chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (Swelling of Legs) and PRURITUS (Itching) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included DICLOFENAC EPOLAMINE, HYDROXYZINE HYDROCHLORIDE, MELATONIN and CYANOCOBALAMIN (VIT B12) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. and IBRUTINIB (IMBRUVICA) (unknown route) 420 milligram once a day. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of Legs) and PRURITUS (Itching). At the time of the report, PERIPHERAL SWELLING (Swelling of Legs) and PRURITUS (Itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment reported for these events.
Pt returned to pharmacy a week later expressing concern he experienced flu-like symptoms, injection site was swollen, "hard as a rock", hot to touch, lasted approximated 30 hours.
Injection site is warm to the touch; Injection site swollen to the size of a golf ball; Injection site is painful; Injection site is red; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Injection site is warm to the touch), VACCINATION SITE SWELLING (Injection site swollen to the size of a golf ball), VACCINATION SITE PAIN (Injection site is painful) and VACCINATION SITE ERYTHEMA (Injection site is red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, J20-2A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is warm to the touch), VACCINATION SITE SWELLING (Injection site swollen to the size of a golf ball), VACCINATION SITE PAIN (Injection site is painful) and VACCINATION SITE ERYTHEMA (Injection site is red). At the time of the report, VACCINATION SITE WARMTH (Injection site is warm to the touch), VACCINATION SITE SWELLING (Injection site swollen to the size of a golf ball), VACCINATION SITE PAIN (Injection site is painful) and VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2021, Heart rate: heart rate increased to 100 (High) Heart rate increased to 100.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-368920 (Patient Link).
IMMUNE SYSTEM PERMANENTLY ALTERED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced immune system permanently altered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of immune system permanently altered was not reported. This report was non-serious.
INTERMITTENT NASAL BLEEDING; VACCINATION ADVERSE REACTION; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 180 pounds, and height was 66 inches. The patient's concurrent conditions included rheumatoid arthritis and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 09-APR-2021 for covid-19 vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number: 1127007 expiry: UNKNOWN) dose and frequency were not reported from 12-MAR-2021 for rheumatoid arthritis. Concomitant medications included duloxetine hydrochloride, folic acid, gabapentin, hydroxychloroquine phosphate, methotrexate, prednisone, sulfasalazine, and tramadol. On 10-APR-2021, the subject experienced intermittent nasal bleeding. On 10-APR-2021, the subject experienced vaccination adverse reaction. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from intermittent nasal bleeding, and vaccination adverse reaction. This report was non-serious.
fever, chills and body aches - took Tylenol and drank a lot of fluids - fever gone today,  small residual headache and small amt of body aches
Axilla lymph node swelling of the vaccinated arm. Swelling began the day after vaccination.  Reported to Employee Health 2 days after vaccination and area measured 70mm at that time.  No tenderness noted to palpation.  Patient is taking ibuprofen.  Encouraged to follow with PCP if swelling continues.
Hospitalized 6/24/22-6/28/22 SOB, cough, BLE edema, dyspnea, O2 supplement, fatigue, respiratory failure, PNA, elevated troponin,
pt rcvd vax; pt devel elevated liver enzymes; symptoms were transient & became normal after 6mo; the elevated MB fraction serum CPK persisted;
Fever 101.8 nausea and vomiting chills headahce severe tiredness lasted for about 36 hours
Absolutely no adverse effects after the first dose 01/12/2021 (Lot #037K20A). This was the second shot. There was a severe spike in blood pressure and extreme vertigo that lasted 3 days.
Pt recvd vax & later exp malaise,chest pain & a fever over 104.Pt was admitted to ER.
mild sore arm after first dose; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (mild sore arm after first dose) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 022B21A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), SERTRALINE HYDROCHLORIDE (ZOLOFT) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 17-Dec-2020 and the estimated date of delivery was 06-Sep-2021. On 23-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On an unknown date, the patient experienced VACCINATION SITE PAIN (mild sore arm after first dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  On 21-May-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, VACCINATION SITE PAIN (mild sore arm after first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported.
Day 1 - tongue swelling within 90 minutes of shot and heart palpitations. Day 2 - tongue swelled two additional times. heart palpitations increased in intensity. blood pressure elevated.  Day 3 through Day 6, heart palpitations continued and blood pressure kept rising. My blood pressure was normal before taking the covid shot. Day 7 was hospitalized with a blood pressure of 225/123. The hospital kept me overnight (2 days / 1 night).  Released with 2 medications. Blood pressure would not stabilize. Day 9 - readmitted to the hospital, bp 220+/120+ with severe headache, back pain, dizziness, heaviness in legs, nausea, blurred vision and heart pounding out of the chest, difficulty walking/moving. Given the 3rd medication while hospitalized. Held overnight (2 days/ 1 night). Released. By day 14, blood pressure normalized with 3 medications. I was medication free prior to the covid shot.
