chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bottom half of my body, hips and below, became completely numb. All at once my hips, legs, feet, and toes did not respond to my muscles. They burned as if they were 'asleep'. I was sitting in a chair for 10 minutes eating lunch when this happened. I was able to use my arms and steady myself to walk to the couch, I tried sitting and laying down. I tried standing up with support but nothing seemed to lessen the pain and inability to move my lower body on its own. After 15 minutes my left leg felt normal and within a minute the rest of my lower body felt fine. Has not happened again.
Inconsolable crying, racing of heart beat. Swelling of throat. Difficulty swallowing. Developed rash all over body. Eye rolled back into head several times. Wheezing and very pale. fever went up to 104.6.
Headache; Redness/erythema; Rash on torso; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness/erythema), RASH (Rash on torso) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 04?B21) for COVID-19 vaccination.     The patient's past medical history included Stomach virus. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced ERYTHEMA (Redness/erythema) and RASH (Rash on torso). On 04-Apr-2021, the patient experienced HEADACHE (Headache). On 04-Apr-2021, ERYTHEMA (Redness/erythema) and RASH (Rash on torso) had resolved. At the time of the report, HEADACHE (Headache) had resolved.            No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-May 2021:Added patient demographics, reporter information, second dose, concomitant medication. Event details were added and updated.
09/04/2021 Booster / Vaccination 01/19/2022 Diagnosed with COVID. I got really sick; 'long-hauler'. I went to Dr. and told it was sinus infection. Test came back originally as negative. Medication was not helping, I couldn't breath. Test then came back positive. I developed asthma. Couldn't get antibody infusions. I am left with a lot of fatigue, RA in my hands, hair loss; inflammatory symptoms.  01/08/2021 1st vaccination Moderna 025L20A 03/27/2021 2nd vaccination Moderna 027A21A I had all 3 vaccinations and had a breath thru case of COVID, resulting in 3 major inflammatory symptoms. Considered a 'long-hauler'.
no other AEs reported; needle malfunction caused a patient to receive a smaller than recommended dose of PROQUAD (0.3ml as opposed to 0.5ml).; needle malfunction; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 15-JUN-2021, when the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number T025509 expiration date 23-JAN-2022 (route of administration was not provided) for prophylaxis, the needle had a malfunction (product quality issue) causing that the patient to receive 0.3 milliliter instead of 0.5 milliliters as the recommended dose (underdose). No adverse event was reported.
Information has been received from a RN concerning a pt who on 28Jun01 was vaccinated with a dose measles virus vaccine live  (+) mumps virus vaccine live (+) rubella virus vaccine live. Subsequently, it was reported that the pt developed autism. Unspecified medical attention was sought. At the time of this report the pt had not recovered and there was no further information provided. No product quality complaint was involved. Upon internal review, autism was determined to be an other important medical event (OMIC). No further information is available.
Patient received the wrong vaccine for age group by clinic RN. Patient was supposed to receive DtaP, IPV, Hib, Hep B, Hep A, and PCV-13. Mother opted to only get 2 vaccines and defer others at a later date. Patient did not experience adverse reaction or notified of any adverse reaction reported by mother. Clinic tried multiple attempts to contact mother to which she did not respond.
RASH ON LEGS 3 DAYS AFTER VACCINES CONSISTENT WITH HSP ALSO SOME EDEMA ABOVE RIGHT KNEE AND OF RIGHT ANKLE
No additional AEs or PQC reported.; VARIVAX administered after temperature excursion; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 28-APR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, subcutaneously, lot # U022321 was confirmed to be valid with expiration date 15-JUL-2023 for prophylaxis (site of administration was not reported). The administered dose was exposed to the temperature of 6 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. No additional adverse events were reported.
