chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting at 15-18 months of age, patient experienced developmental regression, compulsive behaviors, speech delay, pervasive developmental disorder and gross motor and sensory integrative disorders. Speech and occupational therapy began just after second birthday.
Rash may be due to viral illness or may be a reaction to vaccine given today. OK to give dose of BENADRYL to see if this helps with rash. Given rash started after vaccine administration may want to consider skin testing prior to next DTaP vaccine.
Recipient experienced brief loss of consciousness (few seconds per report) / vasovagal syncope from a standing position. He fell and hit his right frontal bone of skull upon fainting. Patient awoke after a few moments per report and was AAOx4 within moments of this reporting clinician's arrival to scene. Vital signs stable. Patient's frontal bone with minor red abrasion / erythema and scant swelling. He did not complain of changes in vision/ nausea / emesis. Neurological and Musculoskeletal exam intact without issues.
hot to touch; fever; swelling at the injection site; injection site redness; edema; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (hot to touch), PYREXIA (fever), INJECTION SITE SWELLING (swelling at the injection site), INJECTION SITE ERYTHEMA (injection site redness) and OEDEMA (edema) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history Provided.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot to touch), PYREXIA (fever), INJECTION SITE SWELLING (swelling at the injection site), INJECTION SITE ERYTHEMA (injection site redness) and OEDEMA (edema). At the time of the report, VACCINATION SITE WARMTH (hot to touch), PYREXIA (fever), INJECTION SITE SWELLING (swelling at the injection site), INJECTION SITE ERYTHEMA (injection site redness) and OEDEMA (edema) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
First shot on 3/9/  About 3/22 had itchy raised bump.  Thought insect bite.  Multiplied greatly as the days progressed.  Sometimes raised bumps, sometimes big  red blotches, sometime  long raised ridges.  Located various parts of body.  Better in the mornings.  Start mid-late afternoon and nights are torture.  Since March 29 have been on mega doses of antihistimines.  Primary physician referred me to allergist who did allergy testing, bloodwork, etc.  Am on zyrtec (3 per day) 40 mg famotidine 2 x day, hydroxyzine 25 mg 2x day, 10 mg singulair per day, plus have started xolair injections.  The only relief I have had has been from 2 rounds of cortisone....each time clears it up and I think it is over.  Lasts about 3 days, then same thing all over again.. In April I went to emergency room because of swelling of lip (in retrospect was probably a hive on it,, but I was fearful that tongue would swell.  All information has been sent to Moderna along with pictures, dates, etc.  (Somehow they got info and contacted me by e-mail.  I would assume had to come from v safe.
STOMACH ACHE; TIRED; HEADACHE; PAIN IN ARM; NAUSEA; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041AV1A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced pain in arm. On 09-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced stomach ache. On 13-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm, nausea on 11-APR-2021, and headache on 12-APR-2021, and had not recovered from tired, and stomach ache. This report was non-serious.
I started coughing a little bit but did not initially feel bad. I took cough medication that night. By the next morning I woke up and my chest felt very heavy. I scheduled an appointment with my provider after I had taken a COVID-19 Home Test that came back positive. They retested me and it was positive. They called in a prescription in, and I began taking it on December 21, 2022. The coughing has improved but I am now nauseous with a headache as well as diarrhea throughout the night. I don't really have an appetite, but I am drinking a lot of fluid. My oxygen level has been between 97 and 98. I have not recovered from these symptoms. I was also prescribed an albuterol inhaler.
received rsv and flu vaccine , one to 2 hours later headache occurred aleve relieves the headache but the headache recurs every 12 hours
This spontaneous report as received from a medical assistant refers to a 62 year old male patient. No information about medical history, drug reactions and allergies was specified. On 30-SEP-2014, the patient was vaccinated with temperature excursion supported PNEUMOVAX 23 injection (lot # K004542, expiry date: 19-AUG-2015, dose 0.5 ml, intramuscular). No concomitant medications were reported. No adverse effects reported by patient. There was no product quality complaint. The outcome is unknown. This is one of several reports received from the same reporter (MARRS # 1410USA002854, 1410USA005576, 1410USA005583, 1410USA005584, 1410USA005586 and 1410USA005587. Additional information has been requested.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000197749.
