chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortness of breathe; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breathe) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breathe). At the time of the report, DYSPNOEA (Shortness of breathe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported.  The treatment information was not provided.
I contracted COVID-19 on 06/27/2022 with symptoms of headache, congestion, runny nose, swollen glands, fatigue, and fever of 99.6. I was prescribed PAXLOVID on 06/28/2022 via a telemedicine visit. I am also taking TYLENOL and MUCINEX as well for my symptoms. I feel a little bit better, but my symptoms have not begun to resolve yet.
Received Covid 19 Pfizer vaccine booster on 03/18/2022. States she started to have side effects on 03/20/2022 of Sore throat body aches no fever bad headache, she took Tylenol and ibuprofen to help alleviate some of the pain but wasn't able to maintain to have it assist.  Went to ER due to not still feeling well and having this sore throat, and thought she might have contracted Covid. She went and got a test done but came back negative for Covid  and still is having sore throat and feeling sick. She states she had a reaction to the 2nd dose she took last year of respiratory issues and seen a provider . States that she will get another Covid test done because it might have been to early
pt says she had sore right arm that was hard to lift for about 3 days.  She had shaking  and chills along with nausea that lasted about a half an hour.  On 4/25/2021 she woke up feeling bad with kidney pain in her back.  She couldn't get comfortable.  She developed headache, nausea, stiff neck and joint pain.  She had head pain, not like a headache and feeling of being cold.  Her right arm became itchy and the pain returned like she had just received the shot.  On 4/27/2021 her upper right arm has a itchy red rash on it, she has a slight temp, headache and her tongue is burning.  She is only taking Tylenol for her symptoms.
red raised hives like symptoms in middle flexion, front, back, and forearm, ones on the waist are bigger compared to others, ones on arm are little itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (red raised hives like symptoms in middle flexion, front, back, and forearm, ones on the waist are bigger compared to others, ones on arm are little itchy) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included LISINOPRIL and DOXYCYCLINE (ORACEA [DOXYCYCLINE]) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced URTICARIA (red raised hives like symptoms in middle flexion, front, back, and forearm, ones on the waist are bigger compared to others, ones on arm are little itchy). At the time of the report, URTICARIA (red raised hives like symptoms in middle flexion, front, back, and forearm, ones on the waist are bigger compared to others, ones on arm are little itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported.
Pt. received flu shot on 8/25/11.  That night at 1:15 am he wokeup and was shivering uncontrollably and running a fever of 101.7. He has body aches.   Took Tylenol and called nurse hotline who told him to go to ER or call doctor.  Was able to go back to sleep around 3am and when he woke  fever and chills were gone but had a pounding headache. He called the Nurse Clinic to report the adverse event. Told to treat symptomatically with Tylenol and Ibuprofen.  He stayed home from work but stated he felt better.
Hand tingling; nausea; Medicine head feel; This is a spontaneous report from a contactable other Healthcare Professional (patient).  A 42 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261), via intramuscular route, administered in Right Arm on 28Jan2021 at 13:00 (42-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. The patients medical history included Penicillin and Sulfonamide allergy, milk and egg intolerance. The patient concomitant medications were not reported. The patient did not receive any other vaccine within in four weeks prior to vaccination. The patient was not infected with Covid prior to vaccination. On an unknown date in 2021, the patient had experienced hand tingling and medicine head feel for 30 mins with nausea occurring 2 days later. Since vaccination the patient was not tested for Covid. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
pneumonia; Fever; chills; nausea; difficulty breathing; This is a spontaneous report from a contactable other HCP (patient). A 33-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 11:00 at a single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient experienced fever, chills, nausea, pneumonia, and difficulty breathing on 11Feb2021 23:00 with outcome of recovering. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was not diagnosed of covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab test post vaccination: negative on 13Feb2021. Therapeutic measures were taken as a result of events (antibiotics, IV fluids, Tylenol). The patient received second dose (Lot Number: EN6201) on 12Feb2021 12:00 PM in the left arm.; Sender's Comments: There is a reasonable possibility that the events fever, chills, and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the events pneumonia and difficulty breathing with Bnt162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Felt increased nasal pressure shortly after receive FluMist, within 20 minutes had feeling that she was going to passout r/t increased pressure, headache.  Felt slightly dizzy, concentration problems for 24 hrs. and general achiness for ~72 hrs. Headache lasted until 11/12/12. All symptoms resolved 11/12/12.
Fainted suddenly the morning after receiving the vaccine. I couldn't get off the floor. I had no strength and I was covered in sweat. I felt pretty bad the rest of the day and stayed in bed. I was lethargic for a couple days.
