chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium
Received Prevnar.  On 1/9/2002 S. pneumonia grew from blood culture and from CSF on 1/10/2002. Per doc 213288, 60 day follow up, no further information available at Health Dept.
shingles; trouble walking; trouble sitting; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles, walking difficulty and mobility decreased. On an unknown date, the outcome of the shingles, walking difficulty and mobility decreased were unknown.   It was unknown if the reporter considered the shingles, walking difficulty and mobility decreased to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received the dose of Shingles vaccine after a week experienced Shingles and had trouble in sitting and walking. Follow-up would not be possible as no contact details available.
developed ache in injection arm after receiving the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (developed ache in injection arm after receiving the first dose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis and COVID-19 virus test positive. Concomitant products included FINGOLIMOD for Multiple sclerosis, DULOXETINE HYDROCHLORIDE (DELAXIN) and VITAMIN D NOS for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (developed ache in injection arm after receiving the first dose). At the time of the report, VACCINATION SITE PAIN (developed ache in injection arm after receiving the first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-122180 (Patient Link).
On 3/25/2007, six days after contact with a soldier who had been vaccinated for smallpox sometime during the week of 3/12/2007, patient noted area of induration, swelling and blisters on inner thigh. Three days prior to blisters, patient noted a bruised sensation in the same area. First treatment was for presumed cellulitis secondary to insect bite on 3/29/07 (Augmentin BID and NSAIDS); next treatment on 3/30/07 was for suspected vaccinia (different provider) with Augmentin continued, Doxycycline added (at this stage there was single approximately 2 cm tender, pruritic, erythematous ulceration that was deep with grey whiteish pustule in center that was lanced and packed. Patient was seen in follow-up (by third provider) on 4/3/07 when ulceration was only about 6 mm in size with no associated erythema: antibiotics discontinued and patient released back to work.
This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with one dose of RECOMBIVAX HB (dose, administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The reporting Nurse stated that on an unspecified date the administered vaccine underwent a supported temperature excursion. No adverse effects were reported. This is one of several reports from the same patient. Additional information has been requested.
Patient first notice when trying to bowl and had trouble holding the ball. Pt had progressive bilateral weakness in limbs, first in upper extremities then in lower limbs also, weakness greater in upper extremities.  Pt reported developing metallic taste in mouth - water/foods tasted unpleasant - this started on 1/20.  Onset of numbness and tingling in hands and feet on 1/21.  CT and MRI scans were essentially normal.
Sharp pain inside my left ear follow by a continued ringing noise. It started in the morning of the third day after the vaccination and has continued since. When I woke up  I felt the sharp pain in my ear follow by strong dizziness or vertigos and the strong ringing in my head.  Following that I had muscle spasm in the upper back for a few days.
01/13/2022 That evening after my vaccine, I noticed I had swelling in my knee. I had chills, was fatigued and had fever. I noticed inflammation of my nerve endings in my knee. It turned into a bacterial infection. I went to the doctor on 3/23/2022. By that time, it had swollen twice the size it should be. I had severe inflammation that was showing on the outside of the knee. Huge red discoloration and fever was noticed in the knee. My skin was also peeling off my knee. I went back to my doctor's office on 4/18/2022. I have been treated with antibiotics for 4 weeks for this infection. I am on the third round of antibiotics. The name of the antibiotics are Bactrim, Levaquin and Clindamycin. I am also taking over the counter probiotics my doctor told me to take. My knee has an abscess, it is draining and has improved. I had a knee replacement in 2016.
4 days after getting the first Moderna shot, I developed an intense headache that has lasted for 10 hours.
