chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the Pfizer Bivalent booster on 10/3/2022. A week later, I woke up one morning to find that both of my hands were extremely swollen, with the swelling in the right hand being more pronounced than that in the left hand. I went to my PCP that afternoon. He did blood work to see if there were signs of inflammation. He also asked me if I could have possibly injured it or exerted it somehow, and I couldn't of any instance in which that may have happened. The results of the blood work were normal, so the PCP didn't know what the explanation could possibly be for the swelling. It's been over a month now, though, and the swelling persists. The swelling is still more pronounced in the right hand than in the left; my right index finger is now twice the size of my left index finger. The joints in both hands constantly hurt even when I'm not using them, though it's worse when I do use them. The doctor recommended that I use VOLTAREN cream to treat it, but it doesn't help at all. I am scheduled to see an internist in the very near future.
Patient said they had pain in their arm, and they couldn't lift it for two days. Today when the patient was contacted later in the day for the follow up. They said their arm is little bit better.
Narrative: Patient with breakthrough Covid infection. Previously received 2 doses of moderna vaccine. Treated with monoclonal antibodies
vaccine that was administered outside of the 12 hour window/stored post puncture in room temperature; No adverse event; 1 patient received Moderna Covid-19 vaccine 12 hours after the vial had been punctured.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient received Moderna Covid-19 vaccine 12 hours after the vial had been punctured.), PRODUCT STORAGE ERROR (vaccine that was administered outside of the 12 hour window/stored post puncture in room temperature) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (LOT number was unknown, Expiration date 20-Feb-2022, Left Arm of administration.) on 21-Feb-2021, Moderna COVID-19 Vaccine (LOT number 031A21A, Expiration date 28-Aug-2021, Left Arm of administration.) on 23-Mar-2021, Moderna COVID-19 Vaccine (LOT number 939904, Expiration date 24-Jan-2022 and Left Arm of administration.) on 27-Oct-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 15-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 2.5 milliliter. On 15-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient received Moderna Covid-19 vaccine 12 hours after the vial had been punctured.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine that was administered outside of the 12 hour window/stored post puncture in room temperature) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient received Moderna Covid-19 vaccine 12 hours after the vial had been punctured.), PRODUCT STORAGE ERROR (vaccine that was administered outside of the 12 hour window/stored post puncture in room temperature) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (1 patient received Moderna Covid-19 vaccine 12 hours after the vial had been punctured.) and PRODUCT STORAGE ERROR (vaccine that was administered outside of the 12 hour window/stored post puncture in room temperature).    No concomitant medication was provided by the reporter.  The vial was initially stored in the refrigerator on 07-NOV-2022. The vial was first punctured at room temperature on 14-Nov-2022 at 10:30.  The vials did not go under temperature excursion.  No treatment medication was provided by the reporter.
Immediate bruise at injection site when received, moderate nose bleed 48 hours after  vaccine.   Bleeding stopped. No medical attention needed.
Immunizations given on 1/15/02. Pt presented in office on 1/16/02 with swelling 1st noticed @4pm on 1/16/02. Pt was treated with antibiotics for the possibility of cellulitis and was seen again on 1/17/02, arm was still hot and painful but had full function of arm. 1st 2 immunizations were DT ?? possible seizures but had subsequently rec'd DTaP for # 3 & 4.
COVID-19 Vaccine EUA.  Although the injection itself was very painful, my arm did not swell at first.  I did feel weak following the shot, but that went away within 20-30 minutes.  Exactly two weeks after I received the shot, I developed delayed cutaneous hypersensitivity.  The morning I started having the reaction, my arm just itched.  By the end of the day, I had started developing a rash which felt hard.  The next day (today), the rash has grown to a few inches in size; however, it is not painful. Please note: correct birthdate is 08/03/1946.  Have attempted multiple times to change it to the correct date on the form, but the form keeps switching it to 08/02/1946.
