chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large local reaction with cellulitis. Treated with antibiotic prescribed from Emergency Room visit. Flu shot admin. 10/20/06, pt called office to inform of ER visit - pt called 10/23/06, we seen her immediately. Referred to clinic - pt did not return.
35 patients exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by another health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patients exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported. Patient age year 1956 is mentioned in source document.
I had COVID in July of 2020.  My workplace, the Medical Center, mandated the COVID vaccine.  Approximately two weeks after having the second vaccine, I developed extreme fatigue.  On April 1st, 2021, I developed right eye heaviness and pain to the back, right side of my head.  Over the next couple of weeks, the pain turned in to sharp, stabbing pain and I started to lose my vision in my right eye.  I was diagnosed with Optic Neuritis and had IV steroids and Plasmapheresis.  In July of 2021, I was diagnosed at  Clinic  by doctor with Neuromyelitis Optica Spectrum Disorder and Transverse Myelitis.  *This is an abbreviated version of my health journey that continues to negatively disable me to this date.
soreness in arm rash with bumps on arm below injection site stomach ache fatigue headache
After first dose pt c/o dizziness, throat pain, sweatiness, light headedness  BP- 160/88 P-87 O2 97% R 16 Then c/o left sided chest pressure and pain, like the pain she has been having for years.  No dyspnea, ambulated to restroom.  EKG reported as no ST elevations.  Transfer to EMS for transport to ED for evaluation
I still have chest pain, shortness of breath and intermittent rashes that I cannot get rid of. I thought it was a temporary side effect and would go away. It never went away, sometimes its really bad chest pain and sometimes it's a discomfort, but it is always on my sternum. A pressure lingers most of the day when it efaces. The shortness of breath is worse after exersicing. I never contracted COVID and I'm afraid to excerise in case of the chest pain/SOB. I never had heart problems, painful rashes or lung problems before. No family history of heart issues. I am not a smoker either. I do have GI issuses IBS, but thats it.
patient had first GARDASIL 9 ata age 12 and second dose at age 17; This spontaneous report was received from a nurse via a Merck Vaccine Customer Center (MVCC) Representative referring to a 13 years old female patient. The patient's concomitant therapies, concurrent conditions, and drug reactions/ allergies were not provided.  Approximately in 2014, the patient had her first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number, expiration date and route of administration were unknown by the reporter) for prophylaxis at age 12. No product quality complaint (PQC) was involved.  On 26-JUL-2019, the patient was in the office to receive her 2nd dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number, expiration date and route of administration were unknown) for prophylaxis at age 17 (inappropriate schedule of product administration).
sore right arm; Headache; This is a spontaneous report from a contactable Consumer or other non-HCP, the patient. A 57-Year-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration in the right arm on 09Mar2021 at 03:15 PM (at the age of 57-years-old) as a single dose for COVID-19 vaccination. The patient's medical history include histoplasmosis in teenage years. It is unknown if patient took any medications for histoplasmosis. Patient has not tested positive for COVID-19 before receiving vaccine. Concomitant medications include Estradiol testosterone 2mg 5 mg (MANUFACTURER UNKNOWN) and Progesterone 200 (MANUFACTURER UNKNOWN) which patient has taken within 2 weeks of vaccination for unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not allergic to medications, food, or other products. Patient has not tested positive for COVID-19 since receiving the vaccine. On 10Mar2021 patient experienced very sore right arm which resolved after applying ice pack on right arm. Patient also experienced bad headache off and on for a week. It was painful and it hurt to touch on both sides of forehead which then extended to sinus area above forehead. Therapeutic measures taken included Tylenol (MANUFACTURER UNKNOWN) and Extra strength Excedrin (MANUFACTURER UNKNOWN). The clinical outcome of sore right arm was recovered and for headache was recovering. Information about lot/batch number cannot be obtained. No further information is expected.
32 year old female attendee with preexisting condition of vasovagal response to needles, reacted within 4 minutes of receipt of vaccination. She was assisted to gurney, exhibited a lower muscle tone which initiated EMS.  EMS arrived 5 minutes and monitored until event self resolved to point Attendee was able to stand and ambulate without assistance 55 minutes later. Discharged self to home with brother driving, declined EMS.
