chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV4
Symptoms: Fatigue, Gait disturbance, Impaired work ability, Insomnia, Loss of consciousness
Clinical narrative: Pain in arm for over 72 hours, Passing out, paralysis, migraines, weakness, insomnia, chronic pain, chronic fatigue, motor tics, functional tics, vocal tics, racing heart, Postural Orthostatic Tachycardia Syndrome
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV4
Symptoms: Loss of employment, Loss of personal independence in daily activities, Memory impairment, Mobility decreased, Musculoskeletal disorder
Clinical narrative: Pain in arm for over 72 hours, Passing out, paralysis, migraines, weakness, insomnia, chronic pain, chronic fatigue, motor tics, functional tics, vocal tics, racing heart, Postural Orthostatic Tachycardia Syndrome
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV4
Symptoms: Nausea, Nervous system disorder, Pain, Postural orthostatic tachycardia syndrome, Tachycardia
Clinical narrative: Pain in arm for over 72 hours, Passing out, paralysis, migraines, weakness, insomnia, chronic pain, chronic fatigue, motor tics, functional tics, vocal tics, racing heart, Postural Orthostatic Tachycardia Syndrome
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV4
Symptoms: Vomiting, Wheelchair user
Clinical narrative: Pain in arm for over 72 hours, Passing out, paralysis, migraines, weakness, insomnia, chronic pain, chronic fatigue, motor tics, functional tics, vocal tics, racing heart, Postural Orthostatic Tachycardia Syndrome
Age: 0.17
Sex: F
Vaccine: MMR
Symptoms: Condition aggravated, Seizure
Clinical narrative: Seizures
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial tachycardia, Cardiac stress test abnormal, Condition aggravated, Electrocardiogram abnormal, Hypoaesthesia
Clinical narrative: 1-vaginal bleeding uncontrolled unless on oral contraceptive, which at my age puts me at risk for clots. I'd prefer NOT to be on birth control but have to if I don't want to bleed and pass clots. began July 2021 after routine pap smear. significant pain, at least one ER visit, and countless money spent on feminine hygiene products. clothes ruined! 2-heart palpitations post panic attack April 2022. I've had panic attacks since 2002 but it wasn't until post COVID vaccine that I began experiencing palpitations and left arm numbness. stress test revealed atrial tachycardia.  I received the Moderna vaccine due to relentless peer pressure placed on me by my superiors and fellow staff while working the administrative aspect of a Friday COVID Vaccine Clinic while employed by the State. I was not willing to receive the vaccine but the Clinic Administrator, several nurses and a lab technician  refused to let up. Now I have long-lasting, possible lifelong and life-altering effects and this is not okay.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Panic attack, Smear cervix, Vaginal haemorrhage
Clinical narrative: 1-vaginal bleeding uncontrolled unless on oral contraceptive, which at my age puts me at risk for clots. I'd prefer NOT to be on birth control but have to if I don't want to bleed and pass clots. began July 2021 after routine pap smear. significant pain, at least one ER visit, and countless money spent on feminine hygiene products. clothes ruined! 2-heart palpitations post panic attack April 2022. I've had panic attacks since 2002 but it wasn't until post COVID vaccine that I began experiencing palpitations and left arm numbness. stress test revealed atrial tachycardia.  I received the Moderna vaccine due to relentless peer pressure placed on me by my superiors and fellow staff while working the administrative aspect of a Friday COVID Vaccine Clinic while employed by the State. I was not willing to receive the vaccine but the Clinic Administrator, several nurses and a lab technician  refused to let up. Now I have long-lasting, possible lifelong and life-altering effects and this is not okay.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Paraesthesia, Urticaria
Clinical narrative: Starting 3/18, Patient broke out in hives on his face and neck.  Hives continued to appear in the evening for several days. He  took Benedryll and starting taking Claritin, and eventually was prescribed an oral steroid to stop allergic reaction. The day after 1st steroid dose, tingling in his fingers on both hands started. Day2, this toes started getting tingly too. Prednisone stopped after 2nd dose. Allergy meds continue and here we are
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Amylase increased, Arthralgia, COVID-19, Crying, Discomfort
