chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of injection site pain in an adult male pt who received Lyme disease vaccine recombinant (LYMErix) for prophylaxis. The reporter is the pt's wife. A physician or other health care professional has not verified this report. The pt received the first injection of LYMErix on 4/9/99. The reporter stated that she did not believe her husband received the second vaccination. At an unknown time after receiving LYMErix, the pt experienced arm pain at the injection site. The outcome of the event is unknown.
2ND SHOT OF SHINGLE VACCINE IN THE EVENING ON 9/8/21, IN THE MORNING OF 9/9/21 BLOOD PRESSURE WENT UP 226/197. SEVERE BODY ACHES, BACK PAIN, FATIGUE
immediately after receiving the Pfizer vaccine the patient had a seizure and passed out. once she regained consciousness she then had an additional seizure. The ambulance was called and she was taken to the hospital.
Breakthrough COVID.  first dose 4/26/21 0039B21A, second 5/24/2021 003C21A, booster 11/29/2021 058H21A.  Positive COVID test 5/30/2022.  64 y/o female presents to the ED  with the CC of SOB, Cough and Wheezing x 2-3 days. Patient with PMH of Systolic CHF 30%, COPD on 4L, DMII, HTN, HLD, Hypothyroidism, OA, Obese, OSA, Mitral valve stenosis bovine MVR 2018, Aortic stenosis pending TAVR presented to the ED due to worsening SOB, Cough and Wheezing x 2-3 days. Pt states that her symptoms were not improving despite neb treatments.
Severely sore shoulder at injection site, sore arm, causing so sever and concerning total arm immobility, red rash below injection site approximately 2" wide x 4" long. Fever 100.9, chills, severe headache (migraine strength), body & joint aches, nausea, dizziness, tachy-heart, constant arrhythmias. Naturally, I have a few a month but these were frequent throughout the day(s).   Arrhythmias are now more chronic, much stronger and longer duration. Have joint pain in left wrist & joints of fingers, much like arthritis and inflammation of the entire left hand, which is same side as injection arm. Also on same left side of body was left foot and ankle inflammation, causing moderate discomfort.
Severe arm Bursitis. Pain, swellling, redness over length of arm, Inability to move elbow, due to limited mobility and severe pain. Sever pain also continued while arm was at rest. Symptons lasted nearly four weeks.   As was travelling during this period, the symptons were treated with frequent high doses of Advil.  The Advil reduced pain but did not restore mobility, nor reduce other symptons,  Advil reduced pain for several hours, though when effect of medication ended, severe pain esumed.
On the 7th day after receiving the vaccination I experienced a sudden onset of severe Vertigo. I could not walk or open my eyes due to the sensation of the room tilting and moving which resulted in severe uncontrollable vomiting. The severe vertigo lasted 24 hours. However, I continue to have intermittent bouts of dizzyness, nausea and loss of hearing that occurs 10-15 times a day lasting 5-10 minutes.  Allthogh I am able to walk about now, I still can not drive due to safety concerns. My biggest fear, of course being if this is going to be permenant or if it will resolve.   Item 21 can not be addressed at this time as it is still unresolved.
28APR91 pt developed large red welts over trunk & legs; 7MAY91 rash is gone & child has recovered;
Approximately 20 minutes after patient received vaccine she complained of swelling in her throat.  Had similar reaction after first vaccine for about 6 hours.  Described is as having a "thick neck in the back of the throat."  Second dose was cleared by her doctor.  Vitals at 0813 122/74 hr 72, 100% on room air.  Denies any difficulty breathing or any respiratory issues.  Benadryl 25mp PO was given at 0813.  Pt transported to ED by RN at 0819 via wheelchair.  Pt talking normally and no signs of distress noted.