Cold sweats, Severe bodyaches, headache, Loss of taste, and high fever.  Symptoms occurred approximately eight hours after injection and lasted for about 12 hours.
she is smelling things no one else can smell; sudden my sense of smell heightened or something; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 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: HALLUCINATION, OLFACTORY (medically significant) with onset Oct2023, outcome "unknown", described as "she is smelling things no one else can smell"; PAROSMIA (non-serious) with onset Oct2023, outcome "unknown", described as "sudden my sense of smell heightened or something".  Clinical course: Caller got the Covid vaccine shout about two weeks ago and nowshe was smelling things no one else can smell. She was experiencing that side effect where she could smell things that other people around her don't smell. So, she was calling to see if that was a side effect with the vaccine. She stated, "it was just odd because even with our furnace, when we first turned that on, she can smell something coming from the vent. She had the furnace man out that day. He and my husband can't smell anything. Like all of a sudden her sense of smell heightened or something. She would smell something and no one else around her could not even smell it. So, she did not know if it was her nose and she was just wondering if that was any kind of a possible side effect.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
9/27/10 11am - vaccine admin./ 9/28/10 2am vomiting and nausea 20hrs. (projectile, per pt) and diarrhea. Called out sick 9/28. 9/29/10 returned to work, arm red and swollen. Advised to see her doctor by author (see attached).
Fever over 101 F; Chills; Nausea; Muscle ache; Fatigue; Sore throat; Headache; Neck pain; This is a spontaneous report from a contactable healthcare professional. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Apr2021 at 19:15 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC), vitamin B12 (MANUFACTUREER UNKNOWN) and colecalciferol (vitamin D3) (MANUFACTUREER UNKNOWN) from unknown dates, for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Mar2021 at 19:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14Apr2021 at 03:30, the patient experienced fever over 101 (Fahrenheit), chills, nausea, muscle ache, fatigue, sore throat, headache and neck pain. The patient underwent lab tests and procedures, which included Body temperature on 14Apr2021 at 03:30 and resulted 101 (Fahrenheit). Therapeutic measures were taken as a result of the events which included treatment with acupuncture. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events fever over 101 (Fahrenheit), chills, nausea, muscle ache, fatigue, sore throat, headache and neck pain was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt reported to clinic today with right sided facial weakness that started yesterday around 7:30pm. Received Shingrix vaccine on 04/04/18 at her local pharmacy. Pt started on prednisone and soothe eyedrops. Pt advised to go to ER if increased weakness, slurred speech, or imbalance.
530PM color pale, lips pale, skin W/D, BP 82/30; 536PM 02 on/mask, BP 88/50; 540PM color pink skin W/D sat @ bedside; no redness, welting @ inj site; lying down feet elevated @ 530; 540PM small sip of H20;
BODY DIFFERENT; SWEAT A LOT MORE; PEOPLE HAVING HARD TIME HEARING ME; BODY ODOR  STRONGER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 not reported, batch number: Unk) 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 subject experienced body different, sweat a lot more, people having hard time hearing me, and body odor stronger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body different, sweat a lot more, people having hard time hearing me and body odor stronger was not reported. This report was non-serious.
Shot on Friday- Friday night had fever 101.6 degrees. Slept most of Saturday - part of Sunday fever 99.5 degrees. Still not feel well 10/27/05 - onset of cold, perfect before flu shot
Information has been received from a registered nurse, for the pregnancy registry for GARDASIL, concerning a 15 year old female patient with no pertinent medical history, drug reactions or allergies who on 07-AUG-2009 was vaccinated IM with a first dose of GARDASIL (Lot# unknown). On 13-OCT-2010, the patient was vaccinated IM with the third dose of GARDASIL (Lot# 666596/0766Z) (Expiration date: 15-Oct-2012). On 13-OCT-2010, the patient also received the third dose of RECOMBIVAX HB (Lot# unknown) (manufacturer unknown) and the first dose of AFLURIA (Lot# unknown) (manufacturer unknown). It was reported that the first dose of RECOMBIVAX HB (Lot# unknown) (manufacturer unknown) was administered on 02-MAR-2009. Patient's Last Menstrual Period (LMP) was 04-FEB-2010. The nurse reported that on 19-OCT-2010 at 36 weeks and 5 days from LMP, the patient delivered a baby boy. It was reported that the patient sought medical attention by a follow up visit. The baby experience has been captured in WAES# 1012USA02470B1. This is one of two reports from the same patient. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC R.  The following information was reported: COVID-19 (medically significant) with onset 16May2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 16May2022 at 12:00, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: Have rebound COVID since 16May2022. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The patient had other medication in 2 weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm was red and swollen at injection site. Arm was warm to the touch and itchy.
pt recv vax & pt died;the COD was unk;reporter felt that the pt death was r/t therapy w/pneumococcal vax;
This case was reported by a physician and described the occurrence of not responding to therapy in an unknown number of subjects of unspecified age who were vaccinated with DTPA-HIBV-IPV (manufacturer unspecified). On an unknown date(s), subjects received 1st dose, 2nd dose and 3rd dose of DTPA-HBV-IPV (unknown details). On an unknown date, at an unknown time after vaccination with DTPA-HBV-IPV, the subjects experienced not responding to therapy. "Titers for anti-HBsAg [antibody to the hepatitis B surface antigen] are now less than 0.1 mIU/mL." The physician reported that "they have seen this in a couple other children who are now grown." The physician reported another case with similar events. See case A1011287A for details on the other case.
