chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. No concomitant therapy was reported. On 30-APR-2015 (also reported as "since 20-APR-2015"), the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous vial (dose, lot#, expiration date and indication were not reported), which underwent supported temperature excursions. NO adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
1st night severe rash over torso, arms, and face. 2 days later vomiting and diarrhea. The whole week after vaccine horrible migraines.
First, I did get covid-19 the omicron version on12/23/2021. On 02/25/2022 I went to the ER with what turned out to be heart arrhythmia and bradycardia. I was kept over night for observation and released with follow up visit with a cardiologist. No one seems to know if this is related to the vaccines, but I was advised to follow up with a report to you.  I am currently experiencing severe headaches that are not responding to OTC NSAIDS. As an aside, I have never had problems with headaches. Never. I am trying to enter the hospital info as requested to the right but I am unable to enter it. I keep getting a red circle with a line through it. So here is the hospital info.
Pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animals (Cats).    On 30-Dec-2020 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Jul-2020 and the estimated date of delivery was 22-Apr-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2020, Pregnancy test: postive (Positive) Positive.     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.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.  Estimated date of conception was reported as 01-Aug-2020.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Pt recv vax on 2/1/99; on 2/10/99 pt exp vomiting, fever, fine/ pinpoint/ red rash on face then back
really bad headaches after each dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (really bad headaches after each dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (really bad headaches after each dose). At the time of the report, HEADACHE (really bad headaches after each dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-417050, MOD-2021-417051 (Patient Link).
Redness, pain, heat at injection site noticed at 10 AM 5/19/21 and within two hours experienced fatigue and tiredness which lasted the rest of the day. 5/20/21 Redness, heat, and hardness at injection site continue and light headache appear but disappears after a dose of Tylenol. 5/21/21 Redness, heat, and hardness at injection site continue.
Patient complained of headache and feeling faint. Also had numbness to one side of leg and complained of foot drop. Had a fever. Was seen the next day. No further symptoms.
her blood pressure, it was a little bit high; little bit shortness of breath; she felt not well; a little bit tired; a fast pulse; This is a spontaneous report from a contactable consumer reporting for herself. An 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Jun2021 as single dose (at age of 80-years old) for COVID-19 immunization. The patient medical history include she still did not see doctor but the last time she saw a doctor was years ago when her husband was in critical condition, for anxiety, and he passed away she still has anxiety off and on. The patient concomitant medications were not reported. The patient had the Pfizer vaccine three weeks ago (Jun2021) and tomorrow (13Jul2021) will be the second shot that she supposed to take, but today (12Jul2021) and during the first week it was fine. she states before she took the first one, and her blood pressure was perfect, she did it twice, but after that, a week later (Jun2021), she felt a little bit tired and fast pulse and it was going on for about a week and she felt not well. She states now she feels better, and she goes to have another shot tomorrow. States on 12Jul2021 (today), she took her blood pressure, and it was a little bit high. It was 144/72 and 71 and sometimes, it came down to 142 so she wondered if it was okay if she comes tomorrow for another shot. She states her doctor was not available, so she wonders if its because of the blood pressure machine, but she did it three times. it was 144/77, 63 and then it came down to 143/71, 72 so was it okay for her to come tomorrow. She did have a little bit shortness of breath for the second week (Jun2021). She wants to know that it was okay if she comes back tomorrow with a little high blood pressure like that she states but tomorrow, it will be her appointment for her second shot and the question was if she could come tomorrow for another shot with a little bit high blood pressure like that because she afraid that the side effect of the second time will be worse than the first one. Caller states she's short and this was not that serious of a reaction because she still keeps on doing her daily tasks, she walks, and jogging around, but with a little bit shortness of breath for the 2nd week in the beginning and a couple days later, and now its coming down, and today she feels good. The outcome of events a little bit tired, a fast pulse, her blood pressure, it was a little bit high and little bit shortness of breath was unknown and the outcome of event she felt not well was resolved on unknown Jul2021.  Information regarding the lot/batch number has been requested.
