, debilitating pain that has spread throughout his body and now he also has pain in both legs, arms, feet and hands.  He?s been living with this pain for almost two years.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Myositis, Pain, X-ray limb, X-ray of pelvis and hip
Clinical narrative: About 9 months after receiving these vaccines, my son started having chronic joint and muscle pain in right thigh/groin area.  The pain was so debilitating, he was often unable to walk,  he would limp or crawl due to pain.  Almost a year later and after extensive testing,  a muscle biopsy revealed Macrophages and Aluminum crystals striated throughout my son?s right thigh muscle, in the same area her received his vaccines.  The biopsy results showed that my son has Macrophagic Myofasciitis (MMF),  caused by the aluminum in his 2017 DTaP vaccine.  He has chronic, debilitating pain that has spread throughout his body and now he also has pain in both legs, arms, feet and hands.  He?s been living with this pain for almost two years.
Age: 41.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Extreme myalgia, diffuse swelling and erythema from upper left arm to left elbow nearly circumferential around left arm. Myalgia near injection site nearly resolved, erythema and swelling unimproved two days post vaccination with myalgia extending down inner left arm to left thumb and left pinky finger.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Detoxification, Discomfort, Fatigue
Clinical narrative: I received vaccine on 10/16/19 & by 10/24/19 not feeling well flu like symptoms, chills my hips were hurting the were aching & heavy & tight. Then the weekend went on a trip for weekend with mom & sisters alot of far walking. Pain started to radiate to legs, groin & knees took me a bit to get up & get moving. By Sat 10/26/19 not feeling well exhausted pain all thru legs could not sleep or relax, kept taking naproxen & flexeril & rub cream. Hot tub & heating pad. Went back to room & crawled in bed sevre pain legs. Hard to relax & enjoy my rest. Then we drove home Sunday 10/27/19. Hard to drive 8 hours, raining out & getting cooler out. Its now Thurs 10/31 & still have tightness & pain & stiff legs. Using furniture to brace myself to walk. Detoxing & flushing system with the oregano tumerica, I called CDC 10/31 they gave me to Vares & this form. Starting my new job Nov 3 & Im miserable I need to sleep & relax. I was instructed to fill out this form & return to clinic that gave me the Tdap & have them report it. The Director insisted on me being seen by their Dr. I was seen by Dr. He prescribed me a muscle relaxer & prednisone. I explained to him this pain in my legs was from my waist thighs knees & to my feet. Its tight & heavy & stiff & difficult to lift up my legs & walk I tried to stretch & do exercise to help stimulate my circulation to get this out of my system. Im using detox natural tumeric tea & lots of purified water. Today 11/2/19 - Some improvement as now the intense pain in stuck in both knees & down to feet. But still hard to lift my legs like doing steps getting up from toilet & getting in & out of car. I did not sleep at all 11/2/19 Dragging all day today. Did rest on couch, took hot bath & my meds.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Feeling abnormal, Groin pain, Impaired driving ability, Influenza like illness, Insomnia
Clinical narrative: I received vaccine on 10/16/19 & by 10/24/19 not feeling well flu like symptoms, chills my hips were hurting the were aching & heavy & tight. Then the weekend went on a trip for weekend with mom & sisters alot of far walking. Pain started to radiate to legs, groin & knees took me a bit to get up & get moving. By Sat 10/26/19 not feeling well exhausted pain all thru legs could not sleep or relax, kept taking naproxen & flexeril & rub cream. Hot tub & heating pad. Went back to room & crawled in bed sevre pain legs. Hard to relax & enjoy my rest. Then we drove home Sunday 10/27/19. Hard to drive 8 hours, raining out & getting cooler out. Its now Thurs 10/31 & still have tightness & pain & stiff legs. Using furniture to brace myself to walk. Detoxing & flushing system with the oregano tumerica, I called CDC 10/31 they gave me to Vares & this form. Starting my new job Nov 3 & Im miserable I need to sleep & relax. I was instructed to fill out this form & return to clinic that gave me the Tdap & have them report it. The Director insisted on me being seen by their Dr. I was seen by Dr. He prescribed me a muscle relaxer & prednisone. I explained to him this pain in my legs was from my waist thighs knees & to my feet. Its tight & heavy & stiff & difficult to lift up my legs & walk I tried to stretch & do exercise to help stimulate my circulation to get this out of my system. Im using detox natural tumeric tea & lots of purified water. Today 11/2/19 - Some improvement as now the intense pain in stuck in both knees & down to feet. But still hard to lift my legs like doing steps getting up from toilet & getting in & out of car. I did not sleep at all 11/2/19 Dragging all day today. Did rest on couch, took hot bath & my meds.