chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Eczema, Fungal infection, Headache, Injection site pain
Clinical narrative: minor eczema breakouts on her back; dental procedure; yeast infection; severe pain after the dupixent injection in stomach; pain in the hands; cramping in hands; neck pain that travels down her neck; uti; unable to sleep; has experienced pain at the injection site after her last; She had a patch on the back of her neck thai itched.; This spontaneous case, initially received on 14-Nov-2024, was reported by a non-health professional and concerns and Other elderly female patient.  Administration of company suspect drugs: On an unknown date, the patient received Influenza virus vaccine for Not Reported., Lot number: No batch number available. Lot number: No batch number available, would be requested upon follow up  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced minor eczema breakouts on her back (outcome: Recovered / Resolved), dental procedure (outcome: Not Reported), yeast infection (outcome: Not Reported), severe pain after the dupixent injection in stomach (outcome: Not Reported), pain in the hands (outcome: Not Reported), cramping in hands (outcome: Not Reported), neck pain that travels down her neck (outcome: Not Reported), uti (outcome: Not Reported), unable to sleep (outcome: Not Reported), has experienced pain at the injection site after her last (outcome: Not Reported), She had a patch on the back of her neck thai itched. (outcome: Not Reported).  Influenza virus vaccine action taken: Not Applicable  Reporter assessment: The reporter did not provide the seriousness and causality assessment of all events; Reporter's Comments: The events were considered as related.
Age: 85.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Pruritus, Sleep disorder, Urinary tract infection
Clinical narrative: minor eczema breakouts on her back; dental procedure; yeast infection; severe pain after the dupixent injection in stomach; pain in the hands; cramping in hands; neck pain that travels down her neck; uti; unable to sleep; has experienced pain at the injection site after her last; She had a patch on the back of her neck thai itched.; This spontaneous case, initially received on 14-Nov-2024, was reported by a non-health professional and concerns and Other elderly female patient.  Administration of company suspect drugs: On an unknown date, the patient received Influenza virus vaccine for Not Reported., Lot number: No batch number available. Lot number: No batch number available, would be requested upon follow up  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced minor eczema breakouts on her back (outcome: Recovered / Resolved), dental procedure (outcome: Not Reported), yeast infection (outcome: Not Reported), severe pain after the dupixent injection in stomach (outcome: Not Reported), pain in the hands (outcome: Not Reported), cramping in hands (outcome: Not Reported), neck pain that travels down her neck (outcome: Not Reported), uti (outcome: Not Reported), unable to sleep (outcome: Not Reported), has experienced pain at the injection site after her last (outcome: Not Reported), She had a patch on the back of her neck thai itched. (outcome: Not Reported).  Influenza virus vaccine action taken: Not Applicable  Reporter assessment: The reporter did not provide the seriousness and causality assessment of all events; Reporter's Comments: The events were considered as related.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Hypertension, Pyrexia
Clinical narrative: Patient reports diarrhea; Tiredness and fatigue; Fever; She has slightly less of an appetite; Lost a little weight; She reports her blood pressure has been inconsistent and has been high a few times; This spontaneous case, initially received on 14-Nov-2024, was reported by a health professional and concerns an elderly female patient.  Administration of company suspect drugs:  On an unknown date, the patient received Fluad (TIV) for Influenza Immunisation. Dose regimen: 0.5 ml. Route of administration: Not reported. Anatomical location: Not reported. Lot number: No batch number available and would be requested upon follow up.  Non-company suspect drugs: COVID-19 vaccine (COVID-19 vaccine). Route of administration: Not reported. Anatomical location: Not reported. Lot number: No batch number available and would be requested upon follow up. Lenvima (Lenvatinib mesilate), Indication: Endometrial Cancer. Dosage regimen: 12mg. Route of administration: Not reported. Lot number: No batch number available and would be requested upon follow up.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Patient reports diarrhea (outcome: Unknown), Tiredness and fatigue (outcome: Unknown), She reports that she had the Covid, (outcome: Unknown), Fever (outcome: Unknown), She has slightly less of an appetite (outcome: Unknown), Lost a little weight (outcome: Unknown), She reports her blood pressure has been inconsistent and has been high a few times (outcome: Unknown).  Patient reports diarrhea, tiredness and fatigue. She reports that she had the Covid, and flu shot and had a fever. Patient reports that she has slightly less of an appetite and has lost a little weight.  She reports her blood pressure has been inconsistent and has been high a few times.  Fluad (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the event as non-serious and causality assessment was not reported.; Reporter's Comments: All the events are related to Fluad (TIV)
Sex: F
Vaccine: COVID19, UNK
Symptoms: Weight decreased
