chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9/25/08 Pt c/o fever, soreness at injection site. Physical exam shows no swelling or redness visible at injection site. RX'ed pt with Zithromax for possible infection and Ibuprofen for pain.  9/26/08 Pt c/o swelling/pain at injection site/Physical exam showed some swelling possible cellulitis/tx pt with Bactrim DS & Kenalog cream.
(R) upper arm with large, red, indurated area at injection site, warm, tender to touch, swelling, rash.
1755 Approx 10 minutes after receiving the J&J covid vaccine.  Patient leaned back in his chair and fainted.  Began to shake, eyes open and became diaphoretic.  Easily arroused but still diaphoretic and weak.    1805 Transferred to patient room on a exam table and head of bed elevated via w/c and assistance of urgent care nurse.  Vitals taken with bp of 138/90 Pulse 22 Temp 97.3 Patient is responsive.  Cold water, ice packs given.  Patient had a large emesis and never lost consciousness again.       18/23 Sitting up at bedsid.  Rechecked vitals and 114/76  Pulse 56.  Oxygen level 97-98. Patient is sitting up but still pale in color, diaphoretic has improved but still present.    1835  Patient states he is feeling better but still weak and dizzy. Recommend he have family member pick him up as he doesn't feel he is able to drive.  BP 125/85  Pulse 53.  Had smaller emesis.     1840 Patients wife is on her way to pick him up.  He is eating crackers and Ice water.  Still weak and somewhat dizzy. BP 128/80 pulse 58   1850  Patient still complains of dizziness and weakness.  Improved.  BP 133/86 pulse 57.   1900 patient sitting up and feels much improved.  Felt up to ambulation.  Ambulated in hall 150 feet and tolerated.  Color improved and no longer diaphoretic.  Dizziness subsided.     1910  Wife here and patient discharged.  Did not drive vehicle home.
experiencing pain at injection site, severe headache and lock jaw. TMJ both R and L sides of my jaw, cannot close teeth. Facial pain on left side where the lock jaw began
Moderna COVID -19 Vaccine EUA   Wednesday I had the vaccine.  Later I had thought I had bit my tongue but could not remember doing that.  Thursday - I still had the feeling of bitten my tongue.  Looking at my tongue to see the damage, no cut tissue but, there was ~ 3 bumps on the Left side of my tongue on the "side" of my tongue. Friday there were about 6.  Saturday they started to disappear there were 2.  By Sunday they were gone.  Do not know if this was from the vaccine but it was a strange thing to happen and the timing made me think there may be a connection.    I HAD MY SHOT IN MY LEFT ARM.   IT WAS MY 1ST SHOT.
Patient was 17 years and 11 months and was inadvertently given Janssen vaccine, which is only approved for 18 years and up. This was likely due to the fact that we were hosting a mobile vaccine clinic and the electronic consent form did not auto-populate the age, only the birth date.
eczema; This spontaneous case was reported by an other health care professional and describes the occurrence of ECZEMA (eczema) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (eczema). At the time of the report, ECZEMA (eczema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided
103 temp x 3 days post vacc. 100 on day 4. Skin became dry and site of injections. Had diarrhea day of vaccination
swelling in knuckle between distal and medial phalanges on the middle, ring, and pinky fingers of the right hand.; Joints are also hot to the touch and finger tips are visibly swollen; Joint pain and swelling in knuckle between distal and medial phalanges on the middle, ring, and pinky fingers of the right hand.  Joints are also hot to the touch and finger tips are visibly swollen.; This is a spontaneous report from a contactable healthcare professional, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration on 21Jan2021 (at the age of 36-years-old) as single dose for COVID-19 immunisation. Medical history included plica syndrome in the left knee. The patient was known allergic to augmentin and mushrooms. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231) via intramuscular route of administration on the right arm on 31Dec2020 (at the age of 36-years-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested  positive for COVID-19. Concomitant medications were not reported.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021, the patient experienced joint pain and swelling in knuckle between distal and medial phalanges on the middle, ring, and pinky fingers of the right hand and the joints were also hot to the touch and finger tips were visibly swollen. The patient did not receive any treatment for the events.  The events didn't resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events joint pain and swelling in knuckle between distal and medial phalanges on the middle, ring, and pinky fingers of the right hand and swollen finger tips was not recovered at the time of this report. No follow-up attempts are needed; no further information is expected.
