chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash, warm to the touch, discoloration (but not red), about 4 inches in length and 1 to 1 &1/2 inches thick. Extremely sore. Skin was raised and inflamed. Based on advice from my corporate advisor I told her to take oral Benadryl and to try icing the area for comfort. If neither helped, she should call the doctor or seek medical attention (ER or Urgent care). She came to me at 6:05pm approximately on 5/24/19
Patient was fully vaccinated for COVID, but was admitted to the Hospital for COVID pneumonia and hypoxia  from 12/3/21 - 12/5/21
Presented 4/10/02 with 10-20 chicken pox vesicles
I HAD DECREASED OXYGEN LEVELS & SHORTNESS OF BREATH. IT HAPPENED 2 OR 3 TIMES AND THEN I WENT TO DR & MY NEBULIZER TREATMENT WAS ELEVATED.
Sat 4/24/2021 13:00 - Vaccine received Sun 4/25/2021 00:15 - Chills, intense shivering/shaking; several episodes over the next 2 hours; temp 102F Sun 4/25/2021 daytime - Fatigue, maiaise, sore injection site, chills but no shivering; temp 101F Mon 4/26/2021 all day - Fatigue, malaise, and injection site soreness all somewhat reduced; temp fluctuated between 100.0 and 100.8 Tue 4/27/2021 - Mild fatigue, arm soreness; temp 97.8F ("normal" for me)
get hot with a feeling of an elevated heart rate /she also experienced similar reactions to her vaccine; get hot with a feeling of an elevated heart rate/she also experienced similar reactions to her vaccine; This is a spontaneous report from a contactable consumer (nephew of the patient). A female patient of unknown age received BNT162B2 on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Approximately 3 to 4 minutes after injection site, the patient started to get hot with a feeling of an elevated heart rate. The action taken with BNT162B2 was not applicable. The outcome of the event swas unknown. Information for Lot/Batch number has been requested.
suspected vaccination failure/ have taken the shot and later still got shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-Jul-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The reporter mentioned that she personally know  many people who have taken the expensive shot and later still got shingles. The shot was expensive and did not work. The follow-up would not possible as no contact details were available. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. This case has been linked with the case US2022AMR105917 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105917:same report, other patient
After 20 hours of receiving vaccine, I had chills,  fever,  sweats, dizziness, & nausea feeling.    Returned to bed;  slept 4 hours; & then ate & began to feel better.
I have a patient with a lump at the injection site; This is a spontaneous report from a contactable pharmacist. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: not reported) via an unspecified route of administration on 25May2021 (at the age of 43-year-old) at a 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 for covid-19 immunisation. On an unspecified date in May2021 the patient experienced a hard lump underneath the skin at the injection site. The lump is not painful, but it is not going away and it bothers the patient that the lump is still there. Outcome of the event was unknown.  Information on Lot/Batch number has been requested.
muscular pain; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced muscle pain and injection site pain. On an unknown date, the outcome of the muscle pain and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced muscular pain in and around the injection site.  The patient told that, the muscular pain in the whole arm that he noticed once he moves his arm. It was noticeable pain.
tingling; numb/numbness; dizziness/dizziness for 0.5 hour after the shot.; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling), HYPOAESTHESIA (numb/numbness) and DIZZINESS (dizziness/dizziness for 0.5 hour after the shot.) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 025B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022, the patient experienced PARAESTHESIA (tingling), HYPOAESTHESIA (numb/numbness) and DIZZINESS (dizziness/dizziness for 0.5 hour after the shot.). On 13-Jan-2022, PARAESTHESIA (tingling), HYPOAESTHESIA (numb/numbness) and DIZZINESS (dizziness/dizziness for 0.5 hour after the shot.) had resolved.            It was reported that patient did not had any medication for symptom relief. Has no medical conditions and takes no medications.
Within 30 minutes, I was completely itchy. After 4 hours, my arm was sore and hard to lift. Day two my arm is swollen and my lymph nodes under my left arm are swollen.
I began to feel like my balance was off. It continue through the weekend. I had to keep a hold of things like walls and chairs when I walked. I contact my doctor to see him on April 09, 2021 because of these Virgo symptoms. He gave a steroid injection into my right ear. My Virgo balance was dormant ever since 2018. I had a wiggle and rocking feeling in both feet. Tingles in the back on my legs. So, my doctor referred me to do vestibular therapy which started on April 19, 2021 to June 8th. My therapist did state that she had 5 patients with post Covid-19 vaccine with Virgo balance issues. He also referred me to a neurologist. My appointment is set for July 30th. I did improve.
