chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mild fever; My left arm felt, including my fingers and arm pits feel swollen; My left arm felt, including my fingers and arm pits feel swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 15:30 (Lot number: FJ8757) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "bee stings allergy" (unspecified if ongoing); "sting rays allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 14May2021, when the patient was 48 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 23Apr2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 29Dec2021 09:00, outcome "recovered", described as "mild fever"; PERIPHERAL SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 29Dec2021 09:00, outcome "not recovered" and all described as "My left arm felt, including my fingers and arm pits feel swollen". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, peripheral swelling, peripheral swelling.  Additional information: My left arm felt, including my fingers and arm pits feel swollen starting about 12 hours after the injection and has been getting worse, still not gone after 48 hours. I did also have a mild fever on the day after the injection, but the fever is gone now. Patient had no other medical history. Patient was not received other vaccine in four weeks and was not received other medications in two weeks. No covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Fever, aches, headache, cold and hot flashes, severe sore arm. Lasted for about 35 hours took Tylenol every 4 hours to take down fever.
Initial report received from a healthcare professional on 08 OCTOBER 2013.  A 5 year old patient had received 0.25 ml FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: None.
This is a spontaneous report from a contactable consumer (Patient) or other non-hcp. A patient of unspecified age and gender received BNT162B2 (COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 09May2021 as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced left shoulder is still tender where I had the shot at, it is still tender. The clinical outcome of the event was unknown. Follow up attempts needed. Further information is expected
Patient had momentary loss of consciousness following HPV-9 which was final immunization. Recovered spontaneously.
she once developed COVID-19; she once developed COVID-19; have significant heart disorder; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she once developed COVID-19"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "have significant heart disorder".  Clinical course: Patient reported that she received the Pfizer COVID-19 booster, the 3 or 4 doses, she was not able to confirm if she received 3 or 4 doses. She informed to have significant heart disorder. She mentioned had a lot of problems and that she had to travel by plane and that she was afraid on planes. She mentioned that she knew that she did not had COVID-19 because she was tested and she was discharged from the hospital 15 days ago. She stated that she read a press release that Pfizer now has a drug for patients who catch COVID-19. Is that correct? Patient asked "do she had to buy some before she go to foreign city?". She also mentioned understanding that the medicine was to avoid being isolated for 10 days. She mentioned that she had to took 2 or 3 heart medications (she named one of the medications but unable to fully understand the name) and that she was a patient of professor. She mentioned that she once developed COVID-19 after moving by bus which she described as 'very light fortunately and now she had vaccinated. She had a pacemaker, a valve, and 2.5 cm hole in the heart that had been patched, she had a monitoring device that records all the data from the pacemaker and sends it to the scientific research center. She was worried because she heard a lot who was flying, who was going up did not had COVID and who was coming down and had COVID-19. She insisted on the fact that she already had a lot of health disorders. Patient asked "What should she do? Do she keep the mask on the plane?"  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received shot on 3/23.  Arm soreness for 48 hours.  The following Wednesday (1 week plus one day) woke up with injection site severely swollen, bright red, hot to touch and extremely itchy for 4 more days.
Redness and swelling of the injection site with warm sensation -  round area about 3 inch diameter.
Bottom lip keeps getting inflamed; This spontaneous case was reported by a consumer and describes the occurrence of CHEILITIS (Bottom lip keeps getting inflamed) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088921A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEILITIS (Bottom lip keeps getting inflamed). At the time of the report, CHEILITIS (Bottom lip keeps getting inflamed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Rapid onset wheezing, hypotension and urticaria within 15 minutes of vaccines.  5/15/07 Received hospital medical records which reveal patient experienced wheezing, dizziness & itching. Admitted for observation 4/6-4/8/07.  Kept on steroids & antihistamines as well as IVF.  Progressed well & d/c home on steroids & antihistamine & local skin care. FINAL DX:  allergic reaction to vaccines & angioedema, both resolved.
c/o funny taste 10 min after vaccination Narrative:  10 min after vaccination employee c/o funny taste. Denies numbness/tingling to lips or tongue. No difficulty swallowing. Monitored pt for 30 minutes. Emploees states funny taste has resolved.
