chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme fussiness with appearance of severe abdominal pain.  No bowel movement for 7 days following vaccine, with pattern persisting for a month. There was question of infant having an ileus.  To date, infant is exhibiting signs of significant food allergies, in a family where food allergies are not prevalent.
My right leg from the knee down was purple and they thought I have a blood clot; My right leg from the knee down was purple and they thought I have a blood clot; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Three days after vaccination the patient felt very sick and he/she was so bad that he/she thought he/she might die with outcome of recovered after one week. The patient reported also that on unknown date his/her right leg from the knee down was purple and they thought he/she have a blood clot, due to which the patient was hospitalized for 14 days. The patient ended in the hospital because his/her right leg from the knee down was purple and they thought he/she have a blood clot but they did an ultrasound that was not the case but they put he/she on antibiotic. The patient was still taking them but his/her leg has got better.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
I experienced blurry vision.  I was experiencing the other common effects as well, but the blurry vision came towards the end of the time I was experiencing the other effects and continued until the all of the other side effects were over. I did not seek any treatment.
irritation in throat; headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (irritation in throat) and HEADACHE (headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (irritation in throat) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, OROPHARYNGEAL PAIN (irritation in throat) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Violent Vomiting, Diarrhea, Chills, Fever, Fatigue lasted about a day.
Infant found unresponsive, not breathing while at daycare. Taken to ER; resuscitation unsuccessful. Autopsy report received on 12/04/2003 states COD was SIDS.
Aches; Fever; Headache; Pain at injection site; The morning after my second dose I fainted.; I had low blood pressure, aches, fever, headache, pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (The morning after my second dose I fainted.), HYPOTENSION (I had low blood pressure, aches, fever, headache, pain at injection site), PAIN (Aches), PYREXIA (Fever) and HEADACHE (Headache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced SYNCOPE (The morning after my second dose I fainted.) and HYPOTENSION (I had low blood pressure, aches, fever, headache, pain at injection site). On an unknown date, the patient experienced PAIN (Aches), PYREXIA (Fever), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, SYNCOPE (The morning after my second dose I fainted.), HYPOTENSION (I had low blood pressure, aches, fever, headache, pain at injection site), PAIN (Aches), PYREXIA (Fever), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) Abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On unknown date, Laboratory test EKG was done and result was unknown.  Relevant concomitant medications included Birth control unspecified.  No treatment information was provided. Company comment: This is a spontaneous case concerning a 25 year-old, female patient with no medical history reported, who experienced the non-serious unexpected (expected for US), event of Syncope. The event occurred approximately 1day after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 25 year-old, female patient with no medical history reported, who experienced the non-serious unexpected (expected for US), event of Syncope. The event occurred approximately 1day after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report as received from a medical assistant refers to a 52 year male patient. The patient had no pertinent medical history. The patient had drug allergies to ibuprofen and aspirin. On 31-AUG-2016 the patient was vaccinated with ZOSTAVAX, 0.5 ml ("half cc", incorrect dose administered) subcutaneous. The patient received an unspecified flu shot (influenza virus vaccine (unspecified) on his other arm on the same day he received ZOSTAVAX). It was not specified which arm received the ZOSTAVAX and which arm received the flu shot. Concomitant therapies included "Senobirate", lisinopril, losartan (manufacture unknown), lycopene, multivitamin, propranolol, simvastatin (manufacture unknown), ascorbic acid (vitamin C), vitamin D and ZYRTEC. On an unknown date in 2016 after receiving the vaccine, the patient developed "general and local reactions" (local and general reactions were not specified), a fever and chills. The patient received unspecified treatment. There was no lab performed. The patient was at medical office at the reporting time and was currently recovering. Additional information has been requested.
Pt stated she "passed out" after using the bathroom, the night after she received her pneumovax and tetanus shot. She also stated, she had redness and swelling down to above the elbow.
after the first shot on January 31, 2021 I had  a reduction in cardio respiratory health including shortness of breath. On April 29, 2021 I had atrial fibrillation that lasted about 10 minutes. Approximately two weeks later, I had atrial fibrillation with very high heartbeat. After hospitalization, I was given drugs to convert my heartbeat to sinus rhythm. Hospital did not test for myocarditis. Since that time, I have experience fatigue and shortness of breath. I did have atrial flutter 15 years ago which was corrected with an ablation. I have not been out of sinus rhythm for the last 15 years, except when I had Pericarditis 2 years ago. At that time I was put into atrial fibrillation which was corrected with drugs. The drugs were discontinued after one set of doses.   Currently, my doctor is maintaining me on  Metoprolol Until they have performed A heart stress test, and Eco
Soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), as dose 2, single (Lot number: EL9261) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: on antihypertension meds; "Atrial fibrillation paroxysmal" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Atenolol for hypertension, notes: take 50 mg in the morning and 25 mg in the evening. Vaccination history included: Bnt162b2 (EK4176, dose 1), for COVID-19 immunization, reaction(s): "soreness in the arm". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness in the arm".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367340 same patient, different vaccine dose number/different event;
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 09/07/2021. PATIENT FULLY VACCINATED ON 05/06/2021.
