chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever of 100.2; body aches; diarea; This is a spontaneous report from a contactable other health care professional (patient). A 65-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration, administered in left arm on 31Jan2021 20:45 at the age of 65 years old as single dose for COVID-19 immunisation. Medical history included physciatrist. There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included gemfibrozil (LOPID), dexlansoprazole (DEXILANT), estradiol, paroxetine hydrochloride (PAXIL), desvenlafaxine succinate (PRISTIQ) and trifluoperazine hydrochloride (STELAZINE). The patient received other medications within 2 weeks of vaccination. On 01Feb2021, 03:30, the patient experienced fever of 100.2, body aches, diarea. The patient assessed the events as non-serious. The adverse event resulted in emergency room. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has not recovered from the events.
arm is hot at the injection site; The redness is growing.; arm is red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm is hot at the injection site), ERYTHEMA (The redness is growing.) and VACCINATION SITE ERYTHEMA (arm is red at the injection site) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (arm is hot at the injection site), ERYTHEMA (The redness is growing.) and VACCINATION SITE ERYTHEMA (arm is red at the injection site). At the time of the report, VACCINATION SITE WARMTH (arm is hot at the injection site) and VACCINATION SITE ERYTHEMA (arm is red at the injection site) outcome was unknown and ERYTHEMA (The redness is growing.) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact
Refridgeration excursions identified; No adverse event; Poor quality vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022 at 4:40 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 15-Sep-2022 at 4:40 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified).    Concomitant medication was not provided.  The patient received previous 3 dose of Moderna vaccine intramuscular in deltoid.  Anatomical location of bivalent vaccine was reported as deltoid.  It was reported that the vaccines had undergone several temperature excursions in August 2022.  Refrigeration excursions identified and vaccine was housed in the units. There were excursions noted. Manufactures were notified and the Regulatory Authority and made aware of the situation. No adverse reactions reported for any patient at the time of report. Date vials moved from freezer to refrigerator was 07-Sep-2022 both monovalent vaccines  Treatment information was not provided.
12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry; No adverse event; 12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry).    No concomitant medications were reported. Dose administered after 30-day Use By Date or after manufacturer date of expiry Vial size was reported as 5.5 mL On 12-Nov-2021, the vial was initially stored in the refrigerator The vial did not undergo any temperature excursions.  No treatment medications were reported.
Within 20 minutes of leaving the facility both arms broke out in hives.  My feet, legs, hands, arms and head have all swelled and the "COVID-19 Arm" rash has covered the majority of my body.   It moved proportionally up from the tips of my toes and fingers up my legs and arms, up my neck and head (face), and this past Friday I saw the first redness on my torso. The rash burns and is tight.  Last Thursday I had a lump come up in my ankle which seems to be growing, my doctor sent me for an x-ray which I went on Friday as I was so wiped out emotionally Thursday that I needed to go home and sleep.  I have what appears to be bruises or spots starting to appear on my body.  I'm maxed out.
My daughter had a cold which I caught.  I had a runny nose, sore throat tired.  I underwent a Covid test 01-13-2021, which was negative.  On 01-12-2021, I also got my Tdap vaccine, on my right arm.
She got the 2nd Moderna booster & experienced a cough & congestion.; She got the 2nd Moderna booster & experienced a cough & congestion.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COUGH (She got the 2nd Moderna booster & experienced a cough & congestion.) and NASAL CONGESTION (She got the 2nd Moderna booster & experienced a cough & congestion.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced COUGH (She got the 2nd Moderna booster & experienced a cough & congestion.) and NASAL CONGESTION (She got the 2nd Moderna booster & experienced a cough & congestion.). At the time of the report, COUGH (She got the 2nd Moderna booster & experienced a cough & congestion.) and NASAL CONGESTION (She got the 2nd Moderna booster & experienced a cough & congestion.) had not resolved.            Allergies were Unknown. No concomitant medications were reported. No treatment details were reported. AE did not caused patient to seek medical care. It was reported that the Symptoms were worsened.   Reporter did not allow further contact
Diarrhea 6-7 episodes per day beginning the day after 12-month immunizations. No fever. No vomiting. No sick contacts.
