chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced burn in her arm and it's about 5 inches and it feels like the iron put on her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 01May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: 10Apr2021, for COVID-19 immunization. The following information was reported: THERMAL BURN (non-serious), outcome "unknown", described as "Experienced burn in her arm and it's about 5 inches and it feels like the iron put on her arm".  Additional Information: caller had the first dose of the vaccine on 10Apr right and she had the second dose of Pfizer vaccine on 01May, however caller experienced burn in her arm and it is about 5 inches and it feels like the iron put on her arm and she wants to report the complain regarding this.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Donor received s/s rabies inj on 03/20/2006. She called center at 13:30 (3/20) complaining of diarrhea, nausea and vomiting. She was unable to return to work due to possible reaction.
injection site was swollen and hot and doubled in size also reports fatigue and slight discoloration.
Pfizer-BioNTech COVID-19 Vaccine EUA fever, chills, nausea & vomiting, muscle aches, bone aches, headache - lasted about 8 hours
2/9/22 66-year-old male with history of congestive heart failure, hypertension, hyperlipidemia, essential thrombocythemia, CVA presented to the emergency department with shortness of breath.  Diagnosed with coronavirus most week ago, no nausea or vomiting, no diarrhea.  No abdominal pain.  No chest pain.  Patient is on chronic Xarelto for history of stroke.  Denies any complaints. Onset: 6 days, Timing: Intermittent, Location: Chest Quality: Shortness of breath, Radiation: None, Severity: Moderate, worsened by: Exertion, Relieved by: Rest, Associated symptoms: None, Review of Systems, Constitutional: Positive for activity change and fatigue. Negative for chills and fever. HENT: Negative for congestion and sore throat. Eyes: Negative for pain and discharge. Respiratory: Positive for shortness of breath. Negative for cough.Cardiovascular: Negative for chest pain, palpitations and leg swelling. Gastrointestinal: Negative for abdominal pain, nausea and vomiting. Genitourinary: Negative for dysuria, frequency and urgency. Musculoskeletal: Negative for back pain and myalgias. Skin: Negative for color change and rash. Neurological: Negative for light-headedness and headaches. 2/10/22  Discharge summary: Patient is a 66-year-old male who presents the hospital with complaints of shortness of breath.  He was diagnosed with COVID-19 6 days prior to admission and did feel weak and congested, however he began having dyspnea with exertion just prior to admission.  He went to the ICC where he was found to have O2 saturations in the mid 80s on room air.  He was placed on oxygen and sent to the ER for further evaluation where he was admitted for treatment of hypoxia related to COVID-19 viral pneumonia.  He was started on IV steroids and Remdesivir and had significant improvement in his symptoms over the last 24 hours.  He was able to ambulate without any significant DOE but will require oxygen temporarily on discharge.  This will be arranged for the patient and I will also discharge him on a course of oral Decadron.  The patient will be discharged home with referral to the virtual hospital as well.  He should also follow-up with PCP in 1 week.  He is stable for discharge at this time and anticipate he will likely need O2 for the next 1 to 2 weeks at most.  He is vaccinated and received a booster dose as well, although he is immunocompromised and therefore likely had a slightly worse course of illness due to this reason.
