chrisvoncsefalvay/vaers-outcomes huggingface dataset:
85 yr old female with pmh of trans aortic valve replacement TAVR, hypertension, hyperlipidemia, benign prostatic hypertrophy, persistent atrial fibrillation. Right-sided CVA,coronary artery disease, mitral stenosis with moderate mitral regurgitation presented to er c/o one weak of nausea , vomiting diarrhea wit progressive increase in weakness to the extent that he could not get up on his own today so came to er . he tsted postive for covid and negative for flu . stool for c diff is pending . cxr is negative
Some pain; Her arm was sore; Bruising/black and blue from the shoulder to the elbow; This spontaneous case was received on 14-Sep-2020 from a pharmacist via Agency (reference number SEQW-01637) and concerned a 78-year-old, female patient.  The patient's medical history and concomitant medication details were not reported.  On 10-Sep-2020, the patient was vaccinated with Fluad Quad (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number was reported as 279784, expiration date: 13-May-2021.   On the same day, the patient noticed some pain and her arm was sore. The patient was treated with Advil (ibuprofen).  On an unspecified date in Sep-2020, the patient noticed the bruising. The pharmacist said that it was black and blue from the shoulder to the elbow and that it looked severe.  At the time of initial reporting on 14-Sep-2020, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  Company comment: The patient developed all events after vaccination with the suspect product, Fluad Quad. Chronology is plausible. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed all events after vaccination with the suspect product, Fluad Quad. Chronology is plausible. No information about medical history and concomitant medications was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Right arm pain up through right side of neck and right side of head, including jaw and ear.  Pressure coming from inside head, head felt enlarged internally.  Chills and shaking.  Dizziness and urge to pass out or vomit but did not.  Headache continued for 38 hours after injection.
I received my seasonal flu shot as I do each year. The injection was immediately painful, much more so than I have ever experienced but I did not think much of it. My left bicep, from the moment of injection was intensely sore. I chalked this up to the normal discomfort accompanying the vaccination, though definitely noticed it was a more severe reaction than I had ever had prior. The pain has not persisted, unrelenting for 3 weeks and has significantly impacted by range of motion, ability to lift, bear weight, or even perform simple tasks like brushing/washing hair, turning my car steering wheel, etc. After 2 weeks of constant pain, I saw my primary care doctor who prescribed Naproxen 500 mg. After 5 days of Naproxen, no relief was experienced and I sought care from an orthopedist. The orthopedist made a preliminary diagnosis of shoulder impingement syndrome/bursitis and administered a cortisone shot. I am awaiting to see if this provides and relief, but thus far, I remain in constant pain. In researching this, I have found SEVERAL message forums, medical discussion boards, etc. where other individuals are reporting this same type of experience following receipt of the seasonal flu vaccine. For many, the pain has persisted for years, or even led to surgery. This is a SERIOUS side effect but may be under-reported or not taken seriously by patients who seek medical attention. I URGE someone to please look into this matter. It likely has to do with improper vaccine administration, and not the vaccine itself. I am so so concerned that I am going to endure this pain for a long time to come, or face surgery. I have a toddler who I am not even able to pick up due to the pain associated, and it is even difficult to just sit at my desk. This has also severely limited my physical activity, which is devastating as I am an extremely active person who exercises on a daily basis, 7 days per week.
I became ill 4 days after the shot. I rec'd the shot on a Monday & on Friday I became ill with sore throat, bad cough, fever.
Developed venous thromboembolism x 2 (popliteal and posterior tibial) in left lower extremity..  Received vaccination on Thursday, 10/20 around 6pm, Woke up Saturday, 10/22 around 6am with LLE pain and tenderness.  Was seen by provider at my MD office on 10/24 and treated for tendinitis.  Pain worsened on 10/29 and had venous doppler on 11/2 showing clots.
pt recvd vax @ AM check-up visit in PM pt awakened 6hrs p/vax w/inconsolable crying;brought to ofc w/inj area tender-mild swelling;
itchy rash on both arms; Rash (not itchy); This case was reported by a consumer via call center representative and described the occurrence of rash in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 29th September 2021, 2 days after receiving Shingrix, the patient experienced rash. On 2nd October 2021, the patient experienced itchy rash. The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the rash and itchy rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself. The patient received shingrix vaccine and 2 days later he developed a rash(not itchy) on right side of face, all around neck to the top of shoulders. The patient stated it had  cleared up since. The patient also reported that around 5 days after the vaccine he developed an itchy rash on both arms (left arm worse than right arm). The patient had not recovered from rash on arms and called his Primary Care Physician.  The patient stated they prescribed him some pills to take, one was a steroid and the other he wasn't sure what type of medicine it was. The patient stated he would go see his dermatologist soon.
