chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Continued pain, swelling, & decrease range of motion in left arms, especially in back of arm ongoing since day after vaccination.
I experienced dizziness on day of onset but it was manageable.  I was able to get through the day.  The following day vertigo was extreme and I had to spend 6 hours flat on my back. Nausea and intermittent racing heart beat occurred during this time as well.  At the end of the day early evening, I was able to sit upright although quite slowing, move about and it seemed the worst of it was over.  The next noticeable symptom was the tinnitus that I normally experienced at a subjective level of six was now up to a subjective level of eight.  The heightened level has not dissipated or returned to my normal.  This has resulted in noticeable hearing loss.
Flu-like symptoms; Upset stomach; Bowel movement; Headache; Fatigue; A spontaneous report was received from nurse concerning a 59-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events flu-like symptoms/influenza like illness, headache, fatigue, upset stomach/abdominal discomfort, bowel movement occurred/bowel movement irregularity.  The patient's medical history included COVID-19 infection. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the events  flu-like symptoms, headache, fatigue, upset stomach, bowel movement.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events flu-like symptoms, headache, fatigue, upset stomach, bowel movement was unknown.
Pt states just after sitting down in observation area she noticed tongue itching. About 20 mins later (1:53) she notified staff that she had tongue itching and arms itching. VS taken: P 85, BP 147/96, SaO2 98%. Pt in NO acute distress, states symptoms NOT as severe as in past when has had anaphylaxis. Does not feel she need epinephrine. Posterior oropharynx without noted edema, airway wide + patient
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 30-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant medications were reported.  It was reported that 113 Bivalent doses were administered after the BUD to patients 12 and up. 51 doses were administered from Lot AS7140C, and 60 doses from Lot AS7148B.  No treatment medications were reported.   Reporter did not allow further contact
Weakness, fatigue, decreased appetite, upper extremity shaking, sternal red blotchy rash, decreased mental status, non-verbal, decreased level of conscious, mottling, left side facial droop, hypertensive, fever, unable to follow commands
Large red area approximately 2.5 inches  at injection site which which was swollen along with swollen left arm pit.  Redness has remained for 3 weeks since receipt of injection as well as itching.  Skin in that area appears wrinkled and is now peeling.  Redness and itching still remain  along with small swelling under left armpit.
FEVER; BODY ACHES; CHILLS; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 11:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 09-MAR-2021, and had not recovered from fever. This report was non-serious.
Two hours after injection  severe pain in my right knee began and continues moderately today 3/3/2021.  (injection given at 1452) The doctor suggested heat/cold, anti-inflammatory,  brace and finally an x-ray which indicated nothing.  Four days after the second injection I've experienced mild pain in my opposite thigh and fatigue. The second injection was given in the opposite arm (left). While chatting with others  in recovery after second injection about knee pain, another woman said she was experiencing the same and thought it was her arthritis but it felt different.
Experienced arm soreness, headache, joints aching and severe chills all which subsided within 48 hours.  Injection site redness slightly larger than golf ball and hot to touch with some itches around the area. Redness is improved on 1/24/2021 after administration of max strength cortizone 10 ointment.  It's not gone but better.
vertigo; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 64 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "vertigo".  Additional information: Reporter wants statistics on reported vertigo for second dose and also stated he has heard reports about vertigo although no information. Nurse Anesthetist calling with a question about an individual that he knows quite well. Caller wants statistics on reported vertigo following second dose. Also asks  if it's positional, Sideling or recumbent. Caller states anecdotally he has heard reports about vertigo although no information. Reporter was asking about cases that have been reported about individuals that experience vertigo after the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stared off unblinking & looked frozen.  I noticed this, looked into her face & loudly said her name w/no response. She wasn't blue. I put my hand on cheek (not cold) & again said her name loudly.  She slowly responded by looking around.  She looked dazed.  I took her to see Dr. He did exam & blood work which were normal.  2/26/10 EEG was performed, waiting to speak w/neurologist now.  There have been other times in the past month where she has "zoned out" unblinking, but nothing this severe.  She received 1st half of H1N1 vaccine on 1/27/10.  She weighed 6 lbs 11 ounces at birth, was delivered about 1 1/2 weeks early & has no siblings.
The infant had a papular rash, pruritis on entire body, most pronounced on right thigh area (site of Prevnar). Treated itching with Zyrtec by mouth.
Patient complained of itchy throat, itchy ear and tight breathing approximately 25 min post-vaccination. Patient has history of allergies. Receives routine allergy shots. Reported these are her normal allergy symptoms. 25 PO Benadryl given. Approximately 1 hour, 15 min post-vaccination, patient reported symptoms had improved. On call MD aware. Patient discharged home.
