chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt in ER on 9-16-10 for "cat scratch" was given ADACEL IM and CIPRO PO. Back to clinic on 9-22-10 - c/o reaction at injection site & itching.
18DEC91 seen for checkup; had cough & congestion but no fever; given HIB; 19DEC91 inc congestion, fever (100) started pediazole; 19DEC91 fever, generalized tonic-clonic sz, about 1-2min, symmetrial, eyes rolled back; Imp: febrile convulsion
Severe Adverse Reaction; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and VACCINATION SITE REACTION (Severe Adverse Reaction) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 DIZZINESS (Dizziness) and VACCINATION SITE REACTION (Severe Adverse Reaction). At the time of the report, DIZZINESS (Dizziness) and VACCINATION SITE REACTION (Severe Adverse Reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Product includes Anti-depressants(not sure) Treatment information was not provided.
Fatigue, body aches, headache, low grade fever, arm pain, axillary pain
0.2ml undiluted pediatric bivalent pfizer booster given.  No immediate symptoms.
Disease recurrence; Caller stated that she has COVID at the moment; Caller stated that she has COVID at the moment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL9266), on 15Mar2021 as dose 2, single (Lot number: EN6204), on 23Aug2021 as dose 3 (booster), single (Lot number: FA7485) and on 04Feb2022 as dose 4 (booster), single (Lot number: 330368D) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jul2022, outcome "unknown" and all described as "Caller stated that she has COVID at the moment"; DISEASE RECURRENCE (medically significant) with onset 02Sep2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Positive; (02Sep2022) Positive. Clinical course: Caller clarified that she had 4 vaccines, she has underlying conditions which she did mail all that information in. She is outside of the window, she got exposed because she is a special education teacher, for some reason they just do not feel masks are important where she works. Her husband and her went traveling for their 30th anniversary trip in the summer, and she was outside window, there was no vaccine available, and so she had to mask up and trust that and know what to do, she did take her flonase and decongestants and knew to rest but she got it, caller clarified that she got covid, she states that over there in other parts of the world there was over crowding, and they did not follow the 6 feet distance. She tested positive for covid on 24Jul2022. On 02Sep2022 is when she had 2 positive at home covid tests and she was symptomatic. She wants this to be informative for both, she thought she would get more immunity without being sick, she was hoping to at least get 90 days.
Severe Brain fog.  Severe headaches.  Multi-day  99-100 F  Fevers.   All symptoms lasting several days.  Affecting daily activities.  Affecting cognitive function, driving, operating self-check-outs, cooking.    Zoning out, spacing out.
Information has been received from a Nurse Practitioner (N. P.) concerning a 23 year old female patient who on 19-MAR-2007 was vaccinated with a first dose of Gardasil (yeast). About two hours later the patient developed itchiness. On the morning of 20-MAR-2007 the patient broke out in hives about the size of a half dollar and they were  painful. The NP reported that they treated the patient with a methylprednisolone (MEDROL DOS-PACK) and sterile triamcinolone acetonide (KENOLOG-40) high dose steroid. The patient was improving , but they will not continue the Gardasil vaccination series for the patient. Patient to be followed up. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow-up information has been received from a Nurse Practitioner and Medical Assistant concerning a 23 year old female with allergies to penicillin and OMNICEF for which she carried an epinephrine pen; who on 19-MAR-2007 at 12:30 pmwas vaccinated with a first dose of GARDASIL IM in right deltoid (lot# 656049/0187U). She had no illness at the time of the vaccination. On 19-MAR-2007, about 2 hours post-vaccination, the patient experienced itchiness. On 20-MAR-2007 at 03:00 (AM or PM not specified) the patient broke out in painful, itchy hives about the size of a half dollar. The hives were all over her body, and were worse around the hairline and joints. The reporter stated that they treated the patient with small dose of methylprednisolone at first then high dose taper, IM sterile KENOLOG-40 high dose steroid and for itching ATARAX. The NP reported that they will not continue with the GARDASIL vaccination series for the patient. Follow up report indicated that on 27-MAR-2007 the patient completely recovered. No additional information is expected.