I had two reactions. Three days after the Maderna shot, I began to have on-going chest pains.  About a month into it, I went to urgent care to see if there was something serious and the doctors office recorded an irregular EKG twice: once in Nov. 2022 and once in early dec 2022. Inverted t waves.  this was a change compared to my March 2022 EKG.  I have been undergoing tests including an echocardiogram in Dec. 2022 that showed no significant changes since baseline of March 2022.  The second reaction is vertigo and pain at the base of my occipital bone.  I have spoken to 8 people in my circle of friends, family, etc. that have experienced the same thing.  The first vertigo event was one month-ish after the Maderna booster, and it was horrible.  I woke up at 4 a.m. w/ room spinning violently and my eyeballs jetting back and forth at a rapid pace, followed by my bowls emptying out and cold sweats and chills.   This occurred again 2 weeks later at a lessor degree.  Since I have abstained from alcohol from the first event at end of Nov. 2022 as it seems this triggers the big events.  I have little episodes of light headiness and dizziness in the day on occasion and at night lying down is worse.   My doctor's office prescribed Meclizine that helps keep it at bay.  The pain in back of head is also on going. it feels like something is being squeezed back there.    and I must take antiinflammatory like advil or it comes back w/ dizziness.
This case was reported by a physician and described a 58 year old male pt who did not respond to immunization with Havrix. On 4/22/02, the pt received the first dose of Havrix (lot VHA711B6). Approximately 23 days, post/vax, on 5/15/02, a Hep A antibody titer was "negative". On 6/10/02, the pt received the second dose of Havrix (lot VHA71186). This represents a schedule of approximately seven weeks between the first and second doses of Havrix which is sooner than the recommended interval of six to 12 months. Approximately 11 months after the second administration of Havrix, on 5/15/03, a Hep A antibody titer was "negative". The physician stated that he was concerned, "that there was a problem with this particular lot of Havrix".
Pt had not eaten, was afraid of injection. 1715 - dilated pupils, loss of vision, weakness, dizziness, drop in BP. 1725 - pupils returned to normal size, able to see, still some weakness. 1735 - checked by EMT - no emergent symptoms at this time advised to seek medical care if symptoms return/persist.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Additional Details: Patient fainted 10 minutes after administration of Janssen vaccine. Patient was unconscious for about 15 seconds before regaining consciousness. 911 was called and EMT arrived on scene to monitor's patients blood pressure and blood sugar. Patient still reported lightheadedness so was taken to hospital by EMT/ambulance.
patient received incorrect dose of  Dtap vaccine:. the dose ordered was Tdap. No adverse event observed or reported.
I had a headachy, achy, low grade very, a bad runny nose, shortly after the coughing started. The fever went away after TYLENOL. It felt like a bad cold or extreme allergies, little difficult breathing and out of breath. Foggy. No energy and fatigue. Still dealing with some of the cough and fatigue and brain fog.
3APR98 approx 1-1 1/2wk p/vax started itching which cont @ present even p/taking DPH for a wk;no rash, hives, SOB or swelling;advised pt to see PMD-was going to wait until p/the weekend to see if improved;
Nephrolithiasis - ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Cough and flu like, I had chills, a low grade fever, fatigue and congestion, sore throat. I'm out of quarantine. I still have cough and fatigue.
breakout Herpes Simplex; Rash; This case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 2LC3P, expiry date 15th November 2022) for prophylaxis.   The patient's past medical history included herpes simplex.   On 16th July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In July 2021, 7 days after receiving Shingrix, the patient experienced herpes simplex and rash. On an unknown date, the outcome of the herpes simplex and rash were recovered/resolved.   It was unknown if the reporter considered the herpes simplex and rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient reported that she received Shingrix vaccine and 7 days later developed rash that she descried as a breakout herpes simplex rash on her right side. No additional information was provided. The patient consented to follow-up. For tolerance of second dose refer linked case US2021AMR206123, reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR206123:same patient
Mother called states left upper arm is with swelling and redness at injection site. States axillary temperature was 99.4  States she gave her ibuprofen which reduced temperature to 97.1. Also stated she is applying cold compresses to left arm. Instructed to continue as she has been.  Instructed to call back for further questions.
covid positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid positive) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to Severe ).   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (covid positive). At the time of the report, COVID-19 (covid positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.   No concomitant medications were reported. Was reported. No treatment medications were reported.
