chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presents with tingling to right sided face and right arm, Johnson and Johnson covid vaccine recieved 7/9/2021. no other neuro deficits. equal bilateral hand grips, equal facial symmetry, negative arm drift. Patient is also complaining of chest pain.  Patient states that 4 days ago they received a Johnson & Johnson vaccination at clinic, and since then they have been experiencing the symptoms.  He states that he called the clinic advice nurse and he was advised to come to the ED for evaluation.  He denies any nausea, vomiting, fever, or diarrhea. On exam, patient moves bilateral upper and bilateral lower extremities with 5 out of 5 strength.  Her neurologic exam is unremarkable.  Laboratory studies are within normal limits, platelets are 323.
Approximately 10 hours after receiving vaccines and witnessing her sister feeling faint following a vaccine. Client stated "I don't feel good", color pale and client leaned back in chair. Client stiffened suddenly and leaned to the right in the chair, slight tremors noted. No response to verbal communication, lost bladder control. Episode lasted approx 5 seconds, client received ammonia et started to respond. Opened eyes sat up and color came back to pink. Sat for 20 minutes. Responded appropriately to all questions. Ice packs applied to neck.
Patient received the moderna brand covid-19 vaccination by mistake (supposed to receive pfizer due to age restrictions). No treatment necessary. Patient and legal guardian aware wrong vaccine was given and will report any adverse reactions if necessary. Will follow up with patient in regard to next steps in completion of vaccination.
Brain fog and chronic fatigue. No longer able to work after struggling over 6 months with no relief.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: patient was feeling chest pain and tightness, was instructed to go to the emergency room for fear of myocarditis in patient specific population...at the emergency room he was given chest x-ray, bloodwork taken and consulted to see pediatric cardiologist later this week
Other female patient with these issues; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Other female patient with these issues) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Other female patient with these issues). At the time of the report, ADVERSE REACTION (Other female patient with these issues) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
patient was given 0.5ml injection of the vaccine 14 days after the beyond use date .
Patient is a 95 y.o. male PMHx AS s/p TAVR (1/3/2019) c/b CHB s/p PPM (1/9/2019), non obstructive CAD (LHC 1/2019), CKD3b (baseline cr ~ 1.5), HTN, HLD, HFpEF, prostate cancer s/p resection (1993), recent COVID infection (positive 9/27/23 s/p paxlovid) who presented from IL on 10/3/2023 with CC weakness, fatigue, myalgias. Hospital course complicated by issues with dizziness/labile blood pressures, as well as acute on chronic back pain from recent fall. Orthostasis improved with gentle IVF as well as holding BP medications. TTE 10/09/2023 showing TAVR with stable function compared to report from 10/31/2019. PT/OT recommending SNF on discharge. Patient stable for discharge on 10/09 in stable condition to SNF.   COVID-19, resolved Fatigue Poor Appetite, improved - Positive 9/27 s/p paxlovid; sxs onset 9/26 - here with fatigue, weakness, myalgias, and restlessness (severe/almost akethisia like) - Continue PT/OT; appreciate CM assistance with SNF at discharge   Dizziness Orthostatic hypotension - Orthostasis quite positive, noted history of HFpEF and AS s/p TAVR - Improved with gentle IVF - TTE 10/09: Unchanged/stable TAVR compared to TTE in October 2019. - Discontinue Bumex and Coreg on discharge. Continue amlodipine 5 mg daily. Follow up with Cardiology as outpatient to discuss further GDMT.   Acute on Chronic Back Pain - suspect OA and in light of fall above - TTP on left SI joint, no tenderness of lumbar SP; no observed erythema; gait with walker observed without foot drop; sacral XR as below - Continue lidocaine patch, tylenol, and gabapentin; encourage PT/OT   Mechanical Fall - trying to get off toilet 10/4, no LOC, did not strike head, no prodromal sxs - "toilet was too low;" neuro checks benign; no skin tears appreciated - sacral XR without fracture - PT/OT following AS s/p TAVR - continue ASA 81   HTN - Home regimen: coreg 6.25 BID, bumex 0.25 mg daily, amlodipine 5 mg daily. - Discontinue Coreg and Bumex.  Increase amlodipine back to 5 mg daily.  Advise accepting higher blood pressures to avoid orthostasis and falls.   Chronic HFpEF - Do not see recent exacerbation (likely was related to AS history) - Holding diuresis and Coreg as above.  Will discontinue on discharge. Follow up with PCP and Cardiology.   CKD3b - at baseline cr(1.6-1.8) - trend BMP daily; trend UOP   CHB - s/p ppm 2019 - Noted.   Gout - Continue allopurinol 150 mg daily (due to CKD).   Toxic metabolic encephalopathy, resolved - ED documentation showing that he is agitated and made a comment "I wish I had a gun"  - s/p haldol and seroquel 10/3; no access to firearms at independent living - no further SI/HI; mentation remains intact; AMA precautions removed. - Monitor.   Numbness, resolved - New 10/7/23, left face, suspect related to CKD and gabapentin - on left face, no dysarthria or dysmetria; no ringing in ears  Continue gabapentin 100 mg TID (reduced dose due to CKD).