Moderna COVID-19 vaccine at 0.5 ml instead of 0.25ml dose; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of OVERDOSE (Moderna COVID-19 vaccine at 0.5 ml instead of 0.25ml dose) and NO ADVERSE EVENT (No Adverse Event) in a 6-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     The patient's past medical history included FLU.    On 22-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced OVERDOSE (Moderna COVID-19 vaccine at 0.5 ml instead of 0.25ml dose) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, OVERDOSE (Moderna COVID-19 vaccine at 0.5 ml instead of 0.25ml 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 OVERDOSE (Moderna COVID-19 vaccine at 0.5 ml instead of 0.25ml dose).    No concomitant medications were reported. No treatment medications were reported.
reporting on behalf of a 6-month old male that received a medication error with Pentacel described as only receiving the DTap-IPV portion and not the Hib portion of the vaccine; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via Agency (Reference number- 00319832) and transmitted to Sanofi on 16-Oct-2020.  This case involves a 6-months-old male patient who was vaccinated with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL] (suspension for injection), (batch number: UJ207ABA/ UJ207AB and expiry date: 30-Apr-2021) (on the left thigh via intramuscular route the vaccine was administered) (incorrect route of product administration) on 16-Oct-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medication of the patient included hepatitis B vaccine, influenza vaccine, pneumococcal vaccine conj (Pneumococcal conjugate vaccine) and rotavirus vaccine.  It was an actual medication error case due to Incomplete dose administered (latency: same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Starting roughly 1 week after dose #1 in the series,  patient reported progressive stiff neck, pain with radiation and stiffness in the right arm, and severely limited range of motion.  After receiving the second dose in the series in the left arm 3 weeks later, the same symptoms presented in that arm, although to a slightly lesser degree.  Treated by 3 visits to chiropractor, and Cortisone injections in both shoulders on 4/2/21 by Orthopedist.  After initial relief of symptoms, symptoms have gradually reappeared to a lesser degree.
I fainted for the first time in my life. Please note I am not afraid of needles, squeamish, or anything of the sort. I have never had any issues or anxiety towards vaccines in the past, and this occurred the day after I received my shot.
01/05/2022: Event occurred after 2nd vaccine. 52-year-old male past medical history Atrial fibrillation, hypertension, diabetes, hyperlipidemia, CAD, MI, CHF presenting for shortness of breath.  Patient states that he has had progressively worsening dyspnea on exertion.  Denies chest pain.  Patient states that he has not had any near syncopal events or fevers or cough.  GI: No abdominal pain, no nausea, no vomiting, no diarrhea.  -Remdesivir (1/9 - ).  receiving prednisone 40 mg daily for acute gout flare. remains in hospital on Jan 11 2022
Arm got sore with swelling to the point I could pick up my arm. Used ice pack but did no good. It's been three days and now just getting my arm to move but still a bit sore.
Body aches, head to foot;  Chills, trembling;  Sore throat;  Eyes red and running;  Runny nose  Please note:  I am filing this report  5 1/2 hours after receiving the injection - so the reaction is ongoing.  I have consulted the enclosure provided by pharmacy;  Not sure if the info I put in on batch number is correct -  It said : Fluzone High Dose, 2019-20 SYR.  Below that: NDC: 49281-0405-65
Severe headache with weakness in both legs requiring a cane to for mobility. Awoke from sleep at 4am with difficulty moving my head and legs. Have been able to ambulate with the help of a cane. I took 2 Tylenol x 500 mg at 4:30am and am feeling slight relief.
RED,SWOLLEN, HOT TO TOUCH, ITCHY CHILD ALSO HAD FEVER MOM GAVE CHILD BENADRYL BECAUSE THE SPOT WAS ALSO ITCHY
5 1/2 x 6cm area of erythema;lt deltoid area onset 48hr p/vax (5 vaccines administered same day uncertain of sites);
Patient presented to the Clinic with the abrupt onset of short-distance right lower extremity claudication and early rest pain; underwent a right transinguinal hybrid revascularization, which consisted of right common femoral, superficial femoral, and profunda femoral artery endarterectomy with vein patch angioplasty and right external iliac to right femoral (patch) self-expanding stent graft placement. Discharged home. This admission was within 6 weeks of receiving the COVID vaccine.
Hives appeared with in 12 hours on left side of neck and face. Hives are large and still present 3 days later.
Patient was given a FLUCELVAX QUADRIVALENT shot on Wednesday October 29th and reported that the next day he felt poorly. He went to the hospital on Saturday November 3rd with an exacerbation of his Lyme disease symptoms.
