chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving the shot, I only developed a sore muscle for 2 days.   Then 6 days after receding the shot, I noticed my upper right arm feeling a bit sore.  I noticed two small red patches on my skin near injection site.  The next day, my arm was still the same soreness, and the redness spread about an Inch and a half. And felt a bit hot.  Today, when I woke up, my arm is still the same soreness, redness has spread to about a size of 3 inches long and and 2 inches wide.  It feels hot to the touch.  I called my doctor.  I got their answering machine and left a message to call me back.  At this time, I have not received a call back from my doctor.  I will call his office tomorrow m
Nausea Fever  Chills Body Aches Elevated Blood Pressure Rapid Heart rate Severe Headaches
This spontaneous report as received from a pharmacist refers to a 52 year old male patient with a negative history of chicken pox. On 18-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose and route not reported). Concomitant therapy was not reported. It was reported that the patient received ZOSTAVAX instead of VARIVAX (Merck). The patient asked for the shingles vaccine, but after vaccination the patient asked if the shingles vaccine would also protect against varicella (chicken pox). The pharmacist reported that the patient wanted to be vaccinated to protect against chicken pox. No adverse event reported. Additional information is not expected.
pain all around her neck; feeling dizzy; feels kind of weak; she can't think straight; feels like her head is big; she didn't feel good; headache; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular on 14Jan2021 12:00 at a single dose on left arm for COVID-19 immunization. Age at vaccination: 72 years old. Medical history included hypertension, infection (term highlighted by the reporter: Yes; patient was admitted to a hospital from 29Dec2020 to 30Dec2020 due to infection), dyspepsia (reported as stomach, digestion), psoriatic inflammatory arthritis (she receives infusions for her arthritis once a month), sinus infection/sinus problems a month or two months ago, had cancer back in 1996 (had lumpectomy), stomach problems, and gastric endoscopy. Ongoing concomitant medications included losartan potassium, hydrochlorothiazide, omeprazole, and methotrexate. Other concomitant medications included folic acid, and plantago ovata (METAMUCIL). The patient had a regular flu shot a month ago (Dec2020). She can't remember when. The patient experienced headache on 14Jan2021. At the beginning, she had one, but then she got home, and the headache was like in the back of her head, like in her neck. She had pain all around her neck. She was feeling dizzy. She was able to sleep, however, the pain in her head is still there. She took aspirin along with her regular medication. When providing details, the patient made the comment that she can't think straight. She also has sinus problems, so she doesn't know if she has a headache from the sinus problems or because of the shot. She doesn't have a fever. She just feels like her head is big. She sees the date of when she is supposed to return for her second vaccine, 04Feb2021. She sees the lot number and then it has (name of center). The actual dose is unknown, she knows this is her first dose. She also receives infusions for her arthritis. She receives an infusion at a facility once a month, she used to receive it less than that, but her arthritis has been really bad, so she now does it once a month. She was supposed to go today but she didn't go because she didn't feel good. She had three COVID tests done because she had the sinus situation going on. A COVID test was done yesterday (14Jan2021) and it was negative. Another one was done when she had a gastric endoscopy on 09Dec2020. This test was also negative. She doesn't remember if she had another one in Dec2020 when she was at the emergency center, but all of her COVID tests have been negative. The patient has not recovered from headache. Outcome of the rest of the events was unknown.
My Husband and I received the same day a strong pain in our left arms. The next day my husband complained about pain in his entire body and weakness, and I had the same.  In the evening he collapsed falling out of his wheelchair.  He tried for an hour to sit down back in his wheelchair with my help, but he couldn't.   He agreed that I call 911.  Two nurses took him to Emergency Room at Hospital and didn't allow me to go with him.  In the morning on Saturday, he was transferred to Room at Hospital and the next day to the Intensive Care Room, where he sadly passed away on Tuesday April 13 at 4:22 am.
developed chest tightness the morning after the vaccine, symptoms have persisted since that time.  symptoms improved by 75% after course of steroids but still persists
Patient reported that next morning after receiving vaccines he was very ill. He had chills, low grade fever and body aches and couldn't get out of bed. These symptoms lasted about 2 days.
