chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness and warmth of the injection site; Itching at injection site; Redness and warmth of the injection site; Rash on back; Swelling on left arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling on left arm), VACCINATION SITE WARMTH (Redness and warmth of the injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness and warmth of the injection site) and RASH (Rash on back) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swelling on left arm). 23-Apr-2021, the patient experienced RASH (Rash on back). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Redness and warmth of the injection site), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness and warmth of the injection site). At the time of the report, PERIPHERAL SWELLING (Swelling on left arm), VACCINATION SITE WARMTH (Redness and warmth of the injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness and warmth of the injection site) and RASH (Rash on back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants and treatments were not reported.
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 20-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & exp t104 & gen rash w/40 lesions some of which ere vesicular;pt recovered;no further details were provided;
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/13/21 (EN9581) Pfizer Dose 2 3/10/21 (EN6205) COVID Positive 9/3/21  9/6/21: History is obtained from patient as well as by personal review of records.  The patient has history of acute kidney injury requiring dialysis superimposed on chronic renal disease , coronary artery disease with recent stent deployments,  recent prolonged hospitalization for unstable angina, COPD, aortic stenosis, aortic aneurysm, sleep apnea and other medical problems.  He had testing done for  SARS-CoV-2 last Friday.  His tested positive.  He was advised by his doctors to go to ED.  EMS staff found him to be hypoxic and started him on oxygen supplementation.  Blood gases showed arterial PO2 of 57. He feels better after hospitalization.  He denied chest pain.  Does report dyspnea on exertion. Reported nonproductive cough and chills going on for few days.  No history of travel.  No history of hemoptysis.  He had both doses of  SARS-CoV-2 vaccine.  9/11/21: The patient is a 79-year-old male from home.  He was admitted in hospital on 09/07/2021 and treated for hypoxia secondary to bilateral COVID pneumonia, acute COPD exacerbation and AKI on CKD 3B.  Patient was treated with IV antibiotics, and dexamethasone.  Symptoms improved and he was able to maintain his sats above 90% on room air.  He was noted with elevated blood glucose reading requiring insulin drip initiation. His blood glucose level improved and he was able to resume his home insulin dosage. Nephrology was consulted for acute kidney injury and patient had to receive hemodialysis a few times. Nephrology team cleared patient for discharge home and will resume his hemodialysis session the Clinic. Today the patient reports feeling much better and is requesting to go home. RN care coordination spoke to family members admit arrangement for visiting nurses services. Patient has stable vital signs and is being discharged in improved and stable condition. I answered all question and address all concerns.
Headaches, fatigue, body aches.  Symptoms subsided within 24 hours
Information has been received from a registered nurse concerning a 17 year old female with no drug allergies or previous medical history reported, who on 26-AUG-2008, was vaccinated with the first dose of GARDASIL, 0.5 mL, IM, into the right deltoid,  and developed random joint swelling and a rash all over her body. The rash was flat and not raised. The patient had also started ethinyl estradiol (+) norethindrone acetate (LOESTRIN) during the same weeks as vaccination and within that same week her symptoms began. The patient discontinued ethinyl estradiol (+) norethindrone acetate (LOESTRIN),  and recovered within a week of stopping it. The patient did not notify the office until she went for second dose which had not been administered yet. The physician had not decided whether or not to continue the series. The patient did not seek medical attention. Additional information has been requested.
SIGNIFICANT HAIR LOSS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On OCT-2021, the patient experienced significant hair loss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of significant hair loss was not reported. This report was non-serious. This case, from the same reporter is linked to 20211046209.
Patient received the varicella (VARIVAX) SQ (R) arm on 3/9/15. On 3/11/15 - pt. mom noticed redness with edema to (R) upper arm at site of injection. Area tender/warm to touch.
No record of 2nd dose administered; He thinks he got Shingrix shot #2 in July of 2020 but the hospital cannot find a record of this; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1s tdose in January 2020, call center representative failed to ask for exact date of injection, lot and expiry date and route).   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 and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the incomplete course of vaccination and circumstance or information capable of leading to medication error were unknown.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not applicable for this report. The patient thought, he got 2nd dose of Shingrix in July 2020 but the hospital could not find a record of this, so they were advising him to start the whole series over again, which led to incomplete course of vaccination and circumstance or information capable of leading to medication error. The reporter consented to follow up.
My Dad received Covid 19 mRNA Bivalent Vaccine-Moderna  on 9-8 2022 @ Hospital. He was transferred to Rehab on 9-8-2022. At a family meeting via phone on 9-12-2022 I asked if he received a Covid 19 Booster @ Hospital before discharge to the rehab facility and was told "we would check" On 9-22 I received a call from the Staff Development person asking permission to administer the Vaccine. I was not aware of the error until 10-5-2022 when I received discharge paperwork from both facilities.I do not know the specific type of vaccine given in error on 9-22-2022.
pt recv vax 4MAR96 & the inj site became red & swollen & a knot developed;mom states the sx are getting worse
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium
I was 35 w 6 d pregnant. The following day I started with contractions and I delivered on early  (days after receiving vaccine). Delivered at 36 w 1 d.  Birth weight 6 lbs 2 oz.  Estimated date of delivery was 11/10.   Prior history of prematurity.  Last delivery was 33w. Also had received the Covid vaccine at 32 w 5 d and my water broke the day after receiving the Covid vaccine.
