chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; vertigo; 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.  An 18-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08May2021 (Lot number: EW0171) at the age of 18 years as dose 1, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 10May2021, outcome "unknown", described as "vertigo"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness". Therapeutic measures were not taken as a result of vertigo, dizziness.  Additional information: The patient received the 1st dose on 08May2021. The patient experienced vertigo a few hours before getting the vaccine and it went away, but today he was experiencing vertigo again. He was just calling to report a possible side effect he was not sure if it was a side effect of the Pfizer vaccine. He thought was experiencing some side effect of the Pfizer vaccine however, he was not entirely sure if it was the vaccine or if it was just something else, he was going through, because he took the vaccine on the 8th (08May2021) which was Saturday and Saturday morning. She felt pretty dizzy for about 10 to 15 minutes and then than just kind of went away and then he went to get the vaccine and now Monday. The patient felt about the same dizziness on Saturday morning before he took the vaccine. So, he does not know if this was a side effect or if it was the same thing, he had Saturday morning. He thought it just be good idea to at least report this. The patient stated, "He believe last time he checked, he was about 5 (feet) 8 (inches) and weigh about 250 pounds. Also stated, "No he haven't used any treatment beside trying to keep him balance because he felt like falling every now and then, he usually he was sitting down so that he does not have to "stand".  No follow-up attempts are possible. No further information is expected.
got a double dose/The patient received  it on 9/28 and just received another one now; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An elderly female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "nervous person to begin with" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 omi xbb.1.5 (DOSE 1, SINGLE), administration date: 28Sep2023, for COVID-19 immunisation. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 10Oct2023, outcome "unknown", described as "got a double dose/The patient received  it on 9/28 and just received another one now".  Additional information: The pharmacist reported an inadvertent administration of the Comirnaty 12 years and up formulation to a patient over 70 years old. It was administered last 28Sep and today 10Oct. She's asking for further guidance or recommendation. On 10Oct2023, pharmacist stated that the patient has no side effects at the moment but has anxiety about it and causing the pharmacist to have anxiety. Pharmacist is freaking out that something is going to happen to the patient but feels that the patient is going to be fine. Pharmacist needs information to be able to assure the patient in some way. Patient doesn't feel bad and is just a nervous nelly, stating patient is a nervous person to begin with. Pharmacist feels horrible it happened but caller doesn't know why caller's system didn't catch it to see patient already received one.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.  Follow-up (10Oct2023): This is a spontaneous follow-up report received from a contactable Pharmacist reported for the patient, Program ID: 004756.  Updated information: Patient's gender, relevant medical history (nervous), and further clinical details  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Raised area at injection site - 3 in x 2 in oval shape - feels hot to the touch and achy.
Had a heart transplant 5 years ago. After vaccination, my calf muscles ached and I had to walk on the balls of my feet. I didn?t feel well and was achy, but all of that resolved after about 4 or 5 days. About 25 days after the vaccine, I woke up and my legs were hurting, swollen and lumpy. I went into the house and elevated my feet. I was sore from my calf to my ankles. I called the doctor and he told me to go the ER. After a 3 hour wait, one of the patients waiting almost threw up me, so I told them I was going home. Later, I went in to see the doctor about what was going on. After rubbing my calf vigorously, some of the lumps started to go away. The only thing my doctors came up with was that I was retaining water. I felt like I had gained some weight. I couldn?t stand long before my legs swelled. They prescribed a strong diuretic called Torsemide and I lost about 10 lbs. I currently wear compression socks every day, which helps with the swelling and my ankles hurt all of the time. I only take the meds as needed because it?s hard on my kidneys, which are already compromised due to my transplant meds.
