chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Medication was administered SQ, which is the only approved route. I have never experienced such a painful reaction to vaccines administered IM. Manufacturer should consider IM route of administration 1. Itchy, painful red welt at injection site. Hot to touch, increased to size of a softball over 48 hours post injection. Welt persists today. 2. Ocular headache on 04/16/17 for 24 hrs. Treated welt with ice pack. Treated headache with Tylenol.
High fever, severe headache, weakness, nausea, vomiting, diarrhea, stomach ache, soreness.
Left arm had excessive redness that extended down to elbow. It was severe enough to patient that she went to ER to be checked out.
Janssen COVID-19 Vaccine EUA  Approx 7 p.m.,  I noticed moderate pain in my lower back, hips, and legs. Around 7 30, I felt very cold and began covering up with several blankets and turning up the heat. Husband and kids reported the house was not cold at all. Within 15 minutes, chills began and increased quickly to an almost violent state. I was shivering so badly, it became painful and scary. My husband added three blankets on top of our down comforter and sent me to bed. It took approx 15 minutes to warm up, stop shivering, and slow teeth chattering enough to relax and fall asleep. Awoke around 1:30am feeling incredibly thirsty and in desperate need of water. Upon standing, the pain in my body was excruciating which made it extremely difficult to walk. Finally in the kitchen, I took Ibuprofen 800mg and filled a large bottle with water. I began to feel incredibly dizzy and needed help from my husband to get to the couch. It took approximately 2 hours before I began to feel any relief from the ibuprofen. Around 6:30 a.m., about 60 to 65% of the pain had abated and I had finished around 100oz of water. The remainder of the day was spent feeling extreme fatigue and a general sense of unwell. Appetite was poor throughout entire event. This all continued into the evening until bedtime at 11pm. Experienced moderate insomnia overnight, falling asleep around 2:30am. Could not fall asleep due to constantly thinking about the stress of the previous 24+ hours. Upon waking this morning, I feel almost back up to 100%.
On September 17, 2022, three days after receiving a Covid 19 Pfizer booster (2nd booster in a series), administered Wednesday, September 14, 2022,  my mother suffered a blood clot (stroke) within the brain, that was subsequently removed via surgery.      Note:  This Pfizer booster was administered in conjunction with a flu vaccine by a pharmacist .
Information has been received from a physician concerning a 4 month old male who on approximately 11 Nov 2006 was vaccinated with the second dose of Rotateq. The physician reported that in November 2006, within two weeks of receiving the second dose, the patient developed vomiting and diarrhea and was hospitalized for 24 hours. At the time of this report, the outcome was unknown. Additional information has been requested.
As injected - immediate Nasty Taste - Told Assistant severe stomach Bloating Next Day - Lasting 4 months severe B.L. Neck pain - upper back - L. sholder - L arm Bronchitis , Severe Fatigue, Severe Brain Fog Shingles 2nd of January stomach bloat moved down to my Gut Bloody Stool - Bloody Mucus - Colitis Severe Pain BL Neck, Left sholder 10-24-22 Dr. (Neurosurgen Refered me to Pain Management. Wants Primary to do Lab for something is going on with your body. Rheumatiod Factor 11-7-22 Pain Management - Allergic to Nickel - so can't implant pain devise - so contacting company To Have them provide me with - Portable Electric Nerve Stimulation Device 12-2-22 PCP - ordered Lab for RHeumatoid Factor - Results iu/L value 21.0 12-7-22 PA-C (Gastrology) stomach severly Bloated pain all across stomach. He ordered Labs, and ultasound Liver enzymes are elevated - ALT u/L - 169 AST u/L - 160 1-3-23 - PA-C Acute bronchitis 10 Day Cephalexin (Keflex) 1-9-23 - FNP Hives (she Thought) stopped cephalexin - ordered Azithromycin for 5 days Hives - Turned into shingles 1-24-23 - Zoom Appointment (RHeumatology) office canced Appt. Rescheduled for 2-14-23 I canceled that appt. - to see what was going on with my body and pain (maybe other Things causing Pain. 1-25-23 - stomach Bloat went down into my Gut 1-20-23 - Company - staff Brought Equip for Pain 2-2-23 - Bloody stool - stopped eating solid Food - Just drinking Plenty of fluids - 2-4-23 - called Emergency contact for PA-C she said she would mark my Request for Appointment for Monday (2-6-23) Top priority. 2-5-23 - Began vomiting water - passing Blood mucus. Went to the "ER" seen By ' MD. Ordered immediate IV, Troponin Value 26 1 HR. Later Value 23 ordered CT of Abdomen and Pelvis Abdominal Pain, Gut spasms ordered Antibiotic - ciprofloxacin - Bentyl - for Gut Spasms 2-6-23 PA-C - ordered vancomycin for 14 days for Colitis, ordered scopes (colon & UGI 2-25-23 Through 3-2, 2023 began drinking 1 TBS vinegar mixed with Koo Aid 3 x day 3-6-23 pre-op Covid Testing 3-9-23 MD - Did the scopes (Colon and UGI) several biopsies, Removed 1 sm. polyp 4-5-23 As of Today, Stomach and Gut OK Pain in Neck, upper back, L. Sholder and Shingles improve. Still Have Fatigue and Brain Fog, but Not as severe. 5 month journey