I experienced several events where my pulse raised (up to 155) and then my O2 tanked (less than 90%); this happened several times after I was vaccinated, but weeks later. I also experienced petechiae and bruising on my limbs and trunk intermittently after being vaccinated. (But my PCP checked my labs and nothing was outside normal limits). But my BP was raised (140/90 or above) and lowered (90/70) on some notable occasions after being vaccinated--when I had never had symptomatic problems with  my BP in the past. However, I very much doubt the events directly were caused by me receiving the COVID vaccinations. This year has been hard for me, with my mom dying after contracting COVID for the second time (in the hospital the second time) and then dying from its complications; this happened in mid-March 2021, right before I got vaccinated. Plus, I started at a new job (moving from LPN to RN scope of practice after graduating during the pandemic), which has been a heavy learning curve and very stressful at points. Given that these two major life events transpired at the same general time that I received my COVID vaccinations or after, my educated self would believe the events are not caused by the immune response any more than any vaccine shot would contribute to stressing the immune system. I certainly did not experience immediate or severe reactions after both COVID shots, merely was tired, draggy, fevery, and experienced some diarrhea for about four days after each shot. That timeframe of four days is slightly excessive, compared to other individuals that I've vaccinated (I'm a COVID-19 vaccination nurse currently). But it did not and does not suggest MIS or something like that to me. Every other symptom above described, barring the four days of misery after each shot and the primary hypertension diagnosis that I finally received after months of trying to figure out what is going on with my body,  were not grouped together and seemed mild/moderate in nature.
27APR93 pt recvd meningitis shot; 3MAY94 broke out in rash over entire body; severe itching; dx reactive erythema by dermatologist; cont to break out x 1 wk; @ first rash was rough/bumpy; but as it cont to break out, became fine;
Monthly period went from 4-5 days to 15 days long.  Discussed with physician and decided to take birth control to help regulate cycle. Also continue to have random hemorrhaging on my extremities.  Currently have noticed 3 different occasions.  Two times on legs and once on arm.   Just had one this past week which is almost one year after first vaccination.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6205), in left arm and on 26Mar2021 as dose 2, single (Lot number: ER8727), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Dec2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma. Concomitant medication(s) included: ADVAIR; FLUTICASONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient treated with Paxlovid for COVID 19 Treatment. It was reported that patient was taking Birth control pills before vaccination. Patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
almost fell; pale; very weak/loses power I start walking; very dizzy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak/loses power I start walking), DIZZINESS (very dizzy), FALL (almost fell) and PALLOR (pale) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included HYDROXYCARBAMIDE (HYDROXYUREA EURECO PHARMA) and WARFARIN for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced ASTHENIA (very weak/loses power I start walking), DIZZINESS (very dizzy), FALL (almost fell) and PALLOR (pale). At the time of the report, ASTHENIA (very weak/loses power I start walking), DIZZINESS (very dizzy), FALL (almost fell) and PALLOR (pale) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
General itchiness all over body Hives over back, approximately 15 mm in size Slight nausea Had hives at bedtime, at 7:45 AM 11/5/09 had one small hive (approximately 3-4 mm) on right lower back.
edema of eyes, papular rash over trunk & extremities;pred, DPH & cream given;dx viral infect;
Patient received 1st dose of COVID pfizer vaccine on 02/01 and 24 hrs after vaccination on 02/02/2022   patient developed  hives , rashes  in the body, No lip swelling, eye swelling , N/V, pain abdomen , SOB, wheezing, noted. Patient state a warm shower was taken prior to  rash and denies any other relatable events Seen in the office and treat with solumedrol. Patient improved  after solumedrol
a second dose of Menactra to a 16 years old, and found out patient had the second dose 6 weeks prior, no AE; Initial information received on 20-Jan-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves a 16 years old male patient who was vaccinated with 0.5 ml second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. (lot U6787AB , expiry date-11-Aug-2021) via intramuscular route in the right arm for prophylactic vaccination on 19-Jan-2021, and found out patient had the second dose (that is; first booster) 6 weeks prior (lot number, expiry date and other dosing details were not reported).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication(s) was given to patient.  It was a case of actual medication error due to extra dose administered (same day latency).  Also the Health Care Professional reported that a patient was administered his 16 year-old booster dose yesterday ( 19-Jan-2021). It was later noted that he had already received that dose 6 weeks prior.   At the time of report 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.  There will be no information on the batch number for the menactra's prior dose.