L arm numb approximately 5 minutes post injection. After total of 30 minutes arm felt the same. Agency was always within designated limits. First VS - temp- 98.1. HR - 110. O2 saturation - 97%, BP - 131/92. At 30 minutes - BP - 131/102, HR - 106. No other signs or symptoms. To Emergency room ambulatory, for follow up with RN assist.
Generalized muscle pain-evolved into extreme fatigue; inc in liver enzymes; leucopenia;
Pt with RSV + bronchiolitis, admitted to hospital 01/02/2007-01/04/2007. Readmitted 01/05/007 2 hours worsening SX's. Increase temp 01/08/07. Bld culture done + strep pneumonia. Now treated adequately and improving.  01/29/07-records received and reviewed DC Summary for DOS 01/05-01/12/2007 DC DX: History of RSV positive bronchiolitis and strep pneumo bacteremia most likely secondary to Strep. pneumonitis.  Hospital Course :presented with respiratory distress and fevers, treated with IV antibiotics and fluids.
fever to 105.3-no other sx;treated w/APAP & motrin;
This case was reported by a consumer via call center representative and described the occurrence of loss of energy in a adult patient who received SHINGIRX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGIRX. On an unknown date, less than a year after receiving SHINGIRX, the patient experienced loss of energy, dizziness, increased blood pressure and feeling anxious. On an unknown date, the outcome of the loss of energy, dizziness, increased blood pressure and feeling anxious were recovered/resolved. It was unknown if the reporter considered the loss of energy, dizziness, increased blood pressure and feeling anxious to be related to SHINGIRX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. After the 1st shot patient had all the listed adverse events,some lasting for 2 weeks. For tolerance to 2nd dose please refer case US2018GSK225408. Lab Comments: Lab test was done on an unknown date.
On 6/9/00, the pt developed crying and multiple 1 to 3 second episodes of stiffening, breath holding, and color changing where she turned red and purple and was hospitalized. She experienced these episodes more than 12 to 15 times during the first 2 to 3 hours; however, she did not experience any episodes while she was sleeping. They gradually decreased overnight. The reporter noted that the infant was monitored and that she did not become bradycardiac nor did she desaturate. She was treated with Tylenol, observed for less than 24 hours, and recovered.
Information has been received from a Licensed Practical Nurse, concerning a 60 year old female patient with coronary artery disease, hypertension, hyperthyroidism, allergy to CIPRO, codeine, DEMEROL, MACROBID, and Sulfa (unspecified), who on 14-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #: 6695331/1383Z, Exp: May-2012) (dose and route not reported). Licensed practical nurse reported that on 15-APR-2011, the day after vaccination with ZOSTAVAX (Merck), patient developed swollen joints, chills, painful arms and hands and shingles on her left arm. Prednisone and VALTREX were given as treatment for the events. No lab/diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. Patient sought medical attention through office visit. Additional information has been requested.
pt recvd vax 11APR94 rt arm c/o 50 x 50 mm redness & 35 x 35 mm wheal beginning 19APR94; also soreness of arm; allergies: sulfa;
Immediately following the MenQuadfi, pt. states her arm was hurting. She said moving the arm made the pain worse. She said she was okay to receive the second vaccine (her Adacel/Tdap), but while administering the vaccine, she stated she didn't feel good and lost consciousness. After about 10-15 seconds, pt. regained consciousness, but was pale and saying she didn't feel good. Pt. then vomited. Dr. went in to assess her and she was still pale and saying she didn't feel well. A few minutes later she vomited again and was given a zofran. 42 minutes into the incident, I checked her vitals again and they were WNL and pt was stating she felt much better and was ready to go home. She was reassessed by the Dr. and sent home stating arm pain was the only remaining symptom.
I got the shot at 1pm and by11pm I had severe shoulder pain with limited movement. 10 am the next day it started to loosen up but still very painful. Went to Dr. and got a anti-inflammatory steroid and pain killers.
Client received vaccination with Janssen Covid 19 vaccine at the age of 16 years; vaccine is only approved for those 18 years old and older.