On November 9, 2019 at ~ 10:30 AM I was washing patient in the bathroom sink and I noticed his body became limp with decrease in muscle tone.  His eyes were half open and half closed and was extremely pale.  He did not respond to me and I began breastfeeding him.  At that time he started feeding and was able to track me, however, his color was still very pale.  We called on call pediatrician and recommended we take temperature and it was ranging from 96.5 - 97.5 rectally.  She recommended we go to ER.  We monitored him at home for a little bit and then due to him not being his normal chippy self we decided to take to ER.  Patient was very quiet and chill and not as excited as he usually is.  When driving to ER @ ~ 3:00 PM - 4:00 PM he went unresponsive again in the car seat and his head dropped down.  I (mother) took him out of his car seat and noted him arms and legs were limp and began breastfeeding.  He started feeding and was tracking me, but color was very pale again.  We called 911 and he was transported to Medical Center via ambulance.  During ambulance transport patient was stable and did not have any episodes.  He then spent 4 days in the hospital for testing and monitoring.   Patient was discharged on 11.12.2019.  We have follow up appointments with neurology and an electrophysiologist in December 2019.
24 hrs- lymphadenopathy, submandibular, ear pain 36 hrs- primary outbreak of VZV- trigeminal n involvement- tingling/burning 48 hrs- rash and vesicles in trigeminal n distribution
Left-side facial numbness. Patient saw her PCP. She is slowly improving but still has some numbness.
bad flair up of her Hidradenitis Suppurativa; This is a spontaneous report from a contactable physician. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included Hidrandenitis Suppurativa, rheumatoid arthritis, Inflammatory bowel, autoimmune issues, Flares. The patient's concomitant medications were not reported. The patient previously took dose 1 BNT162B2 for COVID-19 immunization. The patient experienced 2 days later bad flair up of her hidradenitis suppurativa (condition aggravated) on an unspecified date. Reporter stated, Strong family history of this Hidrandenititis Suppurativa. She flares once a Month, it was temporary, but pretty bad, on the buttocks. Would it be a Flare up caused by the vaccine? The inflammatory reaction looks like a boil, not necessarily with any bacteria. In the long run chronic condition, you end up with sinus tracks. It hasn't formed a pus pocket. Reporter didn't have much of a reaction from the vaccine, either, and was assuming I am safe. reporter have taken the HEP B vaccine and have never had any antibodies after these shots. Patient received treatment of steroids. The outcome of event was unknown.  No follow up attempts are needed. Information on Lot/batch cannot be requested. No further information is expected.
Awakened from sleep by shaking chills 12 hours after vaccine administration lasting ~2 hours.  Mild, frontal headache began soon after, lasting ~8 hours.  This was followed be general malaise/myalgia for the remainder of the day.
4 patients 16-17 years of age were administered from the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (4 patients 16-17 years of age were administered from the Moderna vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No adverse events were reported.  No treatment medications were provided.   This case was linked to MOD-2022-554700, MOD-2022-554702, MOD-2022-554701 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow-up received included no new information.
I have pain, swelling, numbness and tingling in my left arm and hand.  It is most noticeable in my left hand. The numbness and tingling are present all the time, but sometimes it gets worse. It feels like my arm "fell asleep" all the time. My left arm is also sore to the touch. I thought this would pass, since arm pain is a common side-effect, but it has been 11 days and it has not improved and the numbness/tingling concern me, which is why I am reporting it now.
getting sounds inside the ear/tinnitus/ sounds like air flowing in and out; tired; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (getting sounds inside the ear/tinnitus/ sounds like air flowing in and out) and FATIGUE (tired) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 037C21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced TINNITUS (getting sounds inside the ear/tinnitus/ sounds like air flowing in and out) and FATIGUE (tired). At the time of the report, TINNITUS (getting sounds inside the ear/tinnitus/ sounds like air flowing in and out) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Audiogram: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) Picture was not helpful especially for the right side throat.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. Patient went to the doctor because patient thought water got in her ear when patient went swimming. However, the ENT doctor said everything was good. There was no infection, no wax. The next step was audiology. She was able to hear everything they were saying. Then she was sent to get an MRI, which was good, but the picture was not helpful, especially for the right side of the throat. They thought they saw something. She went in for a CT scan to focus on that particular area, but it also came out normal. She will see a neurologist and check on the MRI and CT scan results on 09 February 2022. She specified that her issue was only on the right ear.