Pfizer vaccine administered two days after the Beyond Expiration date of 02/13/2023.
PROVIDER PROGRESS NOTE 2/07/2022 99 y/o F with HTN, history of complete heart block s/p pacemaker placement, restless leg syndrome, history of SBO, sigmoid perforation along with other issues came to hospital with complaints of gradually worsening weakness, fatigue and difficulty ambulation, found to be positive for COVID-19 pneumonia. Hospitalized for further evaluation of weakness.   # COVID-19 infection Tested positive on 1/27 She was hypoxic for a very short time at presentation and was given Decadron until 1/31 Currently O2 sats are stable on room air, remains off Decadron since 1/31.  Remains afebrile with normal procalcitonin. D/w infection control -please DC full barrier precautions since > 10 days   # Weakness/deconditioning:  has been getting weak for the last few days.   UCX wih pansensitive E. coli.  Also turned out to be positive for COVID-19 infection.  These both could be contributing to her weakness.   PT recommends TCU   # Acute cystitis/urethritis: UA was slightly abnormal.  She is asymptomatic.  However cultures are growing E. Coli. Rocephin x3 days from 1/28-1/30 finished. UCX showed pansensitive E. Coli.   # Dehydration: # Mild AKI with ATN: Creatinine slightly high at 1.12, BUN 37.  Electrolytes are otherwise stable.  Previous creatinine was in within normal limit.  With oral intake creatinine improved to 0.94.  Continue to encourage oral intake.  BUN continues to be on the higher side.      # Acute delirium, likely component of metabolic encephalopathy in the setting of acute illness Some evening/nighttime agitation noted.  Seems to be resting well this morning.   Avoid Benadryl, benzos cont melatonin and Zyprexa as needed.    # History of high-grade heart block, s/p pacemaker placement: No intervention needed now.   # Hypertension: Blood pressures stable.  She is on as needed hydralazine.   # DVT prophylaxis: HSQ   # Code status: DNR   # family communication: D/w daughter and SIL on 2/7   # Disposition: TCU    # Discharge criteria: Awaiting bed placement.  No further inpatient work-up. D/w SW
Positive covid test (test on 8/26, results 8/28) after waking up on 8/24 with symptoms similar to sinus infection. Had mild fever (99.5F) for a couple hours on 8/26 before returning to a normal temp (97.3F). Had persistent congestion, pressure in sinuses, sinus drippage, headache, mild body ache, and fatigue/exhaustion for about 10 days.
Difficulty breathing Narrative: Patient's wife called in to report her husband's adverse reactions. Patient's wife listed patient reactions: sleepiness, fatigue, headaches, dizziness, and difficulty breathing. I asked if patient currently had difficulty breathing and patient stated, "yes but that may be because he just tried to go to the bathroom". I assured her that the fatigue and headache is an expected outcomes. I advised her to call 911 or go to the nearest ER especially if the difficulty breathing gets more intense and to keep her primary care provider informed of the event. I asked patient's wife about patient current comorbidities and illnesses and she said that he has congestive heart failure and that having shortness of breath is an occasional occurrence. Patient's wife agreed to contact his primary care physician and go to the nearest ER.
Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; This is a spontaneous report from a contactable consumer via COVID-19 .  A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 (at the age of 22 years old) via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.  Medical history included shrimp allergy from an unknown date and unknown if ongoing. The patient did not have any vaccine in four weeks.  Other medications in two weeks: ADHD medication and birth control. The patient experienced "left arm, breast, butt cheek, and thigh feel sore/weak - left side only" (as reported) on 10Apr2021 15:00 with outcome of not recovered . No treatment was received. The patient did not have covid prior to vaccination, was not tested post vaccination  Information on Lot/Batch number has been requested.
The information provided on the screening and consent form was filled out incorrectly.  The person put that they were born in 2004, but they were born in a different year. They do not meet the FDA age criteria to receive the vaccine.