Palpitations; Received 1st dose 3Jul2021 and has not received his 2nd dose; Couldn't walk for about 2 weeks after leaving the hospital; Dizziness; leg pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion hospitalization), PRODUCT DOSE OMISSION ISSUE (Received 1st dose 3Jul2021 and has not received his 2nd dose), MOBILITY DECREASED (Couldn't walk for about 2 weeks after leaving the hospital), DIZZINESS (Dizziness), PAIN IN EXTREMITY (leg pain) and ARTHRALGIA (Joint pain). At the time of the report, PALPITATIONS (Palpitations), MOBILITY DECREASED (Couldn't walk for about 2 weeks after leaving the hospital), DIZZINESS (Dizziness), PAIN IN EXTREMITY (leg pain) and ARTHRALGIA (Joint pain) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Received 1st dose 3Jul2021 and has not received his 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 170 (High) 170 and 116-120 (High) 116-120.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Product dose omission issue is assessed as not applicable for causality.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Product dose omission issue is assessed as not applicable for causality.
feeling "under the weather".; cough; a general sick feeling all over his body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 21 year-old male patient received bnt162b2 (BNT162B2), administration date 25Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 29Aug2021, outcome "unknown", described as "feeling "under the weather"."; COUGH (non-serious) with onset 29Aug2021, outcome "unknown", described as "cough"; MALAISE (non-serious) with onset 29Aug2021, outcome "unknown", described as "a general sick feeling all over his body".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna Vaccine given thru Health Care at 3/10/21 in late afternoon- intense joint pain started within a couple of day and is still continuing! examined me Fri 3/26, full blood work done but all in normal range. Started on Prednisone today. 2nd Vaccine scheduled for 8:15AM this coming Weds.
Vomiting, nausea, headaches, extreme tiredness, fatigue, diarreha, mild grade fever, muscle aches, stiff neck, pain in calves, quads, and hips.  10/26/07 At request of CDC, f/u started.  T/C to parent to check recovery status of patient.  Spoke w/father/reporter who stated patient is unchanged since s/s first developed 2-3 days s/p vaccination.  Has been f/u in ID clinic at hospital.  No diagnosis made.  Awaiting neurology f/u.  10/26/07 Received t/c from pcp.  Agreed w/info received from parent.  Has referred to neuro but doubts GBS.  Provided NIP contact info. Letter faxed to request med records. 11/6/07 Reviewed vax record from pcp & VAERS database updated w/same. Outpatient ID clinic report of 10/15/07 reveals patient experienced  vomiting, diarrhea & fatigue 3 days s/p vaccine.  This lasted approx 10 days & the fatigue, intermittent HA, sore throat, difficulty sleeping & leg pain  persisted beyond that.  Seen in clinic on 10/15/2007.  Had not be able to attend school or participate in sports.  Had traveled out of the country approx 1 month prior to onset of current illness.  Rheum clinic reports of 10/11/07 reveal left knee pain x 4 mos duration.  Exam revealed marked crepitus of left knee s/o tenderness.  X-rays & MRI  were requested.  Referred to Ortho clinic.  No additional records available. FINAL DX: chronic fatigue of unknown etiology, probable nonspecific post infectious immune process.
2nd dose of COVID vaccine received approx 0800 on 1/19/21, felt healthy throughout the day. Began to feel flu like symptoms approx 1800 on the evening of 1/19/21. Symptoms worsened through the night rapidly, beginning with uncontrollable chills/shivering, body aches, restless, slight vertigo, weakness/fatigue. At approx 0100 the morning of 1/20/21, blacked out while in the bathroom of which awoken and found myself disoriented, weak, and on the ground (no injuries noted as i must have eased myself down).  I was able to hydrate afterwards and tolerate eating some dry cereal to help with the weakness. Symptoms began to dissipate while an intense headache continued throughout the night and even through the daytime. The time is now 1020 on the day of 1/20/21 and i still have quite the headache but all other symptoms seem to be relieved at this time.
