chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 2-3 week after the vaccine I begin having difficulty walking on my right foot.  I had stepped on something sharp,  but it has healed, but a few days later it I begin not being able to walk.  I went to see the Podiatrist who saw a nodule on the bottom of my foot and prescribed Naproxen to help with the symptoms, but  2 days later I ended up in the Hospital because I couldn't walk and was diagnosed with GOUT like symptoms.  Because my Uric acid level was fine the didn't want to diagnose actual GOUT While in the hospital I was hydrated with a saline solution and IV steroid drip to help deal with the various symptoms I was experiencing.  The next day I was released but Drs. could provide any explanation as to what was happening with me because all levels were fine.  My glucose levels were elevated and was advised to monitor for potential diabetes.
SYMPTOMS BEGAN NIGHT OF VACCINATION. PT BEGAN TO ITCH ON NECK AND SHOULDER AREA, THEN LIPS BEGAN TO SWELL. PATIENT WAS GIVEN BENADRYL.
Small bump on both thighs at injection sites sensitive to touch. No redness, no fever and no other health problems. As of today's date 11-13-06
Seriousness Criteria: Other - Medically Significant (OMIC). A 53 year old female patient received an intra-muscular injection of Decavac, lot number U1587AA, in the left deltoid on 11/Jan/2006. Five days later, the patient developed a "hard knob" at the injection site. She treated the area with ice. On 18/Jan/2006, the patient was seen in an emergency room. An incision and drainage of the site was done, and the patient was diagnosed with an abscess of the left deltoid. She was treated with IV Zosyn and Keflex for ten days. She subsequently recovered.
WHILE EATING PEANUTS, DEVELOPED IMMEDIATE SWELLING OF EYES AND HAD THROAT PAIN.  SYMPTOMS  LASTED THREE HOURS.  NO  PMH OF PEANUT ALLERGY.  PATIENT REGULAR INGESTS PEANUT PRODUCTS
07/28 patient had moderna vaccine. husband called 8/9/21 stated day after shot, patient  started getting headache that lasted 2 days,  then coughing, sneezing, fever, and high  temperature. decided to go to to ER 08/07/21 and tested positive for covid.
Itchy ness on day3- day 4 became inflamed and very red -I took Benadryl and the redness faded slightly but the area is still red around the outside - it is already 13 days- there is no pain but slight it hing
Patient reports COVID vaccine inefficacy/ I got COVID two weeks after I got my booster shot; Patient reports COVID vaccine inefficacy/ I got COVID two weeks after I got my booster shot; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 47-year-old male 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 "Patient reports COVID vaccine inefficacy/ I got COVID two weeks after I got my booster shot".  Clinical information: Patient reported COVID vaccine inefficacy. Patient got COVID two weeks after he got his booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug Ineffective and Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Information has been received from a medical assistant concerning a female who was vaccinate with on unspecified dates (doses and LOT# were not reported). When donating blood after vaccinated with GARDASIL the patient's parasite blood test showed positive for Chagas. Further testing showed the original test was false positive and she did not have Chagas disease. The patient was told that Chagas test showed positive was frequently see in patients that have vaccinated with GARDASIL. Follow-up information has been received via a phone call from the physician concerning a 17 year old female who was vaccinated with GARDASIL on unspecified dates (dose and LOT# were not reported). The patient attempted to donate blood and was told that she had a false positive confirmatory test for Chagas disease. It reported that  the false positive test was related to the GARDASIL vaccination. Follow-up information has been received via a phone call from a medical assistant (M.A.) concerning the 17 year old female who on 06-AUG-2007, 15-NOV-2007 and 03-MAR-2008 was vaccinated with a dose of GARDASIL (LOT# not reported, 659435/1265U, 659182/1757U respectively). No other concomitant vaccines were given at the time of the GARDASIL doses. Additional information has been requested.
