chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus in both ears; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0150) via an unspecified route of administration on 08Apr2021 at 20:30 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history and past drug history. Prior to the vaccination, it was unknown if the patient had diagnosed with COVID-19. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient experienced tinnitus in both ears, left ear had ringing at one frequency, sometimes a humming or pulsating sound and the right ear had ringing at another frequency, sometimes loud rumbling on 10Apr2021 at 12:00. The clinical outcome of the event tinnitus in both ears was not resolved at the time of report.  No follow up attempts are possible. No further information is expected.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Jun2021 10:15 (Lot number: EW0183) at the age of 36 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH MACULAR (non-serious) with onset 2021, outcome "not recovered", described as "It is explained that there was some splotchiness between the first and second shot"; DRY SKIN (non-serious) with onset 2021, outcome "unknown", described as "She thought it was dry skin". It is explained that there was some splotchiness between the first and second shot but today noticed it was worse and red. The patient clarifies the splotchiness went away after the first dose; it started a few days after getting the first dose and last a few days then went away. The patient thought it was dry skin. Now after the second dose, the patient notice it was worse than after the first dose. It did not itch but was red and there. She was not allergic to anything. The patient did not visit to emergency room and physician office. No follow-up attempts are possible. No further information is expected.
Pt had a large flat red rash covering approximately 50% of (L) upper arm.
Recieved h1n1 laiv around 12:15pm. At 4:30 I developed nausea and I vimitted four times. Nausea ended around 8pm. At around 8:30pm I noticed a sharp pain under right rib cage and I had difficulty breathing. This continued until 10:00pm
hosp 9DEC93 p/2 days of confusion, loss of appetite, MD thought was CVA-neuro exam abn, t103.4; 13DEC dx viral or bacterial meningitis; lymphocytes inc; culture neg, but on ATB; Anorexia;
I started with a fever, cough, body aches, headache and sore throat. I had lost my sense of smell and taste, so I decided to go see my doctor  08/16/2021 and he test me for  COVID- 19 and the test was positive. And I am in my 14 day quarantine.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE STROKE OF BASAL GANGLIA, UNSPECIFIED TYPE AND ARTERY
Patient reported fever of 103, severe arm pain, itchy welts, swollen lymph node under the arm, swollen arm, and stabbing pain in the heart. He said he had this reaction after both doses
Fever, chills , fatigue and headache 48 hours after shot.  Low grade temperature and chills day 12.  Possible hives on left leg day 12, resolved by next morning -redness, swelling, pain and itching. Unusual muscle pain/stiffness in both thighs (might be unrelated but mentioning just in case).
MEASLES MUMPS RUBELLA VIRUS VACCINE LIVE SUBQ and TDAP VACCINE 7 YR + IM by nurse. I don't know what TDap it was. I just put ADACEL, but the form would not let me continue. You need to follow up with County Health Department for more info. Patient started having pain in her arm that spread into her joint and up into the left side of her neck. The pain did not go away. I tried calling the health department and no one returned my call. Then I call my family doctor Dr., to see if we should come in, because the pain wasn't going away. My doctor said to try ibuprofen. So we tried that, and there is still pain. The pain expanded into her left wrist. Now she is feeling the same type of pain in her ankles and knees. Today there is a new symptom, she is having trouble gripping with her left hand. So I took her to see Dr. 2 days ago and he gave us a referral to a rheumatologist. I don't know if this is significant, but when the nurse gave one of the injections, she said "oh that was the bone, you're skinny". In December or early January patient had a physical with Dr. and she was perfectly healthy. She has always been strong and before Christmas she could climb a rope to the top of a gym ceiling. I'm really upset about this, and very scared.
