chrisvoncsefalvay/vaers-outcomes huggingface dataset:
EYE ACHING; MORE TIRED; DIZZINESS; SPACEY, FLOATY ODD FEELING; EXTREME VOMITING; BODY SHAKING CHILLS; EXHAUSTION; INTENSE HEADACHE/TEMPLES ARE SORE; HIGH FEVER; SEVERE MUSCLE ACHES  FROM NECK TO LOWER BACK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-APR-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced extreme vomiting. On 10-APR-2021, the subject experienced body shaking chills. On 10-APR-2021, the subject experienced exhaustion. On 10-APR-2021, the subject experienced intense headache/temples are sore. On 10-APR-2021, the subject experienced high fever. On 10-APR-2021, the subject experienced severe muscle aches from neck to lower back. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced spacey, floaty odd feeling. Treatment medications included: paracetamol. On 13-APR-2021, the subject experienced more tired. On an unspecified date, the subject experienced eye aching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eye aching, and severe muscle aches from neck to lower back, had not recovered from intense headache/temples are sore, and the outcome of exhaustion, high fever, body shaking chills, extreme vomiting, dizziness, spacey, floaty odd feeling and more tired was not reported. This report was non-serious.
Moderna COVID-19 Vaccine EUA 8-9 hours after my vaccine I fainted. I got up in the middle of the night, used the bathroom and fainted. I was not having stomach issue nor did I have a fever. I had eaten and drank enough fluids before and after the vaccine. I could feel that I was going to faint and started to sit down, luckily I did not fit my head only had a bruise on my forearm and hip. I woke up quickly and family members were nearby to help me slowly sit up. I did not faint anymore after this. I was very fatigued for the next 2 days. I contacted my health care provider, but did not need to be seen or treated. Medical History with fainting: I have fainted before, once in my teens when I had a very high fever and once after my first pap smear (vagal response).
Light headed and slight fever on day of  injection.  Since that time, arm is swollen and red and slightly sore.
STARTED HAVING BILATERAL UPPER EXTREMITY PARESTHESIA/BURNING SENSATION AND LEFT LOWER EXTREMITY  PARESTHESIA/BURNING  THE EVENING AFTER RECEIVING THE VACCINE.
Immediately following the administration of PCV13 and MMRV, in the Right Thigh, the thigh became reddened and had a bleb of what appeared to be fluid beneath the skin. Initially the bleb measured 1 cm and redness measure 42 mm. After 5 minutes the bleb had increased to 2 cm and redness to 42 mm.
No adverse event; Patient was scheduled for first primary covid vaccine but instead was given the booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was scheduled for first primary covid vaccine but instead was given the booster dose) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Relevant medical history or conditions, allergy, concomitant diseases and risk factor were unknown.     On 25-Aug-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 25-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient was scheduled for first primary covid vaccine but instead was given the booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was scheduled for first primary covid vaccine but instead was given the booster dose) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was scheduled for first primary covid vaccine but instead was given the booster dose).    It was unknown if the patient was vaccinated with any other vaccinations 4 weeks prior to the COVID-19 vaccine.  Concomitant medication not reported.   Two patients were involved. The facility ordered Bivalent Moderna COVID-19 Vaccines, but they only got the dark pink cap vials. They had two patients, one that was 8 months and 7 days who had not received the dose and one that was 6 months and 2 days who had received a dose. The patient who received a dose was administered 0.2 mL from the dark pink cap vial (lot number 216K22A). Both patients were previously unvaccinated.  Treatment medication not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2023: Significant follow up received contains patient details added and primary reporter details, event term updated.
Sore (L) arm w/redness (site of injection) and inability to move same arm in all directions per pt. Patient not seen that day by me because I was out.
Rash of <50 lesions started on 8/6/08.  Fever that started 8/6/08, resolved by time of office visit on 8/7/08.
