chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stabbing headache in left temple and ear starting 12 hours after vaccine - would last a few seconds and repeat every few minutes; This is a spontaneous report from a contactable consumer(patient). The 58-year-old male patient received BNT162B2, via an unspecified route of administration on 21Apr2021 15:30 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation.  Medical history included none. She had no known allergies. There was no covid tested post vaccination, no covid prior vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY).  The patient experienced stabbing headache in left temple and ear starting 12 hours after vaccine - would last a few seconds and repeat every few minutes, ended up in emergency room and physician office on 22Apr2021 02:30, which also led to hospitalization for 1 day with outcome of recovering. Treatment received included pain medication infusion.  Information on the lot/batch number has been requested.
Fatigue,  chill,  fever,  pain around shot area,  and pain under right armpit
Pulmonary inflammation and sputum production as well as shortness of breath around 50% more severe than previously; by far the most severe of any time point in her adult life. Symptom onset in AM the day after the vaccination was given and symptoms were debilitating. Symptoms did not improve for months following the vaccination. Symptoms mildly improved through chelation therapy approximately 5 months after onset.
Information has been received from a nurse practitioner concerning a 16 weeks old male who was a premature baby with no drug reactions/allergies, who on 31-AUG-2007 was vaccinated with a first dose of Rotateq and on 26-OCT-2007 was vaccinated po with a second dose of Rotateq (lot number: 657661/0973U). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine and PREVENAR and poliovirus vaccine inactivated (unspecified). On 31-OCT-2007 the patient experienced a rigid abdominal constipation, 17 hours of straight crying, and no bowel movement for 2 days and was hospitalized. On 05-NOV-2007 the patient was discharged from the hospital. No lab diagnostics studies were performed. Mirilax  was given. No further information was provided. There was no product quality complaint. The adverse event was thought to be an other medical event. Additional information has been requested. 12/26/07-records received for DOS 10/31-11/01/07-DC DX: Constiption. Mild dehyrdration. Presented with abdominal pain and fussiness. Decreased feeds for 1-2days. No vomiting. At PCP office no bowel sounds heard.
low grade fever; headache; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported for a female patient (wife). A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 19Mar2021, for COVID-19 immunization. On an unspecified date, the patient experienced low grade fever and headache. Clinical outcome of the adverse events was unknown at time of this report.   Follow-up attempt have been completed and no further information is expected. The lot number is not available despite follow-up attempts made.
Pt developed redness and itching on left deltoid at the site of the injection. He called PCP who advised him to apply ice. Itching worsened and the redness spread over the entire deltoid. After 6 days he presented at urgent care after developing a macular rash on groin and thighs.
Sore throat, loss of voice, 12/17/09 body aches 12/18/09 runny nose Overall flu like sympthoms, except no fever and no stomach upset
Information has been received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 18-SEP-2017, the patient was vaccinated with a dose of improperly stored VARIVAX lot # M040138 and expiration date of 28-SEP-2018, (route of administration and anatomical location were not reported), for prophylaxis, reconstituted with properly stored sterile diluent (lot # M034781 and expiration date 11-APR-2019) The vaccine was stored in the range of 40 Fahrenheit degrees for an hour. No previous temperature excursion was reported. No adverse effects were reported.
Pt recvd 3 doses of Engerix-B & 20OCT91 found to be a non-seroconverter;
This case involves 28 years old female patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in context of patient is pregnant with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported patient is pregnant with no reported adverse event occurred at 33 weeks of pregnancy. The date of last menstrual period was reported as 18-May-2021. The estimated due date is 22-Feb-2022. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 07-Jan-2022, the patient received 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, frequency once, lot U7283AA, expiry date: 02-Feb-2024 via intramuscular route in the left deltoid (formulation, strength: not reported) as prophylactic vaccination (TB skin test--immunization). On 07-JAN-2022 the patient developed a non-serious event "patient is pregnant with no reported adverse event "(exposure during pregnancy) (latency same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was reported "Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test--0.5ml o Strength = standard except for Fluzone HD--standard o Indications = Immunization or TB skin test--immunization" Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable. It was not reported if the patient received a corrective treatment for the event (patient is pregnant with no reported adverse event). At time of reporting, the outcome was Unknown for the event patient is pregnant with no reported adverse event. Additionally, at time of reporting, the pregnancy is still ongoing.