Information was received on 03-APR-2017 from a pharmacist regarding a female patient (age not reported). Medical history, concurrent conditions and concomitant medications were not reported. On 31-MAR-2017 the patient received an injection of ZOSTAVAX (dose not specified) (lot # and expiration date not reported) subcutaneous for the indication of herpes zoster prevention. The pharmacist reported that the patient "got a bump, red and inflammation, had a headache and fever". The pharmacist reported that "patient stayed in the pharmacy for 30 minutes afterwards". The patient returned to the pharmacy on 03-APR-2017 and reported she "took something" and her symptoms "resolved over weekend." No additional information was provided. Action taken was not applicable, and the outcome of the adverse events was reported as resolved. The pharmacist did not rate the causal relationship. Additional information has been requested.
Pt received #2 Hep A vaccine.  3 min. later became dizzy & fell.  ? loss of consciousness x few seconds.  BP- 80/60 Pulse- regular.  Skin warm/dry.  Child fine after going home + next day with symptoms.
Inflammatory flare up; sciatic nerve flare up that had previously been inactive for a long period of time; Finger joint inflammation flare up; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6203), via an unspecified route of administration in left arm, on 01Mar2021 at 03:15 PM (15:15) (at the age of 39 years), as dose 1, single, for COVID-19 immunization.  The patient's medical history included lumbar herniation discectomy or laminectomy, allergies to surgical tape, sciatic nerve flare up (previously been inactive for a long period of time), finger joint inflammation, and minor injuries. The patient's concomitant medication included levocetirizine dihydrochloride (XYZAL). The patient previously took codeine and doxycycline and experienced allergies to both medications. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. On 03Mar2021 at 07:00 AM (48 hours after receiving the first dose of COVID-19 vaccine), the patient experience an inflammatory flare up only in areas where she had previous injuries such as a sciatic nerve flare up that had previously been inactive for a long period of time and a finger joint inflammation flare up in the area. The patient had previously had minor injuries. Treatment to the events included NSAID medication. The patient has not been tested for COVID-19 post vaccination. The patient was recovering from the events.  No follow-up attempts are possible. No further information is expected.
Bell's palsy; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 28Apr2021 at 13:30-13:40 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis and fibromyalgia, both diagnosed over 20 years ago, overweight, and arthritis. Concomitant medications were not reported, but the patient did state she took something for arthritis and thyroid for years prior to the vaccination. There were no prior vaccinations within 4 weeks of the vaccine. On 02May2021, at 15:30-16:00, the patient was diagnosed with Bell's Palsy. She went to the emergency room on 02May2021, where they performed an EKG & MRI of the head to make sure it was not a stroke, which were all negative. The patient was not admitted to the hospital. She tried to speak slow because her words were slurred. The patient was not treated for the event. The clinical outcome of Bell's Palsy was not resolved.   Information on lot number has been requested.
Vaccine administered on 06/01/23 had a beyond use date of 3/22/23 (thawed and kept in refrigerator since 01/25/23
was on steroid dose pack for sore throat and viral URI and antibiotics. All of this started after the second covid shot - "my immune system is now crap", c/o pain in areas of her scars in low abdomen s/p kidney removal "pain like when i was postop from kidney removal", cystoscopy came back inconclusive, urinary burning frequency started up again. Patient claims she feels like she was a healthy person before she got the covid vaccine.  Pt has been seen for multiple visits since vaccine r/t to bladder UTI like symptoms.
Approx. 4.5 mm Red Spot on right eye, below pupil. No pain, no irritation... just the Red Spot on the eye.
Hives occurred 2 dys p/MMR was given; Atarax 1/2 tsp po q4hrs PRN;
pt recvd vax;apap taken for HA;30 mins later,began to break in hives,itch & have swelling of  eyes;fainted;light headed;P=94;to er;thought to have had allergic rxn,apap or TD? no more apap given to pt;
Patient had just received the vaccine.  I walked by and he indicated that he was feeling light headed.   I asked my pharmacy staff to call 911 and attend the patient.  I was attending a patient who was feeling faint after her vaccination.  Staff was in contact with 911 and were attending patient.   His initial blood pressure reading was 138/92. He was sweating profusely.  He was no longer talking.  his next blood pressure reading was higher in the 160's according to our other pharmacist who was attending him.  The paramedics were here very quickly and took the patient to a local hospital.  I believe the attending pharmacist will also be reporting this.