Per CALL HISTORY Creation Time:  12/4/2021  7:35 PM:   KEY SYMPTOMS AND ASSESSMENT: 11/30/21- 4 days- tingling legs worsening, today was standing- just fell down, feet and legs tingling, feet a little swollen, in this past hour- left leg outer side left thigh 4/10 pain right now states anxiety attack- mild SOB, heart racing,  Tried: Excedrin,      PERTINENT HISTORY: asthma, migraine, 11/30/21 Johnson & Johnson vaccine Tuesday,          OTHER: ER Per  Per 12/13/2021 Discharge Summary: Final Diagnoses: Active Hospital Problems   Diagnosis   ? (Principal) GUILLAIN BARRE SYNDROME   ? PARESTHESIA   ? WEAKNESS OF BILAT HANDS   Hospital Course and Significant Findings: Please see prior HBS and Neurology notes for complete course; I assumed care on date of discharge, though she is known to me from ER. ACUTE INFLAMMATORY DEMYELINATING POLYNEUROPATHY (12/9/2021) GUILLAIN BARRE SYNDROME PARESTHESIA (12/7/2021) WEAKNESS OF BILAT HANDS (12/7/2021) MIGRAINE (4/21/2009) HEADACHE - Neurology consulted and suspect sensory predominant GBS - she is s/p LP, CT head, MR brain, MRV - s/p IVIG, though stopped early due to headache.  - PT evaluation recommended intermittent therapy - Pain control with gabapentin qhs PRN, tylenol PRN, dilaudid PRN.  - Outpatient EMG and Neurology follow up. E-consults for both placed. - Work note provided
This spontaneous report was received from a nurse refers to a pediatric patient of unknown age and gender. Information on patient's pertinent medical history and drug reactions/allergies were not reported. On 13-AUG-2018, the patient was vaccinated with an adult dose of VAQTA 50/1.0 U/ml injection (dose and route of administration were not reported) (lot # N032753 and expiry date: 23-MAR-2019) instead of a pediatric dose for prophylaxis. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1808USA007658.
This is a spontaneous report from a contactable medical assistant from a doctor office. A 70 year-old female patient received the first dose of PREVNAR 13 (Lot J80525, expiration date Apr2016) intramuscular on 29Jan2015 at 11:45 am at 0.5 ml single in the left upper arm. Medical history included hypertension and diabetes mellitus, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccine on the same day or in the 4 weeks before to the suspect vaccine administration. The patient had previously taken for immunization PNEUMOVAX in 2011. On 30Jan2015 she experienced cellulitis of left bicep at injection site, she was hypotensive, she had muscle ache, weakness, tachycardia, large amount of erythema at left bicep at the injection site, dehydration. Due to the reported events the patient was transported to the hospital by ambulance but she was not hospitalized. The patient underwent laboratory tests and procedures on 30Jan2015 which included blood glucose: 194, an electrocardiogram which showed tachycardia, negative flu swabs. The outcome of the reported events was unknown.                    Adjudication Data Entry       Select the radio button next to any fields that need editing and enter data.   Box 7 Describe Adverse Event  (and treatment if any)
Losing her voice; Fever now 99.8; Cold sweats; Sweating during the night; Cold; Body aches; Muscle pain; Feverish, fever 100.2; Chills; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Cold sweats), NIGHT SWEATS (Sweating during the night), NASOPHARYNGITIS (Cold), APHONIA (Losing her voice) and PAIN (Body aches) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced COLD SWEAT (Cold sweats), NIGHT SWEATS (Sweating during the night), NASOPHARYNGITIS (Cold), PAIN (Body aches), MYALGIA (Muscle pain), PYREXIA (Feverish, fever 100.2), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). On 08-Feb-2021, the patient experienced PYREXIA (Fever now 99.8). On an unknown date, the patient experienced APHONIA (Losing her voice). At the time of the report, COLD SWEAT (Cold sweats), NIGHT SWEATS (Sweating during the night), NASOPHARYNGITIS (Cold), APHONIA (Losing her voice), PAIN (Body aches), MYALGIA (Muscle pain), PYREXIA (Feverish, fever 100.2), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever now 99.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Pyrexia: 100.2 fever 100.2. On 08-Feb-2021, Pyrexia: 99.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by the reporter. No concomitant medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: TCR form was attached
Severe Migraines and constant vomiting for the whole day after the vaccine shot. Migraines continued on a regular basis after the vaccination. Never had any BP issues prior to vaccination. 3 months later, was admitted in the hospital with severe migraine and very high Blood pressure. Doctors suspected stroke.
