chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 7/23/2022 while on vacation, I started running a fever of 101.7.We had Covid tests with us and I tested positive.  I went to a health clinic near the hotel and had a PCR the next morning.  I had chills, night sweats, headache, sore throat, chest tightness, severe body aches, throat congestion. After 2 days of not being able to get the fever to go down we called my physician at home who prescribed Paxlovid. My symptoms got dramatically better within 8 hours. I still ran a low grade fever, had aches and cough for several more days. Note that for the five days I was taking Paxlovid and for several days after completing the treatment, I had Raynaud's Phenomenon in my left hand.
COVID-19; COVID-19; 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), in Jan2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Additional information: Treatment drug included Paxlovid (Lot number: 00069-1085-30) from 20May2022. Vaccine administration time 10:00AM.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient developed hives on the upper torso and back several hours after administration of COVID vaccine that resolved spontaneously.
high temperature fevers.; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: Unknown) via unknown route of administration on an unknown date as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. After first dose of the vaccine, the patient developed high temperature fevers. The lab data included body temperature was high (high temperature fevers) on an unknown date. The outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Feeling feverish; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Feeling feverish) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (Feeling feverish). At the time of the report, PYREXIA (Feeling feverish) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
Left arm redness warm to touch. Diagnosis: Cellulitis Tx with Cephalexin 250 mg/5 mL bid x 10 days.
constant unrelenting ringing in both ears med pitched started a few days after 2nd injection. It has been 2 months without relief. (No pain)
16 year old patient was administered Moderna COVID-19 vaccination booster dose of 0.25mL. No treatments or negative outcomes reported by patient 2 days post vaccination.
The flu vaccine was short on his left arm, now his left hand pinky (baby) finger has a little force when it is pulled, the right hand one is fine.
Patient came in 3/3/10 stating a rash (itchy) was caused by her H1N1 vaccine. She stated it started a week or so after administration and is itchy and localized. It was not at the injection site and was a raised red rash on her L upper arm toward her back. Still has rash as of 3/4/10.
Abscess (L) thigh started tx 6/20/11. I & D 6/20/11.
arm appeared to be more red; fever of 101.5F; Nauseated; started to become foggy; my arm appeared swollen; my arm appeared bruised; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE BRUISING (my arm appeared bruised), FEELING ABNORMAL (started to become foggy), VACCINATION SITE SWELLING (my arm appeared swollen), VACCINATION SITE ERYTHEMA (arm appeared to be more red) and PYREXIA (fever of 101.5F) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7410C) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Sep-2022, the patient experienced VACCINATION SITE BRUISING (my arm appeared bruised) and VACCINATION SITE SWELLING (my arm appeared swollen). On 15-Sep-2022 at 4:00 PM, the patient experienced FEELING ABNORMAL (started to become foggy) and NAUSEA (Nauseated). On 15-Sep-2022 at 7:00 PM, the patient experienced PYREXIA (fever of 101.5F). On 16-Sep-2022, the patient experienced VACCINATION SITE ERYTHEMA (arm appeared to be more red). The patient was treated with ACETAMINOPHEN on 15-Sep-2022 at a dose of 500 milligram twice a day. At the time of the report, VACCINATION SITE BRUISING (my arm appeared bruised) and VACCINATION SITE SWELLING (my arm appeared swollen) had not resolved and FEELING ABNORMAL (started to become foggy), VACCINATION SITE ERYTHEMA (arm appeared to be more red), PYREXIA (fever of 101.5F) and NAUSEA (Nauseated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2022, Body temperature: 101.5 fever of 101.5F, At 19:00. On 16-Sep-2022, Body temperature: 101 In morning, fever of 101F.         No concomitant medication were reported.  It was reported that the patient did not experience any adverse event within 15 min of vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2022: Follow up received contains no new information.
after about 5 min or so my arm where I received injection started itching very badly. rash formed and spread down my arm
Patients administered Moderna vaccine while temperature excursion assessment was ongoing; Patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 47-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter confirmed that patients had been administered doses while the temperature excursion assessment has been ongoing. No treatment medications were reported.
My arm swelled almost exactly eight days after the first vaccine. Very raised, red, hot and itchy. Called primary care who advised benedryl. Itching and redness lasted 3-4 days. At time of injection, my arm muscle seized around the needle and my arm was extremely sore the day after the vaccine.
Woke up around 3 AM with the chills. It's summer and hot outside and I'm almost never cold.  I was shaking and my teeth were chattering. Then a few hours later, I woke up with a fever and muscle aches. A little later, I started to get a headache and nausea with mild dizziness. Luckily, because of dropping a kidney stone, I had 600 mg. of Ibuprofen and 4 mg of ondansetron HCL so the symptoms are not as severe now.
This spontaneous report as received from a nurse prescriber refers to a patient of unknown age and gender. On unknown dates, the patient received four separate doses of GARDASIL 9 (doses, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse event was reported. Additional information has been requested.
