chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hands that are hurting like it triggered an arthritic condition; in the fingers, particularly the left hand; painful to move/painful to touch; cannot make a fist; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (hands that are hurting like it triggered an arthritic condition), PAIN IN EXTREMITY (in the fingers, particularly the left hand), PAIN (painful to move/painful to touch) and MOBILITY DECREASED (cannot make a fist) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 003B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was provided.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced PAIN IN EXTREMITY (in the fingers, particularly the left hand), PAIN (painful to move/painful to touch) and MOBILITY DECREASED (cannot make a fist). On an unknown date, the patient experienced ARTHRALGIA (hands that are hurting like it triggered an arthritic condition). The patient was treated with IBUPROFEN for Adverse event, at a dose of once in a while and DICLOFENAC SODIUM (VOLTAREN ARTHRITIS PAIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (hands that are hurting like it triggered an arthritic condition) had not resolved and PAIN IN EXTREMITY (in the fingers, particularly the left hand), PAIN (painful to move/painful to touch) and MOBILITY DECREASED (cannot make a fist) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported; Sender's Comments: This case concerns a 67-year-old, male patient with no reported relevant medical history, who experienced the unexpected events of Arthralgia, pain, pain in extremity, and mobility decreased. The events started  approximately three weeks after the third dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report.
I was achy, headache, sore throat, very fatigued, felt puny, I tested for COVID-19 twice once with a home test, and once at the local urgent care with a PCR Rapid COVID -19 test. Both times it came back negative. I was advised to take Tylenol, get rest and retest if the symptoms got worse.
04/14/2006 Right arm swelling last 24 hours after receiving DTaP and IPV in this arm. No fever or other c/o. Arm with 5 cm erythematous patch minimally hot, no skin breakdown. Mild hypersensitivity.
tested positive for COVID and was vaccinated,; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID and was vaccinated,) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced COVID-19 (tested positive for COVID and was vaccinated,). At the time of the report, COVID-19 (tested positive for COVID and was vaccinated,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Oct-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided..  Per reporter its was unknown if patient had taken Pfizer's or Moderna.   No treatment information were provided.; Sender's Comments: This spontaneous report concerns an adult male patient with no medical history who experienced an unexpected non-serious AESI COVID-19. The event occurred after an unknown duration following vaccination with mRNA-1273. Re-challenge is not known due to lack of information about the doses. The outcome of the event is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Swelling 3 x 3 cm rt. thigh. Reaction to varicella shot.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27May2023 as dose 6 (booster), single (Lot number: Gj3268) at the age of 71 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (Sep2023) Positive, notes: Rebound - tested positive for Covid on day 13. Therapeutic measures were taken as a result of covid-19 included Paxlovid from 11Sep2023 to 16Sep2023.  No follow-up attempts are possible. No further information is expected.
Brain fog; Dizziness; migraine headache with visual aura (stars); tingling that started at the base of my neck and spread over my entire head that lasted about 7 hours (sensory aura); felt fatigue; tension; suspicion of a possible MCAS reaction; This is a spontaneous report from a contactable other health care professional (patient). A 23-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, in the right arm on 20Feb2021 at 18:30 (at the age of 23-years-old) as dose 1, single for covid-19 immunisation. Medical history included celiac disease, MCAS (mast cell activation syndrome), CKD (chronic kidney disease), MTHFR (methylenetetrahydrofolate reductase deficiency), HLA-B27+, Morton's Neuroma, migraines, pancreatic insufficiency. Known allergies reported zofran, tanalbit, gluten, wheat, dairy, pineapple, lobster, crab, potatoes, egg plant allergies. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. Concomitant medications were not reported. Patient received other medications in two weeks. The patient did not receive any vaccines within four weeks prior to the vaccination. On 20Feb2021 at 18:45 (about 5-10 minutes after receiving the vaccine), the patient experienced migraine headache with visual aura (stars) and tingling that started at the base of her neck and spread over her entire head that lasted about 7 hours (sensory aura). She felt fatigue and tension. She took 25mg diphenhydramine an hour before, stayed at the administration site for about an hour, and took another 25mg about 1.5 hours after on suspicion of a possible MCAS reaction. Day 2 side effects involved brain fog, dizziness, and migraines. Events seriousness criteria reported as non-serious. The patient did not receive any treatment for the event. The patient underwent lab tests and procedures which included negative sars-cov-2 test (PCR, nasal swab), on 23Mar2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of event suspicion of a possible MCAS reaction unknown and for all other events was recovered in 2021.   Information about lot/batch number has been requested.; Sender's Comments: based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-DEC-2015 at 09:53, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.4 and 5.0 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Left thigh - erythema, swelling mild heat and central pallor - 12.5 cm diameter area.
