chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/14 and 1/15: mild nausea  and diuzziness, mild soreness and hardness as injection site; 11/21: in the evening found myself scratching at my upper right arm and realized I was scatching my injection site so went to look at upper right arm:  realized  a several inch area above, below and around the injectin site was swollen, hard and hot to the touch and a bit red and itchy.  Note I could feel what felt like bumps under the skin vs. above the skin or that they could be seen.   Due to providing support services to a disabled brother at his home during this evening, I did not take any benadryl  or any related medication.  I used cool compress at the site and called my husband to give him an alert.  I had both a landline phone and a mobile phone (which has a medical alert service at the push of 1 button that I could talk to/or that would automotically respond) as I was aware to watch for breathing difficulties...I experienced none.  I alerted our school system nurse about the issue the next morning and she guided me to contact my PCP which I did.  I could not be seen that day, but was no worse regarding symptomes and knew I needed to go to ER or a Urgent Care if anything worsened  which it didn't.  Around 5 p.m. on Friday evening when I was able  to be at my own home I took 1 dose of benadryl (allergen/dye free), drank alots of liquids and rested.  During Saturday I still felt effects of benadryl, but vaccine related things cleared up.  Monday,  1/25 7:15 a.m. to 7:45 a.m. while at home working on my computer, my left eye vision became very distorted like my vision was jumping around/unfocused...no issues of this before and I am not prone to headaches such as migraines..I was getting concerned that I might need to call work that I could not come as was afraid to drive and it cleared up.  Note:  I have routinely gotten many types of vaccines due to working in the medical field and needed to care for at risk family members (flu, phenmonia (sp), shingles, hepititis, tetnus, booster for other preventive illnesses) and have never had adverse reactions.  I do plan to get the second dose of the Moderna vaccine as I work for a school system and am primry care giver for a medical and disability comprimised younger brother.
Rapidly progressive quadriparesis, distal sensory loss, and areflexia.  The constellation of findings is most concerning for an acute polyneuropathy, likely acute inflammatory demyelinating polyneuropathy (AIDP, ie Guillain-Barre syndrome), following the influenza vaccine. The patient required intubation. The patient received 2 rounds of IVIG from October 11-15th and 24-28th. The patient will require extensive rehab and a PEG  tube placement.
Noted severe lower back pain and stiffness starting evening after injection. Prior to that mild fever (100.5) and chills. Morning of 14th extreme difficulty getting out of bed, upon standing, legs buckled causing contact with the floor. Took over 1 hour to get vertical again. No sleep evening of 14th to morning of 15th. Morning of 15th, pain 8/10, started crying. ER visit. BP elevated. Tylenol, Flexeril, Lidocane and Toradol given for pain management. Discharged on 15th. Morning of 16th, no change, spent day immobile. Morning of 17th, slight decrease, mobility decreased as day progressed. Morning of 18th, attempted to shower, lost balance and fell. Lower back pain 7/10. Started gathering documentation.
Date vials were initially thawed: shipment received in liquid state on Oct 11 2022, vaccine was administered 17-Nov-2022; No adverse event; 4 adults patients received doses after its beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date), PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11 2022, vaccine was administered 17-Nov-2022) and NO ADVERSE EVENT (No adverse event) in an adult 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. 061f22a) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11 2022, vaccine was administered 17-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date), PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11 2022, vaccine was administered 17-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date) and PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11 2022, vaccine was administered 17-Nov-2022).    Concomitant product use was not provided by the reporter.  Vials did not undergone any temperature excursions.  Treatment information was not provided.
Headache, vomiting approximately 36 hrs after vaccine administration. Admitted to SICU on 3/21/09 for observation and close monitoring for Intraventricular hemorrhage. 4/8/09-records received-DC DX Left ventricular hemorrhage. Presented on 3/21/09 with C/O severe headache since Thursday with vomiting and nausea occasional.
Pain in arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and PYREXIA (Fever) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYNELOL) for Fever, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pain in arm) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No concomitant medication were provided.
Symptoms started approx. 11 hrs. post injection- sore arm, fever, body aches.  Max temp. 104.2 and fever was constant/ did not go to baseline until Sunday 3/28/21 around 6pm.  I have been sweating on and off since fever broke.  Body aches were severe, Moderate HA with onset of fever and body aches.  Arm pain from injection remained mild to moderate with no swelling or redness.  GI symptoms- diarrhea, pain and nausea started 24 hours after vaccine and mild symptoms remain today 3/29/21.  Fatigue present.  I had a severe COVID illness back on 12/09/20 with Monoclonal Antibodies on 12/11/20 and I did not feel as bad as I did with this vaccine.  With the vaccine my fever never broke for almost 48 hours.  With Bilateral COVID pneumonia I only spike temps mostly at night and broke with Tylenol and Motrin.
Blood clot in right left, pulmonary embolism and pulmonary infarction. Results stated ?excessive? in lungs.
Patient States her arm has been hurting since the administration of the vaccination and has had a limited range of motion since getting the vaccine. She has had significant pain, and has not had relief with over the counter medications.