PT RECEIVED MONOVALENT INSTEAD OF BIVALENT, NO ADVERSE EVENTS AT ALL, PT WILL GET VACCINATED WITH BIVALENT IN 8 WEEKS.
dizziness, faint, lowered blood pressure, low heart rate of 31 to 33 bpm, called 911 transported to Hospital ER, was given a shot of something to increase heart rate, was told I needed a pacemaker.  Monitored EKG and did echocardiogram.  A temporary pacemaker was placed late in the day (11/03/2022) and a permanent pacemaker (Medtronic) was placed late afternoon 11/04/2022.
pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included rest, ice, and elevation
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 09-JUN-2015, the patient was vaccinated with ZOSTAVAX (lot # K026365, expiration date: 15-MAR-2016, route and dose were not reported), that had a temperature excursion. No adverse symptoms reported. Additional information has been requested.
Immediately became dizzy (within 30 seconds of receiving vaccine), which became upon arriving home. Several hours later upon waking in the night face and hands were bright red.  Eight days after vaccine (and after not having had any local effects up until this time), the site became red and inflamed; at the same time hives developed over both sides and hips; treated at ED with Benadryl and methylprednisolone intravenously; sent home with hydroxyzine.
8-26-19 - fever treated with ibuprofen. Decrease in appetite. 8-29-19 Rash - Fine with maximum macules of 5mm. Some palpable (raised only 1-2mm)
pain in her arm was severe; Patient states that she has a 3 inch by 2 inch black mark where the shot was given and it started black and blue but now it just went black; Initial information was received on 29-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involved a 67 years old female patient who experienced pain in her arm was severe (Injection site pain) and patient states that she has a 3 inch by 2 inch black mark where the shot was given and it started black and blue but now it just went black (Injection site reaction), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient the suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number- UJ482AB) (other dosing details were unknown) for Prophylactic vaccination.  On an unknown date (unknown latency) after the first dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE, the patient experienced pain in her arm was severe (Injection site pain) and patient states that she has a 3 inch by 2 inch black mark where the shot was given and it started black and blue but now it just went black (Injection site reaction).  No laboratory test was reported.  It was unknown if the patient received any corrective treatment.  The event outcome was unknown for both the events.  There will be no information available on the batch number for this case.
FEVER; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included valve replacement surgery, and back surgery, and concurrent conditions included diabetes. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced fever. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient recovered from fever. This report was non-serious.
Came through during community vaccine clinic- this was #2 for this person- he and his father who was present after the first vaccine were spoken to  after the first one was given too soon. The father stated he is older than his legal birthdate, he was adopted in  and  there were discrepancies regarding how old he actually was. After the first COVID vaccine the father was informed his son should not get the second vaccine until after he turned 18.
On 1/16/03, felt he had a fever plus headache and body aches. Saw his MD and was told temperature was over 100F and to take Tylenol. On 1/17/03, felt better but had a slight headache. Felt fine on 1/17/03.
Information has been received from a registered nurse concerning an 80 year old female who in September 2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). In December 2009, the patient developed a mild case of shingles. In March 2010, the patient developed a bad case of shingles. The patient went to the emergency room for the pain but was not admitted. Patient was having a nerve block for the pain today. At the time of report the patient's status was not recovered. The two shingles were considered to be significant disabling. Additional information has been requested.
Fever in the evening and the next day, nausea for 3 days, chest tightness and pain on deep breaths, green mucus and pain in throat and ears, exhausted, spreading rash on left forearm towards the hand.   Got negative test for covid on the 11th.  Today feeling pretty good.  Trash is visible but healing and no longer itches.
sore site; This is a spontaneous report from a non-contactable consumer via a Pfizer-sponsored program Corporate (Pfizer) Social Media Platform.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (at an unknown age) at an unspecified dose for COVID-19 vaccination. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a "sore site" after vaccination No treatment information was reported. The clinical outcome of vaccination site pain was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
started having Vertigo when walking outside the house; Dizziness/lightheadedness; Gate Problems; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO, DIZZINESS, and GAIT DISTURBANCE in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced VERTIGO, DIZZINESS, and GAIT DISTURBANCE. At the time of the report, VERTIGO, DIZZINESS, and GAIT DISTURBANCE outcome was unknown.            Concomitant medication of the patient was not reported.  The patient stated that she drank a lot of water when she walks. She had not seen a doctor yet. She was thinking about getting the booster and she was concerned.   No treatment information was provided by the reporter.
on 9/22: Kinrix vaccine given in place of HiB vaccine, so both Kinrix and Pediarix vaccines were given. The clinic has a double check procedure where both clinician and assistive personnel verify correct vaccines and expiration date. Assistive personnel thought that vaccines had been checked, and proceeded to administer vaccines. Provider did not witness vaccines before being given, communication was not effective between provider and assistive personnel.  On 9/22 evening, clinic medical director  reached out to alert mother via phone, mother noted no abnormal findings with infant, ED precautions were given to patient. Clinic medical director reached out to mother again on 9/23, father voiced concern as he has a seizure history, and stated they were going to take infant to the ED.  Local hospital records checked and patient was not seen.
