chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Burning sensation within 10 minutes of taking shot.; Muscle soreness within 10 minutes of taking shot; Prolonged and extended extreme tiredness; Tingling; Crawling sensation in skin that is ongoing since shot.; Menstrual cycle although completedweeks prior restarted within a day ofshot and continued for 2 weeks withheavy bleeding; Developed canker sore in mouth; Developed fever blister; Pain tingling in hands and feet; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 25Mar2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medications. The patient had no known allergies. 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 receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 14:15, the patient experienced burning sensation and muscle soreness within 10 minutes of taking shot, prolonged and extended extreme tiredness, tingling and crawling sensation in skin that was ongoing since shot, menstrual cycle although completed weeks prior restarted within a day of shot and continued for 2 weeks with heavy bleeding. Developed canker sore in mouth, developed fever blister, pain tingling in hands and feet. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events burning sensation and muscle soreness within 10 minutes of taking shot, prolonged and extended extreme tiredness, tingling and crawling sensation in skin, menstrual cycle although completed weeks prior restarted within a day of shot and continued for 2 weeks with heavy bleeding, developed canker sore in mouth, developed fever blister, pain tingling in hands and feet was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
extremely warm at the injection site; sore arm; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (extremely warm at the injection site), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (redness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE WARMTH (extremely warm at the injection site), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (redness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (extremely warm at the injection site), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
This spontaneous report was received from a consumer refers to a female patient of unknown age (also reported as around 70 years-old). On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced adverse reaction. On an unknown date, the patient went to a hospital searching medical attention. The outcome of adverse reaction was unknown.
Erythema and induration covering on area of 3 1/2 x 4 1/2 cm on L upper arm.
Patient showed in our clinic on 3/18/08 approximately 10:35am - 10:40am with mom complaining of breathing/hoarseness and difficulty of breathing and tightness of chest.  Was wheezing some (was given Varicella vaccine in trailer behind clinic around 10 minutes ago.
Information has been received from a physician concerning a 17 month old normal healthy male with no significant medical history and no known recent varicella exposure who on 5/17/01 was vaccinated with varicella virus vaccine live (lot 635605/1151K). On 5/25/01, the pt experienced a rash consisting of maculopapular lesions on both legs. The rash became diffuse over the face and trunk but was mostly concentrated on the legs with over 100 lesions total. There were also some generalized lesions. The pt experienced one vesicle; the rest of the lesions remained maculo-papular. The lesions were varicella-like. The pt experienced over 100 lesions. The pt also experienced mild subjective fever and anorexia. Subsequently, the pt recovered from mild subjective fever and anorexia. The pt's mother (who had no history of chickenpox) was exposed to the pt. She had not been vaccinated with varicella virus vaccine live. She was 33 weeks pregnant at the time of the exposure. Medical attention was sought. It was also noted the pt was not in a daycare or any other preschool environment. The mother did not work outside the home and the pt was home with his mother. As of 5/29/01, the mother had not developed any lesions or other signs or symptoms. No further information is available.
Information has been received from a medical assistant concerning a 26 year old female who last week (approximately 27-March 2008), was vaccinated with the first dose of GARDASIL.  The patient developed back pains post vaccination.  The patient awoke at 2 am in the morning and felt like something was crushing her back like a "bear hug" and she could not breathe.  Medical attention was sought through a call to the medical assistant.  Patient outcome was unknown.  No product quality complaint was involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow up information has been received from a medical assistant concerning a 25 year old female with no known drug allegies who on 27 March 2008, was vaccinated with the first dose of GARDASIL (Lot # 1757O). On 28-MAY-2008 the patient was vaccinated with the second dose of GARDASIL (Lot # 1757O). On 29-MAR-2008 the patient developed back pains post vaccination. The patient awoke at 2 am in the morning and felt like something was crushing her back like a "bear hug" and she could not breathe. It was later reported that the pateint had back discomfort/spasms which the patient determined at the time of the second injection of GARDASIL that signs of complications from the first injection might not have been caused from GARDASIL. The patient had a folt to the body several days before the first injection patient was aware of possible reaction being reported to Merck. The back discomfort lasted 1-2 days. Unspecified medical attention was sought through a call to the medical assistant. The patient had a chest x-ray. Patient outcome was recovered approximately 1-2 days after onset. Additional information has been requested.
After leaving clinic following 20 minute observation period she noticed eyes watering and burning, nose running.  Symptoms continued throughout the day. At 04:15pm she began having blurred vision. She then went home and went to bed. Upon waking in the morning on 1/5/22 at 05:00am she felt a film over eyes, lack of vision and experienced throbbing pain and headache at which point she was taken to Emergency Room. At time of arrival provider noticed swollen eyes and HTN. Numbing eye drops were required to perform eye exam.
Patient described feeling muscle aches approximately 6 hours after receiving the vaccination followed by extreme fatigue and headache over the next two days. She said by Sunday she was starting to feel better only to have her headache come back on Monday.
