chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow-up information has been received from an RN concerning  an 83 year old retired Caucasian female pt with insulin-dependent diabetes mellitus and no known allergies who on 11/2/01 at 14:00, was vaccinated SC in the right arm, with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 640981/1050L). Concomitant therapy that same day at 14:00, included the 1st dose IM in the left deltoid, of influenza virus vaccine (Fluzone) (lot U0694AA). There were no illnesses at the time of vaccination. Subsequently, on 11/4/01 at 11:00, the pt developed red, hot, hard swelling 3"-4" from the elbow to site of injection. The event was described as erythema 3"-4" below the injection site (around elbow area) that was hot to the touch. It was noted that there was no pain and that the pt was afebrile. Cellulitis was suspected and antibiotics were prescribed. On 11/4/01, therapy with erythromycin, 500mg po every 6 hours was started for 24 hours. Therapy with dicloxacillin 250mg po every 6 hours for 7 days was also started. An X-ray of the right elbow was performed on 11/5/01, which showed no fracture. The pt recovered on 11/8/01. The nurse reported 2 other cases of injection site swelling (lot 640981/1050L) (WAES 01110500, 011111376). Additional information is not expected.
Pfizer was not diluted properly.  Instead of diluting the vaccine with 1.8mL, it is our belief it was diluted with 0.8mL.
I had horrible body aches, headache, dizziness for about a week. I took Tylenol and Aleve and Nyquil at night. I have had brain fog for months now since April. I previously was diagnosed with gallstones and all of a sudden I had a horrible problem and they said it had infected my abdomen. I had to go to the ER. They did plenty of tests for the gallbladder, an ultrasound, blood tests and an MRI or CT scan with contrast. I don't even remember some of these. Since the second dose my heart rate has been higher. Resting heart rate is in the higher 90s or 100. For gallbladder they gave me some antibiotics and something for pain.
Rash, swelling, itching, burning on both elbow pits? I don?t know what to call them sorry. I have a picture I can email if necessary. The rash was much worse on the arm that got the injection, lesser on the other arm. I?ve only gotten something like that one other time taking an antibiotic I was allergic to. Not as bad, is mostly gone the next morning. Still itchy, and left behind small whitehead like bumps on a few of the worse patches.
Information has been received from a physician concerning a 22 year old female who on 9/3/99 was vaccinated IM with the first dose of Hep B vaccine. On 9/4/99, the pt developed a blister at the injection site and on her chest and a rash on both wrists. Additionally the pt developed a lump in the right and left neck lymph nodes, and a small lump in her left breast. The pt was treated with Benadryl and her symptoms resolved within a week. No further information is available.
Extreme pressure headache; More like extreme pressure farther back inside the brain; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 29Jan2021 at 10:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC) generic Wal Mart brand and probiotic (unspecified) taken for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1248) via an unspecified route of administration in the left arm on 08Jan2021 at 15:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient previously received sulfamethoxazole; trimethoprim (BACTRIM DS) on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jan2021, the patient experienced extreme pressure headache for 14 days, it felt like the skull was cracking and sometimes the patient wondered if she had a stroke as the pain was so bad. The patient had  to take ibuprofen (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), naproxen (ALEVE), etc. every day for the entire 14 days. The patient  did not like taking much medication so she kept it to no more than 2 times per day of the pain reliever. The patient found that no pain reliever was able to completely take away the headache, so she tried 3 different kinds of pain reliever over the 2-week period. The patient knew that a headache was a possible side effect, but nowhere did she read about the extreme pain and pressure that she suffered. When the patient got a headache, she was afraid it was the same thing starting again. The vaccine headache was different, longer and more severe than other headaches that she had. The patient reported that it was clearly not a sinus headache. It was more like extreme pressure farther back inside the brain. The patient did not seek medical treatment because she assumed nothing could be done. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. On an unknown date, the patient underwent COVID-19 test and the test result was unknown. The clinical outcome of the event extreme pressure headache was recovered on 13Feb2021; while that of more like extreme pressure farther back inside the brain was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Zostavax administered subcutaneously, back of right arm on 10/28/08. (Needle was changed between drawing up and administering.)Pt returned to clinic 10/31/08 to show a local reaction of mild erythema on the back of R arm extending from elbow almost to wrist measuring 22cm L x 12cm width. A raised red area of induration at site measured 5cm L x 7cm W. The area of induration was warm to touch. Pt stated the erythema was better than it had been the day prior.  Pt had been hot-packing, and advised to take Ibuprofen per her friend that was a nurse.  Pt afebrile - no oozing from site. Advised pt to see her MD if area did not cont to improve, if increased pain or if began to run a fever. Called the pt 11/5/08: She stated area of erythema completely resolved except one tiny area of induration left at site. Symptoms never became worse, so did not seek medical attention with her primary care MD
Developed "softball size" lump under arm (arm pit) vaccine was given IM. Lymph node swelling.