HYPERtension, Tachycardia, A feeling of a "hot flash" in her face and upper body which.lasted 10 minutes
48 hrs after injection area of erythema (4cm) and induration (2cm) noted at injection site. Warm to touch.
Pt. experienced allergic reaction swollen, inflamed around injection site. Pt. prescribed hydroxyzine HCl.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 25-FEB-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of VAQTA lot# L023232 and expiration date: 25-FEB-2017, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
INJECTION SITE REDNESS; This spontaneous report received from a consumer concerned a 28 year old male. 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, batch number: 203A21A, and  expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site redness. This report was non-serious.
Member states the event started the day after immunization (Monday). It began with achy/sore joints. Around 2 am the member states he woke up with fever and cold sweats. Tuesday he reported feeling malaise. The soreness/achiness, malaise, and fever continued through Thursday. He states he went to an urgent care on that day and the provider suggested it could be vaccine related as he had no other illness. The member stated the fever finally broke today (Friday) and he is starting to feel better.
Within 5-10 mins post-injection pt became pallor, sweaty, dizzy and had a vasovagal episode while sitting in her chair. Pt exhibited jerking motions and then quickly had a syncope episode lasting <1 min. Pt was lowered to the ground during the episode. No trauma occurred. Pt mother beside pt entire time. During this time a pulse ox was put on pt and her legs were elevated. Pulse ox remained 96-98%.  After waking, water and wet rag was given to pt and pt moved to reclined chair after 5 mins. Pt remained pallor and dizzy x15mins, after 40 mins pt was able to walk and leave the clinic. Mother stated in past that pt had a vasovagal episode after the Gardasil vaccine.
Feaver, Chills\shaking (did not take body temerature) Took 1000Mg Acetaminophen (Generic brand). Woke 4 hours later and felt 'OK'.  No feaver.  I feel this event was related to the booster administration due to the timing and the effects. I am simply reporting it.
The mother of a 6 month old male reported that her son received Prevnar, Hib and DTP vaccines on 6/16/00. By 00:00 AM on 6/17/00, he developed fever, "little welts on the back of the neck which looks like heat rash", decreased appetite and diarrhea. The infant was treated with acetaminophen. The fever persisted as of 6/19/00.
Patient has  been having light headedness and spells where he feels like I could pass out". States about a week ago he left work due to symptoms. Then states "well yesterday they sent me home because I had a spell again but im always kind of light headed faintish a little bit any ways". Slight chest tightness and "heart palpitations I guess" reports patient. States fatigue from the shot as well but has mostly resolved
intermittent sharp substernal chest pain post 1 week of receiving vaccination. No alleviating or aggravating factors.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an expired dose of M-M-R II (dose, route of administration, lot# and expiration date were not reported). The vaccine was reconstituted with non-expired sterile diluent. No adverse effect was reported.
Shot Given on 1/3/07. Arm sore on 1/4/07 fever of 101 on 1/4/07 in evening. Patient returned to MD's office on 1/5/07 had temp of 100.9. Also R upper arm 7 1/2 cm x 7cm red, warm and tender. MD rxd with Keflex and Vicodin.
PT was over the age limit for the vaccine. No adverse reaction occurred. Pt was given HPV in lieu of HBV vaccine.
Arm I got the injection in is stiff; I felt weak this morning.; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm I got the injection in is stiff), ASTHENIA (I felt weak this morning.) and VACCINATION SITE PAIN (Soreness at injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Stent placement since 28-Jan-2021.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm I got the injection in is stiff), ASTHENIA (I felt weak this morning.) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm I got the injection in is stiff), ASTHENIA (I felt weak this morning.) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable Concomitant medications included blood thinner. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-024563 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-JUL-2021 included Mailing address.
Patient experience soreness for 3 to 5 days but had an unusual symptom of tongue soreness and pain at the tip of the tongue.
got first dose on 8/23, on 9/9 had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 23rd August 2022, the patient received Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be possibly related to Shingles vaccine.     Additional Information: GSK receipt date: 11-Sep-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got the patient first dose of the shingles shot on 23 August 2022 and on 9th September 2022 went to physician and they said patient  had shingles. The pharmacist told to patient it was a possibility that the patient got it from the shot. Additional supportive information: The follow up would not possible as no contact details were available.
