chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient started to have a rash develop on her face after 4 days of receiving the vaccine. This rash is very similar to shingles and has occurred for a month with Valtrex treatment. Patient states face is extremely taut, dry, and has red/inflammed pustules/blisters. Upon presentation, patients has extremely dry face and visible redness from previous blisters.  At one point, patient stated blisters developed within her mouth and on the tongue. Patient has tried multiple products over-the-counter products to cure the dryness. Valtrex 1g three times a day was prescribed and patient finished a full month of this prescription without full resolution. Patient was also given prednisone for 1 week. This medication cured the rash, however promptly represented after completion. Patient is continuing treatment, but is unable to get help from a dermatologist due to limited appointments available. Patient has been to an urgent care, hospital, and regular PCP without resolution of issue.
But I contacted the Virus on Tuesday, the Wednesday and I tested positive on Thursday at the clinic we have here and I got tested again, I was positive; But I contacted the Virus on Tuesday, the Wednesday and I tested positive on Thursday at the clinic we have here and I got tested again, I was positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "But I contacted the Virus on Tuesday, the Wednesday and I tested positive on Thursday at the clinic we have here and I got tested again, I was positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive on Thursday at the clinic; Positive, notes: I got tested again, I was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 19Aug2022.  Clinical Information: Reporter stated he had all the Pfizer shots (Pfizer COVID-19 Vaccine). Stated he contacted the virus on Tuesday, the Wednesday and tested positive on Thursday at the clinic and he got tested again, he was positive. He was given Paxlovid and have taken for two and a half days and now he got very severe sore throat, very severe, like almost felt like slit throat.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Legs were extremely weak, very difficult to stand and walk, felt like jello. Did not start to recover until about 6 days after shot. Currently 11 days after shot and my legs feel like they are maybe 90% back to normal. I also had severe chills for about 4-5 days after the shot, literally multiple layers of clothes and blankets and was still cold.
Upon entering the domicile at Correctional Facility, the patient was retrieved and asked to sit in a seat directly outside of his cell. Demographic information was verified by the lead correction officer along with the nurse Via identification band.  The nurse continued to verify if the patient had any allergies to medication, latex, and or band-aid adhesive. The client noted no allergies, at which time the nurse also verified any medication use. The nurse then asked if the patient had taken any covid vaccines Jessen, Pfizer, or modern. The client stated ? I have received the  first covid vaccines months. The client was appropriately cleaned using an aseptic method and vaccinated using PFIZER lot#EW0191 . The patient was then returned to his cell to be monitored for 15 minutes. The Vaccine was tolerated well with no adverse reactions.    pfizer safety manufacture   case #OCPKVG73
Information has been received from a physician concerning a 16 year old female, who "one week ago" was vaccinated with a first dose of Gardasil. Concomitant therapy included Menactra. Subsequently, the patient developed arm and jaw pain while she was still in the office. The patient was taken to the emergency room and released on the same day. An electrocardiogram was performed (no results provided). The patient recovered on an unspecified date. No product quality complaint was involved. The physician considered the arm and jaw pain to be other important medical events. Additional information has been requested.
difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-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 experienced DYSPNOEA (difficulty breathing). At the time of the report, DYSPNOEA (difficulty breathing) outcome was unknown.            No concomitant medication and treatment information provided.
your coronavirus nasal swab came back positive for SARS-CoV-2, the virus that causes COVID-19. This means that you are actively infected and contagious to others. You must isolate at home to prevent spread of the virus.
He died on the 26th; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (He died on the 26th) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The patient had 4 COVID-19 vaccine vaccinations. No treatment medication was provided.  Company Comment: This is a spontaneous fatal case concerning a male patient of an unknown age with no reported medical history, who experienced the fatal serious, medically significant, unexpected event of Death (reported as he died on the 26th), which occurred on an unknown date and with unknown latency after a dose of mRNA-1273.222 (Original/Omicron BA.4/BA.5) vaccine, considered as the fourth dose of COVID-19 vaccination schedule. It was reported that the patient had 4 COVID-19 vaccines. However, no information on vaccination schedule nor detailed vaccine product was disclosed. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. No further information was disclosed. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/BA.5) vaccine is not affected by this report.   Reporter did not allow further contact; Reported Cause(s) of Death: He died on the 26th
Chills Fatigue Joint Pain Body Aches Started 1800 on 12/27/2020 I took no medication but considering  Tylenol
Pneumonia- fever as high as 105 without meds, motrin barely brought it down to 104. High fevers lasted a little over 24 hours. After 2 doses of Antibiotics patient showed signs of imrovement. Day four and patient is still riding the wave of feeling good then bad.
