chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness; did not allow me to have my eyes open; blood pressure was high; felt my body very cold; arm was very swollen; pain, a sharp pain, especially on the right side of the brain and the part of my head; tiredness; heaviness in the head; anxious; felt a lot of heat in my body; One hour later in her right arm she had a lot of pain; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported), via an unspecified route of administration on 01Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had first dose of the Pfizer COVID 19 vaccine on 01Jun2021 and ten minutes after that she started feeling dizzy and could not keep her eyes open and since she was still at the vaccination facility, they took her blood pressure, and it was high. One hour later in her right arm she had a lot of pain and it was swollen she felt the pain was a sharp pain that was on her right arm which was the arm she had the injection. Caller also felt pain in her brain and part of the head. Caller also reported being tired and had dizziness. Caller stated the headache and dizziness was constant, but she felt it mostly on the right side of her body which was the side she received the injection. Caller had to close her eyes so the dizziness would stop. Caller stated this happened on 01Jun2021 and 02Jun2021 and it was making her feel very anxious and she felt really really hot and when she had her blood pressure high, she felt her body cold. The clinical outcome of the events were unknown.    Follow-up 2 (PRD 03Jun2021): This is a spontaneous report from a contactable consumer. This consumer (patient) reported that: dizziness, did not allow me to have my eyes open, blood pressure was high, felt my body very cold, arm was very swollen, pain, a sharp pain, especially on the right side of the brain and the part of my head, tiredness, heaviness in the head, anxious, felt a lot of heat in my body, one hour later in her right arm she had a lot of pain.  Information on the lot/batch number has been requested. further information has been request-ed.
1353 right after last vaccine was given client suffered 6min seizure (absent) sitting in chair 911 was called by clinic 3 min into sz client placed on floor no injuries sustained no respiratory distress no treatment given taken to ER for eval.
had the worst flu ever; Initial information received on 12-Nov-2020 regarding this unsolicited valid non-serious social media case from a consumer (patient).   This case involved a patient with unknown demographics who had the worst flu ever (Influenza), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, (last year) the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had the worst flu ever (Influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  So the patient had decided not to have the flu shot this year.  Details of laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
On June 3rd 2021, I had 99% blockage and loss of mobility, moderate to severe reaction to the second vaccine, 103 fever from the second vaccine. Very unstable and low blood pressure. Was admitted to the ER due to heart attack, and spent 8 days between two Hospital's.
swelling @ inject site, pain to whole arm, fever to 99.2, lightheaded, achey, flu-like sx, tired, lethargic, poor appetite;
This spontaneous report has been received from a pharmacist, concerning to an adult patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided. On 01-JUL-2016, the patient was vaccinated with the first dose number of VAQTA 50/1.0 U/ml (dose, route of administration, lot# and expiration date were not provided) for prophylaxis. Additionally, on 01-AUG-2016, the patient was administered with the booster (second dose number) of VAQTA 50/1.0 U/ml. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated IM with a 0.5 ml dose of RECOMBIVAX HB 5 mcg/0.5 ml (lot # 666804/0658Z) on 17-DEC-2012 that expired on 08-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Significant pain at injection site, elevated temperature, aching muscles throughout body, fatigue, headache
This case was reported by a consumer (subject) and described the occurrence of hepatitis b antibody positive ina  currently 55-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included blood donor. The subject reported that he "traveled on business" but did not report locations. On 6 April 2007, 7 may 2007 and 8 October 2007 the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (1 cc, unknown route, left arm). On 13 June 2012, 5 years after vaccination with TWINRIX, the subject experienced hepatitis b antibody positive. On 13 June 2012, the subject was "tested to see if he could donate blood. he was rejected, due to having positive antibodies of hepatitis B." The subject was "told to wait 8 weeks and return." On 30 August 2012, the subject was tested again and had "the same result" of hepatitis b antibody positive. The subject was then evaluated by his primary care physician. Relevant test results included hepatitis b antibody test positive on 13 June 2012 an d30 August 2012. After the positive Hepatitis B antibody tests, the subject reported that his primary care physician ran additional "tests and they were normal." At the time of reporting the event was unresolved. Follow up was received from physician on 30 September 2013. The physician documented that vaccinations were "distant history vaccinations" and that the subject "recently established care in our office." No further details were provided.