Immediately 2nd of the vaccine: I had a severe headache. And at start it was over 100 degree fever at first and then went to  Low grade fever and it took me almost a week to feel well again.. After that I haven't felt totally healthy since the vaccine.  It feels like my immunity has gone down. I seem to be sniffling or constipated or low energy or gas and bloating since then. It seems like I react to the smallest of things. On July 12,  I had a weird feeling in my throat and I went to sleep again after feeling it. It was a bad sore throat but on the left side only of the throat. I came down with fever - went as high as 103.5 for about two days. Test was positive for Strep. My doctor started with antibiotics for me to take before the test result. It started to get better after taking this in the next day or two. I have recovered from sore throat and fever but I went on to have stomach issues after that and severe constipation and so I'm just recovering from that still. I feel a little nausea sometimes. I don't feel totally fit yet after this event. I'm generally healthy and I have not had to take antibiotics in years. All of a sudden, I seem to be falling sick and generally not feeling energetic.
The patient was admitted on 7/19/21 with acute hypoxemic respiratory failure secondary to COVID19.  The patient claimed she received her second dose of the COVID vaccine on 1/27/2021.  She was started on oxygen, remdesivir and decadron.  She initially was on 2L O2, went up to 3L and was on 1-2L at the time of discharge on 7/22/2021.
patient received vaccines following a temperature excursion; No adverse effects were reported in any patients; This spontaneous report was received from a nurse referring to an unknown number of patients of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On an unknown date, the patients were vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) therapy type: rHA, (lot number R000551, expiration date 08-JAN-2020); measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) therapy type: rHA, (lot number S002494, expiration date 23-JUL-2020); and varicella virus vaccine live (oka/merck) (VARIVAX) (lot number S002084, expiration date 21-JAN-2021); all vaccines for prophylaxis (strengths, doses, routes of administration, and anatomical locations were not provided).   These vaccines followed a temperature excursion (Product storage error). No adverse effects were reported in any patients. The storage temperatures were unknown. Previous temperature excursion and time frame were unknown by reporter. The data logger present but not functioning.  This report was considered as non-valid due to lack of patient identifiers.  As of 25-JUN-2020, a telephone attempt trying to obtain additional information have been unsuccessful.
Client received Twinrix dose #3 on 9/15/04.  At 10/6/04 visit, client claimed that she "felt the injection/vaccine go throughout her whole body" at the time she received it and now states that her R arm still is uncomfortable and also associates lower back pain with the injection.
pt became very rigid in baby seat & started screaming uncontrollably;eyes were rolling all over head;pt screamed as if were being killed;lasted a few min & on & off all weekend;
Tingling in feet and scalp followed by rash on back. Started w/in 24 h and continues to now (approximately 2 months). Patient self-treated by doubling acyclovir.
Cough got worse . Night sweats  pain in back fatigue. Found I tested positive for tuberculosis Sept 7 2021.
a patient recieved an expired FLUBLOK QIV vaccine, no AE; Initial information was received on 14-Sep-2020 regarding an unsolicited valid non-serious case from an other health professional.   This case is linked to cases 2020SA252523 and 2020SA250807. (Same reporter)  This case involves a 50 years old male patient who received an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided. The patient did not receive any concomitant vaccine.  On 12-Sep-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [prefilled syringe, lot number: unknown to reporter (UTR) as the expired vaccines were taken away before reporter could write down, expiry date 30-Jun-2020] via an intramuscular route at the left arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used. (latency: On the same day of vaccination)  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Paralyzed completely. Sent to ER. Transferred to another ER and completed spinal tap, MRI, blood work. Outcome: guillain barre syndrome
multiple blood clots and ischemic stroke after playing soccer, 3 days after 2nd Pfizer vaccine
Site: Swelling at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadedness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium
Recipient experienced bilateral auditory sensitivity, painful hearing,  tinnitus, difficulty hearing certain sounds and was extremely sensitive to other types of sounds beginning the day after the vaccination. Recipient subsequently consulted an ENT physician, was referred for a hearing test and began a course of steroids. Steroids did not improve the condition. Recipient also received reiki treatment, which improved the condition somewhat. Recipient continues to wear earplugs, as needed, but continues to experience sensitive hearing to some sounds and difficulty hearing other sounds, now greater than 6 weeks after the onset of symptoms.