Severe arm pain, fever, red patch under injection site, body aches, headache, swollen and hot patch under injection site, nausea, chills, skin numbness where the red patch was. Treatment was antihistamine and pain relievers. Numbness remains, other symptoms have stopped after a week.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients (couple). This is the second of two reports. An elderly female patient of an unspecified age (reported as over 65 years) and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. Patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced soreness, coughing, and low grade fever. The patient complained and thought that she was going to get pneumonia after getting the shot a day after. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2017472071 same drug/event, different patient.
Moderna COVID-19 Vaccine EUA   Interrupted sleep the first night with shakes.  The next day I had chills, shakes, and muscle weakness.  I had no appetite, slept most of the day, and had a full night's sleep.  I felt better about 9:00 PM and am fine today Friday, the 5th
Hepatitis A vaccine #1 given 06/06/02 (lot VHA719C6). Facial swelling and lips swelled 4 days later 06/10/02. Cleared by steroid therapy ordered by family physician. Advised to consult with him prior to second dose due 12/02.
patient presented for 2nd dose and reported her arm has been "sore" on and off for 4 weeks. While administering 2nd dose RPh noticed patients had a bruise still in the area off the 1st dose
Heavier and more frequent menstrual cycle than normal. Had a period from July 11-15, August 2-6, August 27-31, and now September 16-now.
I was 5 weeks pregnant when I got my first dose of the Pfizer covid-19 vaccine.  I miscarried 4 days later.  I do not know if the vaccine contributed to my miscarriage but wanted to contribute to the existing data.  I had no other side effects or symptoms other than soreness at the injection site.  There were no complications with the miscarriage.
the vaccinated area as being swollen; This is a spontaneous report from a Non-contactable consumer (patient). A 81-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 09Feb2021 as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included she suffered a stroke in Feb2020 (affected left side mobility), contracted COVID last April and fully recovered in early May. She is taking medications for diabetes, high blood pressure, cholesterol, thyroid and gout sometimes. The patient concomitant medications were not reported. On unspecified date, the patient experienced the vaccinated area as being swollen but manageable. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I walk 3-5 miles a day, 10-14-2021 I was very sluggish, chest and lungs started to hurt, starting coughing, sick In stomach , next morning I had diarrhea, tired and sluggish, can?t do my 3-5 miles walk
Day 2: Hard Lump, red circle about the size of a dollar coin.  Hot to touch, and mild pain through arm to arm pit, headaches started same time.  Day 3: spot grew to about 4", painful itchy and hot to touch.  Head aches continue.  day 4: - size 88MM x 120MM. still painful and hot to touch, headache continues.
Hoarseness, cough, high fever. 10/28/09 PCP note - well child visit.
This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 30Apr2021 16:45 as DOSE 2, SINGLE for COVID-19 immunisation. Patient's Medical history and concomitant medications were not reported.The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 16:45 as DOSE 1, SINGLE for COVID-19 immunisation. On 01May2021 03:00, the patient experienced i woke up at 3 am the next morning with a severe migraine, feeling very fatigued/i was very tired all day, nauseous, chills, low grade fever, i would describe the migraine as a throbbing pain in my frontal lobe, i was sensitive to any light, On 01May2021 21:00, When the patient tried to go to bed that night around 9 pm i laid down and began to feel very nauseous and when i got up to go to the bathroom i began throwing up. i vomited until 1 am the next morning, On 02May2021, i felt weak the whole day.Therapeutic measures were taken as a result of i woke up at 3 am the next morning with a severe migraine, feeling very fatigued/i was very tired all day, nauseous, chills, low grade fever, i would describe the migraine as a throbbing pain in my frontal lobe, i was sensitive to any light included treatment herself with paracetamol (TYLENOL). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.The patient took 1000 mg of Tylenol every 4 hours until she reached 4000 mg and her migraine never went away. when she tried to sleep, she could feel the migraine still.The Tylenol and sleep did not help the migraine at all. Every time the patient thought she was done and she would lay back down and try to sleep her stomach kept turning and she kept getting up to vomit and finally the patient was able to fall asleep at 1:30. On 03May2021, the patient was tired, but okay.The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown, if the patient received treatment for the throwing up/vomited and felt weak the whole day. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events that night around 9 PM I laid down and began to feel very nauseous and when I got up to go to the bathroom I began throwing up. I vomited until 1 AM the next morning, I felt weak the whole day were resolved on 02May2021 at 01:00 and other events were resolved on an unspecified date in 2021.No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Headache, body, ache, stomach ache, felt warm to touch, no temp taken, no nausea & vomiting, lowered energy level. Lasting 4/6/04 pm thru 4/8/04 pm. 4/9/04- most states child "better"
Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 27-JAN-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcomes of events reported were unknown. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, 0.5 ml subcutaneous, (Lot number and expiration date were not provided) that was stored outside the recommended temperature range noted in the product insert. Co-suspect therapy and concomitant medications were not reported. No adverse effects were reported. Additional information is not expected since no follow up can be obtained.