Clinical narrative: I immediately started having pain in my neck, shoulders waist, legs all over my body. My girls were graduating high school I have twins. As uncomfortable as it was, I really couldn?t go to the hospital at that point and I waited for the symptoms to go away. They never did it got to the point where I was crying every day in pain and by the time Fourth of July weekend ended I was going to the hospital the next day I couldn?t take it anymore. The pain was excruciating, and I have a very high tolerance for pain. In the hospital, steroids were the only thing that helped reduce the pain. They gave me morphine that didn?t do anything I was taking Aleve, Advil, Tylenol, anything that might relieve the pain prior to the hospital. Nothing worked. I gave me morphine in the hospital that didn?t even work steroids that I?m currently still on almost a year later, That is the only thing that worked. I was taking 10 mg of prednisone as of November last year and when I dropped it down to 9 mg all the pain came back so I had to go back up to 10. Then a few weeks later I got Covid and then the rebound from the paxlovid. After the Covid, I have been able to drop it down and I am currently at 4 mg. Getting Covid somehow made the pain get better. I don?t know why I can?t figure it out. I have no idea what that was about but I have been now getting ready to come off of the steroids hopefully by July I?ll be off of them entirely but it?s been a really really rough year.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Lipase increased, Neck pain, Pain, Pain in extremity
Clinical narrative: I immediately started having pain in my neck, shoulders waist, legs all over my body. My girls were graduating high school I have twins. As uncomfortable as it was, I really couldn?t go to the hospital at that point and I waited for the symptoms to go away. They never did it got to the point where I was crying every day in pain and by the time Fourth of July weekend ended I was going to the hospital the next day I couldn?t take it anymore. The pain was excruciating, and I have a very high tolerance for pain. In the hospital, steroids were the only thing that helped reduce the pain. They gave me morphine that didn?t do anything I was taking Aleve, Advil, Tylenol, anything that might relieve the pain prior to the hospital. Nothing worked. I gave me morphine in the hospital that didn?t even work steroids that I?m currently still on almost a year later, That is the only thing that worked. I was taking 10 mg of prednisone as of November last year and when I dropped it down to 9 mg all the pain came back so I had to go back up to 10. Then a few weeks later I got Covid and then the rebound from the paxlovid. After the Covid, I have been able to drop it down and I am currently at 4 mg. Getting Covid somehow made the pain get better. I don?t know why I can?t figure it out. I have no idea what that was about but I have been now getting ready to come off of the steroids hopefully by July I?ll be off of them entirely but it?s been a really really rough year.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Dysstasia, Erythema, Fall
Clinical narrative: Prior to getting the COVID-19 vaccine I was taking off all of my medications two weeks prior to the vaccine, which are biologics for my autoimmune disorders by my Rheumatologist. I received the first dose of COVID-19 vaccine on 3/12/21 at 7:45am, by 12:30-1pm I started with 102 fevers, left arm was red, burning, swollen and felt like it was on fire. My 102 fevers lasted for 4-5 days along with severe fatigue, headaches that felt like my brain was on fire and severe increase in pain throughout my body. fevers, left arm was red, burning, swollen and felt like it was on fire. On 3/15/21 my symptoms were not getting better. I started to have right side weakness, right leg was dragging behind me, and unstable on my feet, pain intensity was severe throughout my body. By 3/16/2021 I was completely unstable on my feet, falling due to the weakness/bilateral leg swelling and unable to walk, stand, stand-up right, I needed help to get place to place. On 3/17/21 I went to Emergency room due to the extreme pain I was in. I was admitted to Hospital from 3/17/21 -  3/22/21 with extensive blood work, images, IV medications and consultations by specialist due to my symptoms and my autoimmune on medical leave from work from 3/17/21 until I follow up with my Rheumatologist on 4/21/2021. I was unable to return to work on 4/26/2021.   Discussion took placed about the second COVID-19 vaccine. Per my Rheumatologist, I would stay on all my medications except I would stop my Rasuvo 30mg one week prior to the next COVID-19 vaccine and continue on my high doses of Prednisone. On 4/9/2021 I received my second COVID-19 vaccine at 7:45am. Around 1pm, I started with 103 fevers for 3-4 days, fatigue, headaches, increased pain levels, started with lesions and skin started to peel on my tongue, unsteady on my fees, right arm/hand tremor. On 4/17 I was hospitalized with increased pain levels in bilateral legs, numbness in my feet. I am currently still dealing with side effects to the COVID-19 vaccine that I did not have prior to this Immunization.  Current doctors treating me since COVID-19 Vaccine: -Neurology: Numbness in bilateral feet and tremor in right arm/hand. Currently taking Primidone 50mg for my tremor -Pain Management: treating me to get my pain levels back to my baseline before the vaccine. Currently taking Lyrica 100mg for the pain. -Rheumatology: treating me for my autoimmune disorders and currently seeing me monthly for vaccine reactions.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Gait disturbance, Gait inability, Headache, Hemiparesis
