chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow-up information has been received from a physician concerning a 12 year old female patient who on 10-APR-2008 was vaccinated with the first dose of GARDASIL (Lot # was not provided). Concomitant therapy included MENACTRA. On 11-APR-2008 the patient slept all day and four days later she developed rashes on her left cheek, throat and neck. On 8-MAY-2008 the patient went back to the physician's office and she still had hives that time. The hives were treated with BENADRYL (manufacturer unknown) and MEDROL dose pack (manufacturer unknown). On 15-MAY-2009 the patient went back for another checkup, the hives were already gone. Therapy with GARDASIL was discontinued. Additional information has been requested.
not been able to breath for days/difficulty breathing; voice has change; difficulty to  talk; felling scare; throat swollen; Chills; body aches; sly fever; cough; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (not been able to breath for days/difficulty breathing), DYSPHONIA (voice has change), SPEECH DISORDER (difficulty to  talk), FEELING ABNORMAL (felling scare) and COUGH (cough) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced COUGH (cough). On 03-Sep-2021, the patient experienced DYSPNOEA (not been able to breath for days/difficulty breathing), DYSPHONIA (voice has change), SPEECH DISORDER (difficulty to  talk), FEELING ABNORMAL (felling scare), PHARYNGEAL SWELLING (throat swollen), CHILLS (Chills), MYALGIA (body aches) and PYREXIA (sly fever). The patient was treated with GUAIFENESIN (MUCINEX) for Adverse event, at an unspecified dose and frequency. On 06-Sep-2021, CHILLS (Chills), MYALGIA (body aches) and PYREXIA (sly fever) had resolved. At the time of the report, DYSPNOEA (not been able to breath for days/difficulty breathing), DYSPHONIA (voice has change), COUGH (cough) and PHARYNGEAL SWELLING (throat swollen) had not resolved and SPEECH DISORDER (difficulty to  talk) and FEELING ABNORMAL (felling scare) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
a 19 month old child received a dose of ADACEL with no reported adverse event; Initial information received on 03-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 19 months old child received a dose of adacel with no reported adverse event, while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, with an unknown strength, formulation and dose ( lot : U6964AA ; expiry date: not reported)  in unknown administration site for immunization.  On an unknown date the patient developed a non-serious a 19 month old child received a dose of adacel with no reported adverse event (product administered to patient of inappropriate age) (latency: same day ) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (a 19 month old child received a dose of ADACEL with no reported adverse event).  At time of reporting, the outcome was Unknown for the event a 19 month old child received a dose of adacel with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Dizziness; tired; slightly nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FATIGUE (tired) and NAUSEA (slightly nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (Dizziness), FATIGUE (tired) and NAUSEA (slightly nauseous). At the time of the report, DIZZINESS (Dizziness), FATIGUE (tired) and NAUSEA (slightly nauseous) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
9 x 10.5cm swelling to left arm. Warm to touch for 2 days.
Began experiencing high pain/redness/swelling right upper arm on Sat 1/23/10, 2 vaccines administered in right extremity H1N1 in right deltoid, pneumococcal in right octal aspect. Seen at ED on 1/24 and diagnosed with Cellulitis.
12/11/08 6:00pm, Rash appeared on L arm and L side of face and chest.  Pt. also had local reaction of warmth and redness, described "like the size of a fist "Night of 12/11 pt. 's throat and L side of body itchy.  12/12/08 am, On awakening:  She discovered red raised rash all over body.  Pt took BENADRYL and saw MD.  Pt. received steroid injection.  MD instructed pt. to continue BENADRYL.
Initial report received from a non-healthcare professional on 27-Nov-2013. A 48-year-old patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number: UT4719BA) on right deltoid via intradermal route on 10-Oct-2013. On 12-Oct-2013 patient developed redness with nodule at injection site and lasted 3 days. On 15-Oct-2013 the red area turned white. As of 27-Nov-2013 the nodule persists and was painful per patient. Patient stated to reporter she did bump the area and caused bruising at the site as well and no surrounding redness. Patient did not treated herself symptomatically. The events were not resolved. List of documents held by sender: none.