Starting on 1/17/21 had fever of 101.6, 1/18/21 fever of 101.2, 1/19/21 fever of 102.6.  From 1/19-1/23 she had defervesed to normal temp.  Afternoon of 1/23/21 temp 101.4, 1/24/21 fever of 103 and 101.  On 1/25/21 the nurses called the doctor and said that she was lethargic.  Dr. found her to be hypotensive, lethargic, tacchycardic,   They sent her to the ER.  She also had during that day they found her with neck pain with movement, chills and fever.  From 1/25-today she is still admitted to the hospital.   They found her to have staph aureus sepsis - source unknown, encephalopathy related to sepsis, they did rule out meningitis, hyponatremia, UTI with E-coli and some staph, urinary retention, rhabdomyalisis with acute kidney injury and dehydration.  They are treating her with antibiotics, getting better but still hospitalized.
Patient says she started having chills at 8pm , followed by severe headache and muscle spams at 9:30pm. She said it was a level 10 on the pain scale. She also stated she wanted it reported that she had booster dose of Pfizer covid vaccine 8/30/21
Child developed hyponatremia and vomiting one week post vaccination. Was admitted to hospital and diagnosed with Addison's disease.
headache; vomited; not feeling well; This case was reported by a other health professional via interactive digital media and described the occurrence of headache in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2019, the patient received the 2nd dose of Shingrix. On 7th August 2019, less than a day after receiving Shingrix, the patient experienced headache, vomiting and feeling unwell. On an unknown date, the outcome of the headache, vomiting and feeling unwell were unknown.   It was unknown if the reporter considered the headache, vomiting and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient was reporter's husband. The reporter stated that, in the morning of vaccination day, the patient experienced headache, vomiting and feeling unwell.
Rash on entire body, no respiratory distress, BP 118/70 P84, R20, Zyrtec 10 mg given, sent 4 tabs home with patient 1 tab QD.
Diagnosed with COVID (confirmed with a positive COVID test) the say after her vaccine.  Eventually died from complications of COVID.  Because vaccine was administered prior to her illness, I am putting this in the VAERS system.  Symptoms included  SOB, coughing, muscle aches. headache, fever.
Narrative: 80 yo male patient with PAST MEDICAEL HISTORY: DVT seizure disorder after head trauma- was on carbamazepine HTN DM HLD CAD s/p cabg chron's disease psoriasis t cell lymphoma treated with light treatment pyoderma gangrenosum atrial flutter - s/p ablation 6/2012 PE 4/2009 OSA balance problems/vertigo - extensive workup outside - vestibular ankylosing spondylitis cervical spine fracture s/p surgery after fall hx of left foot drop secondary to dm & inpatient admission in 9/2021 for endocarditis and pna -completed iv abx Pt died at Rehab (nursing home-non facility) on 11/25/2021. Pt had received covid vaccines on 1/13/21 & 2/10/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6199) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Adrenal insufficiency" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "tinnitus". The event "tinnitus" was evaluated at the physician office visit.  Additional information: Patient history with adrenal insufficiency It started in 2004 or 2005. On Nov2018 she weened off of steroids after being on them for a long time, and her adrenals kicked in. She has been totally off of steroids since then. Every 6 months she gets her cortisol and ACTH tested which is related to the adrenals, and everything is perfect. She is not sure when it started. It started a bit after she had the first shot. She was washing her hair and thought maybe there was water in her ear or something or she had an allergy. It wasn't like it is now. This never stops. With her first dose she didn't pay much attention to it. Around there everyone suffers with allergies. She has lived in Florida for 30 years and has never had allergies. The first time the tinnitus was very subtle. She is not sure when it started in between 05May2021 and 26May2021, she can't remember if it was an every day thing or just all of a sudden she felt something going on. It was more subtle after the first shot, then after the second shot boom. She didn't pay much attention to it, and it went away. It was not severe, just kind of there. She noticed it when she was washing her hair and she thought she had water in her ear. She went about her business and was happy she had no reaction from the first shot, but everyone said the second shot is what gets you. She thought maybe some people had reactions and not others. She went in optimistic she would be fine. Right when she just turned she felt a little off center. That happens too when she makes certain movements.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
Red spots on legs then spread to entire body including head.  The spots began coalescing, darker around edges.  Spots lasted 5 days. Infectious Disease specialist did not know what the spots were but thought they might very well be related to vaccines given.
URI signs and symptons began approx. 2-2-21 which did not respond to antibiotic,  Predisone,  inhaler,      Nebulizer Tx. etc.  After six office visits to PCP and severe shortness of breath Cat Scan was ordered on 3-09-2021 which revealed multiple Pulmonary Emboli in both lungs. Xarelto was perscribed.
