chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was very sore when she got up it was swollen and red and hurt terribly; arm was very sore when she got up it was swollen and red and hurt terribly; arm was very sore when she got up it was swollen and red and hurt terribly; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 59 years of age), via an unspecified route of administration in the left arm on 25Feb2021 14:15 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunisation. Medical history included chronic blood clot in left leg from an unknown date and unknown if ongoing and environmental allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks prior to covid vaccine. She was not pregnant. The patient had not had covid prior vaccination and she had not been tested post vaccination. It was reported that during the night of 25Feb2021 at 11:00 PM, the patient's arm was very sore when she got up it was swollen and red and hurt terribly. So she went to the ER because she had a chronic blood clot in her left leg; there was no clot in her arm but it was still swollen, red and it hurts. She added that she have very bad environment allergies and queried if she should get the second shot. No treatment received for the events. The outcome of the events was unknown; the events resulted to emergency room visit.  Information on the lot/batch number has been requested.
Covid 19 vaccine expired on 11/30/22 and was given 12/1/22. This was due to a labeling error within our hospital system and is being investigated. Manufacturer was contacted and verified that dose was still effective and patient does not need to repeat dose. Mother was contacted, using interpreter, and informed.
Narrative:  66 yo M with hx of CHF, AF, COPD, HLD, GERD, CAD received J&J COVID vaccine on 4/28/2021. Pt died on 8/11/2021.Death not likely related to vaccinations given pt's medical history & >90 days from vaccination to date of death.
Tested positive for COVID-19; This is a spontaneous report from a Pfizer-sponsored program COVAX  Support. An unspecified age of female patient received first dose of bnt162b2 (BNT162B2; Solution for injection) via unspecified route of administration on 01Feb2021 at single dose for covid-19 immunization. Relevant medical history and concomitant medications were not provided. It was reported that Caller got her first shot of the vaccine on the first Monday of this month. Her mom tested positive Thursday night. She is supposed to get her second dose of the vaccine on 22Feb, but she also tested positive for COVID-19. She is asking if she needs to receive the second dose or if she needs to receive another first dose of the vaccine. The outcome of the event was "Unknown".   information about lot/batch number requested.
A non-serious spontaneous report of patient was given FLUMIST that expired two weeks ago was received from a health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 18-Dec-2011. On 21-Dec-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 04-Apr-2012 and incorporated into the narrative: No late occurring adverse event.
Moderna 3/15, 4/13, and 11/12. Positive on 1/1/22
Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks; Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks; Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks; This is a spontaneous report from a contactable consumer. A 26-year-old male patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number EN5318) via an unspecified route of administration on 30Jan2021 12:45 into right arm at a single dose for COVID-19 immunisation. The patient medical history included epilepsy and cerebral palsy and known allergies is to amoxicillin. The patient had a seizure disorder, epilepsy (Lennox Gastaut Syndrome). He has an average of 1 Tonic-Clonic (Grand Mal) and 2 Series of Myoclonic Jerks a day. There is no other vaccine was administered in four weeks. There is no COVID prior to vaccination. Concomitant medications in two weeks included topiramate (TOPAMAX), lamotrigine (LAMICTAL), clobazam (ONFI), glycopyrronium bromide (CUVPOSA), potassium citrate, citric acid, calcium carbonate and colecalciferol (VITAMIN D). Within the first 24 hours(PENDING CLARIFICATION, as reported as 30Jan2021 02:45AM) of receiving the vaccine his seizure activity increased. Within the first 24 hours he has had 6 Tonic-Clonic seizures & 3 series of Myoclonic Jerks. The patient received emergency seizure medicine Klonopin. The patient did not test COVID post vaccination. The outcome of the events was recovering.
Patient said her arm instantly swelled at the injection site at the time of immunization and the next several days her armed swelled more, was red, brown at injection site, feverish, and itched. Patient went to the doctor 3 days later and was evaluated. The doctor told the patient  to place ice on the arm and take ibuprofen for the pain and fever in the arm.
