chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm a little sore for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm a little sore for a couple of days) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, ATORVASTATIN, FAMOTIDINE, COLECALCIFEROL (VIT D3), OXYBUTYNIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm a little sore for a couple of days). At the time of the report, PAIN IN EXTREMITY (arm a little sore for a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medication Includes- Shampoo for lupus in Scalp.  No treatment medications were reported.
Onset of muscular and joint pain stiffness aching. Time course of 7 days, treated with aspirin.
Rash, low grade fever, runny nose, cough... Dx of mild measles due to MMR vaccine. 2 weeks later developed sudden loss of balance, coordination issues. Brought back in to doctor's office. Dx with Cerebellar Ataxia due to measles.
swelling on arm 1" below injection site; redness, itchy, hot to the touch; oval in shape - 3" long x 2" high
Information has been received from a physician concerning an 8 month old male who received his third 2.0 ml oral dose of Rotateq. On 04-OCT-2007, the patient developed intussusception. The patient sought unspecified medical attention and has recovered. A product quality complaint was not reported. No further information was available. Upon internal review intussusception was determined to be an other important medical event. Additional information has been requested.
Headache & Myalgia Narrative:  missed a day of work following the second dose due to the above symptoms
Symptoms started around 5pm w/Muscle Pain, Chills, Headache, Nausea,  Joint Pain, Fatigue; Around 10pm had a Fever (102) & Vomiting; Around 11pm took Tylenol; Most symptoms subsided throughout the night-  was fatigue, sore, and with headache the next day. I was not given a copy of my Vaccination Record.  I asked for one and they said they did not have it to give.  I have no idea the medical professionals name or the Vaccine Lot # for my records.   I have NEVER had adverse reactions like this from vaccinations in the past.  I honestly thought I was on my death bed.
Tinnitus...ringing in both ears developed within 2 weeks of the 2nd dose. High pitched and constant ringing still exists. Visited my doctor and mentioned it and asked if it could be related to the vaccine. He said no. I was also placed on blood pressure medicine for the 1st time in my life.
Redness, induration, pruritic Reaction on left deltoid at site of 4th Anthrax immunization, began 1 day after vaccination. Was seen in ED, treated with Benadryl.  Redness has decreased, itching is now tolerable, induration persists.
SHOOTING PAIN IN RIGHT EAR; RIGHT ARM SORE/ EXCRUCIATING PAIN IN BOTH LEGS AFTER GETTING OUT OF BATH; CHILLS; SWEATS; BODY ACHES; 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: sulfa allergy, and other pre-existing medical conditions included: The patient was aware of that she do not have any medical condition and currently only taking multivitamin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-NOV-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient experienced sweats. On 02-NOV-2021, the patient experienced body aches. On 02-NOV-2021, the patient experienced right arm sore/ excruciating pain in both legs after getting out of bath. On 02-NOV-2021, the patient experienced chills. On 03-NOV-2021, the patient experienced shooting pain in right ear. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm sore/ excruciating pain in both legs after getting out of bath, chills, sweats, body aches, and shooting pain in right ear. This report was non-serious.
Dose 1 - soreness at injection site; mild fatigue for a 3-4 days, swollen lymph nodes under left armpit about 5-7 days after the dose was given that lasted for 4-5 days. Dose 2 - mild swelling and soreness at injection site beginning in first 24 hours after dose given; active chills for about 30 min beginning just shy of 12 hours after dose was given; nausea and vomiting that last 24 hours after symptoms began; intermittent neck and head pain (sometimes sharp/severe head pain) over first 24 hours after symptoms began; dull headache with light and noise sensitivity between 24-48 hours; backache for 2-3 days; fatigue for first 24-48 hours. Dose given on Tuesday afternoon and worst symptoms experienced Wednesday, feeling slightly better by Thursday morning but milder symptoms described above returned midday. Friday, I was cautiously returning to very light activity around the home and without previous symptoms, but refrained from being up and about too much, as I would feel off and slightly light headed. As of this morning (Saturday), only soreness/light swelling at injection site and slight lymph node pain remain.
Hospitalization for non-STEMI and tested positive for COVID-19 on dates 1/15/2023-1/18/2023. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Pt presented to ED 8/16/21 for URI symptoms - tested positive for COVID-19 on PCR
Pain in armpit on the same side as vaccination injection. Pain started next day after injection and continue to second day/current day.
Pain on right shoulder, scapula, CPS, lat, and forearm  starting several days after second dose on March 12 of Pfizer vaccine
Pt received her 2nd dose of the Moderna COVID19 vaccine and after sitting in observation for 20 minutes reported feeling itching around the injection site. Pt has a red rash above the injection site about the size of a half dollar coin. EMS was called and came to evaluate the pt. Pt's symptoms did not progress, she felt fine otherwise.  BP 126/98 repeat 130/84, HR 130 RR 14 O2Sat 99%  By the time EMS arrived the pt's rash started to subside. Pt signed refusal for transport to the ED with EMS. Pt was given ED precautions.
