chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated awoke in the morning with red rash all over face. Also stated injection site pain and fatigue. However, patient stated has a history of fatigue and did not believe this to be related to the vaccination. The patient was advised to monitor and consider contacting her doctor. The doctor was contacted and they stated they will contact her to have her come in for follow up.
Severe headache which lasted about 7 hours.  Nausea, diarrhea, and fatigue which is I continue to have.  I'm going on the 3rd day of this.
headache with aura; Headache episode with shiny squiggly thing in front of the eyes and it lasted 30 minutes/fifth episode; Fourth episode headache; 3 episodes of vision headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE WITH AURA (headache with aura), HEADACHE (3 episodes of vision headaches), HEADACHE (Fourth episode headache) and HEADACHE (Headache episode with shiny squiggly thing in front of the eyes and it lasted 30 minutes/fifth episode) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (diladid) and Penicillin allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 09-Nov-1991 to an unknown date, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), CYANOCOBALAMIN (VIT B 12), PROBIOTIC [BIFIDOBACTERIUM BIFIDUM;BIFIDOBACTERIUM LACTIS;BIFIDOBACTERIUM LONGUM;LACTOBACILLUS ACIDOPHILUS;LACTOBACILLUS RHAMNOSUS] and CALCIUM for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced HEADACHE (3 episodes of vision headaches). On 08-Apr-2021, the patient experienced HEADACHE (Fourth episode headache). On 13-Apr-2021, the patient experienced HEADACHE (Headache episode with shiny squiggly thing in front of the eyes and it lasted 30 minutes/fifth episode). On an unknown date, the patient experienced MIGRAINE WITH AURA (headache with aura). On 27-Feb-2021, HEADACHE (3 episodes of vision headaches) had resolved. On 08-Apr-2021, HEADACHE (Fourth episode headache) had resolved. On 13-Apr-2021, HEADACHE (Headache episode with shiny squiggly thing in front of the eyes and it lasted 30 minutes/fifth episode) had resolved. At the time of the report, MIGRAINE WITH AURA (headache with aura) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Magnetic resonance imaging head: normal (normal) normal.         No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Date of vaccine, and event information updated.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
positive C-ANCA blood test; heart arrhythmia; This is a spontaneous report from a contactable nurse (patient) reported for herself. This 47-year-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in left arm on 19Jan2021 08:00 (Lot Number: EH9899) as DOSE 2, SINGLE for COVID-19 immunisation. Patient was not pregnant.  Medical history included hypertension.  The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient previously took amoxicillin and experienced drug allergy. Patient previously received first dose of bnt162b2 on 29Dec2020 08:00 AM (lot number=EK9231) in right arm for COVID-19 immunisation and experienced heart arrhythmia.  Almost exactly four hours of receiving vaccine, both times, patient had heart arrhythmia.  She had never had arrhythmias before. Arrhythmias had continued intermittently since but was getting less as times went by.  Additionally, after being in the hospital in March for condition (unrelated) she was diagnosed with a positive C-ANCA blood test on unspecified date. Her primary MD also agreed that she was "most likely" having a parasympathetic reaction to the vaccine. She was not sure if the C-ANCA was related to the vaccine or not - however- she was highly suspicious it may be?  She was a nurse practitioner and was certain she had some sort of reaction to this vaccine. She had never had issues with any vaccines before. Events resulted in Doctor or other healthcare professional office/clinic visit, no treatment received.  The outcome of events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "arrhythmia" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is 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.
Bilateral Pulmonary Embolism Unprovoked Sudden Cardiac Arrest Acute Hypoxemic Respiratory Failure  Ventilator Dependent Respiratory Failure Critical
Patient said she had pain in the entire arm. She had purple patch on the arm. Patch was not at the injection site. She went to her primary care who told her the fluid may have travelled down the arm causing pain and patch. Patient said it got better with time.
Started with aches all over body and pain at the injection site that night after vaccine injection.,Next day had a headache and very tired.  Next day after that started coughing and stuffy nose. Next day after that had a hard time breathing so went to ER. Was tested for Covid but negative and chest X-rays taken.  ER doc thought I was having an immune response to Covid vaccine and/or viral infection. Gave me a prescription for abutirol and cough medicine and told to drink fluids and rest. Today very congested and coughing and very tired.
Patient received her second dose of Moderna COVID-19 vaccination on 3/26/21 under MR#, and first dose was under another number. After receiving her vaccine, patient then walked towards the observation area, but instead sat down at another vaccination pod to receive her vaccine yet again. Patient did not recall getting her 2nd dose minutes before. The nurse asked patient about the bandaid on her left arm, patient stated the bandaid was from "another injection" she got but didn't specify what injection or when. Nurse gave the vaccine in the same arm (left deltoid) without checking vaccination card or platform documentation correctly. Patient then received a second dose of the second series of the COVID 19 Moderna vaccine. Site leads, ER ADN, and ER director notified immediately. Patient was evaluated, stated she felt fine, and then was brought to the emergency room for further observation. Patient was in stable condition when she was brought to ER and during ER stay.
