chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Died; Internal bleeding and died; A spontaneous report was received from a nurse concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced internal bleeding and died.  The patient's medical history was not provided. No concomitant product use was reported.  On unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, a nurse reported she read about a doctor who received the COVID-19 vaccine and died 3 days later. She stated she read that the doctor had internal bleeding. It started with bleeding in his hands and feet, then went to his brain and died 3 days later.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, internal bleeding and died, was considered fatal.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Reported Cause(s) of Death: Internal bleeding
Onset 5 days after vaccination: redness , swelling, itching, and a sensation of heat at the injection site
I had fatigue, elevated temperature, dizziness 2 weeks after the 1st dose
Information has been received from a physician concerning a patient who was vaccinated with ZOSTER vaccine live (Oka/Merck) 0.65ml (lot number, route and site not reported).  After vaccination, the patient experienced shingles.  Follow up information was received from HERPES ZOSTER Questionnaire.  On 10-MAR-2008 the patient with a history of chickenpox was vaccinated with ZOSTER vaccine live (Oka/Merck) (lot number 659325/1823U) into the right arm.  There was no rash at the site of injection or elsewhere within 42 days of the vaccination.  On 09-JAN-2009 the patient developed HERPES ZOSTER.  The pain was at least at grade 5.  There was no fever and other systemic symptoms.  There was no recent exposure to chickenpox or HERPES ZOSTER.  A direct fluorescent antibody was not done and specimen was not collected for polymerase chain reaction (PCR).  There was no photo taken.  The patient's HERPES ZOSTER recovered.  The patient is still having post herpetic neuralgia.  This is one of several reports received from the same source.  Additional information has been requested.
Redness, warmth, cellulitis left upper arm and swelling from elbow to shoulder. Rx: oral and IM antibiotics. As of 10/23 all symptoms in remission.
HIVES INSIDE THE MOUTH WHICH HURTS AND SOMETIMES OPEN UP AND BLEED; FEVER 99.7; HEADACHES; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's past medical history included psoriasis, and psoriatic arthritis, and concurrent conditions included asthma, and antibiotic allergy, and other pre-existing medical conditions included patient have allergies to lots of outdoor stuff, kind of antibiotic. patient was not pregnant at the time of vaccination. 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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced hives inside the mouth which hurts and sometimes open up and bleed. On 06-APR-2021, the subject experienced fever 99.7. On 06-APR-2021, the subject experienced headaches. Laboratory data included: Body temperature (NR: not provided) Fever 99.7. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever 99.7 on 27-JUN-2021, and headaches on 12-APR-2021, and had not recovered from hives inside the mouth which hurts and sometimes open up and bleed. This report was non-serious.
pt recvd vax & had slight t 99; same eve, given apap, devel hives p/ 10dec94; given dph by mom;
Headache, Myalgia, Arthralgia, Fever, chills, fatigue, injection site pain/arm pain, swelling at injection site Narrative:
On 10/24 am-started to not feel well, but began to feel worse in the evening. Headaches started-as long as the patient was laying down still she felt ok. Similar symptoms to a migraine headache (light made headache worse). On 10/25-patient experienced swelling of the face under the right eye to the chin and puffiness on right hand and instep of right foot. On 10/26-went in to see Dr.  and swelling had progressed to just above right eyebrow. Dr. confirmed it was a reaction from the vaccine. Blood pressure was 160/92 (normal blood pressure is 120 something per patient).  Everything else appeared normal. Doctor prescribed Medrol dose pak to start on 10/26 and doctor advised patient to drink plenty of water. Also took 2 Tylenol Extra Strength for headache. Has continued on the Tylenol to help with the headaches-has not helped with the headaches.  Headaches have gotten worse which prompted a call to the doctor on 10/31. Waiting to hear back from the doctor.
Child was administered Pediarix in clinic. No adverse reactions noted at that time. It was later found out on 08/03/2020 that the vaccine was given and it was expired. Dr notified. Family was notified of situation and child had remained free of any adverse reactions.