Menstrual period is usually regular as clockwork (26 days). However, after receiving J&J vaccine, period is late by several days. No chance of pregnancy due to no sexual activity. Also, I am not taking any contraception
This spontaneous report as received from a nurse refers to a patient of unknown age and unknown gender. On 11-AUG-2015, the patient was vaccinated with a dose of improperly stored (Merck) PROQUAD (lot # L005293 and expiry date: 17-AUG-2016). No adverse effects were reported. Additional information has been requested.
2cmx2cm hot, tender knot with heat. Also fever 105 day of vaccine.
15 x12 cm of an urticarial lesion on R upper arm surrounding injection site.  +edema +warmth, No erythema.  No wheezing and lungs clear to auscultation bilaterally.
4 shots of Covid, Pfizer Covid Vaccine; 4 shots of Covid, Pfizer Covid Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old patient received BNT162b2 (BNT162B2), 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) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure; "Asthma" (unspecified if ongoing), notes: Asthma; "HIV" (unspecified if ongoing); "Heart Conditions" (unspecified if ongoing); "Blood clots in my legs" (unspecified if ongoing); "Hyper S protein deficient" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "4 shots of Covid, Pfizer Covid Vaccine". The patient underwent the following laboratory tests and procedures: Oxygen saturation abnormal: 89, notes: my blood oxygen was 89; SARS-CoV-2 test: Unknown result, notes: had COVID / I got second round of COVID. Clinical course: Patient has hyper S protein deficient. Patient got second round of Covid and after prescribed Paxlovid, on three separate occasions, the pharmacies denied patient selling prescription for Paxlovid. Saturday, patient was in the hospital because patient's blood oxygen was 89. They did prescribe the Paxlovid again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hesitant about getting the vaccination to begin with. Decided to do it anyway. At 11:00am I got the dose on my left arm. I waited the full 30 minutes after dose one of the Pfizer vaccination. Everything was good. I left and returned to my house. I felt out of it when I got home kind of a stoned feeling. As the day progressed I started to get amped up like I had a lot of coffee. I was extremely hungry too. Which was rare as I only eat 2 meals a day. Anyway, I tried going to bed around 7pm . Eight hours after I received the vax. As I laid in bed my skin felt like it was burning and became extremely itchy. This went on all night and I had massive insomnia and could not sleep. The following morning I woke up to a red rash all over my face on my arms and it would heat up go away heat up go away. The skin was still burning and massively itchy.  These were the only reactions I had to the shot. I did not have a fever, or joint pain, or any of the other symptoms people described  after the first dose. That I decided to go to my Dr.
This spontaneous report as received from a pharmacist refers to a 77 years old male patient. The patient had no drug reactions/allergies. The patient's medical history included psoriasis. The patient was vaccinated with ZOSTAVAX (lot # 0366AE, expire date 23-MAR-2013) (vaccination site unknown) (route and strength unknown) on 24-AUG-2012. No other co-suspects and concomitant medications were reported. On 25-AUG-2012 the patient developed a rash following vaccination with ZOSTAVAX. The pharmacist described the rash as psoriasis like rash, red, flaky and itchy. The rash was all over the patient's body, sites mentioned included the included the injection site, the hands and the patient's head. The exact development of the whole body psoriasis rash was unspecified at the time of the call. The patient received an unspecified dose of an unspecified steroid as the treatment of the adverse events. The outcome was reported as not recovered/not resolved. The patient sought medical attention via contacted physician. Additional information has been requested.
