chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache was starting to feel more like a migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 14:30 (Lot number: EN6200) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: she was diagnosed with migraines 31 years ago. The patient's concomitant medications were not reported. Past drug history included: Fiorinal for Migraine, notes: Fiorinal 325/25/40mg capsule; Naproxen for Migraine, notes: Naproxen 500mg tablet; Metoclopramide for Migraine, notes: Metoclopramide 5mg. Vaccination history included: Bnt162b2 (1st dose, Lot Number: EN6198, Route of administration: Intramuscular, Anatomical location: Left arm), administration date: 03Mar2021, when the patient was 61 years old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 25Mar2021, outcome "not recovered", described as "headache was starting to feel more like a migraine". Therapeutic measures were not taken as a result of headache.  Additional information: The patient had no additional vaccines administered on same date of BNT162B2. The patient had not received any other vaccines within 4 weeks prior vaccination. The event did not result to ER visit or physician office visit. The patient was asking if it is okay to take her prescriptions for her Migraine (Fiorinal, Naproxen and Metoclopramide) for the reported event headache was starting to feel more like a migraine.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from medical assistant regarding a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-JUN-2016, the patient inadvertently received additional dose of VAQTA (lot # M009377, expiry date 17-JUN-2017) dosing details unknown, intramuscularly. The patient received first dose of VAQTA on 05-DEC-2013 and second dose of VAQTA on 02-FEB-2015. No adverse effects have been reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Day 1-sore arm and body aches, this lasted two days, then he felt better on the third day. Yesterday he woke up with a bad headache and nausea and had to miss school. He felt better later in the day. Today he woke up with another bad headache and stomach pain. Also extreme fatigue in the morning.
Patient's parents came back to the pharmacy carrying her saying that she has suddenly become week about 35 minutes following the vaccine.  We contacted emergency services. When I went to evaluate her she looked lethargic and limp with eyes half open. When I talked to her she perked up a little bit and I checked her blood pressure (100/81 with HR 64). she had no itching, redness, difficulty breathing. EMS arrived and she instantly stood up when she saw them. she seemed a little scared. they checked her sugar, blood pressure, and examined her. EMS examined her for about 15 minutes and offered to take her to the hospital since they could not find any immediate issues. The little girl refused and they determined that she was alright. Her parents asked her if she wanted a meal. she stood up and told them not to forget her pony. Her mom paid for the pony toy and they left.
The patient came in for a vaccine at our clinic at the school and circled pfizer as the second dose. During the clinics we verify name, patient, patients age, consent form and id and covid cards to make sure we give the correct vaccine to the correct patient. The vaccinator gave the second dose according to the paperwork provided by the patient with the consent form that the patient signed. I tried to contact the patient but the patients phone went to voicemail and left patient a message to call us back.
One day after I got my first vaccine, I started to have a constant smell of gasoline. It lasted for a few days and they went away.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: 8732) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAROSMIA (non-serious) with onset 02Apr2021, outcome "recovered" (Apr2021), described as "One day after I got my first vaccine, I started to have a constant smell of gasoline. It lasted for a few days and they went away.". Therapeutic measures were not taken as a result of parosmia.  Additional information: It was reported that one day after the first vaccine, the patient started to have a constant smell of gasoline. It lasted for a few days, and they went away. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Felt nurse injected vaccine too high on the shoulder, where a shirt has a seam. After the shot, arm felt numb, felt like he hit a bone. Talked to others and now thinks he may have hit the rotator cuff. Did not go to see MD. Received PT exercises to do from mother in law. Taking ibuprofen, but it is not helping. She is overweight but not obese. She is 5'3"/170#. About 80% recovered today.
Severe arm pain,  headache, swollen cheeks, periorbital rash, lip angioedema, and shortness of breath all within 1 hour of receiving the vaccine
Patient notified staff of past passing out with blood draws.  Since patient was in the readiness lab he was placed in a reclined position for safety.  Blood was drawn with no issues.  patient was then sat up per his request.  Patient received Hep B and then JEV with no issues.  When his MMR was given with no issues.  Patient was then sitting there and then got up about 45 seconds after vaccines patient reported feeling not well.  Patient was assisted to set back in chair in a reclined position.  Patient's neck hyper-extended, face turned red, patient made a snoring sound.  Some thrashing and tense body posturing was noted.  After a sternal rub he appeared to be out for about 45 seconds.  Ice was applied.  Patient woke and spoke.  Appropriate, oriented and was able to observe all questions.  Patient was resting comfortably, drinking water and observed for about 1 hour.  Discharged home with no issues by Clinical Staff
Developed low blood pressure 3 days after vaccine. Then diagnosed with multiple blood clots in the legs and a 2" saddle pulmonary embolism 10 days after vaccine, and admitted to the hospital (3/30/2021).