4 days after initial shot woke up with severe pain in neck and shoulder on right side. If it grabbed me it shot down my back. 3 days later the severe pain was on the left side while the right side had disapated  somewhat. Today (2 days later) the left side neck pain is troublesome and no pain on the right. Took Aleve Back and Muscle Pain meds. and pain relief cream. Helped somewhat.
Redness and swelling 30mm from site of injection. Reaction about 20mm wide. Felt warm. Treatment: cold compresses.
Very swollen, red, hot left deltoid about 1/2 way down her arm on 8/27/04
Patient given MMR vaccine that expired on 04/22/2017 (2 days ago).
Day after pain intense and unable to lift right arm. Later 2nd day pain extended up to right shoulder still unable to lift arm. (Had been attempting movement with help of left arm) second night sleep impossible because of pain and sensitivity to any pressure to that arm. Pain moved into back of neck on right side. 3rd day felt like I had a severe flu. Felt bad all over. Again no sleep and pain now includes down to elbow. All of these symptoms have remained fairly consistent up to today(day 6) including little sleep. Taking Tylenol with no affect.  Have ERG and have been told not to take Ibupropen.
Chills and tingly feeling quickly after, pain in arm and swelling after 7 hours, headache the next morning, poor appetite, tiredness and soreness all over, low fever (37.6°C) after 26 hours, and high fever (38.5°C) after 30 hours, period is late by about 10 days, swelling in lymph nodes (under armpits) and boobs.
muscle twitching throughout the body such as eyes, legs, arm, stomach, hands, feet. huge swollen lymph nodes in abdomen, swollen and a lot of pain in groin, testicular and penis. Nerve pain especially in penis and testicular, penis hurts to touch. feels like tons of inflammation, shortness of breath, pain in chest, heart palpitations, fast heart beat, fluttering in heart, rashes on body, stomach pain, sore bones ,fatigue and  worsening  Eyesite
Grandmother noted a large red raised area on patients right upper arm. Patient doesn't complain of pain. Told grandmother to take Patient to Dr to look at. Call if symptoms continue or get worse.
Headache, Myalgia, NauseaVomiting, Fatigue. Injection site pain.  Narrative:  Other Relevant History:
Information has been received from a physician concerning a 48 year old (previously reported as a 30+ year old) female pt, with no past medical history of allergies, who on 02/04/2003 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #643789/0876M) into the left deltoid. It was reported that the pt may have received a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) as a child. The reporter indicated that 13 days after vaccination, on 02/17/2003, the pt developed a maculopapular rash mainly on the upper trunk. It was reported that the rash was itchy but the pt had no fever, aches or nausea and vomiting. No other symptoms were reported. The pt was not ill at the time of vaccination. There was no known etiology for the rash reported. The pt was treated with diphenhydramine (BENADRYL) 25 mg TID. The pt recovered from her experience in "several days". Unspecified medical attention was sought. Additional info is not expected.
(1) LUE 8/10/12 approx. 6 AM redness, heat, slight itch at injection site. Pain in LUE 8/10-8/11/12 which resolved. LUE redness & heat diminished and resolved 8/14/12. (2) Cough, scratchy throat onset 8/14/12, loss of voice 8/15/12. Improved. (3) "Spots" left anterior, upper chest and left neck onset 8/18/12, resolved in 1 day. "Spots" base of neck, right side, onset 8/20/2012. Improved. Afebrile.