Clinical narrative: Patient reports diarrhea; Tiredness and fatigue; Fever; She has slightly less of an appetite; Lost a little weight; She reports her blood pressure has been inconsistent and has been high a few times; This spontaneous case, initially received on 14-Nov-2024, was reported by a health professional and concerns an elderly female patient.  Administration of company suspect drugs:  On an unknown date, the patient received Fluad (TIV) for Influenza Immunisation. Dose regimen: 0.5 ml. Route of administration: Not reported. Anatomical location: Not reported. Lot number: No batch number available and would be requested upon follow up.  Non-company suspect drugs: COVID-19 vaccine (COVID-19 vaccine). Route of administration: Not reported. Anatomical location: Not reported. Lot number: No batch number available and would be requested upon follow up. Lenvima (Lenvatinib mesilate), Indication: Endometrial Cancer. Dosage regimen: 12mg. Route of administration: Not reported. Lot number: No batch number available and would be requested upon follow up.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Patient reports diarrhea (outcome: Unknown), Tiredness and fatigue (outcome: Unknown), She reports that she had the Covid, (outcome: Unknown), Fever (outcome: Unknown), She has slightly less of an appetite (outcome: Unknown), Lost a little weight (outcome: Unknown), She reports her blood pressure has been inconsistent and has been high a few times (outcome: Unknown).  Patient reports diarrhea, tiredness and fatigue. She reports that she had the Covid, and flu shot and had a fever. Patient reports that she has slightly less of an appetite and has lost a little weight.  She reports her blood pressure has been inconsistent and has been high a few times.  Fluad (TIV) action taken: Not Applicable  Reporter's assessment: The reporter considered the event as non-serious and causality assessment was not reported.; Reporter's Comments: All the events are related to Fluad (TIV)
Sex: M
Vaccine: UNK
Symptoms: Influenza
Clinical narrative: Contracted influenza after receiving the vaccine; This spontaneous case, initially received on 22-Nov-2024, was reported by a health professional and concerns a male patient.  Administration of company suspect drug: On an unknown date, the patient received Fluad (TIV) for Unknown indication, Dose regimen: not reported, route of administration: not reported, Lot number: 388471.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Contracted influenza after receiving the vaccine (outcome: Unknown).  The patient contracted influenza after receiving the FLD vaccine. Moreover, reporter stated she found the information on the online portal.   Fluad (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide the seriousness and causality of the event.; Reporter's Comments: Causality: Unassessable. The information provided is insufficient to perform a more in-depth analysis (event onset date, vaccination date, and relevant lab details not provided).
Sex: M
Vaccine: FLUA4
Symptoms: Prostate cancer
Clinical narrative: Early onset prostate cancer; This clinical trial case, initially received on 25-Nov-2024,  with additional information received on 26-Nov-2024, was reported by an health professional and concerns an elderly male subject.  Weight: 98.4 kg; Height: 171.5 cm  The subject was enrolled in the study  Past medical history included Watchmen procedure, Cardiac Pacemaker placement (for congestive heart failure indication). At the time of the event the subject had Elevated PSA (7.0), Atrial fibrillation, Hypertension, Cardiac Pacemaker user, Congestive heart failure, Prediabetes, Inversion (poor air quality) allergy, gout, Back Pain, Erectile disfunftion. Concomitant medication: refer to appropriate report section. Historical vaccine included Covid-19 vaccine: (Indication: Covid-19 prophylaxis)  Other basis of causality included newly diagnosed. The patient had no influenza vaccinations within three previous influenza seasons.  Administration of company suspect drug: On 08-Dec-2023 16:18, the subject received aQIVc HD vs QIVr vs aQIV for Prophylaxis of influenza, Dose regimen: 0.5 ml, Route of administration: Intramuscular. The study vaccine was administered as per the protocol.  No additional suspect drugs.  Adverse reactions/events and outcomes: On Aug-2024, the subject experienced Early onset prostate cancer (Medically Significant, outcome: Not recovered / Not resolved).  Event was ongoing at the time of study completion. Reported by subject at their Day 365 visit. Medical records requested.  On an unknown date in Oct-2024, the subject took Influenza vaccine for Influenza prophylaxis, and Covid-19 vaccine for covid-19 prophylaxis, 1 injection intramuscularly and stop date: Oct-2024.  On an unknown date in Oct-2024, the subject took Influenza vaccine for Influenza prophylaxis, 1 injection intramuscularly and stop date: Oct-2024.  aQIVc HD vs QIVr vs aQIV action taken: Not Applicable Treatment medications: Bicalutamide, Radiation therapy   Reporter's assessment: The investigator considered the event Early onset prostate cancer as moderate and serious due to seriousness criterion of medically significant and not related to the administration of the investigational drug. Alternative cause for the event was Other.  The subject remained blinded in the study.; Reporter's Comments: Causality: In line with the investigator's causality assessment, causal role of the study vaccine is assessed as not related based on implausible temporal relationship (almost 8 months) and biological implausibility. There is no physiological connection by which vaccination and the immune response could cause the reported event. Also, the subject had elevated PSA before entering the study (since 2022). Listedness was assessed using version.