Temp 101, right area pain, radiating from shoulder to fingers day after injection, chilling, slightly swollen, hot to touch at injection site. MD advised Benadryl OTC 25mg BID, warm compresses to site. After Tylenol ore Ibuprofen PRN pain, Pt was not able to take Benadryl.
Arthralgia, Fever, NauseaVomiting, chills, insomnia, fatigue, Narrative:
Patient is a 37 years old female with no significant medical history who presented to the ED complaining of dizziness and right-sided weakness x1 week.  Other associated symptoms of blurry vision, double vision, vertigo/dizziness sensation described as "room spinning." Patient endorses receiving her 1st Moderna  coronavirus vaccine shot about on 3/24/21.  She denies any other focal deficits, facial droop, difficulty with speech or trouble walking.  CT head is negative.  MRI and MRA head and neck negative. Orthostatic vital signs negative. She was evaluated by Neurology, who ordered MRI of the cervical and thoracic spine with and without contrast that was negative. Echo showed LVEF 60-65%. Trace mitral regurgitation. Trace tricuspid regurgitation. PT vestibular evaluation was negative for BPPV. TSH/ammonia/B12 WNL. RPR was positive but FTA ABS is negative. Patient's symptoms improved with meclizine. She desired to be discharged to follow up with Neurology for outpatient EMG and nerve conduction test.
Severe muscle crams, continued muscle soreness and cramping, shortness of breathe and tight chest when exercising, elevated heart rate, occasional muscle cramps, joint pain
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 12-NOV-2014 was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported, lot # K003597, expiration date: 12-MAR-2015), that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt recv vax on 1/18/99; on same day pt exp right thigh induration& erythema w/ hard knot
Information has been received from the authors in a published literature article and refers to a 4 patients of an unspecified age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date in 2014, the patients were vaccinated with MMR (manufacturer unknown) (strength, dosage, frequently, lot# and expiration date were not provided). Concomitant therapies were not reported. The authors explained that during an outbreak of measles, on an unspecified date in 2014, 7 to 21 days after vaccination, the 4 patients experienced rash and their genotype was A, which was the same vaccine strain. Therefore, it was categorized as a vaccine associated reaction. The outcome of the event was unknown. The reporter considered measles to be related to MMR (manufacturer unknown). Upon internal review rash was determined to be medically significant. Additional information has been requested.
3rd year in a row that I had an ulcerative colitis flare-up (blood in stool, loose stool) within a day or two of getting the flu shot.
Information has been received from a health professional concerning a 9 yr old male pt with no medical history, who on 01Mar01 was vaccinated with a first dose of varicella virus vaccine live (lot636360/1334K). There was no concomitant medication. The pt was not ill at the time of vaccination. On 08Oct05 the pt developed chickenpox lesions on his back and within 48 hrs they spread all over his body 50-75 lesions in different stages, macular, vesicular, scabbed over arms, legs, trunk and groin area, toes and scalp. There were no lab tests performed. The pt did not seek medical attention. Additional information has been requested.
A spontaneous report was received from a consumer who Is 73-year-old female that received Moderna's COVID-19 vaccine and experienced persistent shoulder redness. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 19-FEB-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 016M20A) via (intramuscular) route for COVID-19 infection prophylaxis. On an unspecified date, after the first dose of vaccine, the patient developed redness on the shoulder that has not gone away. No treatment medication was reported. No lab tests were reported. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event, persistent shoulder redness was considered to be not resolved at the time of this report.; Reporter'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.
Pain, swelling, extreme bruising at the injection site lasting 11 days. Injection site is still dark blue and swollen. Adverse effect happened right after the vaccine process.
The night of the vaccination, I woke up from my arm hurting so much. I hadn't noticed any mark on arm when I first got the shot. When I woke up the next day there was a circle, maybe an inch in diameter that was red, like a hard lump. Each day after it kept getting bigger, it was hurting, burning. The next day it had doubled in size. The 3rd day I contacted my dermatologist because it doubled in size again. The doctor looked at the picture and suggested going to urgent care because they did not know much about the vaccine at that point. At urgent care, they said that my body was having a very strong immune response to the shot. They said usually that occurs usually when someone has previously had COVID 19. I was told to take Allegra to help. Originally when I saw the reaction I started putting hydrocortisone on the site. The Allegra did help. Before the spot went away and got better, it came back again. I went back to my dermatologist. He gave me a prescription topical cream to help with inflammation. The spot started to get better but became itchy.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: Gj5342) at the age of 82 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: Em6062), on 18Mar2021 as dose 2, single (Lot number: Ep7534), on 30Sep2021 as dose 3 (booster), single (Lot number: 301358A) and on 01May2022 as dose 4 (booster), single (Lot number: Fk9893) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection,  batch/lot# not reported), via an unspecified route of administration, on Jul 29, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Previously patient received her first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unknown date in 2021, single dose, for COVID-19 immunization. On an unknown date in 2021, patient was severely ill, couldn't walk and still weak in the legs. The outcome of the events unknown. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up.