Flu like symptoms; sweating; sore arm, couldn't lift; a fever of 103; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPERHIDROSIS (sweating), PAIN IN EXTREMITY (sore arm, couldn't lift), PYREXIA (a fever of 103) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia, Epstein-Barr viremia and Colitis.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPERHIDROSIS (sweating), PAIN IN EXTREMITY (sore arm, couldn't lift), PYREXIA (a fever of 103) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), HYPERHIDROSIS (sweating), PAIN IN EXTREMITY (sore arm, couldn't lift), PYREXIA (a fever of 103) and CHILLS (chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Antinuclear antibody: inconclusive (Inconclusive) Titre was elevated, elevated antibodies. In April 2021, Body temperature: 103 (High) 103.         Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-094672 (Patient Link).
This spontaneous report as received from a non pregnant female patient of unknown age refers to herself. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot # not reported). On an unknown date the patient experienced a welt the size of "half a dime" at the injection site. She had redness and swelling at the injection site as well. Over the weekend (date unspecified) the injection site was "warm to touch". She contacted physician and was advised to take BENADRYL as a treatment. The BENADRYL cleared up her adverse events some, but not all the way. The patient was recovering from the events of a welt the size of "half a dime" at the injection site, redness and swelling at the injection site, the injection site was "warm to touch". Relatedness between all the events and ZOSTAVAX was not specified. Additional information is not expected as the patient did not want to provide any contact details.
This spontaneous report has been received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of (RHA) M-M-R II lot # N008366, expiration date 13-MAR-2019 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (MERCK). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47.5 degrees Fahrenheit for 1 hour 30 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint has been filled. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007677: US-009507513-1709USA007679: US-009507513-1709USA004665.
Information has been received from a registered nurse concerning a female who on 01-MAY-2007 was vaccinated with a dose of Gardasil (lot # not provided). It was unknown if the dose was a first dose or if a previous dose had been given. The morning after vaccination, on 02-MAY-2007, the patient woke up with a swollen face and red spots on her legs. The patient sought unspecified medical attention. The Patient's swollen face and red spots on her legs persisted. Additional information has been requested.
Patient complained of rash approximately 1 hour after receiving first dose of COVID 19 vaccine, at first she developed hives diffusely across chest, upper back, and stomach area. Rash then turned into vesicular rash. She took a course of oral steroids.  It is now resolving. Still experiencing pruritus, and numbness and tingling.
This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender, who received vaccines with incorrect product storage.   On an unknown date, an unspecified number of patients were vaccinated with PNEUMOVAX23. Other suspect therapies included VAQTA, RECOMBIVAX and ROTATEQ. On an unknown dates, an unspecified number of patients received improperly stored vaccines. PNEUMOVAX23, VAQTA, RECOMBIVAX, and ROTATEQ.  The outcome of an unspecified number of patients received improperly stored vaccines is Unknown. No further information was provided. Additional information is not expected.
Information has been received from a physician via medical records concerning a 14 week old inpatient baby girl with anaemia of prematurity, chronic lung disease of prematurity, umbilical hernia, bronchopulmonary dysplasia and retinopathy of prematurity and a history of prematurity, very low birth weight baby, foetal distress, bradycardia, chorioamnionitis, respiration spontaneous decreased, hypotension, apnoea neonatal, metabolic acidosis, necrotizing enterocolitis, infant respiratory distress syndrome, pain, patent ductus arteriosus, renal insufficiency, respiratory failure, sepsis, cardiac operation, eye laser surgery and patent ductus arteriosus ligation (WAES # 0806USA01608) who on 21-DEC-2008 was vaccinated with PEDVAXHIB. Concomitant therapy included PEDIARIX and PREVNAR. On 13-JAN-2009 the baby was diagnosed with aspiration. It was reported that feedings were started on 05-NOV-2008 and were advanced as tolerated. The baby had difficulty transitioning to bottle feedings. The oral feeding readiness was evaluated. The examination was remarkable for oral motor dysfunction and clinical signs of aspiration. A feeding oximetry study (14-JAN-2009) confirmed aspiration. On 21-JAN-2009 the baby was diagnosed with intermittent systolic hypertension and atrial septal defect (ASD), secundum type. The baby developed intermittent episodes of systolic hypertension (systolic blood pressure (SBP) 90-100s). Diagnostic studies were completed. A renal ultrasound showed mild dilation of left renal pelvis without hydronephrosis and otherwise normal anatomy. An echocardiogram (21-JAN-2009) showed a moderate sized ASD secundum and borderline left ventricular hypertrophy. No intervention was required during this hospitalization. Recent systolic blood pressures were 60-80s. Blood pressure monitoring per primary care physician is recommended. On 24-JAN-2009 the baby was given the first dose of SYNAGIS for respiratory syncytial virus (RSV) prophylaxis. On 25-JAN-2009 the baby was discharged home. At the time of discharge, the baby's aspiration, feeding problems, intermittent systolic hypertension and atrial septal defect (ASD) persisted. On 26-JAN-2009 the baby was seen in the office for 2 month well child visit. All the exams presented well. The baby was assessed as premature infant. On 29-JAN-2009 the baby was seen in the office again. It was noted upon examination there was some drainage out of her right ear and the right ear was occluded with wax. The wax was removed. The baby's umbilical hernia was noted to be reducible. The baby was assessed as premature infant as unchanged. Atrial septal defect, secundum type was considered to be a congenital anomaly. Additional information is not expected. All available medical records will be provided upon request. The patient was treated at Health Center.