TIA ( mini stroke) on fourth day after dose two.; This is a spontaneous report from a contactable consumer (patient).  A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6208 and expiration date not provided), via an unspecified route of administration, administered in Arm Right second dose on 25Mar2021 15:00 at single dose for covid-19 immunisation. The patient's medical history included Hypertension and Penicillin allergy. The patient's concomitant medications included lamotrigine (LAMICTAL) and bupropion hydrochloride (WELLBUTRIN). The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6201 and expiration date not provided) via an unspecified route of administration administered in Arm Right first dose on 04Mar2021 administration time: 04:00 PM for covid-19 immunisation. On 29Mar2021 10:00, the patient experienced TIA (mini stroke) on fourth day after dose two. The event resulted in physician office visit, Emergency room visit, and hospitalization for 1 day. The patient was treated and was placed on three medication (unspecified). The patient underwent lab tests and procedures which included Spectrum DNA test: negative on 15Apr2021.  The outcome of the event was recovering.
Local redness, swelling and pain at the site of vaccine. Given BENADRYL PRN. Reaction at site of DTaP.
received an immunosuppressive treatment after receiving first dose; This case was reported by a pharmacist via call center representative and described the occurrence of immune system disorder in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced immune system disorder. The patient was treated with infliximab (Remicade). On an unknown date, the outcome of the immune system disorder was unknown.   It was unknown if the reporter considered the immune system disorder to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The pharmacist called and asked for information in interaction between Shingrix and Remicade. Remicade was prescribed after first dose and the reporter did not know indication. The patient need to receive second dose for Shingrix. No further information was provided.
None at time of injection Symptoms started the end of June Air hunger, rapid, irregular heart beat, pounding in chest, weakness, and pain between shoulder blades
Waited some time to report due to my immune system being ravaged by illness.   Severe arm pain after 1st dose that I could not work the day after my shot? somehow worked thru the day of, just 3 hrs.   Migraine headaches (3 total) after 1st dose, over the course of 11days.   Severe nausea on & off following both doses that got worse when driving & led to cold clammy sweating & becoming red-faced. NOT RESOLVED. Still nauseated off & on. The red-faced issue seems to happen even with very mild exertion, like putting away groceries or sometimes (when I?m not feeling well), happens just getting out of bed in the morning. At times my face is actually hot ? can tell it?s red before I check a mirror. Other times, it?s not. Definitely autoimmune in nature. I?m well-versed on my illness, so I believe this is the only explanation.  Serious hormonal changes. NOT RESOlVED. Were seen on a blood test last month, tho I?d been normal up to that point. High cholesterol, significant difference from last testing 1yr prior, approx 75pts! Also now considered pre-diabetic. I am NOT fat nor have I changed my diet in a major way. If anything, I?m eating a more vegetarian diet though only slightly more so, perhaps 10-15% more veggie. ALSO: Thyroid (which has been hypo since age 10) was within normal range but just barely. Yes, it was a fasting test, as always. NOTE: Hormonal changes are a possible element of Ehlers Danlos Syndrome & seem to have an autoimmune component.   Severe fatigue, ongoing. NOT RESOLVED. Just don?t feel like myself due to this!  Depression & anxiety. NOT RESOLVED. Again, just don?t feel like myself due to this.  Noticeable difference in sense of smell & sense of taste. NOT RESOLVED. I am a super taster, could tell all ingreds in things I ate. This isn?t ok! Comes & goes. Awful.  Fogginess. NOT RESOLVED. Easily forget things I shouldn?t. I?m still young :(
products been administered post excursion with no reported adverse event; Initial information received on 08-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 51 years old female patient who has been administered Diphtheria-2/Tetanus/5 AC Pertussis vaccine [ADACEL] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/TETANUS/5 AC Pertussis vaccine Suspension for injection of lot U7929AA and expiry: 14-Nov-2025 via unknown route in unknown administration site for immunization.  On an unknown date, the patient has been administered Diphtheria-2/Tetanus/5 AC Pertussis vaccine post excursion with no reported adverse event (poor quality product administered) (latency: same day).  No lab data 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 the 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.; Sender's Comments:  US-SA-2023SA353755:01836321, 01836324  US-SA-2023SA353804:01836321
Burning feeling on tongue, bilateral upper extremeties red, diaphoretic.  Given Benadryl 25 mg. Symptoms resolved with Benadryl treatment after 15 minutes.