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Joint stiffness, Malaise, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: I received vaccine on 10/16/19 & by 10/24/19 not feeling well flu like symptoms, chills my hips were hurting the were aching & heavy & tight. Then the weekend went on a trip for weekend with mom & sisters alot of far walking. Pain started to radiate to legs, groin & knees took me a bit to get up & get moving. By Sat 10/26/19 not feeling well exhausted pain all thru legs could not sleep or relax, kept taking naproxen & flexeril & rub cream. Hot tub & heating pad. Went back to room & crawled in bed sevre pain legs. Hard to relax & enjoy my rest. Then we drove home Sunday 10/27/19. Hard to drive 8 hours, raining out & getting cooler out. Its now Thurs 10/31 & still have tightness & pain & stiff legs. Using furniture to brace myself to walk. Detoxing & flushing system with the oregano tumerica, I called CDC 10/31 they gave me to Vares & this form. Starting my new job Nov 3 & Im miserable I need to sleep & relax. I was instructed to fill out this form & return to clinic that gave me the Tdap & have them report it. The Director insisted on me being seen by their Dr. I was seen by Dr. He prescribed me a muscle relaxer & prednisone. I explained to him this pain in my legs was from my waist thighs knees & to my feet. Its tight & heavy & stiff & difficult to lift up my legs & walk I tried to stretch & do exercise to help stimulate my circulation to get this out of my system. Im using detox natural tumeric tea & lots of purified water. Today 11/2/19 - Some improvement as now the intense pain in stuck in both knees & down to feet. But still hard to lift my legs like doing steps getting up from toilet & getting in & out of car. I did not sleep at all 11/2/19 Dragging all day today. Did rest on couch, took hot bath & my meds.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Restlessness, Walking aid user
Clinical narrative: I received vaccine on 10/16/19 & by 10/24/19 not feeling well flu like symptoms, chills my hips were hurting the were aching & heavy & tight. Then the weekend went on a trip for weekend with mom & sisters alot of far walking. Pain started to radiate to legs, groin & knees took me a bit to get up & get moving. By Sat 10/26/19 not feeling well exhausted pain all thru legs could not sleep or relax, kept taking naproxen & flexeril & rub cream. Hot tub & heating pad. Went back to room & crawled in bed sevre pain legs. Hard to relax & enjoy my rest. Then we drove home Sunday 10/27/19. Hard to drive 8 hours, raining out & getting cooler out. Its now Thurs 10/31 & still have tightness & pain & stiff legs. Using furniture to brace myself to walk. Detoxing & flushing system with the oregano tumerica, I called CDC 10/31 they gave me to Vares & this form. Starting my new job Nov 3 & Im miserable I need to sleep & relax. I was instructed to fill out this form & return to clinic that gave me the Tdap & have them report it. The Director insisted on me being seen by their Dr. I was seen by Dr. He prescribed me a muscle relaxer & prednisone. I explained to him this pain in my legs was from my waist thighs knees & to my feet. Its tight & heavy & stiff & difficult to lift up my legs & walk I tried to stretch & do exercise to help stimulate my circulation to get this out of my system. Im using detox natural tumeric tea & lots of purified water. Today 11/2/19 - Some improvement as now the intense pain in stuck in both knees & down to feet. But still hard to lift my legs like doing steps getting up from toilet & getting in & out of car. I did not sleep at all 11/2/19 Dragging all day today. Did rest on couch, took hot bath & my meds.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Eye movement disorder, Loss of consciousness, Seizure, Tremor
Clinical narrative: Approximately one minute after giving immunization patient began to show signs of dizziness, eyes rolled back into her head, began shaking as though she was having seizure and she became unconscious for approximately one minute. She became responsive and continued to shake. EMS arrived and checked her and reported normal BP and HR. Mother refused transport by EMS.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Adverse reaction, Chills, Pyrexia