Narrative: Pt is a 75 y.o. male pt with Parkinson's disease with cognitive impairment, HTN, GERD, BPH, and h/o depression who passed away at home with hospice. No apparent correlation between vaccination and death.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown dates, patients were vaccinated with an improperly stored dose of VAQTA, lot # L043209, expiry date 17-SEP-2017; lot # L002717, expiry date 02-JUN-2017; lot # L013380, expiry date 04-NOV-2017; lot # L004439, expiry date 15-FEB-2016, (dose, frequency and route of administration not reported). No adverse effect reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further details provided. This is one of five reports received from the same reporter. Additional information has been requested.
Narrative:  97 y.o male patient with 3v CAD s/p CABG (1989), HFpEF (56% 12/2020), moderate restrictive lung disease on 2L home O2, OSA (on bipap), AS s/p TAVR (2019), SSS s/p medtronics dual chamber pacemaker (2015), DM2, PVD, HTN, and HLD, followed by HBPC, who presented to the ED 12/02/21 with worsening soa and chest pressure x 3 months, acutely worse x 2 days. Patient reported he could only ambulate ~ 10-12 feet before becoming soa, and was experiencing 4-5/10 chest pressure, substernal, non-radiating. CXR on admission was significant for moderate pulmonary edema with an associated small right-sided pleural fluid collection. He was admitted for acute on chronic respiratory failure on 12/2/21. He is at high-risk for decline and death due to comorbidities and age. He then became agreeable/interested in inpatient hospice services & was transferred to inpt hospice on 12/7/21. Pt hen died on 12/8/21 during inpt hospice care at hospital. Pt had received covid vaccines on 1/12/21 & 2/9/21. This death is not related to covid vaccines.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife and was previously not reported to anyone. The patient experienced pain at the injection site. Limited information was provided. No follow up would be conducted due to refusal to complete the safety report because, the reporter stated that, it was not necessary and the patient had already improved. This case has been linked to case US2018GSK141425, reported by the same reporter.
Redness, swelling, warmth around the injection site. Baseball size. These symptoms progressively worsened in intensity over the next 24 hours.  Ice the area frequently today, and continue to take Ibuprofen as needed for pain control. If the redness worsens, and spreads past the demarcated area, or patient develops fevers, or systemic signs of illness, recommend starting antibiotic-cephalexin, course provided to patient per MD.
patient received vaccine, was walking store after shot was feeling dizzy and came back to pharmacy. Sat down and gave her water, was still feeling dizzy with lump in throat. Had her lay down in vaccination room and called 911. paramedics came and took vitals still feeling lump in throat so they took her to hospital for observation
WITHIN A FEW MINUTES AFTER INJECTION PT C/O R HAND PAIN AND  NUMBNESS, ABD PAIN, DIZZINESS.  PT HAS H/O REACTION TO FLU VACCINE WITHIN THE PAST 5 YEARS , WHICH LED TO HOSPITALIZATION.  PT DENIES RESPIRATORY DISTRESS. BP 135/67 O2 98% HR 67 3:23 PM- SYMPTOMS RESOLVED SpO2 97% 3:30 PM- PT FEELS BACK TO NORMAL. HOME WITH HUSBAND DRIVING. PT ADVISED TO SEEK MEDICAL CARE IF SYMPTOMS RESUME.