Red spot (visible lump about the size of 50 cent coin); Entire arm hurts; Red spot (visible lump about the size of 50 cent coin); diarrhea; Pain in the Arm (injection site); Pain in the Shoulder; Headache; Nausea; Throw up ( Vomit); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Entire arm hurts), DIARRHOEA (diarrhea), VACCINATION SITE MASS (Red spot (visible lump about the size of 50 cent coin)), ARTHRALGIA (Pain in the Shoulder) and HEADACHE (Headache) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included METFORMIN, ATENOLOL, MAGNESIUM, SODIUM and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced ARTHRALGIA (Pain in the Shoulder), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Throw up ( Vomit)) and VACCINATION SITE PAIN (Pain in the Arm (injection site)). On 07-Apr-2021, the patient experienced DIARRHOEA (diarrhea). On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Entire arm hurts), VACCINATION SITE MASS (Red spot (visible lump about the size of 50 cent coin)) and VACCINATION SITE ERYTHEMA (Red spot (visible lump about the size of 50 cent coin)). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 07-Apr-2021, DIARRHOEA (diarrhea) had resolved. On 09-Apr-2021, ARTHRALGIA (Pain in the Shoulder), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain in the Arm (injection site)) had resolved. On 10-Apr-2021, NAUSEA (Nausea) and VOMITING (Throw up ( Vomit)) had resolved. At the time of the report, PAIN IN EXTREMITY (Entire arm hurts), VACCINATION SITE MASS (Red spot (visible lump about the size of 50 cent coin)) and VACCINATION SITE ERYTHEMA (Red spot (visible lump about the size of 50 cent coin)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Rash/hives noticed today 2/21/08 day after vac. was admin. (2/20/08) Treatment: Atarax 25 mg tab QID prn for itching.
Fever or Chills  Muscle or body aches  Headache  Congestion or running nose
I was hospitalized for seizure episodes.; dose 1, single on 17Mar2021 at 16:30 (Batch/Lot Number: EP6955) and dose 2, single on 17Mar2021; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EP6955) via an unspecified route of administration in arm left on 17Mar2021 at 16:30 as DOSE 1, SINGLE and dose 2 (Lot number: ER8734) via an unspecified route of administration in arm left on 17Mar2021 (at the age of 59-years-old) both for covid-19 immunization. Medical history included HBP (high blood pressure) from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medication included lisinopril taken for an unspecified indication start and stop date were not reported. Patient had not received any other vaccine in four weeks. No covid prior vaccination. Patient was tested covid post vaccination. On 23Jun2021 at 10:00 AM (after receiving the dose of vaccine), the patient suffered dizziness, involuntary eye movements, she could not move her hands and legs. She was hospitalized for seizure episodes for 8 days. The adverse event resulted in Emergency or urgency room/department, Hospitalization, Disability, or permanent damage. Therapeutic measures were taken as a result of the events dizziness, involuntary eye movements, she could not move her hands and legs. On 08Jun2021 (Post vaccination), the patient underwent lab tests and procedures which included Covid-19 test (SARs COV 2, (nasal swab (sample) test) was negative. The outcome of the events was reported as not recovered.  Amendment: This follow up is being submitted to amend previously reported information: Suspect vaccine coding and drug authorization country were updated. Upon follow up on 27Jul2021 it was reported that, caller got disconnected after delivering the greetings. Narrative was added with case closure comment.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-JAN-2017, the patient was vaccinated with improperly stored doses of ROTATEQ lot# M031650, expiration date 16-MAR-2018 orally; (dose was not reported) and PEDVAXHIB lot# M034187, expiration date 17-MAY-2019 (dose and route of administration were not reported). There was no adverse effect reported. No product quality complaint was involved. Administered doses of vaccines experienced the temperature excursion with temperature above 8 degrees Celsius and below 25 degrees Celsius for 1 hour and 11 minutes. Data logger was involved. There was no previous temperature excursion. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000235.
12/8/22 I had a screening mammogram. A mass was found. I went for a diagnostic mammogram and ultrasound on 1/23/2023. It confirmed I had a mass in my left breast. On 2/1/23 I had a breast biopsy. It showed HR positive HER2 negative for breast cancer. On 2/27/23 I had a breast MRI. It confirmed that there was a mass, but only the one. On 3/10/23 I had a left lumpectomy and Syntel node biopsy. I do not have the results. I never had any symptoms.