Clinical narrative: Very bad reaction; High fever; Chills; This case was reported by a consumer and described the occurrence of adverse reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving Shingrix and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced adverse reaction, fever and chills. On an unknown date, the outcome of the adverse reaction, fever and chills were unknown.   It was unknown if the reporter considered the adverse reaction, fever and chills to be related to Shingrix and Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows: The age at vaccination was not reported. A year before the reporting date, the patient received 1st dose of Shingrix. At the same time, the patient received Flu shot. The patient had a very bad reaction, ended up in emergency room with.high fever and chills. The patient was reluctant to have second dose wondering if she missed the window on that anyway, and whether she get some coverage against shingles with the one dose.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Anti-thyroid antibody positive, Autoimmune thyroiditis, Disturbance in attention, Fatigue, Hand-foot-and-mouth disease
Clinical narrative: Her periods became random and varied appearing one month and then not again for two or three, sometimes four/diagnosed her with PCOS; Gained substantial weight and was exhausted most of the time/having a difficult time focusing on her school work/was susceptible to illness including the flu, hand foot and mouth and many colds/diagnosed her with Hashimoto's thyroiditis; This report was identified from a line listing obtained on request by the Company from the FDA under the Act (VAERS ID 804393) on 04-OCT-2019.   This spontaneous report was received from a patient's parent regarding an adolescent female patient. She did not have any concomitant therapies or allergies to medications, food or other products. The patient was in perfect health prior to the vaccination, she was a standout competitive swimmer and a 4.0 student.  On 23-MAR-2017, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) into arm (exact dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient was having a difficult time focusing on her school work and was susceptible to more and more illnesses including the flu, hand foot and mouth and many colds. On an unknown date in March 2018 (also reported as 11 months after the vaccine, discrepant information as "date and time adverse event started: 01-AUG-2017 (August 2017)"), her mother took her to an endocrinologist who diagnosed the patient with Hashimoto's thyroiditis with an anti-thyroid antibody (TPO) count of 586 (unit not provided). On an unknown date in August 2018, she gained substantial weight and was exhausted most of the time. On an unknown date, her periods also became random and varied, appearing one month and then not again for two or three, sometimes four. On an unknown date in December 2018 (also reported as 1.5 years after the vaccine, discrepant information as "date and time adverse event started: 01-AUG-2017 (August 2017)"), she was diagnosed with polycystic ovary syndrome (PCOS).  At the time of reporting, the patient did not recover from the events. The relatedness between the events and the suspect therapy was not reported.  The reporter considered the events to be disabling and causing permanent damage.  Follow up information has been received from the nurse coordinator on 29-OCT-2019.  It was reported that the nurse coordinator was unable to identify the patient referenced in the report. Patient identification information was not available.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Infection susceptibility increased, Influenza, Menstruation irregular, Nasopharyngitis, Polycystic ovaries
Clinical narrative: Her periods became random and varied appearing one month and then not again for two or three, sometimes four/diagnosed her with PCOS; Gained substantial weight and was exhausted most of the time/having a difficult time focusing on her school work/was susceptible to illness including the flu, hand foot and mouth and many colds/diagnosed her with Hashimoto's thyroiditis; This report was identified from a line listing obtained on request by the Company from the FDA under the Act (VAERS ID 804393) on 04-OCT-2019.   This spontaneous report was received from a patient's parent regarding an adolescent female patient. She did not have any concomitant therapies or allergies to medications, food or other products. The patient was in perfect health prior to the vaccination, she was a standout competitive swimmer and a 4.0 student.  