NAUSEA; INTERMITTENT TINGLING IN LEFT LEG; INJECTION LEFT ARM NUMBNESS WHICH MADE FEEL LIKE DEAD WEIGHT AND AFFECTED WHOLE HAND; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 10-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-SEP-2021, the patient experienced injection left arm numbness which made feel like dead weight and affected whole hand. On 11-SEP-2021, the patient experienced nausea. On 11-SEP-2021, the patient experienced intermittent tingling in left leg. The action taken with covid-19 vaccine was not applicable. The patient recovered from nausea on 11-SEP-2021, had not recovered from intermittent tingling in left leg and injection left arm numbness which made feel like dead weight and affected whole hand. This report was non-serious.
Pt experienced urticaria following Recombivax. Started on day 2 and has lasted 27 days.
Fatigue, headache, chills, diarrhea, pain at injection site. Symptoms started about 12 hours post vaccination and resolved approximately 24 hours post vaccination, after self medication with Ibuprofen.
Vaccine administered to person of unauthorized age Vaccine only authorized for adults 18 or over Dose administered to 16 year old
Patient developed swelling in the cheeks and chin. There were 4 areas that were red and about 1 inch in diameter. This occured 48hrs after the MMR vaccine. 1 week and 24hours after vaccine, patient developed fever of 103.9R and hives all over body.
approx 5 hr p/vax pt devel an inj site rxn characterized by erythema, induration & pruritus;pt recovered p/ 5 days;this is 1 of 9 pt from this facility to devel an inj site rxn p/flu vax w/lot# 4978139;
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date after the vaccination, the patient developed shingles of unknown severity. The patient visited a physician and was prescribed VALTREX (dose and frequency unknown) to treat the outbreak. The patient did not recover from the shingles outbreak (also reported as currently still recovering) at the time of this report. Causality assessment was not provided. Additional information has been requested.
COVID vaccine breakthrough case. Moderna 2/25/21 010A21A, 3/25/21 047A21A, 8/14/21 052E21A, 3/3/22 027L21A and Moderna bivalents 12/6/22 043H22A and 8/3/23 AS7645B.
Headache; Chills; Nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine headache.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (vomiting). At the time of the report, HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (vomiting) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were provided by the reporter.  No treatment medication was reported.
Beginning on 1/17/22, approximately four weeks after my vaccine, I began to experience mild, intermittent chest soreness. By 1/20/22, the soreness was persistent and moderate, which led me to go to urgent care. At urgent care, my heart rate and blood pressure were high. The urgent care EKG was normal aside from an incomplete right bundle branch block. The urgent care chest xray was normal. The attending doctor at urgent care ruled out heart attack, prescribed 600 mg ibuprofen 3x per day for 7 days to treat possible costochondritis or pericarditis, and instructed to follow up with PCP as soon as possible. The ibuprofen reduced the symptoms. On 1/24/22, saw a PCP, who took another EKG with similar findings, though with normal heart rate and blood pressure. The opinion of the PCP was possible costochondritis and provided a referral to a cardiologist. On 1/26/22, saw cardiologist (listed as doctor to contact in this report), who repeated the EKG with similar findings, and ordered an echocardiogram due to suspecting pericarditis. On 2/11/22, echocardiogram found mild inflammation. As of today, 4/9/22, the symptoms are almost entirely gone. In total, they lasted approximately 8 weeks, first appearing on 1/17/22, worsening through 1/22/22, substantially improving during the 7 days of ibuprofen, with mild occasional symptoms continuing to improve through mid-late March.
Left upper arm became very sore, painful and stiff over a few weeks. 1/9/06 - MD diagnosed "frozen shoulder" and injected with cortizone. Arm was better for about 2 weeks and progressively returned to pain and stiffness. Arm being treated by a chiropractor since 1/30/2006; arm is still stiff and painful in deltoid muscle. Difficult to lift arm, put on seatbelt. Arm still stiff, sore and painful.