I was vaccinated for Smallpox on Feb 2, 2003.  On Feb 3rd, I developed a lesion about the size of a quarter under my left arm (injection arm).  The lesion was approximate size of a nickle and was oval in shape with a dry feel to it.  Resembles ringworm.  In the following days, more lesions appeared away from vaccination site, predominately under arm, on chest, abdomin, under arms and neck.  Other symptoms include ongoing headaches, muscle aches and pains, itching, painful lymphnodes bilateral, diminshed mental alertness with forgetfulness, nausea.
She had an episode of syncope about 22 hours after receiving the vaccine. She was standing in the bathroom first thing in the morning, and said she felt hot. Shortly thereafter, she passed out and her mom caught her. Her mom estimates she was unresponsive for about 30 seconds before she spontaneously awoke. She was brought to the ED, and vomited several times on arrival. She then returned to normal and was able to be discharged from the ED without intervention.
swollen ankles and toes, toe swelling resolved after 3 days, patient still had some ankle swelling on day 4 but was muchimproved
Chest pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHEST PAIN (Chest pain) in an 18-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. It was reported that the patient went to the Hospital complaining of chest pain. They thought the patient was having a heart attack or something. No treatment details were reported.
myocarditis; chest pain on exertion; This is a literature report.  A 14-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; CHEST PAIN (non-serious), outcome "unknown", described as "chest pain on exertion". The patient underwent the following laboratory tests and procedures: Echocardiogram: Normal, notes: Initial ECHO and EK were normal; Electrocardiogram: Normal, notes: Initial ECHO and EK were normal.  Clinical Information: As of 16Jun2022 This is a spontaneous follow-up report received from a non-contactable reporter(s) (Physician). It was reported that a 14-year-old male, double-vaccinated with Pfizer vaccine has recent history of chest pain on exertion. Initial ECHO and EK were normal. Proponent 22,000 increasing to 48,000 in 6 hours. Cardiac MRI with Gadolinium showed transmural enhancement consistent with myocarditis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
My 13-year-old son has autism and was also diagnosed with Landau-Kleffner Syndrome. He received the MMR and varicella vaccines on 09/04/03, a day after his first birthday. Soon after receiving these vaccines, the life went out of him. He stopped talking, became aggressive, head banging, screaming, staying up all night, and tearing the house apart. His hearing was tested and came back normal. He was screened by psychiatry and speech who soon diagnosed him with autism. He was tested by neurologist, who performed a 24-hour EEG that showed seizure activity when asleep affecting patient's speech as well. Patient was put on valium for seizures and focalin for his behavior.