24 hours post vaccine patient's arm started to swell increasingly and felt hot to the touch. She also experienced headache, and felt under the weather. On 7/4/14 went to urgent care and received diphenhydramine and TORADOL, monitored for 3 hours.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (fever). At the time of the report, pyrexia (fever) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
My vaccine(the first one) was mixed up with my husbands (below) so we don?t know which one I actually received and caused these reactions. My PCP said this can be affecting me neurologically hence the constant numbness,tingling,loss of feeling in leg and face.
patient had first shingrix shot in 2018 do they need to restart series; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter asked did they need to restart series. The reporter had no further detail, including details regarding patient or product.  The reporter stated that the patient not actually our patient just came in asking. The consent to follow up was not asked for this reason.
Got very pale immediately after injections. Had seizure in car at 11:30 lasting approx 1 minute, seen in ER at that time. sent home. Had another seizure at 15:30 that day, again seen in ER. Lab drawn/normal results. Follow up w neuro required.
Patient describing myalgias starting one day after receiving the Shingrix vaccine at clinic. No other flu symptoms.
Tested positive for COVID 1/4/2022. Symptoms. Included 2 days of mild nasal congestion, and 4 hours of mild fever the first day
This spontaneous report as received from a Licensed Vocational Nurse referring to 5 unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. In January 2017 (reported as between 10-JAN-2017 through 30-JAN-2017), the patients were vaccinated with improperly stored doses of ROTATEQ liquid, orally, lot # M031807 expiration date 02-APR-2018 (strength and dose were not provided) for prophylaxis. On an unspecified date, the vaccine was exposed to a temperature between 32 Fahrenheit degrees and 36 Fahrenheit degrees for 12 hours. There was no previous temperature excursion. No adverse effects were reported. The call was placed because of a Digital Data logger. This is one of several report from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA001084:
23APR99 child started crying p/nap;had vomiting & diarrhea;last few days irritable w/fever;27APR98 red spot & tender to touch on lt upper arm, down side, belly;
This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HYPOTENSION (hypotension) 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) at an unspecified dose. On an unknown date, the patient experienced HYPOTENSION (hypotension). At the time of the report, HYPOTENSION (hypotension) outcome was unknown.        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.   No concomitant products and treatment informations were provided.
Patient was healthy without symptoms received Tdap booster on 10/3/07 and no problem. Patient called office 10/4/07 c/o nausea, muscle aches, chills and fever. No SOB, no rash. Seen on 10/5/07 and patient stable. No local site reaction. Can't r/o viral influenza coincidental but does feel all potential vaccine interactions.
5/31/12 Patient presented initially 1.5 cm nodule - no erythema and 2.5 cm abscess darkly erythematous to right thigh. On 6/19/12 a small fluctuant abscess central  w/in the 2.5 cm area of erythema on the right thigh. This was I & D with purulent fluid expressed. On 6/12/12 the erythema was smaller but a 1 3/4 cm abscess with fluctuance was I & D.
About two to three  weeks after my second vaccination I woke up with a broken blood vessel in my left eye on the inside corner.  I looked it up and saw it was nothing serious. The following week after it healed I woke up with a bruise under my left eye. I then went to the eye  doctor because I was concerned. She checked me thoroughly and asked if I had taken ibuprofen recently. I had, twice in the last week for muscle soreness. She said she believed that was the cause and not to worry. The bruise went away the same week which was last week. I have taken ibuprofen for decades without any side effects. Today I saw my ex husband and same thing...he had a broken blood vessel in the inner corner of his eye! Again never happened before. Common denominators...we both had the Pyser vaccine, we both took ibuprofen weeks or months after...he?s a doctor so he was vaccinated a few months before me....the point being it?s very  odd it happened to both of us. He did have Covid in November of 2020. I have not gotten it luckily. I am reporting these occurrences because you need to do the math with all the information we can provide you with. Thank you for your time and attention to this matter.
sinus infection; This spontaneous case was reported by an other health care professional and describes the occurrence of SINUSITIS (sinus infection) 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, the patient experienced SINUSITIS (sinus infection). At the time of the report, SINUSITIS (sinus infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient currently an antibiotic for a sinus infection and wanted to see if patient should be concerned getting the booster while finishing up an antibiotic.
experienced mania/mild psychosis as a result of the vaccine. He is having grandiose thoughts, not able to relax, sleeping only 2 hrs or less per night.
Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was  beating fast. She also said that arms and feet felt "tingly". Patient felt this immediately after injection upon standing. Patient was escorted to chair for assessment. She was given water and pulse was normal. Patient said that she was feeling a bit better after a couple of minutes but then started experiencing chest heaviness and shakiness again. Patient alert, oriented, pulse normal, respirations normal. ER called and nurse came to clinic for assessment. Pulse was still normal upon his assessment but offered to take patient to ER via wheelchair for further assessment and patient agreed. Patient left clinic at approximately 8:55am to go to ER.