"My eyes feel strange"  Calm and cooperative.  12:25pm. Lungs clear, symptoms absent. Patients reported eye strain has improved. Raspy voice that patient attributes to as Asthma symptoms.  Pt. declined EMS services and was observed for 50 minutes prior to departure. Oral Diphenhydramine 1 ml. PO,  12.5mg/5ml given at 12:25pm.  Disposition: Patient status stable, declined need for EMS, also no immediate need observed. Observed for 45min.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via COVID-19 Adverse Event Self-Reporting Solution. A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jul2022 at 14:00 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "Cirrhosis of Liver" (unspecified if ongoing), notes: Other medical history: Cirrhosis of Liver. There was no known drug allergies. Concomitant medication(s) included: CIPROFLOXACIN; FUROSIMIDE. Vaccination history included: BNT162b2 (Vaccine Brand: Pfizer, Dose Number: 1, Vaccine Administration Date: 02Jul2022, Vaccine Administration Time: 01:00PM, Batch/lot number: Unknown, Unable to locate or read the details, Location of Injection: Arm Right), administration date: 02Jul2022, when the patient was 54-year-old, for COVID-19 Immunization. The following information was reported: DEATH (death, hospitalization) with onset 23Jul2022 at 22:00, outcome "fatal", described as "Died 36 hours later". The patient was hospitalized for death (hospitalization duration: 1 day(s)). The event "died 36 hours later" required emergency room visit. Therapeutic measures were taken as a result of death. Details were as follows: the patient died on 23Jul2022, at 10:00 pm. This resulted in a day of hospitalization. Treatment included ventilator/life support. The was no noted Covid prior vaccination, and the patient was not Covid tested post vaccination. The patient date of death was 25Jul2022. The reported cause of death was unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Reported Cause(s) of Death: Died 36 hours later.
This spontaneous case was reported by a consumer and describes the occurrence of SKIN LESION (Large red lesion (as big as a cookie) and a lengthy red lesion (same size of a mirror handle)), INJECTION SITE WARMTH (Warm to touch) and VACCINATION SITE PRURITUS (Itchy on the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included UTI, Heart valve replacement in June 2020 and Pacemaker insertion (cardiac) (Had pacemaker (left)) in June 2020. Concurrent medical conditions included AFib. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, DILTIAZEM for Cardiac valve disease, FUROSEMIDE (FUROSIMIDE) for Diuretic therapy, VITAMIN D [VITAMIN D NOS] for Supplementation therapy, ASCORBIC ACID, OLIGOMERIC PROANTHOCYANIDIN, VACCINIUM MACROCARPON (CRANBERRY CHOCOLATE) for Urinary tract infection.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced SKIN LESION (Large red lesion (as big as a cookie) and a lengthy red lesion (same size of a mirror handle)), INJECTION SITE WARMTH (Warm to touch) and VACCINATION SITE PRURITUS (Itchy on the injection site). At the time of the report, SKIN LESION (Large red lesion (as big as a cookie) and a lengthy red lesion (same size of a mirror handle)), INJECTION SITE WARMTH (Warm to touch) and VACCINATION SITE PRURITUS (Itchy on the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Adverse event reporting form completed. Updated the reporter details and vaccination details. On 27-Jul-2021: Non-significant follow-up received. Best doctor/HCP contact detail updated.
Presented to ED on 5/1/05 with history of fever, cough, decreased appetite, increase urination; onset 3 days prior. Labs: Glucose 537. Information received from discharge summary states thirst, agitation, diabetes mellatis, ketosis. Follow-up: Pt. presented to ER on 5/1/05 with history of decrease appetite cough and vomiting x 3 d.
enlarged lymph nodes lt axilla; erythema & pruritus just distal to inj
Taking antibiotic between doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (Taking antibiotic between doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (Taking antibiotic between doses). At the time of the report, NO ADVERSE EVENT (Taking antibiotic between doses) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment information were not provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
ACHY LEGS; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with guaifenesin for hyperactivity.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: LC1820095 expiry: 04-JUL-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUN-2021, the subject experienced headache. On 02-JUN-2021, the subject experienced achy legs. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills on 02-JUN-2021, and had not recovered from headache, fever, and achy legs. This report was non-serious.
Approximately 2 and a half hours after vaccine administration, I had the sudden onset of abdominal cramping, multiple episodes of diarrhea, nausea, and tingling in my hands and lips. I recognized these symptoms as a potential allergic reaction and took cetirizine 20 mg and famotidine 20 mg. These symptoms subsided approximately one hour after onset. Approximately 4 hours later, I experienced moderate fatigue and mild muscle soreness of my left arm (where the vaccine was administered). The fatigue and soreness persisted into the next day and gradually subsided.