After 8 minutes my left neck shoulder got itchy in one main spot.   After 20 minutes I was able to look in mirror after sitting in center for 15 minutes and the main itchy spot on my left neck/shoulder muscle had bubble like allergy look at main location of itchyness.  I also had some hives and redness about the diameter of 4 inches or so on the neck.   I reported the symptoms at the site to a nurse at the front table of the waiting room.  After about 25 minutes the itchness and redness kept subsiding.  After about one hour the itchyness was over and the bumps had completely disappeared.  I did not take any benadryl or epi pen.
No additional AEs were reported; The patient was administered MMR II via intramuscular route instead of subcutaneous route today; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 28-SEP-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (1 dosage form, lot # T001214, expire date: 12-JAN-2022) via intramuscular route for prophylaxis (incorrect route of product administration). No additional adverse events were reported. No further information provided.
Initial report received from a healthcare professional on 01 October 2014. A 87-year-old female patient, whose medical history and concomitant medication were not reported, received a dose of FLUZONE HD (batch number, expiration date, route, site of vaccination and dose in series not reported) on 17 September 2014. The patient had experienced pain in arm, and loss of movement at the time of vaccination on 17 September 2014. It was also reported that extreme pain in right arm was continued and had loss of movement so that she cannot feed herself or care for herself and unable to sleep. The detail of laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome of the events was not recovered. List of documents held by sender: none.
arm pain that feels neuropathic. has been hurting for over 1 week. patient is seeing a chiropractor for it. she says the pain  sometimes runs to her upper back behind her armpit
on monday i had chills for about one hour. i also have a swollen and sore arm but now (two days after vaccination) has decreased
Client reports on Sat., July 4, 09, she noted a mild rash at site of injection.  Denies itching at this time and had no other complaints.  Reports that she had some nausea and stomach pains after eating on Sunday, July 5, 09 with each meal.  She also reports being extremely tired after returning from church and was experiencing some vertigo and "off balance" sensation.  She states the rash still present but no itching.  She states that this morning she is having some mild itching at site of injection and continues with the rash at the site of injection.  She has not eaten this morning, but states her appetite is fine and has been, that she has nausea and stomach pains after she eats.  She has an appointment to see her doctor today, July 6, 09 for a discolored finger which she also went to the ER for on Friday, July 3, 09.  She reports she had a tingling sensation in her right ring finger and her finger was cold and turned purple.  She denies any known trauma to her finger.  The discoloration had started 6-29-09 before she was vaccinated.  She also reports a genetic disorder called Leiden factor 5 (a clotting disorder).  She plans on discussing all of her immediate issues with Dr. today at her appointment.
just got Covid for the first time; just got Covid for the first time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "just got Covid for the first time". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: just got Covid for the first time.  Clinical course: The reporter stated that "symptoms were mild and the whole time just felt so grateful that  didn't have to worried about going to the hospital or putting my older family at risk of dying, and that's all because of your miraculous work to create a vaccine so fast and save so many of our lives.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Seen at clinic on 1/14/19 for febrile illness with onset of fever on 1/13/19 and onset of redness at site of VARIVAX injection at right thigh on 1/12/19. Started on Clindamycin by mouth for myositis. Returned to clinic on 1/15/19 for increased redness at affected area. Had labs done to include CBC, CPK, ESR, CRP, and blood culture on 1/15/19. Labs came back with elevated CRP and ESR. Admitted to hospital on 1/15/19 for cellulitis with concern of abscess formation and started IV Clindamycin. Had incision and drainage of area on 1/16/19 in OR by surgeon. Findings on I&D procedure per report by surgeon: Indurated subcutaneous tissue; no evidence of purulent fluid.  Report of area of erythema at right thigh improving on 1/17/19. Plan possible discharge home on 1/18/19 per note from hospitalist and surgeon.