Information has been received from a pharmacist concerning a male patient of unknown age. The patient was allergic to penicillin and sulfa. The patient's concurrent condition and concomitant therapy information was not provided. On 14-MAR-2018 the patient was vaccinated with PNEUMOVAX 23 (0.5ml, once) (lot# N034512, expiration date: 13-SEP-2019) intramuscularly for prophylaxis. On an unknown date the patient experienced pain at the injection site. The injection site pain radiated to the inner portion of the patient's arm, after patient took his blood pressure in the same unspecified arm, over the injection site. The pharmacist advised the patient to use of over-the-counter drug (OTC) analgesic medicines, however the patient declined the use of an OTC analgesic medicines. The outcome of the events was unknown. The causality between the events and PNEUMOVAX 23 was not provided.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warmth down her arm and chest), DIZZINESS (dizziness) and NAUSEA (Nausea) 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced FEELING HOT (warmth down her arm and chest). On 18-Mar-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (Nausea). At the time of the report, FEELING HOT (warmth down her arm and chest), DIZZINESS (dizziness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
woke up with burning in her ears; fever; Low grade headache/worse headache; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (BNT162B2), on Jan2021 07:30 PM at single dose in Right arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Systemic Lupus Erythematosus. Concomitant medication received within 2 weeks of vaccination included denosumab (PROLIA), trazodone, ezetimibe, simvastatin (VYTORIN), duloxetine, hydroxychloroquine sulfate (PLAQUENIL), cevimeline. Low grade headache occurred the day after the vaccine on 22Jan2021 04:30 AM and has lasted until now. But 24Jan2021 the patient woke up with burning in her ears, a worse headache, and a fever. The outcome was Recovering. No treatment received for the adverse event. The events were assessed 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. All the events were assessed non-serious.   Information on the lot/batch number has been requested.
Large local reaction to left tricep, edema and erythema, warm and painful to the touch. Pt states that he had similar reaction to dose #6.
Papular rash, initially at both injection sites, now entire body covered. No erythema, no mucous membrane involvement or systemic illness. 1mm papules, no palm or sole involvement. 12/10/09 ED records received for DOS 11/03/09-11/04/09. Pt c/o constipation; has not had BM in 3 days.Mother reprts crying and gassiness. Had used mylicon drops but reports not working. Discharged stable. DX: Acute possible infantile colic 12/10/09 Medical records received for DOS 11/6/09. Pt presents with cold, running nose x 3 days.  Assessment: URI 12/10/09 Medical records received for DOS 11/24/09/ Pt. presents with rash,itching. that began  1-2 days after flu shots. DX: vaccine reaction.
She had arm swelling; rapid heart rate; muscle aches; Headache; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (She had arm swelling), HEART RATE INCREASED (rapid heart rate), MYALGIA (muscle aches) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product OFATUMUMAB (KESIMPTA) for an unknown indication.    No Medical History information was reported.   In June 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started OFATUMUMAB (KESIMPTA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PERIPHERAL SWELLING (She had arm swelling), HEART RATE INCREASED (rapid heart rate), MYALGIA (muscle aches) and HEADACHE (Headache). At the time of the report, PERIPHERAL SWELLING (She had arm swelling), HEART RATE INCREASED (rapid heart rate), MYALGIA (muscle aches) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: rapid (increased) Rapid (Increased).  Concomitant medications were not provided by the reporter. It was reported that patient had a Moderna COVID booster vaccine 2 weeks ago in preparation for her cruise. Patient experienced headaches and rapid heart rate which may or may not be related to kesimpta and/or the vaccine. Those symptoms have since resolved as well. No treatment medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2022: Source document contains no new information.
well neck/back/posterior head got WAY worse in pain. recieved xray and mri since then. begging someone to go over mri with me. my neck is awful.. and looks like inflammation occurring. vomitting, see note
Suddenly, I developed chills the evening of the vaccine. I became nauseous and, over the night, my fever rose to 103. When I woke up on 12/27/2021, the chills passed but I was still nauseous and had a severe headache. I contacted my doctor and they called me back that afternoon when my fever peaked at 104.6. I was instructed to take Tylenol and rest. I've been drinking fluids and resting. The fever is reduced, and my temp is back to normal 12/28/2021 and the headache is gone today. I am continuing to be careful with what I eat to make sure I don't get sick.
39-year-old pregnant female came to receive 2nd dose Pfizer vaccine. Reported having  SOB from 1st dose, but MD still recommends patient to get her 2nd dose and may need to administer Epi-pen. Patient received vaccine on 10/15/21 around 10:20am. Within 5 minutes into observation time, patient waved and let us know she has trouble breathing, pharmacist went out to check on patient. Have to administer Epi-pen while patient stands before able to move patient to a clear space. Patient lost consciousness and slightly breathing, called 9-1-1 and did 10 compressions. Pulse came back, and patient was transported by paramedic to ER.
diffuse urticarial rash w/o respiratory symptoms, but with Tmax = 100.5
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Additional Details: about 10 minutes after injection patient became very pale, flushed and sweaty. became nauseus and tried to vomit. Called EMS, symptoms reduced about 15 minutes later. Patient does not want to go to ER
08/9/21 10PM Left arm to shoulder started to ache, increased in severity then I was unable to move left arm(felt like it was frozen in place). My arm was in a bent position. Felt very cold.  Took 2 Tylenol. About 11:30PM, felt no better but decided to go to bed. Fell asleep about midnight. My husband woke me about 8AM. Was able to move arm then the remainder of the day my muscles ached. Relief with ibuprofen. 8/11  Felt fine.