Approximated 4 inch in circumference red itchy spot around injection site. Started at 8 days post injection. Has persisted for 2 days now.
I received the vaccine on Saturday  2/20/2021 at 11:15 am  a couple hours later I started feeling headaches and fatigue tested positive for Covid on Monday.  I had a temperature on Saturday 2/27 and yesterday I woke up with a rash on my hands and arms
3 days post vax the pt developed a severe headache which was severe enough that the pt's mother took her to the ER. No other signs or symptoms. Father states blood tests were done and no diagnosis was made. The pt was sent home on Tylenol. The pt continued to have throbbing headaches until the following evening. Father states that the pt has no history of headaches.
sl convuls, mild sz activity, lips blue, pupils pinpoint; pt was limp, could not respond to mother was like was asleep; this lasted 30 mins;
Fever with seizure. Pt developed fever throughout the afternoon after vaccinations. At 1945 pt had generalized tonic/clonic seizure lasted >10 minutes resolved with rectal valium. Following this patient had poor respiratory effort requiring intubation for respiratory support. Pt intubated overnight with mechanical ventilation. Extubated on 9/8/05 with return of normal/baseline mental status. - 1/13/06 Review of 19-page medical record. Prior to admission child vomited at home and appeared to be in pain as she would not bear weight on her legs. Pt received 2 doses of Valium in the ER and had poor respiratory effort. It took 3 attempts to get the endotracheal tube placed. Cords appeared edematous. Assessment: Typical febrile seizure, respiratory failure, and bilateral pulmonary edema probably secondary to airway obstruction.
pt seen in office for routine exam/immun; called 130PM c/o no resp noted; mouth cyanotic;EMS called;no s/s of distress when at home;returned to office;adm to hosp for observation;
A report has been received from a Physician concerning a male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The physician accidentally gave expired doses of FLUMIST to two patients. The outcome of the event of accidentally gave expired doses of FLUMIST to two patients is unknown. The report was considered to be non-serious.
Headache, body aches, fatigue, red hot welt at injection site, lethargy, nausea, began about 12 hours after shot. Lasted about 18 hours after that.
diarrhea; nausea; headache(next day); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Nov2021 15:00 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (ongoing); "Tubes out in ears" (unspecified if ongoing), notes: put in about age 3; "headaches" (unspecified if ongoing); "stomach issues" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL taken for attention deficit hyperactivity disorder (ongoing). The following information was reported: DIARRHOEA (non-serious) with onset 15Nov2021, outcome "recovered", described as "diarrhea"; HEADACHE (non-serious) with onset 09Nov2021, outcome "recovered", described as "headache(next day)"; NAUSEA (non-serious) with onset 10Nov2021, outcome "recovering", described as "nausea". Therapeutic measures were not taken as a result of diarrhoea, headache, nausea.  Additional Information: Patient did not have any other vaccine in four weeks. She had no known allergies and did not have covid prior and post vaccination. Patient received second dose on 01Dec2021 10:45 with Lot number: FK5127 in the right arm, intramuscularly. Patient did not have a bowel movement for few days and diarrhoea symptoms went away within 24 hrs. No symptoms after second dose.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician assistant referring to a 63 year old female patient with hypertension, hypothyroidism, gastric esophageal reflux disease. The patient has multple allergies to morphine, contrast dye, textile dye and methyldibromo glutaronitrile. On 13-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 (strength, lot#, dosage, frequency and route unspecified) for prevention of pneumococcal virus. Concomitant therapies included bisoprolol, colestipol hydrochloride, KLOR-CON, LASIX, amlodipine, SYNTHROID and ropinirole. In approximately September 2014, "a few days" after receiving the vaccination, the patient began to experienced dehydration, rash, swelling, lethargy, aching, vomiting and nausea. Physician assistant described the rash as an "urticarial scaling dermatitis-like rash" over an unspecified area of the patient's body. The patient was seen by physician assistant and skin patch testing, allergy testing, rash biopsy were performed two times. The patient received unspecified dose of intravenous fluids at an emergency room on an unspecified date due to dehydration. The patient had had "all kinds" of unspecified treatments, provided on unspecified dates and also the patient was given an dose of an unspecified topical steroid (manufacturer unspecified). The outcome of the events was reported as not recovered. Additional information has been requested.
