chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received DTAP on 3/3/03 and developed erythema and warmth on 3/4/03 with increased erythema, warmth and soreness today, 3/5/03. Area to left arm measured 8cm X 7cm. Arm was warm to touch with mild to moderate soreness. Mother treated with Tylenol and Benadryl and cool compresses. Instructed to see PMD if symptoms worsen. Recovered on 3/7/03, per mother.
NUMB SKIN; KICKING BUTT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported 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 subject experienced kicking butt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of kicking butt was not reported. This report was non-serious.
bad cough; fever; sick; Running nose; stopped up nose; Initial information was received on 27-Nov-2021 regarding an unsolicited valid non-serious case from social media via a consumer/non-healthcare professional.  This case involves a patient (demographics unknown) who experienced bad cough (cough), fever (pyrexia), sick (illness), running nose (rhinorrhoea) and stopped up nose (nasal congestion) after receiving INFLUENZA VACCINE and Corona virus disease (COVID-19).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious bad cough (cough), fever (pyrexia), sick (illness), running nose (rhinorrhoea) and stopped up nose (nasal congestion) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 VACCINE.  It was reported "Have two Covid shots, flu shot and they told me cannot have pneumonia shot last one have to wait another year. Been sick 7 days non stop bad cough, running and times stopped up nose, like fever. Worried this goes into pneumonia usually does bronchiole then that. Must get over due for procedure Dec 8".  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the events.  The reporter did not report causality of events with suspect.  At time of reporting, the outcome of the events was unknown.  There will be no information available on the batch number for this case.
Rash, Flushing Red skin upper abdomen, headache, fatigue, swelling in neck, pain in arm, cramps in calves, dizziness, vertigo. Symptoms began on June 15th, 2021 shortly after 2nd dose of Covid 19 Pfizer vaccine and continue until time of reporting June 19th, 2021. Rash and redness and leg cramps, swelling and arm pain lasted 24-72 hours. Others symptoms including headache and vertigo and fatigue continue to date of this reporting.
This patient received his 2nd dose of Pfizer vaccine yesterday.  Today, he had focal weakness and difficulty walking and was  transferred for suspected stroke.
facial swelling, tongue swelling, facial rash, itchy feet. Gave Benadryl. No throat swelling.
Headache and fever of 102 F. Took Advil which relieved the headache. Fever subsided in about a day.
3 days of severe nausea/ vomitting, temp of 104, chills, shaking, hacking cough
Pt immunized 2NOV90 & exp soreness @ inject site; next day had swollen ax lymph node; tx w/hot packs;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 18Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 16Jul2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. No known allergy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Patient started paxlovid for COVID 19 Treatment from 14Aug2023 to 19Aug2023. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
stuffy & runny nose, h/a, sore throat, yellow phlegm, watery eyes;
Swelling of the arm where vaccine was administered started as just small and red on same night.  Next Day 4/30/2021 when waking up it had grown double in size.  Saturday 5/1/21 the arm had swelled and redness over 6 inches in diameter and seemed to be spreading in size.  Skin was very warm to touch and felt tough directly under the skin.  We contacted the doctors office immediately on Saturday  morning of 5/1 and were told to mark around the redness to monitor if the swelling and redness would increase in size.  We were advised at that time to give benadryl to help with swelling.  Nothing seemed to be making the swelling decrease so additional calls were made to the answering service around 7pm.   No call back from the night before and  multiple calls to the same doctors office answering services before normal hours on Sunday morning 5/2/2021  were made, before finally being told to come into the office at 10am on Sunday 5/2 to be seen.
Enlarged Cervical Lymph node, painful, palpable, observed within 24 hours period
COVID arm; the 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 PAIN IN EXTREMITY (COVID arm) and RASH (the 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (COVID arm) and RASH (the rash). At the time of the report, PAIN IN EXTREMITY (COVID arm) and RASH (the rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Severe body aches, especially painful legs; severe headache; foggy-headed; low grade fever (100); fatigue. Aches/pain and headache significant---- severe enough to disrupt schedule, left work four hours early.