pt recv vax 13OCT97 & 21OCT97 pt devel a fever;the following day pt devel chickenpox all over body w/approx 50 lesions;
Dizziness; brain fog; achy; chills; sore arm; This is a spontaneous report from a contactable other HCP(patient). A 48-year-old female patient received first dose BNT162B2, via an unspecified route of administration at Arm Right on 30Dec2020 10:00 at the 48 years old at single dose for COVID-19 immunization. The medical history included Rheumatoid arthritis and Depression. The concomitant medications were hydroxychloroquine phosphate ( PLAQUENIL ), leflunomide(ARAVA), desvenlafaxine succinate(PRISTIQ). The patient previously took Methotrexate and experienced allergies. On 31Dec2020 11:00, the patient experienced Dizziness, brain fog, achy, chills, sore arm. Mild for maybe 6 hours and a couple hours were moderate. Woke the next day on 01Jan2021 feeling fabulous. There was no treatment received for all the adverse events. There was covid tested post vaccination. There was no other vaccine in four weeks. The patient underwent lab tests and procedures, which included Nasal Swab on 30Oct2020 Negative. The outcome of the events was recovered on 01Jan2021.  Information about lot/batch number has been requested.
This spontaneous report was received from a nurse refers to unknown number of patients (age and gender unknown). On an unknown date, the patients were vaccinated with PROQUAD (Merck) (lot number H015624, expiration date on 21-FEB-2014; lot number H015629, expiration date on 21-FEB-2012) (dose and route not reported). Other suspect therapies included on 16-DEC-2012, VARIVAX (Merck) (lot number H106600, expiration date on 05-SEP-2014) (dose and route not reported) and on 19-DEC-2012, VARIVAX (Merck) (lot number H17705, expiration date on 25-SEP-2014) (dose and route not reported). It was reported that some doses of improperly stores PROQUAD (Merck) might have been administered to unknown number of patients. The vaccines were exposed to 4 hours at room temperature and 45 hours at refrigerated temperature and were found to be not stable. No adverse effects reported. In a follow-up, was reported that an unknown number of patients may have received VARIVAX (Merck) that was improperly stored. VARIVAX (Merck) were exposed in addition to 4 hours at room temperature and 45 hours at refrigerated temperature also exposed to 5.86F to 15F for 5 minutes and it was doing this 3 times in 1 hour every day since the received dates of the VARIVAX (Merck). No adverse effect reported. Additional information has been requested.
The mother of a 2 month old male reported that her son received Prevnar and other unspecified vaccines in April, 2000. Following immunization, he developed a "high" fever which persisted for more than 24 hours. He also appeared to have increased gastrointestinal gas. The infant reportedly has "a weird digestive tract" and a history of formula intolerance. The infant recovered.
sore arm x 2 days, fatigue x 1 day Narrative:  Recovered  Other Relevant History:
generalized dense macular rash (appeared 24 hrs p/vax w/periodic dyspnea; seen by ER MD, treated w/Epi & DPH; moderate react-poss related to vax or delayed react to ATB;
We received a phone call with very minimal information that the person who received the second Pfizer vaccine developed a case of Shingles the following day, and was seen by her physician and at Urgent care.   Symptoms started 18 hrs post 2nd dose.  Started approx. size of a quarter on right side chest/breast, and spread to arm pit and arm.  10 days post incident she is recovering
scarring in her lungs; hemiplegic migraines; severe breathing problems / she struggles to breath when doing anything; pleural effusion; migraines; This spontaneous case was reported by a consumer and describes the occurrence of SCAR (scarring in her lungs), DYSPNOEA (severe breathing problems / she struggles to breath when doing anything), PLEURAL EFFUSION (pleural effusion), MIGRAINE (migraines) and HEMIPLEGIC MIGRAINE (hemiplegic migraines) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced DYSPNOEA (severe breathing problems / she struggles to breath when doing anything), PLEURAL EFFUSION (pleural effusion) and MIGRAINE (migraines). In August 2021, the patient experienced SCAR (scarring in her lungs) and HEMIPLEGIC MIGRAINE (hemiplegic migraines). At the time of the report, SCAR (scarring in her lungs), DYSPNOEA (severe breathing problems / she struggles to breath when doing anything), PLEURAL EFFUSION (pleural effusion), MIGRAINE (migraines) and HEMIPLEGIC MIGRAINE (hemiplegic migraines) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Computerised tomogram: but nothing was found then (normal) but nothing was found then. In May 2021, X-ray: but nothing was found then (normal) but nothing was found then. In 2021, Oxygen saturation: low (Low) oxygen level got low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment included Oral steroids & steroid inhalers.  The patient developed scarring in her lungs in August-2021 after visiting the ER and getting x-rays & CT scans.