Shortness of breath; elevated pulse rate of 90 to 120 for over 4 hours; elevated blood pressure as high as 152/83; Initial information was received on 31-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer via Pfizer.  This case involves an unknown age and gender patient who experienced shortness of breath, elevated pulse rate of 90 to 120 for over 4 hours and elevated blood pressure as high as 152/83 after receiving influenza usp trival A-B subvirion no preservative vaccine [Fluzone]and tozinameran [Comirnaty].  The patient's past vaccination(s) included Covid-19 vaccine (Dose 5, 4. 3 , 2, 1). The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Blood cholesterol increased.  Concomitant medications included atorvastatin.  On 23-Oct-2023 at 13:45 hours, the patient received an unknown dose (dose 1) of suspect influenza usp trival A-B subvirion no preservative vaccine (Suspension for injection) (Lot number not reported) for Immunisation and an unknown dose (dose 1) of suspect Comirnaty not produced by Sanofi Pasteur (Solution for injection) (lot HD9876) for Covid-19 Vaccination (Covid-19 Immunisation) (Expiry date, strength: unknown) via unknown route in the left arm. The information on the batch number will not be available.  On 24-Oct-2023 at 01:30 hours, the patient had shortness of breath (dyspnoea), elevated pulse rate of 90 to 120 for over 4 hours (heart rate increased) and elevated blood pressure as high as 152/83 (hypertension) (latency: 11 hours 45 min) following the administration of influenza usp trival A-B subvirion no preservative vaccine and Comirnaty.   Relevant laboratory test results included: Blood pressure measurement - On 24-Oct-2023: 152/83 [elevated] Heart rate - On 24-Oct-2023:  [elevated- 90 to 120 for over 4 hours] SARS-CoV-2 antibody test - On 24-Oct-2023:  [Negative (Nasal swab)]  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovering / Resolving for the events.
Information has been received from a registered nurse concerning a 68 year old female who on 23-OCT-2007 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX.  On 25-OCT-2007 the patient complained of arm pain with cellulitis at the injection site.  Unspecified medical attention was sought.  29-OCT-2007 the patient recovered.  Additional information has been requested.
Patient reported tinnitus and paresthesia post vaccination to left arm. It was reported to occur immediately after vaccine administration. Patient reported symptoms resolved. Vital signs taken, assessment completed.
This spontaneous report was received from a certified medical assistant refers to a 44 years old female patient who on 28-AUG-2012, was vaccinated subcutaneously with the first 0.5 ml dose of M-M-R II (lot number 1117AA, Exp. Date: 12-JUL-2013). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 04-OCT-2012, the patient failed to seroconvert and showed no titers against to rubella when was tested on the same day. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for patient failed to seroconvert and showed no titers against rubella was unknown for M-M-R II. Additional information is not expected.
after first vaccine sick for 4-5 days; flu like symptoms; left hand tingling in finger tips/feels like pins and needles; sometimes numb; fingers swell; hand is sensitive to the touch; pain in left hand; This case was received via an unknown source, no reference has been entered for a health authority, on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, INFLUENZA LIKE ILLNESS, PARAESTHESIA, HYPOAESTHESIA, and PERIPHERAL SWELLING in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VALSARTAN HCL, OMEPRAZOLE, ASPIRIN, DILTIAZEM, TERAZOSIN, DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE TIMOLOL, HUMALAND, and VITAMIN C for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (after first vaccine sick for 4-5 days), INFLUENZA LIKE ILLNESS, PARAESTHESIA, HYPOAESTHESIA, PERIPHERAL SWELLING, SENSITIVE SKIN, and PAIN IN EXTREMITY. At the time of the report, ILLNESS, INFLUENZA LIKE ILLNESS, PARAESTHESIA, HYPOAESTHESIA, PERIPHERAL SWELLING, SENSITIVE SKIN, and PAIN IN EXTREMITY outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-326687 (Patient Link).