Pt's mother presented at clinic reporting possible reaction to Gardasil. States daughter got the Gardasil Friday afternoon. Sat "about 24 hours later" pt was at a dress fitting, states pt hadn't eaten was standing x 20 min and got nauseous and light headed then fainted. States she was out for several minutes and had "some twitching" and "her eyes rolled back". States called emergency line and then went to ER where they spent several hrs, test run there were negative, but they have been advised to get a neuro work up and pt is not to drive. Mother reports no F/H of seizures and the only thing that was different in pt's life was the Gardasil. States she went online and fainting is one of the side effects listed for Gardasil. States doesn't want to have unnecessary testing done if this was caused by the Gardasil. Mother states she is not sure she wants pt to get another Gardasil injection.
Approximately 5 minutes post vaccination patient experienced right arm numbness, followed by flushing of her arms, chest & cheeks;  after another 10 minutes patient  began coughing and wheezing  at which time Epi was administered and wheezing stopped, and patient was placed on 5L oxygen. Approximately 2-3 minutes later, coughing & wheezing restarted, at which time 120 mg Kenalog was administered together with an SVN treatment.  Paramedics were called to transport patient to the ER for observation. Patient was seen the following day in office or follow up and is doing well.
Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-.
Needle/syringe came out when child moved resulting in vaccination not being administered.  The vaccination was repeated during the same visit.
Information has been received from a registered nurse concerning a 12 month old female who on 15-Nov-2006 was vaccinated SC with a 0.5 ml first dose of varicella-zoster virus vaccine live (lot#652946/1012F) instead of a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (upgrade process). It was noted that there was no product confusion. No medical attention was sought. Additional information was received from the administering nurse reported that there was no confusion with the packaging. They kept measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (upgrade process), varicella virus vaccine live, and varicella-zoster virus vaccine live in the freezer together with an intranasal flu vaccine. Occasionally, the flu vaccine would fall onto the other small vaccine boxes. They took the top lid off the boxes so they could easily get to the vials of vaccine. At some point, the boxes got tipped over and someone put the vaccine into the wrong box. The reporter looked for measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live in the purple box and grabbed the vial, not realizing that the lid was the wrong color. Essentially, someone put the vaccine in the wrong box and he did not catch it. He realized a week later that the wrong vaccine was given. Additional information has been requested.
I had had a perfect ultrasound of my 12 week baby. Only to have it die 3 days after receiving the vaccine. I have 3 live children and zero miscarriages.  Stop promoting this vaccine for pregnant women it kills babies.
Administration of the liquid component only; Administration of the liquid component only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comments: The reporter reported that that patient thought only administered only the liquid component of Menveo. And then when tried to collect data about the said that actually there was no patient involved.  The reporter did not consent to follow up. The reporter refused to share personal information. Additional supportive information: The patient received only liquid component of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Per patient, rt shoulder became painful approximately 2 hours after vaccination at 1:15 pm. Patient stated holding newborn around lunchtime at noon. At time of observation by pharmacist at 2:00 pm, patient could not lift rt arm upward or laterally, but could make fist and had range of motion in rt forearm. Arm appeared slightly swollen and warm to touch. Under protocol, I offered 30 minutes of observation to ensure no anaphylactic reaction. Patient refused. I also offered to call 911, which was refused and urged an ER visit, which was refused. Patient agreed to urgent care visit.