On 23-MAR-2017, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) into arm (exact dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient was having a difficult time focusing on her school work and was susceptible to more and more illnesses including the flu, hand foot and mouth and many colds. On an unknown date in March 2018 (also reported as 11 months after the vaccine, discrepant information as "date and time adverse event started: 01-AUG-2017 (August 2017)"), her mother took her to an endocrinologist who diagnosed the patient with Hashimoto's thyroiditis with an anti-thyroid antibody (TPO) count of 586 (unit not provided). On an unknown date in August 2018, she gained substantial weight and was exhausted most of the time. On an unknown date, her periods also became random and varied, appearing one month and then not again for two or three, sometimes four. On an unknown date in December 2018 (also reported as 1.5 years after the vaccine, discrepant information as "date and time adverse event started: 01-AUG-2017 (August 2017)"), she was diagnosed with polycystic ovary syndrome (PCOS).  At the time of reporting, the patient did not recover from the events. The relatedness between the events and the suspect therapy was not reported.  The reporter considered the events to be disabling and causing permanent damage.  Follow up information has been received from the nurse coordinator on 29-OCT-2019.  It was reported that the nurse coordinator was unable to identify the patient referenced in the report. Patient identification information was not available.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Weight increased
Clinical narrative: Her periods became random and varied appearing one month and then not again for two or three, sometimes four/diagnosed her with PCOS; Gained substantial weight and was exhausted most of the time/having a difficult time focusing on her school work/was susceptible to illness including the flu, hand foot and mouth and many colds/diagnosed her with Hashimoto's thyroiditis; This report was identified from a line listing obtained on request by the Company from the FDA under the Act (VAERS ID 804393) on 04-OCT-2019.   This spontaneous report was received from a patient's parent regarding an adolescent female patient. She did not have any concomitant therapies or allergies to medications, food or other products. The patient was in perfect health prior to the vaccination, she was a standout competitive swimmer and a 4.0 student.  On 23-MAR-2017, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) into arm (exact dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient was having a difficult time focusing on her school work and was susceptible to more and more illnesses including the flu, hand foot and mouth and many colds. On an unknown date in March 2018 (also reported as 11 months after the vaccine, discrepant information as "date and time adverse event started: 01-AUG-2017 (August 2017)"), her mother took her to an endocrinologist who diagnosed the patient with Hashimoto's thyroiditis with an anti-thyroid antibody (TPO) count of 586 (unit not provided). On an unknown date in August 2018, she gained substantial weight and was exhausted most of the time. On an unknown date, her periods also became random and varied, appearing one month and then not again for two or three, sometimes four. On an unknown date in December 2018 (also reported as 1.5 years after the vaccine, discrepant information as "date and time adverse event started: 01-AUG-2017 (August 2017)"), she was diagnosed with polycystic ovary syndrome (PCOS).  At the time of reporting, the patient did not recover from the events. The relatedness between the events and the suspect therapy was not reported.  The reporter considered the events to be disabling and causing permanent damage.  Follow up information has been received from the nurse coordinator on 29-OCT-2019.  It was reported that the nurse coordinator was unable to identify the patient referenced in the report. Patient identification information was not available.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Anti-thyroid antibody positive, Autoimmune thyroiditis, Disease susceptibility, Disturbance in attention, Fatigue