I started getting symptoms of scratchy throat, extreme fatigue, and a feeling of wellness. I took a COVID-19 test that was positive. I had nasal issues, cough, brain fog, loss of taste and smell. The cough lingered for 6 weeks. I had respiratory issues and harder to breath. I still have fatigue. I also have muscle issues since COVID-19 that was more severe than my osteoporosis. I contacted my doctor when I tested positive and had a treatment. I was prescribed steroids for a week. I was using FLONASE and an OTC cough medicine. My total symptoms lasted 9 weeks. I feel like I have had long COVID-19.
Case number PHEH2014US023352, is an initial spontaneous report received from a pharmacist on 19NOV2014. This report refers to a 42 year old female patient. Historical condition was not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (seasonal influenza vaccine, batch number: 1412401) from a multi dose vial via intramuscular route on 19NOV2014. It was reported that during vaccination most of the liquid rolled down the patient's arm. No adverse event was reported following this administration error (vaccine under dose). No additional details were available.
On 3/30/2021 visit, patient complaint of chills, lost of taste and smell, "taste bland", feel extremely fatigue.
Pt has Hodgkin's lymphoma (receiving weekly Rituxan treatments) and severe terminal idiopathic pulmonary fibrosis (requiring home oxygen).  Pt has a productive cough, fever, chills, and body aches.  Pt admitted with COVID-19 infection with pneumonia with acute on chronic respiratory failure.
Pericarditis, ground glass opacity /fluid lungs; Pericarditis, ground glass opacity /fluid lungs; Pericarditis, ground glass opacity /fluid lungs; This is a spontaneous report from a contactable Other Healthcare professional (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 08Jan2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunization. The patient medical history was not reported. No known allergies. No covid prior vaccination. The patient was not pregnant. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 on 18Dec2020 10:00 AM in right arm for COVID-19 immunisation. The patient experienced pericarditis, ground glass opacity/fluid lungs on 15Jan2021 with outcome of recovering. The patient was hospitalized for the events for 6 days. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative on 19May2021, negative on 09Jun2021. AE treatment included lasix began.  The lot number for the vaccine bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of pericarditis, ground glass opacity/fluid lungs cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
After receiving vaccine patient became sweating and clammy  he reported not eating today and consuming alcoholic beverages the previous night. patient recovered and was able to leave the site on his own.
Patient repoted a rash that started on her arms, spread to her hands .Rash started on 7/24/03, and patient called 0n 7/29, still repoting rash and hives now.I advised she been be seen by a health care provided to evaluate and treat
Patient complained of severe injection site pain, shortness of breath, sweats.  Arm soreness for several days.  Awakened patient from sleep right after injection.
30sec p/vax pt eyes rolled back & pt went limp;pt assisted to floor-a/reaching mat pt entire body stiffened, eyes open & fixed, jerking of all extremities x 10-15sec;pt responsive & very tired c/o h/a;pt pale to ashen color;
pt recvd vax a 3cm-sized area of redness, inflammation; 1 wk later devel generalized pruritus & hives that have persisted for 5 months; now cont w/papular & urticarial sx all over, treated w/Pred & Hismanal;
On October 4, 2021, I started having numbing on the right side of my face. My right eye was closed shut, my lips were sagging and I couldn't lift my eye brows. At first, they thought I was having a stroke but after a bunch of test doctor said it was Bell's Palsy. They gave me a bunch of meds. My second Moderna was given in June and that lot number is 011D21A.
