chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DTaP area swelled up over the next several hours - about the size of a quarter. The next AM - swelled up to 4 x 4 inches with a fever of 100 degrees. Area red.
Information has been received from a medical assistant concerning a 14 year old male patient with no pertinent medical history and no known allergies who on 17-AUG-2009 was vaccinated SQ with the first 0.5 ml dose of VARIVAX (Merck) (lot number 660407/0103X). On 21-AUG-2009 the patient developed a fever and dizziness. On 24-AUG-2009 the patient was examined in the office. There were no lab studies performed. There was no treatment was prescribed. On an unspecified date, the patient had subsequently recovered. Follow-up information has been received from the medical assistant. On 21-AUG-2009 the patient developed running fever, dizziness, fever, stomach pain, headache, coughing and rash on his back of legs. The outcome of the patient was reported as unknown. Additional information has been requested.
Had influenza vax given 11/7/06 in left thigh. 24hours later had pain in leg and did not want to walk. Developed red raised bumps which later became a ringed area around inject site and swelling went down. Associated malaise.
the patient experienced COVID-19; the patient experienced COVID-19; STUDY NO: FACILITATED COLLECT  This is a non-interventional study received from a non-contactable consumer. A 62-year-old male patient received first dose of bnt162b2 (Batch/Lot number was not reported), intramuscular on an unspecified date as single dose for covid-19 immunization; adalimumab (HUMIRA), subcutaneously, start and stop date, batch/lot number and dose were not reported for psoriatic arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced covid-19 on an unspecified date. Solicited report  by a consumer of an adult male with an event of non-serious COVID-19 with adalimumab. There was no reported medical history. On an unknown date, the patient experienced COVID-19. On an unknown date, COVID-19 resolved. COVID-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. He received first dose COVID-19 vaccine manufactured by Pfizer. Primary reporter contact for lot number information was unsuccessful. The action taken in response to the events for adalimumab was unknown. The outcome of events was resolved on an unspecified date.   The reporter's causality for the events of COVID-19 with adalimumab and COVID-19 vaccine was no reasonable possibility.   Information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (COVID-19) with BNT162b2 can not be fully excluded based on the limited information.
This spontaneous prospective pregnancy report as received from a patient's husband, for VARIVAX (Merck) a Pregnancy registry product, refers to a 29 years old female patient, with no drug reactions/allergies and no pertinent medical history, who received three vaccine shots at the same time while she was pregnant. The patient's history of previous pregnancies and live births is not known. On 25-SEP-2012 the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot # not reported). Other suspect therapy included: flu vaccine (manufacturer unknown) (dose, route and lot # not reported) given on the same day. Concomitant medication included: DTaP (manufacturer unknown) given on the same day. At the time of when she received these vaccines, she did not know that she was pregnant. It was only last week when they found out that they were 2 months pregnant. The last menstrual period (LMP) was on approximately 13-AUG-2012 and estimated delivery date (EDD) is approximately on 20-MAY-2013. The patient was exposed to VARIVAX (Merck) during trimester 1. No treatment was given. The outcome of the pregnancy was pending. The outcome of the fetus was unknown. No laboratory diagnostic studies were performed. The patient sought unspecified medical attention - she spoke to physician. Follow up information has been received from a registered nurse. She stated that physician has no information to share concerning this patient. The complete medical records are unavailable. No further information is available. Additional information is not expected.
SOB, Chest Pain, Extreme  debilitating joint swelling, debilitating headache. Lasted 5-6 hours. Joint swelling, shortness of breath, and very lethargic until 4/10/21.