Extreme dizziness, vomiting, slight headache at lower back of the neck, low fever, some mental confusion, some tingling in extremities, blurred vision.
fatigue, headache, muscle pain, joint pain nausea.  Slept most of the day. No appetite, very little food consumed.
That night after getting the vaccine I went to brush my teeth and was surprised when spitting out the toothpaste that I spit out two mouthfuls of blood before it rinsed clear. After that it stopped.
High fever, up to 103.; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 14:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 02:30, the patient experienced high fever, up to 103 (unspecified units) after taking acetaminophen (TYLENOL) and extreme fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with acetaminophen (TYLENOL). Since the vaccination, the patient had not been tested for COVID- 19. The clinical outcome of the events high fever up to 103 (unspecified units) and extreme fatigue was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Vomiting and diarrhea starting at 0500 on 09/02/15.
Patient is a 58-year-old woman with known history of type 2 diabetes, essential hypertension, GERD, and tested positive for COVID-19 12/31/2021 who presented to emergency department with persistent cough, sore throat, and increased fatigue. The patient first felt unwell last Thursday, 12/30/2021. At that time, the patient had a nonproductive cough and sore throat. The patient tested positive for COVID-19 12/31/2021. By the following day, the patient's sore throat worsened, and the patient presented to an urgent care. At that time, the patient was also diagnosed with sore throat due to group A strep. The patient was prescribed azithromycin and amoxicillin. Over the next several days, the patient lost her sense of taste and smell. Furthermore, the patient became more nauseated. The patient has not been able to eat anything. Because the patient felt more weak and lightheaded due to poor appetite, the patient presented to emergency department for ongoing evaluation and treatment.   In the emergency department, the patient's serum sodium was low to 111. ED provider discussed the patient's case with on-call nephrology, it was felt that the patient required hypertonic saline to correct hyponatremia. A PICC line was placed in the emergency department. The patient was admitted to hospitalist medicine service for ongoing evaluation and treatment.   #. Severe hyponatremia: Patient has hypoosmolar hyponatremia. The patient's hyponatremia  exacerbated by PTA antihypertensive (triamterene-hydrochlorothiazide). -Nephrology consulted. They recommended 3% hypertonic saline 20 ml/hour for 8 hours w/ goal correction 6 (no more than 8) meq over first 24 hours. Na rose above that level so she was given DDaVP. Now off DDAVP. Started NaCl tablets. Continue fluid restriction.   -Continue to hold PTA triamterene-hydrochlorothiazide. Started torsemide.  -PICC line placed. Na now improved to 132.  I will discharge her to home on 1 mg 3 times daily of sodium tablets and advised her to continue holding triamterene hydrochlorothiazide for now.  She will follow-up closely with her PCP and recheck sodium levels.  Stop sodium chloride tablets when sodium normalized.    #TSH mildly elevated but free T4 WNL. Follow up with PCP.     #. Mild COVID 19: The patient is vaccinated and boosted against COVID-19. Covid symptoms began 12/30/2021. The patient is oxygenating well and chest x-ray not demonstrating pneumonia. -Patient does not qualify for systemic steroids -Patient does not qualify for tocilizumab or baricitinib   #. Strep throat: Diagnosed w/ group A strep pharyngitis at urgent care 1/1/2022 (after patient already tested positive for COVID 12/31/2021).  -Patient completing PTA azithromycin and amoxicillin as prescribed by urgent care provider    #. HTN: Holding PTA triamterene-hydrochlorothiazide until sodium normalized and she can follow this up with her PCP.    #. Type II DM: Continue PTA metformin.    Patient is in stable condition and wishes to discharge to home.  She will follow-up closely with her PCP.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 20-JAN-2016 the patient was administered with a dose of improperly stored RECOMBIVAX HB (lot# L027733 and expiration date 13-SEP-2017, dose, dose# and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected since there was no consent for follow up contact.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 05-APR-2014 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-MAY-2016 the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a physician refers to a 12 year old male patient. The patient did not have any medical history, drug reactions or allergies. On 16-JUL-2015, the patient was vaccinated with first dose of GARDASIL 9 at a dose of 0.5 ml (route of administration: subcutaneous). The patient did not take any concomitant medications. On an unknown date, after receiving first dose, the patient experienced annular, well demarcated systemic rash on legs, arms, hands and wrist. On 21-JUL-2016, the patient was vaccinated with second dose of GARASIL 9 (lot # reported as M014929, expiry date: 27-MAY-2017) at a dose of 0.5 ml (route of administration: subcutaneous). On 30-JUL-2016, the patient experienced annular, well demarcated systemic rash on legs, arms, hands and wrist. No complaints of pain or itching were reported. No lab diagnostic tests were performed. Patient received treatment for the events and patient condition was stable at the time of the report. The outcome of the events was unknown. The causality of the events was not reported. Additional information has been requested.
