chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm pain and headache (I had them also with the first dose, but they did not seem outstanding because most people report them) I had a dermal reaction (on the skin) at first it was a welt like a mosquito bite, but During the night I had a very strong rash of hives on my back, on the left side. The hives were very itchy and burning. I took an antihistamine and it improved a lot.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient fainted and hit his head on the way down. Was unresponsive for <10 seconds and came to then was able to sit up and hold a conversation. Had 2 orange juice bottles and patient communicated that this was a known issue with needles.
HIB vaccine, unsure of exact one. He received his vaccine on July 28th 2017.
Numbness and cramps in the fingers of the left hand a few minutes after I have received the vaccine. Pain in the upper left arm close to the humeral grater tubercle almost 8 hours after the vaccine was applied . I think the vaccine was applied higher than expected in the upper part of the muscle near the joint.  The pain increase by the hours. Some dizziness and muscle discomfort.   Slight and constant headache.
Vasovagal syncope.  occurred within 1-3 minutes after vaccine, resolved within 3-5 minutes with supine position and legs up
I had a sore throat and cold like symptoms. I tested 5 or 6 times for COVID-19 and all tests were negative. I was prescribed medication that were normally used for strep throat. Every so often my sore gets sore but not as severe as before. They did not confirm it as strep but provided treatment based on what I described as symptoms and what they observed during the telehealth. I started to feel better a little bit afterwards. I was azithromycin and I started to take it the day after the November holiday.
Case number PHEH2014US022236 is an initial spontaneous report received from a consumer on 03 Nov 2014. This report refers to a 66 year old female patient. Her past medical history included migraine headaches for which she was treated with NEURONTIN and faced adverse events. Her vaccination history included flu vaccinations with seasonal influenza vaccine (manufacturer and batch number: not reported). Sometimes, after the vaccination, she used to have reactions which would linger up to two weeks but then would go away. Her concomitant medications were not reported. On 07 Oct 2014, she was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly into her arm. On the same day, she was vaccinated with FLUCELVAX (batch number: not reported) intramuscularly into her arm. On the same day, after the vaccination, she experienced pain in the arm at the vaccination site, pain radiated up her neck and in her shoulder. The patient went back to the clinic and the nurse practitioner checked her arm. She had no redness; there was a lot of tenderness. The nurse practitioner recommended NEURONTIN but she was not willing to take NEURONTIN due to the adverse events she had earlier. The patient treated herself with muscle rub and went out to do yard work. The outcome of the events was condition unchanged. The seriousness and causality of the events were not reported.
Patient has developed multiple raised bumps on the right arm from elbow to shoulder, as rash.  Have recommend to take benadryl or claritin for the allergic reaction.
Injection site reaction - consisting of moderate to severe redness, swelling, firmness and heat beginning day after vaccine, maximizing 2 days later, and subsiding over 2-3 more days.
8 patients age range 12 to 18 received first dose Moderna Covid-19 vaccine; 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 patients age range 12 to 18 received first dose Moderna Covid-19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 patients age range 12 to 18 received first dose Moderna Covid-19 vaccine). On 24-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 patients age range 12 to 18 received first dose Moderna Covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
The symptoms were dizziness and then I started feeling some aches. I felt pressure in my head. The aches went away the next day but I was still feeling a lot of pressure. I thought maybe it was allergies. I was taking TYLENOL, ZYRTEC, and FLONASE. I was feeling tired, stuffy, and my throat was a little scratchy. I went to the doctor because I really wasn't feeling much better. He told me that he thinks it's a reaction to the shot. He told me to take ibuprofen instead of TYLENOL. Today I'm feeling about 80 percent better. I still feel stuffy and have light pressure in my head.
she's feeling very sick; Chilling/ Shivering; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she's feeling very sick) and CHILLS (Chilling/ Shivering) 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 02-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced MALAISE (she's feeling very sick) and CHILLS (Chilling/ Shivering). At the time of the report, MALAISE (she's feeling very sick) and CHILLS (Chilling/ Shivering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.  No treatment medications provided.  Patient stated that she needs urgent care.   Reporter did not allow further contact
RUNNIE NOSE; MORE PAIN IN A M ,AND NIGHT; headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (RUNNIE NOSE), PAIN (MORE PAIN IN A M ,AND NIGHT) and HEADACHE (headache) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced RHINORRHOEA (RUNNIE NOSE) and PAIN (MORE PAIN IN A M ,AND NIGHT). In January 2022, HEADACHE (headache) had resolved. At the time of the report, RHINORRHOEA (RUNNIE NOSE) and PAIN (MORE PAIN IN A M ,AND NIGHT) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative.  No concomitant medications were reported.  No treatment medications were reported.