Redness and Painful Swelling at the site of Injection. Started on 4/17/21 and as per conversation with Patient today ( 04/20/21 )  it has grown to almost 5 inch diameter.
administered 0.3 mL of Moderna Booster instead of 0.25 mL
pt recv vax & devel an inject site rxn characterized by an orange size area of redness & swelling;the rxn was described as cellulitis;pt self treated w/applications of ice & recovered w/in 5 days;
Pain developed early on and persisted till ~ 3 weeks remains persistent.   Went to internist following tests Positive ANA, Elevated RO-SSA >200,  Elevated sed rate, Elevated crp, change in hgb from 14.9 to 12.7, low iron, muscle pain, bilateral leg swelling, joint pain, tightness, rash on both legs, ankle up to knee over 3-4  days, at four weeks out continued pain, weakness, and swelling.  Persistent soaking night sweats and low grade fever in the evenings. Purple rash on arms and legs with nodules.  Referral made to rheumatologist for further work up.
myself the patient i had the first covid Pfizer vaccine on 01/04/21, symptoms started on monday nite 1-04-21 feeling very fatigue and tired, on 01-05-21 felt just a little tired and fatigued had no rash mark, on 01-06-21. i threw up and just a bit tired. After a few days i fully recovered from the first dose of the covid 19 Pfizer,  When i received the Second dose of the Pfizer on 01-29-21 that nite i started with a massive headache n chills, on 01-30-31 the entire day had diahrea severe chills massive headache and sweats.On 01-30-21 thru today 02-02-21 i have a round circle rash with heat and bump underneath it each day the rash is bigger were the right arm had the covid Pfizer vaccine injected on 01-29-21.
Patient received an Quadracel on 3/9/2022 in the left thigh accidentally by the medical assistant. Patient was due to receive a DTaP only  on this date. No adverse reactions. Spoke with program educator and was advised this dose can count as patient's fourth dosing and no harm would be caused by this accidental administration.  Medical assistant has been educated to prevent these errors in future.
Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chickenpox.  Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated patients was a 10 year old patient who on 20AUG1996 was vaccinated with a dose of varicella virus vaccine live. On 17MAR2003, the patient developed chickenpox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chickenpox post vaccination with varicella virus vaccine live were also identified.  Additional information is not expected.
Rash came back; chills; itching on same side of injection; rash on same side of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching on same side of injection), RASH (Rash came back), INJECTION SITE RASH (rash on same side of injection) and CHILLS (chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itching on same side of injection) and INJECTION SITE RASH (rash on same side of injection). On 22-Feb-2021, the patient experienced RASH (Rash came back) and CHILLS (chills). The patient was treated with CORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (itching on same side of injection), RASH (Rash came back), INJECTION SITE RASH (rash on same side of injection) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up information received on 27-APR-2021 contains non-significant information.
Nausea and fatigue set in about 45 minutes after vaccination. Arm tenderness occurred immediately after vaccination.  Arm slightly swollen a couple hours after. Progressively got worse till it was excruciating to move arm. About  3 hours after vaccination cold flashes, and migraine, sensitivity to light,  sensitivity to sound, skin hurt to be touched, over all felt weak, dizzy when standing. Entire body hurt all over.  Lymph nodes in right arm pit swelled painfully. Felt like I was sunburned. Told I was very very pale. Vomiting around 7 hours after vaccination. Felt like it took all my energy just to breathe. The next day still fatigued and nauseous all day, arm is considerably less painful.