Sex: M
Vaccine: FLUA4
Symptoms: Death
Clinical narrative: Death; This clinical trial case  initially received on 25-Nov-2024, with additional information received on 26-Nov-2024,and 27-Nov-2024, was reported by a health professional and concerns a elderly male subject. Weight: 101 kg; Height: 178 cm  The subject was enrolled in the study    Past medical history included Left Inguinal Hernia, Left Inguinal Hernia Repair, Left Forearm Laceration, Left Forearm Laceration Repair. At the time of the event the subject had benign Prostatic Hyperplasia, Acid Reflux, Tobacco Abuse. Concomitant medication: refer to appropriate report section. The subject received Influenza vaccination within 3 previous season. The subject's historical vaccine included seasonal influenza vaccine (brand not specified) received on 2022 for unspecified indication.   Administration of company suspect drug: On 30-Nov-2023 14:48, the subject received aQIVc HD  vs QIVr vs aQIV for Prophylaxis of influenza, Dose regimen: 0.5 ml, Route of administration: Intravenous, Anatomical location: not reported. Lot number: No batch number available. The vaccine was administered as per protocol.   No additional suspect drugs.   Adverse reactions/events and outcomes: On 31-Oct-2024, the subject experienced Death Severity severe (outcome: Fatal, stop date: 31-Oct-2024).  Staff found on online obituary for this subject on 25-Nov-2024 stating the subject passed away on 31-Oct-2024 at their residence. There was no information if autopsy was performed.  The subject died on 31-Oct-2024. Cause of death: Unknown cause of death.   aQIVc HD  vs QIVr vs aQIV action taken: Not Applicable  Reporter's assessment:   The investigator considered the event Death serious (Severe) due to seriousness criteria of death and causality was not related to the administration of suspect drug. Alternative cause of the event was reported as other.  The subject remained blinded in the study.; Reporter's Comments: Causality: Not related based on implausible temporal and biological relationship (11 months 9 hrs. and 12 min) after administration of study vaccine. Of note, underlying conditions of Tobacco Abuse and elderly age considered as risk factors.  Listedness was assessed using IB version 5.; Reported Cause(s) of Death: Unknown cause of death
Age: 44.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dysgeusia, Parosmia
Clinical narrative: Nearly immediately, I could taste and smell the vaccine. The very same taste/smell you get with contrast for an MRI or CT scan (with heads, I've had several of those). I suppose you could call it metallic. I had the vaccines around 2 and it is currently 5:20 PM. The intensity has decreased but I can still detect the smell and taste.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received a second dose of Abrysvo, off protocol, as they had already received a dose 11/03/2023
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Brain fog, COVID-19, Cardiac disorder, Cardiac stress test
Clinical narrative: Previously completely healthy prior to vaccine. Athletic, long distance runner, very energetic, worked as a nurse standing 10+ hours a day.  No immediate reaction to vaccine. After about 3 hours, severe aching pain at injection site (much more severe than any flu shot I'd had before). Next day, developed fever 103 degrees F. Severe fatigue x 4-5 days, followed by generalized fatigue and weakness. Fatigue and weakness worsened after 2nd dose (Moderna, lot# 012M20A) on January 27, 2021, where 15 hours after vaccine, I developed fever, severe weakness, shortness of breath, loss of consciousness with seizure-like activity. Improved back to general fatigue and mild shortness of breath within a few days, but never fully recovered to my previous normal energy levels and strength. Since vaccine, developed orthostatic intolerance/ dizziness when standing, severe fatigue, shortness of breath/ air hunger, post-exertional malaise, cognitive decline/ "brain fog",  episodes of SVT and V-Tach while at rest, fainting episodes, general weakness, poor circulation to extremities (especially legs and feet), skin allergies resulting in rash and pruritis all over body, mostly extremities. Issues that occurred after vaccine but have since resolved:  Intermittent fever of unknown origin - weekly low grade fevers x 1.5 years, night sweats x 3 years, migraines x 1 year.  Disabled, unable to work full time, lost 3 jobs due to new symptoms since vaccine. Cardiac issues started in December 2021 a few months after testing positive for COVID-19 in September 2021. Migraines began in September of 2021 and worsened in severity and frequency in November 2021, and lasted for a year. Skin sensitivities began in June of 2023. It is unknown whether these particular symptoms were caused by my COVID-19 infection in September 2021 or by lingering effects of the vaccines from December 2020 and January 2021. I have only had 2 positive COVID tests: First one was in September 2021 and the second was in October 2023.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Computerised tomogram thorax, Dermatitis allergic, Dizziness postural, Dyspnoea