Huge inflammation ofwhole arm, redness, went to PMD.  Pt had persistant inflammation, redness and pain of arm for 1 mon. 30Aug93 pt states pus drainage from injection site. Sterile absess and hypersensitivity rxn to plague vaccine.
ten mins after shot left arm started going numb. started having chest pain, nausea, didn't feel like himself bp started going up
Information has been received from a health professional through the Pregnancy Registry for GARDASIL concerning an 18 year old female, with a history of ADHD as a child, who on 18-OCT-2007 was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (Lot # 658563/1063U). On 02-JAN-2008, the patient was vaccinated intramuscularly with her second 0.5 ml dose of GARADASIL (Lot # 659437/1266U). On 27-FEB-2008, the patient had a pregnancy test, in the doctor's office, which was positive (LMP = "mid-December 2007"). the patient sought unspecified medical attention in the office. Follow-up information received from a nurse practitioner concerning the patient. During the patient's pregnancy, on 02-JAN-2008 she developed yeast infection and was treated with TERAZOL on 2-JAN-2008, 1 mg, QHS for 7 days. On 20-FEB-2008, she was treated with prental vitamin, 1 mg, daily. An ultrasound was performed (results not provided). On 20-MAY-2008 cervix biopsy and papanicolaou test (PAP) were performed which revealed low-grade intraepithelial lesion (LSIL). On 12-JUN-2008, a PAP test revealed possible HPV changes. On 24-SEP-2008 the patient developed a paronychia infection and was treated with KEFLEX, tablet, oral, and 250mg twice daily for 14 days. On 04-OCT-2008, at 38 weeks gestation, delivered a normal, healthy female baby weighing 6.1 pounds. Length of the baby was 18 and head circumference was 12.25. On 13-NOV-2008, the patient underwent a repeat PAP test (results pending). No further information is available.
Extremely itchy hives on neck, back of head, behind ears, left elbow,  right thumb, right palm, groin, right leg, buttocks.  Hives are hot and swollen.  Hives are raised from skin and look like insect bites.  Hives range in size up to size of quarters. Onset 2 days after 3rd shot.
dizzy; Vertigo/room spins; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on the left arm on 20Dec2020 15:00 at a single dose for COVID-19 immunization at hospital facility. The patient had no other vaccine in four weeks. Medical history included anxiety, depression, high cholesterol, tinnitus, GERD and seasonal allergies. Concomitant medications in two weeks included valaciclovir hydrochloride (VALTREX), omeprazole (PRILOSEC), iron, atorvastatin (LIPITOR), melatonin, "BCP, and daily vitamin." The patient had no COVID prior to vaccination and was not pregnant. The patient experienced vertigo/ dizzy/ room spins starting in Jan2021 (reported as 08Jan2021/09Jan2021), 1-2 days prior to 2nd vaccine (10Jan2021). The patient did not receive treatment for the events and was not COVID tested post vaccination. The outcome of events was not recovered.   Information on the Lot/Batch number has been requested.
Severe bodyaches and sore injection site; Severe bodyaches and sore injection site; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant 43-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG201), via an unspecified route of administration in the left arm on 19Feb2021 at 14:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 prior to vaccination from an unknown date and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included iron; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); Vitamin D NOS; loratadine (CLARITIN); fluticasone propionate (FLONASE), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient previously took codeine and experienced drug hypersensitivity. On 20Feb2021 at 06:00, the patient experienced severe body aches and sore injection site. The patient did not receive any treatment for the events. The clinical outcomes of the severe body aches and sore injection site were recovered with sequelae.
