chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FLU LIKE SYMPTOMS; HEAT AND COLD SWEATS, UNABLE TO CONTROL BODY TEMP; SWEATS; ABDOMINAL PAIN WHEN USING REST ROOM; RIGHT ARM PAIN- UNABLE TO USE; HORRIBLE HEADACHES; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's past medical history included had neck spinal fusion, and spinal cord neuor stimulator in lower back.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced flu like symptoms. On 11-APR-2021, the subject experienced heat and cold sweats, unable to control body temp. On 11-APR-2021, the subject experienced sweats. On 11-APR-2021, the subject experienced abdominal pain when using rest room. On 11-APR-2021, the subject experienced right arm pain- unable to use. On 11-APR-2021, the subject experienced horrible headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms, horrible headaches, heat and cold sweats, unable to control body temp, sweats, abdominal pain when using rest room, and right arm pain- unable to use. This report was non-serious.
Mother states pt received vaccine then had some blood work in office.  After ten minutes pt complained of dizziness accompanied with numbness in her face also feeling of ears being blocked.  Pt felt faint.  These episodes continue to occur.  Mom states never happened before vaccine.
Patient reports pain at injection site that started a few hours after receiving vaccine.  He presumed it was normal soreness from the vaccine but the pain did not improve.  The pain has worsened over time.  He has intermittent sharp stabbing pain at the injection site that was occurring weekly but it is now occurring daily.
Pt. received H1N1 vaccination and got into car and began feeling "itchy" at spot of injection. Pt. felt welts and went to purchase Benadryl. Pt. took Benadryl and returned to clinic to show staff. Pt. has inflammation at sight of injection approx. 4 cm W X 5 cm H with redness, warmth, and firmness. Pt. given ice and observed. No further complaints stated itching stopped by 1545.
Anthrax vaccine on 9 May and next day when sneezed both arms tightened up and felt stiff for 3-5 minutes.  This continues as recent as last night.  No treatment.  Vaccine given in left subdeltoid region.
Patient was given Bivalent COVID injection where the dose was pulled from two vials to make a complete dose
No physical adverse event occurred due to vaccination. The patient is 16 years old and received the immunization in error. Moderna is currently recommended for persons age 18 years and older.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient with no drug reactions or allergies. On 23-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# J004310, Exp date 07/12/2014) (dose not reported), subcutaneous. Concomitant therapies included atorvastatin and OMEPRAZOLE. The pharmacist reported the patient experienced redness, tenderness and swelling at the injection site after receiving ZOSTAVAX (in October 2013). The patient also received a influenza virus vaccine inactivated (unspecified) ("flu shot") on 26-SEP-2013. No treatment was given for AE. None lab diagnostics studies was performed. The patient was not recovered. The patient had sought medical attention by contacting the pharmacist. Additional information has been requested.
Initial report received from a health care professional on 16 Aug 2010: On 13 Aug 2010, this patient inadvertently received a intramuscular dose of MenA lyophilized conjugate component of MENVEO (batch number not reported) that was reconstituted with a sterile diluent. The patient had not received the MenCWY-135 liquid conjugate component of MENVEO. No adverse reaction had occurred following this administration.
pt recvd vax; pt devel hives which began 12 hrs after inject of vax;
Immediate tingling to left side of face, followed by tachycardia & palpitations, flushing from chest & back up to the scalp.  Taken straight to the ED, evaluated by MD, found to be very anxious & hypertensive (BP 203/128, P 110).  Treated with IV Benadryl & Pepcid.
VS O2 Sat 99%, HR 77, BP 136/98, RR 18 Began having tongue tingling within 10 minutes after vaccine. Denies SOB, difficulty breathing, difficulty swallowing, trouble speaking. Awake alert and oriented x 3. Pt took her own 25 mg Benadryl PO. Able to swallow with no issues. Patient was moved to observation hall. Once there she states it was getting worse. Given 50 mg IM Benadryl at 3:30 pm. By 3:40 pm patient states she felt much better. Educated patient on risks of leaving clinic on own . Pt signed refusal.