Information has been received from a physician assistant concerning a "very elderly" patient (gender not reported) who was vaccinated subcutaneously with a 0.65 mL dose of Zostavax (Merck). Concomitantly therapy included unspecified "eye droops that contain steroids." Subsequently the patient developed a "total body rash immediately after administration" of the vaccine. It was reported that "It was not a zoster rash and was not limited to the injections site. The patient sought unspecified medical attention. The patient's status was not reported. There was no product quality complaint. Additional information has been requested.
rash on bilateral knees, elbows, wrists, hands that occurred 2-3 days after receiving Johnson & Johnson COVID-19 vaccination and later spread to arms, legs, torso, perineum within 1-1 1/2 weeks.  Stayed relatively constant for 3-4 weeks, now starting to taper off.  Rash was pruritic, sensitive to touch with some raised patches coalescing into dime sized areas
ER visit 5/22/13 19:39. Generalized clonic-tonic seizure lasting 4 minutes. (Last seizure activity was August 2012), spontaneous resolution of seizure. Pt. active, happy upon arrival to ER. T 98.1 P 140 R-36 BP 141/100. History to seizures since fall down steps age 2 yrs.
Symptoms much worse than first shot. Site of shot swelled to the size of apple with pain that was felt all the way through my arm to the underneath. Very painful.  Flu symptoms ie: muscle pain, joint pain. fever, nausea, soft stools, severe fatigue, muscles were rubbery feeling, headache, extreme thirst. The worst was the first 3 days then slowly started to somewhat recover. On day 8 had to take deep breaths .  I am still not feeling well with severe fatigue as the worst symptom.
Patient had swelling and itching at injection site approximately 10 min after shot. Applied ice and gave BENADRYL 25mg oral, since no other symptoms of anaphylaxis were present. We monitored patient for 55 minutes, husband took her to Dr to follow up. Called patient 6/25/13 she was fine - still had redness at injection site. No other symptoms.
fever headache body aches without any cold symtoms (runny nose, sore throat or cough)  much better after 24 hours but just left over weekness...may not be related to vaccine but never had this type reaction/ sickness ...
38 years old female patient received a pediatric (0.5 mL) dose; 38 years old female patient received a pediatric (0.5 mL) dose; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 38-year-old female patient who received HAV (Havrix pediatric) (batch number B23EA, expiry date 15th May 2022) for prophylaxis.   On 2nd April 2021, the patient received the 1st dose of Havrix pediatric .5 ml. On 2nd April 2021, unknown after receiving Havrix pediatric, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.  Additional details were provided as follows: All patient identifiers were reported as well as batch number and expiration date. It was reported that the patient received a pediatric dose instead of Adult dose, which led to adult use of a child product and underdose. The reporter consented to follow up.
Breakthrough COVID infection.  Direct admit to Hospital from Medical Center. SpO2 100% on 4LNC, presented to for shortness of breath, had positive COVID test, and pneumonia noted on imaging.