Drowsiness/sleepiness after vaccine every time I take ibuprofen. Started day after vaccine. Have taken 600mg ibuprofen 3 time s/p vaccine and have the same drowsy feeling ( similar to 50mg diphenhydramine). I?ve been taking 600mg ibuprofen PRN for the last 20 years for pain and never once have I had this feeling. Using same ibuprofen bottle for the last 6 months, not expired. No change in medications or diet since first or second dose of vaccine. Can?t think of another reason to why this is occurring with the exception of the vaccine. Sleepy and drowsy to the point I need to lay down.
Pt recv vax on 10/15/98; on 10/16/98 pt exp round/swollen/erythematous/ warm/ pruritic lesion  at vax site
Beginning on 04/06/21 I had pain at injection site, joint, and muscle pain, aches all over my body, chills, mild fever, and headache.  Beginning on 04/07/21 I began having severe shoulder, and neck pain, unable to turn my head to the left (side of injection) and unable to lift my head upwards, pain at base of my head, mild fever, body aches, joint, and muscle pain, headache, pain at injection site.  04/08/21 fever has subsided,  headache, pain at the base of the head, still experiencing pain in my shoulder and neck on the left side, and mobility is still limited.  Still feeling achey, and sluggish.
18hr p/vax onset of a febrile rxn w/mild generalized body edema which lasted 4 days then subsided;there was no erythema, urticaria, pruritus;seen in ER MD gave dx of URI;when pt examined at later date pt was fine;
symptom onset of  fever, cough, loss of smell/taste, sore throat, runny nose, congestion, wheezing, fatigue and myalgias. Admitted to hospital on 9/10/2021.
The day after the vaccination pt developed slight redness and itching. Following day large swelling, warm, itching, redness, and tingling.
Information has been receive from a consumer via Corporate Twitter and an online article, referring to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL, (dose, lot# and route not reported). The article reported a mother claimed her daughter experienced horrendous adverse event which needed permanent care after receiving GARDASIL. The outcome of the event was unknown. The reporter considered the event to be disability. Additional information has been requested.
Onset of rhinnorhea, PND and bronchospasm within 72 hours of anthrax #2. Constellation of symptoms suggestive of a hypersensitivity reaction. On evening of 5/16-5/17, became feverish, experienced malaise, and sore throat began. Symptoms continued through the weekend. On 5/18 developed significant PND-increased swallowing and extremely raw throat. On 5/19 clinic evaluation for sore throat, PND and low-grade fever. Treated with Afrin, Deconsal and Allegra. Throat culture negative. Around 5/22 sore throat improved somewhat, but developed itchy, SOB, chest tightness and wheezing with nonproductive cough. Also, lost voice and experienced hoarseness. Fevers resolved. Clinic evaluation on 5/22 - medications changed to Deconamine, Flonase and Tessalon. Clinic evaluation on 5/28 for continued sore throat, chest tightness and cough with pleural rub. New onset of sinus tenderness with greenish drainage and blister on tongue. Diagnosed with sinusitis and prescribed Levaquin. Instructed to take Allegra, Flonase, Deconsal and Benadryl. On 5/29, significant improvement reported after taking Benadryl.
Significant swelling of auxiliary lymph node, left side. Rash on arm and a little down the left side of chest. Pain from swelling, can't put my arm down. Injection site still sore and pretty far around, up into collarbone area. Cool pack on injection site, heating pad on swollen lymph node, Ibuprofen for pain and swelling. Pain started around 12 hours after injection, swelling started almost 2 days later, armpit pain before then. Still on going.
Information has been received from a pharmacist concerning a 76 year old female who on 28-MAY-2008 was vaccinated subcutaneously with ZOSTAVAX (Oka/Merk). Concomitant therapy included NORVASC, ACTONEL, LIPITOR. On 28-MAY-2008 the patient experienced pain in the arm (unspecified arm). The patient's pain in the arm (unspecified arm) persisted. No product quality complaint was involved. Follow-up information was received from a pharmacist concerning a 76 year old retired female with tetracycline, aspirin, and barbiturates allergies who on 29-MAY-2008 at 1300 was vaccinated subcutaneously with the first dose of ZOSTAVAX (Oka/Merk) (lot # 659408/0300X). There was no illness at time of vaccination. On 04-JUN-2008, sore arm lasting one week at injection site (left arm). On 05-JUN-2008, the patient recovered. Medical attention was not sought. Additional information is not expected.