So I had some irritation in my Vagina and I went to the doctor and she agreed there was irritation and she prescribed a nystatin cream and I followed up with her a week later and there was no improvement and the irritation turned into a mass and caused a blockage, it was too large to drain that day and when she lanced it nothing drained out and we had imaging done it was a 7 cm mass and it was drained in the ER by another physician.  They cultured it and it grew group B strep which it was normal for the vagina and before draining it they put me on a 10 day of Bactrim,  I am still experiencing issues with it and being followed my a general surgeon because that area that was drained is now filled with air.   My primary physician was going to follow but the mass filled with air has traveled to the buttocks area so it is being monitored and I have a CT scan next week for further diagnosis.
COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was initially told to take Vitamin C and Zinc. The patient was prescribed with antibiotics and steroids.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of  COVID-19 is assessed as unlikely related.   This case was linked to US-MODERNATX, INC.-MOD-2021-068675 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow-up information was received which included date of event and treatment.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of  COVID-19 is assessed as unlikely related. US-MODERNATX, INC.-MOD-2021-068675:
w/in 1hr of vax pt devel large red area & itching @ inj site;w/in 2hr a large welt devel;ice pack applied, DPH given;
Had fatigue, malaise, afebrile, itching around injection site. Looked at site, it was edematous and erythemous in a 2" by 3" oval around the injection puncture. Called FDA who encouraged me to make this report.
It is lower jaw that is swollen; Lower teeth has pain there / it has gotten worse since Saturday; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (It is lower jaw that is swollen) and TOOTHACHE (Lower teeth has pain there / it has gotten worse since Saturday) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported.).    On 23-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (It is lower jaw that is swollen) and TOOTHACHE (Lower teeth has pain there / it has gotten worse since Saturday). At the time of the report, SWELLING FACE (It is lower jaw that is swollen) and TOOTHACHE (Lower teeth has pain there / it has gotten worse since Saturday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications were reported. Upon in internal review on 21 May 2021, the age was corrected to unknown age.
Information has been received from a lawyer regarding a case in litigation concerning an approximately 12 month old male child who on 1/25/95 was vaccinated IM with his third dose of hep B vaccine recombinant lot 611468/0653A given on 1/25/95; lot 613800/1291A given on 3/27/95 and 5/26/97. An immunization record indicated that the pt was also vaccinated IM with four dose of Tripedia (lot 3C51043 given on 1/25/95, lot 4A61098 given on 3/27/95 and 5/26/95 and lot U031 given on 12/19/00; one dose of Tetramune lot 429-969 given on 1/29/96 and three doses of HibTITER lot 305lF given on 1/2/95; lot 265LJ given on 3/27/95, lot 005LK given on 5/26/95. It was noted that all of these vaccinations contain the mercury laden preservative thimerasol. It is alleged that due the accumulation of mercury in his body and the resultant mercury toxicity, the pt at approximately 12 months of age was neurologically devastated and "suddenly regressed developmentally, losing milestones and neurological development previously achieved, specifically including, but not limited to, becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior, and the loss of language skills, motor skills and affect." Upon internal review the pt's mercury toxicity, neurological devastation, withdrawn/unresponsive behavior, inability to speak, repetitive behavior and loss of language skills, loss of motor skills and loss of affect were determined to be other important medical events. Additional info is expected.
This is a spontaneous report from a contactable pharmacist via a Pfizer-sponsored program. A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EY0584; Expiration Date: 31Oct2021) via an unspecified route of administration on 23Jul2021 (at the age of 52-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No prior vaccination to Covid Vaccination before 4 weeks. On an unspecified date, the patient experienced covid positive after getting first dose covid vaccine. Pharmacist reported that patient was asking how to go for the second dose, and how to guide the patient about receiving the second dose of Pfizer BioNTech Covid-19 Vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test resulted with positive. Patient received treatment for events with antibody infusion on 03Aug2021. The outcome of events was unknown. Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors, however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness cannot be ruled out.
his arm is hurting; he experienced injection site discomfort during administration of the vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare professional via Medical Information Team. An 87-years-old male patient (Husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL1283) via an unspecified route of administration in left arm on 14Jan2021 and second dose on BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL8982) via an unspecified route of administration in left arm on 04Feb2021 at 17:30 both as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 04Feb2021 05:30 pm, the patient experienced injection site discomfort during administration of the vaccine and on an unspecified date, patient experienced his arm is hurting. Reporter mentioned that the same thing happened on the first shot. Outcome of the events was resolved on unspecified date in 2021.
chills fever nausea vomiting and diarrhea - all began same night as vaccination. all resolved by next day
.Had first COVID vaccine April 6 she had her COVID shot and after two weeks  had "COVID arm and terrible pain" and then two weeks after her second shot May 14th, again had "COVID arm and terrible pain". On June 6 sharp pain transitioned into numbness and tingling.  Can occur anywhere face, hands, legs Also have muscle twitching and "fluttering' throughout entire body all the time. Also have internal buzzing and electrical shock feelings. Constant fatigue and thinking is not clear. Unable to complete daily tasks such as cooking.