This spontaneous report as received from a certified medical assistant refers to a multiple unspecified patients of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an multiple unspecified dates, the patients were vaccinated with improperly stored unspecified doses of GARDASIL 9 injection, lot # L018351 with expiration date 11-AUG-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Around 7 pm I started to develop a scratchy throat that started to make it difficult to swallow and this led to subsequent swelling in the back of the throat. This continued overnight until morning when I took some Benadryl on top of my routine Xyzal that I take daily and that's when I started to notice some relief. I felt profound malaise and fatigue that is still lingering through the day today.  I reached out to my MD in the morning and I scheduled an appointment to be seen today.
On 11/08/2018  began with left leg pain, found to have laboratory confirmed varicella zoster. Rash extensive down left thigh and left lower extremity. Hospitalized due to pain. CDC confirmed vaccine strain. Undergoing immune evaluation now, but previously completely well.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Red, hot, hard spot at injection site.  Skin is itchy, and it feels like the area below the skin is itchy.   The red spot/itchiness has moved some towards my inner arm.
For the first 5 days my arm was just really sore but on day 7 I woke up with a big red knot on my arm at the site of injection. It was very itchy and warm. Day 8 it has gotten bigger, maybe the width of 3 quarters and is swollen and warm.
On 01JAN2023 I came down with extreme flu symptoms stuffy head sore throat sinus drainage, cough, asthmatic conditions, not typical this time of year. I contacted my doctor after having a positive COVID-19 test about one week later.  I was told to continue my inhaler and an antihistamines if needed, OTC flu medicines as needed. I took SUDAFED. Within a few days all the symptoms cleared except the asthma. I continued to use my prescription inhaler until I could get into to see the doctor, I was prescribed a steroid inhaler and symptoms cleared within a week to one week and a half. I need this now prior to bedtime not typical for me during non allergy season. I am about ninety nine percent well today and prescriptions being taken only on a PRN basis.
Migraine-like headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine-like headache) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson and Johnson COVID-19 vaccine (2nd dose) and Johnson and Johnson COVID-19 vaccine (1st dose). Past adverse reactions to the above products included No adverse event with Johnson and Johnson COVID-19 vaccine and Johnson and Johnson COVID-19 vaccine.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced MIGRAINE (Migraine-like headache). On 10-Jan-2022, MIGRAINE (Migraine-like headache) had resolved.            Concomitant and treatment medication was not reported.
pt had prev rxn (see box 21);p/2nd vax pt "out of control again":eating pattern changed, bedwetting @noc, & hyperactivity;currently, child is eating better, "very active";neuro consult not done due to insurance problems;
rash in the injection site; Itchy; Red; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (rash in the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red). On 31-Mar-2021, the patient experienced VACCINATION SITE RASH (rash in the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (rash in the injection site) outcome was unknown.            Treatment information were not provided. Concomitant information were not reported.   This case was linked to MOD-2021-089302.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: the follow-up were received on 24-APR-2021 and include below following updated information;patient details were updated.event were updated.action item updated.
1/27/17 Pt. stated she was seeing white spots and became very pale, had pt. lay down and she was crying, was given Gatorade and said she was a little light headed when she stood up. 1/28/17 AM Pt. went to ER and was given Prednisone and BENADRYL. Follow up in one week with provider. Symptoms were swollen lips and hives all over body.
Began with soreness in opposemite arm as injection site a week after vaccine. The week of 1/4 daily sharp pain shooting down arm opposite if injection site, unable to move or lift items for short period of time. Possible brachianeuritic
Fever of 104.5 at 330am.  Reduced to 101.5 by 500am with Tylenol.   Collasped at 830am on the floor unable to verbalize or move, 02sat =72.   EMTs were called, checked vitals and transported to the ER.
Has hives over most of her body, is taking BENADRYL and using hydrocortisone ointment. Had called PCP stated to wait a few days to see if rash subsides if not call back for apt. Pt stated she has sensitive skin. But had not changed any product.
01/12/22 presents to EC ED for "shortness of breath". PMHx of "ESRD on HD MWF, HLD, secondary hypertension due to kidney disease"
Brain swelling. Chronic croup. Eczema. Food allergies. Sensory processing. Dry skin.
Mom says autistic child had H1N1 mist on Fri (11-6). Developed fever Sat. night 102.4. Also had chills. Scared mom. Had weakness, pale, wheezing, whining. Keeping him home today with low grade fever 99.6. Encouraged to call Dr. Says much better today "violent chills"-per mom.
Information has been received from a woman in a doctor's office concerning a 15 month old white female patient with a history of paroxysmal supraventricular tachycardia (at 14 months and treated with propranolol hydrochloride for two years) who was vaccinated with a first dose of MMR. Subsequently, the patient developed a rash. It was reported that at 4 years of age, the patient developed symptoms after vaccination with varicella virus vaccine live (WAES0403USA02601). Additional information has been requested.