Clinical narrative: Prior to getting the COVID-19 vaccine I was taking off all of my medications two weeks prior to the vaccine, which are biologics for my autoimmune disorders by my Rheumatologist. I received the first dose of COVID-19 vaccine on 3/12/21 at 7:45am, by 12:30-1pm I started with 102 fevers, left arm was red, burning, swollen and felt like it was on fire. My 102 fevers lasted for 4-5 days along with severe fatigue, headaches that felt like my brain was on fire and severe increase in pain throughout my body. fevers, left arm was red, burning, swollen and felt like it was on fire. On 3/15/21 my symptoms were not getting better. I started to have right side weakness, right leg was dragging behind me, and unstable on my feet, pain intensity was severe throughout my body. By 3/16/2021 I was completely unstable on my feet, falling due to the weakness/bilateral leg swelling and unable to walk, stand, stand-up right, I needed help to get place to place. On 3/17/21 I went to Emergency room due to the extreme pain I was in. I was admitted to Hospital from 3/17/21 -  3/22/21 with extensive blood work, images, IV medications and consultations by specialist due to my symptoms and my autoimmune on medical leave from work from 3/17/21 until I follow up with my Rheumatologist on 4/21/2021. I was unable to return to work on 4/26/2021.   Discussion took placed about the second COVID-19 vaccine. Per my Rheumatologist, I would stay on all my medications except I would stop my Rasuvo 30mg one week prior to the next COVID-19 vaccine and continue on my high doses of Prednisone. On 4/9/2021 I received my second COVID-19 vaccine at 7:45am. Around 1pm, I started with 103 fevers for 3-4 days, fatigue, headaches, increased pain levels, started with lesions and skin started to peel on my tongue, unsteady on my fees, right arm/hand tremor. On 4/17 I was hospitalized with increased pain levels in bilateral legs, numbness in my feet. I am currently still dealing with side effects to the COVID-19 vaccine that I did not have prior to this Immunization.  Current doctors treating me since COVID-19 Vaccine: -Neurology: Numbness in bilateral feet and tremor in right arm/hand. Currently taking Primidone 50mg for my tremor -Pain Management: treating me to get my pain levels back to my baseline before the vaccine. Currently taking Lyrica 100mg for the pain. -Rheumatology: treating me for my autoimmune disorders and currently seeing me monthly for vaccine reactions.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Impaired work ability, Magnetic resonance imaging, Magnetic resonance imaging spinal, Pain
Clinical narrative: Prior to getting the COVID-19 vaccine I was taking off all of my medications two weeks prior to the vaccine, which are biologics for my autoimmune disorders by my Rheumatologist. I received the first dose of COVID-19 vaccine on 3/12/21 at 7:45am, by 12:30-1pm I started with 102 fevers, left arm was red, burning, swollen and felt like it was on fire. My 102 fevers lasted for 4-5 days along with severe fatigue, headaches that felt like my brain was on fire and severe increase in pain throughout my body. fevers, left arm was red, burning, swollen and felt like it was on fire. On 3/15/21 my symptoms were not getting better. I started to have right side weakness, right leg was dragging behind me, and unstable on my feet, pain intensity was severe throughout my body. By 3/16/2021 I was completely unstable on my feet, falling due to the weakness/bilateral leg swelling and unable to walk, stand, stand-up right, I needed help to get place to place. On 3/17/21 I went to Emergency room due to the extreme pain I was in. I was admitted to Hospital from 3/17/21 -  3/22/21 with extensive blood work, images, IV medications and consultations by specialist due to my symptoms and my autoimmune on medical leave from work from 3/17/21 until I follow up with my Rheumatologist on 4/21/2021. I was unable to return to work on 4/26/2021.   