Patient had a shingrix immunization on 5/30/2021. On the next morning at home (5/31/21), stated that he felt weak while in the kitchen, passed out and fell to the floor. The patient did not describe any injuries from the incident and said that he just felt weak and fatigued afterwards. Patient chose to rest the day. Patient does not have note of his blood pressure at the time and no medications on file to assess contributing factors. Today, he states he is feeling better. Advised to follow up with provider as well. Left message for patient to get information regarding provider as to notify primary regarding incident
Broke out into sweat. Almost passed out. Dizzy. Pale. Spacy feeling. Tingling in arms and legs.
Tested positive for Covid-19 on 8/4/2021.  Admitted for left sided weakness
First, it started as soreness in the injection site a few hours after the vaccine. Around the same time, I developed extreme fatigue and tiredness. Also, I developed blurred vision and light sensitivity. I remember sleeping for several hours. When I woke up, I felt a little better. It only lasted one day.
04/23/21 AFTERNOON Shoulder/Elbow, 04/24/21 middle of the night, joint paint - full body, hips/ankles/wrist. sx have improved, no longer experiencing at this time, pt took ibuprofen for joint pain did not require HCF/PCP eval.
MCA stroke on 9/4/09. Aphasia. Hemiplegic.   11/18/09:  ED and Hospital Records and Discharge Summary received for dates of service 9/4/09 to 9/10/09.  Dx:  Left middle cerebral artery infarct, right-sided weakness, expressive aphasia.  Assessment:  On day prior to admission child bumped her head while playing at school, no LOC.  Later began having hiccups and drooling out of R side of mouth.  Difficulty speaking and unsteady gait. Developed dense R sided hemiparesis and inability to talk.  Brought to ED and admitted overnight for observation.  MRI of brain showed L MCA infarct.  Transferred to ICU.  Right sided facial weakness, decreased muscle tone, weakness on R. IV fluids provided due to numerous sedations.  Decreased appetite. Discharged to rehabilitation center for PT, OT and speech therapy.
Fever, Erythema Multiforme, Diarrhea, Nausea, Vomiting, chills.
Weak legs, fatigue, nausea, bradycardia. Patient taken to Urgent Care sent via ambulance to ER second degree to heart block pacemaker placed 7-13-07.  8/17/07 Received PCP medical records which reveal patient was in usual state of health on 7/11/07.  Returned to office on 7/24/07 as f/u to hospitalization where pacemaker inserted secondary to bundle branch block.  Had right pneumothorax while in hospital requiring chest tube.  Dx w/COPD at hospital.  8/28/07 Reviewed hospital medical records which reveal patient experienced tiredness, fatigue, dizziness  & worsened SOB over a few days.  In ER found to be in complete heart block w/ventricular rate of 32.  Admitted 7/13-7/20/07 & pacemaker inserted 7/13.  on 7/14 developed right side chest pain & decreased breath sounds.  DX: right pneumothorax.  Chest tube placed 7/14 & had persistent but intermittent air leak, chest tube d/c on 7/20.   FINAL DX: complete heart block; right pneumothorax; s/p pacemaker.
The patient stated that after the vaccine and on and off for the last 4 weeks she has had an uncomfortable ache in the bicep area of her arm.  It does not hurt to the touch and she can perform her normal activities.  She had the normal site pain at the injection site but that resovled after a few days but the ache continues in the bicep area.  She said it doesn't hurt all the time, it comes and goes and she can usually work through it.  She received her second injection on 10/24/21 and said she now has the same feeling again in her bicep area.  The patient stated it was not severe enough to contact her physician.
Received 2 shots on Thursday 11/14/02; Hep B #1 and a Td booster. Karinia came today to the nurse. Showing signs of localized swelling, tenderness, red area approximately 8in. in diameter. Ice applied. Referred to school based health center.