Rash on stomach & back; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6198; Expiration date was not reported) on the right arm on 03Mar2021 (07:00) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included allergies to mold, dust and mites. The patient was not pregnant at the time of vaccination. Concomitant medication(s) included fluticasone propionate, salmeterol xinafoate (ADVAIR), fluticasone propionate (FLONASE), cetirizine hydrochloride (CETIRIZINE D), prednisone and calcium. On 04Mar2021 (05:00), the patient had rash on the stomach and back. The patient did not receive any treatment for the event. The outcome of the event was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date: 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Progressive burning dysaesthesia C5 to L5 over the course of the following 12 days took one dose of Prednisone 60 mg with shingles outbreak within 4-6 hours
Patient came in to receive her 1st dose of the Covid vaccine. At 6:25 the vaccine was administered and at 6:33 the patient passed out. After a few seconds she came to. Emergency personnel were called to the scene. They arrived at 6:41 and checked her out and gave her the clear to go home.
Four days after immunization infant started having multiple seizures and was admitted to hospital, started on anti seizure meds and was weaned off after about 5 months. Now off over a year and without seizures. Child's speech delayed, neurologist feels related to seizures and seizures related to DTaP. Doc 213706, states the following: Delay in speech development. Problem continued more than 1 year after immunization. Report was made 23 mo. after immunization Annual follow up report received 6/10/2003 adds: Date of vaccination was 1/4/2000, date of VAERS report 12/3/01, had been 1 year 11 months between vaccine and report. Symptoms were still present at that time. 4/4/03 phone call to mother revealed child's speech was still delayed, was enrolled in a PPI program and currently being evaluated for autism. A follow up report received on 6/23/2003 adds: Enclosed is a follow-up report to a VAERS report that I submitted on 12/03/2001. At that time, it had been 1 year 11 months since the child had received the vaccine. His mother was concerned the child was still having problems related to immunization. I contacted the mother again on 04/04/2003 for follow up (3 years, 4 months from vaccination date). She states child is no longer on seizure medication and has had no further seizure activity. He still has speech delays and is enrolled in a Pre-Primary Impaired program. He has an appointment to evaluate further for autism. She has chosen note to continue immunizations.  Follow up on 10/31/2003: "Vaccine recipient did not recover from the adverse events.  Date of vaccination was 01/04/2000.  Date of VAERS report 12/03/2001.  Had been 1 year 11 months between vaccine and report symptoms were still present at that time.  04/04/2003: Phone call to mother revealed child's speech was still delayed, was enrolled in a PPI program and currently being evaluated at hospital for autism."
(L) deltoid swelling & redness. Tenderness (+) GI symptoms (+).
Next day I got a headache and muscle pain in my back and at the injection site.  Then my back ache worsened and I started to have burning on my skin on my right side.  Eventually I got sores on my stomach and as per a telehealth conference with Dr. I have shingles.
Information has been received from a registered nurse concerning a female patient who during the morning of 25-APR-2011, was vaccinated intramuscularly with the first dose of GARDASIL (lot number not reported) and developed itching at the injection site. Later, on the same day, the patient developed a burning sensation over her whole body. No treatment was given for the experience since the registered nurse was going to recommend BENADRYL for itch but patient did not take it. The patient sought medical attention by phone. At the time of the report, the patient was recovering. Additional information has been request.
Lymph nodes in my neck is swollen bad; my throat hurts; my throat hurts I can barely eat drink or talk.; My right under arm is swollen; I'm spitting up mucus; My head and and whole body hurts; whole body hurts; I'm weak and very tired; I'm weak and very tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Aug2021 15:30 (Lot number: FC3182) at the age of 22 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergies: Penicillin" (unspecified if ongoing). The patient concomitant medications were not reported. Vaccination history included: Bnt162b2 (vaccine location=Right arm, product=COVID 19, brand=Pfizer, lot number=EW0177, lot unknown=False, dose number=1, vaccine location=Right arm}]), administration date: 27Jul2021, when the patient was 22 years old, for covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 17Aug2021 18:15, outcome "not recovered", described as "Lymph nodes in my neck is swollen bad"; OROPHARYNGEAL PAIN (non-serious) with onset 17Aug2021 18:15, outcome "not recovered", described as "my throat hurts"; OROPHARYNGEAL DISCOMFORT (non-serious) with onset 17Aug2021 18:15, outcome "not recovered", described as "my throat hurts I can barely eat drink or talk."; PERIPHERAL SWELLING (non-serious) with onset 17Aug2021 18:15, outcome "not recovered", described as "My right under arm is swollen"; SECRETION DISCHARGE (non-serious) with onset 17Aug2021 18:15, outcome "not recovered", described as "I'm spitting up mucus"; HEADACHE (non-serious) with onset 17Aug2021 18:15, outcome "not recovered", described as "My head and whole body hurts"; PAIN (non-serious) with onset 17Aug2021 18:15, outcome "not recovered", described as "whole body hurts"; ASTHENIA (non-serious), FATIGUE (non-serious) all with onset 17Aug2021 18:15, outcome "not recovered" and all described as "I'm weak and very tired". Therapeutic measures were not taken as a result of lymphadenopathy, oropharyngeal pain, oropharyngeal discomfort, peripheral swelling, secretion discharge, headache, pain, asthenia, fatigue.  Additional Information: The patient had other medical history: Severe allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received 4 weeks of vaccination: yes. The patient did not receive other medications in two weeks. On 17Aug2021 at 06:15 PM the patient experienced adverse events. This has been going on for two days now. The patient was not received treatment with medications. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Heavy night sweats and moderate weight loss.  Night sweats lasted for a week.  weight loss 12lbs.   Night sweats have stopped.  My weight was 152, now 140. Lost 12lbs in 1 wk.