Diarrhea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and PYREXIA (Fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and PYREXIA (Fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency; BISMUTH SUBSALICYLATE (KAOPECTATE [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency. On 25-Jan-2021, DIARRHOEA (Diarrhea) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment medicines include Motrin, kaopectate and pepto bismol.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: TCR attached; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
At the time of the booster and the next few days, my arm did swell and it was very painful. I iced it. As the days and weeks went on, I started having stabbing pain when trying to put my bra on. After or month or so of this pain and decreased mobility in my arm. I started researching and started doing massages and stretches. It feels like scar tissue. I do have better motion and I now can hook my bra. However, it still feels sore. It's been 7 months.
Very sore arm, with hardness and reddness on upper arm radiating out at least 10 inches from injection site.  Strong aching pain, blotchy skin, swollen muscle, and heat in upper arm.  The pain began to radiate to neck on upper right and down right side of back.  Pain, hardness, redness and blotchy skin moved to bicep area of right arm within two days.  Achy upper body aches, emotional weepiness for two days following injection.  Tenderness continues in upper right arm three days post injection.
After the first dose I felt like a burning sensation. After the second one I kind of felt funky right away. For about 3-4 days I did not feel myself. It has gradually gotten worse in my joints and my left breast its still tender.  I got a mammogram done in 06/23/2021 and they told me that sometimes the vaccine make your lymph nodes get swollen. They told me there was nothing wrong. They told me to report this. 2 weeks after the second dose I also had a respiratory problem and they did 2 Covid tests and they were both negative. They put me in antibiotics.
Left shoulder redness, pain, muscle tightness, limited range of motion. Reported by pt.
Patient needed a TDaP but was given a DAPTACEL. No adverse effects have been found or reported. Patient was seen for well child check up on 12-28-16.
ON 11/16/22 - HAD FEVER, TONIC CLINIC SEIZURE, PURPLE DISCOLORIZATION OF THE MOUTH. FELL ON THE GROUND, NO HEAD INJURY. DURATION 2 MINUTES NO BOWL, NO URINARY INCONTINENCE
Chills, 100.4 fever for 18 hours, fatigue, swollen lymph node under arm pit in the shot arm, cold sore outside lip.
18FEB94 @ 430PM bright red blood in stool; fed pt; placed on abd for nap; 2 hrs later pt began moving around in crib; noticed was not breathing; father gave 2 back thrust & cleared throat of mucus; suctioned w/bulb syringe; to ER;dx: reflux
Vaccine given to pt in office. Issue is with labeling as the label writing very minute, label and cap color exactly the same as Moderna. Due to this reason, 5-11yo vaccine of Pfizer was given to adult, due to the similarities in coloring of bottle. Pt also has c/o very sore arms a few hours after having the vaccine. No VIS is able to be obtained from CDC or online except for ages younger than 11 yo. Pts requesting more information as to side effects for adults being a new variant of vaccine.
16APR96 rash (hive like) on face, neck & chest, joint pain;bumps & bruises on legs;22APR96 elbows & ankles warm, some redness & painful;reported to MD;
Cellulitis; Clammy skin and hands; Nauseous; Fatigue; fever; chills/teeth chattering; red rash; red mark on their right arm; hot to the touch; tender; Arm swollen and sore; A spontaneous report was received from consumer, concerning a 50-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, chills, fatigue, nausea, fever/pyrexia, red mark on their right arm/ vaccination site erythema clammy skin and hands/cold sweat, red rash/ rash erythematous ,arm swollen and sore/pain in extremity, red rash, hot to touch/ feeling hot and tenderness.  The patient's medical history was not reported. Concomitant medications included bomocriptine, doxycycline, cetirizine hydrochloride, ibuprofen.  On 06-JAN-2021, prior to the onset of the events, the patient received mRNA-1273 intramuscularly in Right arm for prophylaxis of COVID-19 infection.  On 07-JAN-2021, after receiving mRNA-1273, the patient's arm was swollen tender, and sore. The patient reported that the arm felt better the next day, after sleeping and taking it easy. The patient stated that on 08-JAN-2021, she woke up with more energy after sleeping and taking it easy. The injection site was not treated directly, but she may have taken some Advil for symptom relief. On 19-JAN-2021, the patient started not feeling well. On 20-JAN-2021, the patient noticed a red mark on their right arm where they had received the injection. The patient reported that she had a red rash on the right arm, below the injection site, that was hot to the touch. On 21-JAN-2021, she reported seeing a physician. The physician ordered an ultrasound to rule out a blood clot in the patient's arm. The doctor diagnosed the patient with cellulitis and prescribed an antibiotic (Doxycycline) and cetirizine hydrochloride. The event cellulitis was assessed as medically significant as per IME list. The patient reported feeling very nauseous and fatigued. The patient also reported chills and fever, chattering teeth, clammy hands and feet. The patient is still fatigued and nauseous but is starting to feel better today 28-JAN-2021. The treatment included an antibiotic (Doxycycline) and cetirizine hydrochloride.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events cellulitis, chills, fatigue, nausea, fever, red mark on their right arm, clammy skin and hands, red rash, arm swollen and sore, red rash, hot to touch and tenderness was resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
3" x 2" area of induration around each vax site;leg circumference 1 1/2" greater or that side;will get IgE to DT ? allergic rxn to the formaldehyde vs the toxoid;
A few hours after receiving the Covid vaccine my ears have started ringing pretty bad. I also feel very warm and was sweating pretty bad at one point. Now I feel nervous and anxious which is not helping my symptoms.        xios
Arm sore for 1 week. Redness, swelling from hand to bicep. Itchiness all over body.