I was told to take Tylenol. I had diarrhea and nausea as well as fatigue and severe body aches. I was mostly advised to take OTC medication like Imodium, Tylenol.  These symptoms were on and off for at least 30 days.  They did an MRI where they found a lesion and I was admitted. I was given dexamethasone.
panic attacks; This is a spontaneous report received from a contactable reporter Consumer or other non Health professional from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PANIC ATTACK (non-serious), outcome "unknown", described as "panic attacks".  Additional information: Reporter stated that . the (pharmacy name ) pharmacist had the same thing and still experiencing it a month later. He told me 2 others experienced panic attacks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Burning pain and red inflammation 2 inches by two inches at the injection site within minutes. 10mm lump under the skin at the site of the injection which is still present 11 days after the injection. Flu like symptoms body aches and soreness within 24 hours of injection lasting 48-72 hours.
Fever, myalgias, swollen/red/tender area at injection site (left) deltoid.
Low grade fevers ranging from 100.7 to100.9 over two days. Lower grade fevers 99.4 - 99.7 day three Fatigue Intermittent diarrhea for one day Day four all was back to normal
Headache at first mild and very flush within 30 minutes of shot then severe and constant upon awaking in the morning. Fever 101.5-100.8 all day.  Fatigue , body aches, lower back pain. Sharp pain in left leg.
After receiving anthrax vaccine, Pt lost consciousness and then went into convulsions x 1 min. Regained consciosuness x 1 min, then lost consciousness again with convulsions x 1 min. Regained consciousness and then was transported by ambulance to nearest civilian ER. Pt also received H1N1, smallpox, and typhoid prior to anthrax vaccine that morning.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Pertinent medical history and concomitant therapies were not reported. On an unknown date, the patients were administered improperly stored doses of ROTATEQ (lot# K020181 expiry date 24-JUN-2016, lot# L004466 expiry date 02-AUG-2016, lot# L008054 expiry date 30-NOV-2016; orally, dose not reported). No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Warm, red, raised rash at injection site. 3.5'x4.5'
7 days p/MMR devel fever 103 7th & 8th days-9 day 101; devel rash over entire body;
Red ring around the injection site, red area going down about 3 inches. No pain or itching. (have photo if interested). By evening started to lighten in color. noticed it was slightly raised.  By next morning, faded to light pink.
Pt recvd 3 doses of Hep B vax 19JUL90, 27SEP90, & 15FEB91 & 15JUN91 it was determined that the titer was neg; booster dose was given 9NOV91 outcome of booster dose is pending as of 3JAN92;
PCV 13 vaccine administered 5/30/2014 right arm at shoulder level. Immediate pain that increased progressively within hours. Pain severe. Limited ROM. TX NSAIDs, steroid (oral) and Rt shoulder joint injection, physical therapy. MRI showed Rotator Cuff tear. Surgery 4/28/15 on Rt shoulder showed sm tear and frozen shoulder. Still in physical therapy.
5 hours after vaccine patient had a fever of 100 to 101, with vomiting and loose stools. Probable viral gastro problem. 07/05/06-records requested and received:DC summary DX: Viral Syndrome.  Blood cultures, CXR, UA CSF negative. Prior to admission had 2 episodes of emesis and watery stools. PMH minor reflux, RX with Axid. Temp at
pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth.) on 11-Dec-2006, Pregnancy (Live, full-term birth.) on 30-Jul-2008, Pregnancy (Live, pre-term birth. Born at 7 months.) on 15-Feb-2010 and Pregnancy (Live, full-term birth.) on 17-Sep-2013. Concurrent medical conditions included Gestational diabetes since November 2020. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, INSULIN, HYDROXYPROGESTERONE CAPROATE (MAKENA) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 12-Apr-2021 at 12:00 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 04-Oct-2020 and the estimated date of delivery was 20-Jul-2021. On 12-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPOSURE DURING PREGNANCY (pregnant) to be not applicable.
dizziness, full head feeling, increase in migraines, sore throat, chest tightness, palpitations.
Swollen arm  the day after vaccination. A couple of days later, my arm started itching really bad. I woke up with a break up in the corner of my eyes and I could pop it and it will have a yellow substance coming out of it. It flares up every now and then.
The 8 year old received 0.2 ml undiluted orange cap; The 8 year old received 0.2 ml undiluted orange cap; The 8 year old received 0.2 ml undiluted orange cap; arms are very sore; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 8 year-old male patient received bnt162b2 (COMIRNATY), administered in deltoid left, administration date 20Nov2021 (Lot number: FK5127) at the age of 8 years as dose 1, 0.2 ml single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 20Nov2021, outcome "unknown" and all described as "The 8 year old received 0.2 ml undiluted orange cap"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "arms are very sore". Therapeutic measures were not taken as a result of overdose, pain in extremity.  Additional information: This is the second case out of 2 cases. Nurse stated, "her two boys received their first COVID Vaccine this weekend and after it was administration to them she was notified a little while later that they were given the vaccine without any diluent added. So, it was administered, so my 8 year received 0.2 ml of the undiluted vaccine and my 12 year old received 0.3 ml of undiluted vaccine, which both are out of a pediatric formulated vial. So I just wanted to speak with someone about, I know there has been some other instances of this happening so far they seems like they are doing okay but I wanted to talk to someone about any other information. The patient didn't experience any other side effects except soreness in both arms.  No follow-up attempts are possible. No further information is expected.