Severe headache starting 10 hours after the vaccine associated with nausea, vomiting, incontinence. Denied LOC/seizure like activity. Was monitored during the entire time by her husband.
The spontaneous report as received from nurse practitioner refers to a female patient of unknown age. The patient was vaccinated with 0.65 ml ZOSTAVAX (Lot# unspecified) within the past 2 weeks in approximately August 2012. No other co-suspects were reported. No concomitant medications were reported. Within the past 2 weeks in 2012 after given ZOSTAVAX the patient experienced severe headache. The patient was still having severe headaches but the reporter didn't specify if they are any better or worse than they were when they started. The patient had sought unspecified medical attention. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to an unknown number of patient with unknown gender and age. The reporter stated that an unknown number of patients were inadvertently administered ROTATEQ (lot#, strength, dose, frequency and route unspecified) during March 2014 and April 2014 that had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
My son had a  stroke in the posterior occipital lobe. He was young and healthy without currrent health issues
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 07Mar2021 as dose 2, single (Lot number: EN6199), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 06May2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "asthmatic cough after upper respiratory infections" (unspecified if ongoing); "upper respiratory infections" (unspecified if ongoing); "Known allergies: Rash with penicillin" (unspecified if ongoing); "Known allergies: Rash with penicillin" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 01Jan2000; HYDROCHLOROTHIAZIDE, start date: 01Jan2000. Past drug history included: Codeine, reaction(s): "Known allergies: codeine", notes: codeine acts as stimulant. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course details: The patient received Andrographis (brand: Planetary Herbald), B-Complex (brand: Natures Bounty), D3 (brand: Nature Made) on 01Oct2022 for unknown indication.
Really tired; Pain on the injection site; Swelling on the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Pain on the injection site), VACCINATION SITE SWELLING (Swelling on the injection site) and FATIGUE (Really tired) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain on the injection site) and VACCINATION SITE SWELLING (Swelling on the injection site). On an unknown date, the patient experienced FATIGUE (Really tired). At the time of the report, VACCINATION SITE PAIN (Pain on the injection site), VACCINATION SITE SWELLING (Swelling on the injection site) and FATIGUE (Really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Severe headache fever chills nausea vomiting on day one. Followed by hair loss beginning on day two and by day seven a bald patch  began to form in an ophiasis pattern consistent with autoimmune response. Over the following ten days the patch slowed until the second shot. I am now missing 25 percent of hair and there is no regrowth. Additionally I have had autoimmune markers drawn which are positive.  The moderna shot triggered an autoimmune disorder which was not present prior to the vaccine.   director of pharmacy at filled out a VAERES back in February but I thought you should know that the effects have not gone away.
This infant had a febrile seizure, temp of 105; five days after his MMR, Varicella, and Prevnar, immunization.
9pm(12 hrs after shot), fever, aches 8am, next day, swelling, itching heat at injection site
Pt states that arm is hurting from the shoulder all the way down to the wrist. Upon examining arm pt has no redness no marks of any kind. Pt has brought this up to primary care as well but no concern was expressed.
A territory representative reported that a 66 year old female received a 2nd dose of Pnu-Imune 23 on 111/28/00; she received a 1st dose on 4/10/98. That day, she developed a large area of cellulitis that extended from the injection site across her upper back. She was seen in the ER and admitted to the hospital. She was treated with IV antibiotics. She recovered.
have shingles breakouts/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st shingles vaccine on an unknown date 6 years ago).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The age at vaccination was not reported. The patient got her first shingles shot approximately 6 years ago and got the 2nd shot close to a year later. In the last couple of years the patient continued to have shingles breakouts.  The reporter asked if the patient should she get a second round of shots. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported. Note: From the narrative it was not clear if the patient received 2 doses of shingrix or received only 1 dose of shingrix hence it only single suspect was coded.
This spontaneous report as received from a medical assistant concerning an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported.  On an unknown date the patients were vaccinated with a dose of RECOMBIVAX HB (dose, dose number, lot number, expiration date and route were not reported). The medical assistant reported that on an unknown date, that unspecified patients received improperly stored RECOMBIVAX HB, exposed to  -1C for 24 hours on 19-AUG-2014. No adverse effects were reported. This is (1) of four (4) reports from the same source (MARRS 1409USA002639, 1409USA006394, 1409USA006395 and 1409USA006396). Additional information has been requested.