pt devel fever 103-104 x 24hr tx w/Advil;mom described red knot on leg 5x5-used warm compresses to relieve discomfort;pt screamed w/high pitched, piercing cry x 24hr;consulted w/pediatrician
I started to feel nauseous, loss of my appetite, lightheaded, hot flashes and I loss my smell. The only thing I could do was drink liquids,
2 days very ill, bad headache, nausea. Took tylenol w/no relief. Ringing in ears lasting 4 mos. Pain in rt ear still. Knots still in arm from Dec 1998 vax. Local rx rt arm, spirals 3 1/4" around arm. Flight Doc says TMJ problem on annual.
Area of redness approximately 2.5"x4" to thigh area with slight induration in middle. Warm to touch.
mom states pt hallucinated & was scared of every thing; i.e. scared to eat, scared of mom, scared to sleep p/vax; t101; pt cried a lot 23MAY-27MAY; lost weight; pt had diarrhea & vomited; pt wasn't right for a wk;
No Additional AE; MMR II vaccine was administered after undergoing temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 17-JAN-2022, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T027914 and expiration date reported 18-AUG-2022), 0.5 milliliter for prophylaxis after undergoing temperature excursions (Product storage error).  The temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) was 9.6 Celsius 47 and there were previous temperature excursions on 18-DEC-2021 was 13.7 Celsius for 6 hours. No additional AE. No PQC.  This is one of several reports received from the same reporter.
The day after the vaccination patient had severe bruising around injection site and swelling.  The injection site also was very itchy
I had my vaccine on 01-27-2021 and about three hours later I started to feel sick. I went to the ER on 01-29-2021 and ran some tests, told me I had pneumonia and Covid. My oxygen level was bit better but my temperature was 100.F. They gave me steroid and antibiotics and was sent home. I went home and by 02-03-21 and was admitted to the hospital due to having Covid. I was in hospital for several days and I got out of hospital 02-09-2021.
vaccination site dysesthesia; arm was sore; vaccination site warmth; Injection site itching; Injection site lump; red and warm around injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DYSAESTHESIA (vaccination site dysesthesia), PAIN IN EXTREMITY (arm was sore), VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE SWELLING (Injection site lump) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE DYSAESTHESIA (vaccination site dysesthesia), PAIN IN EXTREMITY (arm was sore), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE SWELLING (Injection site lump) and VACCINATION SITE ERYTHEMA (red and warm around injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (vaccination site warmth). At the time of the report, VACCINATION SITE DYSAESTHESIA (vaccination site dysesthesia), PAIN IN EXTREMITY (arm was sore), VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE SWELLING (Injection site lump) and VACCINATION SITE ERYTHEMA (red and warm around injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided.  Case comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PYREXIA (fever) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   This case was linked to MOD-2021-076390 (Patient Link).
Started with a sore throat and on the morning of the 25th I became very hoarse eventually losing my voice all together. I used cloroseptic and some percocet for the pain, and rested my voice. Am still slightly hoarse.
Fever from 6pm-6am.  Peaked 103F measured orally and 104F measured temporally.  Teeth-chattering chills.  Lethargy.  Headache and body aches so severe that I couldn?t sleep.  Didn?t take any pain relief medicine.
Ever since my second Pfizer Covid Vaccine on 1/7/21, my lymph nodes under my arms, sides and above my left breast have been enlarged and sore.  When I had my 1st booster in November 2021, The soreness and swelling that was doing a little better started up again.   My last 2 mammograms showed the enlargements of the lymph nodes.  This past March after my mammogram, I was referred for an ultrasound which resulted in being referred to oncology whereby they ordered a PET Scan which showed the uptick of the nodes.  All tests could not determine the reason for the enlarged nodes so need to repeat the Ultrasound in Nov 2022.
Rash on front of abdomen, more visible on the side of injection. Not itchy or hot.