Information has been received from a physician via a company representative concerning a 5 year old healthy  male with no known drug allergies and drug reactions who on 10/4/05 was vaccinated SQ with a 0.5ml dose of MMR (lot # 649675/0240R). Concomitant therapy included a dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanu7s toxoid (lot # A C14A006AA) and a dose of poliovirus vaccine inactivated (lot # Y0496). On 10/4/05, within minutes after vaccination the patient sneezed 3 times, began wheezing, experienced trouble breathing and developed hives. He was treated in the physician's office with epinephrine, diphenhydramine hydrochloride, albuterol sulfate, and dexamethasone and was hospitalized. On an unspecified date, the patient was recovering. There was no product complaint involved. Sneezing, wheezing, trouble breathing and hives were considered to be immediately life threatening, disabling and other important medical events by the reporting physician (OMIC). Additional information has been requested.
About 30 minutes after the injection my mouth started to tingle. After the 2nd dose my tongue had a burning sensation. After 3rd dose I started having a burning sensation, ulcers on the left side of my tongue, lost of taste buds.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Nausea-Medium, Additional Details: Patient was heaving about 3 minutes after administration. She started to cough and vomited right after. Her husband helped translate and said she was having difficulty breathing so we administered an epi-pen for 1 dose. She has chills and felt extremely cold.  We had her in for observation for 45 minutes and she said she felt better.  We advised her husband if she has any worsening symptoms to call 911 immediately.
same as mom-fever that noc then stiff, sore arm;took ASA thru 24MAY for relief of pain
pregnant when she got the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant when she got the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant when she got the vaccine). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant when she got the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
No additional adverse events reported; the administration of VARIVAX to a 9 month old Patient; This spontaneous report was received from a medical assistant and refers to a 9-month-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 09-MAY-2022, the 9-month-old patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U015844, expiration date: 19-MAY-2023, (strength, and route of administration were not provided) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events reported. No product quality complaints reported.
First shot was February 8, 2021. A day later he started to lose control of his nerves. He was constantly shaking. He couldn't hold a glass with water without it flying out of his hand accidentally. He needed someone behind him to walk anywhere because he would faint.  The second shot was March 8, 2021. The symptoms got worse. He was not able to walk without a walker, which quickly led him to a wheelchair. There was one day he felt to confident and tried to sit at the counter barstool. His legs gave out, or he fainted, we're not sure, but he landed on the ground and hit his head so hard he was unconscious and he brought him to the hospital. A week later he was on his way out from discharge and he fell again.  He did not leave the hospital again.  His kidneys failed, then his liver, and then his heart. He died on May 14, 2021.
circle of pain over left ear, wont leave, extreme tenderness of scalp, light sensitivity, instability, circle of pain moved to top of head, then to base of skull, intermitted pain of side of head
I waited the 15 minutes and let the building. After being on the road for about 10 minutes my right side of my cheek and jaw area started itching. I went straight home and took some Benadryl and the rash stopped spreading.
10/30/21 0035 had emesis, Zofran given, T 99.7, ABD distended with hypoactive BS 4 quads, 0400 had BM, began to be congested,  2030 no longer able to take anything po due to lethargy, SA02 down to 86%, no voiding, sent to ER 10/31/21 0025.  Hospital DX acute hypoxic respiratory failure.
Awoke with swollen upper lip  and is having intermittent tachycardia to the 130's at rest. Has taken Benadryl. Lip looks a little better now at 2:25 PM than this AM. Slightly scratchy throat. Has no allergies to meds, foods etc.
on day 8 (17 May), injection site became tender, swollen, achy and red.