Loss of smell; Loss of taste; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for female patient. A 66-years-old non pregnant elderly female patient received (not pregnant at the time of vaccination) bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 27Mar2021 16:30 (Batch/Lot number was not reported) (at the age of 66-years-old) as dose 2, single for covid-19 immunisation. Medical history included non-small cell lung cancer from an unknown date and unknown if ongoing, emphysema from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing. The patient not had allergies to medication, food, or other products. The patient received medication within 2 weeks of vaccination. The patient had previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration, on an unknown date (Batch/Lot Number: unknown) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 30Mar2021 07:30 AM, the patient experienced Loss of smell and Loss of taste 4 days later. The patient not received treatment for the event. The patient underwent lab tests and procedures which included nasal swab (sars-cov-2 test): negative on 04Apr2021. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Allergic reaction 10 minutes after injection. High BP 171/110, chest tightness, eye swelling, left back of shoulder, neck, face pain , moderate severe headache. SOB.
anxiety; ADHD; fainted; fainted; This spontaneous report aws received from a consumer (reported as "office manager") referring to a 11-year-old male patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On an unknown date in September 2021, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (formulation, strength, dose, frequency, route of administration, indication, lot number and expiration date were not reported). The patient fainted briefly after the vaccine (syncope).   On 23-MAR-2022, the patient was vaccinated with his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (formulation, strength, dose, frequency, route of administration, indication, lot number and expiration date were not reported). After receiving the vaccine, the patient fainted for approximately 2 seconds (syncope). The reporter stated that the patient had also been diagnosed with anxiety and attention deficit hyperactivity disorder (ADHD) on an unknown date and was taking unspecified medications for it. The outcome of the syncope events was assesed as recovered (reported as "patient ok"). The outcome of anxiety and ADHD was unknown.   The causal relationshiop between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the reported events was unknown.   Upon internal review, the events of syncope were determined to be medically significant.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and drug reactions/allergies were not reported. The reporter stated that the patient was administered the first dose of GARDASIL 9 (dose, route, lot# and expiration date unknown) on 11-NOV-2015, the second dose of GARDASIL 9 (dose, route, lot# and expiration date unknown) on 21-JAN-2016 and the third dose of GARDASIL 9 (lot # L045711, expiration date 08-MAY-2017, dose and route unknown) on 16-MAR-2016. No adverse effect was reported. Additional information has been requested.
Paper says she received DTaP, Hib, Hepatitis B, polio, PCV13 and a rotavirus vaccine. A day later she was running fever of 100.7. TYLENOL brought it down next day fever hit 104.1 and went to emergency room because she was shaking uncontrollably, blue lips and hands, and then very sleepy even though she just napped two almost three hours. TYLENOL brought it down. Her stomach is also tore up and causing issues. Screaming in pain and grunting to pass loose stool (diarrhea) it's day three and she's no better.
Patient began having seizures very soon after being given shots. Her attitude and demeanor changed immediately after shots. She became angry, hostile and unhappy. She was hospitalized for eight days on November 10th. The seizures started within a day or two after receiving shots, but I can not give the exact date, because I did not realize what was happening to her until the 10th of November. She has been on anti seizure medication since November 11 2007. The seizures are not stopping, but seem to be getting worse. Her doctors can find no cause for the seizures. We have had CT scans and MRI's. I have no doubt in my mind that her seizures were caused by these immunizations.  6/20/08 Reviewed hospital medical records of 11/13-11/17/2007. FINAL DX: complex partial epilepsy left posterior Records reveal patient experidnced new onset of seizures over approx 2-4 weeks.  Symptoms included: staring eyes, head tilted, smiling, arms extended, unable to communicate lasting approx 1 min.  On day before admission had 14 seizures.  Headaches & stomachache x 2-3 mos.  Seen at outlying hospital & multiple meds tried unsuccessfully.   8/5/08 Reviewed initial hospital medical records of 11/10-11/13/2007. FINAL DX: seizure disorder Records reveal patient experienced 2 episodes at home of staring & non-responsive each lasting approx 1 min.  Additional episodes observed in ER.  Started on antiseizure meds.  Continued w/seizure like activity.  Transferred to higher level of care for peds neuro consult.   1/21/2010 Patient continues to have siezures daily. She is taking 4 anticonvulsant medications.