Hospitalized (9.26.21);  COVID-19 positive (9.26.21);  Fully Vaccinated  Discharge Provider Primary Care Provider: MD Admission Date: 9/26/2021 Discharge Date: Sep 27, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Other acute pulmonary embolism without acute cor pulmonale Pneumonia due to COVID-19 virus COVID-19 HOSPITAL COURSE: Patient is a 56y/o male male who presented with flu like symptoms and chest tightness. He was found to be COVID positive but was not hypoxic and did not meet criteria for either Remdesivir or Decadron. He had a CT angiogram done that showed acute nonocclusive pulmonary emboli in the proximal basal segmental branches of the left lower lobe, posterior right lower lobe and posterior right upper lobe without right heart strain.  Patient was started on heparin infusion.  Lower extremity ultrasound was done and did not reveal any evidence of DVT. He continued to remain hemodynamically stable and did not require any oxygen therapy. Care management did check that patient had coverage for Eliquis. He was transitioned off heparin drip and placed on Eliquis. He had no other acute issues and was discharged home in stable condition 9/27 Discharge Disposition:  Home without services  Active Issues Requiring Follow-up:  Acute pulmonary embolism-to continue with Eliquis therapy. Patient's PCP office was contacted and informed that patient had been started on anticoagulation COVID 19 pneumonia-to follow with PCP
02/05/21 Developed headache 3-4 hours after receiving COVID vaccine, along w/ metallic taste in mouth & tingling in right hand.  6 hours after COVID vaccine had tingling in both hands.  02/06/21 4 AM felt chilled.  8 AM had mild headache & fatigue, tingling in both hands continued all day. 02/07/21 Tingling in both hands continued.  Then developed tingling in left foot & increased tingling in left hand.  02/08/21 Increased tingling in both hands, worse in left 3rd digit.  6 PM had increased tingling in left hand & tingling up into left elbow.  9 PM had increased tingling in right hand.  02/09/21 Tingling in both hands continued all day.  Fingers feel cold off &on.  02/10/21 Tingling in both hands continued all day.  Fingers feel cold off & on.  Tingling in feet, left leg up to knee in evening.  02/11/21 Tingling in both hands continues, fingers feel cold in both hands.  Tingling in feet.
11-11-2021 Day 2 arm pit itching and large hive on arm and chest area. Arm is swollen beside injection site not where injection was given. Took Benadryl. Day 3 hives larger and I am nauseated. 11-13,14,15,-2021 I was nauseated, had very bad gushing watery diarrhea and was unable to do anything except rest. Was very weak and my legs could barely hold me up. On 11-16-2021 I felt much better and took no Benadryl. Hives gone and feel fine 11-18-2021.
COVID Breakthrough Infection; COVID Breakthrough Infection; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). A 13-year-old male patient received BNT162b2 (PFIZER COVID-19 VACCINE), on 23May2021 as dose 1, single (Lot number: EW0177), on 13Jun2021 as dose 2, single (Lot number: EW0178) and on 24Mar2022 as dose 3 (booster), single (Lot number: FJ6369) at the age of 13 years, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. No known allergies. Covid was not diagnosed prior vaccination. There was no other vaccine in four weeks of vaccination. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jul2022, outcome "recovering" and all described as "COVID Breakthrough Infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Positive, notes: test type: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
SICKNESS; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (SICKNESS) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    It was unknown if the patient was enrolled in covid-19 vaccine trial.  Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On an unknown date, the patient experienced ILLNESS (SICKNESS). At the time of the report, ILLNESS (SICKNESS) had resolved.            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.  The concomitant medication was not reported.  The reporter causality for the events with respect to Rinviq was provided as no reasonable possibility.  The treatment medication was not provided.
Upon waking, some nausea, mild headache, sore arm, dizziness, inability to walk or stand without support, needed to look straight ahead. Subsided somewhat after a few hours and eating. Expect full recovery within day.
Patient possibly inadvertently received 1cc of Moderna COVID vaccine instead of 0.5cc. Patient was notified.
I felt flushed shortly after leaving the clinic and i became light headed as well. By evening time I was tired and I was too exhausted to get up from the couch. The following day I woke up to a headache and body aches. When I went outside my eyes were very sensitive to light.
Pain in joints of hands, wrists, elbows, and knees bilaterally lasting 10 days so far; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in joints of hands, wrists, elbows, and knees bilaterally lasting 10 days so far) in a 29-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058856) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 30-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 02-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ARTHRALGIA (Pain in joints of hands, wrists, elbows, and knees bilaterally lasting 10 days so far). The patient was treated with PREDNISONE at a dose of 15 milligram once a day and MELOXICAM at a dose of 7.5 milligram twice a day. At the time of the report, ARTHRALGIA (Pain in joints of hands, wrists, elbows, and knees bilaterally lasting 10 days so far) had not resolved.            Concomitant medication was not reported. Patient had pain in joints of hands, wrists, elbows, and knees bilaterally lasting 10 days so far.   Reporter did not allow further contact
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 55-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 93T79, expiry date June 2016). Concomitant products included MICARDIS, SYNTHROID and ALLEGRA. On 17th November 2015, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. In November 2015, less than a week after receiving FLULAVAL QUARIVALENT, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved. The reporter considered the injection site erythema to be related to FLULAVAL QUADRIVALENT. Additional details provided were as follows: On 17th November 2015, at 13:31 pm, the patient received a dose of FLULAVAL QUADRIVALENT vaccine in right arm. The patient experienced red area at the injection site, which measured 4.5cm by 4.5cm.