The morning after I received the vaccine, I woke up and tried to sit up. I was unable to do so. My back arched, and I could not sit or stand up. I also had no strength because I could not hold on to things, such as a full glass of water or my phone. I dropped both items on the floor. In addition, I couldn't walk. My left leg might as well have been a wet noodle for all the support it didn't give me. I fell two times, and I could not get my leg to support me. I held onto the wall and my husband to walk. I had tics in my hands, particularly the left hand. I was typing, and suddenly, there were multiple letters (either d or s) on the screen.  Later in the day, my symptoms started to subside. I can walk unassisted now. The tics in my hands diminished and are gone as I write this. Right now, I feel as if I have a sinus infection with a headache.
t102.6 prior to vax w/clear liquid under nose-vaccinated anyway-red spots appeared on body;MD dx roseola;screamed,fussy,vomited,temp kept rising;gen sz secondary to meningitis;screamed several hrs;neck & spine irritated;dx meningitis;h/a
Covid 19 breakthrough.  Vaccinated on 04/29/2022.  82 y/o PMH of Asthma, Afib on Xarelto, PAD, HTN, HLD, Simoid stricture with exp lap, CEA presents to ED with c/o Abdominal pain, nausea, diarrhea and increasing weakness x3 weeks.  When admitted was not tested for Covid until several days into admission when Oxygen demands increased and pt required 3L NC.  Treated with Steroids, ABX and Remdesivir.
The area around administration of th MMR vaccine became red slightly swollen and tender. He was monitored for 30 min with no change and resp distress.
Had itching with maculopapular erythematous rash.  In 1 1/2 hours rash progressed from trunk to thighs, to face no difficulity breathing or other signs or symptoms.  Took to ER for assessment of rash.  IV benadryal and tagamet given with relief of itching.  Vistar, IM given at d/c.  Tastnicted to d/c tegadim and only use guaze and paper tape to dress vaccine site. E.R. doctor diagnosed rash as a hypersensitivity reaction to the vaccine.  Followed-up with infectious disease physician.  He also advised d/c tegadim dressings.  Ct removed from direct patient care at work and utilizing gauze with paper tape to cover site.  Continues to have sesitivity to paper tape, and instructed to leave site open to air in evening at home until bedtime, then cover with gauze dressing again.  As of 2/24/03 generalized rash almost completely resolved, but site remains prurtic secondary to tape sensitivity.  Site also erythematoul, and scab begining to heal.  Digital photos emailed to Dr.
Tongue and the back of her pallet tingled; This is a spontaneous case from, initially received from other non-health professional via agency (SEQ19-05696) on 28-Oct-2019, concerning an 66-year-old elderly, female patient.   The patient's medical history includes allergy's to eggs and peanuts, asthma and high blood pressure. The patient's concomitant medications include Claritine (loratadine), hydrochlorothiazide all for unknown indication.  On 22-Oct-2019, the patient was administrated Flucelvax Quadrivalent [influenza vaccine, subunit influenza virus vaccine, polyvalent, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid, batch number and expiration date: not reported] for influenza prophylaxis.  On the same day, 5 minutes after receiving the vaccine, the patient experienced her tongue and the back of her pallet tingled. She took Albuterol (salbutamol) inhaler, and 2 Benadryl (diphenhydramine) later within 5 minutes. The symptoms then subsided, and she didn't experience any further problems.  The outcome of the event was recovered, on 22-Oct-2019.  The reporter assessed the case as non-serious but did not provide causality.  Event's causality was assessed as related to the suspect product per company.; Sender's Comments: Event's causality was assessed as related to the suspect product per company.
Pt in post observation are after receiving 2nd dose of Pfizer. Pt states lightheaded and "1st shot I had a reaction". Pt verbalized having the expected outcome of the 1st Pfizer outcome of the 1st Pfizer vaccine similar to having covid19. Pt provided health hx but denies any heart related issues. Pt denied anxiety. Encouraged to hydrate and evaluated and cleared by EMS.  VS per medics 1103 BP 132/80 HR 53 RR18 O2 sat 98% on RA
12/27/10 at home - red eyes, burning & slight swelling. No treatment. Symptoms resolved.
Possibly unrelated to the vaccine: 2, 5, and 8 days after the vaccine was administered, I experienced short but very painful episodes of abdominal pain, similar to gas pains. Each attack lasted 15 to 25 minutes, and seemed to be alleviated by taking anti-acid (simethicone) pills. Quite likely related the vaccine: 11 days after the vaccine was administered, I experienced a rather severe headache, plus slight general weakness, and a raised temperature of between 98.9 and 100.4 degrees. The first 10 days I had discerned no adverse effects. This has lasted16 hours so far, with little alleviation.
pruritic morbilliform rash began within 48 hours of receipt appeared on trunk and extremities feels achy has not self treated
persistent tingling in her right foot, toes, and ankle; lips were feeling dry and tingling; lips were feeling dry and tingling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (persistent tingling in her right foot, toes, and ankle), LIP DRY (lips were feeling dry and tingling) and PARAESTHESIA ORAL (lips were feeling dry and tingling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (rash and hives), Drug allergy (welbutrin: rash and hives) and Menopause (experiencing hot flashes and chills). Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PARAESTHESIA (persistent tingling in her right foot, toes, and ankle), LIP DRY (lips were feeling dry and tingling) and PARAESTHESIA ORAL (lips were feeling dry and tingling). At the time of the report, PARAESTHESIA (persistent tingling in her right foot, toes, and ankle), LIP DRY (lips were feeling dry and tingling) and PARAESTHESIA ORAL (lips were feeling dry and tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient applied Vaseline for the event lips were feeling dry and tingling, and felt better at the time of report.