This patient was admitted to  Hospital on 1/5/2022 for COVID pneumonia. This is considered a breakthrough case.
big red rash on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (big red rash on the injection arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RASH ERYTHEMATOUS (big red rash on the injection arm). At the time of the report, RASH ERYTHEMATOUS (big red rash on the injection arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Pt was seen in the emergency room brought in by medic for fever, chills, HA, GI upset, and muscle cramping. Pt had labs, IV fluids, a sepsis panel, EKG and chest XRAY. Pt was in the ER for 6 hours.
1st dose vaccine 1/30/21; 2nd dose vaccine 2/20/21; new onset weakness 2/21/21; fell at home and seen in ED and admitted to hospital 2/22/21 Dx on admission:  1. Hypoxia   2. Elevated troponin   3. Elevated brain natriuretic peptide (BNP) level   4. Generalized weakness   5. Closed head injury, initial encounter
I felt tingling in the feet hands and mouth; After a lot of sleep; second day strong pains began in the back; Inflammation in the ganglia; shortness of breath; High or slow heart rate; I began to feel strong pain in my spine, legs and joints; I feel uncoordinated to speak; I began to feel strong pain in my spine, legs and joints; It is a horrible feeling.; This is a spontaneous report from a contactable consumer (patient herself). A 56-years-old non-pregnant female patient started therapy with bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0162), via an unknown route on 16Apr2021 at 1:00 pm in the arm left as a single dose for COVID-19 immunization. The patient's medical history included hypertension and a liver problem. Patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient 2 weeks prior to the COVID vaccine included Bisoprolol (5mg). Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. The patient did not have allergies to medications, food or other products. On 17Apr2021 at 14:30, the patient felt tingling in her feet, hands and mouth and became very sleepy. On the second day after vaccination, patient felt strong pain in her spine, legs and joints and neck. The patient also reported neck lymph nodes inflammation and shortness of breath. Patient reported that high or low heart rate and she felt uncoordinated to speak. Patient described that it as a horrible feeling. The outcome of the events was not resolved. It was unknown if the patient taken any treatment due to AE.   No follow-up attempts are needed. No further information is expected.
Pain at injection site, swelling, headache began at 6:00 PM followed by fatigue and muscle pain. Gave ibuprofen. Symptoms continued through next day.
Major swelling of entire upper arm ---more than twice normal size---, nausea, stomach ache.  Treatment: patient used BENADRYL and ADVIL. Next day swelling reduced by 50 %. Nausea and stomach gone.
pt recv vax;devel clonic movements in rt leg;grimaced,drooled and unresponsive for approx 3 min;eyes also rolled back,might have bitten tongue;disoriented,confused state;looked :out of it", brief starring spells;interruption of activity;
50F w/ mixed connective tissue disorder/ILD on rituximab, prednisone, and methotrexate who was symptomatic w/ COVID19 on 3/14, PCR+ on 3/19, and decompensated on 3/28 requiring admission w/ transfer to BWH on 3/30 for consideration of additional therapies. ID was consulted on 3/30. Treatment included steroids and remdesivir.