I received the vaccine without any issues, then waited thirty minutes in the waiting room.  Within 30 minutes, while driving home, my lips and the inside of my mouth started tingling.  This resolved on its own in 30 minutes or so.
30 second episode, child lost consciousness while sitting hit her head against piece of furniture episode of espasticity might have had tonic-clonic episode test arm recovery completely with 30 seconds.
Information has been received from a consumer, concerning her 19 year old daughter, with no pertinent medical history, who on 11-MAY-2007 was vaccinated in the gluteal area with the first dose of Gardasil (lot # not provided). There was no concomitant medication. On 11-MAY-2007 her daughter had an irregular period. At the time of this report, she had recovered (date not specified). The patient sought unspecified medical attention. No further information is available.
trouble (pain) in her arm and shoulder; trouble (pain) in her arm and shoulder; This is a spontaneous report from a contactable consumer. A 79 (unspecified age unit) old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine, patient had trouble (pain) in her arm and shoulder for 4 days, caller were told that with the second dose it would be more difficult and painful. They would like to know if the second dose was a stronger vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
on ride home from pharmacy, patient complained of shooting pains in arm; 40 hours later, patient had bright red (sunburn-like) skin on the left arm (receiving arm), swollen, shoulder to elbow. Also had low grade fever, nausea, and dizziness. Pt still has 3 days later. Was prescribed a steroid and an antibiotic (not filled at pharmacy where shot was given).
Got them all! :( Chills, fever, nausea, body aches all over, headache, fatigue.  Couldn?t get out of bed the next day until 5pm.
nausea, entire body tingling, hypertensive (197/103) at highest, feeling very hot. laid down on cool bench for 25 minutes while BP was taken, left facility went BP was 149/88. slept for about a hour and felt better  returned to normal at the 2 hour post shot mark
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On 30-AUG-2017, the patients were vaccinated with improperly stored PROQUAD (lot # and expiration date were not reported), that was mixed with a properly stored sterile diluent (STERILE DILUENT). Administered doses of vaccines underwent a temperature excursion of 3.6 degrees Celsius, which lasted for 23 hours. There was no previous temperature excursion. A digital data logger was involved in recording the excursion. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA000928:
89 yo female with PMH HTN and hepatitis B was COVID19+ on 2/2/2021.  On 2/20/21, patient received a first dose of Pfizer BioNTech COVID19 vaccine 30 mcg/0.3 mL IM x 1 (lot# EL9261; left arm). Was seen in ED c/o back pain and bruising.  On admission Platelets=3k and Hgb=8.6.  Patient treated for Evans syndrome: ITP and hemolytic anemia. Patient received 1 units platelets, IVIG 55gm IV daily x 2 days, Rituximab 560mg IV weekly x 4 (1 dose given during this admission), dexamethasone 40mg IV x 4 days followed by a prednisone taper. Per hematology, "spontaneous development of warm atuimmune hemolytic anemia as well as ITP is of unclear etiology. No malignancy has been isolated. There are some rare case reorts of ITP from COVID vaccination. Ultimately, we cannot prove whether this is due to the COVID vaccine."  Patient was counseled to not undergo the second dose of COVID vaccine.
I had a bad reaction to the vaccine worse than the other two shots which is why I called the doctor. The night before last. My daughter tested positive, and I started staying with her. My Daughter tested positive Friday 06/17/2022 and I have been at her house try to isolate.  Sore throat  Sinus congestion Body aches Eyes Water Eye Burning  Headaches Coughing Low grade fever around 100 Its still the very early stages of it so I have been pushing fluids and lots of rest.  I went to a clinic because the home test was negative and it was 4 mos old. The clinic test was positive
Patient complains of dull achy pain lasting more than 8 weeks after the injection. Onset was at the time of injection and comes and goes. It is worst when she sleeps on that particular arm or does yoga.