employees gave someone expired Tenivac with no reported adverse event.; Initial information received on 21-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age male patient who reported employees gave someone expired tenivac with no reported adverse event. while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Feb-2022, the patient received a  dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult lot U6922AA via unknown route in unknown administration site for immunization..  On 21-FEB-2022 the patient developed a non-serious employees gave someone expired tenivac with no reported adverse event. (expired product administered) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event employees gave someone expired tenivac with no reported adverse event.  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.
11-12 days after received VZV in LA child began with fever- then URI- then day 13 a rash at the injection site was noted. Started on Tylenol day 12. Area on injection site is apprx. 32 x 45mm in size. Red with small raised knots. Child denies pain. C/O itching.
the patient initially reported to the scheduler that she was having severe dizziness.  at 1220 reports having mild lightheadedness, feeling hot, strange sensation in her mouth, dry mouth and foggy thinking.  In addition, she admits to being apprehensive about receiving the vaccine. .  BP 140/103 P is 100, Temp is 97.4 resp are 16.  given water and placed in front of fan.  at 1230 bp 140/96, pulse 100, Resp 16, O2sat 100%.  At 1300 reports that she is feeling better and ready to leave if this RN feels it is ok for her to go.  patient has partner waiting for her in parking lot.  Discharged hom.
My daughter ran a high temperature 104 for 3 days. we called the hospital and the nurse said it was normal after receiving the MMR vaccine
SEVERE CHILLS; NAUSEA; This spontaneous report received from a consumer 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported and has been requested.  No concomitant medications were reported. On an unspecified date, the subject experienced severe chills, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and severe chills was not reported. This report was non-serious.
I am the immunizing pharmacist.  I was giving a child a Pfizer COVID vaccine.  Another person drew the dose up and the needle was not on tight.  When I gave the injection, a portion of the vaccine sprayed into my left eye.  It left my eye blurry, and watery.  I had a headache and drainage in my sinus shortly after the exposure.
entire body hurt,terrible headache ,102.6 fever,chills,vomiting,nausea,abdominal pain,diarrhea,racing heartbeat,passed out
Pt reports local reaction at site within 30 minutes post injection with redness and swelling, which increased to 4 x 3 inches, indurated without drainage. Tender, able to move joint. No oral airway sx. No fever or rash. Endorses no egg allergy. Advised: NSAIDS or TYLENOL OTC. Cool compress. Antihistamine. Reviewed indications for urgent care.
Injection given on 10/18/13. Received call from Pt on 10/22 reports: 10/19/13 - Stiff neck thought slept wrong; 10/21/13 - Limited movement to L arm; 10/22/13 - Increase moving arm - still some stiffness. No redness or swelling at site.
Information has been received from a pharmacist referring to an 11 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 24-JUN-2015 the patient was vaccinated with expired doses of MMR II, lot # J006953, (dose and route were not reported). This dose of MMR II had an expiration date of 07-JUN-2015. No adverse events were reported. This is one of several cases from the same reporter. Additional information has been requested.
Became ill with major flu/cold like symptoms that last for 3 weeks and linger still (12/19/21).  Tired.  Pain at injection area still (12/19/21).  Blood clot in right calf (on orbefore /11/21).
This study case was received from the investigator on 05 December 2012. A 24-year-old male subject received the following vaccinations on 22 August 2012: an injection of ACAM2000 (lot number not reported), an injection of TYPHIM VI, sanofi pasteur SA (lot number not reported) a dose of Influenza, live, intranasal (manufacturer and lot number not reported) and ANTHRAX (manufacturer and lot number not reported). Medical history and laboratory/diagnostic tests were unavailable. On 02 September 2012, the subject was diagnosed with unspecified disease of pericardium. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.