Information has been received from a healthcare professional concerning a 63 yr old male who on 31Aug05 was vaccinated SC with a 0.5ml dose pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). On approx 31Aug05 the pt experienced erythema and soreness at the injection site. Unspecified medical attention was sought. The pt recovered without treatment within 48 hrs. The reporter would like to know if there have been any other problems with this lot number. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
I have been sick each month since receiving this flu shot. I have symptoms of URI, flu, achy joints and other signs of illness. I have never been sick over the years, and tolerate flu vaccines just fine. If anything, I have gotten one flu during the entire year and it was mild as a result of my being vaccinated. I have a collection of symptom - ranging from low level to serious bronchial distress each month since the day I got the shot from this clinic. I'm not sure if the needles were contaminated or the vaccine or both.
Nausea- started about 48 hours after injection.  Began with a feeling of slight motion sickness and progressed over the next 12 hours to be severe enough to cause vomiting.  Nausea only present when standing and improves when laying down.
pt adm to hosp 10/13/99 w/fever, leg pain, abd distention & leg purple;dx Beta-hem, streptococci group A invasion.-transported to hosp; complications; cardiopulmonary arrest;
little sore at injection site; swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little sore at injection site) and VACCINATION SITE SWELLING (swollen at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (little sore at injection site) and VACCINATION SITE SWELLING (swollen at injection site). At the time of the report, VACCINATION SITE PAIN (little sore at injection site) and VACCINATION SITE SWELLING (swollen at injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-028543 (Patient Link).
About 12 hr after influenza vaccine was administered, child had severe lower extremity pain, weakness, refused to walk, was sent to ER.
"Moderna COVID-19 Vaccine" Very sore left arm, moderate body aches, fatigue, moderate headache, chills, fever, uncontrolable shaking, shallowing breathing occurred 24 hours after the vaccination.  Called 911 when I couldn't control the shaking as I thought I was having a severe allergic reaction to the vaccine.  I was not transported to the hospital.
This is a spontaneous report from a contactable lead Medical Assistant who reported for a patient. This 60 year old female patient received PREVNAR 13 (lot number G73023, expiration date 01Oct2014, NDC 0005197102) on 30May2013 at 0.5 ml single dose through a prefilled syringe as she was going to have a cochlear implant on left side of her head. Relevant medical history included cochlear implant on right side of her head, hyperlipidaemia, diabetes and back pain, all since an unknown date. Relevant concomitant medications included FLEXERIL for back pain, vitamin C and vitamin D. The patient received on an unknown date PNEUMOVAX. On 30May2013, the patient was given PREVNAR 13 through a wrong route which was elaborated that instead of intramuscular it got into the blood stream of the patient. On 31May2013 morning, the patient had shortness of breath and stress discomfort and after the electrocardiogram (EKG), it was found that she had acute myocardial infarction on 31May2013 due to which she went to the emergency room and was hospitalized for 3 days from 31May2013 to 02Jun2013. Relevant laboratory data included also several other unspecified tests in which everything was found normal. Therapeutic measures taken included nitroglycerine and aspirin since 31May2013 at an unknown dose and frequency. Clinical outcome was unknown at the time of report.
pt recv vax 13JAN98 & pt broke out w/blisters all over body by 14JAN97 dx w/chickenpox by MD;APAP given for fever;pt scabbing over;
Patient reported pain and redness in the arm on 09/19/2018. Pharmacist told patient that those are common adverse effects for vaccines.
Mother brought patient into clinic with immunization record. Nurse input vaccine record into database. Database reported patient needed HepA, Pneumococcal, Varicella, and Flu. Nurse reviewed immunization record and database, saw that patient had only had 3 pnemococcal vaccines. Nurse recognized that most children receive 4 pneumococcal vaccines in childhood, did not realize 3rd dose was given >1 year which would complete patient's series. Mother consented to all vaccines and vaccines were administered.
The caller stated that most of the medication came out of the syringe and did not go into the patient, with no adverse event; the medication came out of the syringe with no adverse event; Initial information received on 20-Sep-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/ non healthcare professional via Media Information (under reference 00776928).  This case involves a patient (unknown age and gender) who was vaccinated with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT), but most of the medication came out of the syringe and did not go into the patient (underdose and syringe issue).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to vaccine underdose and syringe leak (same day latency).  It was reported "The caller stated that a call back on 21 SEP 2021 is okay as she is ending her shift for today. The caller stated that she administered a FLUZONE HIGH DOSE QUADRIVALENT injection to a patient today. The caller stated that most of the medication came out of the syringe and did not go into the patient. The caller would like to know if the patient must be revaccinated."  At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.  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.