Alodynia began in back of thighs with severe dysuria.  Alodynia progressed to constant burning and aching involving both lower extremities symmetrically then up to the umbilicus level.  Then right inferior ribs. No rash or UTI.   Autonomic symptoms included sphincter dysfuction, sexual dysfunction and heat intolerance.   Low back pain.  Anxiety as pain was extreme .  MRI showed enhancement of conus and thoracolumbar nerve root ganglia.  Spinal tap elevated WBC, protein.   MS panel, Lyme, etc all neg.  Metabolic profile negative. Neurology Dx Transverse Myelitis.
19 y.o. female with h/o Hashmoto's thyroiditis now admitted 4/29/2021 with cerebral venous thrombosis.  She received J&J COVID vaccine on 4/12.
PATIENT COMPLAINED OF SWELLING AT SITE OF THE INJECTION AND SEVERE HEADACHE.
Spontaneous Dermatorgraphia.  Itching, redness all over body, heartburn, chest tightness
Was contacted on 2-14-23 by family member patient had blacked out and fell at home between 3 to 4 hours after receiving vaccine. Patient currently has a rash that is not very itchy.  Patient has contacted physician and was told to contact pharmacy.  Pharmacy was contacted hence this report. Later from initial contact pharmacy was told she fell again today 11-14-23 Pharmacist has repeated twice patient needs to be seen by a physician.
Anaphylactic shock, throat closed up, couldn?t breathe, hives, rash, bruising
17SEP93 adm to hosp w/acute deliruim placed on ventilator 18SEP93 for acute resp failure; unresponsive; dx of past immun encephalitis; recvd flu vax 13SEP93; reported confusion;
Facial Swelling, rash prescribed Orapred and given Benadryl at ER
swelling @ site of Td inj administered 12MAR96-edema shoulder to fingers;c/o arthritic sx bilat in hands w/weakness shortly p/inj-reported 9APR96
pt recv vax & devel arm achiness;the next day devel reddened area (size of 50 cent piece) & edema;edema dec by the 3rd day,but the redness progressed to a 5-6" area;redness improved but has not totally resolved;
The patient noticed a redness in her left arm the night of the shot. The redness continued to get worse. The next day, the patient came back to the pharmacy to show the pharmacist. The redness began right below the injection site and extended down to just above the elbow when observed by the pharmacist. The redness wrapped the entire way around the arm. The patient was instructed to see a provider to have it evaluated. The patient was called the next day and it was confirmed by the provider that it was an allergic reaction and no infection was present. The patient was given anti-inflammatories. She said it was improving at that point.
Dizziness, didn't eat breakfast. The patient is taking metformin for diabetes and metoprolol  for Tachycardia. The patient had  COVID-19 on 12,2020 and got monoclonal antibodies infusion. pulse 94 respiration 12  spo2 96 bp 132/78 Patient took juice/snack Become normal to discharge home
Patient has a hypertensive reaction with a BP of 160/100 compared with her normal readings of 104/80. She experienced facial numbness and heart palpitations.
I have been recently diagnosed with pemphigus. A very rare autoimmune condition and the symptoms started right after getting vaccinated for covid.
The following day developed typical flu like symptoms, but also developed "moderna arm" at site of injection. The second day after the dose I found a golf ball sized lump on the back of my shoulder inches away from the injection site. I had a telehealth session through medical provider that day  who believed it was  a skin reaction to the first dose. After the weekend I went to see my primary care physician who was uncertain on if it was a swollen lymph node or something else. I received following up testing involving an ultrasound on the area to rule out cancer, and met with a surgeon who discussed surgical removal of benign lipoma. After two weeks the golf ball sized lump reduced to the size of a very large marble. It is still in my shoulder to this day and I have pain in that area and inflammation.  Also around the time of this event I developed significant acid reflux conditions and difficulties with congestion and inflammation. I had an endoscopy done on 6/14 to rule out any identifiable difficulties. The endoscopy was unremarkable. I continue to have difficulties with congestion in my throat and inflammation throughout my body.