Vomiting every 20 min for 4 hours the next morning.  Almost totally recovered by evening.  No fever, just lethargic while vomiting continued
A nurse reported that a 55 year old female received Pnu-Imune 23 on 12/7/99. That evening, she developed a "severe" injection site reaction characterized by swelling and redness "which wrapped clear around to axillary area" and low-grade fevers. She recovered. This is 1 of 4 pts, out of 6 vaccinees, from this facility who experienced this event following receipt of Pnu-Imune 23.
Pt states tight throat on left side BP 126/77 HR 78 o2 100% on RA Observed pt and discharged in stable condition at 10:40
Never stopped hurting from time of shot. Swollen, red, hard upper arm closer to elbow. Sent to MD. Hurt left arm to lift.
Very painful after second vaccine, large lump that itched at site. Swelling and at site itching relieved on day 3. On day 4 following second vaccination, I began to itch, severely, all over my body. I had no rash. Intense itching with small welts continued for ten days before subsiding. I now have slight, sporadic itching on arms and around my waist area but it is much improved. I can?t say, with any evidence, that this is a direct result of the vaccine but I cannot think of any other possible cause.
Fever 102, chills, extreme fatigue, severe left arm pain at site (unable to move arm for one day), headache
Non-ADVERSE EVENT, THE VACCINE WAS ADMINISTERED BEYOND DATE., MODERNA IS EVALUATING EFFECTIVENESS PERCENTAGE OF THE VACCINE ADMINISTERED.
Swelling of R thigh-splotchy rash started on day post vaccine given (7/30). pt seen on 7/31. Remains on Benadryl and antibiotics (Augmentin) started.
Atypical heartbeat -- arythmia, onset 1 day after injection. Each event was a single "double-beat". Started with several events per day and night (~10-15), diminished in frequency over several weeks, and largely gone by week 4 after injection.
Localized redness, swelling, itching at injection site 5cm X 4cm warm to touch.
Tested positive for COVID-19 on 6/11/2021 after receiving covid vaccine on 12/22/20 and 1/11/2021  Narrative:
Pt. c/o funny feeling in chest that started 5-6mins after sitting for post observation, pt. denied any other symptoms, pt stated the sensation in her chest was just a different feeling, not described as chest pain, flutters, palpitation or tightness, hard to describe.
grandma reported that pt was cranky, no fever for couple of days p/vaxed; 23JAN93 started running fever; 24JAN seen in ER w/fever, cranky, no appetite; pt also vomiting; MD dx pneumonia;
TEMP. OF 103.0 TYMPANIC GIVEN 0.8 TYLENOL VOMITTED ALL WITHIN 10 SECONDS. iN AM HAD TEMP. OF 101.2. hAD DIARRHEA 2 DAYS AGO BUT NOT NOW. gAVE PEDIALYTE NIGHT OF TEMP. DIDNOT SLEEP WELL LAST NIGHT KICKING LEGS.
A nurse did a double dose (1ml) in error; A spontaneous report was received from a nurse concerning a 36-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inappropriate dose administered.  There were no medical history and concomitant medications provided.  On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 025L20A) for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the nurse gave the patient a double dose (1 ml) of the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event "inappropriate dose administered" was considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a 36-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot Number: 025L20A), reporting Incorrect dose administered.
Hoarseness and weakness which started at 11:00 AM next day. Weakness has resolved, hoarseness remains. Pt. feel well otherwise. No treatment at this time.