Shot was at 7:20 am 3/9.  Started feeling very cold and shaky about 1PM, took an Advil and that helped for a couple hours. By 4:30PM uncontrollable shakes, felt electric zaps, and very, very cold.  Temperature around 100.9F.  For a couple hours continued shaking and couldn't get warm.  Finally stopped shaking and then very hot around 8pm, Temperature was 103.5F.  Took Advil and tried to cool down.  Heart rate was around 120bpm and pounding hard for a number of hours.  Couldn't sleep due to pounding heart.  Finally around 3am the next morning heart rate back to normal and temperature back to 100.9.  Achy throughout the afternoon and night yesterday and this morning.  Feeling much improved at 3pm on 3/10. Temperature 99.5F.
SORE THROAT; THROBBING HEADACHE; STOMACH PAIN THAT HE DESCRIBED AS MUSCLE PAIN; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, non smoker, and stuffy head, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced sore throat. On 13-MAY-2021, the subject experienced throbbing headache. On 13-MAY-2021, the subject experienced stomach pain that he described as muscle pain. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from throbbing headache, stomach pain that he described as muscle pain, and sore throat. This report was non-serious.
Patient returned to pharmacy on 10/16/2016 with symptoms of redness, swelling, and warm to touch from shoulder to elbow of vaccinated arm. Patient was referred to PCP to have the reaction checked out.
Info has been received from a CMA concerning a 32 year old white female pharmacist with no medical history or allergies who on 3/3/98 and 4/21/98 was vaccinated, IM, in the left arm with a 1st and 2nd 0.5 mL dose of varicella virus vaccine live (lot 624782/0052H). There was no illness at the time of vaccination. A titer was done recently (date unspecified) and the result was below the seroconversion limit. Unspecified medical attention was sought and no symptoms were noted. A product quality complaint was not involved. Additional info was received from the CMA who reported that there was no adverse event. The reporter was told by the pt's OB/GYN of a low varicella titer and recommended re-vaccination. The pt had no adverse events following prior vaccination. No further info is expected.
Stroke; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 038AZIA) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No medical history reported).   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 22-Mar-2021 to 25-Mar-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) was resolving.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient received dose on Saturday 8/20/11 and came in on Thursday 8/25/11 with complaints of itchiness. Site also red at injection.
Pt states pain to left arm immediately after vaccine placed, and pain never went away, 7/10.  Fever of 101.9 11/4/15, took Motrin, effective for fever but not for pain.  Pt woke up this morning w/ a bump on vaccine site, red, hot, and extremely painful.  Seen by Dr. today, w/ dx of possible vaccine reaction vs possible cellulitis. Pt given Rx for Bactrim and Augmentin, pt will start as soon as she gets meds. Pt also currently taking Zithromax for sinusitis dx'd by Dr. on Wed, 11/3/15.
No sleep due to fever beginning 1 day after receiving shot. Got better, fever came back and repeat for several days, still no sleep. This went on up until January 8 2022 and my heart began to flutter, I became dizzy, shortness of breath, tight chest and pain behind my heart and numbness in my hands and feet. I went to the ER and the doctor determined it was a panic attack.
Nausea Low grade fever, Dizziness, Extreme inflammation in back Causing Pelvis to Go out Of place Causing extreme pain
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration, on an unknown date, as single dose for COVID-19 immunisation. The patient's medical history included hypertension, diabetes, visual problems and kidney transplant. Concomitant medications were not reported. On an unknown date in Apr2021, the patient tested positive for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in Apr2021. The patient's doctor told him that because the patient tested positive for COVID he have to wait 90 days before taking the next dose. The event resulted in emergency room visit. The patient was supposed to get his 2nd dose on 14Apr2021 but has to cancel because he tested positive last week for COVID. He wanted to know how long does he have to wait before he can get his 2nd dose of the COVID vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Narrative: 76 y/o male with cad s/p pci, ulcerative colitis s/p colectomy w/ J-pouch (ileo-pouch-anal anastomosis), primary sclerosing cholangitis, pouchitis, hypothyroidism, & Myasthenia Gravis died on 9/26/2021 outside facility. No information given on cause or circumstances of pt's death. Pt had received covid vaccines on 1/28/21 and 2/25/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Lymph Node on my clavicle on the left side swelled up after reciving the first dose of the Covid Vaccine and never went away. It swelled up more after the 2nd dose. It has been swelled up for months and has recently started to cause pain in that area.