Fever of 101.4 for 2 days.  Lesion around injection site.  Loss of appetite, fussiness and crying.
Pfizer-BioNTech Dose 3 - 10/21/2021. Lunch time evening 9pm worse migraine, in duration lasted all night into the next day it lingered. Symptoms was low level headache and light show, pounding and brain fog, the day unsure of taking the medication at the onset to cut the intensitive and duration from 4-8 hours, did not get a chance to take the medication  and intensitive Symptom in 08/09 symptom get infection in eye lids and right nostril that was infected as secondary issue. Daily masked all day long for a full month. Took care of the migraines with medication, PRN medication that was prescribed by doctor on report. Last year 9 different occasions of the migraine. Same date as booster Vaccination 3.
Redness in injection site; Itchiness in injection site; warm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness in injection site), VACCINATION SITE PRURITUS (Itchiness in injection site) and VACCINATION SITE WARMTH (warm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 1. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness in injection site), VACCINATION SITE PRURITUS (Itchiness in injection site) and VACCINATION SITE WARMTH (warm). At the time of the report, VACCINATION SITE ERYTHEMA (Redness in injection site), VACCINATION SITE PRURITUS (Itchiness in injection site) and VACCINATION SITE WARMTH (warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient had 1 year vaccines of Fri 4/27/12. Mother states rash appeared on Sat. Patient was fussy, started running a fever of 101 degrees on Sunday - Mon noticed rash on injection site - Rt leg. When patient was brought into office on Mon 5/1/12 it had spread to his left foot, groin, and face. Had decreased appetite, and decreased wet diapers. Dx with Varicella was given nystatin for rash in groin and to F/U in 1-2 weeks.
4/19/2021 DVT of iliac vein Lt lower extremity 4/22/2021 acute multiple pulmonary emboli
This spontaneous report as received from a registered nurse and refers to a 90 year old female patient. The patient's concurrent conditions include cardiac failure congestive, Parkinson's disease and drug hypersensitivity to DETROL LA, VESICARE and trospium chloride. The patient's historical conditions include atrial fibrillation and melanoma. The patient's  concomitant therapies included melatonin, metoprolol, famotidine, FLONASE, vitamin D, lisinopril (manufacturer unknown), pravastatin, spironolactone, aspirin(manufacturer unknown), carbidopa (+) levodopa (manufacturer unknown), MIRALAX, digoxin, vitamin B complex, dexamethasone, neomycin sulfate, MAXITROL, triamcinolone, cranberry with vitamin C and unspecified stool softener. On 17-APR-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscular injection, on an unspecified arm, as prevention of pneumonia, lot number N030111 with expiration date on 21-APR-2019 (strength and dose were not reported). On 18-APR-2018, the patient began experiencing urticaria, rash, hotness (feeling hot), swelling (peripheral swelling), and pain (pain in extremity) in the arm that the PNEUMOVAX 23 was administered in. It was stated that on an unspecified date, the patient called her physician and she was placed under therapy treatment with BENADRYL, TYLENOL, and cool compress to the affected area. At the reporting time, it was unknown if the patient was recovered from the events pain in extremity, feeling hot, peripheral swelling, rash and urticaria. The reporter did not assess the causal relationship between therapy with PNEUMOVAX 23 and the aforementioned events. This is one of several reports received from the same reporter.
Information has been received from a physician concerning a 13-month-old male who on 24-MAR-2008 was vaccinated with a dose of MMR II (lot# 657356/1314U). Suspect vaccination included a dose of VARIVAX (lot# 659720/1657U). Other concomitant vaccination that day included a dose of ACTHIB. On 26-MAR-2008 the patient experienced a febrile seizure and a 103.6 degree fever 2 days after receiving vaccinations. Unspecified medical attention was sought and the patient improved on therapy. On an unspecified date the patient recovered. No product quality complaint was involved. Follow-up information has been received from a nurse who indicated that the patient did not have any concurrent conditions or pertinent medical history. The treatment for the seizure was MOTRIN and ROCEPHIN. The nurse noted that the physician believed that febrile seizure was caused by MMR II (lot# 657356/1314U) (expiration 17-Aug-2009). Secondary suspect was VARIVAX (lot# 659720/1657U) (expiration 13-Oct-2009). Upon internal review, febrile seizure was considered to be an other important medical event. Additional information is not expected.