had series of hepatitis vaccines 2 years ago through public middle school/ health dept. Then within 1-2 mnths came down with psoriasis after 1st dose.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 4/1/2021 and 4/29/2021. Presented to the hospital 01/17/2022 with bilateral leg pain, intermittent cough, congestion, SOB and chest pain. Admitted for NSTEMI and COVID pneumonia. Tested COVID positive 2 days prior to presentation to the hospital. Coded due to PEA on 01/18/2022, successfully resuscitated, intubated and sedated. Chest CTA negative for pulmonary embolism but noted patchy bilateral infiltrates compatible with atypical multifocal pneumonia with trace dependent pleural effusions. Noted to have an NSTEMI and was taken to the cath lab where she was found to have non-obstructive coronary arteries. An Impella was placed due to cardiogenic shock. 1/19/22 transferred to Med Cntr -for higher level of care. Patient in cardiogenic shock with suspected myocarditis. Patient received: pressors, inotropes, steroids, and antimicrobials. Required CRRT due to hyperkalemia and anasarca. On 1/23/2022, spouse requested DNR/COT and patient expired at 1638.
After vaccination, client stated he already received 1 dose of Moderna vaccine in April 2021 at a different jail.
On Monday May 3rd I woke up with bloodshot eyes and my lip was starting to swell. It was 12 days after receiving the 1st covid shot. Once Thursday May 6th arrived I was having a full on herpes breakout. Cold sores on my top lip and lesions/fever blisters on my tongue, multiple. I have never had an oral herpes outbreak before in my life so I didn?t even know that I had it in me until now.
SORE THROAT; GENERAL BODY ACHES; HEADACHE; FALSE POSITIVE HIV TEST; PAIN IN ARM/ SORE ARM; TIRED; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included gastric bypass surgery, and concurrent conditions included nonsmoker, and other pre-existing medical conditions included the patient has no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and 041A21A expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, the subject experienced pain in arm/ sore arm. On 30-MAR-2021, the subject experienced tired. On 02-APR-2021, the subject experienced false positive hiv test. Laboratory data included: HIV test (NR: not provided) Positive, Negative. On 08-APR-2021, the subject experienced sore throat. On 08-APR-2021, the subject experienced general body aches. On 08-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from false positive hiv test on 02-APR-2021, and tired on 2021, was recovering from pain in arm or sore arm, and had not recovered from sore throat, general body aches, and headache. This report was non-serious.
Injection site (left arm) is swollen (fist size) red, hard & painful (throbbing).
Hives around eyes , swelling, and redness  Treated with Benadryl  Went away within 10 minutes
Vaccine was given 7 days past beyond use date. Per Pfizer Manager of Quality Operations, their data stated, "Stability assessment indicates there is no product quality impact and the vaccine was suitable for use."
Pt vaccinated with MMR/HIB developed fever of 104 (R), eyes matted shut, cough, & loss of appetite.
This spontaneous report as received from a pharmacist via Company Representative refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, route, lot number and expiration date were not reported). Secondary and concomitant therapies were not reported. The pharmacist reported that after an unspecified patient was administered ZOSTAVAX they developed a "mild case" of shingles. The outcome of the shingles was not reported. Additional information has been requested.
Received vaccine on 03/12/2021 and on 03/18/2021 client went for a walk and her legs became like "jello". She did not think she was going to make it back to her apartment. Upon returning to her home, she had numbness in her lower extremity. She felt terrible and contacted her healthcare provider.  She was seen and it was noted that she may have had a mild TIA but her blood pressure was significantly elevated and she was placed on hypertension medication. The weakness has resolved.
took the flu after taking a flu shot and almost died; Initial information was received on 05-Nov-2020 regarding an unsolicited valid non-serious case from consumer/non health care professional (patient's child) via social media.  This case involves an adult female patient of unknown age who got flu after taking flu shot and had almost died (influenza), while the she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got flu after taking flu shot and had almost died (influenza), (unknown latency) following the administration of INFLUENZA VACCINE. The reporter reported that the doctor had told the patient not to take flu shot again. Also stated that the reporter also did not take flu shots.  Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown at the time of report.  There will be no information available on the batch number for this case.
Approx. 30 seconds after injection became unresponsive and stopped breathing. Cyanotic and seizure activity. Rescue breathing administered, carotid pulse present. Began cheyne-stokes breathing and gradually became responsive to verbal stimuli approx 3-4 minute after injection.