Rash, upper arm, shoulder to elbow, itchy, sore. Cortaid topical treatment to quell itching. Duration 5 days so far, diminishing.
Patient was given Moderna-2nd dose Booster on 4/26/2022.  Vial expired on 4/24/22. Denies adverse reaction. Moderna and CDC notified. Advised to re-vaccinate patient.
I WAS INJECTED WITH THE FLU VACCINE IN 2016, SUNDAY AFTERNOON I WAS DRIVING HOME FROM WORK AND FELT EXTREMELY NAUSOUS, TO THE POINT WHERE I PULLED OVER THE SIDE OF THE FREEWAY. I GET HOME AND I IMMEDIATLY FEEL LIGHT HEADED AND HAVE A MIGRAINE. I THEN LAY DOWN AND ASK MY SISTER FOR A PLASTIC BAG, SHE BRINGS IT TO ME, AND I PROJECTILE VOMIT INSIDE IT. I CONTINUED TO THROW UP FOR THE REST OF THE NIGHT.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. Patient treated with Paxlovid from 12May2023.  No follow-up attempts are possible. No further information is expected.
Information has been received from a 60 year old female consumer who on 04-AUG-2010, was vaccinated with a dose of ZOSTAVAX (Merck). On 04-AUG-2010, at "about 17:00" the patient experienced itching in the middle finger of left hand, then went to hair. On 05-AUG-2010, in the morning the patient was experiencing itching "all over". The patient did not seek medical attention. At the time of the report, the patient had not recovered. Follow-up information has been received from a physician concerning the speech pathologist and teacher with allergy to levofloxacin, codeine and erythromycin, iodine hives and no illness at the time of vaccination. On 04-AUG-2010 the patient was vaccinated SQ with a first dose of ZOSTAVAX (Merck) (lot# 664671/0149Z) in her left deltoid and a first IM dose of ADACEL (lot# 03082AA) into her right deltoid. On 04-AUG-2010, one hour after receiving the two vaccines, the patient developed urticaria and generalized pruritus. She received treatment with ZYRTEC, MEDROL "dose pack" and ranitidine. At the time of the report, the outcome of urticaria was unknown. Additional information is not expected.
bib mother states for redness and swelling on right arm  redness has not grown since yesterday. no pain. per pt itchy at times. no fever. arm is sore with movement.
small rash on left side of chest; This is a spontaneous report from other Health Professional (reported for herself). A 36-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EJ1685), on arm left via an unspecified route of administration on 31Dec2020 08:00 at single dose for covid-19 immunisation . Medical history included none. Concomitant medication included levothyroxine sodium (EUTHYROX, strength: 150mcg), drospirenone, ethinylestradiol (NIKKI, strength: 3mg/0.02mg). It was reported that after first shot (31Dec2020) developed small rash on left side of chest. Persisted for three weeks and was starting to fade when patient got second dose. Grew 4-5 times larger, raised, painful, red itched and tender. Now reaches my neck and breasts and shoulders. White normal skin in center, edge is now scaly and dry, itches very badly. Dr won't prescribe steroid fears it will dampen immune response. Taking Allegra, Benadryl and hydrocortisone cream did not help. Never had a reaction to a vaccine before. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19. Post vaccination Covid test done on 29Jan2021, Covid test type post vaccination was nasal Swab, covid test result was negative. Outcome of the event was not recovered.
I had a very bad red itchy body rash all over my arm, my chest and my face; I had a very bad red itchy body rash all over my arm, my chest and my face; My throat is not sore but it was very weird; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 24Mar2021 19:00 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 2nd shot a day before reporting night at 7 pm and at 9:30 am on 25Mar2021, the day of reporting, the patient had a very bad red itchy body rash all over the arm, chest, and face. Patient's throat was not sore, but it was very weird. Patient took one Benadryl as treatment and it was going away at the time of reporting. The patient was told to call and report the symptoms and just make sure they were okay or not. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started with itching as I left clinic at around 12:45, progressed to hives. Swelling at injection, extreme itching (especially on wrist of the arm that the injection was given, swelling at hairline, scalp, mouth, tongue, throat, chest - redness similar to sunburn on nose, folds along side of nose leading to mouth. Doctor gave cortisone injection, symptoms began to improve starting about 40 minutes after injection and continued improvement over the next few hours.