Clinical narrative: Her periods became random and varied appearing one month and then not again for two or three, sometimes four/diagnosed her with PCOS; Gained substantial weight and was exhausted most of the time/having a difficult time focusing on her school work/was susceptible to illness including the flu, hand foot and mouth and many colds/diagnosed her with Hashimoto's thyroiditis; This report was identified from a line listing obtained on request by the Company from the FDA under the Act (VAERS ID 804393) on 04-OCT-2019.   This spontaneous report was received from a patient's parent regarding an adolescent female patient. She did not have any concomitant therapies or allergies to medications, food or other products. The patient was in perfect health prior to the vaccination, she was a standout competitive swimmer and a 4.0 student.  On 23-MAR-2017, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) into arm (exact dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient was having a difficult time focusing on her school work and was susceptible to more and more illnesses including the flu, hand foot and mouth and many colds. On an unknown date in March 2018 (also reported as 11 months after the vaccine, discrepant information as "date and time adverse event started: 01-AUG-2017 (August 2017)"), her mother took her to an endocrinologist who diagnosed the patient with Hashimoto's thyroiditis with an anti-thyroid antibody (TPO) count of 586 (unit not provided). On an unknown date in August 2018, she gained substantial weight and was exhausted most of the time. On an unknown date, her periods also became random and varied, appearing one month and then not again for two or three, sometimes four. On an unknown date in December 2018 (also reported as 1.5 years after the vaccine, discrepant information as "date and time adverse event started: 01-AUG-2017 (August 2017)"), she was diagnosed with polycystic ovary syndrome (PCOS).  At the time of reporting, the patient did not recover from the events. The relatedness between the events and the suspect therapy was not reported.  The reporter considered the events to be disabling and causing permanent damage.  Follow up information has been received from the nurse coordinator on 29-OCT-2019.  It was reported that the nurse coordinator was unable to identify the patient referenced in the report. Patient identification information was not available.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hand-foot-and-mouth disease, Influenza, Menstruation irregular, Nasopharyngitis, Polycystic ovaries
Clinical narrative: Her periods became random and varied appearing one month and then not again for two or three, sometimes four/diagnosed her with PCOS; Gained substantial weight and was exhausted most of the time/having a difficult time focusing on her school work/was susceptible to illness including the flu, hand foot and mouth and many colds/diagnosed her with Hashimoto's thyroiditis; This report was identified from a line listing obtained on request by the Company from the FDA under the Act (VAERS ID 804393) on 04-OCT-2019.   This spontaneous report was received from a patient's parent regarding an adolescent female patient. She did not have any concomitant therapies or allergies to medications, food or other products. The patient was in perfect health prior to the vaccination, she was a standout competitive swimmer and a 4.0 student.  On 23-MAR-2017, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) into arm (exact dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient was having a difficult time focusing on her school work and was susceptible to more and more illnesses including the flu, hand foot and mouth and many colds. On an unknown date in March 2018 (also reported as 11 months after the vaccine, discrepant information as "date and time adverse event started: 01-AUG-2017 (August 2017)"), her mother took her to an endocrinologist who diagnosed the patient with Hashimoto's thyroiditis with an anti-thyroid antibody (TPO) count of 586 (unit not provided). On an unknown date in August 2018, she gained substantial weight and was exhausted most of the time. On an unknown date, her periods also became random and varied, appearing one month and then not again for two or three, sometimes four. On an unknown date in December 2018 (also reported as 1.5 years after the vaccine, discrepant information as "date and time adverse event started: 01-AUG-2017 (August 2017)"), she was diagnosed with polycystic ovary syndrome (PCOS).  At the time of reporting, the patient did not recover from the events. The relatedness between the events and the suspect therapy was not reported.  The reporter considered the events to be disabling and causing permanent damage.  Follow up information has been received from the nurse coordinator on 29-OCT-2019.  It was reported that the nurse coordinator was unable to identify the patient referenced in the report. Patient identification information was not available.