Starting Tuesday noon, starting feeling sick, fever 101 BP 170/60. This lasted 36 hours, then began to subside.  Left arm was red and swollen, very sore and very red and very hot.  This has gone away
*Lip swelling,  numb lip, (right lower lip)  Others: Fever,  arm pain
Day 1  After - overall body aches Day 2 After- no ill effects until evening - noticed red rash on upper torso (front and some on back) Not itchy.  No medical attention sought Day 3 After - rash persists and has spread to entire torso - front (Today is day 3)
has experienced persistent arm pain to the right arm described as occurring with any movement and the pain being severe; Initial information regarding an unsolicited valid non-serious case received from a nurse on 14-Nov-2019.  This case involves a 60 years old female patient who has experienced persistent arm pain to the right arm described as occurring with any movement and the pain being severe (Vaccination site pain), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 07-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ256AB, Expiration date 30-JUN-2020) via intramuscular route in the right deltoid.  On an unknown date (unknown latency) the patient experienced persistent arm pain to the right arm described as occurring with any movement and the pain being severe (Vaccination site pain), following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was not reported if the patient received a corrective treatment.  The outcome is reported as Not Recovered.
This report was received from the investigator of a trial on 20 May 2010. A 22 year-old male subject with a medical history significant for asthma received the following vaccines on 02 September 2009: ACAM2000 (lot number not reported); TYPHIM VI (sanofi pasteur, lot number not reported) and anthrax (manufacturer and lot number not reported). Ten days after vaccination on 12 September 2009, the subject was diagnosed with unspecified disease of the pericardium and on 14 September 2009 was diagnosed with subendocardial infarction. The subject had no reported results that were available. No other information was provided. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Immediately after vaccine, pt screamed inconsolably for 20-25 mins and legs became beefy red B from knees down. no palpable urticaria. Pt was eventually calmed and given 6.25 mg Benadryl. Redness gradually faded in patches.
Rash( raised pink patches and whelps)  to back, bilateral arms, buttock, and legs. Characterized by dryness, redness and itchiness. Given Solu-Medrol and Atarax; better by 01/21/2020
About a week after the shot a small itchy rash developed around the site of the injection, over the next few days the rash spread across the entire arm and down to my elbow. The rash was extremely itchy and my arm was swollen and sore.
Case number PHEH2014US021578 is an initial spontaneous report received from a consumer on 24 Oct 2014. This report refers to a 23 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412701) intramuscularly on 21 Oct 2014. It was reported that on the same day after vaccination, she experienced shortness of breath, trouble swallowing and burning of skin. She was hospitalized on 22 Oct 2014. She was given breathing treatment, liquid BENADRYL, epinephrine, intravenous sulpha on 22 Oct 2014. She continued to be in hospital on 23 Oct 2014 and was administered intravenous ZANTAC and breathing treatment. The burning of skin continued, but all other events resolved. The events were reported serious due to hospitalization. The causality of the events was not reported.
Headache; Fever (100.5); Body aches; Lasted 12 hours only.
COVID-19; COVID-19; Pfizer Dose 3 14Nov2021, Moderna Dose 2 01Apr2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 10:30 as dose 5 (booster), single (Lot number: GH9703) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Nov2021 at 10:30 as dose 3 (booster), single (Lot number: FD0809), in left arm and on 14Jun2022 at 10:30 as dose 4 (booster), single (Lot number: LP4554), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Feb2021 at 10:30 as dose 1, single (Lot number: 022M20A), in left arm and on 01Apr2021 at 10:30 as dose 2, single (Lot number: 020B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Nov2021, outcome "unknown", described as "Pfizer Dose 3 14Nov2021, Moderna Dose 2 01Apr2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (29Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Zoster like rash left buttock, L heel, abdomen, nausea, fatigue, sensitive tongue. Rash and symptoms started one days after getting vaccine.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 11:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:58 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 63.39.  No concomitant medications were reported.  The vial was initially stored in the fridge on 09-Mar-2021, moved to the clinic on 20-Mar-2021 and proposed beyond use date was 08-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 30 degree Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report as received from Registered Nurse regarding multiple unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unspecified dates, multiple unspecified number of patients were vaccinated with improperly stored doses of VARIVAX (lot # L039093, expiry date 06-OCT-2017) dosage regimen and route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. This report is one of the several reports received from the same reporter. Additional information has been requested.
temp of 104.2 for over 4hrs, APAP & Advil given; rash & severe swelling of lt arm; pt seen by PMD;