Pt reports that 5 min after receiving the vaccination yesterday, she felt dizzy, lightheaded, "jaw tension and tightness."  Symptoms lasted approximately 10 minutes.  She also reports that for a split second she could not open her mouth due to jaw tightness, but reports that she has not had any further issues with this.  She did not notify any of the immunization clinic staff about any of these symptoms. This morning when patient was at work, she noticed that she had some circumoral numbness and tingling with chin numbness and mild tongue swelling and numbness.  The symptoms started at approximately 1030 this morning and are still occurring.  "It feels like I just went to the dentist."  Patient denies difficulty swallowing her secretions, but she does feel like there is possibly a "mild compression" in her esophagus.  Denies any new foods or fluids, itching, shortness of breath, wheezing, voice changes, nausea/vomiting, syncope.  She has not taken any over-the-counter medications for her symptoms.
Pt received IZ on 11/17/00 and on 11/19/00, the child developed an afebrile seizure and was hospitalized. Placed on phenobarbital.
Swelling right arm X 2 days. Dx-Keflex 500mg daily X 5 days, Zertec 5mg prn.
See attachment #1 symptoms of encephalomyelitis began 1 month post 5/22/07 vaccine visit.  10/30/07 Reviewed hospital medical records which reveal patient experienced left hemiparesis starting w/left leg dragging then spread to left arm.  Seen at outlying hospital where CT of brain was c/w tumor.  Transferred to higher level of care & admitted 9/1-9/7/2007.  Tx w/high dose IV steroids for ADEM s/p vaccinations noted to be in July, 2007.  LP done.  Improved almost immediately s/p steroids but continued to have weakness of left leg & dragging leg at d/c.  D/C to home on tapering steroids & PT/OT as outpatient w/follow-up in Neurology clinic & pcp. 11/2/07 Received vax record from pcp. which confirms dose & lot as reported. Follow-up: Child Primary Dr. last saw him in February 2008. He displayed no neurologic deficits and appeared to have recovered from encephalomyelitis symptoms. She states that patient is still taking prednisone and is under the care of Dr. (pediatric neurologist) at hospital. You can contact Dr. for further medical information. He is overseeing any future immunizations that patient will receive.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient was extremly nervous and concered about recieving a vaccination. Per patient it was the first time he was recieving a vaccination and was scared of the needle. Patient felt slight dizziness after the vaccination. Provided the patient with water and monitored patient until dizzines was resolved. Called patietn before end of shift (5:45pm), patient indicated that he was at work, slightly tired, with no  dizzines.
Fever 103.5, wheezing, listless, pale, "difficulty catching breath", slept 7 hrs from 1230PM-7PM, lethargic;
pt had lump in leg size of fifty cent piece-red, hot-2hr later lump doubled in size applied ice;2nd day doubled in size again w/blisters;
Loss of appetite; Frequent urination; Chills; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), POLLAKIURIA (Frequent urination), CHILLS (Chills) and INJECTION SITE PAIN (Pain at the injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced DECREASED APPETITE (Loss of appetite), POLLAKIURIA (Frequent urination), CHILLS (Chills) and INJECTION SITE PAIN (Pain at the injection site). At the time of the report, DECREASED APPETITE (Loss of appetite), POLLAKIURIA (Frequent urination), CHILLS (Chills) and INJECTION SITE PAIN (Pain at the injection site) outcome was unknown.            No treatment medications were provided by the reporter. No concomitant products were provided by the reporter.
Have had a stiff neck and bit of a headache on and off constantly; Have had a stiff neck and bit of a headache on and off constantly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 (Lot number: EN2603) at the age of 71 years as dose 1, single and administered in arm left, administration date 19Mar2021 (Lot number: EN6204) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure. Concomitant medication(s) included: VALSARTAN; ROSUVASTATIN. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), HEADACHE (non-serious) all with onset 27Feb2021, outcome "not recovered" and all described as "Have had a stiff neck and bit of a headache on and off constantly". Therapeutic measures were not taken as a result of musculoskeletal stiffness, headache.  Additional information: Consumer stated, since he got first Covid shot on the 26Feb, he had a stiff neck and bit of a headache on and off constantly and was having it ever since he had that shot and even it became worse after he had second shot.  No follow-up attempts are possible. No further information is expected.
Local reaction, upper arm. Itch, swelling, erythematous rash arose 24hrs post injection site of DTaP.
Rash, UrticariaPruritus, appeared to be subQ injection, with significant inflammatory reaction, followed by cellulitis. Narrative:  employee reported injection site abnormality to EOH day of vaccination, too far posterior and likely subQ. per vaccinator due to difficulty lifting sleeve. had immediate profound inflammatory reaction with swelling and erythema. improved but then developed increasing redness, heat, and tenderness, treated for cellulitis.