On 05/30/2021, the day after my vaccination, I started to have pain in my knees. The pain resolved after 2 days. Now when I have my periods, the knee pain returns for the 1st 2 days while I am on my period. I never had the pain in my knees prior to the vaccination. The period following my vaccination, 06/29/2021, I began having heavy periods with light diarrhea. The periods would last 7 days. I continue to have heavy periods. On 08/2021- I was having chronic diarrhea. Every week I was having diarrhea and I still have it. I will be having a colonoscopy in December. I need to check that with the insurance I never had heavy periods or chronic diarrhea prior to having the 2nd dose of the Pfizer.
nausea - couldn't hold down water or food for first day abdominal pain back ache blood in urine on third day after shot still in pain...haven't slept last two nights
Severe hives and rash on neck, torso, upper thighs (left and right), and forearms (left and right).
Following the second dose of Pfizer client c/o dizziness, weakness and a headache. Client denied any pre-existing condition prior to vaccine being given, but admitted to a history of Myasthenia Gravis and arthritis. 10 minutes after the vaccination client expressed her discomfort and I immediately took her vitals (118/88, 20, 77, 98% o2, 96.8 temp). Her breathing was regular and unlabored and her safety was maintained throughout the incident. So , I applied and ice pack to the rear of her neck and forehead. 10-15 minutes later she said she felt better but weak, she asked for a drink of water. I assessed her swallowing and it went without incident. I then gave her some water to drink. She stated again that she felt weak and then admitted to the pre-existing conditions mentioned above. After resting for another 10-15 minutes she stated that she was feeling much better. I then had her stand but her gait was unsteady then I had her sit. The Husband and daughter then  expressed that her gait is sometimes off due to her illness. She did have a cane to assist with her ambulation. So I re-took her vitals (122/84, 16, 84, 99%o2). She said that she was feeling much better and her head ache was mild but she was fatigue but had no dizziness.  I then decided to discharge the client to her family and have them follow up with her primary doctor. So I asked her husband to pull the car up to the door so she would have a shorter distance to walk. We pushed her to the door in a chair with wheels and had her stand and did stand by assist until she was in the car. Her daughter did all of the translating.  It went with and problems and I did call to follow up and the daughter stated she was in bed resting and felt much better.
Sensation of a throat closure; Swelling of the lips; Swelling of the tongue; A spontaneous report  was received from a consumer concerning a 74-year-old male patient, who experienced a sensation of throat closure, lip swelling and swelling of the tongue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number:016m20a) in the left arm for prophylaxis of Covid-19 infection.  The patient reported that while he was driving home less than an hour after receiving the vaccine, he started to have a sensation of a throat closure, swelling of the lips and swelling of the tongue. As he was noticing increasing reaction while time was passing by, he went to the hospital. In the ER, they gave him Decadron, Diphenhydramine (injections) and Pepcid. The following day, he visited his primary physician by advice of health care workers at the ER. Right now, he has no symptoms. No further information was provided.   Treatment for the events included Decadron, Diphenhydramine(injections), and Pepcid.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events of sensation of a throat closure, lip swelling and swelling of the tongue were considered to be recovered on 16 Feb 2021.; Reporter's Comments: This case concerns a 74-year-old male who experienced Serious unexpected events of pharyngeal swelling, lip swelling, swollen tongue. The events occurred within 1 hour after the first dose of mRNA-1273. Treatment included Decadron, diphenhydramine, and Pepcid. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Lot number: EW0175 and the expiry date was not reported), in left arm and on 18May2021 as dose 2, single (Lot number: EW0183 and the expiry date was not reported) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Walnuts" (unspecified if ongoing). The patient was 30 weeks pregnant at the event onset. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Reportedly the patient did not receive any other medication in 2 weeks. Reportedly the patient received Paxlovid for COVID 19 Treatment (start date: 20Jun2022). It was reported that the patient experienced nausea/reflux and a persistent bad taste in mouth and back of throat considered as symptoms of covid-19.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
swollen, very painful lymph node in right arm pit that began about 36 hours after receiving vaccination and lasted for about 48 hours
01/23/21-large bump at injection site left arm, ,extremely  warm and painful to touch. The next day the redness and warmth was from my shoulder to my elbow and I was itchy in that area. about 1 month later I broke out in a red raised rash on my upper body that was itchy and felt like I had a sever sunburn.This continued to last for months. I took Medrol dose packs and IM injections of cortisone with no relief. I continued  with this rash for months. I then started developing sores in my mouth and nose, enlarged lymph nodes in my neck. and saw an ENT doctor. first week in July 2021 started having hair loss and rash continued. Nail beds are  becoming discolored and rash is reoccurring. I have an appointment to see a Rheumatologist this week to see what might be causing all these issues.