Went to Urgent Care 12-24-2019 Doctor Put me on Prednisone 10mg 12-24-2019 also the pharmacist told me to take Benadryl and Alg Pill, which I did and Ibuprofen. I did what she said, went to doctor next day I think it was. It was a lady pharmist, the next day they tried to help. 01-09-20 upper eyelid and corner of eye still red and burns like I thing its getting Better though Friday itched really bad But I tried not to touch, I put anti Bio cream on and then that didn't work so I put a hydrocortisone cream on and it help some. Went to Bed got up Saturday morning all the way around my neck and up my neck in my hair a lot more. Didn't know what to do call number on this paper no in on weekdays, called medical center (closed Pill for nose drainage generic alergan, then Took a shower, By time I was done, I was getting some relief, But felt dryed up but I didn't hurt. A friend, said to make a paste of Baking Soda Its 1:00PM eating my oatmeal, Took my morning pills Was my check up, doctor or eye doctor said gets any worse call my reg doctor, which I did go to clinic next day P.S. Just wanted you to know all, its still around left eye, can't ware make-up and its 01-09-20 Hurt to put any then around it (bump)
C/O recurrent tingling and numbness in left arm since may 10,2021. had pain shooting down the arm at that time. pain and tingling comes and goes. lasts about 15 minutes to 1-2 hrs. holding something in left hand triggers the symptoms. tylenol temporarily helps.
Breakthrough case admission after three vaccines Pfizer 4/13/21 Lot# EW0164;  Pfizer 5/4/21 Lot# EW0168;  Pfizer 11/3/21 Lot# EW0164
Initial unsolicited report received from pharmacist on 01-Nov-2017. This case was linked to 2017SA216202 (same reporter). This case involves female patient (age not reported) who was vaccinated with 0.5 ml once dose of FLUZONE HIGH-DOSE (Batch number: UI808AB, expiration date, dose, and site of administration was not reported) via intramuscular route on 30 Sep 2017. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed large local reaction at injection site with redness and swelling to 5-inch size and then followed up with doctors. Lab data and corrective treatment were not reported. On an unspecified date, the patient was recovered from events. List of documents held by sender: none.
Patient had trouble breathing. Ambulance was called immediately & she became unresponsive just as they arrived. She was taken to Hospital & we were told right away that her condition was probably fatal.  She was put on life support & died on 11/21/21 a few hours after she was taken off of it.
Information had been received on 21-OCT-2016 from a nurse who reported that a patient (gender not reported), who is 15 years old, received a dose of PROQUAD (lot# M007963, expiration date 15-APR-2017) on 30-AUG-2016. Patient then received a second dose of PROQUAD (lot# M006102, expiration date 01-AUG-2017) on 13-OCT-2016; this is outside the recommendations per the PROQUAD prescribing information. No adverse effects reported. No further information provided. Additional information has been requested.
1/21 vaccination Twelve hours later, I woke up with flu like symptoms. I had fever, chills, joint pain, body aches and a HA. I also had cervical lymph node swelling (size of a golf ball) and axillary lymph nodes on the R side was severely swollen. I called my PCM and they put me on a call with a specialist. They told me to take Ibuprofen and 72 hours for lymph node swelling to go down, which they did.
Redness, swelling, itching at injection site.  Spread approx 4-5cms.  Beginning to abate after 8 days.
This spontaneous report received from a patient concerned a 59 year old African American female of unspecified ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: In 2019, the patient got Covid-19, received an antibody infusion in JAN-2020, and concurrent conditions included: high blood pressure, alcohol user, non-smoker, and sciatic nerve. The patient had no known drug allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 18-SEP-2021) dose was not reported, 1 total administered to left arm on 09-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol (Tylenol) and other anti-inflammatory drugs for sciatic nerve. On an unspecified date, the patient experienced scratchy throat and had tested positive in PCR (Polymerase chain reaction) test which indicated suspected Covid-19 infection (mild) and suspected clinical vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected Covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint: 90000220543, 90000220643. This case, involving the same patient is linked to 20220312273 (Dose number in series 2). Sender's Comments: V0:20220314408--COVID-19 VACCINE Ad26.COV2.S--suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
100.4 F fever, Body & Joint Aches, Fatigue, Brown Urine
Pt vaccinated with DTP/OPV/HIB Titer 5 hrs later wouldn't drink, white skin color & pale, grunting respiration. Lasted for about 1 hr. Also parents indicated didn't smile since shot.
A few minutes after having the 1st vaccine, both of my legs started moving up and down by themselves. I couldn't stop this. This lasted about 10 minutes. Then I felt all my leg muscles tightening and loosening. I couldn't stop this. This lasted for  about 24 hours -into the next day. I have this reaction when given Compazine. I did notice there is a drug in your vaccine that is in Compazine called  polyethylene  glycol. I'm wondering if my reaction to polyethylene  glycol could have caused this reaction. I also had this reaction when I had surgery and this reaction started. The nurse pulled something they had on my legs off and my heart stopped. I had my heart checked out thoroughly and it is fine. I'm very concerned about the 2nd dose. I want to be vaccinated , but not if I could hurt me because of my allergies. Could you please let me know your opinion. My husbands had the vaccination with no problem.