Red, swollen, inflamed area about 7cm diameter surrounding site of Tdap/Menactra vaccination. Tx - Clindamycin
Pt vomited about 1 minute after being vaccinated. Proceeded to state she was dizzy. Never lost consciousness.  States pt. was anxious to get the vaccine. Pt sat quietly for about 10 more minutes after getting cleaned and felt better before leaving facility. Parent was with pt. at time.
patient fainted as soon as I administered the vaccine to her. she did not fall because she was leaning against her friend. I offered to put her on the floor but she declined. she put her head between her knees and got her consciousness right back. EMT was called but pt told her she was fine and no assessment was done.
Edema & inj site - Vesicle rash lower breast right & right axilla.  Rec. some MEDROL 80 mg IM in ED; Rx for MEDROL dose pack & AUGMENTIN X 5 days.
Patient reported swelling at site of injection the occurred on 9-2-16. When she woke up on the morning of 9-3-16, the swelling had spread significantly to include area between shoulder and elbow. Does not report excessive pain.
At 10:30 I started feeling fatigued and over the next hour got the chills.  I added layers and turned on a heater, started feeling worse and by 12:15 I had to give up working and spent 5 hours in bed. Low grade fever- 99.4 F. Also nauseous from 12:30 got about an hour.  My heart rate was elevated from 10:30 am until 2:30am the next morning (my smart watch showed close to 100 for most of the time period.
This spontaneous report was received from a nurse and refers to a 1 year-old male patient. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 22-JUN-2017 at 13:20, the patient was vaccinated with improperly stored VARIVAX, in the left thigh (lot # M047662 with the expiration date of 02-DEC-2018, first dose; exact dose and route of administration were not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). The patient was concomitantly vaccinated with a dose of VAQTA and M-M-R II. There were no adverse events. The administered dose of VARIVAX experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1706USA009938:
VACCINE ADMINISTERED AFTER TEMPERATURE EXCURSION OCURRED BUT UNKNOWN TO PROVIDER; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 07-AUG-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced vaccine administered after temperature excursion ocurred but unknown to provider. On 24-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after temperature excursion ocurred but unknown to provider and out of specification product use was not reported. This report was non-serious.
clear runny nose, woke up 1JAN98 w/spots, no fever, etc;
Irregular urticarial reaction left deltoid noted with largest patch in region of injection and a linear series of welts going around anteromedially. Benadryl and tylenol for pain
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Covid-19 vaccine that were given beyond the 30 day use by date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022 at 2:59 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022 at 2:59 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   of the patient was reported . No concomitant medication information was provided. It was reported that, vaccine was administered on 04-Apr-2022 at 14:59:04 Its 30 days expiry date vaccine went into 2 to 8 °C thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg date of 04-Apr-2022 No treatment information was provided.   This case was linked to MOD-2022-542869 (Patient Link).
The next day, I had a fever of 100, body aches, sore shoulder, and headaches after getting the vaccine. It's been two days already, and I'm still down with a fever, bad headaches, dizziness, and a sore shoulder - I put ice pack, which didn't really work. Whenever I stand, I feel like I'm gonna pass out. I've been in bed for the past two days, and I can't work.