Discussion took placed about the second COVID-19 vaccine. Per my Rheumatologist, I would stay on all my medications except I would stop my Rasuvo 30mg one week prior to the next COVID-19 vaccine and continue on my high doses of Prednisone. On 4/9/2021 I received my second COVID-19 vaccine at 7:45am. Around 1pm, I started with 103 fevers for 3-4 days, fatigue, headaches, increased pain levels, started with lesions and skin started to peel on my tongue, unsteady on my fees, right arm/hand tremor. On 4/17 I was hospitalized with increased pain levels in bilateral legs, numbness in my feet. I am currently still dealing with side effects to the COVID-19 vaccine that I did not have prior to this Immunization.  Current doctors treating me since COVID-19 Vaccine: -Neurology: Numbness in bilateral feet and tremor in right arm/hand. Currently taking Primidone 50mg for my tremor -Pain Management: treating me to get my pain levels back to my baseline before the vaccine. Currently taking Lyrica 100mg for the pain. -Rheumatology: treating me for my autoimmune disorders and currently seeing me monthly for vaccine reactions.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Skin exfoliation, Skin lesion
Clinical narrative: Prior to getting the COVID-19 vaccine I was taking off all of my medications two weeks prior to the vaccine, which are biologics for my autoimmune disorders by my Rheumatologist. I received the first dose of COVID-19 vaccine on 3/12/21 at 7:45am, by 12:30-1pm I started with 102 fevers, left arm was red, burning, swollen and felt like it was on fire. My 102 fevers lasted for 4-5 days along with severe fatigue, headaches that felt like my brain was on fire and severe increase in pain throughout my body. fevers, left arm was red, burning, swollen and felt like it was on fire. On 3/15/21 my symptoms were not getting better. I started to have right side weakness, right leg was dragging behind me, and unstable on my feet, pain intensity was severe throughout my body. By 3/16/2021 I was completely unstable on my feet, falling due to the weakness/bilateral leg swelling and unable to walk, stand, stand-up right, I needed help to get place to place. On 3/17/21 I went to Emergency room due to the extreme pain I was in. I was admitted to Hospital from 3/17/21 -  3/22/21 with extensive blood work, images, IV medications and consultations by specialist due to my symptoms and my autoimmune on medical leave from work from 3/17/21 until I follow up with my Rheumatologist on 4/21/2021. I was unable to return to work on 4/26/2021.   Discussion took placed about the second COVID-19 vaccine. Per my Rheumatologist, I would stay on all my medications except I would stop my Rasuvo 30mg one week prior to the next COVID-19 vaccine and continue on my high doses of Prednisone. On 4/9/2021 I received my second COVID-19 vaccine at 7:45am. Around 1pm, I started with 103 fevers for 3-4 days, fatigue, headaches, increased pain levels, started with lesions and skin started to peel on my tongue, unsteady on my fees, right arm/hand tremor. On 4/17 I was hospitalized with increased pain levels in bilateral legs, numbness in my feet. I am currently still dealing with side effects to the COVID-19 vaccine that I did not have prior to this Immunization.  Current doctors treating me since COVID-19 Vaccine: -Neurology: Numbness in bilateral feet and tremor in right arm/hand. Currently taking Primidone 50mg for my tremor -Pain Management: treating me to get my pain levels back to my baseline before the vaccine. Currently taking Lyrica 100mg for the pain. -Rheumatology: treating me for my autoimmune disorders and currently seeing me monthly for vaccine reactions.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin warm, Tremor
Clinical narrative: Prior to getting the COVID-19 vaccine I was taking off all of my medications two weeks prior to the vaccine, which are biologics for my autoimmune disorders by my Rheumatologist. I received the first dose of COVID-19 vaccine on 3/12/21 at 7:45am, by 12:30-1pm I started with 102 fevers, left arm was red, burning, swollen and felt like it was on fire. My 102 fevers lasted for 4-5 days along with severe fatigue, headaches that felt like my brain was on fire and severe increase in pain throughout my body. fevers, left arm was red, burning, swollen and felt like it was on fire. On 3/15/21 my symptoms were not getting better. I started to have right side weakness, right leg was dragging behind me, and unstable on my feet, pain intensity was severe throughout my body. By 3/16/2021 I was completely unstable on my feet, falling due to the weakness/bilateral leg swelling and unable to walk, stand, stand-up right, I needed help to get place to place. On 3/17/21 I went to Emergency room due to the extreme pain I was in. I was admitted to Hospital from 3/17/21 -  3/22/21 with extensive blood work, images, IV medications and consultations by specialist due to my symptoms and my autoimmune on medical leave from work from 3/17/21 until I follow up with my Rheumatologist on 4/21/2021. I was unable to return to work on 4/26/2021.   