Patient got a vaccine a influenza vaccination in his left deltoid.  He was bleeding a little following.  After putting a band-aid on the area, patient leaned forward as if he just needed a moment to get himself together.  He then fell back in his chair causing it to move backward, he seemed to making some seizing movements and his eyes rolled back.  He fell from the chair.  He hit his head.  A coworker helped to get him to the ground.  He came to within a minute.  We kept him there with a sweater under his head until paramedics arrived within five minutes.  They took his blood pressure, pulse and glucose.  Everything was normal.  Patient refused to go to the hospital.  He sat on the floor for about 20 minutes, drank a soda, and returned to work.  He did say this occurred about 5 years early after receiving the meningitis vaccination which he did not report prior to getting the vaccination today.
Tinnitus lasting for years since injections. Trouble swallowing. Heart palpitations while laying down.
arm was sore as typical with vaccine for 48 hours  itchy, slightly painful,  3" red spot formed several days later along with enlarged lymph nodes in right armpit
Patient stated after receiving the 1st dose of Pfizer on 09/17/2021, symptoms of burning in the lungs and heartburn (lasting 7 days then subsided) developed on 09/24/2021. Primary communications recommendation delay of 2nd vaccination.
Itching throat, neck and chest off and on for 2 weeks.  Raised localized rash 5inx5in
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 05-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 which had a lot number of L001312 and expiration date on 24-FEB-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the GARDASIL 9 vaccine had six temperature excursions as follows: one for 64 hours with a highest recorded temperature of 48 F (8.888888889 Celsius), one for 328 hours with a lowest recorded temperature of 29 F (-1.666666667 Celsius), one for 88 hours with a lowest recorded temperature of 30 F (-1.111111111 Celsius), one for 64 hours with a lowest recorded temperature of 31 F (-0.555555556 Celsius), one for 264 hours with a lowest recorded temperature of 33 F (0.555555556 Celsius) and the other one for 64 hours with a lowest recorded temperature of 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Diarrhea  Narrative:  Pt received 2nd COVID-19 vaccine (Pfizer) 3/10/21. One day after vaccine, began to have diarrhea (4-6x/day). This has continued 8 days post-vaccine.
Possible Covid Spots; just wants to sleep all the time; "getting very tired"/more progressively tired"/"not wanting to do anything."; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Possible Covid Spots) and FATIGUE ("getting very tired"/more progressively tired"/"not wanting to do anything.") in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 28-Feb-2021, the patient experienced FATIGUE ("getting very tired"/more progressively tired"/"not wanting to do anything.") (seriousness criterion hospitalization). On 16-Apr-2021, the patient experienced SOMNOLENCE (just wants to sleep all the time). On an unknown date, the patient experienced COVID-19 (Possible Covid Spots) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Possible Covid Spots), FATIGUE ("getting very tired"/more progressively tired"/"not wanting to do anything.") and SOMNOLENCE (just wants to sleep all the time) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was hospitalized and prescribed antibiotics. Multiple test were done including head CT and chest x-rays done that showed "possible COVID spots."  Patient was discharged to hospice.; Sender's Comments: Although a temporal association exist, based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the fatal event of Covid-19 and the product use is assessed as unlikely. Fatigue and somnolence are also assess as symptoms of Covid-19.  However, based on temporality, causality with the product use cannot be excluded.
Patient was seen for a well child visit on January 22, 2004. His examination was perfectly negative and vaccines were given. He was again seen on February 24th 2004. His parents brought him in for evaluation of a rash which he had for about a month. Immunizations were given on January 22, 2004, these were the second doses of the vaccines. It was reported that a couple hours after the vaccines were given, the same afternoon, a red rash appeared. The rash had not changed over the month period of time. The child had a bit of a cold when he was first seen. He is breast fed. His physical examination revealed a healthy appearing child who had a large number of petechiae on the extremities. There was some bruising in the groin crease, along the diaper line, and there appeared to be a larger bruise, which was fading, on his back. He was immediately sent for evaluation following a CBC which showed a platelet count of less than 10,000. The remainder of the CBC was normal.
Pregnancy was normal, estimated date of delivery August 14, 2019.  The symptoms include: Arthritis in joints and seizures