It knocked the crap out of my legs; Could hardly walk for a week; Initial information was received on 04-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves an (unknown demographic) patient who experienced it knocked the crap out of my legs (limb discomfort) and could hardly walk for a week (gait disturbance) while received INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious it knocked the crap out of my legs (limb discomfort) and could hardly walk for a week (gait disturbance) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got a flu shot about 3 weeks ago! It knocked the crap out of my legs! Could hardly walk for a week!"  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  The event outcome was unknown for all the event.  There will be no information available on the batch number for this case.
This case was reported by a nurse and described the occurrence of anaphylactic reaction in a 17 year old female subject who received hepatitis B vaccine recombinant (Engerix B). On an unspecified date in March 2005 on or before March 28 2005, the subject received the first dose of Engerix B in the left arm (lot AHBV0077AB). At an unspecified time following the first dose of Engerix B, on March 28 2005, the subject experienced soreness, redness, tingling and a rash covering the entire arm. The subject was diagnosed with an anaphylactoid reaction. The events resolved on 3/31/2005. The nurse considered the events to be related to vaccination with Engerix B. Anaphylactoid reaction was considered medically serious by manufacturer (OMIC).
This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 02 Apr 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 02 Apr 2022) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Apr-2022 at 10:21 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 10:21 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 02 Apr 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 02 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 02 Apr 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021 and administered on 02 Apr 2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient ethnicity reported as White. No concomitant medications were reported. Vaccine went into 2-8 Celsius thaw state on or about 24 Dec 2021, this vaccine was administered up until its manufacturing expiry date of 04 Apr 2022. It was reported that patient received second booster vaccine past its 30 days expiry date. No treatment medication was reported by reporter.
Hives covering entire body, treated with ZYRTEC OTC, resolved within 72 hours.
Started not feeling good on day of injection. This continued until I was diagnosed w Acute myeloid leukemia on  May 28th 2021
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 03May2021 at 09:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medication was not reported. The patient previously took cipro and strawberries. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 15:00 the patient experienced sore arm. The clinical outcome of the event sore arm was recovering at the time of report..   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient presented to ED complaining of generalized weakness and diarrhea. PMH of obesity, DVT/PE on chronic anticoagulation with rivaroxaban, CKD stage III, COVID-19. Patient was diagnosed with COVID-19 on 01/28/22 and states that her symptoms have progressively worsened. Previously vaccinated and boosted with Pfizer on 2/6/21, 2/21/21, and 1/5/22. Admitted to facility on 2/19/22.
Pt covered in hives over trunk and extremities 24 hours following vaccination. Physician notified.
patient states normal mild pain at injection site, maybe a little bit tired. Starting evening of day 2, (9-8-21) started feeling extremely cold in 80 F room., checked temperature and was at 102 F.  Her left arm is much warmer to the touch than her right arm. Her doctor advised her to take ibuprofen  and Tylenol.
Fever-101.5 Severe whole body aches- felt like I had been in a car accident Headache Fatigue
Patient was scheduled for her second dose COVID 21 days after her 1st dose instead of 28 days. Full disclosure to patient done. PCP Dr. notified. Patient called this reporter the following day and she mentioned that her laft arm was sore and felt "swollen". I advised the patient to call PCP for a video visit and or go to the ER if any other symptoms. Denies any other symptoms. States she "feels okay."
Case number PHEH2015US023064, is an initial spontaneous report received from a health care professional on 06 Nov 2015. This report refers to a 62-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was administered expired FLUVIRIN (batch number: 1414101) intramuscularly at a dose of 0.5 ml on 04 Nov 2015. The case was reported as non-serious. No adverse event was reported.
Information has been received from a registered nurse concerning a patient at an elementary school who was vaccinated with a dose of varicella virus vaccine (Oka/Merck). subsequently, the patient developed a mild case of breakthrough varicella. There was no product quality complaint involved. Additional information has been requested.
Instantly after receiving the shot I felt pain my arm. On Thursday my arm was real sore and I started feeling bad. I felt tired, real weak, sleeping, wanting to sleep, fever, headache, pressure on my head, sweating, calmly feeling, cold sweats. As of today I started to feel a little better but I still have a grade fever. I have been taking Tylenol for it.