All of a sudden, at 6pm on Feb 23, 2021, my ever-present tinnitus became dramatically worse - unceasing high hissing whining sound.  It has not to date reverted to the way it was before.  I did not connect it with the vaccine I had received earlier that day.  On March 22, 2021 I read an article about someone who committed suicide b/c of post-COVID tinnitus.  Three people commented that their tinnitus worsened after their COVID vaccinations.  I checked dates and, sure enough, my tinnitus worsened 4 hrs after my vaccine.  I got tinnitus in 2006 and since then have had every vaccination known to man:  typhoid, meningitis, Tdap, shingles (Zostavax and 2 Shingrix), pneumonia (Pneumovax and
pretty bad high fever; chills; really not well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, (the other three shot she got pretty bad high fever, chills, really not well.)), for Covid-19 immunization, reaction(s): "Chills", "really not well", "pretty bad high fever"; Bnt162b2 (DOSE 1, SINGLE, (the first one she was semi-okay with it)), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "pretty bad high fever"; CHILLS (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "really not well".  Additional information: The patient had 4 shots, the first one she was semi-okay with it but the other three shot she got pretty bad high fever, chills, really not well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201252978 same product, patient, different AEs, different dose;
This is a spontaneous report from a contactable Nurse (Patient). A 23-years-old Non Pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207, Expiry date was not reported), via an unspecified route of administration on 06Nov2021 13:30 (at the age of 23-years-old) in Arm Left as dose 3 (booster), single for COVID-19 immunization and influenza vaccine (FLU), via an unspecified route of administration on 06Nov2021 (Batch/Lot number was not reported), in Arm Left at dose 1, single for immunization. The Patient Medical history included, Vasovagal Syncope, temporomandibular joint syndrome (TMJD), bursitis in L hip. Concomitant medication included desogestrel, ethinylestradiol (KARIVA); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) and Probiotic. Previously patient received dose 1 BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6202 and Expiry date was not reported), via an unspecified route of administration on 26Feb2021 as dose 1, single for COVID-19 immunization and Patient received dose 2 BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EN6207 and Expiry date was not reported), via an unspecified route of administration on 19Mar2021 as dose 2, single for COVID-19 immunization. The Patient was not pregnant at the time of vaccination. Patient had no known allergies. No other vaccine in four weeks. The Patient was not diagnosed with COVID prior vaccination and Patient tested COVID post vaccination. Facility type vaccine: Pharmacy or Drug Store. On 06Nov2021 13:30, The patient received dose number 3. On 07Nov2021 08:00, Patient experienced pain and swelling in left underarm, limiting movement. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Nov2021 Nasal swab. The Patient visited emergency room. The Patient did not received treatment for the events. The outcome for the events was recovering. Follow-up attempts are completed. No further information is expected.
Left upper arm red, hot and swollen and itches. Was treated in ER 11/10/2010.
1.   First he started to feel as though his sugar was rising. When he tested his sugar had spiked to 250 and his diet had not changed in any way to make it rise that high.       2.  He 30 minutes after that he started to shake uncontrollably. He was freezing.  His temperature was 100.5.    .      3.  By 1 hour  of onset  his temp was 101.5  Given tylenol and all diabetic meds to treat symptoms.
Patient complaint that vaccine was too high, about an inch from the acromion process and the patient did not feel that it even entered the deltoid muscle.
Patient. received booster dose of Covid-19 Moderna Vaccine at 2:30pm,  The Patient was walked to observation area. At 2:35pm she complained of dizziness and light headedness, patient provided with a chair to prop legs on and given 4 cups of cold water.  Patient continued to complain of lightheadedness followed by chills.  She was moved closer to heater vent in room.  Vital signs obtained at 2:50pm blood pressure - 156/91, heart rate - 110,bpm  pule oxygenation - 99% on room air. Patient was asked multiple times if she?s experiencing any shortness of breath or trouble breathing, nausea, vomiting,  but continues to deny this throughout stay in observation area.  RN in observation area recommended we call 911, but patient refused. Repeat Vital signs obtained again at 3:50p,m, and are as follows Blood Pressure 140/88, Heart rate 98BPM, Pulse oxygenation 99% on room air. Patient refused again transfer to hospital via EMS and does not want 911 called.  Patient  stated, she is willing to go to hospital and stated that she would prefer to have her friend take her.  Patient's friend arrived at 4:15pm and they are escorted to vehicle out front door in stable condition with a RN. Patient's information collected for follow up. RN followed  up on 11/30/21 at 8:50am.  Patient stated she is feeling better and is not experiencing any shortness of breath, chills, fever or lightheaded ness. She is at home at the time of the follow up.