14 he after injection had fever, body aches, 24 he of injection arm on site of injection red puffy and itch.
Initial report was received from a health care professional on 05 October 2012. A 77 year-old female patient with a history of Vitamin D deficiency, asthma, diabetes, hypertension, elevated cholesterol, eczema and thyroid, had received on 01 October 2012 and intramuscular right deltoid injection of FLUZONE HIGH-DOSE, lot number U4492BA and by the evening of vaccination experienced shortness of breath and a rapid heart rate. The patient was evaluated the next day by a physician however the symptoms had already resolved. The patient had no illness at the time of vaccination. The patient's outcome was recovered. Documents held by sender: None.
Pt developed cellulitis on right upper thigh around injection site, 2-3 days after injection. Pt was started on antibiotics.
Thrombocytopenia (10/13/2022). Positive anti-SS-A on 11/28/2022. Elevated enzymes (aldolase, AST, ALT), positive ANA (1:640), positive anti-TPO antibodies and positive anti-platelet antibodies (IIB/IIIA, IB/IX, IA/IIA) on 1/16/2023. Of note, the patient had COVID-19 (PCR confirmed) -19 on 1/19/2022. Primary COVID-19 vaccine series on 6/8/2021 and 7/28/2021. The patient was evaluated at the pediatric rheumatology clinic on 1/19/2023 and a treatment plan will be established after her evaluation is complete.
Fever 102, headache, chills, body aches, joint aches, left arm very painful and diaphoretic nauseous stomach pain. Lasted 3 days.
pt recv vax on 8MAY96 & devel inj site edema & h/a & diff focusing eyes;pt recovered p/24hr & remained;
Patient reported adverse effect of covid vaccine dose one  during her second dose appointment. Patient self reported that 12 hours after she received dose 1 of her covid vaccine she woke up with her cheek swollen on her right side. Also part oher her lip and the inside of her ight cheek was swollen. Patient reported she spoke with her oncologist, who recommended she take benadryl. She took Benadryl a few times a day for a couple days, which helped her symptoms. Her symptoms lasted for 1-2 days.  Patient reported per d/w her oncologist she took Benadryl as a pre-medication for dose 2 of the covid vaccine.
CDC reports 6 yo child developed fever to 103 & marked alteration in LOC following DTP/OPV immunization. Duration of illness 4 days.
Fatigue, headaches, muscle pain, feeling unwell, swollen lymph nodes in the side of the injection after the first dose.; Fatigue, headaches, muscle pain, feeling unwell, swollen lymph nodes in the side of the injection after the first dose.; Fatigue, headaches, muscle pain, feeling unwell, swollen lymph nodes in the side of the injection after the first dose.; Fatigue, headaches, muscle pain, feeling unwell, swollen lymph nodes in the side of the injection after the first dose.; Fatigue, headaches, muscle pain, feeling unwell, swollen lymph nodes in the side of the injection after the first dose.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration on 18Apr2021 (at the age of 40-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration on 09May2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. Other medication within two weeks of vaccination was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient experienced fatigue, headaches, muscle pain, feeling unwell, swollen lymph nodes in the side of the injection after the first dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events fatigue, headaches, muscle pain, feeling unwell, swollen lymph nodes in the side of the injection after the first dose was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
The primary reporter is a medical assistant who administers vaccines. This medical assistant noted that patient was inadvertently administered an expired dose of VARIVAX (1233Z; 09/24/2012) on 10/08/2012. The medical assistant noted this is the first and only dose of VARIVAX the patient has received. No adverse effect reported. No further information is available.
Administered Tdap L arm 6/1/07 - mother called 6/4/07 - client had severe site reaction. Swelled to baseball size, red, hot, sore arm on 6/2/07 and 6/3/07.
COVID-19; COVID-19; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 11Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHOTREXATE; SIMVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (Sep2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Negative; (Sep2022) Negative; (Sep2022) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ ritonavir (PAXLOVID) from 10Sep2022 to 14Sep2022. Per clinical course, the patient tested negative three times after treatment with PAXLOVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swelling in the joint of her knee replacement and above it in her thigh area; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling in the joint of her knee replacement and above it in her thigh area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement on 08-Sep-2020.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Swelling in the joint of her knee replacement and above it in her thigh area). At the time of the report, JOINT SWELLING (Swelling in the joint of her knee replacement and above it in her thigh area) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Non Significant Follow-up Append; Sender's Comments: Very limited information regarding the event has been provided at this time.  However, the patient's history of knee replacement surgery approximately 4 months before receiving the vaccine confounds causality assessment.  Further information has been requested.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on an unknown date, was vaccinated with ZOSTAVAX (dose, route and lot number not reported) instead of his first dose of VARIVAX (Merck). No adverse symptoms were reported. Additional information has been requested.