Had a raspy throat and nasal itch almost like allergies but more. 2nd day it increased its severity. The third day I was really congested. I felt like my lungs were only filling up half way; I was a little shortness of breath. Mucous buildup and had to cough to clear my throat to breathe. I felt like there was swelling in my throat. By Thursday, I went to get seen by doctor. Dr. noticed little pustules on my lymph nodes and she tested me for strep, negative. QR, inhaler steroid, prednisone for 5 days. Nasal spray to clear the nasal passages, Flonase. I have taken albuterol when needed to help clear up my breathing. I'm still feeling a little congested with sinus drainage, voice a little horse. Note: I did have a Tetanus shot about a month or a little bit more than a month before this vaccine.
Pt attended outreach clinic and received Moderna COVID-19 Vaccine dose #1 at age 17.  Current EUA states Moderna vaccine is ineligible for pts < 18yo; pt was not an original participant on provided list.  Pt left in stable condition and per CDC recs is ok to receive dose #2.
Received Tdap vaccine 3/18/13, started having a local reaction 24 hours later = swelling to (L) arm with heat & redness at the site of injection & a hard induration measuring 12 cm x 9 cm. Parent instructed on care = cool compress, TYLENOL / MOTRIN for discomfort & BENADRYL if itch arises. Come in for visit if swelling increases.
Covid arm (rash, tenderness, swelling, firmness) beginning 2/11,  less painful/more itchy by 2/14
Symptoms (has lasted more than a week) : muscle pain in the right side of the body from neck to the waist. Strengthless, hard to breath, headache. Feeling very cold.
101 fever started 20 hours after injection, mom noticed swelling left thigh to ankle and hives bilateral waist to feet at 9pm 4/12/06, mom administered Tylenol symptoms subsiding at time of call to HD 4/13/06 11:00 am.
Vaginal bleeding at 3:30 am, bloodied underwear and sheets.  Gynecologist gave me an internal ultrasound of uterus, ovaries etc. were perfect. Had fatigue and aches for 24 hr. after vaccine. Also had a very bright pink, red rash covering the underside of my right arm and right chest, hot to the touch, some swelling, primary Doctor put me on antihistamines and antibiotics. Bleeding stopped. Rash and swelling is improving, still slight swelling on the underside of right arm 8 days later.
Patient was about 4 weeks pregnant at the time of the shot. Her due date was Dec. 13, 2021. About a week after taking the shot, her HCG levels stopped rising, and she ultimately miscarried.
Itching; neck rash; cough; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 27Dec2020 08:15 at a single dose for COVID-19 immunisation. Medical history included hypertension and allergies from IVP dye, sulfa, and iodine. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Concomitant medications included hydrochlorothiazide (HCTZ), lisinopril, and calcium carbonate (CALTRATE). On 27Dec2020 08:30, the patient experienced itching, neck rash and cough. The patient underwent lab tests and procedures which included investigation: unknown results (Pending) on 02Jan2021. Therapeutic measure was taken as a result of the events that included Benadryl. Clinical outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
SIGNIFICANT WORSENING OF PRE-EXISTING MILD TINNITUS. ONGOING AS OF TODAY'S DATE.  TEMPORARY  L HIP PAIN WITH INFLAMMATION UNTIL 4/3/21
Shingles, left T4 dermatome. Treated with valacyclovir. Adequate response to treatment.
She knows a lot of people that didn't take 2nd dose because of side effects.; 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 VACCINATION COMPLICATION (She knows a lot of people that didn't take 2nd dose because of side effects.) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (She knows a lot of people that didn't take 2nd dose because of side effects.). At the time of the report, VACCINATION COMPLICATION (She knows a lot of people that didn't take 2nd dose because of side effects.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.
In late July I started having shortness of breath and tight chest on the hot humid days.  My PCP referred me to a cardiologist in September.  The cardiologist ordered a stress test for Oct 4 2021. But on Oct 3 2021 I was urinating blood and went to the ER. The ER put me on 3L of oxygen because they saw my oxygen level drop on the pulse-ox.  I was admitted from Oct 4 2021 to Oct 8 2021.  I had a stress test,  echocardigram,  CT SCAN,  lab work,  chest x-ray and all test seemed to come back ok. I was walked by the nurse with a pulse-ox on and within 30 feet my oxygen level dropped from 97 to 82 so a lung Dr was called in.  She ordered a pulmonary function test,  blood gas test and a echocardigram bubble study.   I was discharged on Oct 8 2021 with oxygen to have at home.  I was sent to a facility for a possible pulmonary avm.  But at that visit that Dr did he did not believe that was evident and would refer us back to the initial pulmonary Dr to do a heart catheter test and a test to sample fluid in my lung.  I have not been able to work.  And was healthy before my vaccines.