Six days post vax, developed a raised red , warm area around injection site 13 x 6 cm. Minor itching, reports that no problems prior to now, Referred to primary MD for diagnosis and treatment.
pt recv vax 13JAN96 & JUL96 pt exp chickenpox w/approx 20 lesions on trunk;it was noted that the lesions did not itch;
Missed second shot / I took my fist shot in July  / July 2020; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The age group was not reported but was selected as adult as per vaccine indication. Till the time of reporting patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. No additional Information provided.
Information and follow up information has been received from a nurse practitioner, concerning a 19 year old female student with no pertinent medical history and no known allergies, who on 18-SEP-2007 at 1:00 p.m., was vaccinated IM in the deltoid, with the first dose of Gardasil (lot #658560/1062U). There was no concomitant medication. There was no illness at the time of vaccination. On 18-SEP-2007, following the vaccination, she developed red patches with itching all over her body. On 03-OCT-2007, the patient returned to the office, and treatment with CLARITIN was prescribed. At the time of this report, the patient had not recovered from the events. Additional information has been requested.
mom states pt is red all over face, arms, trunk (back & chest) & legs since afternoon of 2MAR93; vax recvd 22FEB93; mom stated pt had fever on the evening of 2MAR93 was given APAP; states face swollen the AM of 2MAR93;
Hello- 24 hours after receiving my first COVID vax, I had arm soreness and mild flu symptoms, which were totally expected and resolved in a day. However, almost two weeks after getting the shot, I began experiencing arm pain directly where the vaccination site was, and running down part of my arm. It's very strange, as the pain is constant. It has not gone away since it began. I have been taking 800mg of Advil around the clock, and it's very apparent when the medication begins to wear off, as it's extremely uncomfortable. I have never experienced any health issues like this before and do not engage in any activities that would cause muscle pain. Additionally, I have a very high pain tolerance and am rarely bothered by aches or pains (and certainly never had an issue that required me to take Advil so regularly to control the pain). I wanted to report this, as I do not believe it's likely coincidental that this issue began in the exact spot on the same arm as the shot was administered. Please feel free to reach out with any questions or if you need additional info. Thank you so much!
Pain radiating down arm, swelling and redness whole arm, warm to the touch, large knot.
Patient received the vaccine, and waited 30 minutes, due to history of allergies.  After the vaccine, he walked to his car, and he felt flushed and facial tightness.  He was driven home, took Benadryl, and then a 1.5 hour nap.  When he woke up all symptoms had resolved and he has not had any symptoms since.
7/30/12 received all required vaccinations. Prevnar and HiB in Left leg, another in Right, and Polio (oral).  -Injections at approx 11am.  -Cried non-stop until 6:30pm  -Gave Tylenol, Benadryl, ice pack, juice (vitamin C) for reaction in left leg.   -Left leg swollen and stiff.  -Left thigh, knee, ankle, foot all red and hot to the touch.  -Mild fever.
Mom reports slightly itchy rash on neck and anterior chest papular in nature approx 3 hrs after vaccine. No other symptoms. No fever. Mom gave BENADRYL.
Pt recv vax on 1/20/99; post vax pt exp numb rt arm x 5 min
First vaccination 04/14/2021, sore arm for two days. Second dose 05/05/2021, 24 hours later I am peeing by the drop.  Treated myself, Perdisone 2X 10mg day, no help. Treated myself Cephalexin 500mg 2X day, 3 days, no help. Talked to doctor on 05/11/2021, Picked up Macrobid 100mg, Reluctant to try, can give you a heart attach. Tried two days, Ceph & Mac, 1ea. dadocty, day 3, tried 2ea. Macrobid per day, BP went to 170/102.  Could kill me, stopped all meds.  Still pee by the drop.  05/29/2021, Piller Cyst on my head ruptured, leaking puss, origional removal consultation, 04/12/2021 w/Dr.  Only had it for 20+ years.  Schedualed removal 05/21/21. 29 Days after the second dose
19 YRS OLD MALE. NO KNOWN MEDICAL HISTORY. SEVERE HEADACHE, FACIAL DROOP, TINGLING SENSATION ALL OVER HIS BODY. CHEST PAIN, SOB, BLOOD WENT UP. SINUS TACHYCARDIA.