Discussion took placed about the second COVID-19 vaccine. Per my Rheumatologist, I would stay on all my medications except I would stop my Rasuvo 30mg one week prior to the next COVID-19 vaccine and continue on my high doses of Prednisone. On 4/9/2021 I received my second COVID-19 vaccine at 7:45am. Around 1pm, I started with 103 fevers for 3-4 days, fatigue, headaches, increased pain levels, started with lesions and skin started to peel on my tongue, unsteady on my fees, right arm/hand tremor. On 4/17 I was hospitalized with increased pain levels in bilateral legs, numbness in my feet. I am currently still dealing with side effects to the COVID-19 vaccine that I did not have prior to this Immunization.  Current doctors treating me since COVID-19 Vaccine: -Neurology: Numbness in bilateral feet and tremor in right arm/hand. Currently taking Primidone 50mg for my tremor -Pain Management: treating me to get my pain levels back to my baseline before the vaccine. Currently taking Lyrica 100mg for the pain. -Rheumatology: treating me for my autoimmune disorders and currently seeing me monthly for vaccine reactions.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pelvic pain
Clinical narrative: Constant pain in inner thigh muscle region of both legs and pelvic areas.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Immediate post-injection reaction, Migraine, Seizure
Clinical narrative: Within 5 minutes, I had seizure activity and a migraine.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Covid tested positive. Mild cough, runny nose. Received Paxlovid.. Negative within 5 days and continue to feel well with negative tests
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 4/29/21 Lot# Ew0164;  Pfizer 5/25/21 Lot# Ew0172
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy peripheral nerve, Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: Started having reactions that were later determined to be autoimmune in nature and I was diagnosed with chronic inflammatory demyelinating polyneuropathy (CDIP); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (medically significant), outcome "unknown", described as "Started having reactions that were later determined to be autoimmune in nature and I was diagnosed with chronic inflammatory demyelinating polyneuropathy (CDIP)". The patient underwent the following laboratory tests and procedures: Biopsy peripheral nerve: Unknown results. Therapeutic measures were taken as a result of chronic inflammatory demyelinating polyradiculoneuropathy. Clinical Course: Patient received Pfizer COVID-19 monovalent booster on 08Dec2021 and started having reactions that were later determined to be autoimmune in nature and he was diagnosed with chronic inflammatory demyelinating polyneuropathy (CDIP). He did not have any trouble with the first two Pfizer COVID-19 injections. Patient doctor prescribed IVIG as treatment but his insurance does not cover it. He was working with a couple of neurologists that did a biopsy of the nerves on the ankle and prescribed a Rituxan protocol but that did not work.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300133556 same patient, different product and event;US-PFIZER INC-202300134288 same patient, different drug/event;
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No ADR Bivalent booster administered prior to primary series
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No ADR Bivalent booster administered as first dose of primary series
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No ADR Bivalent booster administered as first dose in primary series
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No ADR Bivalent booster administered as 1st dose of primary series
Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19-2, FLU4, VARZOS
Symptoms: Bacterial test positive, Body temperature increased, COVID-19, Chest X-ray normal, Cough
Clinical narrative: My husband had been away and came home and tested positive for COVID-19. I then tested positive for COVID-19 ON February 23, 2023. I used two test to ensure that I made sure I had done the test correctly. I called my doctor, who said I could not take the antiviral because I am on a blood thinner. I went to the emergency room where they also tested me for COVID-19, it came back positive. I was admitted to the hospital as my fever had reached 103.7F and my oxygen was very low. I was given an IV antibiotic and fluids to help get my temperature down and combat the infection. I stayed in the hospital for three days and was released once my temperature was down and my oxygen was up. I am not sure if I am completely over this yet, I still have fatigue.
Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19-2, FLU4, VARZOS
Symptoms: Dyspnoea, Electrocardiogram normal, Full blood count normal, Hypoxia, Laboratory test normal
Clinical narrative: My husband had been away and came home and tested positive for COVID-19. I then tested positive for COVID-19 ON February 23, 2023. I used two test to ensure that I made sure I had done the test correctly. I called my doctor, who said I could not take the antiviral because I am on a blood thinner. I went to the emergency room where they also tested me for COVID-19, it came back positive. I was admitted to the hospital as my fever had reached 103.7F and my oxygen was very low. I was given an IV antibiotic and fluids to help get my temperature down and combat the infection. I stayed in the hospital for three days and was released once my temperature was down and my oxygen was up. I am not sure if I am completely over this yet, I still have fatigue.
Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19-2, FLU4, VARZOS
Symptoms: Nasal congestion, Oxygen saturation decreased, Procalcitonin normal, SARS-CoV-2 test positive, Tachycardia
Clinical narrative: My husband had been away and came home and tested positive for COVID-19. I then tested positive for COVID-19 ON February 23, 2023. I used two test to ensure that I made sure I had done the test correctly. I called my doctor, who said I could not take the antiviral because I am on a blood thinner. I went to the emergency room where they also tested me for COVID-19, it came back positive. I was admitted to the hospital as my fever had reached 103.7F and my oxygen was very low. I was given an IV antibiotic and fluids to help get my temperature down and combat the infection. I stayed in the hospital for three days and was released once my temperature was down and my oxygen was up. I am not sure if I am completely over this yet, I still have fatigue.
Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19-2, FLU4, VARZOS
Symptoms: Urine analysis abnormal, Urine leukocyte esterase positive, White blood cells urine positive
Clinical narrative: My husband had been away and came home and tested positive for COVID-19. I then tested positive for COVID-19 ON February 23, 2023. I used two test to ensure that I made sure I had done the test correctly. I called my doctor, who said I could not take the antiviral because I am on a blood thinner. I went to the emergency room where they also tested me for COVID-19, it came back positive. I was admitted to the hospital as my fever had reached 103.7F and my oxygen was very low. I was given an IV antibiotic and fluids to help get my temperature down and combat the infection. I stayed in the hospital for three days and was released once my temperature was down and my oxygen was up. I am not sure if I am completely over this yet, I still have fatigue.
Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19-2, FLU4, VARZOS
Symptoms: Blood test abnormal, COVID-19, Chest X-ray normal, Exposure to SARS-CoV-2, Fatigue
Clinical narrative: My husband had been away and came home and tested positive for COVID-19. I then tested positive for COVID-19 ON February 23, 2023. I used two test to ensure that I made sure I had done the test correctly. I called my doctor, who said I could not take the antiviral because I am on a blood thinner. I went to the emergency room where they also tested me for COVID-19, it came back positive. I was admitted to the hospital as my fever had reached 103.7F and my oxygen was very low. I was given an IV antibiotic and fluids to help get my temperature down and combat the infection. I stayed in the hospital for three days and was released once my temperature was down and my oxygen was up. I am not sure if I am completely over this yet, I still have fatigue.
Age: 68.0
Sex: F
Vaccine: COVID19-2, COVID19-2, FLU4, VARZOS
Symptoms: Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: My husband had been away and came home and tested positive for COVID-19. I then tested positive for COVID-19 ON February 23, 2023. I used two test to ensure that I made sure I had done the test correctly. I called my doctor, who said I could not take the antiviral because I am on a blood thinner. I went to the emergency room where they also tested me for COVID-19, it came back positive. I was admitted to the hospital as my fever had reached 103.7F and my oxygen was very low. I was given an IV antibiotic and fluids to help get my temperature down and combat the infection. I stayed in the hospital for three days and was released once my temperature was down and my oxygen was up. I am not sure if I am completely over this yet, I still have fatigue.
Age: 39.0
Sex: M
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: COVID-19, Cough, Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as DOSE 4 (BOOSTER), SINGLE (lot number: GJ2524) at the age of 39 years old, administered in the left arm for COVID-19 immunization; Covid-19 vaccine (COVID-19 VACCINE), as DOSE 1, SINGLE (batch/lot number: unknown), as DOSE 2, SINGLE (batch/lot number: unknown), and as DOSE 3 (BOOSTER), SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "Fatty liver" (unspecified if ongoing). Patient had no known allergies. Concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19 Treatment." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive, notes: COVID-19 treatment. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.