New onset of Atrial Fibrillation with Rapid Ventricular Response (>250). Treatment with multiple anti-arrhythmic medications including Adenosine (12 mg bolus x2), Diltiazem (20 mg bolus + drip), Amiodarone (bolus + drip) and Ibutilide bolus over a 8 hour period. Conversion to sinus rhythm after Ibutilide bolus and have remained ever since. Kept overnight in ICU with Lovonox x2 and continued Amiodarone drip and discharged the following afternoon. New medications upon discharge: Multaq and Eliquis. Follow up with cardiology and electrophysiology cardiologist.
Had increasing fluid build up in lungs, necessitating repeated coughing to expel.  Became worse after retiring to bed, ingested two sudafed tablets but no significant relief.  Condition abated at around 1:00 AM, four hours later.  Also experienced mild dizziness during this period.  On rising at 4:30 AM had no residual effects other than feeling tired.
About 2 weeks after vaccine, I got very tired tired and lethargic, with brain fog. This lasted about 2 weeks.
Erythema, swelling, pain at  BCG vaccine site (received as a child in Costa Rica).
On the morning of April 22, I woke up with a bright red rash the size of my palm about three inches below the injection site. That resolved by the morning of April 24. On the morning of April 27, I woke up with red spots that look similar to chicken pox all over my torso, a few on my back, left arm, and left thigh.
Am became swollen, red painful, & nodules developed under arm with a fever & hot feeling well. Patient had to leave work.
Joint pain; chest pain; difficulty breathing; headaches; diarrhea; swelling; hives; rash; watery eyes; ear pain; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EP7534, Expiration date was not reported), via an unspecified route of administration in arm right on 20Mar2021 at 01:30 AM (at the age of 26-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. The patient's concomitant medications in two weeks were reported as no. The patient did not receive any other vaccines within 4 weeks. No covid prior vaccination and no covid tested post vaccination. On 15Apr2021 at 12:30 PM, the patient experienced joint pain, chest pain, difficulty breathing, headaches, diarrhea, swelling, hives, rash, watery eyes and ear pain. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received the second dose of Pfizer with Lot number: ER8734 in arm left. Treatment was not received for the events. The outcome of the events was recovered with sequel (recovered with lasting effects).   Follow-up attempts are completed. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-MAY-2012, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) at a clinic (by an unspecified healthcare professional) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 03-NOV-2015, the patient was treated at the clinic (by an unspecified healthcare professional) for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The patient was prescribed VALTREX, prednisone and gabapentin for management of her painful symptoms and chronic pain. On or about 15-NOV-2015, the patient sought subsequent treatment from the clinic for a persistent vesicular rash, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections. The patient was prescribed ZOSTRIX for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
both arms started shaking like having seizures on the outside; could not breathe good; heart rate high like 140; Headache; has been sleeping a lot ever since; This is a spontaneous report from a contactable nurse. A 56-years-old female patient (sister) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: FC318), dose 2 via an unspecified route of administration, administered in right arm on 20Sep2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included ongoing asthma which was diagnosed years ago. There were no concomitant medications. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number of FCJ183) via an unspecified route of administration, administered in right arm on 30Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. On 21Sep2021, the patient's both arms started shaking like having seizures on the outside which started at 01:00 to 02:00, could not breathe good, heart rate high like 140, headache and was sleeping a lot ever since. They had to call her doctor and they did some things that helped. She took Ibuprofen for headache and did breathing treatment. The patient underwent lab tests and procedures which included heart rate was 140 and heart rate high like 140 on 21Sep2021. The outcome of sleep disorder was not recovered; headache was recovering and all the other events wee recovered on 21Sep2021. There was product quality complaint (PQC) present. Follow-up attempts are completed. No further information is expected.