Patient complained of an enlarged tongue and soreness of the throat that began 8 hours after vaccine administration (7/29/2021). Patient reported no difficulty breathing. The pharmacy reached out as a courtesy to check-in on patient. He informed the pharmacy of the symptoms described above. After consultation with the pharmacist, he was told to take 1 (one) cetirizine 10 mg tablet and 1 (one) famotidine tablet each day for relief of symptoms. Patient was instructed to call a physician or report to a hospital if symptoms did not resolve in 24 hours.
had bad chills for 15 min; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer Sales Representative. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bad chills on an unspecified date. The outcome of the event was recovered on an unspecified date (with the reported duration of 15 minutes).  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
No adverse event; adult patient was accidentally administered with 1 booster of Moderna COVID-19 Vaccine Bivalent for pediatrics on 1Feb2023; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (adult patient was accidentally administered with 1 booster of Moderna COVID-19 Vaccine Bivalent for pediatrics on 1Feb2023) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR6965B) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Ozempic, Paxlovid (Unknown if patient had COVID-19) and Spironolactone. Past adverse reactions to the above products included No adverse event with Ozempic, Paxlovid and Spironolactone. Concurrent medical conditions included Asthma and Obesity.    On 01-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 01-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (adult patient was accidentally administered with 1 booster of Moderna COVID-19 Vaccine Bivalent for pediatrics on 1Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (adult patient was accidentally administered with 1 booster of Moderna COVID-19 Vaccine Bivalent for pediatrics on 1Feb2023) 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 WRONG PRODUCT ADMINISTERED (adult patient was accidentally administered with 1 booster of Moderna COVID-19 Vaccine Bivalent for pediatrics on 1Feb2023).    Concomitant products were not reported.  It was unknown whether patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine. No adverse event was reported and reporter does not have any information about patient previous doses.  Treatment medications were not reported.
Rash 3-4 times larger than the injection site, lumpy rash; Itchy near injection site; Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), VACCINATION SITE PRURITUS (Itchy near injection site) and RASH (Rash 3-4 times larger than the injection site, lumpy rash) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DISCOMFORT (Discomfort). On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy near injection site). On 18-Feb-2021, the patient experienced RASH (Rash 3-4 times larger than the injection site, lumpy rash). On 12-Feb-2021, DISCOMFORT (Discomfort) had resolved. On 18-Feb-2021, VACCINATION SITE PRURITUS (Itchy near injection site) had resolved. At the time of the report, RASH (Rash 3-4 times larger than the injection site, lumpy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Started feeling tightness in my left arm and left side. Then, eventually, I had muscle spasms on my left side. They had to issue 2 CC of lidocaine in my left shoulder. My muscles were so painful that I couldn't drive or stand any type of vibrating sensations, and I was issued muscle relaxers  My left arm will go numb frequently and I have trouble moving it. For a while, I couldn't sit up straight or work because of my arm.  My blood pressure has also shot up significantly and is often over what is healthy for me
Myocarditis and pericarditis  Rapid heart beating, I work from home and sometimes I have to lay on the floor in the bedroom because the pain can get that intense.
nausea, headache, body aches, chills - 19 hours.  Treated with acetaminophen.
96 patients received Pfizer Monovalent Covid-19 vaccine instead of receiving Pfizer Bivalent Covid-19 vaccine during a drive thru vaccine clinic.   0 of 96 patients reported/complained of any adverse reactions/side effects.
Since the day after my first injection (4/3) I have had a constant headache. Every single day since that headache has not left. It varies in intensity, it is generally the worst in the morning and evening or at least I block it out enough to do my job. Pain is in the back of my head/upper neck, in front of my ears on the sides of my head, sometimes I also get it on the crown of  my head. I have also been nauseous pretty much every day since then. I have vomited once. Nausea is worst in the mornings. Occasionally I feel like I have a concussion, hard to describe that feeling.
Patient's mother called our health department on March 11, 2004. She told one of the nurses that her daughter's left arm was sore and she was not using it. It was also painful to touch. She was advised to use Tylenol and call us back if there was no improvement. On March 15, 2004 I called the mother to see if there was any improvement. She said she was getting better, but that during the night (last night) she woke up complaining that it hurt. She stated that patient says it hurts in the muscle. I told mother to call her physician. I also told her I was going to fill out a VAERS form. I asked for a detailed description of events. She stated that within an hour of receiving her vaccines on March 9, 2004, patient started complaining of pain in upper left arm. She also developed a fever. Mother did not take temperature but knew she had one. She gave her Tylenol and continued to give it over the next few days. She said the fever was high for 24 hours and then she only had fever at night for about 4 days. She stated that patient was "whining and crying" a lot --just "not herself". She would not let her mother remove the bandaid, but when she did, a few days later, she noticed redness and swelling. That had improved but there is still a small red area and a knot. She was mostly concerned that after the shots patient made a fist with her left hand for days and held her hand close to her chest. She was worried that she might have some paralysis in that limb. She is now using that hand. She said her daughter just "really hasn't been herself" and it was this way when she had her last dose of DtaP (at 21 months).