Joint muscle pain, twitching of  lips on the left side, (minor) My niece had a severe reaction of twitching on both sides of face  for 5-6 days, now she has right side drooping
RNs x 2  responded to pt's vehicle c/o nausea, left arm tingling. RN reported pt was visibly "panicked " and self-reports he "passed out twice:"  after seeing blood after getting vaccine. RN  reported pt had small of blood on bandaid. Reports history of anxiety, especially r/l  blood needles
Stiff arm at injection site day of vaccine then radiating pain up and down arm with stiffness, feeling achy and "flu like" dizzy.
loud ringing in ears... no treatment.  has only increased in 1 week has not resolved
patient received the diluent because the pharmacist failed to dissolve the vaccine and just gave the diluent with no reported adverse event; Initial information received on 15-Jun-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2023SA185167.  This case involves a 6 years old male patient who received the diluent because the pharmacist failed to dissolve the Yellow Fever Vaccine [YF-VAX] vaccine and just gave the diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Jun-2023, it was reported that 0.5ml dose of suspect Yellow Fever Vaccine Solution for injection (lot number and expiry: not reported) was not reconstituted and the patient received the diluent because the pharmacist failed to dissolve the vaccine and just gave the diluent with no reported adverse event (product preparation error) (latency: same day). Information on the batch number was requested.  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Keep getting pain in left arm at injection site. It is either sharp shooting pain, or throbbing pain.; I have also experienced chest pain and difficulty breathing.; I have also experienced chest pain and difficulty breathing.; dose 1 and 2 on 05Jun2021; This is a spontaneous report from a contactable other HCP(patient herself reported).  A 50-year-old female patient received BNT162B2(Solution for injection, Lot number EW0176)via unspecified route on left arm on 05Jun2021(age at vaccination: 50 years) at 12:15PM as DOSE 1,SINGLE FOR  COVID-19 Immunisation .The patient received second dose (Lot number:EW0181) via unspecified route on left arm on 05Jun2021 DOSE 2,SINGLE for covid19 immunisation. The patient was not pregnant at time of vaccination. The patient's medical history included hyperthyroidism. The patient has known allergies to Claritin, Tramadol. On 10Jun2021, patient experienced pain in left arm at injection site which was either sharp shooting pain, or throbbing pain, patient also experienced chest pain and difficulty breathing. No other vaccine was given in four weeks of vaccination. Patient was not given any treatment with respect to the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events pain in injection site, chest pain and difficulty breathing not recovered.  Follow-up attempts are completed. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A little achy), PAIN IN EXTREMITY (Had a sore arm) and ANOSMIA (Then he called me back & said he couldn't smell anymore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Couldn't smell anything).    On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PAIN (A little achy), PAIN IN EXTREMITY (Had a sore arm) and ANOSMIA (Then he called me back & said he couldn't smell anymore). At the time of the report, PAIN (A little achy), PAIN IN EXTREMITY (Had a sore arm) and ANOSMIA (Then he called me back & said he couldn't smell anymore) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.  Company comment: This is a spontaneous case concerning a  male patient of an unknown age with medical history of COVID-19 and anosmia, who experienced non serious, unexpected event of anosmia. The event occurred the same date after the second dose of mRNA-1273 vaccine. No information about the first dose was disclosed. Treatment details were not provided. Medical history of the patient remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a  male patient of an unknown age with medical history of COVID-19 and anosmia, who experienced non serious, unexpected event of anosmia. The event occurred the same date after the second dose of mRNA-1273 vaccine. No information about the first dose was disclosed. Treatment details were not provided. Medical history of the patient remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Left thigh where Pediarix was given was swollen, warm to touch and red.  Left arm where ProQuad was given was swollen, warm to touch and red. Seen by Dr. in office and was given Atarax syrup to be taken orally and Topicort cream to apply topically.
pt recv vax 27AUG96 230PM & 6PM pt awoke from nap screaming nonstop x 2hr;no fever;purple knot noticed on lt thigh;taken to ER threw up 2x in ER given ibuprofen-was not adm;