Left arm pain, body aches, 103.6 fever, headache, nausea
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no information regarding concomitant medication, medical history or drug reaction/allergies. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L029618 with expiration date 20-MAY-2017; dose was not reported; oral). It was reported that the vaccine was improperly stored at 33.6 (unit not provided) for 89.5 hours and then was back in range. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
c/o of arthritis sx in a prev injured leg w/in 24hr of vax;pain persisted till 23OCT97;saw PMD on 22OCT97 gave med anti-inflammatory;
expired ACT-HIB was given to a patient with no reported adverse event; Initial information received on 12-Apr-2023 regarding an unsolicited valid non-serious case received from Nurse.  This case involves a 16 months old female patient to whom an expired haemophilus type B (HIB) vaccine [ACT-HIB] was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (Varicella Vaccine) for immunisation.  On 11-Apr-2023, the patient received 0.5 ml (dose 4) of expired haemophilus type B (HIB) vaccine, powder and solvent for solution for injection (lot U7261AA, U7261AA, expiry date: 07-Apr-0223, 05-Jun-2023) (unknown strength) via intramuscular route in the left thigh for immunization with no reported adverse event (expired product administered) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for an 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 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.
A nurse reported a pt received vaccine's on 2/22/00, within 24 hrs she developed a fever of 101.1F, headache and generalized body aches. She recovered.
Fever, body aches, joint pain, nausea, throwing up, dizziness, diarrhea, headache, fatigue, chills, sweats, loss of appetite, loss of smell and taste buddy?s, swollen glands, painful sinuses, cough, runny nose, scratchy throat, and brain fog.
12 hours after injection, had fever of 102, up all night in lots of pain,felt worse than I ever have. Pain continued, fever continued until next day. Fever broke 24 hours after injection. Pain continued in joints, back, everywhere for following day. Ibuprofen mitigated pain. Stayed in bed for 48 Hours after injection, still in pain. Felt like hell for two more days. Finally, on the Saturday after the injection on Tuesday, began to feel better, but still not quite right.Never had a reaction like this one, EVER.
Patient experienced pain at deltoid injection site which extended up to neck.  Also report night sweats and rigor.  Symptoms have resolved by 12/28/20.
Developed upper back pain/ Probably muscular in origin; Fever; This spontaneous case was reported by a physician and describes the occurrence of BACK PAIN (Developed upper back pain/ Probably muscular in origin) and PYREXIA (Fever) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Rheumatoid arthritis (moderate to severe ) since an unknown date.   On 08-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced PYREXIA (Fever). On 16-Jun-2021, the patient experienced BACK PAIN (Developed upper back pain/ Probably muscular in origin). On 05-Jun-2021, PYREXIA (Fever) had resolved. At the time of the report, BACK PAIN (Developed upper back pain/ Probably muscular in origin) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  The reporter's causality for the events of fever and Developed upper back pain/ Probably muscular in origin with HUMIRA(adalimumab)) was no reasonable possibility.  No treatment information was provided.
8 patient out of 125 patients either didn't get their dose or received partial dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (8 patient out of 125 patients either didn't get their dose or received partial dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (8 patient out of 125 patients either didn't get their dose or received partial dose). At the time of the report, INCORRECT DOSE ADMINISTERED (8 patient out of 125 patients either didn't get their dose or received partial dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information not provided. Concomitant medications were not provided.   This case was linked to MOD-2021-065559, MOD21-071476 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow up document is received on 07-APR-2021 and it doesn't contain any new information
Less than one minute after the injection, I had a prickly sensation all over my scalp which worsened.  I got very hot then passed out.  I lost control of my bowels while unconscious.  I came to about one minute later and remained at the clinic for another hour and one half for observation.  Since that time, I have had an unclear feeling in my head similar to the effect of nighttime cold medicine.  The second ongoing symptom since the time of this vaccination is dizziness.  This has not improved any since the time of vaccination.
Redness to Left Deltoid.  No pain, tenderness, temp at site. Resident started on Cephalaxin 500mg BID x3 days as a precaution.
Mother notes red area on RU LAT leg x 24 hours. Today LG 3x4" red, hot, indurated area RU LAT thigh area where DTaP given 06/11/02 ref. to priv. MD.