Joint range of motion decreased cervical spine; Pain; Swollen lymph nodes; Feverish; could not move the neck; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased cervical spine), PAIN (Pain), LYMPHADENOPATHY (Swollen lymph nodes), PYREXIA (Feverish) and MUSCULOSKELETAL DISCOMFORT (could not move the neck) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Chronic disease.    Concurrent medical conditions included Asthma chronic (almost died from), Non-smoker and Abstains from alcohol.   In December 2015, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In February 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose every two weeks. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased cervical spine), PAIN (Pain), LYMPHADENOPATHY (Swollen lymph nodes), PYREXIA (Feverish) and MUSCULOSKELETAL DISCOMFORT (could not move the neck). In April 2021, JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased cervical spine), PAIN (Pain), LYMPHADENOPATHY (Swollen lymph nodes), PYREXIA (Feverish) and MUSCULOSKELETAL DISCOMFORT (could not move the neck) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Action taken of co-suspect HUMIRA40MG/0.4ML(ADALIMUMAB)  was unknown with respect to all the events.  Treatment information was not provided.  The reporter's causality for the events of Joint range of motion decreased cervical spine, swelling of lymph nodes, could not move the neck, feverish, fever and pain with HUMIRA40MG/0.4ML(ADALIMUMAB) was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-626070 (Patient Link).   Reporter did not allow further contact
I felt a sudden surge of tightness in my throat muscles about 45 minutes post shot. Then, my throat began to tighten, and I could not speak without coughing. I could only manage whispers.; I could not speak without coughing; I could not speak without coughing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 45-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EN6198), via an unspecified route of administration, administered in arm left on 04Mar2021 17:15 (at the age of 45-year-old), at a 1st dose, single dose for covid-19 immunisation. Medical history included patient was allergic to Sulfa, penicillin, tramadol, compazine, Levaquin. No other medical history was reported. Concomitant medications included desvenlafaxine succinate (PRISTIQ); buspirone hydrochloride (BUSPAR); bupropion hydrochloride (WELLBUTRIN); gabapentin (GABAPENTIN); topiramate (TOPAMAX). Patient did not had other vaccine in four weeks, patient did not had covid prior vaccination and patient has not covid tested post vaccination. On 04Mar2021 17:45 the patient experienced I felt a sudden surge of tightness in my throat muscles about 45 minutes post shot. Then, my throat began to tighten, and I could not speak without coughing. I could only manage whispers. Adverse events resulted in emergency room visit. Therapeutic measures were taken as a result of I felt a sudden surge of tightness in my throat muscles about 45 minutes post shot. Then, my throat began to tighten, and I could not speak without coughing. I could only manage whispers. Patient was treated with Steroid, benedryl, and Pepcid injections. Outcome of the events was resolved with sequel on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
pt has been ill w/T99-102, h/a, chills, fever, pain in leg & back for past 2wks since shot;has seen MD 3x & MD sending pt to infect disease MD 19OCT95;
This spontaneous report was received from a registered nurse via company representative and refers to a 9 year old female patient with gluten allergy. The patient's pertinent medical history was not known by the reporter. On 12-JUN-2001, "at the age of three years old", the patient received the first dose of VARIVAX (dose, route of administration, lot # and expiration date were not provided). It was unknown if the patient took any concomitant medication. On an unspecified date (reported as "at the age of nine years old"), the patient was diagnosed with celiac disease. It was unknown if any treatment was given for the event. The outcome of celiac disease was unknown at the time of this report. The relatedness between event of celiac disease and VARIVAX was not specified by the reporter. Upon internal review, the event of celiac disease was considered to be medically significant. Additional information has been requested.
10 cm in diameter over left upper thigh with a 2cm in diameter nodule in the center of erythematous area.
Vaccines administered at 11:00 a.m. Child returned at 12:15 with facial edema, urticaria, and wheezing c/w anaphylactic rxn. Sent to ER. for immediate care.