March 26th 2021- Dose 2 Again within 10 minutes, I felt very dizzy and nauseous, tightness in the chest and palpitations. I was given anti-nausea medication.  I found the longer that I spoke the tighter and more sore my throat felt.  Symptoms of lightheadedness, headaches, brain fog, pain in throat, ear pressure, nausea, diarrhea, body aches and pain, chills, fever of 102 at 6am on March 27th, neuropathy was exacerbated, palpitations and sore left arm.  I feel a sharp pain in my right arm, deltoid muscle, when I try to lift it, I can barely move it. It feels as if I had the shot there but I know it was in the left arm for both doses.  March 27th all symptoms continue and my temp is fluctuating between 99.5 and 100.5 so far today.   March 5th 2021- Dose 1 Within 10 minutes I started to feel the vaccine. I felt a few pangs, brain fog, and exhaustion.  The first night I had terrible nightmares.  The first three days I experienced dizziness, light headed and off-balance, headaches, brain fog, pain in throat, ear pain, tinnitus and pressure, nausea, diarrhea, body aches and pain, difficulty breathing, chills, fever of 99.5, neuropathy was exacerbated, heart racing and palpitations and sore arm.   On the fourth day, I felt normal but was very tired.  On the fifth day (March 9th) I again felt exhaustion, brain fog, throat and ear pain, loose stools, body aches and pain, sharp chest pain and neuropathy.
From faxed correspondence received from reporting health professional stated that a 46 year old female pt received a Rabies Imovax vaccine intradermal in the left deltoid on 5/22/01 at 1pm. At 2pm that same day the pt developed tingling in her left arm that lasted for one week; tingling continues in left forearm and hand. Pt took ASA with relief. As of 6/8/01 these symptoms periodically occur. From mailed correspondence received on 8/28/01 it was reported, "Pt's recovery status: as of 8/20/01, pt reported, decreased tingling in arm and fingers of her left arm. Pt stated "everyday, feel tingling getting less." Occasionally uses arm brace to help relieve tingling. Pain level when tingling first occurred 5/22/01 was 8-9 on pain scale, and today 8/20/01 pain level is 1-2 on pain scale. The correct spelling of the vaccine administrator, the city and the lot number were also provided. This case is closed.
Little bit of sore arm; Pressure in the vaginal area and I think it might be Urinary tract infection; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced little bit of sore arm and pressure in the vaginal area and the patient think it might be urinary tract infection and patient thought it probably 99% nothing to do with the vaccine. The patient confirmed that It's 6 days after receive the vaccine, no other complications, no other side effects." The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Had a big circle and itchiness.; This is a spontaneous report from a non-contactable consumer (patient), from a Pfizer sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 for COVID-19 immunization on an unspecified date. It was reported that, patient got second covid shot. On an unspecified date had a big circle and itchiness. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given 3rd shot of Pfizer (gray cap, premixed). Within 5 minutes patient was having feeling stressed and had trouble breathing.  Epinephrine 0.3 mg was delivered intramuscularly into the left thigh and patient was able to breath within a minute.  Patient rested in the pharmacy for another 15 minutes with no additional symptoms of anaphylaxis. Patient's other two shots were benign with no such reaction.
Ran a fever of 100.4 for 8 hours started at 5pm. Severe body aches and chills
IMMEDIATELY AFTER ADMINISTRATION OF THE VACCINE, PATIENT STARTED TO SHAKE AND TURN PALE. PATIENT REPORTED THAT HE "BLACKED OUT". INTERN PHARMACIST AND PATIENT'S FATHER HELD THE PATIENT TO MAKE SURE HE DID NOT FALL OVER WHILE SEATED. PATIENT WAS SHAKING FOR ABOUT 10 SECONDS.  PHARMACIST ATTEMPTED TO LIE PATIENT ON THE FLOOR BUT HE REFUSED ONCE HE REGAINED CONSIOUSNESS.  HE REPORTED TO FEEL NORMAL AFTER REGAINING CONSIOUSNESS. HE REMAINED IN THE WAITING AREA FOR 30 MINUTES UNDER PHARMACIST SUPERVISION. IN THE MEANTIME, HIS BLOOD PRESSURE WAS CHECKED AND WAS 107/63. HE DRANK A FULL BOTTLE OF WATER WHILE WAITING.