Age: 65.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Arthralgia, Blood test, Gait disturbance, Injected limb mobility decreased, Laboratory test
Clinical narrative: A rheumatologist confirmed that the patient have Polymyalgia; This is a spontaneous case, reported by other health professional to VAERS (VAERS ID: 833534-1) and initially retrieved on 24-Oct-2019, concerning a 65-year-old, female patient.  The patient's medical history included high blood pressure and depression.  The patient's concomitant medications included lithium carbonate for depression, eszopiclone and olmesartan medoxomil all for unknown indications.  On 15-Jan-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, anatomical location: left arm, dose, route of administration, batch number and expiry date: not reported] for an unknown indication.  On 16-Jan-2019, one day after vaccine administration, the patient's left arm (injected arm) started to hurt a great deal all the time for 2 weeks, with stiffness beginning in her both arms.  On 25-Jan-2019, the patient woke up and was not able to lift herself up from bed and crawled to a chest of drawers to pull herself up using the knobs. The patient's hips and legs became stiff and painful.  By 31-Jan-2019 and shortly before that date, the patient had trouble walking and could only take small steps.   On 13-May-2019, the patient started treatment with prednisone at dose of 10 mg.  On unknown dates, the patient's condition improved. The patient was finally able to walk and move well. The patient performed magnetic resonance imaging (MRI), blood tests and nerve tests but the results were not provided.  On 29-Jul-2019, a rheumatologist confirmed polymyalgia.  On unknown dates, the treatment with prednisone was continued at a decreased dose of 7 mg every day, despite the patient still had symptoms, but she could get out of bed easier and walk outside a few times a week when the pain was not severe.  On 13-Sep-2019, the patient still felt a lot of pain in her arms and legs and the pain was appearing and disappearing.  The outcome of the event polymyalgia was not recovered, at the time of this report.  This case was assessed as serious and the patient did not provide causality assessment.  Company comment: The patient experienced polymyalgia rheumatica associated with Fluad (TIV). Chronology seems plausible. Concomitant drugs, here reported, may have an influence in developing reported event. More information regarding start date of concomitant drugs is needed in order to establish a propper causal relationship. Considering immunological characteristics of reported event, casuality is assessed as possibly related.; Sender's Comments: The patient experienced polymyalgia rheumatica associated with Fluad (TIV). Chronology seems plausible. Concomitant drugs, here reported, may have an influence in developing reported event. More information regarding start date of concomitant drugs is needed in order to establish a propper causal relationship. Considering immunological characteristics of reported event, casuality is assessed as possibly related.
Age: 65.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Pain in extremity
Clinical narrative: A rheumatologist confirmed that the patient have Polymyalgia; This is a spontaneous case, reported by other health professional to VAERS (VAERS ID: 833534-1) and initially retrieved on 24-Oct-2019, concerning a 65-year-old, female patient.  The patient's medical history included high blood pressure and depression.  The patient's concomitant medications included lithium carbonate for depression, eszopiclone and olmesartan medoxomil all for unknown indications.  On 15-Jan-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, anatomical location: left arm, dose, route of administration, batch number and expiry date: not reported] for an unknown indication.  On 16-Jan-2019, one day after vaccine administration, the patient's left arm (injected arm) started to hurt a great deal all the time for 2 weeks, with stiffness beginning in her both arms.  On 25-Jan-2019, the patient woke up and was not able to lift herself up from bed and crawled to a chest of drawers to pull herself up using the knobs. The patient's hips and legs became stiff and painful.  By 31-Jan-2019 and shortly before that date, the patient had trouble walking and could only take small steps.   On 13-May-2019, the patient started treatment with prednisone at dose of 10 mg.  On unknown dates, the patient's condition improved. The patient was finally able to walk and move well. The patient performed magnetic resonance imaging (MRI), blood tests and nerve tests but the results were not provided.  On 29-Jul-2019, a rheumatologist confirmed polymyalgia.  On unknown dates, the treatment with prednisone was continued at a decreased dose of 7 mg every day, despite the patient still had symptoms, but she could get out of bed easier and walk outside a few times a week when the pain was not severe.  On 13-Sep-2019, the patient still felt a lot of pain in her arms and legs and the pain was appearing and disappearing.  The outcome of the event polymyalgia was not recovered, at the time of this report.  This case was assessed as serious and the patient did not provide causality assessment.  Company comment: The patient experienced polymyalgia rheumatica associated with Fluad (TIV). Chronology seems plausible. Concomitant drugs, here reported, may have an influence in developing reported event. More information regarding start date of concomitant drugs is needed in order to establish a propper causal relationship. Considering immunological characteristics of reported event, casuality is assessed as possibly related.; Sender's Comments: The patient experienced polymyalgia rheumatica associated with Fluad (TIV). Chronology seems plausible. Concomitant drugs, here reported, may have an influence in developing reported event. More information regarding start date of concomitant drugs is needed in order to establish a propper causal relationship. Considering immunological characteristics of reported event, casuality is assessed as possibly related.