Big knot under shoulder pit; Everything swolled up on the side were got the shot. Shoulder and under shoulder and hurting; Everything swolled up on the side were got the shot. Shoulder and under shoulder and hurting; This is a spontaneous report from a contactable consumer. This 67-year-old male consumer reported for himself that.  A 67-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0180), dose 2 via an unspecified route of administration, administered in Arm Right on 09Jul2021 10:00 as (At the age of 67-years) DOSE 2, SINGLE for covid-19 immunisation. Medical history included multiple sclerosis from 2016 and ongoing, hypertension from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium 50mg tablet once a day taken for hypertension from an unspecified start date and ongoing. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186 or EW0180), administered in left shoulder dose 1, single for covid-19 immunisation on 06Jun2021 10:00, and teriflunomide taking 14mg tablet, but he does not take it anymore. He stopped taking a year ago. However, he was informed it stays in system for 2 years. No other Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks. No AE following prior vaccinations. No Family Medical History Relevant to AE. It was reported that patient got his second dose on Friday. He had a side effect that was not listed, and he was calling to report on that. He was reading the side effects and he had one that was not listed. He had a big knot under shoulder pit on the side where he got the shot. It all swelled up underneath the arm pit. It was like the size of an orange. He also added he thinks we should know he has multiple sclerosis. Caller explained he had a big knot under shoulder pit, and everything was swollen. His whole shoulder was swollen, and he could not lift it. That whole side was swollen. He had a big red knot underneath arm pit. It was the size of an orange. He noticed the early part of the morning on Saturday his shoulder was bothering him. He woke up from the pain at 3:00 AM. His shoulder and under should was hurting. Now everything is going back down, and he does not really have pain. It is just more soreness and stiffness. He commented he went to the doctor for a checkup, but not due to vaccine. At end of call, he mentioned he was just looking at the side effect list and saw the side effects and symptoms. However, he did not see this event listed with a knot underneath shoulder. He stated, he did have just about half of the symptoms listed after getting the Covid-19 vaccine. Attempted to clarify event details further. However, he did not specify further which events occurred. He only stated it was just about all of them. Patient did not require a visit to Emergency Room or Physician Office. The outcome of events was recovering at the time of report.  Follow-up attempts are completed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 17Jan2021 as dose 1, single (Lot number: EL2247), in left arm, on 04Feb2021 as dose 2, single (Lot number: EL9264), in left arm and on 17Aug2021 as dose 3 (booster), single (Lot number: EW0181) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11Jan2022 as dose 4 (booster), single (Lot number: 068H21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Benign prostatic hyperplasia" (unspecified if ongoing). Concomitant medication(s) included: AMBIEN; ROSUVASTATIN; TADALAFIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; Unknown results, notes: Paxlovid rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient had no known allergies. The patient received other medications in 2 weeks. On 23May2022, the patient received Paxlovid for treatment of COVID-19 and stopped on 28May2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the lack of efficacy  cannot be ruled out.
Exactly 2 weeks after receiving the Moderna Vaccination I was awakened by heat and itching of my left upper arm in the area of the injection site. I was scratching it in my sleep. The area was red, hot and blotchy. I applied CBD pain cream and tried to sleep.  In the morning I applied Benadryl cream and an ice pack.  Later in the day I was still in distress so I applied cortisone 1% ointment which helped. For night time I took a Benadryl tablet and continued to apply Cortisone ointment thru Sunday.  On Monday morning I went to my dermatologist who immediately went online to the CDC where we learned that the reaction was not uncommon and that I should get the 2nd dose. I have continued to have flare ups.
Lightheaded/ Dizziness; Chills; Slight soreness; A spontaneous report was received from a consumer concerning her mother, a  95-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events; slight soreness/pain, lightheadness/dizziness and chills.  The patient's medical history was not provided. Concomitant medication list was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 20 Jan 2021 .  On 17 Feb 2021 the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in an unspecified arm for the prophylaxis of COVID-19 infection.  On 17 Feb 2021, after receiving mRNA-1273 the patient experienced slight soreness and chills. 48 hours later that is on 19 Feb 2021, the patient started feeling lightheaded and dizziness. It comes and goes but still happens everyday. Treatment provided for the events were not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events; slight soreness, lightheadnes/dizziness and chills was considered to be unknown.  Follow up received on 26 Feb 2021include the event that occurred two days after second dose of mRNA-1273; dizziness/lightheadness.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age.  No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 15-DEC-2015, the patient was vaccinated with ZOSTAVAX (dose, route of administration and lot number were not provided) 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 11-JUL-2016, the patient was treated by a physician for an ongoing vesicular outbreak, which was diagnosed as herpes zoster, or shingles. 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.
Patient experienced swelling of the tongue and self-administered Benadryl.  She did not seek emergency medical care.