Severe pain in shoulder, chest on left side, after 1 day it spread to left shoulder and chest as well, movement is impede severely as well, now pain is spreading to knee.
Patient with symptoms of severe myalgias, low back spasms, fevers, chills, headache, SOB since Saturday.  Treatment included intravenous fluids, Tylenol, magnesium repletion, frequent reassessments, infectious disease consultation in the Emergency room.
SARS-CoV-2 (2019-nCoV) Nucleic Acid Amplified Test performed on 7/19/21 at 16:46. Test came back positive. Case investigation interview with patient has not been conducted as of the time of this note.
shingles on the left side of her face, in her left nostril and along the gum line in the left side of her mouth; left eye started to flutter she couldn't keep it closed.; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Shingles outbreak in September 2018).   On 27th September 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, not applicable after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced shingles, eye disorder and incomplete course of vaccination. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles and eye disorder were recovering/resolving and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles and eye disorder to be related to Shingrix.  Additional details were provided as follows: The patient did not have an outbreak after receiving the vaccine until before date of reporting.  Till the time of reporting the patient had not received the 2nd dose which led to incomplete course of vaccination. She had shingles on the left side of her face, in her left nostril and along the gum line in the left side of her mouth and her left eye started to flutter she could not keep it closed.  She had been taking acyclovir and the symptoms were resolving.  The reporter consented to follow up.
82 yo spanish speaking M former smoker (quit 1981) hx of HTN, HLD, DM (A1c 6.5 diet controlled), asthma, stg I papillary thyroid ca (deferred surgery per ENT 6/2020), protein S deficiency on Coumadin (leg DVT 2006), diverticulosis, diverticular bleed 3/2017 (stopped Coumadin 1 mo then resumed), afib, GERD, BPH, COVID vaccinated, p/w intermittent cough, fever, significant weakness. Symptom onset 8/23/21. COVID+ 8/27/21. Admitted given desat to high 80s on ambulation, started on remdesivir/decadron for COVID PNA. Lives with wife, ambulate wo assistive device. Independent in ADL/iADLs.    Overnight remained on RA, afebrile, hemodynamically stable.  Review of systems denies fever, chills, cp, shortness of breath, n/v/d, abdominal pain.  Does have R hand mild tremors but otherwise feels well and desires to go home  Passed road test without desat. Given no oxygen requirement, no indication for discharge with remdesivir/ dexamethasone. Family inquired regarding mAb therapy as outpatient. D/w ID, mAb only offered to transplant or severely immunocompromised patients /w daughter-in-law who will pursue mAb therapy. OP referral to continued follow up with anticoagulation clinic and life care planning.    Primary Procedures:  None    Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  COVID Pneumonia
CONFIRMED CLINICAL VACCINATION FAILURE; BREAKTHROUGH COVID-19; This spontaneous report received from a patient concerned a 56 year old female. 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 not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-APR-2021 to left arm for prophylactic vaccination. (Dose number in series 1). No concomitant medications were reported. On 27-NOV-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive.  On an unspecified date, It was reported that, the patient experienced (fever, cough, congestion, yesterday lost sense of smell and taste) breakthrough covid-19, and confirmed clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breakthrough covid-19 and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint 90000205216.; Sender's Comments: V0: 20211206786-COVID-19 VACCINE AD26.COV2.S- confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
On day after immunizations felt lump at injection site. Size of lump increased in the next 24 hours and was described as the size of an avocado. Area around site was reddened. No fever or streaking. To ED to R/O cellulitis. No cellulitis appreciated by MD in ED. Phone call to family today with report of improvement of symptoms decrease of redness and discomfort.