Clinical narrative: Previously completely healthy prior to vaccine. Athletic, long distance runner, very energetic, worked as a nurse standing 10+ hours a day.  No immediate reaction to vaccine. After about 3 hours, severe aching pain at injection site (much more severe than any flu shot I'd had before). Next day, developed fever 103 degrees F. Severe fatigue x 4-5 days, followed by generalized fatigue and weakness. Fatigue and weakness worsened after 2nd dose (Moderna, lot# 012M20A) on January 27, 2021, where 15 hours after vaccine, I developed fever, severe weakness, shortness of breath, loss of consciousness with seizure-like activity. Improved back to general fatigue and mild shortness of breath within a few days, but never fully recovered to my previous normal energy levels and strength. Since vaccine, developed orthostatic intolerance/ dizziness when standing, severe fatigue, shortness of breath/ air hunger, post-exertional malaise, cognitive decline/ "brain fog",  episodes of SVT and V-Tach while at rest, fainting episodes, general weakness, poor circulation to extremities (especially legs and feet), skin allergies resulting in rash and pruritis all over body, mostly extremities. Issues that occurred after vaccine but have since resolved:  Intermittent fever of unknown origin - weekly low grade fevers x 1.5 years, night sweats x 3 years, migraines x 1 year.  Disabled, unable to work full time, lost 3 jobs due to new symptoms since vaccine. Cardiac issues started in December 2021 a few months after testing positive for COVID-19 in September 2021. Migraines began in September of 2021 and worsened in severity and frequency in November 2021, and lasted for a year. Skin sensitivities began in June of 2023. It is unknown whether these particular symptoms were caused by my COVID-19 infection in September 2021 or by lingering effects of the vaccines from December 2020 and January 2021. I have only had 2 positive COVID tests: First one was in September 2021 and the second was in October 2023.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Fatigue, Impaired work ability, Implantable cardiac monitor insertion, Injection site pain
Clinical narrative: Previously completely healthy prior to vaccine. Athletic, long distance runner, very energetic, worked as a nurse standing 10+ hours a day.  No immediate reaction to vaccine. After about 3 hours, severe aching pain at injection site (much more severe than any flu shot I'd had before). Next day, developed fever 103 degrees F. Severe fatigue x 4-5 days, followed by generalized fatigue and weakness. Fatigue and weakness worsened after 2nd dose (Moderna, lot# 012M20A) on January 27, 2021, where 15 hours after vaccine, I developed fever, severe weakness, shortness of breath, loss of consciousness with seizure-like activity. Improved back to general fatigue and mild shortness of breath within a few days, but never fully recovered to my previous normal energy levels and strength. Since vaccine, developed orthostatic intolerance/ dizziness when standing, severe fatigue, shortness of breath/ air hunger, post-exertional malaise, cognitive decline/ "brain fog",  episodes of SVT and V-Tach while at rest, fainting episodes, general weakness, poor circulation to extremities (especially legs and feet), skin allergies resulting in rash and pruritis all over body, mostly extremities. Issues that occurred after vaccine but have since resolved:  Intermittent fever of unknown origin - weekly low grade fevers x 1.5 years, night sweats x 3 years, migraines x 1 year.  Disabled, unable to work full time, lost 3 jobs due to new symptoms since vaccine. Cardiac issues started in December 2021 a few months after testing positive for COVID-19 in September 2021. Migraines began in September of 2021 and worsened in severity and frequency in November 2021, and lasted for a year. Skin sensitivities began in June of 2023. It is unknown whether these particular symptoms were caused by my COVID-19 infection in September 2021 or by lingering effects of the vaccines from December 2020 and January 2021. I have only had 2 positive COVID tests: First one was in September 2021 and the second was in October 2023.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Magnetic resonance imaging heart, Malaise, Migraine, Night sweats
Clinical narrative: Previously completely healthy prior to vaccine. Athletic, long distance runner, very energetic, worked as a nurse standing 10+ hours a day.  No immediate reaction to vaccine. After about 3 hours, severe aching pain at injection site (much more severe than any flu shot I'd had before). Next day, developed fever 103 degrees F. Severe fatigue x 4-5 days, followed by generalized fatigue and weakness. Fatigue and weakness worsened after 2nd dose (Moderna, lot# 012M20A) on January 27, 2021, where 15 hours after vaccine, I developed fever, severe weakness, shortness of breath, loss of consciousness with seizure-like activity. Improved back to general fatigue and mild shortness of breath within a few days, but never fully recovered to my previous normal energy levels and strength. Since vaccine, developed orthostatic intolerance/ dizziness when standing, severe fatigue, shortness of breath/ air hunger, post-exertional malaise, cognitive decline/ "brain fog",  episodes of SVT and V-Tach while at rest, fainting episodes, general weakness, poor circulation to extremities (especially legs and feet), skin allergies resulting in rash and pruritis all over body, mostly extremities. Issues that occurred after vaccine but have since resolved:  Intermittent fever of unknown origin - weekly low grade fevers x 1.5 years, night sweats x 3 years, migraines x 1 year.  