Age: 65.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Arthralgia, Blood test, Gait disturbance, Joint stiffness, Magnetic resonance imaging
Clinical narrative: A rheumatologist confirmed that the patient have Polymyalgia; This is a spontaneous case, reported by other health professional to VAERS (VAERS ID: 833534-1) and initially retrieved on 24-Oct-2019, concerning a 65-year-old, female patient.  The patient's medical history included high blood pressure and depression.  The patient's concomitant medications included lithium carbonate for depression, eszopiclone and olmesartan medoxomil all for unknown indications.  On 15-Jan-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, anatomical location: left arm, dose, route of administration, batch number and expiry date: not reported] for an unknown indication.  On 16-Jan-2019, one day after vaccine administration, the patient's left arm (injected arm) started to hurt a great deal all the time for 2 weeks, with stiffness beginning in her both arms.  On 25-Jan-2019, the patient woke up and was not able to lift herself up from bed and crawled to a chest of drawers to pull herself up using the knobs. The patient's hips and legs became stiff and painful.  By 31-Jan-2019 and shortly before that date, the patient had trouble walking and could only take small steps.   On 13-May-2019, the patient started treatment with prednisone at dose of 10 mg.  On unknown dates, the patient's condition improved. The patient was finally able to walk and move well. The patient performed magnetic resonance imaging (MRI), blood tests and nerve tests but the results were not provided.  On 29-Jul-2019, a rheumatologist confirmed polymyalgia.  On unknown dates, the treatment with prednisone was continued at a decreased dose of 7 mg every day, despite the patient still had symptoms, but she could get out of bed easier and walk outside a few times a week when the pain was not severe.  On 13-Sep-2019, the patient still felt a lot of pain in her arms and legs and the pain was appearing and disappearing.  The outcome of the event polymyalgia was not recovered, at the time of this report.  This case was assessed as serious and the patient did not provide causality assessment.  Company comment: The patient experienced polymyalgia rheumatica associated with Fluad (TIV). Chronology seems plausible. Concomitant drugs, here reported, may have an influence in developing reported event. More information regarding start date of concomitant drugs is needed in order to establish a propper causal relationship. Considering immunological characteristics of reported event, casuality is assessed as possibly related.; Sender's Comments: The patient experienced polymyalgia rheumatica associated with Fluad (TIV). Chronology seems plausible. Concomitant drugs, here reported, may have an influence in developing reported event. More information regarding start date of concomitant drugs is needed in order to establish a propper causal relationship. Considering immunological characteristics of reported event, casuality is assessed as possibly related.
Age: 65.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Musculoskeletal stiffness, Myalgia, Nerve conduction studies, Pain in extremity
Clinical narrative: A rheumatologist confirmed that the patient have Polymyalgia; This is a spontaneous case, reported by other health professional to VAERS (VAERS ID: 833534-1) and initially retrieved on 24-Oct-2019, concerning a 65-year-old, female patient.  The patient's medical history included high blood pressure and depression.  The patient's concomitant medications included lithium carbonate for depression, eszopiclone and olmesartan medoxomil all for unknown indications.  On 15-Jan-2019, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, anatomical location: left arm, dose, route of administration, batch number and expiry date: not reported] for an unknown indication.  On 16-Jan-2019, one day after vaccine administration, the patient's left arm (injected arm) started to hurt a great deal all the time for 2 weeks, with stiffness beginning in her both arms.  On 25-Jan-2019, the patient woke up and was not able to lift herself up from bed and crawled to a chest of drawers to pull herself up using the knobs. The patient's hips and legs became stiff and painful.  By 31-Jan-2019 and shortly before that date, the patient had trouble walking and could only take small steps.   On 13-May-2019, the patient started treatment with prednisone at dose of 10 mg.  On unknown dates, the patient's condition improved. The patient was finally able to walk and move well. The patient performed magnetic resonance imaging (MRI), blood tests and nerve tests but the results were not provided.  On 29-Jul-2019, a rheumatologist confirmed polymyalgia.  On unknown dates, the treatment with prednisone was continued at a decreased dose of 7 mg every day, despite the patient still had symptoms, but she could get out of bed easier and walk outside a few times a week when the pain was not severe.  