pt recvd vax; w/in several hrs exp fever, chills & pnu immune became swollen, red & warm to touch; dx cellulitis; to hosp w/ questionable pneumonia rt middle lobe infiltrate; no cough; tx w/ atb;
low grade fever and chills, headache, back pain, soreness at injection site - no treatment, resolved by next day except soreness at injection site lasted 7 days
Breakthrough case admission after three vaccines; patient expired  Moderna 1/26/21 Lot# 032420A;  Moderna 2/25/21 Lot# 001M20A;  Moderna 11/16/21 Lot# 051F21A
Sore arm, swollen lymph nodes under left arm, metallic taste in mouth, 101 degree fever, chills, muscle aches, headache
Little soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 16:45 (Lot number: ER8731) at the age of 25 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pneumonia" (unspecified if ongoing), notes: required hospitalization and mainly affected my left lung. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Little soreness". Therapeutic measures were not taken as a result of pain.  Additional Information: It's been a little over 24 hours since patient second dose. The day of the vaccination (yesterday, May5th) patient didn't experience anything; patient was actually really surprised at how little soreness felt, in comparison to the first dose. However, today patient experienced what could best describe as the typical signs that a heavy cold is fixing to knock out in the coming days. patient had ongoing moderate body aches, internal fever, a slight headache, and, what seems unusual, slight chest pain. Patient feel it specifically on left side, almost as if over the heart. There's also a slight intermittent ache in left armpit. But specifically to the chest pain, patient mainly feel it upon exhaling deeply. No other symptoms thus far to report at this time. Patient did not receive any vaccine within four weeks prior to covid vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 after vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
No additional AE.; an improperly stored vaccine was administered to a patient PROQUAD (Lot: U029319)/PROQUAD (Lot: W024548); This spontaneous report was received from a registered nurse and refers to a 4-year-old female patient. The patient's medical history included haemangioma. The patient was also a premature newborn (31 weeks, 1480 g birth weight). Her concurrent conditions included dysuria. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX) and influenza vaccine (manufacturer reported as GSK).   On 12-OCT-2022 the patient was vaccinated with of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, lot number W024548, expiration date: 31-JAN-2024, administered subcutaneously in the right vastus lateralis for prophylaxis. Before the administration, the vaccine underwent temperature excursion of 10.8 degrees Fahrenheit for 18 hours 30 minutes (product storage error). There was no previous temperature excursion. There was no adverse event reported (no adverse event).  This is one of several reports from the same reporter.
male was administered a dose of Havrix on 11Apr2023  which had an expiration date of 16Dec2022.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 35-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16-DEC-2022) for prophylaxis.   On 11-APR-2023, the patient received Havrix. On 11-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: male was administered a dose of Havrix on 11Apr2023  which had an expiration date of 16Dec2022.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date- 12-APR-2023 Pharmacist reported that patient administered a dose of Havrix on 11th April 2023 which had an expiration date of 16th December 2022, which led to expired vaccine used.  The pharmacist did not know which dose number in the series this was for the patient. The reporter was consented to follow up.
Site in left upper arm was painful and reddened, now has localized redness and swelling.
Hives that began at the injection site (upper left arm) and spread across chest, up neck and face, and onto eyelids. Present for 6 days so far and continuing. Began increased antihistamine treatment on evening of 5/11/21: AM - 5 mg levocetirizine dihydrochloride (Xyzal), PM - 50 mg Benadryl
This spontaneous report has been received from a consumer refers her approximately 19 years old son. The patient was vaccinated with the three dose of hepatitis b vaccine (recombinant) (manufacture unknown) on 23-AUG-1993, 08-OCT-1993 and 07-DEC-1994. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient was showing low antibody titers. Reporter said, "My son's physician says he is only 34 to 39% immune to hepatitis B." No treatment information was reported. The patient sought medical attention by office visit. Hepatitis B antibody titers were performed. The patient was not recovered at the time of report. Additional information is not expected.
Broke out in itchy hive, within 2 hours developed achiness, chills, fever of 101 degrees. Cough.
The pt developed problems beginning 8 months post vax. Symptoms included a strange rash on neck, fatigue, vision problems, headache, memory problems, dizziness. MD thought it was demyelination of brain possibly from Lyme disease. First Lyme test was positive, but the pt was told it was a false positive test. The pt was sent to another facility and they believed it was a concussion. The pt states "No one knows!"  Pt was told her symptoms are like MS and Lupus. 60 day follow-up provided no data changes.
Immediately after getting the shot, I felt a heaviness on the arm (left) that was given the shot.  Then, that heaviness moved to my left leg, thighs, and calf.  My joints (knees, elbows, etc.)  are stiff and sore.  My left calf feels numb and stiff like after getting a nasty leg cramp.