fever up to 103 x 2 days following inject; also irritable & poor appetite x 2 days; no fever on 14OCT93 (97.3); pt seen by MD 2 days p/vax given & blood work performed (all WNL);
1245 pm, vaccine given, 1300 noted red blotches to her neck and she said she felt 'itchy' she denied resp distress or difficulty. EHS ambulated her to the ER triage for eval. Prednisone 60 mg po x 1; BENADRYL 25 mg po x 1.
runs out of immunity; fatigue; her macular degeneration had gotten markedly worse; the macular degeneration in her left eye had "severely changed from dry to wet macular degeneration"; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 11Feb2021 as dose 1, single for COVID-19 immunisation. Medical history included ongoing stable disease for 11 years with "dry macular degeneration in both eyes". The patient's concomitant medications were not reported.  Caller stated that she was thinking about taking Pfizer booster. Stated that she took the first two Pfizer shots. The patient wanted to know had anyone complained about their macular degeneration problem getting worst. The patient stated that after she got first shot on 11Feb2021, about 12 days later in Feb2021 her macular degeneration had gotten markedly worse and the macular degeneration in her left eye had "severely changed from dry to wet macular degeneration". Stated that it had been watched by the hospital every 6 months and wanted to know if it showed up in the literature with people that had had macular degeneration. She stated that the right was still the dry eye of macular degeneration and wanted to know if it was safe to get booster shot. The patient also reported fatigue after vaccination on an unknown date. She also stated that it was said that she ran out of immunity for 6-8 months and because of that she was getting the booster. The outcome was unknown for "runs out of immunity" and not recovered for rest of the events.   Information regarding lot/batch number has been requested.
Pain in chest, burning sensation in chest, shortness of breath and tired with normal walking and talking.
Patient with dementia, moderate persistent asthma, GERD, CAD, mild aortic stenosis, chronic pain,  admitted 11/2/21 with chest pain. Known CAD with non-STEMI in 6/2021 at which time LHC showed mild atherosclerosis in the major epicardial coronary arteries as well as 100% stenosis of distal limb of a bifid rPDA likely the culprit lesion but too small and distal for  revascularization. He was medically treated with dual antiplatelet therapy. ED to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Information has been received from a nurse via Drug and Medical Device Contact Center Services referring to a patient of unknown gender between 6 years and 12 years old, who was involved in a patient support program. Information concerning medical history and concurrent condition was not reported. On 07-JUL-2015, the vial of VARIVAX (Merck) underwent temperature excursions on 8.9 degrees Celsius for 1 hour and 28 minutes. On 04-AUG-2015, the patient was vaccinated with the improperly stored VARIVAX (Merck) (dose, strength and route were not reported, lot # K026386, expiry date: 15-DEC-2016). There was no concomitant therapy reported. The patient had not experienced any adverse events. It was unknown if there was any relevant laboratory data. This case is one of several cases received from the same reporter. Additional information has been requested.
pt recvd vax 18JUL95 & devel an extensive erythema multiforme rash & presented to physician;18AUG95 lab eval revealed a weakly pos streptococcus antigen;pt was w/o sxs;No further details were provided;
This spontaneous report as received from a other health professional refers to a 13 year old female patient. On an unknown date the patient was vaccinated with GARDASIL for prophylaxis. Other suspect therapies included GARDASIL 9. On an unknown date the patient experienced interchange of vaccine products and no adverse event. The outcome of no adverse event is unknown. The reporter considered interchange of vaccine products to be not related to GARDASIL 9 and GARDASIL. The reporter considered no adverse event to be not related to GARDASIL and GARDASIL 9. {Additional information has been requested. / Additional information is not expected.}
Pain in the left arm strong can not raise the arm and swelling in the area of ??the shots with the area red and hard.
History of Present Illness: This 54 year old  presents with: 1.  palpitations  Began April 11,2021. Occurs few times a day. Aggravated by cold drink. Associated symptoms include heart fluttering and chest pain. Denies: ha, crushing cp, same/similar s/s in past, sob, dizziness and lightheadedness. Pt states palps lasted 8 days. PT got Moderna covid vaccine on April 9 (first dose). getting a few times a day, not as much as before. no exertional sx.
This is a spontaneous report from a contactable other healthcare professional, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an intramuscular route of administration in the left arm on 17Nov2021 at 16:30 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Nov2021, the patient experienced fever, chills, fatigue and nausea. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, fatigue and nausea was resolving at the time of this report.No follow-up attempts are possible. No further information is expected.
Hives noted within 1 hour of vaccination. No wheezing alert. Given Epipen .15, BENADRYL 20 mg prednisolone 20 mg. Sats 99 HR 88. Urticaria numbing pain to discharge, discharge to ER via EMT.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Medium