Patient developed 3rd cranial nerve palsy on right eye.  Pt had a CT and reports no aneurysm or abnormalities.
the patient received an unauthorized vaccine/ patient was not age 12 at the time that vaccine was administered
Swollen and sore at the injection site Instructed ice packs 20 minutes 3 times today and tomorrow. Ibuprofen for discomfort.  Monitor borders of swelling and f/u if significant worsening redness, pain, swelling
Tested positive for Covid after friends we were with were in contact with a family member who had Covid.  I had bronchitis at the time, my Covid symptoms were mild, basically loss of smell and some taste.  I was given the Monoclonal IV treatment on September 02, 2021.
4/25/2021 Patient present to the ED w/ complaint of LE erythema and edema. She was found to be positive for SARS-CoV-2. She was admitted for cellulitis and was started on IV Ancef. She had a normal CXR at that time. She did require O2 at 2LNC and was started on IV decadron. She had high sugars requiring insulin and was newly diagnosed with type 2 DM. She was started on IV remdesivir on 5/1 and was given Tocilizumab on 5/2. On 5/4 she had an acute decline in her respiratory status and sats were in the high 80's on 6L NC. Repeat CXR showed pneumonia. Pt refused home oxygen and was hospitalized until 5/6 when she could maintain sats on room air.
Next day: 24 hours aches, chills (did not take temp) Following day: Okay Following day: PT appt for ankle, light exercise. Down and out by that evening. Severe left side headache/eye area. Very stiff neck. Overall fatigue. Not a migraine but extreme pain and nausea; needed Sumatriptan to break pounding headache. Would last a few hours or for sleep, then come back again. 3 days of this.  Fatigue in limbs, a bit of light numbness, feeling of overworked legs without having done anything physical. General fuzziness and feeling of not being well/myself.
10/23 redness, swelling, warm from area of shot to elbow. Advised pt to start BENADRYL and ice if desired. 10/24 pt reports less swelling tiredness after taking BENARYL on 10/23. Will follow up w/pt on 10/26.
very stiff neck lasting from  4/8 to present 4/11 cannot move neck..hard to sleep very painful
Information has been received from a physician concerning a 37 year old Hispanic female nursing student who on 4/18/00 was vaccinated IM in the right deltoid with the 1st dose of Hep-B vaccine (1380J) and subsequently, the pt experienced severe malaise, red-warm injection site, pain and swelling at the injection site, fatigue, headache, nausea and chills and fever. The pt sought unspecified medical treatment. It was noted that the experiences lasted approx. 7 days and on an unspecified date, the pt recovered. No further information is expected.
Pt presented to the ED on 11/15/2021 for a Head Contusion from a fall at home.  The patient tested positive for COVID- 19 at that time.  The pt developed progressive respiratory failure and was transferred to the ICU for BiPAP  While at RN the patient was treated with a course of remdesivir as well as Decadron.  The pt had high oxygen requirements and was on high-flow oxygen at 60L/minute with 65% FiO2.  Pt was noted to have significant delirium and there were concerns about the patients swallowing mechanics and the significant delirium, so patient was on TPN for nutritional support on admission to hospital. The plan was for the patient to continue on high-flow oxygen, Pulmonary Service was consulted to help with the patients respiratory failure.  While at hospital it was noted that the patient had worsening hypoxic respiratory failure likely due to COVID.  On 12/5/2021 family met with the Pulmonary physician and patients current respiratory status and prognosis were discussed, family at that time was deciding on comfort cares.  Family made the decision on 12/5/2021 at 0915, patient expired on 12/6/20210 at 1027.
zoster-like rash across the chest; This spontaneous report as received from a lawyer refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 24-APR-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered a severe inflammatory reaction and was diagnosed with a painful, zoster-like rash across the chest. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using the vaccine. Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result zoster vaccine live (ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of rash vesicular was reported as not recovered/not resolved. The reporter considered rash vesicular to be related to Zoster Vaccine Live (ZOSTAVAX).  Zoster-like rash across the chest was considered to be disabling.
Within 10-minutes of vaccination, the patient reported feeling lightheaded. EMS assess the patient on-site and they were found to be hypertensive (152/88). No PMHx of HTN. Patient was anxious during evaluation. Their 12-leade EKG and other vitals were WNL. Patient's BP decreased (140/66) during the evaluation and refused transport to a hospital. Patient appeared improved and was in proper decision making capacity.