Metallic taste the mouth and smell; Her hair are falling off; Can feel the pain on bony area, ribs, joints; Metallic taste the mouth and smell; Pain that is radiating to back down to their finger/can feel the pain on bony area; Have arm pain at the injection site; Can feel the pain on bony area, ribs, joints; 6 weeks after the 1st dose to get the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Metallic taste the mouth and smell), ALOPECIA (Her hair are falling off), MUSCULOSKELETAL CHEST PAIN (Can feel the pain on bony area, ribs, joints), DYSGEUSIA (Metallic taste the mouth and smell) and PAIN (Pain that is radiating to back down to their finger/can feel the pain on bony area) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Suspected COVID-19 (Patient had a past medical history of quarantine with COVID-19 symptoms since her boyfriend who was full diagnosed with COVID-19. They both were on quarantine prior to getting the vaccine. All the symptoms related to COVID-19 was cleared up before starting the new job.). Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (BUPRENORPHINE/NALOXONE) for an unknown indication.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-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 PAROSMIA (Metallic taste the mouth and smell), ALOPECIA (Her hair are falling off), MUSCULOSKELETAL CHEST PAIN (Can feel the pain on bony area, ribs, joints), DYSGEUSIA (Metallic taste the mouth and smell), PAIN (Pain that is radiating to back down to their finger/can feel the pain on bony area), VACCINATION SITE PAIN (Have arm pain at the injection site), ARTHRALGIA (Can feel the pain on bony area, ribs, joints) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (6 weeks after the 1st dose to get the 2nd dose). At the time of the report, PAROSMIA (Metallic taste the mouth and smell), ALOPECIA (Her hair are falling off), MUSCULOSKELETAL CHEST PAIN (Can feel the pain on bony area, ribs, joints), DYSGEUSIA (Metallic taste the mouth and smell), PAIN (Pain that is radiating to back down to their finger/can feel the pain on bony area), VACCINATION SITE PAIN (Have arm pain at the injection site), ARTHRALGIA (Can feel the pain on bony area, ribs, joints) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (6 weeks after the 1st dose to get the 2nd dose) outcome was unknown.            No treatment information provided.  Patient was taking buprenorphine/naloxone 8mg/2mg and believed that her metallic taste could be correlated to this medicine. But other symptoms were from the vaccine.   This case was linked to MOD-2021-336567 (Patient Link).
patient received a dose of Daptacel too early and that there was only a 10 day interval between doses with no reported adverse event; Initial information received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 months old and unknown gender who received a dose of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] too early and that there was only a 10 day interval between doses with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine Live Reassort Oral 5V (Rotateq) for Prophylactic vaccination.  On 20-Jul-2023, the patient received a dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine suspension for injection lot number not reported via unknown route in unknown administration site for prophylactic vaccination (Immunisation), too early and that there was only a 10 day interval between doses with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  Information on the batch number was requested.  It was reported that "the patient did not experience any redness at the injection site or any fever after the most recent dose of Daptacel".  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  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 guidelines. 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.
05/29: Clients mother called to report that her son received 4 vaccinations on 05/27/2003 at the clinic.  Stated he was behind on his immunizations.  Was healthy and she gave Motrin x1 after the vaccines.  Noted felt warm after nap at 16:00.  Temperature at 22:00: 105F, tepid bath and Motrin lowered it to 101F-returned to 103.9 F during night.  On 05/28 was irritable and appetite down but just had low grade temperature (99F).  Had scheduled checkup with Doctor.  05/29/2003: Eating well, afebrile.
malaise and feeling bad the day after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  An 88-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 88 years 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 Number=1), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "malaise and feeling bad the day after receiving the vaccine".  Additional information: The patient stated that the patient reports a general feeling of unwell and feels horrible. Caller states the patient saw another provider 25Feb and 26Feb in which they believed the patient was experiencing serum sickness. The physician that saw her on 25Feb and 26Feb gave her a shot of steroids and prescribed her a Medrol dose pack. Caller states that the patient reports feeling much better the day after receiving the shot of steroids.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse referring to an 18 year old female patient. The patient had no concurrent or historical condition. No drug reactions or allergies were reported. On 06-JUN-2016 the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L049532 with expired date 08-DEC-2017, subcutaneous, dose unknown) to prevent chickenpox. However, the patient was already 22 weeks pregnant that day (exposure during pregnancy and product use issue). The last menstrual period (LMP) was 03-JAN-2016 and estimated due date (EDD) was 09-OCT-2016. No known adverse effects. No concomitant therapy was reported. No lab diagnostics study was performed. Additional information has been requested.
no adverse event; 2 doses of expired PNUEMOVAX 23 were administered to 2 patients; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 29-MAR-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U027357 exp date 25-MAR-2023) (dose and route not reported). Product had not experienced any temperature excursions through the date of administration.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2303USA010488:
Approx 3 min after injections, Redness noted around mouth of patient with sob and wheezing. Rash around mouth occurred almost immediately, with sob and wheezing approx. 30 minutes after.  Rash began to spread through out extremities.