Age: 39.0
Sex: M
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Restlessness, SARS-CoV-2 test positive
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as DOSE 4 (BOOSTER), SINGLE (lot number: GJ2524) at the age of 39 years old, administered in the left arm for COVID-19 immunization; Covid-19 vaccine (COVID-19 VACCINE), as DOSE 1, SINGLE (batch/lot number: unknown), as DOSE 2, SINGLE (batch/lot number: unknown), and as DOSE 3 (BOOSTER), SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "Fatty liver" (unspecified if ongoing). Patient had no known allergies. Concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19 Treatment." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive, notes: COVID-19 treatment. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.
Age: 39.0
Sex: M
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as DOSE 4 (BOOSTER), SINGLE (lot number: GJ2524) at the age of 39 years old, administered in the left arm for COVID-19 immunization; Covid-19 vaccine (COVID-19 VACCINE), as DOSE 1, SINGLE (batch/lot number: unknown), as DOSE 2, SINGLE (batch/lot number: unknown), and as DOSE 3 (BOOSTER), SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "Fatty liver" (unspecified if ongoing). Patient had no known allergies. Concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19 Treatment." The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive, notes: COVID-19 treatment. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.
Age: 41.0
Sex: M
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Body temperature increased, COVID-19, Illness, Infection, Malaise
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 14:30 as dose 4 (booster), single (batch/lot number: GH7694) at the age of 41 years, in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (batch/lot number: unknown), as dose 2, single (batch/lot number: unknown) and as dose 3 (booster), single (batch/lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 04Mar2023 to 09Mar2023.
Age: 41.0
Sex: M
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 14:30 as dose 4 (booster), single (batch/lot number: GH7694) at the age of 41 years, in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (batch/lot number: unknown), as dose 2, single (batch/lot number: unknown) and as dose 3 (booster), single (batch/lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 04Mar2023 to 09Mar2023.
Age: 41.0
Sex: M
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 14:30 as dose 4 (booster), single (batch/lot number: GH7694) at the age of 41 years, in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (batch/lot number: unknown), as dose 2, single (batch/lot number: unknown) and as dose 3 (booster), single (batch/lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 04Mar2023 to 09Mar2023.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Limb injury, Poor quality product administered, Syringe issue, Underdose
Clinical narrative: RN reporting adverse event was training another RN and was supervising event. RN had the patient on exam table and had a good hold on her legs, RN told mom to make sure she had a good hold on her hands but when RN went to administer MMRV, the patient grabbed for the needle prior to it being placed in her right thigh, when she tried to reach for the needle, the needle scratched her leg and subsequently some of the MMRV vaccine was dispensed out prior to administering vaccine. Supervising RN stepped in and helped mom grab hold of the patient's hands and other RN continued to administer MMRV and then DTap-IPV and Flu in her left thigh. Supervising RN did make mom aware after all immunizations were administered that due to the patient trying to grab the syringe, she did receive a scratch on her leg but was otherwise completely fine. Mom verbalized understanding. Since event, mom has been spoken to and updated on recommendations.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Patient uncooperative, Scratch, Underdose
Clinical narrative: RN reporting adverse event was training another RN and was supervising event. RN had the patient on exam table and had a good hold on her legs, RN told mom to make sure she had a good hold on her hands but when RN went to administer MMRV, the patient grabbed for the needle prior to it being placed in her right thigh, when she tried to reach for the needle, the needle scratched her leg and subsequently some of the MMRV vaccine was dispensed out prior to administering vaccine. Supervising RN stepped in and helped mom grab hold of the patient's hands and other RN continued to administer MMRV and then DTap-IPV and Flu in her left thigh. Supervising RN did make mom aware after all immunizations were administered that due to the patient trying to grab the syringe, she did receive a scratch on her leg but was otherwise completely fine. Mom verbalized understanding. Since event, mom has been spoken to and updated on recommendations.