throwing up clear liquid; legs hurts- muscle and joint pain; symptoms felt like a flu; tired/exhausted/ didn't look good; feel bad; trouble sleeping/ no sleep yet; have anxieties; feel sick; arm from injection site hurt so bad and swollen; arm from injection site hurt so bad and swollen; gland underarm of injection site is swollen; stabbing headaches; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (trouble sleeping/ no sleep yet), ANXIETY (have anxieties), ILLNESS (feel sick), VACCINATION SITE PAIN (arm from injection site hurt so bad and swollen) and VACCINATION SITE SWELLING (arm from injection site hurt so bad and swollen) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A. and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and ALPRAZOLAM (XANAX) for Anxiety, MONTELUKAST SODIUM (SINGULAIR) for Asthma, TRAZODONE for Sleep disorder.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced SLEEP DISORDER (trouble sleeping/ no sleep yet), ANXIETY (have anxieties), ILLNESS (feel sick), VACCINATION SITE PAIN (arm from injection site hurt so bad and swollen), VACCINATION SITE SWELLING (arm from injection site hurt so bad and swollen), LYMPHADENOPATHY (gland underarm of injection site is swollen), HEADACHE (stabbing headaches), INFLUENZA LIKE ILLNESS (symptoms felt like a flu), FATIGUE (tired/exhausted/ didn't look good) and FEELING ABNORMAL (feel bad). On an unknown date, the patient experienced VOMITING (throwing up clear liquid) and MYALGIA (legs hurts- muscle and joint pain). The patient was treated with PARACETAMOL (TYLENOL) on 05-Apr-2021 at an unspecified dose and frequency. At the time of the report, SLEEP DISORDER (trouble sleeping/ no sleep yet), ANXIETY (have anxieties), ILLNESS (feel sick), VACCINATION SITE PAIN (arm from injection site hurt so bad and swollen), VACCINATION SITE SWELLING (arm from injection site hurt so bad and swollen), LYMPHADENOPATHY (gland underarm of injection site is swollen), HEADACHE (stabbing headaches), VOMITING (throwing up clear liquid), MYALGIA (legs hurts- muscle and joint pain), INFLUENZA LIKE ILLNESS (symptoms felt like a flu), FATIGUE (tired/exhausted/ didn't look good) and FEELING ABNORMAL (feel bad) outcome was unknown.            Patient took Xanax on 6Apr2021 for her anxiety and trouble sleeping. She also took Tylenol last night (5Apr2021) 10 hours after her 2nd dose of vaccine and put some ice on her arm where she had the injection.
Herpes zoster (Shingles) left back area Acyclovir 800mg TID x 7D ordered.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Sep2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: SYNTHYROID, start date: 02Jul2017; LISINOPRIL.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received
Presented to Clinic on 7/28/05 with rash over majority of body. Reported having pruritis the day prior with rash onset noted upon waking on the 28th. No other complaints of. Received smallpox vaccine on 7/18/05. Prednisone 20mg bid, Benadryl 25mg tid, and Triamcinolone cream 0.1% bid ordered. Seen on follow up on 7/30/05 and 8/1/05. Sx. improving slowly.
Hives on legs and back. Given PO steroids and BENADRYL. Seen in ER on 11/11/14.
PfizerpBioTech Covid19 Vaccine EuA awakened in night with fast heartbeat of 93-96
Expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vial was opened for more than 12 hours, left outside in room temperature, and administered to the patient.  No treatment medications were reported.
Severe headaches, hand (Lt) (Rt) tremors, loss of appetite. 2 days after bowel & bladder paralysis, numbness ou lower extremities & then paralysis to ou legs. Fever.