Information has been received from a mother of a 14 year old female patient with no known medical history and no known drug allergies, who on 16-Sep-2008 was vaccinated with the first dose of GARDASIL . Concomitant therapy included HEP A vaccine and Lisdexamfetamine Dimesylate. The mother reported that on the night of 28-Sep-2008, her daughter's knees felt very weak. The mother also reported that on 29-Sep-2008, her daughter went to school, then around 12:30 pm she had came home from school because the weakness moved from knees to her thighs and she felt like she didn't have knees and she was going to fall over. The mother reported that on 29-Sep-2008 her daughter went to her pediatrician who did strength test on her legs but her strength was fine, and she did say she had some fluid in her right knee but her knee was not hot. The mother reported that the physician was not sure what was causing the symptoms since the patients activities did not change, but stated to give it 72 hours and if nothing had changed the patient had come back and get blood work done. The mother also reported that on 29-Sep-2008 her daughter did stay home from school. The patient sought medical attention. At the time of the report the patient had not recovered. Additional information has been requested.  11/4/2008 PCP records received. Healthy with no problems noted at WCC 9/16/08. Vax given. Returned 9/29/08 with c/o joint/muscle pain and weakness. Tx ibuprofen and rest. Pt has recovered.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date in Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In the first week of Jan2021, she got the first vaccination. She is a dialysis patient so they are constantly taking her temperature. She went and had dialysis. The patient tested covid positive on an Jan2021. Her temperature went up to 101, so they called the medic who took her to the hospital. was not admitted in the hospital, but they did a blood test and confirmed she had COVID. No one feels it was related to the vaccination because it was already in the facility. She is concerned about her second dose. She was asymptomatic. On an unspecified date COVID test was negative. The outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.
Rash face and trunk c/w chicken pox mild form about 8 days post vaccine.
On 10/03/16, 84 yo F presented to clinic for scheduled appointment. During this visit, pt was ordered to receive pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13) [IMM78] (Ord #217343176). Per immunization record, pt received 0.5 mL in left deltoid (NDC #0005-1971-01; Lot #n16561). Pt tolerated injection without incident and was discharged home. On 10/10, pt called clinic and reported that she had persistent redness at the injection site that started to spread towards her inner arm, was accompanied by pain and was not responding to treatment with ice and ibuprofen 400 mg every 4 hours. On exam, pt was found to be afebrile with Temp:  36.9 °C (98.5 °F). MD advised continued symptomatic care with ice and acetaminophen. Pt was advised to return to clinic in about 1 week if symptoms worsened or failed to improve.
Information has been received from a consumer concerning her baby daughter who on 26-JUN-2008 was exposed via her mother who was intramuscularly vaccinated with her first dose of GARDASIL vaccine. Concomitant therapy included cephalexin. The consumer reported that, she had her baby girl "but she had some problems"; the baby had hydronephrosis in her kidneys and had two surgeries. The baby was "doing fine now". The mother's experience has been captured in WAES 0807USA04523. Additional information has been requested. This report was previously sent to the PLA V501 on 25-NOV-2009 in WAES #0807USA04523.
2 hours after shot to right arm, right leg broke out in hives and pocks, does not appear to bother child, goes away within a day (April 22) 7 days after shot, diarrhea in each diaper (April 27th) 9 days after shot, vomited 3 times when given milk or formula on, diarrhea  continues day and night during her bowel movement times (April 30th)
Information has been received from a nurse concerning a 53 year old female patient (also a nurse) who on 28-OCT-2010 cut her finger on a shard of glass when she tried to remove a broken vial of RECOMBIVAX HB from the carton. The patient did not seek medical attention and was fine at the time of report. Additional information has been requested.
This morning after his second shot yesterday he had a fever of 99.  This afternoon about 24 hours after his vaccination it was 100.8.  Normal for him is 97.5.  He's complained of chills also and dizziness.
Client was given Moderna as a second dose and should have received Pfizer. No adverse outcomes noted. Researched CDC information and found if a second dose of the same kind is not available or a different type is inadvertently given the dose does not have to be repeated. Explained the information to the client and her family member.  Family member states she understood the information.