This spontaneous report as received from a pharmacist refers to an adult patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. The patient was administered the first dose of RECOMBIVAX HB three-dose series on 03-JUN-2014 and had come back to pharmacy on 11-NOV-2015 (today) to be administered second dose of the series. This dosing schedule was outside the labeled recommendations of RECOMBIVAX HB prescribing information. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Pt began experiencing feeling "short of breath" pt is double masked. Pt removed mask and did a couple deep breaths and felt slight improvement but s/s returned. Offered and pt accepted cold water, alleviating feeling short of breath. 5 pm pt began feeling more short of breath and was breathless w/speech. Nurse alert called and PO benadryl 25 mg in 10 ml PO given lot c13e exp 3/21. Vitals taken 145/745 56 HR and 95 O2. Pt taken to advanced urgent care by staff via wheelchair 507 pm
Red spot on arm below injection site (2"x3") and didn't start to fade for two weeks. But more concerning full body rash, red and raised, occurred and lasted four days.
Arthralgia, Fever & Diarrhea Narrative:  joint pain ankle and shoulder. fever 110.6 on day 3. diarrhea for 3 days
The minor patient was at the pharmacy to receive a second Pfizer Covid vaccination.  Upon review he stated he had experienced dizziness with previous vaccinations years ago, but never fainted.  The technician administered the vaccine and the father knocked on the window to get my attention.  I ran out front as the patient was stating his vision was becoming blurry.  The technician and I lowered him to the ground as he lost consciousness.  We elevated his feet and he immediately regained consciousness.  He started to stand and we advised him to remain seated.  We laid him back down and after several minutes he requested water which was given.  A few minutes later he was able to stand and took a seat in the waiting area for 30 minutes.  He was feeling better and had no other compaints.
pt said having N & V knot on her arm at injection site, redness and fever at injection site and sharp pain in right side
Complete numbness in arm where vaccination was received, from hand to the neck for 30-40 minutes roughly 5 hours post vaccine administration. Sore arm for 48 hours. Fatigue for 24-48 hours.
Sore muscle, having pain upon resting on shoulder and moving arm. Injection placed in upper deltoid.
the same patient may have received the second dose of GARDASIL 9 at a later than recommended time interval; This spontaneous report has been received from a pharmacist via a company field representative referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.   The patient received the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (route, lot number and expiration date unknown by reporter; strength, dose and frequency were not reported) at 15-years-old (date unknown) for prophylaxis. The patient might have received the second dose of GARDASIL 9 (lot number and expiration date unknown by reporter) at a later than recommended time interval (Inappropriate schedule of product administration).
Pt developed nephrotic syndrome 8/11/11. Has been resistant to standard treatment. Nephrologists now think it is focal segmental glomerulosclerosis. Mom is concerned that her 3rd GARDASIL shot given at her well check 5/25/11 could be causally related. She had a normal urinalysis at her well check 5/25/11.
nausea, vomiting, dizziness 30 mon after vaccine administration BP 125/82 HR97 RR14 O2 98 Pale, no respiratory distress, no wheezing CV normal, Abdomen normal Improved after observation for 30 minutes Refused transfer to ED
1) Day of immunization soreness 2) 12 hours after immunization fever and chills, took Tylenol every 4 hours 3) 24 hours after shot, sore 4) 72 hours after shot a 2 inch red band appeared below the injection site, lasted for <24 hours
Ataxia (cerebellar ataxia) - hospitalized on 3/3/07 and discharged 3/5/07, slightly improved.  04/19/2007 D/C Summary received from PCP.  Onset of acute ataxia began 3/3/07.  It improved throughout the day, but worsened in the afternoon.  Child was afebrile, no h/o head trauma, nomal mental status.  No UOP for ~24 hrs.  Cathed then began voiding spontaneously.   Neuro consult gave a DX of "likely post-infectious cerebellitis".    05/14/2007 MR received for 2 night hospital stay 3/3-5/07 for c/o difficulty walking including bumping into walls.  Had no UO for ~24 hours.  Cathed with spontaneous voiding after. No worsening during hospitalization so D/c home.  PE: (+) for wide-based ataxic gait.  Otherwise WNL.  DX: Probable post-infectious/vaccine cerebellitis.