Patient presented at clinic for COVID19 Vaccine administration on 04/09/2021 at 1:26 pm. Upon checking in for her appointment, she was provided with clinic's COVID19 vaccine screening and consent form in which she denied the following:  ? Having allergies and reactions to any medication, foods, vaccines, or latex.  ? Carrying an Epi-pen for emergency treatment of anaphylaxis.  ? Having had a severe reaction to previous dose of this vaccine or to any of the ingredients of this vaccine.  After the vaccine administration, patient was guided to the observation area for a 15-minute observatory period.  At approximately 2:00 pm- while in the observation area, approximately 5 minutes from vaccine administration,  patient, expressed to the clinical staff member monitoring the observation area, Medical Assistant,  that she felt lightheaded and the clinical alert team was activated. While sitting, patient stated that she was feeling dizzy, she leaned forward and at this time patient was lowered to the floor; a pillow was placed under her head and her feet were elevated.  Vitals reported were taken in the presence of ARNP while patient  was laying on the floor.  2:00 pm Vitals  ? Blood pressure 60/40 ? Oxygen saturation level 99% 2:01 pm-Paramedics were called by Lead Medical Assistant ARNP reports that patient was laying on the floor, alert, oriented to place, time and person. Patient never lost consciousness.  At this time, patient  was asked the following series of questions: ? How do you feel? As per patient, she felt bilateral ear pressure without losing ability to hear were she was dizzy weak, and nervous.   ? Are you allergic to any medications or have you had any allergic reactions to a vaccine? Patient denied having had a history of any adverse or allergic reaction to any medication or vaccines in the past.  2:09 pm- Blood pressure:  60/50  2:13 pm-Blood pressure 95/60 2:14 pm -Paramedics arrived.  2:16 pm- Blood Pressure taken by paramedics 104/68 2:22 pm- Patient asked for water. Water bottle was supplied, and Patient began to take sips of water.  2:30 pm-Patient fully functional, bloop pressure stable. Patient  was walking, drinking water, and utilizing her cell phone.   At 5:00 pm- Staff , (Center Administration) called Patient, she stated that she felt fine and that she had had something to eat. No other symptoms reported.
This spontaneous report as received from a nurse refers to a 13 years old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Patient was given the COVID vaccine after the expiration time (20-25 minutes after the 6 hours mark). Patient did not report any adverse symptoms after receiving the vaccine. The pharmacy is contacting Pfizer to verify the effectiveness of the expired vaccine and to see if the patient should repeat the dose. The pharmacy will also contact the patient's doctor and the patient after talking to Pfizer.
Cold symptoms in head; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptoms in head) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold symptoms in head). At the time of the report, NASOPHARYNGITIS (Cold symptoms in head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Pt 0 vaccines rec'd previously pt began decreased coordination, screaming, arching trunk x 1 month. Verbiage -> none. No sleep x 1 month. Coordination still decreased.
24 hr after shot she developed redness, swelling, itching and pain 5" X 3.5" around shot
Patient stated that after her vaccine she received a cold. She went to the DR. He gave her a strong antibiotic shot. She was driving home and she started itching and loosing her voice. She exited and went to the nearest emergency room. They gave her Benadryl, steroid shot, and a Elfin pin. She went into A fib  with her heart. They got her stabilized and released her, They wanted to keep her but she refused. Since taking the shot she has developed allergies to medication that she was not allergic to before. Patient also stated that she has developed this fungus on her breast and under the bottom of both her feet.
My heart hurt. At first I thought it was my breast so I went to MD and had a thorough exam of my left breast...nothing was found. Upon reading about COVID vaccines causing heart inflammation, I figured that's what the pain was
Pt reports post vaccine on 5/15/00, on 5/25/00 he developed hives. The pt recovered. Follow up #1 (5/15/02): during internal auditing of all files, it was deemed necessary to amend the report by updating the adverse coding (corrected vesiculobullos rash to maculopapular rash).
Patient called day after vaccine given (L) arm swollen, red and warm, skin was stretched. Used ice/Ibuprofen. Patient stopped at store on 6/8/17, 2 days later, arm still red, hot 6-8 inch swollen on inner arm, 2 inch red line around arm. Patient contacted family MD told her ice/Ibuprofen. Otherwise patient felt ok.