Disabled, unable to work full time, lost 3 jobs due to new symptoms since vaccine. Cardiac issues started in December 2021 a few months after testing positive for COVID-19 in September 2021. Migraines began in September of 2021 and worsened in severity and frequency in November 2021, and lasted for a year. Skin sensitivities began in June of 2023. It is unknown whether these particular symptoms were caused by my COVID-19 infection in September 2021 or by lingering effects of the vaccines from December 2020 and January 2021. I have only had 2 positive COVID tests: First one was in September 2021 and the second was in October 2023.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Orthostatic intolerance, Poor peripheral circulation, Pruritus, Pyrexia, Rash
Clinical narrative: Previously completely healthy prior to vaccine. Athletic, long distance runner, very energetic, worked as a nurse standing 10+ hours a day.  No immediate reaction to vaccine. After about 3 hours, severe aching pain at injection site (much more severe than any flu shot I'd had before). Next day, developed fever 103 degrees F. Severe fatigue x 4-5 days, followed by generalized fatigue and weakness. Fatigue and weakness worsened after 2nd dose (Moderna, lot# 012M20A) on January 27, 2021, where 15 hours after vaccine, I developed fever, severe weakness, shortness of breath, loss of consciousness with seizure-like activity. Improved back to general fatigue and mild shortness of breath within a few days, but never fully recovered to my previous normal energy levels and strength. Since vaccine, developed orthostatic intolerance/ dizziness when standing, severe fatigue, shortness of breath/ air hunger, post-exertional malaise, cognitive decline/ "brain fog",  episodes of SVT and V-Tach while at rest, fainting episodes, general weakness, poor circulation to extremities (especially legs and feet), skin allergies resulting in rash and pruritis all over body, mostly extremities. Issues that occurred after vaccine but have since resolved:  Intermittent fever of unknown origin - weekly low grade fevers x 1.5 years, night sweats x 3 years, migraines x 1 year.  Disabled, unable to work full time, lost 3 jobs due to new symptoms since vaccine. Cardiac issues started in December 2021 a few months after testing positive for COVID-19 in September 2021. Migraines began in September of 2021 and worsened in severity and frequency in November 2021, and lasted for a year. Skin sensitivities began in June of 2023. It is unknown whether these particular symptoms were caused by my COVID-19 infection in September 2021 or by lingering effects of the vaccines from December 2020 and January 2021. I have only had 2 positive COVID tests: First one was in September 2021 and the second was in October 2023.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Seizure like phenomena, Sensitive skin, Supraventricular tachycardia, Syncope
Clinical narrative: Previously completely healthy prior to vaccine. Athletic, long distance runner, very energetic, worked as a nurse standing 10+ hours a day.  No immediate reaction to vaccine. After about 3 hours, severe aching pain at injection site (much more severe than any flu shot I'd had before). Next day, developed fever 103 degrees F. Severe fatigue x 4-5 days, followed by generalized fatigue and weakness. Fatigue and weakness worsened after 2nd dose (Moderna, lot# 012M20A) on January 27, 2021, where 15 hours after vaccine, I developed fever, severe weakness, shortness of breath, loss of consciousness with seizure-like activity. Improved back to general fatigue and mild shortness of breath within a few days, but never fully recovered to my previous normal energy levels and strength. Since vaccine, developed orthostatic intolerance/ dizziness when standing, severe fatigue, shortness of breath/ air hunger, post-exertional malaise, cognitive decline/ "brain fog",  episodes of SVT and V-Tach while at rest, fainting episodes, general weakness, poor circulation to extremities (especially legs and feet), skin allergies resulting in rash and pruritis all over body, mostly extremities. Issues that occurred after vaccine but have since resolved:  Intermittent fever of unknown origin - weekly low grade fevers x 1.5 years, night sweats x 3 years, migraines x 1 year.  Disabled, unable to work full time, lost 3 jobs due to new symptoms since vaccine. Cardiac issues started in December 2021 a few months after testing positive for COVID-19 in September 2021. Migraines began in September of 2021 and worsened in severity and frequency in November 2021, and lasted for a year. Skin sensitivities began in June of 2023. It is unknown whether these particular symptoms were caused by my COVID-19 infection in September 2021 or by lingering effects of the vaccines from December 2020 and January 2021. I have only had 2 positive COVID tests: First one was in September 2021 and the second was in October 2023.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Tilt table test, Ventricular tachycardia