Event occurred after full vaccination. The patient is a 70-year-old female presents to the emergency department with worsening shortness of breath. Ascorbic acid, Tylenol Discharged
Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Jan2021 as dose 1, single (Batch/Lot number: unknown), on 15Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood cholesterol increased" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin, and apparently paxlovid. Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: 5 days of testing negative; Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral details: Product:COVID 19 Treatment,  Brand: Paxlovid  treatment start date: 19Jul2022  treatment stop date: 23Jul2022  indication: Treatment of COVID-19   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Patient is a 32 year old female who presented to community Center for her first dose of the Pfizer vaccine.  She admits to a history of newly diagnosed Hypertension.  She currently states she takes a combination of 2 high blood pressure medications, but she is unsure of the names of her meds.  She denies taking her blood pressure medications today and said she normally takes them in the evening.  Patient received her first dose of Pfizer in her left arm.  During observation she asked for her BP to be assessed due to c/o a pounding headache.  VS were taken and the first reading was 179/120 HR 109, followed by a second BP reading of 200/120, HR 106, then final HR was 84.  It was explained to the patient that she is currently in a hypertensive crisis and should be taken to ER STAT for further treatment.  Patient agreed with medical advice and paramedics was called and she was taken to the ER.  Patient denies diplopia, dizziness, N/V, weakness, syncope or any symptoms of COVID-19.  Patient notified observation staff at 1403 hours and EMS & patient out time 1425 hours.
Patient visably sweating and eyes droopy. EMS was called vitials initially HR 52 BP 51/24. Patient was able to communicate verbally, he has Hx of anxiety with any injection. BP returned to 114/66 after about 5 minutes. Released to go home.
PATIENT CAME IN AND STATED THAT ON 10/7 AROUND 5PM, SHE NOTICED A HARD, SWOLLEN LUMP ON HER ARM AND THE INJECTION SITE THAT WAS HOT TO THE TOUCH. IT WAS THE APPROXIMATE SIZE OF A GOLFBALL IN DIAMETER.
Approx. 19 hours after Vaccine was administered, I was feeling tired and then I began to experience a mild headache then that was accompanied with dizziness.  Temperature taken after dizziness started and temp. was 100.5F.   Also has some mild body aches mostly in the lower back area. Took Tylenol and then took it easy the rest of the day and even took an hour nap.  Felt better by the next morning(Thursday)  No fever or other symptoms to report.
Father noticed red rash on right arm 11/11/2008 pm, site of flu injection.  Removed band-aid on 11-7-08 & there was no signs of redness.  Treated with zyrtec for urticarial region right upper arm.
day 7 queasy stomach after eating breakfast, lasted all day.  Day 10 intense itching all over skin, continued for duration.  Day 12 Diarrhea  10-20 minutes apart for 5 days. GI tract slowed or stopped for 48 hrs, continued eating, Vomited @ 48 hours and diarrhea again for 2 days, GI tract slowed for 2 days, Vomited and Diarrhea for 8 hours, GI tract slowed, when the full feeling was there this time I fasted and exercised until there was pressure relieved by constipated bowel movement. My GI tract seems to be flipping from purging and slow down. The itchy skin subsided more or less as the GI tract stopped purging.  as of  April 5 my GI tract seems to have settled into a mild constipated state, not it?s normal.
Vision problem; Styes in the eyes; Ocular migraines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "Vision problem"; HORDEOLUM (non-serious) with onset 2021, outcome "unknown", described as "Styes in the eyes"; OPHTHALMIC MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "Ocular migraines".  Additional information: At this point he wanted to call Pfizer "you folks" to let you know what was going on and what's so interesting is that the same exact 2 events, the styes in the eyes and ocular migraines, were experienced by a female coworker of his. She had never had this before in her life also and described her vision problem and that was when he told her she has ocular migraines. These have been going on with her too and they both are about the same age. She had both of her Pfizer shots too. No further details provided.    This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Recently had a chest pain; Muscle pain; After their booster develop tinnitus, a ringing in the ears; More recently nerve pain in the arms and legs; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (After their booster develop tinnitus, a ringing in the ears), NEURALGIA (More recently nerve pain in the arms and legs), CHEST PAIN (Recently had a chest pain) and MYALGIA (Muscle pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B, 010M20A and 012L20A) for COVID-19 vaccination.     Patient never had COVID test or diagnosis. There was no history of Myocarditis/pericarditis.  Concurrent medical conditions included Drug allergy (Topiramate allergy).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced TINNITUS (After their booster develop tinnitus, a ringing in the ears), NEURALGIA (More recently nerve pain in the arms and legs) and MYALGIA (Muscle pain). On 06-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (Recently had a chest pain). At the time of the report, TINNITUS (After their booster develop tinnitus, a ringing in the ears), NEURALGIA (More recently nerve pain in the arms and legs), CHEST PAIN (Recently had a chest pain) and MYALGIA (Muscle pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac function test: normal (normal) abnormal- no. On an unknown date, Electrocardiogram: normal (normal) ECG show no voltage and abnormal (abnormal) abnormal. On an unknown date, Troponin: normal (normal) normal value.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. Hx relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. AE caused the patient to seek medical care. It was reported that symptoms were worsened.  There was no diagnosis of myocarditis or pericarditis. Patient did not experience dyspnea/shortness of breath/pain with breathing. Patient did not experience palpitations/pericardial rub. Patient did not experience syncope. There was no myocardial edema/cardiomyopathy/pericardial effusion/infective pericardial effusion/pericardial effusion malignant. The patient had not experienced a similar event in the past. It was reported that the symptoms had worsened and had not resolved. There was no cause determined for the reported adverse events MRI of the heart was not performed.  No treatment medications were provided.