High fever with chills  ( 101.6) that marginally reduced ( to 100.4)  despite taking Tylenol 1gm and Advil 600mg   Sinus congestion was also noted with headaches
Prostatits; Burning of the urination; sore arm; Fever of 101 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATITIS (Prostatits), DYSURIA (Burning of the urination), PAIN IN EXTREMITY (sore arm) and PYREXIA (Fever of 101 degrees Fahrenheit) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 038B21A) for COVID-19 vaccination.     No medical history was provided.  The patient's past medical history included Meningioma (Meningeoma) on 04-Mar-2011. Concurrent medical conditions included PSA (PSA), Drug allergy (Tetracycline) and Drug allergy (Inapsine). Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) for Acid reflux (oesophageal), CITALOPRAM from 09-Jan-1992 to an unknown date for Depression, CLONAZEPAM (KLONOPIN) for Seizure, CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (Fever of 101 degrees Fahrenheit). On 10-May-2021, the patient experienced PROSTATITIS (Prostatits) and DYSURIA (Burning of the urination). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 07-May-2021, PYREXIA (Fever of 101 degrees Fahrenheit) outcome was unknown. On 03-Aug-2021, PROSTATITIS (Prostatits) and DYSURIA (Burning of the urination) had resolved with sequelae. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Prostatic specific antigen: normal (normal) normal. On 05-May-2021, Body temperature: 101 (High) 101 degrees fahrenheit. On an unknown date, Urine analysis: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-216975 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Follow up information received on 20-JUN-2021 contains No significant information. On 13-Jul-2021: follow up received contains Email: nonsafety info - question On 13-Jul-2021: Email: nonsafety info - Question On 06-Aug-2021: follow up received contains Additional information included reporter details On 12-Aug-2021: significant follow up appended. Patient demographics, relevant history and outcome of events was added
had four doses of the Pfizer COVID-19 vaccine, she still got COVID-19 and has now long Covid for two months now; had four doses of the Pfizer COVID-19 vaccine, she still got COVID-19 and has now long Covid for two months now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "had four doses of the Pfizer COVID-19 vaccine, she still got COVID-19 and has now long Covid for two months now".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201018374 same reporter/drug/event for different patients;
Severe pain, dizzy, nausea upon administration. By 8pm, shaking, pain in back, chest. Couldn't unclench my fist. Severe headache, mTachycardia, low grade fever. Day two continue with pain, woke up that night with my night shirt soaked with sweat. Never had this before.
Diagnosed with Gastritis on 07/19/2021 at Urgent Care. Prescribed Ondansetron ODT same day. Medicine initially helped with first dose that day but symptoms reappeared after taking 2nd dose later that night. I discontinued use of medication after 2nd dose. Symptoms have not gone away but are not as severe (almost 3 weeks later).
PAIN IN LUNGS; BODY PAIN; BONE PAIN; FEVER; HEADACHE; NAUSEA; MUSCLE PAIN; 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, and batch number were not reported) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced pain in lungs, body pain, bone pain, fever, headache, nausea, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in lungs, and body pain, and the outcome of fever, headache, nausea, muscle pain and bone pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210432269.; Sender's Comments: v0-Medical assessment comment not required as per standard operating procedures.
Patient developed a rash(spots) on both arms and legs but not trunk. No trouble breathing or anaphylactic symptoms described. Patient states it is itchy, suggested hydrocortisone for now and talk with MD about treatment going forward.
PATIENT IS EXPERIENCING BODY ACHES, FATIGUE, NAUSEA, HEADACHE, AND EYE PAIN.
Fever (102*), all skin turned bright red and felt like a sunburn, nausea with vomiting, body aches, chills, insomnia, headache, extreme joint pain; especially in joints with previous arthritis. 36 hour duration.
slight fever, body soreness, slight chest congestion for 3 days after the vaccine. By 4th day I had bronchitis.
This is a spontaneous report from a contactable consumer (patient). A 30-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EP7533), at the age of 30, via an unspecified route of administration, left arm, on Apr 8, 2021, at 15:00, single dose, for COVID-19 immunisation. The patient has no medical history. The patient has no allergies to medications, food or other products. The patient received medications (unspecified) within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On Apr 8, 2021, at 15:30 (30 minutes after the vaccine), patient experienced numb lips and tongue. At 15:45 (45 minutes after the vaccine), patient still had numb lips and tongue. She also experienced numb palate and a lump in the throat. At 16:00 (60 minutes after vaccine), patient still had all the reported events and also experienced numbness in bilateral 4th and 5th fingers. The events resulted in emergency room/department visit or urgent care. Therapeutic measures taken as a result of adverse events included treatment with prednisone and Ativan (lorazepam). The clinical outcome of numb lips, tongue and palate, lump in throat and numbness in bilateral 4th and 5th fingers: recovering (at the time of this report). No follow-up attempts needed. No further information expected.
Flu-like symptoms, fever, ear ache, sore throat, swollen glands....still persisting through to 06/12/2013 patients physician is monitoring.
2 hours after HepA vaccine was given rash, redness, hives around injection site.
Next Morning left arm swollen, extremely red, itching, painful, hot.  Still red and angry one week later, turning purple, and a blood spot the size of a pinky finger above the vaccination site. The red spot is moving around to the back of the arm.