Age: 16.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No symptomatic side effects reported  (no adverse event); A 16 year old was inadvertently given PROQUAD.; This spontaneous report was received from registered nurse and refers to a 16-year-old patient.  The patient's pertinent medical history, other concurrent conditions, previous drug reactions and allergies were not reported. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 27-FEB-2023, the patient inadvertently was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliter, lot #W026327, expiration date: 18-FEB-2024, administered subcutaneously for prophylaxis (strength and anatomical site injection was not provided) (product administered to patient of inappropriate age). No symptomatic side effects reported  (no adverse event).
Age: 16.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptomatic side effects reported  (no adverse event); A 16 year old was inadvertently given PROQUAD.; This spontaneous report was received from registered nurse and refers to a 16-year-old patient.  The patient's pertinent medical history, other concurrent conditions, previous drug reactions and allergies were not reported. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 27-FEB-2023, the patient inadvertently was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, at a dose of 0.5 milliliter, lot #W026327, expiration date: 18-FEB-2024, administered subcutaneously for prophylaxis (strength and anatomical site injection was not provided) (product administered to patient of inappropriate age). No symptomatic side effects reported  (no adverse event).
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Chills, Discomfort, Herpes zoster, Nausea
Clinical narrative: Developed burning/dull ache to R chest. The next day a painful red rash developed to R posterior chest which has worsened and spread across back of R chest wall. Confirmed to be shingles outbreak by employee health doctor on March 29, 2023.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Developed burning/dull ache to R chest. The next day a painful red rash developed to R posterior chest which has worsened and spread across back of R chest wall. Confirmed to be shingles outbreak by employee health doctor on March 29, 2023.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Herpes zoster, Rash, Rash erythematous
Clinical narrative: Developed burning/dull ache to R chest. The next day a painful red rash developed to R posterior chest which has worsened and spread across back of R chest wall. Confirmed to be shingles outbreak by employee health doctor on March 29, 2023.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE.; VARIVAX was administered after expiration; This spontaneous report was received from a Medical Assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 16-MAR-2023, the patient was vaccinated with a dose of expired varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter subcutaneous injection, 0.5 milliliter, lot #U008180, expiration date: 12-MAR-2023, administered for prophylaxis(route of administration was  not provided) (expired product administered). This dose did not experience any temperature excursion. No additional adverse event.
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported.; RN reporting that a dose of GARDASIL 9 with a labeled expiry of 3/13/2023 was administered to a patient on 3/14/2023. Caller declined consent to contact. No additional information provided. No additional AE/PQC reported.; This spontaneous report was received from a registered nurse regarding a 17-year-old female patient. Information regarding medical history, concurrent conditions and concomitant medications was not reported.   On 14-MAR-2023, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)(lot number T029522 has been verified to be a valid lot number as well the expiration date, which was confirmed to be 13-MAR-2023) (expired product administered) at a dose of 0.5 mL. No additional adverse event was reported (no adverse event).
Age: 0.25
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: extra dose administered; Inappropriate schedule of vaccine administered; This spontaneous report has been received from other health care professional via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (MARRS# 2110USA001194) concerning 3-month-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 19-JUL-1999 and on 12-NOV-1999, the patient was vaccinated with first and second dose (Inappropriate schedule of vaccine administered) of hepatitis b vaccine (recombinant) (RECOMBIVAX HB); the third dose on 28-JAN-2000 and a fourth dose on 17-JUL-2000 (Extra dose administered); all administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  This is one of 4 cases of the same patient.; Sender's Comments:  US-009507513-2110USA001194: US-009507513-2303USA008561: US-009507513-2303USA008560:
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous report was received from other health care professional via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (MARRS# 2110USA001194) concerning 13-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-MAY-2010 and 20-JUL-2012 (inappropriate schedule of vaccine administered), the patient was vaccinated with the first and second dose, respectively, of hepatitis a vaccine, inactivated (VAQTA) administered for prophylaxis (strengths, lot numbers, expiration dates, routes of administration and anatomical location were not provided).  This is one of 4 cases of the same patient.; Sender's Comments:  US-009507513-2303USA008560: US-009507513-2303USA008558: US-009507513-2110USA001194:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reported expired dose of MMR II was administered; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 24-MAR-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # U006488, expiration date: 26-FEB-2023 (dose, rout of administration, anatomical location not provided) as prophylaxis. The vaccine was reconstituted with sterile diluent (lot # W014210, expiration date: 27-NOV-2024). No additional adverse events were reported.