NP was alerted that pt had an episode of syncope immediately following Pfizer booster dose while seated on exam chair.  Pt regained consciousness immediately. Alert and oriented at this time. Pt denies symptoms or respiratory distress and all other symptoms at this time. She states she has a history of syncopal episodes after vaccination. Vitals stable: Bp 132/80, p 61/ o2 99%. Repeat vitals 10 minutes later: bp 135/75, p 63, o299%. Pt denies dizziness when standing, then when ambulating. Pt assisted to observation area without further incident.
Discomfort at injection site; Persistent Confusion; similar to what is observed post-concussion; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Sep2021 (Lot number: Ff8839) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Moderate asthma" (unspecified if ongoing), notes: Moderate asthma. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose1, single, lot number: El1283,), administration date: 21Jan2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (Dose2, single, lot number=En5318,), administration date: 24Feb2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset 30Sep2021, outcome "recovering", described as "Discomfort at injection site"; CONFUSIONAL STATE (non-serious) with onset 30Sep2021, outcome "recovering", described as "Persistent Confusion"; POST CONCUSSION SYNDROME (non-serious) with onset 30Sep2021, outcome "recovering", described as "similar to what is observed post-concussion". Therapeutic measures were not taken as a result of vaccination site discomfort, confusional state, post concussion syndrome.  Additional information: Patient past drug event included BO and experienced allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Covid19 breakthrough.   1st Vaccine received on 05/28/2021.  76 y/o with PMHx of Afib, HTN, CAD, HF, AAA, HLD, BPH was recently discharged on 01/04/2022 for TIA vs CVA found to have Ecoli ESBL Urine. (covid not tested that admission)  Now readmitted where family states pt more confused than usual and c/o cough.  O2 sats room air 97%, CXR with trace bilat effusions and adjacent atelectasis.  Urine culture + again for ESBL Ecoli.  Started on IV Abx.
This is a 10 week old infant who received her first set of immunizations, all four shots, as of 10/1/04 around noon and then went home and was completely well for a little over 24 hours. The next day around 5:00 PM, she started having inconsolable crying and cried nonstop until about 2:00 AM this morning and was brought to the emergency room and admitted for observation. There is no history of any fever. She was unable to feed well and vomited once during this period of crying. Stools are normal once daily. In the emergency room, the child had abdominal x-ray done, which revealed significant gaseous distention. CBC was normal and heel stick electrolytes were normal except for elevated potassium. Medical Record received on 1/7/2005 states pt experienced a low grade fever.
Narrative:  Patient was hospitalized to agency hospital on 5/11/2021 d/t psychosis. No reported ADR since receiving COVID-19 vaccine. Symptoms:  & HOSPITALIZATION Treatment:
On 08/02/2021 (3 days after I received the first dose), I woke up to pins and needles. I had tingling and numbness in my arms all day. On 08/03/2021, the tingling and numbness moved from my arms to my legs. I also had other reactions including a rash at the injection site that was hot, red, and looked like a raised skin bump, and diarrhea. The reactions mostly subsided within 1 week; however, I have had occasional mild waves of tingling/numbness in my arms.