absolute monocytes went from 551 to 1053/ leukemia levels; his body is fighting an infection; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MONOCYTE COUNT INCREASED (absolute monocytes went from 551 to 1053/ leukemia levels), INFECTION (his body is fighting an infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for COVID-19 vaccination.    No medical history was provided by the reporter.  Concomitant products included CITALOPRAM, LORATADINE, MULTIVITAMIN [VITAMINS NOS], VITAMIN D NOS, CALCIUM and VITAMINS NOS for an unknown indication.   On 25-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) (Intramuscular) 1 dosage form. On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On an unknown date, the patient experienced MONOCYTE COUNT INCREASED (absolute monocytes went from 551 to 1053/ leukemia levels) and INFECTION (his body is fighting an infection). On 01-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, MONOCYTE COUNT INCREASED (absolute monocytes went from 551 to 1053/ leukemia levels) and INFECTION (his body is fighting an infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Monocyte count: 1053 (High) absolute monocytes went from 551 to 1053 which are leukemia levels..         No treatment medications was provided by the reporter.  Patient received the booster dose and about 3 days later, on ??-NOV-2021, patient had blood test and monocyte count was increased which are leukemia levels. Patient levels show his body was fighting an infection.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, chills Narrative:
little soreness of left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little soreness of left arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040AZ1A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Cholesterol.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (little soreness of left arm). At the time of the report, VACCINATION SITE PAIN (little soreness of left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was taken for arm complaints. Concomitant medication included cholesterol medication.   This case was linked to MOD-2021-044454 (Patient Link).
Body aches and lethargy (2 days, onset same day as vaccination); redness, pain, and swelling at injection site (same day and continuing to spread today, possible cellulitis)
Patients mother called in to report that day care had called her to report patient is very lethargic, abnormally sleepy and has projectile vomited  Approximately 2 feet. Mother picked up patient and assessed his and agrees that he looks pale and unusually sleepy. Overall not acting like himself. This morning patient was given 2 vaccines, Pentacel and rotateq RN advised mother to bring patient into ED to be evaluated. Mother agrees
Poison ivy-like rash on lower leg (calf) appeared within 17hrs. It was intensely itchy but temporary relief was gained using Benadryl cream. This rash has turned into a large welt 7cm x 9cm. It's lost most of its color now and only itches occasionally in the evening. 10 days later (Jan 5) I began experiencing spontaneous urticaria (hives) on lower legs which appear every evening and resolve by morning. This has continued for the past 10 days. The hives are intensely itchy and disrupt sleep, but temporary relief is gained using oral Benadryl.
fever; Headache; Achy all over; Chills; Did not sleep good last night; This spontaneous case was reported by a patient family member or friend and describes the occurrence of POOR QUALITY SLEEP (Did not sleep good last night), PYREXIA (fever), HEADACHE (Headache), PAIN (Achy all over) and CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced POOR QUALITY SLEEP (Did not sleep good last night). On 26-Jan-2021, the patient experienced PYREXIA (fever), HEADACHE (Headache), PAIN (Achy all over) and CHILLS (Chills). At the time of the report, POOR QUALITY SLEEP (Did not sleep good last night), PYREXIA (fever), HEADACHE (Headache), PAIN (Achy all over) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient Covid + on 10/18/2021. Received Pfizer vaccine with 1st dose on 04/02/2021 and 2nd dose on 04/23/2021.  Per ED Note: History of Present Illness     Patient is a 59-year-old male with a past medical history significant for MS, coming from nursing facility for concern of COVID-19 and hypoxia.  Patient states he was told he was Covid positive.  Patient denies use of oxygen at home.  Per EMS the patient was at 85% on room air requiring 4 L of oxygen.  Patient states he just generally feels uncomfortable and malaise.  Patient denies chest pain, palpitations, headache, unilateral weakness or sensory changes.  Patient states he has had a cough but denies outright shortness of breath.