reaction to being administered with Fluzone High-Dose Quadrivalent; Initial information received on 05-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 68-year-old female patient who experienced reaction to being administered with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (vaccination complication).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ479AA, expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious reaction to being administered with fluzone high-dose quadrivalent (vaccination complication) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  Event outcome was unknown at the time of report.
MILD ILLNESS; This spontaneous report received from a parent via social media via a company representative concerned a male of unspecified age. 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 (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced mild illness (dose number in series 1). The reporter posted as  "My son and I both had the J and J vaccine and have recently gotten the booster as well. We only had mild illness after the vaccine and no symptoms after the booster". The patient received additional covid-19 vaccine (unspecified manufacturer, dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination.  The patient had no symptoms after booster dose (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild illness was not reported. This report was non-serious. This case, from the same reporter is linked to 20220624885.
Patient call facility 45 min after receiving H1N1 vaccine stating she was have a reaction, nausea, vomiting and headache. Patient states she would go to her primary care provider office.
slight dizziness immediately, then 1 hour later: chills, fever (100.5), elevated heart rate (up 18 beats per minute compared to normal), normal blood pressure, slight aches  At 8:00 am on Oct 10 (next morning and 17 hrs after injection), symptoms persist and fever and heart rate up compared to prior day  Have NEVER had a reaction to vaccines previously except for tender injection site
I received 2nd injection of Pfizer COVID-19 Vaccine at 1015AM on 1-12-21 and was doing great. I had taken one 325mg Tylenol and one  200mg Ibuprofen approximately 60 minutes prior to receiving vaccine (which is what I did prior to the first vaccine). I was doing great initially following the vaccine. I took another 325mg Tylenol and 200mg Ibuprofen when I went to bed at 2000  1-12-21. At 0300 1-13-21 I woke up feeling nauseated and when attempting to turn over to my right side I moaned loudly because I could not hardly move my left arm. My husband was woken and turned on the bedroom light and we noted a 3 inch bruise and large knot on my left deltoid at the injection site. He told me that I felt warm. I took my temperature that was 101.2 degrees. I took 650mg Tylenol and that time. At 0500 1-13-21 I was having chills, muscle and joint aches. I could not fully close my hands into a grip. My "brain" hurt, not a headache but literally it hurt to move my head. I would occasionally get a sharp pain in the front and back of my head. My temperature went to its highest at approximately 1500 1-13-21 to 102.5 degrees. I continued to offset Tylenol with Ibuprofen throughout the day. At 2000 1-13-21 my temperature was 101.8 and began to trend downward.  I went to bed and when I woke up on 1-14-21 I felt 100% better with just a little fatigue from the inability to sleep the day prior.
PT HAD 2 FEBRILE SEIZURES SAME DAY AFTER VACCINES
A little more than 24 hours after getting vaccine, my left arm pit began to hurt. The pain increased and about two hours later my arm pit and muscle were swollen and the muscle area was red.   Thought I might have infection so went to urgent care. Doctor had me take Ibuprofen 4x/day and gave me a prescription for Sulfamethoxazole-Trime800-160 every 12 hours for 7 days.
FEELING LIKE HE HAD COVID SYMTOMS; SPENT 2 DAYS IN BED; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unk) dose was not reported, administered on 05-APR-2021 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 feeling like he had covid symptoms, and spent 2 days in bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spent 2 days in bed and feeling like he had covid symptoms was not reported. This report was non-serious.