Pt experienced tenderness and itching. Also redness over the entire upper back part of arm - injection site. Symptoms fading. Tenderness noted on 02/14 and redness and itching on 02/16.
This case was reported by a healthcare professional via sales representative and described the occurrence of blood pressure abnormal in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included ADD, allergy to BENADRYL and low weight. Previous and/or concurrent vaccination included MENACTRA (non-gsk); Sanofi Pasteur MSD; unknown; unknown given on 16 September 2010; TDAP vaccine (non-gsk); Sanofi Pasteur MSD; unknown; unknown given on 16 September 2010. On 16 September 2010 at 13:00 the subject received 1st dose of CERVARIX (.5 ml, unknown, left arm). On 16 September 2010, within seconds of vaccination with CERVARIX, the subject experienced blood pressure changes upon sitting verses standing, loss of color in skin, lips turned white and shaking. The nurse reported the subject was sent to the hospital emergency room (ER) but was not admitted. Neither the ER staff nor the reporting nurse believed that CERVARIX caused the reaction, but rather it was just a reaction to receiving a vaccination. The nurse believed that the subject's low body weight may also be related to these events. On 16 September 2010, the blood pressure abnormal, skin color change, lip color altered and tremor were resolved.
Temperature 100.4° Lowgrade nausea - treated with Meclizine All over ache 2"x5" rash and soreness on upper arm just  below injection site
This spontaneous report as received from a nurse refers to a 13 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 29-MAR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 3, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
I started running a high fever and became lethargic fatigue was terrible my entire body hurt I had a cough and that's when I went to Urgent Care he prescribed to me prednisone 10mg, amox-cile 875mg, azithromycin 250mg and I made an appt with my regular Dr.  2 weeks after the first shot I tested positive for covid, I still struggle with fatigue and headache and now I had a rash on my hands and neck
Patient developed round/oval raised inflammation rash on arm over deltoid. Also developed flu like symptoms, fever, sweats, and soreness in arm.
temperature excursion of 18 degrees C for 24 hours, no AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves two unknown demographic patients who were vaccinated with a dose of vaccine QUADRIVALENT INFLUENZA VACCINE [INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED] lot number not reported via unknown route in unknown administration site which had temperature excursion of 18 degrees c for 24 hours on an unknown date.  It is a actual medication error case due to incorrect product storage.  At the time of reporting, no adverse event was reported.  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 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.  Information on the batch number was requested  List of documents held by sender: none.
Severe arm and wrist pain almost immediately after injection, tingling sensation radiating from wrist up through 4th and 5th metatarsals. Woke up in the night with low fever and sweats. Pharmacist notes visible inflammation of whole right arm.
no adverse event; patient's initial series was started with the 4-valent GARDASIL (GARDASIL dose 1 on 09/05/2014 and GARDASIL dose 2 on 11/5/2014) then her third dose was with GARDASIL 9 (GARDASIL 9 on 11/27/2017) / received her fourth dose with GARDASIL 9  4/17/2023; This spontaneous report was received from a nurse prescriber and refers to a 18 year old female patient. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  It was reported that the patient's initial series was started with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), dose 1 on 05-SEP-2014, for prophylaxis (dose, route of administration, lot/batch # and expiration date were not reported), and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) dose 2 on 05-NOV-2014, for prophylaxis (dose, route of administration, lot/batch # and expiration date were not reported).  Then her third dose was with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 27-NOV-2017 (interchange of vaccine products) for prophylaxis (dose, route of administration, lot/batch # and expiration date were not reported) which the nurse prescriber referred was intended to be the patient's last dose. However, the patient then received her fourth dose with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 17-APR-2023, lot# W008445 with expiration date of 09-NOV-2024, 0.5ml, for prophylaxis (route of administration was not reported).   No other event reported. No further clarify.