I had fever 103.  101 after 24 hours.  I had body chills and aches as well.  I had extreme fatigue.
Following vax pt devel conjunctivitis in one eye the following day;  No other episodes of conjunctivitis; cleared w/ATB drops;
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 08-JUL-2013 the patient was vaccinated with ZOSTAVAX (lot # J001692, expired date 08-MAY-2014) (0.65 ml, subcutaneous) as shingles prevention. After receiving ZOSTAVAX on 08-JUL-2013, the patient experienced redness at injection site. The following day, 09-JUL-2013, the patient had "less redness" however the injection site was warm to the touch and there was a lump at the site. The patient also stated that there was pain and itching, no rash, at the injection site as well. She also stated that she had unspecified "pimples" on her tongue. There was no treatment given for adverse event. The outcome of there was reported as not recovered. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Vasovagal response, patient blacked out for 5 seconds. Pt was laying down, stabilized and examined by MD. Repeat vitals taken.
102.4 fever; This is a spontaneous report received from a non-contactable consumer (patient). This non-pregnant 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 06Apr2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing, and penicillin allergy from an unknown date an unknown if ongoing. Concomitant medications included meloxicam from an unknown date for an unknown indication, and levothyroxine sodium (SYNTHROID) from an unknown date for an unknown indication. The patient had not received any other vaccines in the four weeks prior to the COVID vaccination. On 06Apr2021 the patient experienced 102.4 fever, further reported as higher than when she had COVID. No treatment was received for the event. The clinical outcome of 102.4 fever was recovered on an unspecified date in Apr2021. It was also reported that since vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot number cannot be obtained.
Child received FLUMIST #2 on 11/28/11. Swelling of face, hands, itching. Redness of cheeks evening of vaccine. Seen by M.D. on 12/1/11. Sx resolving duration days.
Inadvertently administered Pfizer vaccine as the second dose, patient received Moderna vaccine for the first dose.
Per patient, 3 hours after receiving vax, she had severe pain in left arm of the injection site of the pneumococcal vax along with burning, redness that was shaped like the letter J 1/2 circle below the injec. site and it was hard. The patient did report to her PCP but was not seen. Patient is taking BENADRYL, ibuprofen and applying ice to injec site.
itching sensation in my arms and legs; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two doses. This is the first of two reports, for first dose. A 37-years-old male patient received the first  dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number and expiration date were not reported) via an unspecified route of administration at the left arm on 27Apr2021 12:30 (at the age of 37-years-old) at single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously took omeprazole and experienced allergies to omeprazole. After the first dose the patient had an itching sensation in the arms and legs that eventually went away; no rash/hives in 2021. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was recovered in 2021.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021754038 same patient, same reporter, different dose, similar events
injection site pain and soreness, Headache, joint pain all over body, Fever 100.5, stomach pain, low back pain, nausea
Information has been received from a mother concerning her 12 month old daughter who on 26Jun03 at 4:50PM (also reported as 27Jun03) was vaccinated SC into the left thigh with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). There was no concomitant medication. Ten to twelve days later the pt broke out in big red blotchy patches that appeared on her legs, belly and face and this lead to little scabby dots on the child's body. The pt's mother took her to the physician. The physician thought that the pt might have had a slight case of the measles. However it was reported that the pinpoint went away in 2 days and then the physician thought the cause may have been due to the pt's fever. The physician also thought according to the pt's mother, that the pt might have hives but after the hives did not go away over a period of time the physician thought otherwise. It was reported that hives generally go away after a period of time and new ones appear. The pt is still experiencing the big red blotchy patches and scabby dots on child's body. No further information was provided. Follow up information has been received from a nurse practitioner which indicated that the pt presented to the office with a rash, hives and fever on 08Jul03. It was noted that all symptoms had resolved per the reporter. There are no ongoing problems according to the chart. It was reported that this does not appear to be an adverse event. Additional information is not expected.