Headache; chest pain; dizziness; leg weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 08:30 (Lot number: FK5618) at the age of 9 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 13Nov2021 14:30, outcome "recovered" (Nov2021), described as "Headache"; CHEST PAIN (non-serious) with onset 13Nov2021 14:30, outcome "recovered" (Nov2021), described as "chest pain"; DIZZINESS (non-serious) with onset 13Nov2021 14:30, outcome "recovered" (Nov2021), described as "dizziness"; MUSCULAR WEAKNESS (non-serious) with onset 13Nov2021 14:30, outcome "recovered" (Nov2021), described as "leg weakness". The events "headache", "chest pain", "dizziness" and "leg weakness" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of headache, chest pain, dizziness, muscular weakness.  Additional information: The reporter considering the events as non serious. Facility where the most recent COVID-19 vaccine was administered was School or Student Health Clinic. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any known allergies. The patient received treatment for the events with ekg, glucose screen.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unknown age and gender. Concomitant medications, pertinent medical histories and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M002055, expiry date 11-JUL-2017; lot # M007965, expiry date 15-AUG-2017; lot # M007964, expiry date 15-AUG-2017; lot # M022403, expiry date 01-NOV-2017, lot # M032496, expiry date 02-JAN-2018 (albumin status of rHA (recombinant human albumin)) (lot # and expiry date reported twice); dose and route of administration were not reported) for prophylaxis. The doses of the vaccine were exposed to a temperature excursion of -4.8 degrees Celsius for a time frame of 1 hour 20 minutes (date unspecified). A digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1611USA013382.
This spontaneous prospective pregnancy report as received from a nurse refers to a 15 year old female patient. The patient had a history of menstrual at regular intervals, but she had only "spotted" in "June 2014" without experiencing her regular menstrual period. On 29-AUG-2014 the patient was vaccinated with first dose of GARDASIL injection, 120Y, lot # K004204, Expiration Date 12-JAN-2017 (dose, frequency and route unknown). The patient discovered she was pregnant after she received her first dose of GARDASIL. Prior to receiving the dose of GARDASIL, the patient had been unable to void in the clinic, so routine pregnancy screening was not able to completed prior to administration of the dose of GARDASIL. The patient's mother preferred for the patient to receive GARDASIL, so the dose was administered without pregnancy screening. The patient had a positive "home" urine pregnancy test on an unspecified date. The patient sought medical attention via consulting her pediatrician, who detected fetal heart tones by doppler (result not provided). The patient was estimated to be approximately 4 months pregnant, she was scheduled for an Ultrasound to determine the gestational age. The patient was not demonstrating any adverse effects, and she was offering any complaints. Outcome of the events was unknown. Additional information has been requested.
Initial and follow up information has been received from a nurse concerning an 84 year old white female patient with gastrointestinal reflux disease, mild dementia and hypercholesteremia who on 10-DEC-2007 at 3:30 pm was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #659149/1383U) intramuscularly in the right deltoid. Concomitant therapy included ezetimibe (+) simvastatin (MSD). Later that same day she experienced swelling, redness and warmth and pain in her right arm from her shoulder to her elbow. The adverse symptoms became worse during the next few days. Four or five days after receiving pneumococcal 23v polysaccharide vaccine, on approximately 15-DEC-2007, the lymph gland under her right arm became swollen and subsequently this traveled to her right breast. She was diagnosed as having cellulitis. Approximately one week after receiving pneumococcal 23v polysaccharide vaccine the swelling and redness began to diminish and fade, but this was only in her right arm, shoulder and breast. She said that beginning twenty years ago she has had a pneumonia vaccine every five years and has never had any adverse experience until the one she received in DEC-2007. Follow up information was received on 18-FEB-2008. The patient developed swelling and redness on the right arm at the injection site and cellulitis at the right arm. The patient recovered on 07-JAN-2008. No additional information is expected. This is one of several reports received from the same source.
Had tingling and numbness from vaccine site to fingers - left arm. Also had intermittent tunnel vision. Given Benadryl 50 mg po without relief. Taken to ED. Given Pepcid 20 mg IV and methylprednisolone 125 mg IV with improvement of symptoms. Discharged home.
I developed a cellulitis infection in my left arm where a tetanus vaccination was given by the Medical Clinic.  The individual who administered by tetanus shot didn?t follow good cleanliness measures to protect me.  I know this because he left the room where I was brought to get the vaccination to go somewhere else within the clinic to get my vaccine.   I have a growing 4.5 x 6 red, swollen, patch on my upper arm that is painful.  I?ve been given antibiotics by my regular PCM through medical home.
Urticaria, reoccurring in spontaneous parts of the body. Taking over the counter antihistamine
Terrible migraines; awful body aches all night, especially ribcage; nausea; exhaustion; and very sore upper arm for over a week after Covid booster shot, just like after previous Covid shots, except symptoms were the worst and the longest-lasting this time.
SWOLLEN LIPS; TINGLING LIPS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-APR-2021, the subject experienced swollen lips. On 13-APR-2021, the subject experienced tingling lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen lips and tingling lips was not reported. This report was non-serious.