Clinical narrative: Previously completely healthy prior to vaccine. Athletic, long distance runner, very energetic, worked as a nurse standing 10+ hours a day.  No immediate reaction to vaccine. After about 3 hours, severe aching pain at injection site (much more severe than any flu shot I'd had before). Next day, developed fever 103 degrees F. Severe fatigue x 4-5 days, followed by generalized fatigue and weakness. Fatigue and weakness worsened after 2nd dose (Moderna, lot# 012M20A) on January 27, 2021, where 15 hours after vaccine, I developed fever, severe weakness, shortness of breath, loss of consciousness with seizure-like activity. Improved back to general fatigue and mild shortness of breath within a few days, but never fully recovered to my previous normal energy levels and strength. Since vaccine, developed orthostatic intolerance/ dizziness when standing, severe fatigue, shortness of breath/ air hunger, post-exertional malaise, cognitive decline/ "brain fog",  episodes of SVT and V-Tach while at rest, fainting episodes, general weakness, poor circulation to extremities (especially legs and feet), skin allergies resulting in rash and pruritis all over body, mostly extremities. Issues that occurred after vaccine but have since resolved:  Intermittent fever of unknown origin - weekly low grade fevers x 1.5 years, night sweats x 3 years, migraines x 1 year.  Disabled, unable to work full time, lost 3 jobs due to new symptoms since vaccine. Cardiac issues started in December 2021 a few months after testing positive for COVID-19 in September 2021. Migraines began in September of 2021 and worsened in severity and frequency in November 2021, and lasted for a year. Skin sensitivities began in June of 2023. It is unknown whether these particular symptoms were caused by my COVID-19 infection in September 2021 or by lingering effects of the vaccines from December 2020 and January 2021. I have only had 2 positive COVID tests: First one was in September 2021 and the second was in October 2023.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Brain fog, Decreased appetite, Fall, Fatigue
Clinical narrative: Received Moderna Booster vaccine. extreme fatigue, nausea, walking backwards, cramping, extreme neuropathic pain, brain fog, no sleep for 4 days, lack of appetite, spinal pain, balance is off, falling and inflammatory response. Could not walk. went to ER by ambulance 4 times. Was seen at ER 11/23/2024 and the last time was 11/28/2024.  Hospital located in same city. Not any better after a week.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Inflammation, Insomnia, Muscle spasms, Nausea
Clinical narrative: Received Moderna Booster vaccine. extreme fatigue, nausea, walking backwards, cramping, extreme neuropathic pain, brain fog, no sleep for 4 days, lack of appetite, spinal pain, balance is off, falling and inflammatory response. Could not walk. went to ER by ambulance 4 times. Was seen at ER 11/23/2024 and the last time was 11/28/2024.  Hospital located in same city. Not any better after a week.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Spinal pain
Clinical narrative: Received Moderna Booster vaccine. extreme fatigue, nausea, walking backwards, cramping, extreme neuropathic pain, brain fog, no sleep for 4 days, lack of appetite, spinal pain, balance is off, falling and inflammatory response. Could not walk. went to ER by ambulance 4 times. Was seen at ER 11/23/2024 and the last time was 11/28/2024.  Hospital located in same city. Not any better after a week.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Insomnia
Clinical narrative: I have chronic insomnia and I have often had a rapid heartbeat after a covid vaccine, eventhough with the previous vaccines, this was less then the first ones. Now this vaccine gave me a bad rapid heartbeat all night. Then the next night no more rapid heartbeat but bad insomnia like described in the case below;
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, SARS-CoV-2 test negative
Clinical narrative: Third pregnancy, one miscarriage; live birth via c-section to 8 lb baby, post-part preeclampsia; currently pregnant with due date 3/17/25
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Injection site induration, Injection site pruritus, Injection site rash
Clinical narrative: Donor reported after the next day of the vaccination of having an skin rah on the site of the injection, size: approximately of 6 inches diameter on the left deltoid where the injection was performed, itchy on the affected area (left deltoid), and skin hardness following the 72 hours after the immunization,. No further complications were reported by donor.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumococcal infection; This spontaneous report has been downloaded from Regulatory Authority referring to a male adult (age: 50-54) patient. The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.   On unknown dates, the patient was vaccinated with two doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.   On an unknown date in 2023, the patient developed pneumococcal infection. The patient's streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was unknown. The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.   Upon internal review, the event of pneumonia pneumococcal was determined to be medically significant.  Additional information is not expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Respiratory tract congestion