PATIENT REPORTS WAKING AT 3AM AFTER GETTING THE SHOT WITH EXTREME JOINT PAIN, FULL BODY ACHE AND RED SWOLLEN ARM.
Pfizer-BioNTech COVID-19 Vaccine  Metallic taste in my mouth, started right after the vaccination and lasted about three days
Immediately developed soar arm, chills, swollen arm, fever, night sweats, body aches, tachycardia.  I have never missed a day of work in 22 years, I kept going to work and it eventually kept getting worse and made a appointment with my PCP. Over the two weeks my thyroid became swollen, every muscle in my body was hurting and had bad neck pain and my thyroid was swollen.  I went to get Blood work that my PCP ordered and it came back having Hyperthyroidism. She told me to see an Endocrinologist. I have seen the Endocrinologist twice and  have blood work again and said I was in with Hyperthyroidism and started 6 weeks of prednisone.  I still feel terrible.
Patient recieved Moderna #1 dose at the age of 17 which its not recommended for this age group. At this time patient does not have any symptoms or adverse reaction.
This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 78-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose was received on unknown date). On 22nd October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, 3 days after receiving SHINGRIX, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved. It was unknown if the reporter considered the vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a rash 3 to 5 days after the vaccination that would not go away. The patient was extremely convinced that it's shingles from the shot. The patient visited her dermatologist and was told that it should not be shingles, but the dermatologist believed that it looks like shingles. The rash was located in the lower extremities. The vaccine administration facility was the same as primary reporter.
Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 005C21A and 023C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient received Moderna Covid-19 vaccine that underwent a temperature excursion. The temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna Covid-19 vaccine was stored in. The reporter (Nurse) had used the online Temperature excursion tool and was comfortable that the patient's dose was valid and that the affected vaccine was viable for future doses. Side effects after any doses were unknown. No treatment information was reported.   This case was linked to MOD-2022-612827 (Patient Link).
***Moderna COVID-19 Vaccine EUA*** Experienced symptoms of stroke - SUDDEN weakness, confusion, cognitive and physical difficulty in speaking, slight weakness and drooping on right side of face (uneven smile/facial expression), sharp painful headache on right back side of head. Very difficult to physically sit or stand up, unable to drive, unable to hold a conversation, unable to communicate verbally what was happening to me. Symptoms subsided on their own after a few hours. Lingering symptoms of drooping facial muscles on right side, increased difficulty in word recall, and periodic headache in the same place. INCORRECTLY diagnosed with hyperthyroidism. I believe I had a TIA. Will be seeing a neurologist to confirm.
no additional adversse effect reported; patient was administered a dose of properly stored but expired VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 18-MAY-2020, the patient was vaccinated with a dose of properly stored but expired hepatitis a vaccine, inactivated(VAQTA) lot # S002459 with expiration date 15-MAY-2020 (dose, route and anatomical location were not reported) for prophylaxis. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S002459; expirationdate: 15-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Tdap on 2/4 and developed unilateral L sided joint pain of shoulder, elbow, and knee that resolved after 24-48 hours.
Shot given high in left arm and EE immediately felt pain.  1 month later EE continued to have severe pain and was seen by provider (11/3/2020). At rest has sensation of discomfort and pressure in left shoulder and along outside of her arm towards the elbow.  With any movement she has pain rated at 7/10 from injection site and radiating downwards towards the elbow on outside of arm. Received cortisone injection in November with relief and started PT. 12/31/2020 pain was starting to come back.
knee pain [tendonitis] developed in October after lap swimming for exercise which responds to rest - I've never experienced this before and don't know whether this is significant. Seems like a minor thing in the face of so many tragic events - in case it's important, feel free to contact me.
Reoccurrence of genital herpes; This case was reported by a consumer via sales rep and described the occurrence of genital herpes in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2019, the patient received Shingrix. On 16th September 2019, 6 days after receiving Shingrix, the patient experienced genital herpes. On an unknown date, the outcome of the genital herpes was unknown.   It was unknown if the reporter considered the genital herpes to be related to Shingrix.  Additional details were provided as follows: The patient experienced a reoccurrence of genital herpes. The patient stated that not had an active incidence of herpes for approximately 4 years.
Patient had a syncopal episode followed by tonic/clonic seizure like activity. This lasted between 3 and five minutes. When she came out of it, her body and face were white and lips were purple. She had no recollection of what had taken place. The next 36 hours she described significant stomach pain, extreme fatigue, dizziness, and anxiety/depression.
Patient is a 82 y.o. male who presents with a fever and cough. PMH pertinent for relapsed CLL with Richter's transformation to high grade lymphoma on chemotherapy (last chemo 1/31), recent Covid-19 infection 1/18, hypothyroidism, CKD 3, BPH.