1-1/2 days after second shot I developed a bump/nodule just under my shoulder blade above the armpit on the same side as the injection (left arm).  it is getting bigger and hurts.  right now it feels to be about 1/2" in diameter.
Felt a little cold about 4 hours after. Didn?t realize it was the start of chills.  Woke up at 1am shivering, chills, felt warm but could not get up to take temp, sweat through my clothes, headache, nausea. 6am headache was worse like a migraine. Severe nausea, felt cold.
Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; This spontaneous case was received on 30-Sep-2020 from other health professional (nurse) via agency (reference number: SEQW20-02593) and concerned a patient of an unknown age and gender.   The patient's medical history and concomitant medications were not reported.    On an unknown date in Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, indication, dose, route of administration and anatomical location: not reported). The batch number reported was 279838.     On the same day, a few hours after receiving Flucelvax QIV, the patient experienced warmth, pain and edema at injection site.   The outcome of events was not reported.   The reporter did not provide a causality assessment.  This case is linked to cases 202004826, 202004882, 202004883 and 202004884 (the same reporter).  Company comment: The patient developed vaccination site warmth, vaccination site pain and vaccination site oedema a few hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed vaccination site warmth, vaccination site pain and vaccination site oedema a few hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
I developed a very painful swollen lymph node in my left armpit, the evening after the shot.  This continued to be painful for weeks. Now almost a year later, the pain comes and goes. It flares up before my period (never had this before the shot) and I can feel it in my armpit. Sometimes it causes discomfort shooting down my arm.
Rt. ARM IS RED AND TENDER TO TOUCH ON Rt. DELTOID AREA.
Pt received ZOSTAVAX 8/27- The next day pt said the inj site became itchy and red- on 8/29, 2 days later, pt said it appeared to expand and continued to be itchy and red.
Pfizer COVID-19 Vaccine EUA  Was shaky and lightheaded sent to medical obs and provider kept for 30 mins. Felt better after juice and crackers. Patient presents today for medical monitoring of complaint of being dizzy, sweating s/p COVID - 19 vaccine # 1.   Past medical history is significant for intermittent vertigo and asthma.  Patient reports previous history of vasovagal episodes with blood draws.      Patient was monitored for a total of 30 minutes.  Patients vital signs remained stable.  Patient reported improvement in symptoms prior to being discharged.
Patient present with altered mental status and fevers, headache generalized body ache fever chills at the time of admission (4/21) generalized rash mild splenomegaly mild thrombocytopenia and elevated ferritin and CRP.  He did not have any evidence of coagulopathy.  His lactate and LDH are also within normal limits.  Vasculitic workup and infectious disease workup till date have been negative.  His CSF protein and glucose were within normal limits.  He developed Worsening altered mental status as well as renal failure requiring hemodialysis.  treatments for the most part have been supportive including steroids, intubation for altered mental status, antibiotics empirically, hemodialysis for renal failure.  To date ( 04/27/2021)  there has been no significant improvement in patient's status.
Dizziness, brief syncopal episode X 2. Possible seizure activity with visual disturbance, light colored flashes, rapid eye movement and tonic limb jerks.
Itching; A biopsy was performed and it showed dermatitis.; Rash/She developed bumps on the top part of her legs, from her knees to her hip and both arms; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Itching), DERMATITIS (A biopsy was performed and it showed dermatitis.) and RASH (Rash/She developed bumps on the top part of her legs, from her knees to her hip and both arms) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 033B21A) for COVID-19 vaccination.     The patient's past medical history included Hip replacement.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced RASH (Rash/She developed bumps on the top part of her legs, from her knees to her hip and both arms). On an unknown date, the patient experienced PRURITUS (Itching) and DERMATITIS (A biopsy was performed and it showed dermatitis.). At the time of the report, PRURITUS (Itching) and DERMATITIS (A biopsy was performed and it showed dermatitis.) outcome was unknown and RASH (Rash/She developed bumps on the top part of her legs, from her knees to her hip and both arms) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment included use of Aquaphor which seemed to provide a barrier to the spreading of rash  Patient reported that she had went to a walk in clinic because she was not able to stand the itching. Patient stated that a biopsy was performed which showed dermatitis. Patient also stated that the doctor told her that the immune system is fighting the vaccine just like it does in the case of pericarditis, but her body is attacking her skin. The patient reported that her sister developed the same events after receiving the vaccine, but it was on her back, chest, legs and arms and also the patient's granddaughter had the same rash, but only on her legs. Patient stated that the doctor at the walk in clinic told her that she had seen similar cases, specifically a (ethnicity given) (gender given) patient, but it was all over her body and big huge patches.   This case was linked to MOD-2021-392143, MOD-2021-391875 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Reporter information added, Patient demographics updated, Patient's historical procedure hip replacement added, Dose 1 and dose 2 details updated, Events Pruritus and Dermatitis NOS added.