Clinical narrative: hoarse voice; congested chest/Congestion in chest; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An adult female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 22Nov2024 as dose 1, single (Lot number: LM2224, Expiration Date: 01Apr2025) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: RESPIRATORY TRACT CONGESTION (non-serious) with onset Nov2024, outcome "unknown", described as "congested chest/Congestion in chest"; DYSPHONIA (non-serious) with onset Nov2024, outcome "unknown", described as "hoarse voice".
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: still have pain in their arm and their arms are sore; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 29Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2024, outcome "not recovered", described as "still have pain in their arm and their arms are sore".  Additional information: Patient received the influenza vaccine and Comirnaty Covid-19 Vaccine on 29Oct2024. He stated it was two shots. She still had pain in her arm and her arms were sore.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400309844 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Illness/Sick; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPILUMAB), first regimen since 21Jun2024) at 200 mg (200 mg, (qow)) and second regimen since 10Jul2024) at 300 mg (300 mg, (qow)), all subcutaneous for asthma. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Illness/Sick". The action taken for dupilumab was unknown.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: COVID-19 twice; COVID-19 twice; COVID-19 twice; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 29-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "recovered" and all described as "COVID-19 twice". Clinical course: The reporter considered events as caused by suspect product. Patient reported experiencing nightsweats, chills, and fatigue after administration of Comirnaty. Patient directly attributed the reaction to the vaccine. Additionally, patient reported contracting COVID-19 twice since his initial two-dose series in late 2021. Description of event was reported as Negative side effects with outcome resolved.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: if she should take Acetaminophen Tylenol for pain; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "if she should take Acetaminophen Tylenol for pain".  Additional information: Reporter wanted to confirm if she take Acetaminophen Tylenol affects the efficacy of Covid 19 vaccine and if she should take Acetaminophen Tylenol for pain.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4-year-old patient inadvertently received a dose of Flublok vaccine with no reported adverse event; Initial information received on 19-Nov-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who inadvertently received a dose of INFLUENZA TRIVALENT RECOMBINANT VACCINE [FLUBLOK TIV] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Nov-2024, the patient inadvertently received INFLUENZA TRIVALENT RECOMBINANT VACCINE  Solution for injection dose 0.5 ml 1x (once) lot TFAA2416 expiry 31-May-2025 via intramuscular route in the left deltoid for Immunization (strength unknown) with no reported adverse event (product administered to patient of inappropriate age) (latency same day).   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 the 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.
Age: 15.0
Sex: F
Vaccine: DTAPIPVHIB, DTP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: consumer was to receive a tdap vaccination but accidently was given pentacel with no adverse event; Initial information received on 19-Nov-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 years old female patient as the consumer was to receive a tdap(diphtheria, tetanus and nos pertussis vaccine) vaccination but accidently was given Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Oct-2024, the patient was to received tdap but accidently was given Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection, 0.5 ml 1x (Once)  Strength =standard via unknown route in unknown administration site for Immunization with no adverse event (wrong product administered) (latency same day).  Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.   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 the 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.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: dermotographia - developed 2 weeks after booster with zero previous symptoms or dicease indications. still present 6 months later.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test, Chest X-ray, Electrocardiogram
Clinical narrative: Atrial fibrillation; eliquis until additional testing can be completed
Age: 11.0
Sex: F
Vaccine: HPV9, MENB, TYP
Symptoms: Fall, Injury, Syncope
Clinical narrative: She fainted 10 minutes after shots were given and fell off exam table hitting her left side.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Hand and forearm numb and tingling 5 hours after administering
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm still sore 2 months later feels like a bruise
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: NO adverse reaction. Pt was supposed to receive meningitis b, Trumenba vaccine but was administered the menquadfi. He already had this at age 11 and 16. This was an adverse event.