Fever 102, debilitating fatigue and muscle pain, headache, chest pain, heart palpitations, for 24 + hours. Went to ER
This was patient's second dose. Patient accompanied by his father. Father was holding the thigh. However, the child pulled the leg when vaccinating. Content of the vaccine spilled over on his thigh. Unable to administer the vaccine. Revaccinated in the right thigh successfully.
I started feeling extremely tired like absolutely no energy; Headache; Nausea; Low grade fever; loss of energy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Jan2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that on an unspecified date of 2021 the patient started feeling extremely tired like absolutely no energy and felt like that way for three days. Beside the loss of energy and extremely tired, patient had a headache and some nausea, it was not there all the time and a low-grade fever like about 99. The patient underwent lab tests and procedures which included body temperature: about 99 on an unspecified date of 2021. The outcome of events feeling extremely tired like absolutely no energy, headache, nausea, low grade fever, loss of energy was unknown.  Follow-up attempts are completed. No further information is expected.
In addition to "normal" side effects (I took ibuprofen for the miserable fever) I woke up the next morning after the vaccine with my knees and elbows all swollen, painful and hot. My wrists and hands too but not as bad. The next day was better tho and the next better
Patient came in for 2nd dose of Pfizer. However RN erroneously gave patient an empty,  pre-prepped with air in syringe (no vaccine yet). No adverse effects noted to the reporter.  Patient was then correctly given vaccine dose.
lip swelling; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 06Mar2021 at the age of 72-year-old as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient receive vaccine shot on saturday at about 9 or 11 in the morning. On 08Mar2021 this morning, her lip is swollen, and she has never had swelling of the lip before. Patient wanted to know if this is a known side effect of the product, and she is trying to decide if she needs to go to the ER. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Came on 12-4-08, c/o right arm itchy, warm to touch.  Raised area approx 4 cm in diameter.  Looked at by FNP.  Pt given 1 LOMTIDINE 10 mg po.  Approx 4:45 pm.
Patient reports that she was very sore, noted fever, chills, upset stomach and headache after receiving her second SHINGRIX vaccine. She ended up staying home from work and laid in bed all day. She notes that she feels much better today, 08/16/2018.
Headache, possible slight dizziness short acting, throat ached & felt tight, ears felt tight, petechiae on inside right ankle, stomach ache, possible rash on back; legs weak the next morning
This spontaneous report as received from a registered nurse refers to a 5 months old patient of unknown gender. The nurse reported that on 07-FEB-2014, the patient was vaccinated with the second dose of ROTATEQ, (Lot # J007283), expiration date: 27-SEP-2014. Route and dose were not reported. On 10-MAR-2014, the patient received the third dose of ROTATEQ, (Lot # J008735), expiration date not reported. No other co-suspect or concomitant medications were reported. The nurse reported that both doses received by patient were vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the storage temperature reading in the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. No adverse effects reported. This is one of several reports received from the same source.
Developed headache and nausea 2 weeks after H1N1 and seasonal flu vaccine. Progressed over following week to severe headache, blurry vision, diplopia and vomiting. Admitted to the hospital with increased intracranial pressure and papilledema, and sixth nerve palsy.
Alcohol (beer)  is causing hives on my face neck and back. Even vegan alcohol, which I can normally drink without any problems.
Dose 1. Swelling at injection site plus from shoulder to wrist. Fever x2 days.  Dose 2. Swelling round circular raised painfully sore to touch, weakness in that arm. Exhaustion, Fever, Headache,