nervousness; hunger; feeling bad; insect bite; headaches; Initial information received on 10-Feb-2022 regarding an unsolicited valid  non-serious case received from a consumer   This case involves a 63 years old male patient who experienced nervousness, hunger, feeling bad, insect bite and headaches while receiving vaccine influenza USP trival A-B subvirion no preservative vaccine [Fluzone].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient's past medical history included minor itch At the time of the event, the patient had ongoing Allergy to formaldehyde  Concomitant medications included Vitamin B12 Nos [Vitamin B12 Nos].  On 28-Oct-2021, the patient received a dose of suspect influenza USP trival A-B subvirion no preservative vaccine (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination. Information on batch number was requested.  It was reported that after the administration of vaccine the patient had developed nervousness and hunger that lasted till Jan-2022 and he started to feel better but then took a B12 shot and he started back feeling bad (feeling abnormal). Also, mentioned that he took Vitamin B 12 injections before starting the flu shot which was given by his employer, does not remember which site had it in or the exact name and Vitamin B 12 gives him a minor itch. States he is seeing a neurologist and has been having headaches (headache) (onset and latency: unknown) and will have some minor surgery for a hernia but doesn't know when since he hasn't scheduled it as yet, has an insect bite he is going to start antibiotics for in the next couple of days. Further the patient had asked that how long does the flu shot stay in your body and Would antibiotics help this situation, as patient had heard that it has formaldehyde in it and patient was allergic to formaldehyde but his doctor usually signs off so, patient do not have to take it but this year he didn't get a chance to have him sign me off.  Also, he had a patch test recently for allergies and is allergic to formaldehyde.   Relevant laboratory test results included: Skin test - On an unknown date:  patch test [allergic to formaldehyde]  Action taken: was not applicable.  It was not reported if the patient received a corrective treatment for the events (nervousness, hunger, feeling abnormal, arthropod bite and headaches)   Outcome: recovered/resolved on an unknown date in Jan-2022 for hunger and nervousness and unknown for rest all events
No additional AE information provided; Nurse reported the patient was administered an improperly stored dose ofMMRII on 4/3/2020.; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. No information regarding the patient pertinent medical history and drug reactions or allergies was provided.   On 03-APR-2020, the patient was administered an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (therapy type: recombinant Human albumin (rHA)) (M-M-R II) (lot#S006048 with expiration date: 27-FEB-2021;  dose, frequency, strength and route of administration were not provided) for prophylaxis. The sterile diluent was properly stored. No additional adverse event (AE) information provided.  Administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) experienced the temperature excursion under 47.3 degrees fahrenheit (F) for 14 minutes. There was no previous temperature excursion. The digital data logger was involved to capture the temperature excursion.
The single dose vial is labeled 0.25 mL, a pediatric dose is 0.25 mL, but the vial contains 0.5 mL of vaccine. The whole vial was drawn and administered to the patient.
not received 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27 February 2023 batch number XG7RF expiry date 21 MAY 2024 on Left arm).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 The reporter reported that she was more than 6 months after her first dose and had not received her second dose of Shingrix. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Daughter called our pharmacy on Saturday 10/14/17, told us that the patient was hospitalized shortly after receiving the vaccine. I believe the daugher indicated the patient had swelling of her arm and has a generalized malaise from being administered two vaccine (the patient also received a high dose fluzone that same time in a different arm).
Immediately after injection a nickel sized bump formed in the RA at site of injection. Within a few min the area surrounded the site turned red, hot to touch, and the patient stated very itchy - called MD and prescribed and dispensed steroid cream.
On 7/30/2021, patient developed sudden onset chest pain that worsened to midsternal, radiating pain to the back and left arm on 7/31/22 that forced him to seek medical attention in the emergency room. Patient had just returned from a camp earlier that day. On admission, his troponin-I was noted to be elevated at 22.10 ng/mL, admission EKG showed signs of pericarditis, mildly reduced EF on TTE (404-5%), cardiac catheterization showed angiographically normal coronary arteries and left ventriculography was positive for Takotsubo cardiomyopathy with hyperdynamic basal segments and hypokinetic distal segments, and hypokinesis was most prominent in the anterior and apical portion with the inferior wall being normal. Patient was started on colchicine, metoprolol tartrate, lisinopril, and furosemide, has transitioned out of the ICU and is pending a rheumatology consult prior to discharge.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: Fk9893) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient had no known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment start date:25May2022 treatment stop date:29May2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.