Patient received DTaP-IPV- without Hib. Parent was called to re-due the vaccine per pharmacist recommendation .
This spontaneous report was received from a patient's mother and refers to a 21-year-old female patient. The patient's concurrent conditions and concomitant therapy were not reported. On approximately 10-OCT-2018 (reported as two days ago), the patient was vaccinated with varicella virus vaccine (manufacturer unknown) (manufacturer, lot #, expiration date and dosage regiment were not reported) for prophylaxis. On an unknown date in October 2018, the patient's arm had a raised, itchy, red, irritated area. Her mother witnessed the reaction through live social media with the patient on 11-OCT-2018.The outcome of the events was not reported. The relatedness between vaccination with varicella virus vaccine (manufacturer unknown) and the events was not reported.
pt recv vax;devel gen jerky movements of body & tonic neck & eyes rolling up in eyes balls, lasting approx 1-2 min;T 101; tx w/ phenobarb; neuro exam wnl on 23aug95; 4 episodes w/in 5hr interval
Sore arm following 2days. Large Rash/itching at injection point ,11 days after shot
Patient C/O sore throat, aching, warm, headache, redness around injection area since 07/08/2020, patient states she is feeling better today 07/10/2020
Patient is pregnant, 31week 3 days gestation when immunized. Patient received Tdap at a prenatal visit on 8/19. On 8/21 she went to Urgent Care complaining of left arm pain and inability to lift her arm. She was instructed to take Tylenol and apply ice. On 8/24 she called complaining of worsening arm pain, reports she has been to the ER with no relief. 8/26 she sees Orthopedic provider with shoulder pain and inability to lift her arm without assistance. Pain is rated 7/10. No redness or swelling at the original injection site and no fever. Diagnosis Adhesive Capsulitis Left Shoulder. Physical Therapy prescribed. 9/4 returns to Ortho pain improving 3/10.
Acute Non-STEMI (myocardial infarction). She presented by ambulance to the emergency department with atypical chest pain in a very low risk group for coronary artery disease and ended up having elevated cardiac troponins levels leading to emergency heart catheterization for myocardial infarction.
This spontaneous report as received from a nurse refers to a 13 months old patient (gender was not specified). The reporter stated that on 20-MAY-2014 the patient was vaccinated with M-M-R II ((lot # H009784) subcutaneous, dose/frequency: 0.5 ml, once) that was expired on 15-MAY-2014. Pertinent medical history and concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. No further information was provided. Additional information has been requested.
Information has been received on 05-FEB-2019 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) in 2015 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. The patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the vaccine ZOSTAVAX 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. Additional information has been requested.
About 2 or 3 days after the 2nd vaccine shot, I noticed that I was hearing a ringing in my hears when everything was quiet around me. I didn?t realize it was there all the time until a day later when I?m noticing that my ears are still ringing. I started paying attention and noticed it was there all the time. It wasn?t super loud ringing, so I wasn?t noticing constantly, but there was days where it was so loud. It?s like a high-pitched whine 4/5 on a scale. And it never went away. Since then, I?ve never had any moments where I?ve not heard this sound. There are times where it?s relatively quiet and sometimes loud. This is not something I?ve ever had before but I do recall where I might think I am hearing ringing, but I can always tell why it was why happening or something else. But I?ve never had it happening for no reason and continuing. During the first 3 months, there was times where it was almost overwhelming. It was so loud, at times I had to leave work because it was so loud. It is on average, a lot quieter, so I think it?s improving but it?s not going away. My wife said she had the same symptoms but hers mostly went away 3-4 months ago while I?m still listening to this thing. That was the first thing that made me switch my booster because I was worried that it would extend the ringing in my ear because I hope that it goes away. Just a low-level ring. Haven?t gone to doctor to discuss with him yet.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
headache, fever, body aches, diarrhea, ear pain, nasal congestion, post nasal drainage, ear fullness. starting 11/9/21. Husband recently tested positive for COVID