On 13-Sep-2019, the patient still felt a lot of pain in her arms and legs and the pain was appearing and disappearing.  The outcome of the event polymyalgia was not recovered, at the time of this report.  This case was assessed as serious and the patient did not provide causality assessment.  Company comment: The patient experienced polymyalgia rheumatica associated with Fluad (TIV). Chronology seems plausible. Concomitant drugs, here reported, may have an influence in developing reported event. More information regarding start date of concomitant drugs is needed in order to establish a propper causal relationship. Considering immunological characteristics of reported event, casuality is assessed as possibly related.; Sender's Comments: The patient experienced polymyalgia rheumatica associated with Fluad (TIV). Chronology seems plausible. Concomitant drugs, here reported, may have an influence in developing reported event. More information regarding start date of concomitant drugs is needed in order to establish a propper causal relationship. Considering immunological characteristics of reported event, casuality is assessed as possibly related.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination site pain
Clinical narrative: Pt arm was sore and inflammed due to shot being too high. Pt okay and was able to complete course
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inflammation, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Pt arm was sore and inflammed due to shot being too high. Pt okay and was able to complete course
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL, MMR, PNC13, VARCEL
Symptoms: Constipation, Decreased appetite, Diet refusal, Fatigue, Hyperhidrosis
Clinical narrative: Developed rash/spots around injection sites. Became feverish. Decreased appetite. Constipation, Diarrhea. Spots/rash resolved around inj sites but reappeared on face & body. Carson was fussier than usual. Occasionally had sweats. As of 10-30-19 ~ 2:00pm. Spoke with mom. Fevers resolved. Red spots fading. Returned to normal bowel movements. Mom reports seeing improvement
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Irritability, Pruritus, Pyrexia, Rash
Clinical narrative: Developed rash/spots around injection sites. Became feverish. Decreased appetite. Constipation, Diarrhea. Spots/rash resolved around inj sites but reappeared on face & body. Carson was fussier than usual. Occasionally had sweats. As of 10-30-19 ~ 2:00pm. Spoke with mom. Fevers resolved. Red spots fading. Returned to normal bowel movements. Mom reports seeing improvement
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rhinorrhoea, Skin warm, Somnolence
Clinical narrative: Developed rash/spots around injection sites. Became feverish. Decreased appetite. Constipation, Diarrhea. Spots/rash resolved around inj sites but reappeared on face & body. Carson was fussier than usual. Occasionally had sweats. As of 10-30-19 ~ 2:00pm. Spoke with mom. Fevers resolved. Red spots fading. Returned to normal bowel movements. Mom reports seeing improvement
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL, MMR, PNC13, VARCEL
Symptoms: Constipation, Decreased appetite, Diarrhoea, Hyperhidrosis, Injection site rash
Clinical narrative: Developed rash/spots around injection sites. Became feverish. Decreased appetite. Constipation, Diarrhea. Spots/rash resolved around inj sites but reappeared on face & body. Carson was fussier than usual. Occasionally had sweats. As of 10-30-19 ~ 2:00pm. Spoke with mom. Fevers resolved. Red spots fading. Returned to normal bowel movements. Mom reports seeing improvement
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia, Rash, Rash erythematous
Clinical narrative: Developed rash/spots around injection sites. Became feverish. Decreased appetite. Constipation, Diarrhea. Spots/rash resolved around inj sites but reappeared on face & body. Carson was fussier than usual. Occasionally had sweats. As of 10-30-19 ~ 2:00pm. Spoke with mom. Fevers resolved. Red spots fading. Returned to normal bowel movements. Mom reports seeing improvement
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: was given Fluzone High Dose at the age of 64 years ago on 26Sep2019 with no AE; was given Fluzone High Dose at the age of 64 years ago on 26Sep2019 with no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 64 years old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and reported that was given Fluzone High Dose at the age of 64 years ago on 26-Sep-2019 with no AE (product administered to patient of inappropriate age) and (overdose).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 26-Sep-2019, the patient received a dose of suspect 0.5 ml INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ253AA and expiry date: 06-May-2020 via intramuscular route in the left deltoid.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.