Pain  tenderness  inside of arm  and armpit running to elbow.  Pain when lifting arm and touching the area.
Pain on bone and muscle; Pain on bone and muscle; Swelling of under arm, lymph nodes and breast; Swelling of under arm, lymph nodes and breast; Swelling of under arm, lymph nodes and breast; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient experienced side effects such as pain on bone and muscle, swelling of under arm, lymph nodes and breast. The outcome of the events pain on bone and muscle, swelling of under arm, lymph nodes and breast was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Pt experienced "quarter-sized" hives all over the body, including bottom of the feet, lasting 2 to 3 weeks. Pt sought physician who recommended treatment with Benadryl. Physical does not recommend pt receive second shingrix dose.
Woke up with upper chest discomfort that lasted all day.  Checked myself with pulse oximeter-Normal Around 8 pm started feeling like I had a fever. Exhausted went to bed early at 10 pm.  Very low grade fever, but extreme chills . At 11pm, I was uncomfortable in bed with chest discomfort and freezing feet despite electric blanket. Went to sleep in recliner wrapped in a blanket with heavy socks on and wearing a hoody with drawstring tight on head.  At 12:30  I woke up hot. Fever was gone. Appetite was back. Had a snack and went back to bed.  Back to normal next day. I have had much higher fevers without chills that bad.
I have ringing in both ears that started after the vaccine.  Never had it before. The ringing became constant on May 28, 2021.  I went to urgent, my family doctor and any ear specialist.  All could find to reason for the ringing and could offer no relief.  It is now almost November 2021 and the ringing is still constant.  I have trouble falling to sleep and hearing because the ringing and buzzing can be loud at times.  The ringing wakes me up when I'm trying to sleep.
Called Nov. 14, 2017 complaining of continued pain in left upper arm. Did see her medical provider who suggested the injection may have been give to high on the arm.
TDAP ordered by provider. Given by MA. Reported as incorrect by MA. MD notified. No adverse effect noted to pt.
At the injection site it pulsed for an hr or so. Now it itches  is hot and red spot is growing to cover my upper arm.
Aching in both arms.  Muscle aches.  Aching in lower back by midnight on day of vaccination.  Cold and shivering.  Fever 101. Aching continues in Day 2.  Weakness. Tiredness.
Delayed symptom about a week later where I woke up with an itchy red bump at the injection site. Today is day 3 and it's been red, itchy, and a hard lump.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case was created for 90th patient of the 190 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Transient ischaemic attacks; memory was shot; balance, cognitive abilities were greatly reduced; confusion; loss of balance; memory loss; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP6955 and Expiry date: 30Jun2021), dose 1 via an unspecified route of administration on 11Mar2021 (at the age of 69-years-old) at 09:15 as first dose, single for Covid-19 immunization. Medical history included staph infection in his heart in Dec2014, obesity, onset date: Whole life or within the last 10 years, blood pressure. Concomitant medication included carvedilol and lisinopril both taken for blood pressure. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced transient ischaemic attacks.It was reported that patient had adverse reaction neurological, similar to TIAs after the first dose. On 11Mar2021, the patient experienced memory was shot balance, cognitive abilities were greatly reduced (they stayed reduced for weeks and weeks, gradually he began to remember things, very gradually, his cognitive abilities became gradually better, he was still not back to normal, but it was subtle at the time of reporting), confusion, loss of balance, memory loss. Patient went to emergency room the next morning and side effects continued for weeks. The patient underwent lab tests and procedures which included computerized tomogram head: nothing new on an unspecified date. The outcome of event memory was shot, cognitive abilities were greatly reduced, confusion, loss of balance, memory loss was recovering while the outcome of event transient ischaemic attacks was unknown.
I received the flu vaccine on 11/29/16 and woke up on 11/30/16 with intense pain in shoulder. I had decreased range of motion until after Christmas. I had an X-Ray saw my PCP and they sent me to orthopedist, who is monitoring and considering dif treatments, possible injections (steroid).