very bad pain in upper arm-difficulty moving arm above head;arm swelled @ inj site, fever in arm, still has knot @ inj site;
Back pain, stomach pain, shortness of breath, light headed. Follow up 06/05/2000: "Patient recovered from adverse event."
clothes that make me warm or hot; small rash all along the axillary border that appeared very inflamed; hives/broke out in whelps under my armpits that hurt and itched a lot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (clothes that make me warm or hot), RASH (small rash all along the axillary border that appeared very inflamed) and URTICARIA (hives/broke out in whelps under my armpits that hurt and itched a lot) in a 65-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no.) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: ARMOUR THYROID. Past adverse reactions to the above products included Thyroid disorder with ARMOUR THYROID. Concurrent medical conditions included Hashimoto's thyroiditis.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced RASH (small rash all along the axillary border that appeared very inflamed) and URTICARIA (hives/broke out in whelps under my armpits that hurt and itched a lot). On an unknown date, the patient experienced FEELING HOT (clothes that make me warm or hot). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, FEELING HOT (clothes that make me warm or hot) outcome was unknown and RASH (small rash all along the axillary border that appeared very inflamed) and URTICARIA (hives/broke out in whelps under my armpits that hurt and itched a lot) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported patient receive any other vaccines in the 4 weeks prior to COVID-19. About 3 weeks later, approximately 05-Nov-2022, patient broke out in helps under armpits that hurt and itched a lot. It soon developed into a small rash all along the axillary border that appeared very inflamed. It was somewhat better there as it was intermittent, but it was all over patient torso, anterior and posterior. It gets worse if patient had on clothes that make warm or hot. Patient had never had hives before and patient very healthy 65-year-old. Patient did not had symptoms of Hypothyroid with the medication and had again never had hives.  It was very uncomfortable and only controlled somewhat with antihistamines and topical hydrocortisone ointment or cream   This case was linked to US-MODERNATX, INC.-MOD-2022-693148 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-693148:case (reporter)
Moderna COVID 19 requirement  Brought to ER for memory issues, mania like symptoms, lack of sleep, wandering, noncompliance with medications, paranoia  Admitted to Geriatric Inpatient Psychiatric unit
MMR vaccine given 08/26/04. Rash was noted to injection site 08/28/04 and was all over chest. Pt also developed a low grade fever of 100 degrees. Pt was seen in office on 08/30/04 to evaluate.
Pt developed a red circular rash on the 13th, his rash was hot to the touch and his arm was sore. On the 14th, the rash had doubled in size was still hot to the touch and his arm was sore from the shoulder to the wrist. He went to the doctor that same day (14th) and was diagnosed with cellulitis. He is required to take IC CEPHALEXIN (500mg) twice daily for 7 days. Please note that he never developed a fever or showed other symptoms. We expect a full recovery. I wanted to share our experience so maybe it will help other parents. This was a frighting experience.