Narrative:  83yo male patient died on 1/8/2022 at home in home hospice care. with the following: Medical Hx: Alzheimer's dementia, vascular dementia, moderate valvular aortic stenosis, HTN, HLD, BPH, iron deficiency anemia, peripheral vascular disease, esophagitis, Rectal cancer s/p Lower Ant. Resection (2003) and ileostomy closure (2004), LUL carcinoma s/p wedges 2007 then lobectomy 2009. Surgical Hx: Lower Ant. Resection 2003, ileostomy closure 2004, Fem-Fem bypass 2006, LUL VATS Wedge 2007 and LUL Lobectomy 2009, OU IOLs 2021 Pt had received covid vaccines at nonfacility site on 7/14/21 & 8/13/21. This pt's death appears to not be related to covid vaccines given pt's advanced age, comorbidies, and long length of time between death & date of vaccine administrations.
DONOR STATES HE DID NOT EAT ALL DAY, HE THEN DONATED PLASMA AFTER DONATING; HE RECEIVED A TETANUS VACCINATION. WE FINISHED THE CENTERS PAPER WORK FOR THE VACCINATION AND AS HE WAS LEAVING THE EXAM ROOM HE BECAME LIGHT HEADED AND PASSED OUT FOR 2-3 SEC (HE NEVER FELL TO THE FLOOR HE WAS CAUGHT AND ASSISTED TO EXAM TABLE). HE WAS GIVEN 500ML NORMAL SALINE BY IV AND RECOVERED.
1. Hazy/blurred vision about 30 mins after vaccine- has improved, but not back to normal yet. 2. Sore arm/neck/back- 8 hrs after vaccine- recovered within 3 days. 3. Bad dry mouth, some swelling in tongue & throat- 16 hrs after vaccine- recovered within 10-15 mins.
Raised, Large red area covering the right thigh. A knot also came up under the skin. It remained red for a week, then began to turn black and blue like a large bruise, before turning a green/purple color.  Pt also complained for 2.5 weeks of his right leg hurting.  I have pictures.
Redness and swelling and itching at injection site of Kinrix vaccine (Right Arm).
Pre-syncope.  Chest tightness/short of breath. Sternal Chest pain.  Symptoms started 30 minutes after vaccination.  Serial vitals and exam x 2 were normal.  Symptoms resolved after another 60 minutes of observation.
Seven days after vaccination, noted bump returned under skin and area was itchy. Noted area was red. Grew larger over the next two days before redness started to fade and bump under skin resolved.
I had big side efforts with the Moderna; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had big side efforts with the Moderna) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I had big side efforts with the Moderna). At the time of the report, VACCINATION COMPLICATION (I had big side efforts with the Moderna) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant information was reported. Information about allergies to vaccines, medications, food and other products were unknown. Potential cause of the event was unknown and event caused the patient to seek medical care was unknown. No treatment information was reported.   This case was linked to MOD-2022-546564 (Patient Link).
Ths spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 21-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J006831 and expiry date: 14-SEP-2014) which was improperly strored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
No known adverse event. Immunizations for a 12 month old given to this patient on 4/4/06, at 12 days.
From the patient's chart (regarding the vaccination on 02/03/2021): "The nurse states that when she gave the injection that upon exit of the needle there was some bleeding. This was stopped with a Band-Aid. After the vaccination there was a slight area of erythema that may be more contusion or bruising from the injection. The area is not tender but we will need to keep a watch on this. The patient was told to elevate this and put some ice to this for the next hour or so. Waiting 15 minutes after the injection for evaluation and other side effects was unremarkable."  The patient later stated that the injection site got somewhat warm on the day of the vaccination after she received the vaccine. She stated that she placed some ice packs on her arm for about 15 minutes on that day and that she and the injection site had no issues or adverse reactions after that. - 02/10/2021  "I tried reporting this today electronically but was unable to submit it because the website would not let me submit it. When my cursor hovered over the "Submit" button, my cursor turned to a circle with a line through it. I checked the electronic form to make sure I was not missing required information then called the contact number and left a message explaining the situation so they can call me back to assist me in reporting this information."  02/10/2021
103 degrees F temp - 5x6 rash - painful/itchy/burning/hot, malaise. Treatment Acyclovir.
Date & time is estimated. Shortly after receiving Fluvirin flu shot, I began to feel fatigue, hot flashes, followed by symptoms of narcolepsy & cataplexy. I was recently diagnosed with the disorder, but believe the onset was caused by the flu shot.
pt recvd MMR vax 5JUN91 & on 16JUN91 devel maculopapular rash, swollen lymph nodes & a fever; following day lab eval revealed rubella IgM of 1.060 which was equivocal for a virus; 28JUN91 rubella IgM was 3.107 which indicated primary infec;
2-3 days after receiving the shingrix vaccine, patient developed a rash on right inner thigh. this rash developed into herpetic like pustules. at which time the patient seen the prescriber listed above. provider confirmed that the patient had shingles and wrote 2 prescriptions, valacyclovir and mupirocin.
pt recv vax & immed p/vax pt cried & was comforted by mom;w/in 5min pt became dusty, diaphoresing & was checked by RN & MD 02 was administered;pt transferred to another hosp;
Fever, Chills, joint and muscle ache, headache nausea. Fever through the night. Treated with ibuprofen fever came down by noon and chills and headache continued throughout the day. These symptoms started 2 days after the shot and have continued for 2 days and it is unknown at this time how many days the symptoms lasted.