Difficulty Speaking, stuttering, slurring words, would automatically substitute words for other words I wanted to say, when trying to pronounce words, the wrong sounds would come out. B would become V sounds and vice verse, confusion, tired, headaches, and irritable for the last two weeks. I"m only finally starting to feel somewhat normal. though I'm not 100%.
67-year-old female who presented to ED with worsening SOB.  Pt tested + for COVID on 11/3.  Comorbidities of COPD and obesity.  Patient also had diabetes.  The patient presented on November 4th and progressively worsened throughout stay. Treatment with decadron, remesivir and proning.  She continually required more and more oxygen and then she was required to be intubated.  On 11/13, the patient lost her pulse early in the morning and this was after her pressures continually decreased despite multiple pressors. Pt expired.
Swelling and pain across top right of foot onset one day after and continues. Recommended f/u w Dr.
pt recv vax; nausea & vomit; inability to concentrate; numbness in lt hand; muscle soreness;
This spontaneous report as received from a physician refers to a patient of unknown age and gender. In 2014 (reported as about month ago") the patient was vaccinated with VARIVAX (Merck) (dose and route of vaccination was not reported). In 2014 the patent was inadvertently administered VARIVAX (Merck) instead of ZOSTAVAX (Merck). No adverse effect reported. Additional information has been requested.
Pt recv vax on 2/20/98; on 2/21/98 pt exp red blotches w/ pruritus & swelling on both hands; tx=Benadryl; pt imp in several dy
11/15/10 Mon 3:00 PM. Arm sore (left arm) where injection was administered. 4:30 PM Arm began to itch and area became very hot. 8:00 PM Noticed arm was very red and hot. Put cold compress on it. 11/16/10 Tues went to dr's office to get FLU shot. He looked at arm and would not administer vaccine. Informed me that it was cellulitis and if it got worse to call him immediately. 11/17/10 Wed arm still hot, reddish, swollen. Took BENADRYL, still applying compresses. PM - arm little better. 11/18/10 Thurs arm better, little sore from needle, but very tired. 11/19/10 Fri 8:00 AM went to doctors (heart) after exam heart rate "ok" still very tired he also said I had an inflammation and prescribed "Nabumetone", should feel better after (2)-(3) days. 11/20/10 Sat arm better - not tender to touch or red. Overall, all much better, but not as good as I usually feel.
Itching at the injection site; hard sharp, stabbing pain in lower part of right head; Headache; Tiredness; vein discoloration; This spontaneous case was reported by a consumer and describes the occurrence of VEIN DISCOLOURATION (vein discoloration), VACCINATION SITE PRURITUS (Itching at the injection site), HEADACHE (hard sharp, stabbing pain in lower part of right head), HEADACHE (Headache) and FATIGUE (Tiredness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RIVAROXABAN (XARELTO), BUDESONIDE (PULMICORT), TRAMADOL, GABAPENTIN (NEURONTIN) and ALPRAZOLAM (XANAX) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VEIN DISCOLOURATION (vein discoloration), HEADACHE (Headache) and FATIGUE (Tiredness). On 28-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site) and HEADACHE (hard sharp, stabbing pain in lower part of right head). On 22-Mar-2021, VEIN DISCOLOURATION (vein discoloration), HEADACHE (Headache) and FATIGUE (Tiredness) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site) and HEADACHE (hard sharp, stabbing pain in lower part of right head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included, antihistamines was provided.
Pain and soreness in Left Arm around injection site. Soreness with movement and touch. Soreness has lasted about 3 - 4 days.
Appx 24 hours after injection I presented with a sharp lower left back pain.  This lasted about 34 hours.  Another strange anomaly was that my dog bit me twice 12 hours after injection.  He is 7 years old and has never done that.  Wonder if he smelled something strange
Erythematous macular eruption on his trunk, back, flanks, upper arms and legs 5 days after vaccine administration.
pt recv vax & exp blurred vision, a rash & fatigue;ER or MD was required;tx Seldane;sx resolved p/5 days;
Ear problems and severe headache. Afterwards I started to notice symptoms of Bell's Palsy. I went to the ER on 09/29/2022 in the morning due to symptoms. There was concern of possibly having a stroke. The reason I believed Bell's Palsy is because I felt a droopy eye and swollen tongue on my right side. I brushed my teeth and noticed I couldn't hold water in my mouth and my lymph node on my right side is still swollen. I have a severe headache on the right middle area of my head. They did keep me over night, and they did run a CT scan and MRI scan. There were no findings associated with the MRI or CT scans. I have come to realize in the hospital that I should have prednisone and a prescription for prednisone. A couple of days later I started on VALTREX. I started to feel a bit better however I then began to feel worse. My stomach was upset and my headache was worse. The Bell's Palsy symptoms slightly improved. I have ceased taking the antiviral. I have been feeling better since getting off the antiviral.
COUGH; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (COUGH) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 23-Nov-2021, the patient experienced COUGH (COUGH). At the time of the report, COUGH (COUGH) outcome was unknown.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-621428 (Patient Link).