Phone call from ER doctor requesting documentation of which vaccines received & their ingredients (faxed). Pt. presented with hives per doctor on phone.
This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 25-MAY-2016, the patient was vaccinated with improperly stored doses of VAQTA lot # L039659, expiration date: 15-MAR-2017 (dose, strength, and route unknown). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Redness at the site with warmth, 2 in by 3 in left deltoid.  Enlarge lymph node in axilla area, seen after mom picked up from school.
shortness of breath; 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 43 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 15Sep2021 16:00 (Lot number: FC3183) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSPNOEA (non-serious) with onset 15Sep2021 18:00, outcome "not recovered", described as "shortness of breath".  Additional Information: No other vaccinations within four weeks prior to the first administration date.  No follow-up attempts are possible. No further information is expected.
Symptoms with nervous system -tingling, pain, numbness, weakness.  Trouble walking. Diagnosed with Gulliane-Barre Syndrome.
I contracted Bell's Palsy from my second dose of the Moderna Covid 19 vaccine administered in June 2021.
Had side effects on 3/4 of chills no fever, muscle aches, fatigue and vomited 3 times on way to work at 6pm. Drank some water within 30 minutes only fatigue. Friday and Saturday felt fine. Sunday morning woke up at 930 with severe chills, fever, muscle aches, fatigue, headache, dry cough , sore throat and left gland sore. Today woke up with just the dry cough and sore left gland realizing that last 3 symptoms were separate event from rest.
INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 27 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: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included covid-19 vaccine for prophylactic vaccination.  On an unspecified date, the subject experienced inappropriate schedule of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inappropriate schedule of vaccine administered was not reported. This report was non-serious.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No concomitant medication was reported. 60 doses were received with Lot AS7148B.  No treatment medication was reported.   This case was linked to MOD-2022-690899 (Patient Link).
Sever aches and pain, diarrhea, vomiting, low grade temp.
Employee reported to have a cough, scratchy throat, itchy chest. Was given 4L 02 via nasal canula. EMS was contacted and transported to ER
I was fine  all day working from home and it was the end of the day at 5:12 PM and was walking to the bathroom in my home and all of a certain I started shivering and was extremely cold.  I could barely  use the bathroom, but did and  felt bad so I hurried and put on my pajamas and went to the family room and sat down my whole body shaking /shivering and I was freezing.  I covered up with a blanket and shook profusely for about 25 minutes.  I checked my temperature and it was 97.5 and then a few minutes later it was 97.7.  The severe shivering and cold ceased and was kind of intermittent but not too bad.  I was very tired and slept in my chair on and off until about 10:00 PM and then I went to bed and I had a headache.  I also was a little warm after the shivering stopped.  My temperature before bed was 98.2.    The next morning had a mild headache most of the day, I took a Tylenol and didn't feel real good until about 3:00 PM, but I was fully functioning .
Children received first dose of the primary series with the Moderna bivalent vaccine booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Children received first dose of the primary series with the Moderna bivalent vaccine booster) and NO ADVERSE EVENT (No adverse event) in a 6-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Children received first dose of the primary series with the Moderna bivalent vaccine booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Children received first dose of the primary series with the Moderna bivalent vaccine booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Children received first dose of the primary series with the Moderna bivalent vaccine booster).    No concomitant medications were reported. No treatment details were reported. It was reported that total 3 Children's with age 6, 8 and 10 were involved who received Moderna bivalent booster dose instead of Primary series.   This case was linked to MOD-2022-664264, MOD-2022-664266 (E2B Linked Report).; Sender's Comments:  MOD-2022-664264:Patient 2 of 3 MOD-2022-664266:Patient 3 of 3
Patient jerked his head to the right and his mouth twisted down a few hours after receiving his vaccinations. Saturday, he had several episodes doing the same movements.The after hours nurse suggested he go to the ER. They tested calcium, potassium, and electrolytes. He also had a head CT. We were told to follow up with his pediatrician. On Sunday, he continued movements then changed from jerking the right side to shaking his head side to side. The nurse suggested we go back to ER. He was admitted for 3 days and given an EEG.
3/9/2021 pt developed a headache and her tongue was numb, on 3/10/2021 pt developed Right sided facial drooping, and the same nodules to Left breast, pt went to ER on 3/10 and was provided Prednisone, Acyclovir and eye drops. pt R eye is not closing at all on attempt. pt has reported the adverse event on her online portal