Initial report received on 08 April 2010 from a health care professional. Additional follow-up information was received from a physician on 09 April 2010. A 15-year-old female patient had received a first left arm dose of MENACTRA (lot number U3017AA) on 15 March 2010. Pre-existing medical conditions were reported as acute bronchitis, otitis media, and depression. The patient was using concomitant medications of "ZITHROMAX", PROZAC, and inhaler. It was unclear if the bronchitis and otitis media were concurrent illnesses at time of vaccination on 15 March 2010. Several hours post vaccination (also reported as 7 days post-vaccination) the patient experienced burning, tingling sensation described as if someone was rubbing a dry towel across her back from her head to the sacral area. The sensation was more prominent in the sacral area. The patient was evaluated by a physician the following day, and palpation along the area of sensation caused an increase in discomfort. The sensation had not changed in intensity, had not radiated along any specific dermatome and had not resulted in the development of any abnormal neurological signs on physical examination. No relevant diagnostic tests/laboratory data have been performed at this time. The physician will provide follow-up when more information is available, or when etiology has been established. At the time of this report, the symptoms were still persisting as of 02 April 2010. It was unknown if the patient has recovered.
lightheaded, nausea, vomiting x2. Evaluated by EMS-Refusal to transport.
I first became exhausted 4 hours after the shot and my arm started to hurt. I had headaches, intermittent sweating, deep exhaustion and body aches, occasional sharp shooting pains around my body, and a feeling of heaviness and lassitude. My arm remained sore, and these symptoms lasted for 5 days. I stayed in bed.  I also took ibuprofen the next day, for the symptoms, not realizing I was not meant to do that.  I was already weary, and dealing with major stress for weeks before the vaccine. And I had been taking max doses of OTC painkillers for an extracted tooth for over two weeks before the shot. The tooth extraction had problems but because of Covid risk my dentist told me to "tough it out." I took 800mg of ibuprofen and 1000 of Tylenol every six hours for over two weeks.
Developed left foot pain and purplish skin discoloration (resembling purpura fulminans) over middle three toes and midfoot, also had concurrent severe headache.
Acute cerebellar ataxia 11/02/06, 11/03/06, requiring ER visit, multiple Dr visits.
bluish bruising 2 in x 2in noticed on first evening. bruise increased in size as days passed. When reported on 10/19/09, bruise was 4 in x 5 in in size. No itching, no swelling. Tender to touch. No OTC treatments applied.
Patient reported left calf pain on 4/6/2021.  She underwent lower extremity duplex which was positive for left  deep vein thrombosis.
Malaise; Nausea; Vomiting; Given a higher dose of the Moderna vaccine than the one required in error; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Malaise), NAUSEA (Nausea), VOMITING (Vomiting) and ACCIDENTAL OVERDOSE (Given a higher dose of the Moderna vaccine than the one required in error) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2.5 ml. On 06-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Given a higher dose of the Moderna vaccine than the one required in error). On an unknown date, the patient experienced MALAISE (Malaise), NAUSEA (Nausea) and VOMITING (Vomiting). On 06-Nov-2021, ACCIDENTAL OVERDOSE (Given a higher dose of the Moderna vaccine than the one required in error) had resolved. At the time of the report, MALAISE (Malaise), NAUSEA (Nausea) and VOMITING (Vomiting) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant mediation was reported.  Patient received booster dose 2.5ml dose of the Moderna vaccine instead of the 0.25ml. Events were mostly ok the last check up on 7Nov2021. No medication was prescribed to alleviate the symptoms. Patient was under care of a doctor.     Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: Follow up received contained significant information reporter details, product details and new events were updated.
Pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 039J20A) for COVID-19 vaccination.     Concurrent medical conditions included Alcohol use (1 drink per week). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 08-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 05-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 02-Jul-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2020, Pregnancy test: positive (Positive) Positive. On 25-Mar-2021, Glucose tolerance test: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Moderna COVID-19 Vaccine formulation administered by Subcutaneous route as per source document.  Patient had Ultrasound on 15FEB2021 and had no concerns, Genetic Screen on DEC2020  No concerns, Glucose Tolerance on 25MAR2021 which was Normal.  Patient had Pregnancy previously and the end date was  where the outcome was Live, full term birth.   No treatment information is provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15JUL2021 and has new information about Patient demographics, Lab details, Pregnancy details, Moderna vaccine Dose details and Concomitants. On 02-Aug-2021: NNI.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Mom states patient developed fevers Sunday night & continues to run 99-101 degree F.  No other symptom.  States has been giving TYLENOL.  Instructed to notify physician.
1215-1230 head-dizzy-chills; pt did not feel well until 21OCT91;
Muscle pain on both arms at injection site, weakness, dizziness, difficulty breathing, fatigue, mental fogginess, -like a bad flu. Conditions gradually improved but lasted 6 days.
The day after injection started to have right eye pain, similar to being bumped in the eye.  One week later the eye has a stye.  It is red with a bump under the lid.  Confirmed diagnosis on 3/22/21 with health care professional:  Hordeolum externum of right upper eyelid.