Rapid heartrate started 13 hours (11:00pm on 6/1/2021) after vaccine was administered (10:00am 6/1/2021) and lasted consistently for 18 hours (5:00pm on 6/2/2021), even while sleeping through the night.
Rash, fever, irritability, restlessness, sleep problems, vomiting, congestions, wheezing, and general weakness.
extreme exhaustion - couldn't stay awake, headache, nausea, severe joint pain, light-headedness/dizzy, a large swelling/lump formed in L armpit that was very sore/tender, temperature up to 101ºF, chills, tongue: swelling, dark red spots, circles with raised bumps, cracks in surface, burning, tingling, no change in taste sensation, plus burning lips. 48 hrs later: awake, no headach, nausea gone, joint pain back to normal, no dizzy, temperature down to 99, few chills, lump less sore, tongue hurts, but no new symptoms. By 03/8/2021 all symptoms gone except tongue still healing - almost back to normal but still some redness, dryness, tingling. Thirst increasing. Healing faster after 2nd shot than after 1st shot.
2nd Varivax administered 8-23-06 diagnose with Varicella 9-20-06.  This started 1 week ago.
No adverse event. Dosing error, patient received 0.25mL of Moderna Bivalent Booster instead of recommended 0.5mL
Pt admitted with H-Flu meningitis on 24Jun90. Pt expired on 25Jun90. Pt received HIB vaccine at 18 months of age.
Patient stated she felt dizzy/lightheaded while sitting in observation area. The patient had a baby in her arms, The LVN transferrred the baby to the patient's mother-in-law while she obtained vital signs. B/P: 145/73, HR: 73, O2: 100%, Temp: 98.3  at 10:21. LVN helped patient with deep breathing/ relaxation exercises and was able to calm patent to where she said she "feels much better". Vitals at 10:31 AM B/P: 122/82, HR: 73, O2: 100%. Patient had steady gait, Alert and oriented X4, Mother-in-law will drive patient home.
covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2022 as dose 3 (booster), single (Lot number: EL9267) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient had no other medication in 2 weeks since vaccination. Patient received treatment with Paxlovid from 10Jun2022 till Jun2022  No follow-up attempts are possible. No further information is expected.
shot given on thu 10/22/20. that evening it was red and hurting. on friday it was red from injection site down to elbow and hot. on saturday was hot and blister like. sunday had elbow pain but by the evening was feeling better. monday it wasn't hot at all but was still red and now a bruise. she called pharmacy monday afternoon around 2pm to report the side effects.
pt reported extremely painful arm, restricting movement onset shortly p/inj; denies redness, swelling instructed pt to use warm packs, ice packs, APAP & call back if not better in 2 days; pt called back 8FEB w/no improvment; pt sent to MD:
A patient got 0.25ml as their first dose of the Moderna COVID-19 Vaccine instead of the recommended 0.5ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (A patient got 0.25ml as their first dose of the Moderna COVID-19 Vaccine instead of the recommended 0.5ml) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milligram. On 27-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (A patient got 0.25ml as their first dose of the Moderna COVID-19 Vaccine instead of the recommended 0.5ml). On 27-Dec-2021, ACCIDENTAL UNDERDOSE (A patient got 0.25ml as their first dose of the Moderna COVID-19 Vaccine instead of the recommended 0.5ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.