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Atrial fibrillation, Cardioversion, Dyspnoea, Fatigue, Loss of personal independence in daily activities
Clinical narrative: Patient says that she started having atrial fibrillation 14 days after receiving her vaccines and is experienceing ongoing symptoms as of 11/30/24. Patient states that since it has started cardioversion has not set her back to normal and she is experiencing fatigue and shortness of breath along with her Afib that she never had before. This is impacting her lifestyke and ability to be active.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Chromaturia
Clinical narrative: I experienced blood red urine for three days starting Nov 21 through Nov 23.2 (no red food or berry juice had been ingested) - swollen lower abdomen.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Dizziness, Exposure during pregnancy, Flushing
Clinical narrative: ON 11/30/24 PATIENT BECAME FAINT AND FLUSH WITH IMMEDIATE LOCAL REACTION AND DROP IN BLOOD PRESSURE.  GIVEN BENADRYL 50MG PER HER PROVIDER, DR., AND BOTTLE OF WATER WITH ELECTROLYTES UNTIL AND REMAINED SEATED UNTIL BLOOD PRESSURE RETURNED TO NORMAL.  WAITED 30 MINUTES AND ALL SYMPTOMS RESOLVED.  PATIENT PREGNANT AT TIME OF ADMINISTRATION. FIRST BLOOD PRESSURE READING AFTER REACTION WAS  86/49 AND HEARTRATE (HR)=60 BPM, SECOND BP TAKEN 10 MINUTES LATER= 109/65 AND HR 71BPM, THIRD AND FINAL BP TAKEN 5 MINUTES LATER=106/69 AND HR 63 BPM
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: patient felt dizzy/lightheaded post vaccine. no anaphylaxis.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Heart rate increased, Muscular weakness, Oxygen saturation decreased
Clinical narrative: Patient received the vaccine at 10:30 AM on 11/19/24. The next morning the patient experienced muscle weakness and had trouble standing. Patient went to the hospital where he stayed 11/20/24 until 11/23/24.  Patient had increased heartrate and decrease in blood oxygen levels. Patient's wife said patient had similar adverse reactions with the previous Pfizer COVID-19 vaccines, however this episode was more severe. Patient was discharged to home and is now feeling well.
Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two flu vaccinations one on 09/19/2024 and another one 11/27/2024- Patient does not have any adverse reactions at this time.
Age: 17.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Feeling abnormal, Hyperhidrosis, Hypotension, Mydriasis, Pallor
Clinical narrative: After getting the Spikevax first, patient started to feel a little off, was given the flu vaccine and started feeling worse, he began to sweat profusely, and his color drained, patient then reported his vision going dark and his pupils were dilated, he was laid down on the ground and started to feel better, after his vision started to return he reported ringing in his ears. He laid on the ground for a few minutes and he was able to walk out of the store under his own power. After an hour or so of leaving the pharmacy I called and spoke with his mom and she reported that he was doing great.
Age: 17.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Tinnitus, Visual impairment
Clinical narrative: After getting the Spikevax first, patient started to feel a little off, was given the flu vaccine and started feeling worse, he began to sweat profusely, and his color drained, patient then reported his vision going dark and his pupils were dilated, he was laid down on the ground and started to feel better, after his vision started to return he reported ringing in his ears. He laid on the ground for a few minutes and he was able to walk out of the store under his own power. After an hour or so of leaving the pharmacy I called and spoke with his mom and she reported that he was doing great.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Purpura, Vasculitis
Clinical narrative: 2 weeks after Fluad, vasculitis with purpura
Age: 73.0
Sex: M
Vaccine: COVID19, PNC20, RSV
Symptoms: Erythema, Skin exfoliation
Clinical narrative: The patient experience red skin on his face similar to a burn.  He also broke out on his face.  He skin is peeling on his face.  His doctor gave him Diphenhydramine 25mg every 6 hours.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Muscle weakness in legs and arms.  Tingling and numbness in feet.  First day of shot extreme fatigue.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain in extremity, X-ray normal
Clinical narrative: Patient states there has been pain in the arm that began immediately following vaccination that has gradually moved down the arm to the wrist/hand over past 2 months. She describes the feeling as "like a piece of the needle being stuck in the arm".
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Throat tightness, Urticaria
Clinical narrative: withing 30 minutes of injection, I developed Hives on my neck ,tightness in my chest and throat and difficulty breathing. I took 1 zyrtec and 1 25 mg tablet of Benadryl with improvement.