After the first vaccination on 2/10/2021 he started feeling weird in a nonspecific way.  About 10-40 minutes later he started having episodes that have been diagnosed as seizures.  He also developed erectile dysfunction in the same timeframe.  Seizures are classified as facio-brachial-dystonic seizures and temporal lobe seizures.  Clinically seizures began with a warmth feeling going up the left side of his neck, then has a quick vocalization and a sudden body jerk more on the left side.  There is no postictal state.  They can occur up to 10 times a day or more.  They occur in sleep as well.  Documented on video EEG testing.  Has been refractory to medication, is currently on Keppra and Vimpat without full seizure control.  Also had hyponatremia.  Having memory decline.  See test results below.
Per phone conversation triage, Left leg red, not hot, no fever, no irritability, left leg pimples (rx to band aid).
Vaccines given, provided OJ and lollipop, observed for 15 min, pt had syncope episode 5 minutes into administration. Pt slouched in chair, diaphoretic, pale, dizzy (witnessed by father). Pt settled supine on table. BPs monitored, observed for additional 15 min, ice pack and lollipop provided.  Dr assessed pt at bedside. Pt verbalizes he feels like self again, color returns to face, walked hallway. Pt stabilized before discharge. Left with dad in stable condition. Pt verbalizes understanding of rest needed, no sports or activity for the day.
No adverse event; A dose of the Moderna COVID-19 vaccine bivalent was given at 0.25mL by intramuscular injection; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (A dose of the Moderna COVID-19 vaccine bivalent was given at 0.25mL by intramuscular injection) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 03-Oct-2022, the patient experienced UNDERDOSE (A dose of the Moderna COVID-19 vaccine bivalent was given at 0.25mL by intramuscular injection). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (A dose of the Moderna COVID-19 vaccine bivalent was given at 0.25mL by intramuscular injection) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (A dose of the Moderna COVID-19 vaccine bivalent was given at 0.25mL by intramuscular injection).    No concomitant medications were reported.  A dose of the Moderna COVID-19 vaccine bivalent was given at 0.25mL by intramuscular injection.  The patient has not reported any symptoms. No additional doses, medications or treatments have been administered at this time.
pt recvd vax & exp fatigue, muscle pain followed by arthralgia; pt devel also nodules in finger joints; lab tests revealed elevated ESR;
on 4/10/2021 patient developed cough, nasal congestion, and shortness of breath.   tested positive for COVID.
Right Side of body Upper and Lower Paralysis, Rt Side of tongue swollen with slurring of speech. Symptoms began around 8:30pm Paramedics called. Attempted to stand before paramedics arrived. Fell to floor face down. Rug burn to Right Orbital Area, bruised, swollen. Conscious. Initially unable to move Rt. side as directed by Paramedics. Within 30 minutes, able to move Rt side extremities. Able to walk, talk w/o slur, able to swallow. Paramedics offered to be taken to ER. Declined.
soreness, hardness of arm @ inject site 1 wk redness, itching scaling of upper arm 3 wks fever, skin eruption, transfer of 2cm knot from upper arm to below; ER visit 3JUL93;