BODY ACHES; VOMITING; COLD CHILLS; LEG PAIN; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known medical history.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced vomiting. On 13-MAR-2021, the subject experienced cold chills. On 13-MAR-2021, the subject experienced leg pain. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, cold chills, leg pain, nausea, and headache on 14-MAR-2021, was recovering from fever, and had not recovered from body aches. This report was non-serious.
I waited for a total of 15 mins at clinic as requested for side effects. After the 15 mins past, I went to my car. By the time I got to my car (about 5 mins later at the most), my face felt flush and I had shortness of breath and began coughing. I then used my emergency inhaler for asthma and was able to breathe better. I went back inside clinic to be monitored by a doctor. The coughing continued and resided after about15 -30 minutes. My blood pressure was normal per the doctor and my breathing returned to normal per the doctor.
A 3"x4" rash at location of injection on upper left arm; This is a spontaneous report from a contactable consumer (patient's parent). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in upper left arm on 15Dec2020 at a single dose for COVID-19 immunization. The COVID-19 vaccine was administered in a hospital. The patient has no medical history and there were no concomitant medications. Patient has no allergies to medications, food, or other products. The patient experienced a 3"x4" rash at location of injection on upper left arm in Dec2020. The event was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the adverse event. The outcome of the event at the time of last observation was recovering.  Information about lot/batch number has been requested.
Pt rec'd vaccine (Fluzone) on 10/15/07 at flu clinic at pharmacy. Pt called pharmacy on 10/20/07 complaining of soreness at and around injection site. Pt noted no swelling, redness. Pain worsened during night per pt report. Pt was called again on 10/24/07 to follow-up on symptoms. Pt continues to report and pain in upper arm and lower shoulder upon movement, but severity is lessening. At does not desire to seek medical attention at this time (10/24/07). Plan on calling patient again on 10/29/07 to follow-up.
Body Aches Mild-Moderate; Headache Mild-Moderate; Joint Pain Mild-Moderate; Feeling Queasy; Pain Injection Site; Difficulty Sleeping; A spontaneous report (US)  was received from a 76-years-old male consumer, who received Moderna's COVID-19 vaccine (mRNA-1273)  and experienced Mild-Moderate body aches, Headache, joint pain, feeling queasy, Injection site pain and difficulty sleeping.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02-FEB-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 029K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 02-FEB-2021, the patient experienced difficulty sleeping. On 03-FEB-2021, the patient experienced mild-moderate body aches, headaches, joint pain, feeling of queasy and injection site pain.  Laboratory details was not provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events was unknown.
This is a spontaneous report from a non-contactable physician via Pfizer sales representative. A 12-year-old female patient otherwise healthy of an unspecified ethnicity received TRUMENBA at single dose in one arm and HPV9 in the other arm, both via an unspecified route of administration on an unspecified date at an unspecified dose for immunisation. The patient medical history and concomitant medications were not reported. The next day she presents body rash and difficulty breathing managed at office until ambulance arrived-upon arrival at ER situation resolved. No follow up attempts are possible. No further information is expected.
I had hives all over the body. I took Benadryl and Zyrtec around the clock, from the beginning of adverse event and they continued. Was prescribed Prednisone by her spouse who is a physician. It started to clear up soon after taking the Prednisone.
Severe bodyaches at 1am, migraine, chills, sweating, fatigue lasted until 9pm.
Information has been received from a registered nurse concerning a 65 year old male with type 2 diabetes mellitus (DM 2), hyperlipidaemia, hypertension (HTN), gastrooesophageal reflux disease (GERD) and iron deficiency (FE def.) anaemia and no illness at time of vaccination who on 28-OCT-2010 9:00 AM was vaccinated IM into the right deltoid with the first dose of PNEUMOVAX 23 (lot number 667271/0880Z). Concomitant therapy included the third dose of FLUZONE given IM into the left deltoid on 28-OCT-2010, LIPITOR, metformin, lisinopril (manufacturer unknown), iron (unspecified), omeprazole (manufacturer unknown) and low dose aspirin (ASA). On 28-OCT-2010 9:00 PM, "day after immunization", the patient reported by phone that right arm was sore, swollen, red and itchy. Advised symptomatic treatment of ice, TYLENOL and BENADRYL and to call if worsened or not resolving. On an unspecified date, the patient recovered from right arm was sore, swollen, red and itchy. No diagnostic laboratory tests performed. No further information is available. This one of several reports received from the same source.
This case was reported by a gastroenterologist, via a sales representative, and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified) for prophylaxis.  On an unspecified date the subject received the 3rd dose of Hepatitis B vaccine (unknown) to complete the series.  At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced not responding to therapy.  At the time of reporting the outcome of the event was unspecified.
Acute dizziness, especially with movement.  Starting 1 hour after vaccine, ending 20 hours after vaccine.  Also "felt like a dream" first evening, mild headache morning after vaccine.