An elevated Heart rate; Headaches; Body aches; Feeling feverish; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (An elevated Heart rate), HEADACHE (Headaches), MYALGIA (Body aches) and PYREXIA (Feeling feverish) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced HEART RATE INCREASED (An elevated Heart rate), HEADACHE (Headaches), MYALGIA (Body aches) and PYREXIA (Feeling feverish). At the time of the report, HEART RATE INCREASED (An elevated Heart rate), HEADACHE (Headaches), MYALGIA (Body aches) and PYREXIA (Feeling feverish) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Heart rate: 100 (High) Elevated heart rate. Heart rate was over 100 Beats Per Minute for two hours.. On 18-May-2021, Heart rate: 120 (High) Heart rate has been over 120 Beats Per Minute..         The Patient did not experience any adverse events after the first dose of vaccination. Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. .
A little over a week after getting the shot, on May the 5th, the injection sight began to swell and itch. This turned into a rash that spread and continued until it encompassed the whole of my bicep and shoulder. The rash itched, as well as became painful and was constantly hot to the touch. Claritin-brand antihistamines did not bring relief, though acetaminophen did bring relief from the pain for short time periods. Hydrocortisone cream was applied, but this made the rash worse, rather than provide any relief. I went to my PC group, where I was diagnosed with a combination of an allergic reaction mingled with a bacterial infection due to bacteria entering the injection sight.
Haven?t had an MS exacerbation in over a year. Two days after my second vaccine my feet and legs were tingling, balance and confusion, weak legs   Broke out with Shingles- flu like symptoms  Lasted over a week
Red, warm, swollen measurment of 2" X 2" inches. Total measurement of 3 1/2 " X 3 1/2 ".
Information has been received from a physician concerning a 75 year old male with no known history who on 02-MAR-2007 was vaccinated SC in the left deltoid with a 0.65 ml first dose of Zostavax (lot # 652925/0621F). There was no concomitant medication or illness at the time of vaccination. Two hours after vaccination on 02-MAR-2007, the patient started developing pain in his neck as well as some achiness. He developed some disorientation and erratic driving over the weekend and was seen by the physician on 05-MAR-2007. The physician recommended work-up for possible Zostavax related meningoencephalitis or viral encephalitis. He was admitted to the hospital observation unit and under went neurological consultation. A MRA of the brain showed no acute infarct, no MRA evidence of encephalitis or meningitis. A 13 mm right medical posterior inferior cerebellar cystic lesion represents a small arachnoid cyst versus the etiology of doubtful clinical significance. He underwent a spinal tap under fluoroscopic guidance which revealed the following findings: fluid protein 80 mg/dl, glucose 68 and white blood count was 23 white cells per microliter, 100% of mononuclear. The patient had PCR for herpes simples virus which was negative. The patient's basic metabolic panel was normal and his white count was 10,800 with 68% neutrophils, 17% lymphocytes, 8.4% monocytes and 5% eosinophils. The patient was discharged to home on 08-MAR-2007. His mental status did not change and he still had the same symptomatology of some disorientation and loss of higher cortical function. The discharge diagnosis was viral meningitis of undetermined etiology possibly post vaccination with Zostavax. The patient's discharge medications included PROTONIX "quarter" mg QD, naprosyn 300 mg PO BID and MIDRIN one capsule PO q 6h for severe headaches. The plan was for the patient to follow-up as an outpatient. As of 30-MAR-2007 the patient was at home and "doing much better". A lot check has been requested. It was reported that CSF fluid was available for PCR testing and the patient was enrolled in the Varicella Zoster virus identification program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the manufacturer vaccine VZV strain. The patient's viral meningitis was considered to be immediately life-threatening. Additional information has been requested. 04/24/07-records received from facility for DOS 03/05-03/08/07-DC DX: viral meningitis of undetermined etiology possible post vaccination with Zostavax. 3/2/07-Two hours after receiving vaccine C/O pain in neck as well as some achiness, developed disorientation and erratic driving.
Pt recvd vax & exp unspecified react; pt recovered; No further details provided