Mother reported to ER that at 2:00 PM she removed band aid on arm where pt. received shots at 9:00 PM and pt immediately became pale and fell down and arms were shaking. Pt was unresponsive  1-2minutes.
Within the first 5 minutes, my chest got very warm, I felt dizzy, and my heart began racing.  This was after the shot and I was calm before.   This feeling went away and I left the facility.  When I arrived home, I felt very sick.  I was nauseated, dry heaving, my chest was tight, my pulse was staying above 100 even while lying down, my chest felt like it was on fire, and I was dizzy.  I was also shaking uncontrollably.  I called the doctor's office and they told me it may be anxiety and to wait it out.   I continued to have similar symptoms throughout the weekend (I had the shot on a Friday).  My skin felt as though it was on fire.  I had no fever.   On Monday, I felt the same and did not go to work.  On Tuesday, I did not feel much better and went to my primary care doctor to be seen.  He conducted a physical exam and took blood.  My blood tests came back with low potassium and low blood urea nitrogen.  My physical exam was normal outside of higher than normal blood pressure (146/94).  The symptoms got better slowly throughout the week.
This spontaneous report was received from a physician referring to a 15-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 13-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012764.
20 patients rceeived vaccine with possible temperature ecursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT STORAGE ERROR (20 patients rceeived vaccine with possible temperature ecursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (20 patients rceeived vaccine with possible temperature ecursion). On 15-Mar-2021, PRODUCT STORAGE ERROR (20 patients rceeived vaccine with possible temperature ecursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Patient previously received J&J COVID-19 vaccine at a different facility. He then scheduled an appointment online for the Pfizer COVID-19 vaccine with Pharmacy. He did not let the pharmacy know about the previous J&J vaccine and received the first dose. Previous J&J date is unknown to pharmacy. Patient currently has no unusual symptoms at this time.
A 48 year old female reported that she received injections of Flu Shield and Pnu-Imune-23 on 12/06/2001. Medical history included multiple sclerosis and recent urinary tract infection for which she received 10 days of ciprofloxacin therapy (ending on 12/03/2001). Concomitant therapy included Avonex, (interferon beta), Celexa, baclofen, Provigil, and "Uromax." On the evening of vaccination, the pt experienced flu-like symptoms of vomiting, diarrhea, and "low-grade" fever of 99 deg. F. She visited the physician on 12/10/2001 and was prescribed Compazine for vomiting. She was also diagnosed with another urinary tract infection for which she was prescribed Bactrim. FOLLOW-UP information was received on 01/15/2002 from the pt's physician. the pt's medical history included multiple sclerosisis, depression, andasthma. Other concomitant therapies included Topamax, Ditropan, Cylert and Advair. A complete blood countperformed on 12/06/2001 was within normal limits. The reporting physician felt that the symptoms were due to the urinary tract infection rather than an "immunization reaction".
large blister that formed on her R forearm a day after receiving her covid spikevax and flu shot. Covid on the right and flu in the left. Blister formed on day 2 and stayed intact until 10/2 when it ruptured a clear fluid. Area was still sore and she was not experiencing pain int he remainder of hte upper extremity. She said she had typical soreness in each arm after the vaccines as she would expect. No hx of reaction.
This spontaneous report as received from a pharmacist refers to a 28 years old female patient with no medical history and no drug allergy. The patient was vaccinated with the first dose of VARIVAX (Merck) (lot# unspecified) "many years ago". No other co-suspects were reported. No concomitant medications were reported. On 13-OCT-2012 the patient had exposure and possible symptoms of chickenpox. No treatment information was given. No lab tests were performed. The outcome of chickenpox was reported as not recovered. The patient had sought medical attention via contacting with the physician. Additional information is not expected.
At 1000am 5/17/17, patient received PPSV23 left deltoid. By early evening patient was having 9/10 pain left deltoid and was having chills. Spouse stated "he also said a few things which did not make sense". Patient was checked by EMS temp was 99F and other VS and CBG were all normal. Left deltoid area not red or swollen per spouse. Patient has discomfort left deltoid area am of 5/18/17 but is feeling much better per spouse.