Client reports that about an hour after having the 2nd Moderna vaccine she felt achey and tired. By 7pm that night, her right arm where the vaccine was given was starting to swell and hurt.  She had a fever of 100.2F until 7pm the next night.  She tried using baking soda compresses to help without much relief.  She did not take Tylenol because she had heard not to use after the COVID shot.  Plans to see her doctor today but had to report it to the health department before the doctor would see her.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 21-NOV-2015 at time- 13:12, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.4 and 2.9 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
VERTIGO; TROUBLE BALANCING; CONCENTRATION LOSS; ARM NUMBNESS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced vertigo, trouble balancing, concentration loss, and arm numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vertigo, arm numbness, trouble balancing, and concentration loss. This report was non-serious.
pt recv vax & arm became very swollen, red & warm p/vax;taken to ER;
My issues started with my second dose on the second day about 24 hours after , I began getting a low grade fever with chills and just not feeling myself but my real issue was my fluctuating heart rate. I thought it was from the fever , I was wrong.  My fever and chills were actually mild and stopped completely a couple days later, however my fluctuating heart rate continued for almost two weeks after.      I wear a smart watch and I always have , first a Fitbit and now I wear an Apple Watch 6 , so I know my numbers , blood pressure etc.  The fluctuating I was experiencing was NOT NORMAL for me , at one point my heart rate shot up to 204 bpm doing nothing and then would drop like a rock and then go back up again. I actually showed my husband so he can see because I could not believe it was happening, and just to make sure the watch wasn?t messing up I put it on his wrist and his was fine , so at that point I knew something was wrong.      We both watched as it would rise to all different scary highs back down , I did feel at times a little lightheaded and some chest discomfort but nothing bad at all as it wasn?t continuous but my fluctuating heart rate was scary so I decided to got the the emergency room. They did testing and said it was possible it wasn?t coming from vaccine but no way to tell so they sent me to a cardiologist.      I have to say as well that I do have all my data on my watch to prove from around the time after my shot my issues with my fluctuating heart rate began.  I excercise and eat right and have no underlying health issues and this was the scary part , so I felt it necessary to report it because I am sure I?m not the only person out there that this happened to. What about the people that don?t wear watches or they don?t know their normal numbers and weren?t aware of what was happening, that?s scary too
Pt was c/o tingling to tongue & scalp at 4:30pm. BENADRYL 25mg was given for txmt.
Right after the shot had a severe headache, chills, dizzy, lightheaded, arm was very sore, bones was hurting extremely, couldn't eat,  and was always cold and she was always tired.
1. Nausea 2.  Terrible Stomach Ache burning below ribs 3. Achy all over 4. Major fatigue 5.  No appetite 6.  Chills 7.  Headache 8. Slept for many, many hours 9.  Left  Arm swollen  like a balloon 10. Arm itches,  still swollen on day 4 11. Arm rash from elbow to shoulder
I have suffered from cognitive problems like memory loss, the inability to think clearly, brain fog, and confusion.  I also have had headaches and dizziness.
Pt c/o increasing numbness down arm after receiving last four anthrax vaccinations.  Last vaccination on 19 May 09, pt experienced two episodes of numbness down his right arm over a 24 hour period.
1 of 5 pts vaxed during the month of APRIL from the same lot exp local rxn @ vax site;rxn described as enlarged,swollen,red & painful;exp diff moving vaxed arm for several days;recovered;
after receiving vaccines, child began coughing and wheezing. Also developed bilateral eyelid edema. 5/23/08-records received for DOS 5/2-5/3/08-DC DX: Anaphylaxis. Questionable vaccine reaction. C/O difficulty breathing after vaccine administration. Immediately after receiving vaccine developed swelling of eyes and difficulty breath.