HCP states that they accidentally gave a patient act-hib in which the diluent that came with it was expired, with no reported adverse event; Initial information received on 12-Jan-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 69 years old male patient whose hcp states that they accidentally gave a patient act-hib in which the diluent that came with it was expired, with no reported adverse event after receiving vaccine haemophilus type B (HIB) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (CRM197) (MENVEO) for Immunisation.  On 28-Nov-2022, the patient received a standard 0.5 ml dose of suspect haemophilus type B (HIB) vaccine Powder and solvent for solution for injection (lot UJ603AA, expiry date: 29-Oct-2022)  via intramuscular route in the deltoid nos not specified as immunization.  On 28-NOV-2022 the patient developed hcp states that they accidentally gave a patient act-hib in which the diluent that came with it was expired, with no reported adverse event (expired product administered) on same day  The HCP asks if the dose is valid and if they should revaccinate the patient    Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event    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 the guidelines. 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.
redness, feels like a marble under the skin, shooting pain into shoulder, sore arm (like a bruise not when moving arm)
Approximately 10 minutes after giving shot patient fainted in waiting area at front desk. NP was first to aid student. No apparent injury noted. LOC 3-5 seconds. Responsive. Pale and diaphorectic but alert. P:96 4:30 taken via wheelchair to infirmary. B/P: 100/76 P: 96. Dr. aware. Given water and gatorade and crackers. Lying in bed elevated legs. Cool compress to forehead. 4:45pm B/P96/78P:96 Dangled legs at bedside before ambulating. Color back to faceand no reports of dizziness. Stable and A&Ox3 before discharge.
Pericardial effusion with some evidence of cardiac tamponade. Status post pericardiocentesis. Admitted to inpatient hospital unit with critical care and cardiology services.
The site of injection is dark purple; The site of injection is sore/ painful; Swelling (size of an orange); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (The site of injection is dark purple), VACCINATION SITE PAIN (The site of injection is sore/ painful) and VACCINATION SITE SWELLING (Swelling (size of an orange)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (The site of injection is dark purple), VACCINATION SITE PAIN (The site of injection is sore/ painful) and VACCINATION SITE SWELLING (Swelling (size of an orange)). At the time of the report, VACCINATION SITE DISCOLOURATION (The site of injection is dark purple), VACCINATION SITE PAIN (The site of injection is sore/ painful) and VACCINATION SITE SWELLING (Swelling (size of an orange)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.   This case was linked to MOD-2021-114285 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Additional information received included no new information.
Event occurred after full vaccination. Patient was diagnosed with COVID-19. Tylenol. Inpatient.
April 5th - Sore at injection site April 6th-8th - Sore and swollen at injection site, dizzy, nausea, headache, fatigue -- I took most of April 7th and all of April 8th off to rest.  Successful.  April 12th (evening)  and April 13th (today) - Sore and swollen at injection (note, for the second time), fatigue -- I took an OTC allergy pill to help with the swelling.  Unsuccessful by next morning. (April 12th) -- I have been holding a cold compress over the site to reduce swelling and soreness.  Soreness is weakened but still persistent.  Swelling is still present. Unsuccessful.  (April 13th) -- I have been trying to get in touch with my primary care physician's office all morning during breaks in work.  Unsuccessful.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: 10 mins post injection pt presented with difficulty swallowing/breathing, felt tightness in her throat, reported tingling and numbness of tongue I checked her vitals her BP was elevated and she complained about her symptoms getting worse and was extremely anxious. I called EMS and they came in within 10 mins however pt refused to go with them. Within a few mins her sister was with her which helped calm her down she left the store within 45 mins post reaction and was feeling better.
2 weeks after woke up for work and couldn't walk and had a huge purple line on inside of my right leg and turned out to be a 15 inch long blood clot and as of the past 2 months i have numbness in my right arm , severe numbness
The patient received booster too soon, he should have after 6 months, he did not give vaccine card until after given dose. This went through insurance fine, and was not seen that it was soon until vaccine card was seen.
green bile coming out of my behind/ having little green bowel; Bowel like a diarrhea, or bowel movement; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program Pfizer First Connect. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated "I am experiencing green bile coming out of my behind. Can your covid-19 vaccine cause that?" It was clarified as seeing green bile after going to the bathroom and having a stool. It was stated that Sunday she started having little green bowel until today; bowel like a diarrhea or bowel movement. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
I have had persistent ear ringing in both ears that started approximately 2-3 weeks after second vaccine. I have never been bothered by this in the past or after any other vaccine. It's persistent and annoying. I'm an RN at a large hospital and believe in vaccines but this ringing in the ears is miserable.
Migraine, chest pain, shortness of breath, dizziness, gagging, muscle and joint aches, fever 104.5, extreme exhaustion, over the course of 48 hours
I have Rheumatoid Arthritis but, have not had significant symptoms in many years.  About a week or so after my second vaccine I began experiencing some RA type pains in Hands.  The pain/flare continued to May 5, 2021 at which time pain was extremely intense to point it was hard to sleep. Pain meds did not help.  The next day symptoms had decreased to very minor pain/discomfort.  This is slowly getting better but it still present.
Pt presents to the clinic with 3 day hx of headache, joint pain, low grade fever, nausea, aphtous stomatitis.  Tx with SoluMedrol 125mg IM injection and 7 day course of Benadryl, with f/u instructions given.