Pt told his neighbor who works in the pharmacy that he had a severe urinary tract infection and they had to rush him to ER. They thought it was from the vaccine, but they called later and dr said it wasn't from the vaccine.
Pfizer-BioNTech COVID-19 Vaccine: During clinic visit eleven days after vaccination patient reports they started to experience diffuse paresthesias including tingling into face, arms bilaterally, hands, legs bilaterally, and feet. Started five days after getting vaccine. No other associated symptoms. No loss of muscle strength, slurred speech,  shortness of breath, throat tightening, skin reaction such as rash or hives, or visual changes. No history of multiple sclerosis, diabetes, or thyroid disorder. Based on lab values patient advised to start vitamin B12 supplementation. Two days after clinic visit reported symptom improvement.
MISSED THE SECOND DOSE; A spontaneous case report was received from a caregiver on 17-Jun-2019 for four consumers.  Based on the information obtained from the caregiver, four individual case safety reports PVX201906-000505 (PVX2019-1565; 14-year-old male consumer), PVX201906-000506 (PVX2019-1566, 10-year-old female consumer), PVX201906-000507 (PVX2019-1567; 13-year-old female consumer), and PVX201906-000508 (PVX2019-1568; 16-year-old female consumer) were created and cross-linked in the database.  This case describes a 14-year-old adolescent male consumer who "missed the second dose", while being on oral Vivotif (one capsule every other day) (lot number: 3003277) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 14-Jun-2019 and missed to take the second dose, which was due on 16-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the second dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201906-000506: US-PaxVax Berna GmbH-PVX201906-000507: US-PaxVax Berna GmbH-PVX201906-000508:
big red rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (big red rash) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (big red rash). At the time of the report, RASH ERYTHEMATOUS (big red rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD21-069938, MOD21-069979 (E2B Linked Report).; Sender's Comments:  MOD21-069938:Crosslink MOD21-069979:Crosslink
DEATH; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. 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 (suspension for injection, route of admin, batch number and expiry were not reported) dose and start therapy date were not reported, 1 total administered 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 died from an unknown cause of death. The reporter stated that, "The covid vaccine killed my mother. Can I finally post this without being ostracized. I needed my mother more than she needed that shot". It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20220515166-covid-19 vaccine ad26.cov2.s-Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
both have COVID; both have COVID; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 15Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from two contactable consumers (patient's wife and patient) via a Pfizer-sponsored program, Pfizer First Connect. This consumer (patient's wife) reported similar events for two patients. This is the second of two reports.    A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EH9899, unknown expiration), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization in a clinic. Medical history included prostate cancer, off rapid radiation (over two years ago by robotic surgery. He followed all the recommendations for rapid off radiation, no side effects. He took hormone therapy. He is cured), acid reflux, allergies (takes antihistamine when allergies act up; his allergies blossomed because of the leaves), and he used to be five nine, but he shrunk a little. Concomitant medications included rosuvastatin, acetylsalicylic acid (BABY ASPIRIN), losartan, pantoprazole for he had a bout with acid reflux, and tadalafil.  The patient's wife and the patient both received the COVID-19 vaccine on 04Jan2021 and stated they have a mild case; they did not have any severe symptoms of the COVID and did not have a fever. The patient's oxygen level was normal. The patient's wife confirmed that she and her husband both had the vaccine on the same day and they both have COVID. The patient got a cough and was going to go the (clinic name). They went there and had lungs checked. Their lungs were clear and oxygen level was good. They both have been tested a few times. The patient's wife and the husband quarantined for two weeks and test were negative. When they were there this past Monday, they were asked if they wanted to be tested. They both got the results on Wednesday and were shocked; they were now quarantining again. COVID testing was done on 11Jan2021 and got the positive results on 13Jan2021. The patient's wife and the husband gave them a card, for when to come back. It was given at a drive through clinic in (county name). The patient feels fine and is sleeping well.  The patient recovered from the event in Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021045610 same reporter/drug, similar events in different patients
Patient woke up during night after receiving vaccine feeling itchy all over and unable to sleep. Gradually subsided over 3 days til gone.
6/25/05 T/C BY MOC, LEFT UPPER ARM SWOLLEN, RED, HOT TO TOUCH, AREA APPROXIMATELY 3" DIAMETER, ITCHES.  MOC HAD BEEN WARNED THAT ON 4TH OR 5TH DTaP MIGHT SEE THIS REACTION AND TO PLEASE CALL AND LET US KNOW.  MOC STILL ALARMED.
(Only 1 dose) Pain in left arm first day, couldn't  sleep on left arm due to pain (second day) more pain in left arm, couldn't sleep on left arm due to pain, left arm weak, pain when fully  extending left arm, difficult to lift things with left arm, groggy for two day, flu like feeling but no fever