HIGH PITCHED INCONSOLABLE CRYING, EYES ROLLING UPWARD, LETHARGY, UNABLE TO HOLD HEAD UPRIGHT, HEAD SWELLING, INTENSE HEAT FROM ANTERIOR FONTANEL, SEMI CONSCIOUS, MONITORED AT HOME BY REGISTERED NURSE AND 3 ADULTS, NIGHT AND DAY, GRADUAL IMPROVEMENT OVER A 5 DAY PERIOD, SOME RESIDUAL EFFECTS SUCH AS UNUSUAL BEHAVIORS, HEAD BANGING, SCREAMING, POSSIBLE COGNITIVE DELAYS APPEARING THEREAFTER.
9-4-07 Pt receive 2 Tdap within 2 hrs apart. He should have gotten Hep A. I found out 9-5-07 by school nurse.
This spontaneous report as received form a nurse (office manager) via a company representative refers to a patient of unknown demographics with history of shingles. On 14-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX injection (strength, dose, route of administration, lot# and expiry date unspecified). No concomitant mediations were reported. On 24-MAY-2014, the patient developed shingles. The nurse also stated that the patient received ZOSTAVAX again (at an unspecified time) and developed shingles again. The patient sought medical attention and contacted the nurse. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Rash and hives all over body; nausea and vomiting; nausea and vomiting; 3 week Delayed reaction; severe diarrhea; Itchy feet; Rash and hives all over body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (3 week Delayed reaction), DIARRHEA (severe diarrhea), PRURITUS (Itchy feet), RASH (Rash and hives all over body) and URTICARIA (Rash and hives all over body) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION COMPLICATION (3 week Delayed reaction), DIARRHEA (severe diarrhea), PRURITUS (Itchy feet), RASH (Rash and hives all over body), NAUSEA (nausea and vomiting) and VOMITING (nausea and vomiting). On an unknown date, the patient experienced URTICARIA (Rash and hives all over body). At the time of the report, VACCINATION COMPLICATION (3 week Delayed reaction), DIARRHEA (severe diarrhea), PRURITUS (Itchy feet), RASH (Rash and hives all over body), URTICARIA (Rash and hives all over body), NAUSEA (nausea and vomiting) and VOMITING (nausea and vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment products were not provided.
Initial report received on 16 December 2009 from a health care professional. A 7 year old male patient with a history of asthma developed a fine, raised rash which started on the abdomen and spread to the arms, legs, back, and face 2 days after receiving H1N1 (lot number UP048CA) intramuscularly in the left deltoid on 12 December 2009. The patient also complained of abdominal pain and a low grade fever. On an unspecified date, the patient had a doctor's visit. Concomitant therapy included ADVAIR, ZYRTEC, and NASONEX. The patient did not recover. Additional information was received on 04 January 2010 from health care professional. The patient had no illness at the time of vaccination. The doctor's visit previously noted as unspecified was on 15 December 2009. The patient was treated with BENADRYL as needed and recovered on an unspecified date. List of Documents held by Sender: none.
I had heart palpitations immediately after receiving the vaccination. The paramedics took my blood pressure and it was within normal range. That evening I have heart palpitations while sleeping. I would awake suddenly. This has happened every night since I receive the vaccine. I also have palpitations during the day.
transient ischemic attack; Dental procedure; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DENTAL CARE (medically significant) with onset 2022, outcome "unknown", described as "Dental procedure"; TRANSIENT ISCHAEMIC ATTACK (hospitalization, medically significant) with onset 2022, 3 days after the suspect product(s) administration, outcome "unknown", described as "transient ischemic attack". The patient was hospitalized for transient ischaemic attack (start date: 2022).  Clinical course: female patient after receiving the COVID-19 vaccine (possibly from Pfizer) had a transient ischemic attack 3 days after and was hospitalized some time last year (2022). Reporter noted that she also had a dental procedure around the same time and it was thought that could be an explanation for her symptoms. Reporter doesn't have a lot of information because it happened last year (2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that the suspect drug contributed to the reported events, that most likely were due to underlying medical conditions. The case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
pt c/o severe pain & swelling post inject of Tetanus Toxoid in lt arm; tc to pt 27MAY93 pain was 3" below & above elbow for 4 days; pain was minor; it did not interfere w/move;