Onset of hives 2-4-11 in the evening, became worse with bath.  Mom gave 2 doses of Benadryl which eleviated symptoms.  Had no difficulty breathing.  Also had first dose of strawberry Pediasure this day.  Had not had in the past and mom unaware of a soy allergy.  Had an office visit 2-8-2011, rash had resolved.  Mom instructed to replace Pediasure with Carnation Instant Breakfast and to avoid foods with soy products.
NOT BEEN ABLE TO WEAR SHOES OR SANDAL; COUGH; SOB AT NIGHT AND COUGHS IF SHE LAYS DOWN,COULD NOT TAKE DEEP BREATH  UNLESS SHE COUGHS; CHEST HEAVINESS; BAKER'S CYST  IN THE BACK OF THE KNEE OF THE LEFT LEG; LEFT LEG IS BIGGER THAN THE RIGHT LEG, LEFT LEG DID NOT LOOK LIKE THE  RIGHT ONE; DOES NOT FEEL WELL; NO ENERGY; THE VEINS OF THE LEGS HAD BEEN LEAKING; BELLY  BUTTON AREA SWELLING; SWELLING OF BOTH LEGS; EXHAUSTION, CHRONIC FATIGUE.; RASH; SORE LEG AND VERY UNCOMFORTABLE, STANDING IS VERY PAINFUL; WORST HEADACHE, HEADACHE WAS HORRIBLE AND  TERRIFIC; FELT ACHY; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included: back surgery, and concurrent conditions included: hypothyroidism, polycystic ovary, and hashimoto. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient experienced felt achy. On 09-APR-2021, the patient experienced worst headache, headache was horrible and terrific. On 10-APR-2021, the patient experienced swelling of both legs. On 10-APR-2021, the patient experienced belly button area swelling. On 10-APR-2021, the patient experienced sore leg and very uncomfortable, standing is very painful. On 10-APR-2021, the patient experienced rash. On 10-APR-2021, the patient experienced exhaustion, chronic fatigue. Treatment medications included: ibuprofen. On JUL-2021, the patient experienced the veins of the legs had been leaking. On an unspecified date, the patient experienced not been able to wear shoes or sandal, cough, sob at night and coughs if she lays down, could not take deep breath unless she coughs, chest heaviness, baker's cyst in the back of the knee of the left leg, left leg is bigger than the right leg, left leg did not look like the right one, does not feel well, and no energy. Laboratory data (dates unspecified) included: Chest X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt achy, and worst headache, headache was horrible and terrific on 10-APR-2021, and rash on 30-APR-2021, had not recovered from swelling of both legs, the veins of the legs had been leaking, left leg is bigger than the right leg, left leg did not look like the right one, sore leg and very uncomfortable, standing is very painful, and belly button area swelling, and the outcome of not been able to wear shoes or sandal, cough, sob at night and coughs if she lays down, could not take deep breath unless she coughs, baker's cyst in the back of the knee of the left leg, no energy, exhaustion, chronic fatigue., does not feel well and chest heaviness was not reported. This report was non-serious.
Developed tinnitus 5 days after first dose of the COVID vaccine and its has not gone away
It's been 9 days since my first shot,  my left arm started to get itchy a couple of days ago.   Did not think much of it till today.  It started to itch again and I finally looked at the spot and saw red blotches where I've been scratching.  Its still a bit tender when I rub the spot where I got the shot.  No other issues that I can see or feel, other than my heart issue and allergies mimick Covid systems.  I will call my primary Dr. on Monday to see if an office visit is necessary.
After the shot initially I only had a sore arm and a little fatigue the day after. 10 days after my shot I started to develop a large rash on my left arm.
Fever; Chills; body aches; Migraine; Nausea; Vomiting; Blurry vision; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 at 10:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Other medical history included autoimmune disorder nos.  Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and propranolol (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 at 10:45, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 00:00, the patient experienced fever, chills, body aches, migraine three days, nausea, vomiting and blurry vision. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of fever, chills, body aches, nausea, vomiting and blurry vision was recovering while the clinical outcome of the event of migraine was recovered on 18Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.